Clinical Research Regulation For Kenya and Liberia

Last content review/update: August 29, 2025

New Info (Not Yet in Profile)

The Pharmacy and Poisons Board issued Revision 5 of Guidelines for the Conduct of Clinical Trials in Kenya, effective January 2, 2026, which includes additional/revised definitions; alignment with ICH, WHO, PIC/S, and GCLP standards; new application process/requirements for multicenter clinical trials; clarification on investigator categories and qualifications; clarification on safety reporting; and alignment of study monitoring requirements to ICH E6(R3).

Overview

In accordance with the PPA, the CTRules, the G-KenyaCT, and KEN-21, Kenya’s Pharmacy and Poisons Board (PPB), together with its Expert Committee on Clinical Trials (ECCT), is responsible for reviewing, evaluating, and approving applications for clinical trials using registered or unregistered investigational products (IPs). The G-KenyaCT specifies that the scope of the PPB’s assessment includes all clinical trials (Phases I-IV). As delineated in the CTRules, the G-KenyaCT, and KEN-21, the PPB review and approval process may not be conducted in parallel with the ethics committee (EC) review. Rather, EC approval must be obtained prior to applying for PPB approval. As delineated in the STI-Act and G-ECBiomedRes, the principal investigator or the head of a research institution must obtain a favorable opinion from an EC accredited by the National Commission for Science, Technology and Innovation (NACOSTI) and a NACOSTI research license prior to initiating a study.

Clinical Trial Review Process

Pharmacy and Poisons Board

Per the CTRules and the G-KenyaCT, the PPB, through the ECCT, communicates the decision to approve, request additional information, or reject the application to the sponsor or the representative in writing within 30 working days of receiving a valid application. The G-KenyaCT indicates that in the case of rejection, the applicant may appeal and provide additional information to satisfy PPB requirements. In specific cases, the PPB may decide to refer the matter to external experts for recommendation.

As specified in the G-KenyaCT, each ECCT member, prior to reviewing the application, will declare any conflict of interest in the study and should have no financial or personal interests, which could affect their impartiality. During the protocol review, the reviewers must use the standard criteria (including available clinical and non-clinical data etc.) defined by the PPB. Confidentiality must be maintained during the review. Per the CTRules and the G-KenyaCT, the PPB/ECCT’s review must consider:

The reliability and robustness of the data generated in the clinical trial, taking into account statistical approaches, design of the clinical trial, and methodology, including sample size and randomization, comparator, and endpoints
Compliance with the requirements concerning the manufacturing and import of IPs and auxiliary medicinal products
Compliance with the labelling requirements
The completeness and adequateness of the investigator's brochure

Regarding protocol amendments, the CTRules and the G-KenyaCT stipulate that any new information affecting the conduct/management of the trial, safety of the participants, and manufacture of the IP necessitating changes to the protocol, consent form, and trial sites require immediate submission of the amended documents to PPB for review and approval. Arrangements must be in place to take appropriate urgent safety measures to protect participants against any immediate hazard where new events relating to the conduct of the trial, or the development of the IP are likely to affect the safety of the participants. A copy of a favorable opinion letter from the EC on record must be submitted with the request for approval of a proposed amendment to the PPB. PPB approval must be obtained for all substantial amendments. Minor amendments or administrative changes may be implemented after getting the EC’s approval, but a record of these amendments must be kept for possible inspection by the PPB. See Submission Process and Submission Content sections for additional details on amendment submissions. Also, see the G-KenyaCT for examples of substantial amendments.

In addition, per the G-KenyaCT, the sponsor or the representative is required to request approval annually from the PPB at least six (6) weeks prior to the expiration of the previous approval.

Per the CTRules and the G-KenyaCT, the PPB may withdraw the authorization to conduct a clinical trial if it finds that the safety of the participants in the trial is compromised or that the scientific reasons for conducting the trial have changed. Additionally, per the CTRules, the PPB may revoke the approval if it determines that the IP has expired or is not usable.

As delineated in the G-KenyaCT, the PPB may inspect clinical trial sites to ensure that the generally accepted principles of good clinical practice (GCP) are met. The objectives of the inspection are to:

Ensure that participants are not subjected to undue risks and that their rights, safety, and wellbeing are protected
Validate the quality of the data generated
Investigate complaints
Verify the accuracy and reliability of clinical trial data submitted to the PPB in support of research or marketing applications
Assess compliance with PPB guidelines and regulations governing the conduct of clinical trials
Provide real-time assessment of ongoing trials

Per CRO-Inspect, the PPB is responsible for inspecting clinical trial and bioequivalence study sites that generate data for registration of medicines. The PPB requires that these sponsor and contract research organization sites comply with applicable good practices, including GCP, good laboratory practice (GLP), and good documentation practices. Based on risk assessments, the PPB will determine compliance with generally accepted good practice through inspections and, where appropriate, document reviews. In addition, see Cert-Emrgcy for information about GCP and good manufacturing practice certifications during emergencies.

Special Circumstances and Public Health Emergencies

The CTRules delineates that the PPB may, in special circumstances, authorize the conduct of a clinical trial under fast-track procedures or non-routine procedures. PPB may recognize and use clinical trial decisions, reports, or information from other competent authorities authorizing fast-track clinical trials. The special circumstances may include:

A public health emergency
The rapid spread of an epidemic disease
Any other circumstance as may be determined by the PPB

The G-KenyaCT outlines PPB’s scope of assessment of a clinical trial application during a public health emergency. The PPB will conduct an expedited review and liaise with relevant stakeholders (including relevant ECs and other oversight bodies) to facilitate a holistic review of an application in a fast-track manner. The following prioritization criteria must be applied in the selection of applications for expedited review:

Epidemiology of the emergency
Morbidity and mortality associated with the emergency and/or condition under study
Supporting scientific data/information available for the IP at the time of submission
Feasibility of the implementation of the trial design within the context of the emergency
Benefit impact of the intervention and/or trial design

In addition, PPB’s assessment will consider the following:

The research does not compromise the response to an outbreak or appropriate care
Studies are designed to yield scientifically valid results under the challenging and often rapidly evolving conditions of disasters and disease outbreak
The research is responsive to the health needs or priorities of the disaster victims and affected communities and cannot be conducted outside a disaster situation
The participants are selected fairly and adequate justification is given when particular populations are targeted or excluded, for example, health workers
The potential burdens and benefits of research participation and the possible benefits of the research are equitably distributed
The risks and potential individual benefits of experimental interventions are assessed realistically, especially when they are in the early phases of development
Communities are actively engaged in study planning to ensure cultural sensitivity, while recognizing and addressing the associated practical challenges
The individual informed consent of participants is obtained from individuals capable of giving informed consent
Research results are disseminated, data are shared, and any effective interventions developed or knowledge generated are made available to the affected communities

National Commission for Science, Technology and Innovation

STI-Act stipulates that NACOSTI issues research licenses if it finds that the conduct of the research is beneficial to the country and will not adversely affect any aspect of the nature, environment, or security of the country. The license issued will have NACOSTI’s seal and will indicate the commencement and expiration of the research. In addition, NACOSTI maintains a register of all persons granted a license, which is available for public inspection during normal working hours free of charge.

KEN-31 states that if a research license application does not meet the conditions required under the STI-Act, NACOSTI must reject the application and communicate the reasons to the applicant. Any person may appeal NACOSTI’s decision to the Cabinet Secretary within 30 days of being notified of the decision. For approved research, NACOSTI may conduct an evaluation to assess compliance with the conditions of the license. If the research project has not been completed within the stipulated period, the researcher may apply for renewal of the license and pay the requisite fee. The researcher is expected to apply for renewal by attaching a progress report instead of a proposal. KEN-31 indicates that the duration of the research license is one (1) year.

Forward and 1

Glossary of Terms, Introduction, 1.1, 1.7-1.25, 1.189, 1.492-1.506, 1.519-1.534, 1.557-1.574, and Annex 7

3A, 3B, and 25A

Part IV

Part II (Sections 4 and 5), Part IV (Sections 11 and 18), and Part V (Sections 19 and 23)

Last content review/update: April 13, 2026

Overview

In accordance with the LMHRA-Act, the LibCTReg, and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) is responsible for reviewing, evaluating, and approving applications for clinical trials using registered or unregistered investigational products (IPs). According to the G-LibClinTrial, proposed clinical trials of registered medicines may include changes to indications, new methods of administration, or new combinations, etc. The G-LibClinTrial specifies that the scope of the LMHRA’s assessment includes all clinical trials (Phases I-IV). In addition, per the LibCTReg and the G-LibClinTrial, the National Research Ethics Board of Liberia (NREB) and LMHRA reviews may be conducted in parallel. However, the G-LibClinTrial and the G-NREB specify that the LMHRA will only issue final approval once NREB (ethics committee (EC)) approval is obtained.

Clinical Trial Review Process

As indicated in LBR-30, the LMHRA’s Clinical Trials Unit within the Pharmacovigilance & Clinical Trials Department is responsible for coordinating all clinical trial activities. According to LBR-29, the LMHRA has established a Scientific Advisory Committee (SAC) to review clinical trial applications.

Per the G-LibClinTrial, the LMHRA will only process an application upon receipt of a completed application and the prescribed fees. Upon receipt, the LMHRA screens the clinical trial application package for completeness and must inform the applicant in writing about the validity of the application or the formal grounds for non-acceptance of the application. After validating the application package is complete, the LMHRA conducts a scientific assessment of the application.

During the clinical trial scientific assessment process, the LibCTReg and G-LibClinTrial also explain that relevant clinical trial decisions, reports, or information from other national regulatory authorities or regional and international bodies can be recognized or used by the LMHRA. The LibCTReg further specifies that the scope/extent of utilization of relevant clinical trial decisions, reports, or information from other national regulatory authorities or regional and international bodies will be at the sole discretion of the LMHRA. In such instances, business and company secrets must remain confidential.

The LibCTReg also states that the LMHRA must inform the NREB if it is in possession of information about other clinical trials that is relevant to the board's assessment of the trial for which it is to issue an expert opinion; this applies especially to information on aborted or otherwise prematurely discontinued investigations. In such instances, business and company secrets must remain confidential. Also, the LMHRA must ensure that the list of approved and rejected clinical trial applications, the summary of evaluation reports, and the status of approved clinical trials are publicly available and periodically updated.

Per G-LibClinTrial, all applications must be evaluated with the same set of criteria based on up-to-date scientific knowledge and ethics standards, regardless of the applicant. The LMHRA may also request additional documents or changes through a query letter. Once a query has been raised and issued to the applicant, the process stops when the LMHRA receives a written response to the query. If the LMHRA requires changes to the application, the applicant must modify the application within an established timeline, or it will be rejected.

As indicated in the G-LibClinTrial, the LMHRA must issue a clinical trial certificate, including the LMHRA clinical trial number, to the applicant upon application approval. The clinical trial certificate may contain conditions required by the LMHRA with respect to the conduct or reporting of the trial. If the application is rejected, the applicant can submit a written appeal to the LMHRA’s Managing Director. Moreover, the information provided in a clinical trial application must not be disclosed by the LMHRA to a third party except with the applicant’s written consent or in accordance with the directive of the LMHRA Board of Directors.

Per the G-LibClinTrial, under certain circumstances, the LMHRA may accept an expedited application and review process for clinical trials (e.g., epidemics or other urgent public health interests requiring fast use of new medicines or health products and/or fast gathering of health product information). The LibCTReg also notes that in the case of emergency situations, the LMHRA may also apply an expedited review process and make exemptions to the documentation requirements for the submission of clinical trial applications. Refer to 2.3 of the G-LibClinTrial for additional information on how to submit an expedited clinical trial application package.

As delineated in the LibCTReg, any amendments to approved clinical trial documentation, trial arrangements, and the IPs referenced in the application must be classified and processed in accordance with the LMHRA guidelines. The G-LibClinTrial explains that depending on the nature of the change, trial amendments are regarded as substantial or non-substantial/minor amendments. Amendments to a clinical trial are regarded as “substantial” when they are likely to have significant impact on the safety or physical or mental integrity of the trial participants and/or the scientific value of the trial. Any substantial amendments to the clinical trial protocol, clinical trial arrangements, or the IP—or a related product deemed to be an amendment—must be approved by the LMHRA and the NREB before such amendments are carried out. Written NREB approval is also required before the LMHRA can reach a decision on an amendment. The LMHRA should respond within 20 calendar days upon receipt of the NREB’s written decision, and may accept or reject the amendment, or recommend a revision of the sponsor’s classification.

Per the G-LibClinTrial, non-substantial/minor amendments, by comparison, can be implemented immediately by the sponsor and should always be documented and notified to the LMHRA and the NREB as soon as possible. See the G-LibClinTrial for additional amendment requirements. See the Submission Process section for amendment submission requirements.

Per the LibCTReg, the LMHRA’s written approval of a clinical trial with IPs involving human participants is based on the conclusion that the anticipated therapeutic and public benefits justify the risk and may be continued only if compliance with this requirement is permanently monitored. An LMHRA authorization may only be refused if:

The documents submitted are incomplete up to the expiration of an appropriate deadline given to the applicant for their supplementation
The documents submitted, especially the data on the IP(s) and the trial protocol including the investigator's brochure (IB), do not comply with the current state of scientific knowledge, and especially, the clinical trial is unsuitable for providing proof of IP(s) safety or efficacy
In the case of trials involving human participants, the documentation requirements (see Section 1 (d) of LibCTReg), particularly insurance coverage for trial participants, are not fulfilled
The LMHRA is in possession of findings which indicate that the testing facility is not suitable to conduct the clinical trial
The LMHRA is of the opinion that the number of clinical trial participants to be recruited in the trial is not scientifically justified, or
The requirements provided for in the general conditions and special preconditions for conducting a clinical trial (see Part II (Section 2) of LibCTReg) are no longer fulfilled

The LibCTReg indicates that, in a clinical trial involving an IP that consists of, contains, or is a combination of genetically modified organisms, unjustifiable harmful effects on the health of third persons and the environment are not to be expected when the trial is conducted according to the state of scientific knowledge and in relation to the trial’s purpose.

(See the Submission Process and Submission Content sections for detailed submission requirements and the Timeline of Review section for additional LMHRA timeline information.)

The LibCTReg further explains that the LMHRA must suspend a clinical trial authorization for a limited period of time if at least one (1) of the following conditions is true:

It becomes known that one (1) of the grounds for refusal previously indicated existed at the time the trial authorization was issued (see also Part II (Section 6 (1) of LibCTReg)
The conditions surrounding the clinical trial do not correspond to the information contained in the authorization application
The facts presented give reason to doubt the safety or the scientific basis of the clinical trial

Per the LibCTReg, the LMHRA must withdraw a clinical trial authorization when scientific justification for resuming the trial is not provided to address the reasons previously indicated for suspension. The LMHRA must also immediately inform the NREB through a written communication stating the grounds for its action. Before the LMHRA issues a decision, the applicant must be allowed a deadline of 10 working days to submit a statement, unless the LMHRA orders the immediate interruption of the clinical trial. The lodging of an objection and an action to rescind the withdrawal or the order to suspend the authorization should not have a suspensive effect. If the authorization to conduct a clinical trial is withdrawn or suspended, the clinical trial may not be continued. Also, if the LMHRA, in the context of its activities, becomes aware of facts which justify the assumption that one (1) or more of the investigators or the sponsor or the sponsor’s representative no longer fulfills their obligations with regard to the proper conduct of the clinical trial, the LMHRA must immediately inform this individual(s) and must order remedial measures to be taken by the individual(s).

Pursuant to Part VIII of the LMHRA-Act, the LibCTReg states that any person(s), institution(s), corporate entity(ies), their designees, or legal representatives who violates the clinical trial authorization procedures, the serious adverse event notification requirements, and/or the suspension/withdrawal provisions delineated in the LibCTReg will be liable to pay administrative fines. See the LibCTReg for details.

Inspection

As stated in the LibCTReg, the LMHRA should inspect a clinical trial site to ensure that the general public is adequately protected against the adverse event risks related to a clinical trial with IP(s); and, to confirm that the PI and the sponsor, including the sponsor’s representatives, are strictly adhering to the specific and general conditions to which the trial was authorized. The G-LibClinTrial also indicates that the LMHRA may inspect clinical trial sites and/or the sponsor's/contract research organization (CRO)’s premises and/or the manufacturer’s premises to ensure that the clinical trials comply with good clinical practice (GCP) provisions before, during, or after the trial is conducted.

Per the LibCTReg and the G-LibClinTrial, NREB representatives may accompany the LMHRA during clinical trial site inspections, or, per the LibCTReg, they may choose to do the inspections independently. The G-LibClinTrial also notes that the LMHRA may include other relevant regulatory authorities in the inspection. The PI and/or the sponsor/CRO and/or the manufacturer must be notified in writing of the inspection unless the LMHRA has reasonable cause to believe that the approved protocol is being violated. In this case, an unannounced inspection may be conducted. Following these inspections, the LMHRA must prepare an inspection report, and the report will be made available to the PI and/or sponsor while safeguarding the confidential aspects. The report may also be made available to the NREB and other regulatory authorities upon their request. Additionally, the LibCTReg specifies that the LMHRA, based on its findings, may also request additional information, suspend or stop a trial, or withdraw authorization to conduct a clinical trial, if the agency is of the opinion that the participant safety may be jeopardized, the scientific reasons for conducting the trial have changed, or the integrity of the data is compromised.

Clinical Trials Unit

1, 2, 4-5, and 9

Intellectual Property

Part IV (Sections 1 and 2), Part V (Section 5), and Part VIII

Part I (Section 2), Part II (Section 1 (b and d), Section 2, Section 5 (3, 5-6, 9, and e (13)), and Sections 6-7), and Part III (Administrative Sanctions (1 and 3))

Regulatory Fees

Last content review/update: March 19, 2026

Pharmacy and Poisons Board

Per the PPA and the G-KenyaCT, the sponsor or the representative is responsible for paying a fee to the Pharmacy and Poisons Board (PPB) to submit a clinical trial application for authorization. The PPB currently requires a non-refundable application fee of $1,000 USD, or the equivalent in Kenya Shillings at the prevailing bank rates.

Payment Instructions

As stated in Annex 2 of the G-KenyaCT, payment is to be made by a bank check payable to the “Pharmacy and Poisons Board” and presented to the PPB’s accounts office upon submitting the application.

Payment can also be made by electronic fund transfer (EFT) to the PPB Bank account, if required. The sponsor or the representative is responsible for all bank charges associated with the EFT. Details of the EFT payment should be obtained from the PPB prior to initiating such a transaction.

National Commission for Science, Technology and Innovation

As delineated in KEN-31, the National Commission for Science, Technology and Innovation (NACOSTI) charges a fee that varies depending on the applicant’s status as Kenyan or non-Kenyan, and standing as a researcher (i.e., student, public/private institution, private company). The fees are non-refundable and also apply to research license renewals. Details on additional requirements are provided in the Submission Content section.

Student, Undergraduate/Diploma: East African Community (EAC) Countries – 100 Kenya Shillings; Kenyan Citizens – 100 Kenya Shillings; Rest of Africa – 200 Kenya Shillings; Non-Africans - $150 USD
Masters: EAC Countries – 1,000 Kenya Shillings; Kenyan Citizens – 1,000 Kenya Shillings; Rest of Africa – 2,000 Kenya Shillings; Non-Africans - $350 USD
PhD: EAC Countries – 2,000 Kenya Shillings; Kenyan Citizens – 2,000 Kenya Shillings; Rest of Africa – 4,000 Kenya Shillings; Non-Africans - $400 USD
Post-Doctoral or Individual: EAC Countries – 5,000 Kenya Shillings; Kenyan Citizens – 5,000 Kenya Shillings; Rest of Africa – 10,000 Kenya Shillings; Non-Africans - $500 USD
Public Institutions: Kenyan Citizens – 10,000 Kenya Shillings
Private Institutions and Companies: Kenyan Citizens – 20,000 Kenya Shillings

See KEN-31 for information on service charges.

Payment Instructions

Per KEN-31, NACOSTI has migrated payment services for research licensing to the eCitizen platform (KEN-12). East African citizens have the following payment options on KEN-12 with a Kenya Shillings account: mobile money via Mpesa Express or Paybill Number 222222; or these other available payments via KEN-12:

Airtel Money
Kenya Commercial Bank
Co-operative Bank
Pesaflow Direct
National Bank
RTGS

KEN-31 indicates that non-Kenyans should use the US Dollar account on KEN-12 with these payment options:

Kenya Commercial Bank (USD)
Co-operative Bank (USD)
NBK (USD)
Equity Cash
Debit/credit/prepaid card

1.7-1.12 and Annex 2

3A and 25A

Last content review/update: April 13, 2026

Liberia Medicines and Health Products Regulatory Authority

The LibCTReg and the G-LibClinTrial require proof of payment of the clinical trial application fee in the application dossier. Per LibCTReg, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) charges a non-refundable fee to submit a clinical trial application for authorization. As delineated below, authorization fees vary depending on the phase and institution conducting the study:

Industry Funded (Phase I): $25,000 USD
Industry Funded (Phase II): $20,000 USD
Industry Funded (Phase III): $15,000 USD
Clinical Research Organization (CRO) Funded Phase I: $10,000 USD
CRO Funded Phase II: $8,000 USD
CRO Funded Phase III: $6,000 USD
Investigator/Local Phases III & IV: $2,500 USD
Academic Research Trial (Individual): $2,000 USD
Amendment (Substantial) to Clinical Trial Protocol: $1,000 USD
Administrative Charges: $500 USD
Material Transfer Agreement (MTA) Fees: $1,500 USD
Good Clinical Practice (GCP) Inspections: $1,000 USD

Payment Instructions

No information is currently available regarding payment instructions.

2.0

Part II (Section 1 (d)) and Part IV

Ethics Committee

Last content review/update: August 29, 2025

Overview

As per the G-KenyaCT, the G-ECBiomedRes, and KEN-30, Kenya requires an independent review of research through a National Commission for Science, Technology and Innovation (NACOSTI)-accredited ethics committee (EC) in one (1) of the local institutions charged with the responsibility of conducting research in human participants. KEN-25 provides a list of the accredited institutional ECs.

Ethics Committee Composition

As delineated in the G-ECAccred, institutional ECs should consist of at least seven (7) members, or an odd number above seven (7). The G-ECBiomedRes states that these members should be multidisciplinary and multisectoral in composition, collectively encompass relevant scientific expertise, balanced age and gender distribution, and include laypersons representing community interests and concerns. Per the G-ECAccred, the composition should meet the following requirements:

At least one (1) member with knowledge and understanding of Kenyan law
At least one-third of the members must be female, and one-third must be male
At least one (1) member who is unaffiliated with the institution
At least two (2) members must have research expertise and experience, one (1) of whom must be in the health field
At least one (1) member must be a lay member
For ECs reviewing clinical research, at least two (2) members must be clinicians, one (1) of whom is currently in active practice or clinical research
Reflect the regional and ethnic diversity of the people of Kenya

The chairperson must also have some basic training and/or experience in bioethics and leadership. All EC appointments are the responsibility of the institution’s administrative head. See the G-ECAccred and the G-ECBiomedRes for detailed institutional EC requirements.

Terms of Reference, Review Procedures, and Meeting Schedule

Per G-ECBiomedRes, ECs need to have independence from political, institutional, professional, and market influences. As delineated in the G-ECAccred, the G-ECBiomedRes, and the STI-Regs, institutional ECs must operate within written standard operating procedures (SOPs) which delineate the EC’s process for conducting reviews. Per the G-ECAccred, SOPs should include but are not limited to information on EC scope, responsibility, and objectives, institutions served, committee functions, terms and conditions of member appointment, business procedures including meeting schedules and types of reviews, documentation, recordkeeping, and archiving procedures, quorum requirements, communication procedures, and complaint process and dispute resolution procedures. Per the G-ECAccred and the STI-Regs, these documents must be provided to NACOSTI.

Per the G-ECAccred, the quorum for NACOSTI-accredited EC meetings must include:

At least 50 percent of the membership to form the quorum
A lay person present in all meetings
For ECs reviewing clinical research, at least two (2) clinician members, one (1) of whom is currently in active practice or clinical research.

The G-ECBiomedRes also indicates that ECs should establish the specific quorum requirements for reviewing and deciding on applications including:

The minimum number of members required to compose a quorum (e.g., more than half the members)
The professional qualifications requirements (e.g., physician, lawyer, statistician, paramedical, or layperson) and the distribution of those requirements over the quorum; no quorum should consist entirely of members of one (1) profession or one (1) gender; a quorum should include at least one (1) member whose primary area of expertise is in a non-scientific area, and at least one (1) member who is independent of the institution/research site

Per G-ECBiomedRes, EC member terms of appointment should be established that include the duration of an appointment, the policy for the renewal of an appointment, the disqualification procedure, the resignation procedure, and the replacement procedure. A statement of the conditions of appointment should be drawn up that includes the following:

A member should be willing to publicize their full name, profession, and affiliation
All reimbursement for work and expenses, if any, within or related to an EC should be recorded and made available to the public upon request
A member should sign a confidentiality agreement regarding meeting deliberations, applications, information on research participants, and related matters

Regarding training, EC members should have initial and continued education regarding the ethics and science of biomedical research. The conditions of appointment should indicate the availability and requirements of introductory training, as well as on-going continuing education. This education may be linked to cooperative arrangements with other ECs in the area, country, and region.

For detailed institutional EC requirements and information on other administrative processes, see the G-ECAccred and the G-ECBiomedRes. See KEN-17 and KEN-26 for examples of accredited EC submission and review guidelines.

Definition of Terms, 1.0, 2.0, 3.0, 4.0, and Annexes I-III

1 and 7.1

1.188-1.212 and 1.492-1.496

The Science, Technology and Innovation (Registration and Accreditation of Research Institutions) Regulations, 2014 (Third Schedule); and The Science, Technology and Innovation (Relevance and Quality Assurance in Research) Regulations, 2014 (Part II)

Review Process, Submission Forms, Electronic Submission, SERU Applicant SOPs, and Contact Us

Last content review/update: April 13, 2026

Overview

Per the G-ACRE-IRB and the G-NREB, all research involving human participants should be reviewed by an ethics committee (EC). According to the NatResHlthPlcy, Liberia has two (2) ethics committees (ECs): the National Research Ethics Board of Liberia (NREB) and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) (formerly known as the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB)). (Note: The UL-PIRE Africa webpage has not yet been updated to reflect the transition to ACRE IRB.)

Per LBR-38, the NREB has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the ACRE IRB in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

National Research Ethics Board of Liberia

As explained in the G-NREB, the NREB is an advisory institution that reports to the Ministry of Health (MoH), and its members are appointed by the Minister of Health. The G-NREB states that the board ensures all research related protocols within and outside of Liberia are in compliance with internationally recognized ethical standards (including the Belmont Report (LBR-11), the Declaration of Helsinki (LBR-27), the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (LBR-8), and the Council for International Organizations of Medical Sciences (CIOMS’) International Ethical Guidelines for Health-related Research Involving Humans (LBR-2)), as well as Liberia’s applicable regulations and guidelines. In addition, per the G-NREB and LBR-12, the NREB is responsible for reviewing research proposals involving human participants to assess their compliance with ethical principles, regulatory requirements, and international guidelines, and for approving research protocols that meet ethical standards and providing recommendations for addressing any ethical concerns.

Per the NatResHlthPlcy, the G-NREB, and LBR-12, the NREB is also responsible for the following (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Ensuring that researchers obtain informed consent from participants and that participants’ rights, privacy, and confidentiality are protected
Evaluating the potential risks and benefits of research projects and ensuring that the risks are justified and minimized
Developing and disseminating policies, guidelines, and standards for ethical conduct in research
Providing guidance and support to researchers, research institutions, and ECs on ethical issues related to research involving human participants
Fostering awareness and understanding of ethical principles and regulatory requirements among stakeholders in the research community
Conducting training programs, workshops, and seminars to educate researchers, EC members, and other stakeholders on ethical principles and best practices in research ethics
Building the capacity of research institutions and ECs to effectively review and oversee research involving human participants
Promoting a culture of ethical conduct and responsible research practices within the research community
Monitoring compliance with approved research protocols and ethical standards throughout the duration of research projects
Conducting periodic reviews or audits of research activities to ensure adherence to ethical principles and regulatory requirements
Investigating and addressing any allegations of research misconduct or breaches of ethical standards
Establishing guidelines for the ethical review of health research protocols for use by other review boards
Providing advice on ethical research issues to the MoH and related government ministries and agencies
Engaging with the public, policymakers, and other stakeholders to raise awareness of ethical issues in research and to foster dialogue on ethical considerations
Advocating for the protection of research participants’ rights and the promotion of ethical conduct in research at the national and international levels
Collaborating with relevant government agencies, institutions, and organizations to advance the ethical governance of research
Establishing and maintaining a repository of all protocols reviewed in the country along with completed research/study reports

Atlantic Center for Research and Evaluation Institutional Review Board

As stated in the G-ACRE-IRB, the ACRE IRB is mandated by the Board of Directors of the ACRE Africa Center, and is tasked with ensuring quality and consistency in its review of social, behavioral, clinical, and biomedical research protocols that comply with LBR-2 and the national ethical guidelines for research on human participants. However, as noted above, per LBR-28, the ACRE IRB does not review and approve clinical trial protocols. Some members of the ACRE IRB also serve on the NREB and provide expertise in the review of clinical trial protocols.

Ethics Committee Composition

National Research Ethics Board of Liberia

According to the G-NREB, the NREB is composed of 21 members who jointly represent a diverse community with a range of expertise. The G-NREB notes that the majority of the board members are clinicians, scientists, and national subject matter experts. Per LBR-18, the NREB board typically consists of experts in various fields related to research ethics, such as medicine, public health, social sciences, ethics, law, and community representatives. Board members may include researchers, ethicists, healthcare professionals, legal experts, and representatives from government agencies and civil society organizations. LBR-38 further specifies that the NREB membership includes, but is not limited to, a sociologist, an infectious disease scientist, a biologist, a lawyer, a pharmacist, an epidemiologist, a statistician, a bioethicist, a mental health specialist, a health system strengthening specialist, a religious elder, community elders, surgeons, clinicians, and public health specialists.

In addition, per LBR-18, although the NREB organization structure may vary based on its specific mandate, size, and operational requirements, the board typically consists of a chairperson/executive director, a secretariat or administrative staff, ethics review committees/panels, and advisory groups that may provide specialized expertise or support for specific activities or initiatives.

Atlantic Center for Research and Evaluation Institutional Review Board

As specified in the G-ACRE-IRB, the ACRE IRB members (full, regular, and ad-hoc) must be recommended by the ACRE IRB Chair and appointed by the ACRE Board of Directors. The IRB Executive Committee should consist of the Coordinator, the Chair, and two (2) members of the IRB recommended by the Chair in consultation with the Coordinator. The IRB Secretariat, which will handle administrative functions, should also include the Coordinator, IT Officer, and Finance Officer.

The ACRE IRB must be comprised of 12 members with the qualifications and experience, individually and collectively, to review and evaluate the scientific, medical, and ethical aspects of research protocol submissions. The ACRE IRB membership must include the following from diverse backgrounds to undertake an impartial and adequate review of research proposals:

Scientists (including, but not limited to, professionals in natural science, social science, and behavioral science)
Non-scientists (health practitioners, legal experts representing the community, and civil society)

In addition, the ACRE IRB must ensure social inclusivity and gender sensitivity in its membership and in the recruitment of ad-hoc reviewers. The board must include adequate representation across age, gender, community, etc., to safeguard the interests and welfare of all segments of society. ACRE IRB members must be drawn from both public and private institutions within the country.

Terms of Reference, Review Procedures, and Meeting Schedule

National Research Ethics Board of Liberia

Pursuant to the G-NREB, the NREB follows standard operating procedures (SOPs) as well as applicable ethical guidelines and regulations to ensure compliance with research ethics principles and to uphold societal interests. The NREB may seek subject matter expert opinions regarding specific research protocols and/or ethical issues, provided that the experts have no conflict of interest, including participation in the research, financial interest in the outcome, and/or involvement in competing research, among other reasons.

NREB members should meet bi-monthly for regular meetings and adhere to the board’s threshold requirement to review a minimum of three (3) complete applications at each meeting. When applicable, the NREB director may also convene ad-hoc meetings. All complete applications submitted by the deadline must be reviewed at the next regularly scheduled meeting, if the minimum applications threshold is met. Members are encouraged to attend all meetings and the quorum required for voting is two-thirds of the NREB membership. Members who cannot attend a meeting due to unforeseen reasons must inform the NREB director two (2) weeks prior to the scheduled meeting. If unable to attend, members must also advise the NREB director regarding their views or concerns on specific agenda items one (1) week prior to a scheduled meeting. Meeting agendas and research protocols should be distributed to members no later than three (3) weeks before a regular meeting. Refer to the G-NREB and LBR-12 for detailed committee requirements.

Atlantic Center for Research and Evaluation Institutional Review Board

As delineated in the G-ACRE-IRB, the ACRE IRB Chair must be the head and chief spokesperson of the board and must conduct meetings in accordance with the policies, regulations, and timetable approved by the board. ACRE IRB members must be appointed initially for a term of three (3) years, which must be renewable and is subject to the ACRE IRB Board of Directors’ decision. To maintain continuity in ACRE IRB operations, at least one-third of the membership must be retained at any given time. The outgoing Chair must be an ex-officio member of the incoming ACRE IRB. ACRE IRB members and consultant reviewers must be provided with all relevant SOPs by the Secretariat to guide in the review process of all submitted protocols. ACRE IRB members are required to review, discuss, and consider protocols submitted to the board for evaluation to safeguard the rights, safety, and well-being of study participants; review progress reports and monitor ongoing research studies appropriately; evaluate final reports and outcomes; maintain absolute confidentiality in all document deliberations at board meetings; state conflicts of interest, where applicable; and participate during deliberations. Members with a conflict of interest will recuse themselves from the review of submissions with which they have a conflict, except to answer specific questions posed by the board. Additionally, per LBR-28, ACRE IRB reviews are conducted virtually via the Zoom platform.

G-ACRE-IRB further provides that the ACRE IRB must convene a meeting every month or when deemed necessary. The Chair, or a delegated board member, must call the meeting to order, provided there is a quorum. If there is no quorum, the meeting must be rescheduled. A quorum must be greater than 50% of the voting board members at any given event. A quorum must consist of regular and/or alternate board members (persons formally selected by the board to substitute for regular members who are unavailable), and it must include at least one (1) member whose primary background is science related, and one (1) member whose primary background is not science related. Special/independent consultants cannot be used to establish a quorum. Members who are recused from the review of a protocol cannot be used to establish a quorum. A simple majority vote of ACRE IRB members in attendance is required for a protocol to be approved. The ACRE IRB Chair may also invite individuals with competence in special areas to assist in the review of issues that require expertise beyond, or in addition to, that available on the board. These individuals will be required to sign a confidentiality agreement before they review a protocol or attend a board protocol discussion, however, they are not permitted to vote. The consultant will provide the Chair with a written report to be shared with all reviewers summarizing relevant information.

Additionally, G-ACRE-IRB indicates that during IRB meetings, all deliberations must be recorded either electronically or written manually. The Secretary should also prepare meeting minutes, which include a summary of each protocol that has been considered for approval. The IRB Chair should confirm the accuracy and completeness of the minutes by signing and archiving them, together with the meeting’s agenda and other relevant attachments. Refer to G-ACRE-IRB for detailed information on ACRE IRB administrative processes.

2. Functions

Foreword, Article V, Article VI (Sections 6.01-6.03, 6.07, and 6.13), Article VII (7.05-7.06), Article VIII (Sections 8.01-8.04), and Article IX (Sections 9.02 and 9.05)

Forward, Background, and Intellectual Property

2.5, 5.1.3, and Annex 3

Scope of Review

Last content review/update: August 29, 2025

New Info (Not Yet in Profile)

The Pharmacy and Poisons Board issued Revision 5 of Guidelines for the Conduct of Clinical Trials in Kenya, effective January 2, 2026, which includes additional/revised definitions; alignment with ICH, WHO, PIC/S, and GCLP standards; new application process/requirements for multicenter clinical trials; clarification on investigator categories and qualifications; clarification on safety reporting; and alignment of study monitoring requirements to ICH E6(R3).

Overview

According to G-ECBiomedRes, the primary scope of information assessed by the institutional ethics committees (ECs) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. The G-ECAccred further states that the National Commission for Science, Technology and Innovation (NACOSTI) accredits ECs in order to uphold the standard of ethics review in the country; develop public confidence and trust in the national research system; facilitate equitable access to research and human health records in health facilities; and facilitate coordination and collaboration among ECs. See the G-ECAccred and the G-ECBiomedRes for detailed ethical review guidelines.

Role in Clinical Trial Approval Process

As per the G-KenyaCT and KEN-21, the Pharmacy and Poisons Board (PPB)’s review and approval of a clinical trial application is dependent upon obtaining approval by an accredited institutional EC. Consequently, the PPB and EC reviews may not be conducted in parallel.

As set forth in the G-ECBiomedRes, ECs must be constituted to ensure an independent and competent review and evaluation of all ethical aspects of clinical trials. ECs must review research involving human participants to ensure they meet the following ethical principles:

Respect for persons, including respect of autonomy, protection of vulnerable groups, and protection of privacy and confidentiality
Beneficence
Justice, which in research means equitable distribution of the benefits and the burdens

For additional details on the principles and benchmarks for ethical review, see G-ECBiomedRes.

Per the G-ECBiomedRes, expedited review may be permitted for protocols involving no more than minimal risk to research participants.

The G-ECBiomedRes indicates that all ECs should carry out regular monitoring of approved protocols involving human participants. In case of any adverse events, the EC should report this immediately to Kenya’s National Bioethics Committee (NBC).

Per the G-ECBiomedRes, with collaborative research projects, the collaborating investigators, institutions, and countries must function as equal partners with safeguards to avoid exploitation of local researchers and participants. An external sponsoring agency should submit the research protocol to their country’s EC, as well as the Kenyan EC where the research is to be conducted. Further, this research must be responsive to the health needs of Kenya and reasonably accessible to the community in which the research was conducted. Consideration should be given to the sponsoring agency agreeing to maintain health services and faculties established for the purposes of the study in Kenya after the research has been completed. Such collaborative research must have a local/Kenyan co-principal investigator.

1.0-1.2

3.0, 3.1, 4.1, 4.2, 6.0, and 7.1

Glossary of Terms and 1.188- 1.212 and 1.492-1.496

Last content review/update: April 13, 2026

Overview

According to G-NREB and G-ACRE-IRB, the primary scope of information assessed by ethics committees (ECs) in Liberia relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a study. The NatResHlthPlcy states that Liberia has two (2) ECs: the National Research Ethics Board of Liberia (NREB) and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) (formerly the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB)). However, per LBR-38, the NREB has sole responsibility to review all clinical trial protocols. Per LBR-28, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB.

The G-NREB and the G-ACRE-IRB also state that the ECs are responsible for ensuring independent, timely, and competent reviews of all ethical aspects of the clinical research protocol. The ECs must also act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants, and they must verify the adequacy of confidentiality and privacy safeguards.

Atlantic Center for Research and Evaluation Institutional Review Board

The G-ACRE-IRB is tasked with ensuring quality and consistency in the ACRE IRB’s review of social, behavioral, clinical, and biomedical research protocols that comply with the Council for International Organizations of Medical Sciences (CIOMS’) International Ethical Guidelines for Health-related Research Involving Humans (LBR-2) and the national ethical guidelines for research on human participants. (Note: While the G-ACRE-IRB includes references clinical trials, per LBR-28, due to a MOU between the NREB and the ACRE IRB in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB.) See the G-ACRE-IRB for the ACRE IRB’s research review processes and guidelines regarding initial review, protocol amendments, and oversight.

Role in Clinical Trial Approval Process

As per the LibCTReg and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) and the NREB must approve a clinical trial application prior to the sponsor or the representative initiating the clinical trial. Per the LibCTReg and the G-LibClinTrial, the NREB and LMHRA reviews may be conducted in parallel. However, the G-LibClinTrial and the G-NREB specify that the LMHRA will only issue final approval once NREB ethical approval is obtained. In addition, per the LibCTReg and the G-LibClinTrial, any substantial amendment to the approved clinical trial research protocol must be approved by the LMHRA and the NREB before such amendments are carried out.

Additionally, per the LibCTReg, the LMHRA must inform the NREB if it has information about other clinical trials that is relevant to the board's assessment of the clinical trial on which it is to issue an expert opinion; this applies especially to information on aborted or otherwise prematurely discontinued investigations. In such instances, business and company secrets must remain confidential.

As per the G-NREB, a protocol will be reviewed if the number of submitted protocols meets the board’s threshold requirement to review a minimum of three (3) complete applications at each meeting.

As delineated in the LibCTReg, the NREB provides its opinion on a clinical trial application in accordance with its written standard operating procedures (SOPs). According to LBR-20, upon receipt of a research proposal, the NREB conducts a preliminary screening to ensure that all required documents and information are included and that the proposal meets the applicable submission requirements. Incomplete or insufficient proposals may be returned to researchers with instructions for revisions or additional information. Following a preliminary screening, an ethics review committee/panel composed of experts in relevant fields, such as medicine, public health, ethics, law, and community representatives is then assigned by the NREB. Committee members review the proposals independently or collectively, depending on the complexity of the research and the availability of resources. The ethics review committee/panel thoroughly evaluates each research proposal based on established ethical review criteria.

Per LBR-31, the NREB follows established ethical review criteria to evaluate research proposals to help ensure that research studies adhere to ethical principles and protect the rights, welfare, and dignity of research participants. The ethical criteria delineated in LBR-31 include informed consent, beneficence, justice, privacy and confidentiality, respect for participants’ rights and dignity, scientific validity and integrity, and compliance with regulatory requirements. See LBR-31 for details.

Per LBR-20, the committee members also assess the ethical implications of the proposed research, including the risks and benefits to participants, the adequacy of the informed consent process, the protection of vulnerable populations, and the equitable distribution of research burdens and benefits. The review process may involve discussions, debates, and deliberations among committee members to reach consensus on the ethical acceptability of the research proposals. See also LBR-23 for additional EC review guidelines.

LBR-20 further explains that the NREB communicates the outcomes of the ethical review process to researchers, including decisions on protocol approval, conditional approval pending revisions, or rejection. Researchers receive feedback and recommendations from the EC to address any ethical concerns raised during the review process and may be required to revise their proposals, provide additional information, or address specific ethical issues before final approval is granted.

The LibCTReg also notes that a request for clinical trial authorization from the NREB may only be refused in the following cases:

The documents submitted are incomplete after the expiration of an appropriate deadline given to the applicant for their supplementation
The documents submitted—including the trial protocol, the investigator’s brochure, the methods for selecting trial participants, and informed consent/assent materials—do not correspond to the current state of scientific knowledge, and particularly when the clinical trial is unsuitable for providing IP(s) proof of safety or efficacy, or
The applicable requirements specified in the general conditions for conducting clinical trials (see Part II (Section 1) of LibCTReg) are not fulfilled

Per the G-NREB, a principal investigator (PI) will be contacted in writing (by letter or email) if the NREB determines that additional materials are required to complete its review. PIs may also be asked to be available to provide presentations and/or be contacted during the meetings. The G-NREB further explains that, where applicable, the NREB should notify PIs in writing of its decision within two (2) weeks following a board meeting, after a complete review of the protocols. The NREB will also communicate its decisions to the NREB Secretariat. An approval expiration date is not specified. Pursuant to the G-NREB, PIs may also re-submit previously considered protocols, which will require a full NREB review. Per LBR-20, once all the ethical requirements have been met, the NREB grants final approval for the research proposals to proceed.

As indicated in the G-NREB, the NREB Secretariat reviews continuing review reports submitted by the PI at least eight (8) weeks prior to the approved protocol’s expiration date. If the NREB has not reviewed and approved a continuing review request by the current expiration date, study activities should cease until the board determines whether continuation of the research is in the best interest of all previously enrolled participants. Prior to the expected NREB approval expiration date, the NREB also reviews continuing review submissions for ethical approval extension requests to continue research project implementation. See LBR-6 for the NREB Continuing Review Form. See the Progress Reporting section for additional information on continuing review.

Additionally, per LibCTReg, the NREB’s clinical trial authorization must be suspended or withdrawn if the NREB subsequently becomes aware that grounds for a refusal as referred to in the clinical trial authorization procedures (see Part II (Section 5 (1)) of LibCTReg) existed at the time the authorization was issued. The authorization must be withdrawn if the NREB subsequently becomes aware that at least one (1) of the following is true:

Requirements regarding the suitability of the investigator, the investigator’s deputy, or the trial site are no longer fulfilled
Trial participants are no longer properly insured or the prerequisites for an exception to the insurance obligation no longer exist
Modalities for selecting trial participants no longer correspond to the current state of medical knowledge and, especially, the clinical trial is unsuitable for providing proof of the IP(s) safety or efficacy
Prerequisites for the inclusion of persons pursuant to the general conditions and special preconditions for conducting a clinical trial (see Part II (Sections 1-2) of LibCTReg) are no longer fulfilled. The NREB must inform the LMHRA through written communication.

For protocol amendments, per the G-NREB, the NREB must review and approve any protocol amendments prior to implementation. The NREB secretariat must first consult with the NREB Chair to determine the type of review required (full board review or expedited review based on the risk). Protocols that pose no or minimal risk to participants, have no formal informed consent process, or are subject to NREB continuing review, may be considered exempt and may qualify for expedited review. Refer to the G-NREB for detailed information on decision types and various review processes the NREB uses to consider protocol submissions.

Additionally, the G-NREB explains that, as a condition of research protocol approval, the NREB requires the PI to provide regular updates to the Secretariat from the date of approval. LBR-20 also notes that researchers are required to report any significant deviations from the approved protocol or ethical concerns arising during the course of the research to the NREB for review and guidance. The NREB may also provide ongoing monitoring and oversight to ensure continued compliance with ethical standards and regulatory requirements. The G-NREB specifies that the NREB must conduct site visits at appropriate intervals, which may, in certain cases, be unannounced to ensure the integrity of the study.

Reviews During Public Health Emergencies

As delineated in the G-CTEmergncy, in the event a public health emergency is declared in Liberia or a neighboring country by the World Health Organization (WHO), the Ministry of Health (MoH), or the National Public Health Institute of Liberia (NPHIL), the NREB will expedite the initiation of research. During such emergencies, many processes (i.e., drafting documents, translations, and obtaining approvals) will occur in parallel, rather than sequentially, as is typical during non-emergency situations.

Per the G-CTEmergncy, in addition to the NREB review form (if applicable), the following checklist will be included to streamline fast-tracking of epidemic-related research:

Identify the research as epidemic or outbreak-related to facilitate fast-tracking
Specify whether prior research data on the disease exists, referencing relevant local and international studies
Ensure the inclusion of at least one (1) (preferably two (2)) PIs or co-PIs from the country where the research and review take place
Provide qualifications of key investigators, including details of their previous experience with outbreak-relevant research
Indicate if the protocol is part of a multicenter trial. If so, describe the status of ethics approval for the master protocol or the ethics approval from the sponsoring country

The G-CTEmergncy indicates that the NREB will also use the following guidelines to ensure compliance during health emergencies:

Establish surge capacity for protocol reviews and implement systems for virtual discussions (via platforms like Zoom)
Identify core members to handle the majority of the review burden, providing specialized training in outbreak-related research review to ensure high standards without compromising ethical considerations. Additional members can be called upon as demand increases
Ensure that the Director alerts members and determines whether they are available for emergency review
Identify subject experts (technical and ethical) within the country and abroad who are willing to serve as ad-hoc or co-opted members during outbreaks, anticipating the need to review multiple studies in a short time
Establish a quorum consisting of one-third of NREB members, including pre-identified subject matter experts. If a pre-identified member submits their review but cannot attend the meeting, the member will still count towards the quorum

The G-CTEmergncy further states that revised SOPs will be circulated to all review committee members. Meetings may be virtual or electronic to reduce health risks during highly infectious outbreaks (e.g., COVID-19, Ebola). Protocols should be submitted electronically for efficiency, with hard copies to follow, if mandatory. PIs must inform the NREB as early as possible of their intent to submit a high-level overview of their research (e.g., trial of a new medicine or vaccine, observational study, or survey) to prepare the committee for forthcoming protocols. Face-to-face meetings with PIs are not mandatory and may be conducted electronically or virtually, if necessary. Also, protocols will be sent to reviewers within 48 hours of submission. Reviewers should complete their reviews within five (5) days during an outbreak. The PI should receive consolidated reviews with suggestions or approval within 10 working days and should respond to the review within 48 hours. The director of the NREB secretariat will be the primary contact for communication with PIs, and all communications will be documented and archived for future reference.

II-IV

1, 2, 4, and 9

Foreword, Articles I-II, Articles IV-V, Article VI (Section 6.04), Article XIV (Sections 14.01 and 14.05), Article XVII (Sections 17.01-17.02), and Article XXV (Sections 25.02 and 25.04)

Forward, Background, Administrative Procedures, Researchers, and Intellectual Property

2.5, 5.1, Intellectual Property, and Annex 3

Part II (Sections 1-2, Section 5 (1-2, 5, and 9), and Section 6 (6))

Ethics Committee Fees

Last content review/update: August 29, 2025

As per the G-KenyaCT, G-ECBiomedRes, and KEN-30, Kenya requires an independent review of research through a National Commission for Science, Technology and Innovation (NACOSTI)-accredited ethics committee (EC) in one (1) of the local institutions charged with the responsibility of conducting research in human participants. The EC fee to review a clinical trial application will vary depending on the institution. See KEN-25 and KEN-38 for lists of NACOSTI-accredited institutional ECs. For an example of institutional fee requirements charged by the Scientific and Ethics Review Unit (SERU) at the Kenya Medical Research Institute (KEMRI), see KEN-27.

1, 4.1, and 7.1

Glossary of Terms

Where do I get a letter of ethical approval before applying for a research license?

Last content review/update: April 13, 2026

Note: Per LBR-38, the National Research Ethics Board of Liberia (NREB) has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

National Research Ethics Board of Liberia

As described in the G-NREB, the NREB must charge a minimal fee for the review of each submission type. Submissions include research protocols, re-submissions, amendments, and continuing reviews. The fee structure is based on the following application types: research protocol, behavioral research, investigational product (IP) (clinical trial), non-clinical trial, or waiver/exemption. Fees specifically associated with conducting a clinical trial involving IPs are based on a project’s scope, duration, sample size, and complexity, as well as the types and quantities of IPs, among other criteria. The fees delineated in the G-NREB are as follows:

Clinical trial: $7,000 USD
Re-submission: $1,500 USD
Continuing Review: $1,500 USD
Amendment: $1,500 USD

Payment Instructions

No information is currently available regarding payment instructions for the NREB.

Atlantic Center for Research and Evaluation Institutional Review Board

As per the G-ACRE-IRB, the ACRE IRB fees for protocol review other than clinical trials are as follows:

Health, Behavioral and Education Research: $500 USD
Re-Submission: $500 USD
Continuing Review: $500 USD
Amendment: $250 USD
Foreign Student: $300 USD
Liberian Student: $100 USD

The fee for non-sponsored research conducted by individual investigators is 50 percent of the sponsored research fee.

Payment Instructions

No information is currently available regarding ACRE IRB payment instructions for protocol review other than clinical trials.

Article VI (Section 6.14) and Article XXV (Section 25.01)

Administrative Procedures

Oversight of Ethics Committees

Last content review/update: August 29, 2025

Overview

As set forth in the STI-Act and KEN-32, the National Commission for Science, Technology and Innovation (NACOSTI) is the central body responsible for the oversight, promotion, and coordination of research. NACOSTI’s role is to regulate and ensure quality in the science, technology, and innovation sector, and to advise the Kenyan government on related matters. As per the G-ECAccred, NACOSTI has delegated the task of reviewing research proposals for ethical clearance to accredited institutional ethics committees (ECs) to ensure that research conducted in the country observes high research ethics standards.

Per the G-ECBiomedRes, Kenya's National Bioethics Committee (NBC) advises NACOSTI on research ethics. In addition, NBC offers dispute resolution if an applicant is dissatisfied with the decision of an EC. Finally, the NBC must terminate research at any stage if it is found to be harmful to the participants.

Registration, Auditing, and Accreditation

As per the STI-Regs and the G-ECAccred, NACOSTI is responsible for accrediting institutional ECs. Per the G-ECAccred, the application requirements for accreditation are:

A completed application form (KEN-10 or Annex III of the G-ECAccred)
Copy of the standard operating procedures (SOPs)
Copies of abridged curriculum vitaes (CVs) (no more than four (4) pages) for each member of the proposed EC (including the training attended)
Profile of the organization/institution detailing the areas of competence (no more than four (4) pages)

As indicated in KEN-40, institutions can apply for a license to establish a research institution on the NACOSTI eCitizen platform (KEN-12).

Per the G-ECAccred, NACOSTI issues a certificate of accreditation to accredited institutional ECs, which is valid for three (3) years from the date of NACOSTI’s notification. All accredited ECs must submit annual reports to NACOSTI by July 31st for review and monitoring. Applications for renewal of accreditation should be made six (6) months before expiry of the accreditation period. Failure to renew accreditation or failure to maintain the appropriate standards for continuity of accreditation will mean that the accredited status of the EC will lapse at the end of the current accreditation period. Accreditation must be terminated if the accredited committee fails to maintain the required standards. For re-accreditation review purposes, ECs must provide the SOPs under which they will operate. The SOPs are not required as part of the annual reporting process, unless they have been amended, but are required to be stated/included for the re-accreditation review process (every three (3) years). See the G-ECAccred for additional details on the accreditation process.

See the Site/Investigator Selection section for more information on the sponsor and site’s registration and application requirements.

1.0, 2.0, 4.0, and Annex III

4.1 and 7.1

Part II

The Science, Technology and Innovation (Relevance and Quality Assurance in Research) Regulations, 2014 (Part II)

Last content review/update: April 13, 2026

Overview

There are no applicable regulations or guidance regarding the authorization of ethics committees (ECs) in Liberia. However, per G-NREB, the National Research Ethics Board of Liberia (NREB) is responsible for maintaining a registry of health research ECs and mitigating conflicts among ECs, researchers, and research entities.

Registration, Auditing, and Accreditation

No information is currently available on registration, auditing, and accreditation requirements.

Background

Submission Process

Last content review/update: March 19, 2026

New Info (Not Yet in Profile)

The Pharmacy and Poisons Board issued Revision 5 of Guidelines for the Conduct of Clinical Trials in Kenya, effective January 2, 2026, which includes additional/revised definitions; alignment with ICH, WHO, PIC/S, and GCLP standards; new application process/requirements for multicenter clinical trials; clarification on investigator categories and qualifications; clarification on safety reporting; and alignment of study monitoring requirements to ICH E6(R3).

Overview

In accordance with the PPA, the STI-Act, the CTRules, the G-KenyaCT, the G-ECBiomedRes, KEN-21, and KEN-16, Kenya requires the sponsor or the representative to obtain clinical trial authorization from the Pharmacy and Poisons Board (PPB)’s Expert Committee on Clinical Trials (ECCT) and an independent ethics review through a National Commission for Science, Technology and Innovation (NACOSTI)-accredited ethics committee (EC) in a local institution. In addition, the STI-Act and KEN-31 specify that applicants must obtain a research license from NACOSTI prior to initiating a study. The G-KenyaCT also states that the PPB review and approval process may not be conducted in parallel with the EC review. EC approval must be obtained prior to applying for PPB approval.

Regulatory Submission

Pharmacy and Poisons Board

As described in the G-KenyaCT and KEN-16, the sponsor or the representative is expected to submit the clinical trial application electronically via the PPB online system (KEN-16). The clinical trial application form is available in KEN-16. Per the G-KenyaCT, in the event of a multicenter clinical trial, the sponsor should only file one (1) application to the PPB. According to KEN-34, all application documents should be signed, dated, and version referenced, if applicable, and should be in English. For specific instructions on uploading and attaching files in KEN-16, see Portal-Att. Also see Annex 7 of the G-KenyaCT to view a flowchart of the submission and approval process.

Per the G-KenyaCT, upon receipt of a clinical trial application, the PPB’s Clinical Trial Division of the Product Safety Department screens the application package for completeness. When an application for a clinical trial is accepted, an acknowledgement of receipt will be issued with a reference number for each application. This PPB/ECCT reference number must be quoted in all correspondence concerning the application in the future. This will be communicated through email to the applicant or through KEN-16.

Per the G-KenyaCT, sponsors (applicants) can request pre-submission meetings with the PPB to discuss pertinent issues prior to making a formal submission. The request must be made via KEN-16 or in an official letter and include the following information:

Background information on the disease to be treated
Background information on the product
Quality development
Non-clinical development
Clinical development
Regulatory status
Rationale for seeking advice
Proposed questions and applicant’s positions

In addition, per the G-KenyaCT, the letter must be addressed to the Chief Executive Officer of the PPB and sent to admin@pharmacyboardkenya.org and copied to cta@pharmacyboardkenya.org. The request for a meeting should propose two (2) different dates for the meeting at least three (3) weeks away.

Per G-KenyaCT, any new information that affects the conduct/management of the trial; safety of the participants; and manufacture of the product necessitating changes to the protocol, consent form, and trial sites, etc. will require immediate submission of the amended documents to the PPB for review and approval. Minor amendments or administrative changes may be implemented after getting the EC’s approval, but a record of these amendments must be kept for possible inspection by the PPB.

National Commission for Science, Technology and Innovation

Per KEN-31, an application for a NACOSTI research license should be submitted online via the Research Information Management System (RIMS) (KEN-24).

Ethics Review Submission

Each institutional EC has its own required submission procedures, which can differ significantly regarding the application format and number of copies. See KEN-17 for an example of a NACOSTI-accredited EC’s guidelines.

1.0 and 4.1

Glossary of Terms, Introduction, 1.1-1.29, 1.182-1.185, 1.492-1.496, and Annexes 1-7

25A

Parts II, IV, V, and X and Fourth Schedule

Part II (Section 4)

Last content review/update: April 13, 2026

Overview

In accordance with the LibCTReg and the G-LibClinTrial, the sponsor, the legal representative, the principal investigator (PI), or the sponsor-investigator is required to submit a clinical trial application to the Liberia Medicines and Health Products Regulatory Authority (LMHRA) and obtain written permission from the National Research Ethics Board of Liberia (NREB) to be granted authorization to conduct a clinical trial in Liberia. However, per the G-NREB, the PI must obtain ethics committee (EC) approval. The LibCTReg and the G-LibClinTrial state that the NREB and LMHRA reviews may be conducted in parallel. Per the G-LibClinTrial and the G-NREB, the LMHRA will only issue final approval once NREB approval is obtained.

Regulatory Submission

As indicated in the LibCTReg and the G-LibClinTrial, the sponsor or the representative should submit the application form and associated documents along with the prescribed fee. Also, per the G-LibClinTrial, four (4) sets of the application should be submitted both electronically and as printed copies to the LMHRA. The clinical trial application and any accompanying material must be submitted in English. If the documents are written in another language, a certified translation is required. Per LBR-29, the sponsor's representative must also submit a power of attorney attesting that the representative is a duly appointed agent.

Additionally, per the LibCTReg and the G-LibClinTrial, any substantial amendment to the approved clinical trial documentation, trial arrangements, or the investigational product must be submitted by the applicant to the LMHRA and the NREB, together with the prescribed fee, for the evaluation and authorization related to such amendment. Per the G-LibClinTrial, the submitted amendment(s) must be indicated in a signed cover letter that specifies the clinical trial and the sponsor (applicant), and must describe the possible consequences for clinical trial participants already enrolled in the trial as well as the possible consequences for the evaluation of the results. The amendment(s) must also be described in a completed Clinical Trial Amendment form (Annex 2 of the G-LibClinTrial). The amended documents should include updated version numbers and dates. In addition, the submitted documents should clearly present scientific arguments justifying the classification of the amendment to the LMHRA and the NREB, and, where applicable, supporting information must be included with the submission.

Per the G-LibClinTrial, the signed cover letter and clinical trial application dossier should be sent to the following:

The Managing Director
Liberia Medicine and Health products Regulatory Authority (LMHRA)
2^nd & 3^rd Floors Clay Building
Sekou Toure Avenue
Mamba Point
Monrovia, Liberia

Ethics Review Submission

Note: Per LBR-38, the NREB has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

National Research Ethics Board of Liberia

As delineated in the LibCTReg, application submissions to the NREB must include all of the information and documents as required for the board’s opinion. According to the G-NREB, PIs must submit typed, dated, and signed submissions electronically and in hard copy to the NREB. The documents should be formatted in standard 12-point font, double-spaced, with the pages printed on one (1) side only. The NREB requires 15 comb-bound copies of the complete research protocol, along with the attachments listed in the G-NREB, and where applicable, an email version that includes the protocol title and the PI’s name. All protocols must also be numbered appropriately and separately from all other supporting documentation (e.g., letters, participant information sheets and consent forms, questionnaires, curriculum vitae(s) (CVs), etc.). Supporting documents should also be numbered separately. Refer to LBR-32 for the NREB Research Protocol Template.

In addition to protocol submission requirements, the G-NREB also specifies that the PI should submit the complete application for ethical review and approval of a proposed health research study to the NREB Secretariat three (3) weeks prior to the next NREB meeting. Applications submitted by a PI and researchers from foreign institutions must also include a local (resident) Liberian researcher on the research team as well as support letters and CV(s). See the G-NREB for detailed application submission requirements.

Per the G-NREB, NREB submissions should be submitted to the following address:

Director
National Research Ethics Board of Liberia (NREB)
First Floor West, John F. Kennedy Medical Center
Monrovia, Liberia
Email: nreb.liberia.gov@gmail.com

As delineated in the G-CTEmergncy, during a public health emergency in Liberia or in a neighboring country, the NREB requires protocols to be written in English and include, at a minimum, the proposed study, the corresponding ethics approval, consent or assent forms, and data collection tools and forms. In addition, along with the standard documents for review (protocols, CVs, Human Subject Protection Certificates, Good Clinical Practice, etc.), the following must be submitted:

A collaboration letter (in the form of an MOU) with sponsor institutions and research funders, including declarations of interest, when possible
A monitoring and safety management plan for the project provided by the PI and the study sponsor
Data-sharing and material transfer agreements for data and biological materials, especially if samples will be exported out of the country, to ensure compliance with the Laws of Liberia (a draft version may be submitted initially)
Clear procedures for dissemination, publication, co-authorship, co-presentation, and intellectual property rights
Plans to disseminate findings to the affected community, to ensure continued engagement and trust, especially among research participants
Depending on the type of research, a local insurance policy for trials and interventions may be required

Atlantic Center for Research and Evaluation Institutional Review Board

As indicated in the G-ACRE-IRB, PIs are required to submit the research protocol as part of an application packet that includes the documentation specified by the ACRE IRB submission form (see Article XXV in the G-ACRE-IRB). According to LBR-28, the ACRE IRB has not reinstated the requirement for PIs to submit eight (8) hard copies of the protocol. Applications should be submitted electronically. See the Submission Content section for additional documentation requirements.

Per the G-ACRE-IRB, all research proposals are to be submitted (either via electronic mail or in person) to:

The IRB Coordinator
Atlantic Center for Research and Evaluation (ACRE)
Ground Floor, Graduate School Building
University of Liberia
Capitol Hill
Monrovia, Liberia

Per LBR-28, proposals submitted electronically should be sent to ulpireirb@gmail.com and smithedwardg@yahoo.com, in copy.

II-III

1, 2, and 9 (includes CT Amendment form (Annex 2))

Article V, Article IX (Section 9.01), and Article XXV (Section 25.02)

Forward, Background, Administrative Procedures, Researchers, and Intellectual Property

Part II (Section 1 (b-d, and Section 5 (1))

Submission Content

Last content review/update: August 29, 2025

Regulatory Authority Requirements

Pharmacy and Poisons Board

As per the CTRules, the G-KenyaCT, and KEN-34, the following documentation must be submitted (signed, dated, and version referenced) to the Pharmacy and Poisons Board (PPB) (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Cover letter
Study protocol
Proof of study registration in the Pan African Clinical Trials Registry (KEN-19)
Patient information leaflet and informed consent form (ICF)
Investigator’s Brochure (IB) and package inserts
Investigational Medicinal Product Dossier (IMPD), including stability data for the investigational product (IP)
Adequate data and information on previous studies and phases to support the current study
Good manufacturing practice (GMP) certificate of the IP from the site of manufacture issued by a competent health authority in the manufacturer’s jurisdiction of origin
Certificate of analysis of the IP
Pictorial sample of the IPs, including the labeling text
Signed investigator(s) curriculum vitae(s) (CV(s)), including that of the study pharmacist (the CV should include the current workload of the principal investigator (PI))
Evidence of contractual agreement between the relevant parties
Evidence of recent good clinical practice (GCP) training of the core study staff
Data and Safety Monitoring Board (DSMB) information, including the charter, composition, and meeting schedule
Detailed study budget
Financial declaration by the sponsor and PI (KEN-2 and Annex 5 of the G-KenyaCT)
No conflict of interest declaration by the sponsor and PI
Signed declarations by the sponsor, PI, and the monitor that the study will be carried out according to the protocol and applicable laws, regulations, and GCP requirements (KEN-1 and Annex 4 of the G-KenyaCT)
Indemnity cover for PI, investigators, and study pharmacist
Clinical trials insurance cover for the study participants
Copy of favorable opinion letter from local ethics committee (EC)
Copy of current practice licenses for the investigators and study pharmacist
Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
For multicenter/multi-site studies, an addendum for each of the proposed sites including, among other things, the sites’ capacity to carry out the study (e.g., personnel, equipment, laboratory)
A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate, and is not false or misleading (Annex 4 of the G-KenyaCT)
Payment of fees
Statistical analysis plan
A signed checklist (KEN-34 and Annex 2 of the G-KenyaCT)

Per the G-KenyaCT, a request for approval of an amendment must include a summary of the proposed amendments; the reason for the amendment; the impact of the amendment on the original study objectives; the impact of the amendments on the study endpoints and data generated; and the impact of the proposed amendments on the safety and wellbeing of study participants.

KEN-35 describes the submission content for requesting annual approval from the PPB.

National Commission for Science, Technology and Innovation

Per the STI-Regs and KEN-31, non-Kenyan applicants must be affiliated with a Kenyan institution. Per KEN-31, applicants must apply online through National Commission for Science, Technology and Innovation (NACOSTI)’s Research Information Management System (RIMS) website (KEN-24) and upload the following:

Passport size color photo in JPG or PNG format
Scanned ID/passport in PDF format
Introductory letter from relevant institution signed by an authorized officer
Affiliation letter from relevant local institution for foreigners signed by an authorized officer and valid for one (1) year
Grant letter from the funding agency to support the amount indicated to fund the research
PPB clinical trial approval
Prior Informed Consent (PIC), Mutually Agreed Terms (MAT), or Material Transfer Agreement (MTA) where applicable, for applications to conduct research on genetic resources and derivatives
Approved research proposal in PDF format
Certificate of ethical clearance of the research (see list of accredited ECs in KEN-25)
Evidence of payment as the last page of the uploaded proposal

Per KEN-31, the following conditions apply to the research license:

The research license is valid for the proposed research, site, and specified period
Both the research license and any rights thereunder are non-transferable
NACOSTI may monitor and evaluate the research
The licensee must inform the relevant County Director of Education, County Commissioner, and County Governor before research commencement
Excavation, filming, and collection of specimens are subject to further permissions from relevant government agencies
The research license does not give authority to transfer research materials
The licensee shall submit one (1) hard copy and upload a soft copy of their final report within one (1) year of completion of the research
NACOSTI reserves the right to modify the conditions of the research license including its cancellation without prior notice

KEN-31 states that if the research is not completed within the stipulated period, the applicant may apply for renewal of the research license and pay the requisite fee. A progress report should be submitted with the request for renewal instead of a proposal. The progress report must indicate the objectives and activities that have been accomplished, as well as the research work that has yet to be undertaken. KEN-31 further indicates that submissions requesting renewal should be made at least 30 days prior to the expiration of the approval period.

Ethics Committee Requirements

EC requirements vary depending on the specific EC. See KEN-17 and KEN-26 for examples of accredited EC submission and review guidelines.

As set forth in the G-ECBiomedRes, a foreign sponsoring agency must also submit its research protocol for ethics review according to its own country’s standards. This research must be responsive to the health needs of Kenya and reasonably accessible to the community in which the research was conducted.

Clinical Protocol

Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14). The CTRules the G-KenyaCT, the G-ECBiomedRes, and KEN-14 outline the key elements of a research protocol in Kenya (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

A project title that adequately captures the essence of the study
The names, addresses, signatures, and updated abridged curriculum vitae of the investigators
Evidence that the PI has prior training in GCP
Contact information for the EC and collaborating institutions
A summary of the project
Introduction, background, and literature review, including nonclinical data
Study objectives, rationale, questions, and hypothesis/es
Study site, design, and methodology
Ethical considerations
Role of investigators
Schedule
References
Budget
Publication policy
Consent explanation - elements of consent explanations
ICF with signature provisions for participants and the PIs
Risks and benefits
Mode of assessment of the safety and efficacy of the IP
Mode of collecting, analyzing, and reporting the statistics of the clinical trial
Source data documents of the clinical trial
Quality control and quality assurance
Confidentiality
Recruitment, selection, treatment, and withdrawal of participants
Compensation and post-trial access program
Undue inducement and coercion
Voluntariness
Alternative treatment(s) if available
Storage of specimens
MTA, where applicable
Data management and statistical analysis

In addition, per the G-KenyaCT, the protocol should have a clear description of study stoppage rules indicating reasons, who makes the decision, and how the decision will be communicated to the PPB and the EC.

1.0, 4.2, and 6.0

1.48, 1.63, 1.89-1.130, 1.495, 1.533, and Annexes 1-2 and 4-5

Part II (Section 4) and Part IV (Section 9)

The Science, Technology and Innovation (Research Licensing) Regulations, 2014 (Part II)

6

Guidelines for Proposal Development

Submission Forms

Last content review/update: April 13, 2026

Regulatory Authority Requirements

As set forth in the LibCTReg and the G-LibClinTrial, the sponsor, the legal representative, the principal investigator (PI), or the sponsor-investigator is required to submit the following documentation to the Liberia Medicines and Health Products Regulatory Authority (LMHRA) (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Cover letter (signed, witnessed, and notarized) including list of documents submitted and their version numbers and date
Clinical trial application form, including cover page
Clinical trial protocol (see below for detailed protocol requirements)
A list of the planned clinical trial sites and the planned number of study participants to be recruited at the sites located in Liberia
Details of the site(s) where the trial is to be conducted, and a duly justified written statement on the suitability of the clinical trial sites adapted to the nature and use of the investigational product (IP) and including a description of the suitability of facilities, equipment, human resources, and description of expertise, issued by the head of the clinic/institution at the trial site or by some other responsible person
Participant information sheet, informed consent form(s) (ICF(s)) or video(s), or assent form(s) in case of minor(s) or persons under legal disability who are to participate in the trial, and informed consent procedures for clinical trials in humans
Product information for registered IPs (e.g., summary of product characteristics, patient information leaflet/package insert, and labelling)
Investigator’s Brochure (IB) containing relevant chemical, pharmaceutical, pre-clinical pharmacological and toxicological data, and where applicable, human or animal pharmacological and safety and efficacy clinical data about the IP
If applicable, synopsis of previous trials with the IP(s)
If applicable, electronic copies of key, peer-reviewed publications following the International Committee of Medical Journal Editors (ICMJE) recommendations to support the application
Copies of recruitment advertisement(s), if applicable, and questionnaires
Investigational medicinal product (IMP) dossier, if applicable
Product information and certificate of analysis (CoA) for concomitant and rescue medications
Good Manufacturing Practice (GMP) certificate issued from the national regulatory authority of the country where the IP is manufactured, translated into English
CoA of the IP(s)
Certificate(s) of accreditation for the central laboratories
Workload forms for investigators
Signed declaration by the applicant (including a commitment to adhere to the ethical principles outlined in the Declaration of Helsinki (LBR-27) and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (LBR-8))
Signed declaration by the national PI
Signed curriculum vitae (CV) for all key staff participating in the conduct of the clinical trial (e.g., PI and/or co-investigators, study coordinator, regional and local monitor, contract research affiliate, etc.)
Signed declaration(s) by each investigator(s)
Signed joint financial declaration between the sponsor and the PI
Signed declaration by the sub-investigators and key staff participating in the trial
Signed declaration by the regional clinical trial monitor(s)
Signed declaration by the sponsor/sponsor-investigator
Proof of registration with the Pan African Clinical Trials Registry (PACTR) (LBR-36) or another World Health Organization (WHO) Primary Registry (LBR-35)
Active clinical trial insurance for Phase I, II, and III trials
Evidence of insurance coverage for prospective participants
Proof of sponsor indemnification for investigators and trial site
Good Clinical Practice (GCP) certificates for the investigators
Proof of registration of the key investigators with a professional statutory body, if applicable
Proof of residence in Liberia for the PI
Proof of professional indemnity (i.e., malpractice insurance)
Study budget
In case of parallel submission, proof of submission of the clinical trial application to the National Research Ethics Board of Liberia (NREB)
The written permission of the NREB in case of sequential submission, and in case of parallel submission, the updated versions of documents or information as requested by the NREB, for the conduct of the clinical trial, if applicable
Information on the composition of the Data and Safety Monitoring Board (DSMB)—including the list, terms of reference, and CVs for its members—justifying their expertise as members of the DSMB
Summary of product characteristics or other professional information for all registered medicines used in the trial, or the international equivalent if the medicines are not registered in Liberia
Registered IPs should include the registered indication or registered dosage regimen
Recruitment arrangements
Request for authorization of export of biological samples out of Liberia as well as the respective material transfer agreement (MTA), if applicable
Summary of the clinical trial (100-150 words) to be made publicly available on the LMHRA website
Proof of payment of the appropriate application fee

Refer to the LibCTReg and the G-LibClinTrial for detailed application requirements and expedited application documentation requirements.

The LibCTReg also notes that in the case of emergency situations, the LMHRA may also make exemptions to the documentation requirements for the submission of clinical trial applications. Refer to 2.3 of the G-LibClinTrial for additional information on how to submit an expedited clinical trial application package.

Ethics Committee Requirements

Note: Per LBR-38, the NREB has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

National Research Ethics Board of Liberia

As indicated in the G-NREB, for clinical trials and biomedical/epidemiological study submissions, the following documents may be included, but are not limited to:

Full protocol and executive summary (refer to LBR-32 for research protocol template)
Sponsor’s protocol, if applicable (per LBR-32)
Signed agreement between sponsors and PI, where applicable
A statement that the researcher(s) agree to comply with ethical principles set out in relevant guidelines
IB
MTA for shipment of specimen(s)/biological material(s) outside of Liberia, where applicable (See also Specimen Import & Export and Consent for Specimen sections)
Data Sharing Agreement, where applicable
Administrative information on study sponsors
Signatory page of key persons from the collaborative institutions involved in the study (i.e., Sponsor Signatory Approval Page duly signed, with date, where applicable)
Written ICF with dates and version number and translations into the local language, where necessary
Written parental consent form for children under 17 years of age (if study involves minors)
Written parental consent form and assent form for children under 18 years of age (15-17 years) (if study involves adolescents)
All forms, documents, and community engagement advertisements to be used in the recruitment of potential participants
All data collection forms to be used in the research including, but not limited to, case report forms, questionnaires, interview schedules, etc., clearly indicated and dated
Referral forms for treatment, where applicable
Study budget
Study timeline
Any other information deemed necessary to facilitate the review process
Current CV(s) of PI and co-investigator(s), if not submitted to the NREB in the preceding 12 months
Profile on previous study (i.e., Phase I & Phase II studies, where applicable)
Investigator Agreement (PI’s responsibility), page duly signed with name and date, and current Certificate of Training in GCP for PI(s)
DSMB membership and charter of work/current member CVs
Insurance coverage for study participants
Scientific review approval
LMHRA approval letter for use of the IPs/devices and clinical trial approval (this should be submitted after the NREB approval)

Atlantic Center for Research and Evaluation Institutional Review Board

Per the G-ACRE-IRB, the following documentation must be submitted along with the application for an initial application review of a protocol for clinical research other than a clinical trial:

Cover letter
Protocol summary (Article XXV (Section 25.02) in the G-ACRE-IRB)
Protocol and/or amendments (including data collection instruments, surveys, tests, questionnaires, debriefing information, etc.)
IB, where applicable
Evidence of submission and/or approval from other ECs, where applicable
Proof of research ethics training (i.e., certificate in human subject protection) by research team members
ICFs, where applicable
Questionnaires and other study instruments, where applicable (including interview schedules, recruitment and interview scripts, and recruitment materials (Article XXV (Section 25.02) in the G-ACRE-IRB)
DSMB and Institutional Biosafety Committee (IBC) records, if applicable
MTA, if applicable (See also Specimen Import & Export and Consent for Specimen sections)
Status report for ongoing study (applicable for continuing review)
Letter of collaboration or support with collaborating entity/researcher(s), if applicable
Capacity building plan for collaborating agency/researcher, if applicable
Investigator(s) CVs
Social corporate responsibility plan for communities, if applicable
Letter from an appropriate official permitting research activities on their premises, if the research/recruitment will take place in or through schools, businesses, care facilities, or other organizations
Budget

Clinical Protocol

Liberia Medicines and Health Products Regulatory Authority

Per the G-LibClinTrial, the contents and format of the clinical trial protocol should follow the requirements laid down in LBR-8. Refer to LBR-8 for detailed protocol guidelines.

In addition, as indicated in the G-LibClinTrial, the protocol should contain a statement indicating that the trial will be conducted in compliance with the protocol, GCP, and the applicable regulatory requirements, and signed and dated by both the sponsor/sponsor’s representative and the PI to document the their agreement to the protocol. If the protocol is not signed and dated by both parties, a corresponding declaration that is signed and dated by both must be submitted to the LMHRA with the application.

National Research Ethics Board of Liberia

The LBR-32 requires the following elements to be included in the research protocol template submission:

Specific aims
Background and significance of research
Research locations and collaborating sites
Study team
Study design
Recruitment methods
Consent process
HIPAA privacy protections
Vulnerable populations
Risks
Benefits
Participant privacy
Data confidentiality
Data/statistical analysis plan
Costs and compensation
Sharing study results
Research related injuries
Reportable events
Regulatory compliance
Data or specimen banking (repositories)
Clinical trials
Device, if applicable
Drug/biologic

National Research Ethics Board of Liberia/Atlantic Center for Research and Evaluation Institutional Review Board

Per the NatResHlthPlcy, Liberian ECs including the NREB and the ACRE IRB, should structure the research protocol according to the follow format:

Title
Investigators’/researchers’ information including contact addresses
Abstract/summary
Background/Introduction
Aims and objectives
Study design and methods
Data collection, management, and analysis
Study administration and ethical issues
Resource requirements
Study plan
Supervision
Dissemination and outcome

For more details, see Annex 2 of the NatResHlthPlcy.

Atlantic Center for Research and Evaluation Institutional Review Board

According to the G-ACRE-IRB, the clinical research protocol should contain the elements included in the ACRE IRB submission form (see Article XXV in the G-ACRE-IRB). The initial protocol submission should also contain:

Original protocol (including cover sheet, abstract, and research section including the Human Subjects Section)
Application letter
ICF and/or assent form
Sample questions survey
Investigator(s) CVs
Qualification of study site(s)
Protocol budget
Copy of ACRE IRB approval, if available
Study design
Study participation, including informed consent procedures and content/language and participant information sheet content (See also the Documentation Requirements section)

Note: Per the G-ACRE-IRB, for regular renewal or interim modification reviews of a protocol, PIs should attach current consent document(s) and include instruments ONLY if changes are being proposed (Article XXV (Section 25.02) in the G-ACRE-IRB).

1, 2, and 9

Article V, Article IX (Sections 9.01 and 9.03), and Article XXV (Section 25.02)

Forward, Background, Administrative Procedures, Researchers, and Intellectual Property

Annex 2

Part I (Section 1 (c-e (13)) and Part II (Section 1 (3-4) and (Section 5))

Timeline of Review

Last content review/update: August 29, 2025

Overview

Based on the CTRules and the G-KenyaCT, the Pharmacy and Poisons Board (PPB)'s review and approval of an application to conduct a clinical trial is dependent upon obtaining ethics approval from a National Commission for Science, Technology and Innovation (NACOSTI)-accredited ethics committee (EC). Therefore, the PPB and EC reviews may not be conducted in parallel. In addition, the STI-Act and KEN-31 specify that all applicants must obtain a research license from NACOSTI prior to initiating a study.

Regulatory Authority Approval

Pharmacy and Poisons Board

Per the G-KenyaCT, sponsors (or applicants) can request pre-submission meetings to discuss pertinent issues prior to making a formal submission. The request must be made via the PPB online system (KEN-16) or in an official letter addressed to the Chief Executive Officer of the PPB and sent to admin@pharmacyboardkenya.org and copied to cta@pharmacyboardkenya.org. The request for a meeting should propose two (2) different dates for the meeting with the proposed dates being at least three (3) weeks away. (See Submission Process section for details on the content of the request.)

Per the G-KenyaCT, upon receipt of a clinical trial application, the PPB’s Clinical Trial Division of the Product Safety Department screens the application package for completeness, which takes five (5) days. If accepted, an automatic system-generated reference number will be issued for each application. If additional information is needed, the sponsor will have 10 days to respond. The PPB aims to respond to applications within 30 working days. The sponsor or the representative must reference the PPB/Expert Committee on Clinical Trials (ECCT) number in all future application-related correspondence. The application is then evaluated by the ECCT and PPB staff according to their respective standard operating procedures. The PPB/ECCT’s decision to approve, request additional information, or reject the application is communicated to the sponsor or the representative in writing within 30 days of receiving a valid application. If additional information is requested, the sponsor has 90 days to respond after which the PPB has 15 days to issue a final decision. In certain cases, the PPB may refer the application to external experts for their recommendation.

Per the G-KenyaCT, the sponsor or the representative is also required to request approval annually from the PPB at least six (6) weeks prior to the expiration of the previous approval. Refer to the Checklist for Submitting a Request for Annual Approval (KEN-35) for relevant documentation requirements.

National Commission for Science, Technology and Innovation

Per KEN-5 and KEN-31, the timeline for NACOSTI’s license application process is 30 days.

KEN-31 states that if a research license application does not meet the conditions required under the STI-Act, NACOSTI must reject the application and communicate the reasons to the applicant. Any person may appeal NACOSTI’s decision to the Cabinet Secretary within 30 days of being notified of the decision.

Ethics Committee Approval

The EC review and approval process timeline will vary by institution.

1.13-1.29, 1.182-1.185, and Annex 7

Part II (Section 4)

Last content review/update: April 13, 2026

Overview

According to the LibCTReg and the G-LibClinTrial, the National Research Ethics Board of Liberia (NREB) and the Liberia Medicines and Health Products Regulatory Authority (LMHRA) reviews may be conducted in parallel. However, per the G-LibClinTrial and the G-NREB, the LMHRA will only issue final approval once NREB approval is obtained.

Regulatory Authority Approval

The LibCTReg and the G-LibClinTrial state that the LMHRA must inform an applicant in writing about the outcome of an assessment of a clinical trial application within a maximum of 45 working days for pharmaceutical investigational products (IPs); 60 working days for biological and biotechnology IPs; and 90 working days for genetically modified organisms. However, the G-LibClinTrial also indicates that the LMHRA must inform the applicant within a maximum of 60 working days.

As indicated in the LibCTReg and the G-LibClinTrial, upon receipt of a clinical trial application, the LMHRA screens the application package for completeness and must inform the applicant in writing about the validity of the application or the formal grounds for non-acceptance of the application within 10 working days of application receipt. If applicable, the applicant, in turn, must address formal grounds for non-acceptance within 10 working days. These timelines exclude time taken for the applicant to respond to queries from the LMHRA during the review and decision process. If changes are required and the applicant fails to modify the application within a maximum of 30 working days, the application will be rejected.

Additionally, the G-LibClinTrial further notes that if the LMHRA requires changes to the application, and the applicant fails to modify the application within a maximum of 90 days, the application will be rejected.

As explained in the G-LibClinTrial, upon approval of the application, the LMHRA must issue a clinical trial certificate to the applicant that includes the LMHRA clinical trial number. The clinical trial certificate may contain conditions required by the LMHRA with respect to the conduct or reporting of the trial. If the application is rejected, the applicant can submit a written appeal to the LMHRA’s Managing Director within 60 days of receipt of the rejection notice.

Per the G-LibClinTrial, in the case of expedited clinical trial application reviews, the LMHRA will review the application within no more than 14 working days for approved products and within 21 days for new products.

Additionally, per the G-LibClinTrial, the LMHRA must respond to any substantial clinical trial amendment within 20 calendar days upon receipt of the written decision from the NREB.

Ethics Committee Approval

Note: Per LBR-38, the NREB has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

National Research Ethics Board of Liberia

Pursuant to the G-NREB, principal investigators (PIs) are required to submit new research protocols no later than one (1) month prior to the next bi-monthly board meeting. The NREB should notify PIs in writing of its decision within two (2) weeks following a board meeting, where applicable, following a complete review of the protocols. The G-NREB does not specify an approval expiration date.

The G-NREB explains that for protocol amendments, the NREB Secretariat, in consultation with the Chair, will make a determination regarding the type of review (full board review or expedited based on the risk) and will notify the investigator within three (3) weeks upon submission per the board’s decision. Expedited reviews must take no more than three (3) weeks, and if any committee member raises a concern about a protocol that was expedited, the protocol must undergo a full board review.

Refer to the G-NREB for additional information on the various submission types that may be submitted to the board and their corresponding review and approval processes.

Atlantic Center for Research and Evaluation Institutional Review Board

As specified in the G-ACRE-IRB, PIs are required to submit all application materials to the ACRE IRB four (4) weeks in advance of the date that a decision is requested. In the case of full review studies, submission is required four (4) weeks prior to the next scheduled ACRE IRB meeting. The ACRE IRB will convene a special meeting, if necessary, to accommodate the PI’s compliance with an external funding deadline; however, submission is required four (4) weeks prior to the special meeting date.

No timeline of review is specified for the ACRE IRB’s review. However, the G-ACRE-IRB states that the clinical research protocol and accompanying documents are approved as they are submitted. Approval will commence on the day the study is approved and will expire within a defined time period based on a risk assessment and regulations. If specific conditions are stipulated in the approval letter, those conditions must be met by the designated date or approval may be withdrawn.

The G-ACRE-IRB states that the ACRE IRB must also review and approve any clinical research protocol amendments prior to those changes being implemented. The clinical research protocol submission is reviewed either via expedited procedures (for minor changes) or via full board review (for all other changes). Refer to the G-ACRE-IRB for clinical research protocol amendment documentation submission and procedural requirements.

2, 4, and 9

Article IV, Article XIV (Sections 14.01 and 14.05), Article XV, Article XVI, Article XVII (Sections 17.01 and 17.02), Article XXIII (Section 23.01), and Article XXV (Sections 25.02, 25.04, and 25.05)

Administrative Procedures, Researchers, and Intellectual Property

Part II (Section 1 (d) and Section 5 (4))

Initiation, Agreements & Registration

Last content review/update: August 29, 2025

Overview

In accordance with the PPA, the STI-Act, the G-KenyaCT, the G-ECBiomedRes, KEN-21, and KEN-16, a clinical trial can only commence after the sponsor or the representative receives authorization from Kenya’s Pharmacy and Poisons Board (PPB), and ethics committee (EC) approval from an institutional EC that has been accredited by the National Commission for Science, Technology and Innovation (NACOSTI) prior to initiating a study. ECs are accredited pursuant to the requirements delineated in the G-ECAccred. The G-KenyaCT specifies that the PPB review and approval process may not be conducted in parallel with the EC review. In addition, the STI-Act and KEN-31 state that all applicants must obtain a research license from NACOSTI prior to initiating a study. No waiting period is required following the applicant’s receipt of these approvals. Regarding notifications, KEN-31 requires the licensee to inform the relevant County Director of Education, County Commissioner, and County Governor before commencement of the research. Further, the licensee must disclose to NACOSTI, the institutional ECs, and the relevant national agencies any findings that are of national strategic importance.

As per the PPA and the G-KenyaCT, the sponsor or the representative is required to obtain an import license for the shipment of an investigational product to be used in the trial. (See the Manufacturing & Import section for additional information).

As stated in the G-KenyaCT, Kenyan clinical trials should be conducted in compliance with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (KEN-14).

Clinical Trial Agreement

Prior to initiating the trial, the G-KenyaCT requires that the sponsor agree with investigator(s) on the definition, establishment, and assignment of responsibilities specified in the protocol. These responsibilities include conduct of the trial in compliance with KEN-14 and the approved protocol; data management; unblinding of treatment codes; statistical considerations; and preparation of the final clinical report. The sponsor, in a written document, may agree to transfer all related activities of the clinical trial to designated research institutions. However, all responsibility for the trial lies with the sponsor. Prior to the initiation of the clinical trial, the agreement between the sponsor and investigators should be in writing as part of the protocol submitted for PPB approval or in a separate agreement. The sponsor and investigators must sign and date the protocol of the trial to confirm the agreement.

Clinical Trial Registration

As per the G-KenyaCT, all clinical trials taking place in Kenya must be registered in the PPB’s Online Clinical Trials Registry System (KEN-16). The principal investigator is required to log in and set up an account to register a study.

In addition, as required by KEN-34, all clinical trials taking place in Kenya must be registered in the Pan African Clinical Trials Registry (KEN-19).

Introduction

1.0, 4.1, and 5.1

Introduction, 1.1, 1.48, 1.63-1.88, 1.346-1.354, and 1.542-1.555

Part III (25A) and Part IV (44)

Parts II, IV, V, and X, and Fourth Schedule

1.25, 4, and 5.5

Last content review/update: April 13, 2026

Overview

In accordance with the LMHRA-Act, the LibCTReg, and the G-LibClinTrial, a clinical trial can only commence after the sponsor or the representative receives authorization from the Liberia Medicines and Health Products Regulatory Authority (LMHRA). The LibCTReg and the G-LibClinTrial further state that the sponsor, the legal representative, the principal investigator (PI), or the sponsor-investigator must obtain written permission from the National Research Ethics Board of Liberia (NREB). In addition, per the G-LibClinTrial, the appointed PI must provide proof of residency in Liberia in the clinical trial application submission package.

As per the G-LibClinTrial, the sponsor or the representative is required to obtain LMHRA approval for the clinical trial before the import of an investigational product (IP) to be used in the trial is authorized. However, parallel submission is permitted for approval of the clinical trial and the IP import permit if the import permit application is included in the clinical trial application submission package.

In addition, per the LibCTReg, the applicant must inform the LMHRA in writing of the exact clinical trial commencement date (i.e., first patient first visit). If the trial does not begin within 90 calendar days from issuance of the clinical trial certificate, the applicant must show cause for the failure to commence as scheduled and solicit issuance of a new clinical trial certificate. Pursuant to Part VIII of the LMHRA-Act, the LibCTReg delineates that failure to inform the LMHRA of the commencement, or not starting the clinical trial within this period, will have regulatory implications including, but not limited to, the payment of administrative charges for the re-issuance of the clinical trial certificate on its expiration.

The LibCTReg also states that the sponsor, the investigator, and all of the persons involved in the clinical trial must fulfill the requirements of good clinical practice in accordance with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (LBR-8) and the World Health Organization (WHO)'s Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (LBR-25), as determined by the LMHRA. The G-LibClinTrial further specifies that the LMHRA has adopted LBR-8 for use along with the LMHRA guidelines.

Clinical Trial Agreement

While a formal clinical trial agreement is not an official requirement, the G-LibClinTrial states that the protocol should contain a statement that the trial will be conducted in compliance with the protocol, LBR-8, and the applicable regulatory requirements. The protocol should also be signed and dated by both the sponsor or the representative and the PI to document the investigator’s and the sponsor’s agreement to the protocol. If the protocol is not signed and dated by both parties, a corresponding declaration, signed and dated by both, must be provided to the LMHRA with the application.

Clinical Trial Registration

As delineated in the LibCTReg, the sponsor or the sponsor-investigator must register all clinical trials with a public international database. The G-LibClinTrial further specifies that the LMHRA requires the sponsor or the representative to provide proof of registration with the Pan African Clinical Trials Registry (PACTR) (LBR-36) or another WHO Primary Registry (LBR-35).

1, 2, and 3

Part IV (Sections 1 and 2), Part V (Section 5), and Part VIII

Part II (Section 1 (a-b and d), Section 5 (8), and Section 9 (1-3)) and Part III (Administrative Sanctions (2))

Safety Reporting

Last content review/update: August 29, 2025

Safety Reporting Definitions

According to the CTRules and the G-KenyaCT, the following definitions provide a basis for a common understanding of Kenya’s safety reporting requirements:

Adverse Event (or Adverse Experience) (AE) – Any untoward medical occurrence in a participant in a clinical investigation study or intervention product, and which does not necessarily have a causal relationship with the treatment
Adverse Drug Reaction (ADR) – All noxious and unintended responses to a clinical trial study or interventional product related to any dose or all unintended noxious responses to a registered medicinal product which occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function
Serious Adverse Event (SAE) – Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
Suspected Unexpected Serious Adverse Reaction (SUSAR) – A serious adverse reaction that is not identified in practice, severity, or frequency by the referenced safety information

Safety Reporting Requirements

Investigator Responsibilities

Per G-KenyaCT, the investigator must ensure that all SAEs are reported promptly to Kenya’s Pharmacy and Poisons Board (PPB) within the mandated timelines, as described below. Proper protection procedures or treatments should be administered to trial participants with SAEs.

Sponsor Responsibilities

As indicated in the CTRules and the G-KenyaCT, the sponsor should report to the PPB and all relevant institutions, all SAEs and SUSARs occurring during the course of the trial. The G-KenyaCT specifies that the sponsor should expedite reporting all SAEs to the PPB and the ethics committee (EC), and the sponsor and investigators should immediately undertake appropriate and necessary measures and treatment to protect the trial participants. The CTRules delineates that where a sponsor conducts a clinical trial on the same health product or active pharmaceutical substance in another country, the sponsor must submit a report of any SUSAR or SAE that occurs in the other clinical trial to the PPB. Per the CTRules and the G-KenyaCT, a sponsor must submit an initial report of a fatal or life-threatening SUSAR or SAE as soon as it occurs but, in any case, no later than seven (7) days after the occurrence of the event. The G-KenyaCT indicates that if the initial report is incomplete, the sponsor must submit a completed report based on the initial information within an additional eight (8) days. As required in the CTRules and the G-KenyaCT, a report of the occurrence of a SUSAR or SAE must specify whether the SUSAR or SAE is related to the clinical trial.

As indicated in the CTRules and the G-KenyaCT, other important considerations and timelines include the following (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

The sponsor must notify all the investigators involved in ongoing clinical trials of the investigational product (IP) of all SAEs and SUSARs within 15 calendar days
Any IP-related SAE must receive immediate medical attention and be reported to the PPB
The SAE report form must be completed (including lab results) and submitted to enable causality assessment
All fatal cases must be accompanied by a formal autopsy report, and a verbal autopsy report should be submitted in those exceptional cases where a formal autopsy is not possible
Any frequent IP related AE/ADR must receive immediate medical attention and be reported to the PPB within seven (7) days
The sponsor must submit a report on a SUSAR that is not fatal or life-threatening within 15 days after the occurrence of the event
The principal investigator (PI) is required to submit follow-up information as soon as it becomes available
All additional information should be clearly marked as updated and must include the Protocol Number and Participant Number
Foreign regulatory decisions that affect the safety or use of the product under study must be reported to the PPB within seven (7) days through a detailed report
Literature reports that have implications for the safety of the IP must be submitted within 15 days with a detailed report and a copy of the publication
New information or notification of change in nature, severity, or frequency of risk factors for the product under study or conduct of trial must be submitted within 15 days

Other Safety Reports

The G-ECBiomedRes indicate that ECs should monitor research, and will report to the National Bioethics Committee upon notification of an AE.

The CTRules and the G-KenyaCT state that the sponsor must also submit a safety report to the PPB once a year throughout the clinical trial, or upon request. The purpose of the annual safety report is to briefly describe all new safety information relevant to one (1) or more clinical trial(s), and to assess the safety conditions of the participants enrolled in these trial(s). The safety report must include a log of SAE and SUSAR events. The SAE and SUSAR log should include the following:

Patient Identification
Age
Date of recruitment into the study
Type of SAE or SUSAR
SAE or SUSAR start and end dates
Reason for reporting the event as an SAE or SUSAR
Relation to IP
SAE or SUSAR outcome

Note that the PPB may require more frequent reporting of the safety reports depending on the nature of the clinical trial being implemented. When this is the case, the PPB must communicate the required frequency to the PI and sponsor in writing.

Form Completion & Delivery Requirements

As per the G-KenyaCT and KEN-16, all SAEs and SUSARs must be reported to the PPB via the Pharmacovigilance Electronic Reporting System (PvERS) (KEN-6).

4.1 and 5.1

Glossary of Terms, 1.59, 1.63-1.88, and 1.318-1.339

Part I (2) and Part IV (12)

Last content review/update: April 13, 2026

Note: Per LBR-38, the National Research Ethics Board of Liberia (NREB) has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

Safety Reporting Definitions

According to the LibCTReg, the LibPVReg, and the G-LibPVSys, the following definitions provide a basis for a common understanding of Liberia’s safety reporting requirements (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Adverse Event (or Adverse Experience) (AE) – Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product, or any abnormal sign (e.g., any abnormal physical exam or laboratory finding), symptom, or disease, that is temporally associated with the participant’s involvement in the research; AEs encompass both physical and psychological harms
Adverse Drug Reaction (ADR) – Any noxious and unintended responses in a participant to an investigational medicinal product which is related to any dose administered to that participant. A causal relationship between a medicinal product and an adverse event is at least a reasonable possibility (i.e., the relationship cannot be ruled out)
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or may jeopardize the participant’s health and may require medical or surgical intervention based upon appropriate medical judgment (e.g., the development of drug dependency or drug abuse). A causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out
Unexpected Adverse Drug Reaction – An adverse reaction where the nature or severity is inconsistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product (IP) or package insert/summary of product characteristics for an approved product)

Safety Reporting Requirements

Per the LibCTReg and the G-LibClinTrial, the principal investigator (PI) or the sponsor should report any SAEs/SADRs suspected to be related to the IP immediately, and in any event, no later than three (3) calendar days after becoming aware of the event, to the Liberia Medicines and Health Products Regulatory Authority (LMHRA) and the NREB. However, per the LibCTReg, in the case of death, all SAEs must be reported within 24 hours. Per the G-LibClinTrial, in the case of multicenter trials involving clinical trial sites both within and outside of Liberia, the PI or sponsor must submit all SAEs/SADRs deemed to be related to the IP within 15 calendar days to the LMHRA and the NREB. The PI or the sponsor is also required to indicate the timelines allocated for related investigations.

In addition, the LibPVReg provides the following serious adverse reaction reporting timelines:

All serious adverse reactions associated with the use of a product must be reported on an expedited basis as soon as possible, but not later than 15 calendar days of initial receipt of the minimum required information. If all the information needed is not available within 15 days, the applicant should submit an initial report containing at least the minimum required data elements (i.e., patient details, suspected product details, reaction details, and the reporter details) in order to meet the expedited reporting timeframes. A follow-up report containing more detailed information should be submitted later as soon as this becomes available
Every serious suspected adverse reaction occurring in all post-marketing studies of which the manufacturer is aware must be reported to the LMHRA on an expedited basis

However, the LibPVReg also states that the reporting of SAEs and serious unexpected adverse drug reactions (SUSARs) occurring during clinical trials must comply with the requirements stipulated under the LibCTReg.

The G-LibPVSys also notes that all SUSARs occurring in Liberian post-authorization safety studies, of which the local representative or marketing authorization holder (MAH) is aware and includes the design and conduct of company-sponsored, post-marketing surveillance studies (i.e., Phase IV clinical trials), should be reported within seven (7) days.

Investigator Responsibilities

Pursuant to the LibPVReg, for fatal or life-threatening, unexpected events during clinical development, the PI is required to alert the LMHRA as soon as possible but not later than seven (7) calendar days after first knowledge. If a case qualifies, the PI should subsequently submit a complete report as soon as possible within eight (8) additional calendar days.

The G-NREB indicates that investigators are required to submit a report to the NREB for all AEs, except those resulting in death, within seven (7) calendar days. Investigator(s) must report all deaths that are possibly, probably, or definitely related to the study within 24 hours to the NREB.

Other events that must be reported to the NREB include the following:

Unanticipated problems involving risks to participants or others
Non-compliance (including major protocol deviations and non-compliance unrelated to a protocol deviation)
New information that might affect the willingness of participants to enroll or continue to participate in the study

For studies other than clinical trials that use the ACRE IRB, the G-ACRE-IRB states that the investigator must promptly report any unanticipated problems to the ACRE IRB in accordance with the following guidelines:

Unanticipated problems that are SAEs must be reported to the ACRE IRB within five (5) business days of the investigator becoming aware of the event. The board strongly recommends that a preliminary report be submitted by the investigator within 48 hours of learning of the SAE with a formal follow-up report submitted within the above timeline
Any other unanticipated problem should be reported to the ACRE IRB within two (2) weeks of the investigator becoming aware of the problem. The board strongly recommends that a preliminary report be submitted by the investigator within five (5) business days of learning of the unanticipated problem with a formal follow-up report submitted within the above timeline

See the G-ACRE-IRB for additional details on the information the investigator should provide.

Sponsor Responsibilities

As explained in the LibPVReg, AEs/ADRs, AEs following Immunization (AEFI) of a vaccine or biological product, fatal or life-threatening AEs of special interest (AESIs), and unexpected ADRs that occur during clinical investigations qualify for very rapid reporting. The sponsor must notify regulatory agencies (e.g., by telephone, facsimile transmission, or in writing) as soon as possible but no later than seven (7) calendar days after first knowledge that a case qualifies, followed by as complete a report as possible within eight (8) additional calendar days. The healthcare facilities, public health programs, manufacturers, MAHs, or any other designated person is required to report AEs/ADRs which include the following to the LMHRA:

All suspected ADRs resulting from prescription and non-prescription medicinal products
Unexpected reactions, regardless of their nature or severity, whether or not consistent with product information or labelling
All ADRs regardless of whether or not the product was used in accordance with the product information provided by the company marketing the product
All AEs following immunization or use of a biological product
A serious reaction, whether expected or not
ADRs in a special field of interest including drug abuse and drug use in pregnancy and during lactation
ADRs occurring from overdose or medication errors

See the LibPVReg for additional reporting requirements.

Per the LibPVReg, a case initially classified as a non-expedited report, would qualify for expedited reporting upon receipt of follow-up information that indicates the case should be re-classified. The reporting timeframe begins again upon receipt of any medically relevant information for a previously reported case.

Other Safety Reports

Per the LibPVReg, every sponsor and MAH is required to submit an annual Development Safety Update Report (DSUR) to the LMHRA for drugs under development, including marketed drugs under further study. A single DSUR must be prepared for each IP with data pertinent to all dosage forms and strengths, all indications, and all patient populations under study with the IP, wherever feasible. If this is not possible, an explanation should be provided in the introduction section of the DSUR. If more than one sponsor is involved in drug development, a single DSUR can be submitted. The DSUR must provide safety information from all ongoing clinical trials and other studies that the sponsor is conducting or has completed during the review period, including the following:

Clinical trials using an IP (e.g., human pharmacology, therapeutic exploratory, and therapeutic confirmatory trials (Phase I to III))
Clinical trials conducted using marketed drugs in approved indications such as therapeutic use trials (Phase IV)
Therapeutic use of an IP
Clinical trials conducted to support changes in the manufacturing process of medicinal products
Any significant other findings pertinent to the safety of the IP

Form Completion & Delivery Requirements

Liberia Medicines and Health Products Regulatory Authority

As per the G-LibClinTrial, all SAEs/SADRs and SUSARs must be reported on the LMHRA’s Suspected Adverse Drug Reaction Reporting Form (Annex 3 in the G-LibClinTrial). In addition, the LibPVReg states that medication errors arising during routine clinical practice must be reported to the LMHRA. The MAHs, healthcare providers, and public health programs must also notify the LMHRA of any reports of unusual failure in efficacy using the Suspected Adverse Drug Reaction Reporting Form. Additionally, patients or consumers may report any suspected ADR/AE associated with the use of a product immediately to the nearest health facility, healthcare provider, or directly to the LMHRA using the Suspected Adverse Drug Reaction Reporting Form.

Atlantic Center for Research and Evaluation Institutional Review Board

Per LBR-28, since all clinical trials protocols submitted to the ACRE IRB are referred to the NREB for review, all AEs/ADRs and SAEs/SADRs are only sent to the NREB. Safety reports for clinical research protocols other than clinical trials should be sent to the ACRE IRB.

National Research Ethics Board of Liberia

No information is available on NREB safety reporting forms and delivery requirements.

2, 6, 9, and Annex 3 (SADR Report - Form)

Glossary and Section 4 (4.5)

Article XXII

Researchers

Part I (Section 4) and Part II (Section 8)

Sections 3, 5 (1-2 and 6), 6 (2), and 9 (4)

Progress Reporting

Last content review/update: August 29, 2025

Interim and Annual Progress Reports

As stated in the G-KenyaCT, the sponsor and/or the principal investigator (PI) is required to send progress reports to the Pharmacy and Poisons Board (PPB) on an annual basis, or as may be required, from the date of the trial’s initiation. The progress report should contain the following:

Current status of the study
Summary of the participants screened (e.g., failed screenings, participants enrolled, withdrawn, or lost to follow-up, and other challenges)
Summary of protocol deviations and violations
Updated investigational product Investigator’s Brochure
Drug Safety Update Report
Copy of the latest Data Safety Management Board report
Copy of favorable opinion from the ethics committee (EC) on record
Copy of annual practice license for the investigators and pharmacists
Suspected, Unexpected, Serious Adverse Event (SUSAR) and Serious Adverse Event (SAE) Log

For multisite trials, per the G-KenyaCT, the sponsor or the representative must submit a summarized report for all of the sites and include the information listed above.

Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14). As per KEN-14, the investigator should promptly provide written reports to the sponsor and the institutional EC on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants.

According to the G-KenyaCT, for annual renewal of the study, the sponsor or the representative must submit a copy of the progress report including the documents listed above. The request must also be accompanied by copies of annual practice licenses for the investigators and pharmacists, and a copy of valid insurance coverage for the participants. All documents must be submitted using the PPB’s Online Clinical Trials Registry System (KEN-16). The sponsor or the representative must receive an acknowledgement of this submission before proceeding with the study. These documents must be submitted to the PPB at least six (6) weeks prior to the expiration of the previous approval.

Pursuant to KEN-14, the investigator should submit written summaries of the trial status to the institutional EC annually, or more frequently, if requested.

Final Report

Per the G-KenyaCT, the sponsor must notify the PPB of the end of a clinical trial taking place at a Kenyan site within 15 days. After the trial has been conducted and closed, the applicant must submit an executive summary report of the study within 30 days. This should be followed by a clinical study report within 180 days of the study closure unless otherwise justified. The report must comply with the International Council for Harmonisation's ICH E3 format (KEN-13). The report must include a short but comprehensive summary of the trial’s essential findings and methodology and should also contain a layman’s summary. Additionally, the sponsor must inform the PPB of any results that will be publicly released at least 14 days before release. In addition, upon completion of the trial, as delineated in KEN-14, the investigator is required to submit a final report to the institutional EC summarizing the trial’s outcome.

For multi-site research, the G-ECBiomedRes requires all parties to decide on procedures for drafting a common final report and publication at the onset of the research. Individual sites or institutions must not publish any data until the appropriate authorities accept the combined report.

KEN-31 further indicates that the research license applicant must submit one (1) hard copy and upload a soft copy of the final research report to the National Commission for Science, Technology and Innovation (NACOSTI) within one (1) year of the research’s completion.

5.1

1.48, 1.63, 1.497-1.506, 1.515-1.518, and 1.533-1.536

4.10 and 4.13

Last content review/update: April 13, 2026

Note: Per LBR-38, the National Research Ethics Board of Liberia (NREB) has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

Interim and Annual Progress Reports

Liberia Medicines and Health Products Regulatory Authority

Pursuant to the LibCTReg, the applicant must submit to the Liberia Medicines and Health Products Regulatory Authority (LMHRA) and the NREB progress reports containing safety updates and duly signed and authenticated Data and Safety Monitoring Board (DSMB) reports, as specified in the corresponding clinical trial guidelines. As specified in the G-LibClinTrial, the applicant must provide a progress report at least annually on the clinical trial to the LMHRA, unless otherwise stipulated in the clinical trial certificate. The report should contain recruitment status, safety updates, and DSMB reports, as well as an update on the use and results collected on biological samples exported out of Liberia, if applicable.

National Research Ethics Board of Liberia

As indicated in the G-NREB, for continuing review submissions, PIs must submit review reports to the NREB Secretariat at least eight (8) weeks prior to the approved protocol’s expiration. See LBR-6 for the NREB Continuing Review Form. Additionally, according to LBR-38, the NREB is also using LBR-24 for continuing review, for annual reports, and as a final report to close a study.

Per the G-LibClinTrial and the G-NREB, research in Liberia should comply with the International Council for Harmonisation's (ICH)’s Guideline for Good Clinical Practice E6(R2) (LBR-8). Refer to LBR-8 for additional progress reporting guidance.

Atlantic Center for Research and Evaluation Institutional Review Board

For clinical research studies using the ACRE IRB, the G-ACRE-IRB requires the principal investigator(s) (PIs) to submit progress reports (also referred to as continuing review submissions in Liberia) to the ACRE IRB. If no work was conducted on a study during the last approval period, the PIs should explain why (e.g., too busy with other projects; a delay in funding; or unable to hire a graduate student to work on the project). If the PI(s) are closing the study, a copy of any publications or manuscripts resulting from the study should be attached.

See the G-ACRE-IRB for details on the required documentation to submit a continuing review to the ACRE IRB.

Final Report

Liberia Medicines and Health Products Regulatory Authority

The LibCTReg states that the applicant is required to submit a final clinical trial summary report to the LMHRA. As per the LibCTReg and the G-LibClinTrial, the applicant must notify the LMHRA within 30 business days from the end of a clinical trial. Per the G-LibClinTrial, the end of the trial definition should be documented in the clinical trial protocol.

The LibCTReg and the G-LibClinTrial also indicate that the applicant must submit a closeout report with a copy of the LMHRA-issued disposal certificate to the LMHRA. The G-LibClinTrial specifies this report should be submitted within 90 days from completion of the clinical trial. (See Annex 5 of the G-LibClinTrial for closeout report form).

In addition, per the LibCTReg and the G-LibClinTrial, the applicant must submit a comprehensive end of study report conforming to the ICH’s Structure and Content of Clinical Study Reports (E3) (LBR-37) guidelines, within one (1) year from the trial’s completion.

Per the LibCTReg and the G-LibClinTrial, the end of study report must also contain any AEs reported by the PIs.

National Research Ethics Board

The LibCTReg states that the applicant is required to submit a final clinical trial summary report to the NREB. The applicant must also notify the NREB within 30 business days from the end of a clinical trial.

Additionally, per the LibCTReg, the PI must also inform the NREB of any AEs as part of the end of study report.

The LibCTReg further specifies that the applicant must submit a comprehensive end of study report to the NREB conforming to the LBR-37 guidelines, within one (1) year from the trial’s completion.

According to LBR-38, the NREB is using LBR-24 for continuing review, for annual reports, and as a final report to close a study.

Atlantic Center for Research and Evaluation Institutional Review Board

Per the G-ACRE-IRB, PI(s) should complete Section 12 (Disposition of Project) of the ACRE IRB Submission Form (Section 25.02 in Article XXV of the G-ACRE-IRB) for the final ACRE IRB review. For the board’s purposes, the project has ended when there is no further participant enrollment, intervention(s), or data collection, and the remaining data are either de-identified or maintained with safeguards. The PI(s) should use this section to describe the disposition of the project and its data and to provide a brief summary of their findings.

Foreword, 6, and 9 (Annex 5)

Article XVI and Article XXV (Sections 25.02 and 25.05)

Background and Submission Types

Part II (Section 8 (2) and Section 9 (4-5 and 7-9))

Definition of Sponsor

Last content review/update: August 29, 2025

New Info (Not Yet in Profile)

The Pharmacy and Poisons Board issued Revision 5 of Guidelines for the Conduct of Clinical Trials in Kenya, effective January 2, 2026, which includes additional/revised definitions; alignment with ICH, WHO, PIC/S, and GCLP standards; new application process/requirements for multicenter clinical trials; clarification on investigator categories and qualifications; clarification on safety reporting; and alignment of study monitoring requirements to ICH E6(R3).

As per the G-KenyaCT, a sponsor is defined as an individual, a company, an institution, or an organization who takes legal responsibility for the initiation, management, and financing of a trial. According to the G-KenyaCT, a sponsor, in a written document, may agree to transfer all related activities of the clinical trial to designated research institutions. However, all responsibility for the trial lies with the sponsor. The G-ECBiomedRes indicates that sponsors may be foreign, but must comply with certain conditions including affiliating themselves to institutions recognized in Kenya.

Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14). In accordance with KEN-14, Kenya permits a sponsor to transfer any or all of its trial-related duties and functions to a contract research organization (CRO) and/or institutional site(s). However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality control.

4.1 and 6.0

Glossary of Terms, 1.48, 1.63, and 1.68

5.1 and 5.2

Last content review/update: April 13, 2026

As stated in the LibCTReg and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with LMHRA guidelines. Per LibCTReg, the sponsor is defined as an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.

LibCTReg also defines a sponsor-investigator as an individual who both initiates and conducts an investigation, alone or with others, and under whose immediate direction the investigational product is administered or dispensed. The term does not include any person other than an individual. The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.

In addition, per the LibCTReg, the sponsor may hire a contract research organization (CRO) (commercial, academic, or other) to perform one (1) or more of the sponsor’s trial-related duties and functions. See LBR-8 for additional guidance on sponsor responsibilities.

Foreword

Part I (Section 4) and Part II (Section 1 (a))

Site/Investigator Selection

Last content review/update: August 29, 2025

Overview

The G-KenyaCT, which requires sponsors to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), states that the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial and for ensuring that the investigator(s) are qualified by education, training, and experience.

Per the CTRules and the G-KenyaCT, investigators must also meet the following requirements (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Provide evidence of their qualifications and experience through an up-to-date curriculum vitae (CV)
Have a current practice license from the relevant regulatory authority
Be familiar with the characteristics and appropriate use of the investigational product (IP) as described in the protocol, current Investigator’s Brochure (IB), in the product information, and in other information sources
Have a clear understanding and willingness to obey the ethical, good clinical practice (GCP) and legal requirements in the conduct of the trial
Permit monitoring and auditing of the trial and inspection by the Pharmacy and Poisons Board (PPB) or appointed representatives
Keep a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties
The principal investigator (PI) must be an appropriately qualified and competent person having practical experience within the relevant professional area and who is responsible for the conduct of the clinical trial at a clinical site
The PI must have a degree in medicine, pharmacy, pharmacology, toxicology, biochemistry, dentistry, or a related discipline from a university recognized in Kenya
The PI must have a valid practice license from the relevant regulatory authority
The PI must have a valid professional indemnity cover
The PI must be a citizen of Kenya or a permanent resident in Kenya
A PI must have had previous experience as a co-investigator in at least two (2) trials in the relevant professional area
Have adequate time and resources to carry out the study (See Annex 6 of the G-KenyaCT for the PPB’s recommended format to document the investigator’s workload)

Further, the G-KenyaCT states that sponsors must ensure that investigators have had formal training in GCPs with proof that a GCP course was attended within the last two (2) years. If training has not been completed, it is the responsibility of the sponsor to organize this training prior to initiating the study. The investigators will need to provide evidence of having obtained this training. As delineated in KEN-14, prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor should provide the investigator(s) with the protocol and an IB. Furthermore, the sponsor must sign an agreement or contract with the participating institution(s). Additionally, the sponsor must define and allocate all study related duties and responsibilities to the relevant parties participating in the study. (See the Submission Content section for additional information on clinical trial application requirements.)

Institutional Registration

The STI-Act and the STI-Regs require research institutions to register with the National Commission for Science, Technology and Innovation (NACOSTI) and obtain a Certificate of Registration. For detailed guidance on the vetting and approval process, see the STI-Regs and the G-InstitutionRegistration.

The application for registration of research institutions is provided in KEN-11, and the reporting tool for registered research institutions is provided in KEN-36. As indicated in KEN-40, institutions can apply for a license to establish a research institution on the NACOSTI eCitizen platform (KEN-12).

Foreign Sponsor Responsibilities

The G-ECBiomedRes requires that with collaborative research projects, the collaborating investigators, institutions, and countries must function as equal partners with safeguards to avoid exploitation of local researchers and participants. An external sponsoring agency should submit the research protocol to their country’s EC, as well as the Kenyan EC where the research is to be conducted. Further, this research must be responsive to the health needs of Kenya and reasonably accessible to the community in which the research was conducted. Consideration should be given to the sponsoring agency agreeing to maintain health services and faculties established for the purposes of the study in Kenya after the research has been completed. Such collaborative research must have a local/Kenyan co-principal investigator.

Data and Safety Monitoring Board

The G-KenyaCT indicates that the PPB recommends establishing a Data and Safety Monitoring Board (DSMB) to monitor trials in the following types of studies:

Where the endpoint is such that a highly favorable or unfavorable result, or even a finding of futility at an interim analysis, might ethically require the trial to be terminated early
When there are safety concerns due to the use of a particularly invasive treatment
Where there is prior information suggesting the possibility of serious toxicity with the study treatment
Where the participants involved represent a vulnerable population (e.g., children, pregnant women, elderly, terminally ill, or mentally incapacitated)
When the participants represent a population at higher risk of death or other serious outcomes
When the study is large, of long duration, and multi-center

KEN-14 states that a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Per the G-KenyaCT, the DSMB must provide the following documentation to the PPB:

DSMB composition
Copy of DSMB charter
DSMB reports to be submitted to the PPB within two (2) weeks of its deliberations and in the request for annual approval

For multicenter trials, the G-ECBiomedRes requires that centralized data management and analysis should be planned as per G-WHO-DSMB.

Multicenter Studies

Per the G-KenyaCT, for multicenter studies in Kenya, the coordinating investigator should be a Kenyan resident and should assume full responsibility for the trial.

The G-ECBiomedRes requires that multicenter trials conducted simultaneously by several investigators at different sites follow the same protocol. Ideally, these trials should be initiated at the same time at all sites. The sponsor must provide the protocol to the investigators, who will accept the protocol in writing. If approved by the EC of the local host institution, the protocol may be modified to suit the local conditions. Meetings should be organized at the initial and intermediate stages of the trial to ensure uniform procedures at all sites. All sites and parties should also agree on procedures for publication of a final report. Research staff should receive training at every trial site on the uniform procedures. In addition, research staff at all sites should implement standard methods for recruitment and evaluation/monitoring of laboratory procedures and conduct of trial. There must be monitoring to ensure the sites are following the protocol, which must include measures to terminate the participation of some sites, if necessary. Finally, centralized data management and analysis should be planned as per G-WHO-DSMB.

Additional multicenter guidance is delineated in KEN-14:

All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and, if required, by the PPB, and given EC approval
The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
Investigator responsibilities are documented prior to the start of the trial
All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs
Communication among investigators is facilitated

4.1, 5.1, and 6

Glossary of Terms, 1.30-1.88, 1.340-1.345, and Annex 6

Part V

Part III (7)

Science, Technology and Innovation (Registration and Accreditation of Research Institutions) Regulations, 2014 (Part II, First Schedule, and Second Schedule)

1.25, 5.5, 5.6, and 5.23

Last content review/update: April 13, 2026

Overview

According to the LibCTReg and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with LMHRA guidelines. Refer to LBR-8 for additional guidance on sponsor site/investigator selection requirements.

As stated in the G-LibClinTrial, all investigators must be trained in good clinical practice (GCP), as documented by the provision of training certificates that are no more than three (3) years old at the time of application. Any other training or experience from previous clinical trials and patient care, as needed for the conduct of the trial, must be provided for the investigators to prove their qualifications. The principal investigators (PIs) should have acted as a PI, or at least as an investigator, in at least one (1) prior clinical trial and must provide proof of residency in Liberia in the clinical trial application submission package. The LibCTReg further states that the trial is to be conducted in an appropriate facility by a suitably qualified investigator in a responsible manner and managed by an investigator who can provide evidence of sufficient experience in the conduct of clinical trials, as determined by the LMHRA.

Per the G-NREB, PIs are also required to be able to provide a current Certificate of Training in GCP for PIs, be qualified to undertake the particular study, and be knowledgeable in the values and tenets of ethical and regulatory principles and scientific method applications associated with conducting research in human participants.

In addition, the G-LibClinTrial requires the applicant to provide details of the site(s) where the clinical trial is to be conducted, along with a duly justified written statement on the suitability of the trial sites, adapted to the nature and use of the investigational product in the clinical trial application submission package. The statement should include a description of the suitability of facilities, equipment, human resources, and description of expertise, issued by the head of the clinic/institution at the trial site or by some other responsible person.

See also LBR-8 for information on sponsor agreements with investigators/institutions.

Foreign Sponsor Responsibilities

No information is currently available on foreign sponsor requirements.

Data and Safety Monitoring Board

As per the G-LibClinTrial, the sponsor or the representative should provide information on the composition of the Data and Safety Monitoring Board (DSMB) in the clinical trial application submission package. This information should include the list of members, the terms of reference, and the CVs of its members to justify their expertise as members of the DSMB.

See LBR-8 for additional DSMB guidance.

Multicenter Studies

See LBR-8 for guidance on sponsor requirements for multicenter clinical trials.

Foreword, 2, and 9

Researchers

Part II (Section 1 (a and 9))

Insurance & Compensation

Last content review/update: August 29, 2025

Insurance

As set forth in the G-KenyaCT and the G-ECBiomedRes, the sponsor must provide insurance cover for the study participants and ensure that the clinical trial institution, contract research organization (CRO), and researchers have sufficient insurance cover for the clinical trial. Per the G-KenyaCT, the sponsor’s policies and procedures should address the treatment costs for trial participants in the event of trial-related injuries, and the sponsor should submit this information as part of the clinical trial application (see KEN-34). In addition, a no-fault insurance cover must be obtained for all controlled human infection studies. The International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14) guides sponsors on providing insurance. Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in KEN-14.

Per the G-KenyaCT, for all sponsor-initiated studies, insurance coverage must be provided by an insurer registered by Kenya’s Insurance Regulatory Authority (IRA), and a valid insurance certificate must be issued by the IRA prior to the trial’s initiation and cover the duration of the study. The insurance certificate must be submitted as evidence to the Pharmacy and Poisons Board (PPB). The certificate must be properly executed by an insurance company under a valid insurance policy which makes explicit reference to the proposed study. In addition, the policy must grant coverage for any participant injury that is causally linked to trial activities. The policy must also cover the investigator(s)’ and the sponsor(s)’ liability in the trial, without excluding any damage which may be attributed to negligence. Moreover, self-insurance of the participants by other entities will not be sufficient.

Further, per the G-KenyaCT, the sponsor must ensure that the investigators and CROs have professional indemnity insurance coverage for the period of the trial. The host institution must also have in place sufficient insurance to meet the potential liability of its investigators, those acting on behalf of the investigators, and its research members.

Compensation

Injury or Death

As specified in the G-KenyaCT and the G-ECBiomedRes, the sponsor is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death. Per the G-ECBiomedRes, participants are entitled to such financial or other assistance as would compensate them equitably for any temporary or permanent impairment or disability. In the case of adverse events, there should be proper assessment, evaluation, and compensation. The G-ECBiomedRes also indicates that when investigational vaccines contain active or live-attenuated micro-organisms, should participants in the control group contract the disease for which a vaccine is being tested, free treatment must be provided.

In addition, the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14) provides guidance for sponsors on providing compensation to research participants in the event of trial-related injuries or death. The sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

Trial Participation

The G-ECBiomedRes defines compensation to include offers to participants, monetary or otherwise, to offset the time and inconvenience for participating in research.

Post-Trial Access

Per the G-KenyaCT, the sponsor must put in place measures to ensure that the study participants have access to successful investigational products for their disease condition before the products have received a marketing authorization in Kenya, especially for Phase III clinical trials. The G-ECBiomedRes indicates that when investigational vaccines contain active or live-attenuated micro-organisms, post-trial access to the vaccine should be available to the control group.

Definitions, 3.2, 4.2, and 5.3

1.48, 1.63-1.130, 1.173-1.181, and 1.437-1.490

4.8 and 5.8

Last content review/update: April 13, 2026

Insurance

As set forth in the LibCTReg and the G-LibClinTrial, the applicant should include documentation in the clinical trial application submission package to verify active clinical trial insurance that covers Phases I, II, and III; proof of professional indemnity (malpractice insurance); and proof of sponsor indemnification for investigators and the trial site. The LibCTReg also notes that an indemnity, in the form determined by the Liberia Medicines and Health Products Regulatory Authority (LMHRA), is to be signed by the participant to protect the LMHRA from liability related to an injury or an adverse event that may be sustained by a person, directly or indirectly, as a result of the conduct of the trial and that occurs or reveals itself at the time of the trial or subsequently. The LibCTReg further notes that any person(s), institution(s), corporate entity(ies), their designees, or legal representative(s) who fail to provide insurance coverage for prospective participants as required, and where bodily injury or substantial harm results in the course of the research, commits a first degree misdemeanor.

The G-LibClinTrial also specifies that a study insurance certificate and an indemnity provision should be current and valid for the full duration of the trial and follow-up period. If the validity is shorter, a written renewal commitment for the trial duration is required. The certificate should contain a reference to the clinical trial, the clinical trial protocol number, and the countries to which the insurance cover is extended. The insurance cover should be provided from an internationally recognized company. Additionally, the LibCTReg, requires an insurance policy to be in place to provide benefits in the event that a clinical trial participant suffers injury or death related to the study.

In addition, per the G-LibClinTrial, under certain circumstances, the LMHRA may accept an expedited application and review process for clinical trials (e.g., epidemics or other urgent public health interests requiring fast use of new medicines or health products and/or fast gathering of health product information). In the case of trials involving human participants, the applicant must provide proof of current, relevant, and appropriate study insurance for all participants, or professional indemnity insurance for investigators, as part of the application submission package to be sent to the LMHRA. Furthermore, as specified in the LibCTReg and the G-LibClinTrial, the LMHRA has adopted the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines. See LBR-8 for additional sponsor insurance requirements.

Compensation

Injury or Death

Pursuant to Part VIII of the LMHRA-Act, the LibCTReg specifies that the principal investigator (PI) or organization is subject to an action of damages for any Serious Adverse Event (SAE)/Serious Adverse Drug Reaction (SADR) that is life-threatening, or results in persistent or significant disability/incapacity or congenital anomaly/birth defect, during the conduct of a clinical trial. Additionally, any SAE/SADR that is life-threatening or results in persistent or significant disability/incapacity, congenital anomaly/birth defect to a participant during the conduct of a clinical trial, subjects the PI or organization to an action of damages.

See LBR-8 for additional sponsor compensation requirements related to trial-related injuries.

Trial Participation

See LBR-8 for guidance on sponsor compensation requirements for trial participants.

Foreword, 2, and Annex 9

Part VIII

Part II (Section 1 (a, d (29, 30, and 34), and e (10 and 11))) and Part III (Civil Liability and Criminal Penalty)

Risk & Quality Management

Last content review/update: August 29, 2025

Quality Assurance/Quality Control

As stated in the CTRules and the G-KenyaCT, the sponsor is responsible for maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol, the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), the STI-Regs, and other applicable regulatory requirements. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. In addition, per the STI-Regs, all persons and research institutions (i.e., sponsors) undertaking research in Kenya must ensure the highest standards and quality of research for the realization of institutional mandates and national priorities.

In addition to complying with KEN-14, the G-KenyaCT indicates QA processes should be developed to ensure:

Regular and continuous monitoring of the study and the implementation of monitoring reports’ recommendations
Submission of the study monitoring plan to the Pharmacy and Poisons Board (PPB) during the initial submission of the application
The clinical trials research site must have valid registrations and approvals
Patient safety and confidentiality are not compromised
Analysis or evaluation of samples is performed in accordance with the protocol and good clinical practice (GCP) principles and, where applicable, the contract/agreement, the work instruction, and associated methods
Adherence to the laboratories’ policies and SOPs
Trial data is recorded and reported accurately, legibly, completely, and in a timely manner
Trial data is archived
Preparation of a work instruction detailing the procedures that will be used to conduct the analysis or evaluation prior to the initiation of sample analysis or evaluation, as necessary
Be built or adapted for the purpose
Have automated equipment for routine hematology, biochemistry, and serology tests
Have procedures for analyzer calibration and quality control
Regular maintenance of all the equipment, including point-of-care equipment
Have a procedure for transporting samples safely and quickly from clinical areas to the laboratory
Have written procedures for all assays, and to validate the assays
Reagents and consumables are used within their expiry dates based on a stock control procedure
Records are kept, including source documents and final reports
Have a procedure for authorizing and releasing results
Have a procedure for ‘flagging’ and notifying medical staff of abnormal results
Have a laboratory information management system, and validate and back up the system
Protective clothing and safety equipment are provided for staff
Have a central alarm system for all fridges and freezers
Have an internal audit program

Per KEN-14, the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes:

During protocol development, identify processes and data that are critical to ensure participant protection and the reliability of trial results
Identify risks to critical trial processes and data
Evaluate the identified risks against existing risk controls
Decide which risks to reduce and/or which risks to accept
Document quality management activities and communicate to those involved in or affected by these activities
Periodically review risk control measures to ascertain whether the implemented quality management activities are effective and relevant
In the clinical study report, describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken

Per the G-KenyaCT protocol violations and protocol deviations must be reported to the PPB within seven (7) days of the principal investigator (PI) becoming aware of them. The details to be reported must include:

Date of the deviation/violation
Study participant(s) affected
Name of the treating physician
Detailed description of the deviation/violation
Indication whether the study participants were adversely affected by the deviation/violation
Explanation of why the deviation/violation occurred
Measures taken to address the deviation/violation
Measures taken to preclude future recurrence of the deviation/violation

In addition, see G-KenyaCT for information about medical care of trial participants during and following the clinical trial. Also see the Bft-Risk for a standardized approach for evaluating and reporting the balance between the benefits and risks of health products, which includes investigational products (IPs) undergoing clinical trial application.

The CT-Emrgcy provides guidance to sponsors, PIs, and institutions on the conduct of clinical trials during public health emergencies to maximize the safety of research participants, minimize risks to participants and the community, and ensure the integrity of the clinical trials. See CT-Emrgcy for details on a range of issues, including contingency planning, communication with participants, changes to studies, protocol deviations, reporting, and supply of IPs during a public health emergency.

Controlled Human Infection Studies

The G-KenyaCT also provides detailed information on controlled human infection studies (CHIS) requirements to ensure investigator/study personnel compliance with GCP and other QA/QC requirements, including the following:

The well characterized strain of an infectious agent should be administered at a controlled dose and by a specific route to carefully selected adult volunteers
The studies require safe and accurate microbiology, good clinical facilities, careful recruitment, and monitoring
Participants must be monitored for evidence of carriage or infection under medical supervision to anticipate or manage symptoms of disease and adverse events
The value of the information to be gained should clearly justify the risks and the study must have a risk mitigation plan
The investigators should be adequately qualified, trained, and experienced in the conduct of CHIS as well as treating patients with the infectious disease being investigated

For the complete list of requirements, see the G-KenyaCT.

The G-ECBiomedRes provides additional considerations when investigational vaccines contain active or live-attenuated micro-organisms:

The participant to be vaccinated should be given adequate information about the adverse effects.
Should participants in the control group contract the disease for which a vaccine is being tested, free treatment must be provided.
Because the risks associated with vaccines produced by recombinant DNA techniques are not completely known, PPB guidelines must be strictly followed.
Post-trial access to the vaccine should be available to the control group

Monitoring Requirements

As part of its QA system, the G-KenyaCT requires the sponsor to develop an internal audit program. The G-KenyaCT defines an audit as a systematic examination, carried out independently of those directly involved in the trial, to determine whether the conduct of a trial complies with the agreed study protocol and whether data reported are consistent with those on record at the site. Further, the sponsor is required to obtain agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities. An investigator must, upon request from any properly authorized officer or employee of PPB at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the investigator.

Per KEN-14, the sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency. The sponsor may choose onsite monitoring, a combination of onsite and centralized monitoring, or, where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).

KEN-31 indicate that the National Commission for Science, Technology and Innovation (NACOSTI) may conduct an evaluation, or cause an evaluation to be conducted, of a research study to assess and evaluate compliance with the conditions of the applicable research license.

Premature Study Termination/Suspension

The G-KenyaCT indicates that the protocol should have a clear description of study stoppage rules indicating reasons, who makes the decision, and how the decision will be communicated to the PPB and the EC. If a trial is terminated by the PI or the sponsor, the PI or the sponsor must inform the PPB not later than 15 days following the termination date. The co-investigators must also be informed as soon as possible and should be advised in writing of potential risks to the research participants, and they must ensure that patients continue to receive medical care. The PPB must be provided with reason(s) for the termination and its impact on the proposed or ongoing trials with respect to the IP, including issues relating to IP accountability and disposal as well as record(s) maintenance. In addition, the PPB may withdraw the authorization to conduct a clinical trial if it finds that the safety of the participants is compromised or that the scientific reasons for conducting the trial have changed.

According to KEN-14, if it is discovered that noncompliance significantly affects or has the potential to significantly affect participant protection or reliability of trial results, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions. Further, the EC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor.

4.2 and 5.3

1.42A, 1.63-1.88, 1.125, 1.437-1.491, 1.497-1.506, 1.525, and 1.533-1.536

Part III (8)

The Science, Technology and Innovation (Registration and Accreditation of Research Institutions) Regulations, 2014 (Part III); and The Science, Technology and Innovation (Relevance and Quality Assurance in Research) Regulations, 2014 (Parts I-III)

5.0-5.2, 5.5, 5.18-5.19, 5.21, and 6.10

Last content review/update: April 13, 2026

Quality Assurance/Quality Control

As specified in the LibCTReg and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation (ICH)'s Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines. Refer to LBR-8 for guidance on sponsor responsibilities related to quality assurance (QA) and quality control (QC) systems throughout the conduct of the trial.

Monitoring Requirements

See LBR-8 for sponsor monitoring requirements.

Premature Study Termination/Suspension

Pursuant to the LibCTReg, if the trial is suspended or terminated before its purpose is achieved, the applicant must convey the reason(s) in writing to the LMHRA and the National Research Ethics Board of Liberia (NREB) within 10 working days, and all information must be provided as determined by the LMHRA. The G-LibClinTrial also states that the applicant must inform the LMHRA of a clinical trial suspension or premature termination of a clinical trial within 10 working days, and clearly explain the reasons for this decision. See also LBR-8 for additional guidance on sponsor requirements related to premature study terminations/suspensions.

Foreword, 2, and 5

Part VIII

Part II (Section 1 (a) and Section 9 (6)), and Part III (Administrative Sanctions)

Data & Records Management

Last content review/update: August 29, 2025

Electronic Data Processing System

Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14). As per KEN-14, when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. Per KEN-14, the sponsor should base their approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain standard operating procedures (SOPs) for the systems that cover setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be provided with training. Refer to KEN-14 for additional information.

Records Management

According to the G-KenyaCT, it is the responsibility of the investigator and the sponsor to archive safely all trial-related documentation. All Kenyan trial site-related documentation must be archived within the country and not exported. Additionally, the sponsor/applicant must inform the Pharmacy and Poisons Board (PPB)’s Expert Committee on Clinical Trials (ECCT) in writing prior to destroying any trial documents. The notification must include the protocol number, start and end date, and the license number.

The G-KenyaCT states that study documents must be archived for a minimum of 10 years from the end of the study. Also, records must be made available to the PPB within three (3) days if there is a concern regarding the use of a clinical trial drug and/or a risk to the health of the clinical trial participant. In any other case, records must be provided within seven (7) days of request.

Per the STI-Regs, sponsors should store research findings and information regarding research systems in a designated location with clear labels of the subject area. Research findings must be documented in bound books or documents with the research title, author, year, and other relevant information clearly printed on the cover page. A report of research work by staff and the research institution must be submitted to the National Commission for Science, Technology and Innovation (NACOSTI) within two (2) months after publication or compilation of the research report.

In addition, KEN-14 states that the sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

Glossary of Terms, 1.48, 1.63, and 1.537-1.541

The Science, Technology and Innovation (Registration and Accreditation of Research Institutions) Regulations, 2014 (Part IV)

1.65, 5.5, and 8

Last content review/update: April 13, 2026

Note: Per LBR-38, the National Research Ethics Board of Liberia (NREB) has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

Electronic Data Processing System

As specified in the LibCTReg and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation (ICH)'s Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines. See LBR-8 for sponsor requirements when using electronic data processing systems.

Records Management

The G-LibClinTrial specifies that the principal investigator (PI) must keep an Investigator Site File (ISF), and the sponsor must keep a Trial Master File (TMF) containing essential documents relating to the clinical trial, which provide verification for the trial conduct and the quality of the data generated, taking into account all trial characteristics. The files must be readily available and directly accessible upon request from the LMHRA. The sponsor and the investigator must archive the contents of the TMF and ISF, respectively, for at least 25 years after the end of the trial including the medical files of study participants.

See also LBR-8 for additional sponsor requirements related to record management.

As per the G-LibClinTrial, data handling and recordkeeping should be conducted in conformity with the World Health Organization's Good Clinical Practice Guidelines (LBR-25) (refer to Section 8 for details).

Per the G-ACRE-IRB, for clinical research studies using the ACRE IRB, research records from a study must be retained by the investigator(s) for a period of no more than five (5) years following the closure date. If other regulations and policies apply to a particular protocol, then the duration of protocol retention is in accordance with the applicable regulations/policies. For detailed ACRE IRB recordkeeping requirements, refer to the G-ACRE-IRB.

The G-ACRE-IRB also specifies that although a research protocol has been closed, the investigator(s) should keep the data they have collected, including identifiable private data, in a manner consistent with the board-approved protocol and participant consent requirements. The investigator(s) must continue to honor any confidentiality protections applicable to the data. Refer to the Informed Consent topic for additional information on documentation requirements and research participant rights during the informed consent process.

8

Foreword and 7

Articles X (Section 10.016) and XI (Section 11.05)

Part II (Section 1 (a))

Personal Data Protection

Last content review/update: August 29, 2025

Responsible Parties

The DPA delineates that the “data controller” determines the purpose and means of processing personal data. The "data processor" processes personal data on behalf of the data controller. Data controllers and processors must be registered with the Kenya Data Commissioner. Per the DataProtect, an application for registration of a data controller or data processor must be on Form DPR1 (found in the First Schedule of DataProtect) with supporting materials and the required registration fees as specified in the Second Schedule. See the DataProtect for additional details on registration requirements.

Data Protection

Per the DPA, the data controller (sponsor) must ensure that personal data is:

Processed in accordance with the right to privacy of the data subject
Processed lawfully, fairly, and in a transparent manner in relation to any data subject
Collected for explicit, specified, and legitimate purposes and not further processed in a manner incompatible with those purposes
Adequate, relevant, and limited to what is necessary in relation to the purposes for which it is processed
Collected only where a valid explanation is provided whenever information relating to family or private affairs is required
Accurate and, where necessary, kept up to date, with every reasonable step being taken to ensure that any inaccurate personal data is erased or rectified without delay
Kept in a form that identifies the data subjects for no longer than is necessary for the purposes for which it was collected
Not transferred outside Kenya, unless there is proof of adequate data protection safeguards or consent from the data subject

The DataProtect, which implements the DPA, requires data controllers and data processors to develop, publish, and regularly update a policy on their personal data handling practices. The policy should include the nature of personal data collected and held, how a data subject may access their personal data, complaints handling mechanisms, the lawful purpose for processing personal data, and requirements for when personal data is to be transferred outside Kenya. Regarding cross-border transfers of data, a data controller or data processor who is a transferring entity must (before transferring personal data out of Kenya) ascertain that the transfer is necessary. This necessity decision should be based on considerations such as data protection safeguards, an adequacy decision made by the Data Commissioner, and if there is consent of the data subject.

Per the DataProtect, data controllers and/or data processors must retain personal data processed for a lawful purpose and only as long as may be reasonably necessary for the purpose for which the personal data is processed. A data controller or data processor must establish a personal data retention schedule with appropriate time limits and periodic reviews. When the retention period has ended, the personal data must be erased, anonymized, or pseudonymized.

See DataProtect for additional details on data protection, including data subject rights, data protection design and principles, notification of breaches, impact assessments, and exemptions.

See Parts IV-VII of the DPA for detailed requirements on data processing, sensitive personal data, exemptions, and transfer of personal data outside of Kenya. The G-ECBiomedRes requires compliance with the DPA.

Consent for Processing Personal Data

Per the DPA, the data controller (sponsor) or data processor must bear the burden of proof for establishing a data subject’s consent to the processing of their personal data for a specified purpose. For the purposes of processing personal data, consent means any manifestation of express, unequivocal, free, specific, and informed indication of the data subject’s wishes by a statement or by a clear affirmative action, signifying agreement to the processing of personal data relating to the data subject. Unless otherwise provided under the DPA, a data subject has the right to withdraw consent at any time. The withdrawal of consent must not affect the lawfulness of processing based on prior consent before its withdrawal.

The DataProtect requires data controllers and data processors to ensure that a data subject has the capacity to consent and voluntarily gives consent. In seeking consent (prior to the processing), the data subject should be informed of:

The identity of the data controller or data processor
The purpose of each of the processing operations for which consent is sought
The type of personal data that is collected and used
Information about the use of the personal data for automated decision-making, where relevant
The possible risks of data transfers due to absence of an adequacy decision or appropriate safeguards
Whether the personal data processed will be shared with third parties
The right to withdraw consent
The implications of providing, withholding, or withdrawing consent

Per the DataProtect, this information may be presented to the data subject through a written notice, oral statement, audio or video message. The data controller or a data processor must ensure that the data subject has the capacity to voluntarily give consent that is specific to the purpose of processing.

Children

The DPA indicates that in cases where the data subject is a minor, a person who has parental authority or a guardian may exercise personal data protection rights conferred on the subject. With regard to data processing, the DPA requires that every data controller (sponsor) or data processor must not process personal data relating to a child unless consent is given by the child's parent or guardian and the processing is in a manner that protects and advances the rights and best interests of the child. A data controller or data processor must incorporate appropriate mechanisms for age verification and consent to process personal data of a child, including available technology, volume of personal data processed, proportion of such personal data likely to be that of a child, possibility of harm to a child arising out of processing of personal data, and other factors as may be specified by the Kenya Data Commissioner.

Mentally Impaired

The DPA indicates that in cases where the data subject has a mental or other disability, a person duly authorized to act as the participant’s guardian or administrator may exercise personal data protection rights conferred on the subject.

4.2.5

Part I (2), Part III (18) and (25), and Parts IV-VII

No. 263 (Parts I-X) and No. 265 (5, First Schedule, and Second Schedule)

Last content review/update: April 13, 2026

Responsible Parties

No information is currently available related to responsible parties for personal data protection.

Data Protection

No information is currently available related to data protection.

Consent for Processing Personal Data

As stated in the LibCTReg, the clinical trial participant must be informed of the purpose and scope of the collection and use of personal data, especially medical data. The trial participant must be informed especially of the fact that, where necessary, the collected data should be:

Kept available for inspection by the Liberia Medicines and Health Products Regulatory Authority (LMHRA) or for monitoring or auditing by the sponsor in order to verify the proper conduct of the clinical trial
Be passed on to the sponsor and the LMHRA without disclosing the identity of the trial participant

The LibCTReg further notes that a declaration of consent to participate in a clinical trial can be revoked at any time in the presence of the investigator or a member of the investigating team, orally or in writing, without disadvantage to the trial participant. In the case of a revocation of consent, the study participant must decide whether their stored data may continue to be used.

Part II (Section 1 (e (7-8))

Documentation Requirements

Last content review/update: August 29, 2025

New Info (Not Yet in Profile)

The Pharmacy and Poisons Board issued Revision 5 of Guidelines for the Conduct of Clinical Trials in Kenya, effective January 2, 2026, which includes additional/revised definitions; alignment with ICH, WHO, PIC/S, and GCLP standards; new application process/requirements for multicenter clinical trials; clarification on investigator categories and qualifications; clarification on safety reporting; and alignment of study monitoring requirements to ICH E6(R3).

Obtaining Consent

In all Kenyan clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the CTRules, the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (KEN-14). (Per the G-KenyaCT, research must be conducted in accordance with the requirements set forth in KEN-14.) The informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by a National Commission for Science, Technology and Innovation (NACOSTI)-accredited institutional ethics committee (EC). The ICF must be provided to the Pharmacy and Poisons Board (PPB) with the clinical trial application. (See the Required Elements section for details on what should be included in the form.)

The CTRules, the G-KenyaCT, and the G-ECBiomedRes state that the investigator, or the designated representative, must provide detailed research study information to the participant or legal representative/guardian. Per G-ECBiomedRes, all individual consent must be written and, in no case, should collective community agreement or the consent of a community leader or other authority substitute for an individual informed consent. The G-KenyaCT and the G-ECBiomedRes also specify that the oral and written information concerning the trial, including the ICF, should be easy to understand and presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. None of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant or legal representative/guardian to waive or to appear to waive the legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or the representatives from their liabilities for any negligence. The participant or legal representative/guardian should also be given adequate time to consider whether to participate.

Re-Consent

According to the CTRules, the G-KenyaCT, and KEN-14, any change in the ICF due to a protocol modification should be approved by the EC before such changes are implemented. The participant or legal representative/guardian will also be required to re-sign the revised ICF and receive a copy of any amended documentation.

Language Requirements

As stated in the CTRules and the G-KenyaCT, the ICF content should be presented in either English or Kiswahili, and the local spoken language of the area, where applicable. Copies of the English ICF should be submitted to the PPB and to the EC.

Documenting Consent

The CTRules and the G-KenyaCT state that the participant or legal representative/guardian, and the person who conducted the informed consent discussion should sign and personally date the ICF. Where the participant is illiterate, and/or the legal representative/guardian is illiterate, verbal consent should be obtained in the presence of and countersigned by an impartial witness. Before participating in the study, the participant should receive a copy of the signed and dated ICF, and any other written information provided during the informed consent process. The participant or legal representative/guardian should also receive a copy of any updates to the signed and dated ICF.

According to KEN-14, where the participant is illiterate and/or the legal representative/guardian is illiterate, an impartial witness should be present during the entire informed consent discussion. The witness should sign and date the ICF after the following steps have occurred:

The written ICF and any other written information to be provided to the participant is read and explained to the participant or legal representative/guardian
The participant or legal representative/guardian have orally consented to the participant’s involvement in the trial, and has signed and dated the ICF, if capable of doing so

Before participating in the study, the participant or legal representative/guardian should receive a copy of the signed and dated ICF.

Waiver of Consent

No information is available.

Definitions, 4.1, 4.2, and 4.13

1.48, 1.63, and 1.188-1.212

Part IV (11)

2, 4.4, 4.8, 8.2, and 8.3

Last content review/update: April 13, 2026

Note: Per LBR-38, the National Research Ethics Board of Liberia (NREB) has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

Obtaining Consent

In accordance with the LibCTReg and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines. According to the G-ACRE-IRB and the G-NREB, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an ethics committee (EC).

As delineated in the LibCTReg, the trial participant should be informed of the nature, significance, and implications of the clinical trial and should provide a voluntary written informed consent. The trial participant or witness, if applicable, must be informed by an investigator, who is a healthcare professional or by a person designated by the investigator, and who is knowledgeable about the nature, significance, risks, and implications of the clinical trial, as well as about the participant’s right to withdraw from the clinical trial at any time. A generally comprehensible information sheet is to be handed out to the participant. The trial participant is also to be given the opportunity to have a counseling session with an investigator or a person designated by the investigator about the other conditions surrounding the conduct of the clinical trial.

The LibCTReg further notes that a declaration of consent to participate in a clinical trial can be revoked at any time in the presence of the investigator or a member of the investigating team, orally or in writing, without disadvantage to the trial participant. In the case of a revocation of consent, the study participant must decide whether their stored data may continue to be used. See also LBR-8 for additional consent guidelines.

Per the G-ACRE-IRB, the ACRE IRB must assess the research study to ensure the voluntary, non-coercive recruitment of research participants.

(See the Required Elements section for details on what should be included in the ACRE IRB and NREB forms. Refer to LBR-33 for the NREB Exempt Human Research Consent Script Form and LBR-34 for the NREB Short Consent Form.)

Re-Consent

Refer to LBR-8 for re-consent guidelines.

In addition, per the G-ACRE-IRB, in the case that ACRE IRB approval for a research protocol is reinstated, the ACRE IRB may require previously enrolled participants to re-consent.

Language Requirements

As stated in the G-LibClinTrial, all clinical trial application documentation must be submitted in English. If documents are written in another language, a certified translation is required.

Documenting Consent

As explained in the LibCTReg, if the trial participant is unable to read or write English, the informed consent should be obtained in the language the participant understands and in the presence of at least one (1) witness. The witness, who should be able to read and write English and understand the local language in which the trial participant is informed, should not be a member of the investigating team. The consent given by the trial participant must be documented in writing, dated, and signed by the witness and thumb printed by the trial participant.

LBR-34 also provides a sample NREB ICF for adults capable of consent. A witness must also be present during the consent process and must sign and date the ICF. The number of copies to be signed and distributed is not specified.

Waiver of Consent

No information is currently available from the LibCTReg, G-LibClinTrial, or G-NREB regarding clinical trial waivers.

As specified in the G-ACRE-IRB, to obtain a waiver or alteration of informed consent, the investigator must include the request (and provide justification for the waiver or alteration) in the protocol submission to the ACRE IRB. The request for waiver or alteration will be reviewed by the convened board, the ACRE IRB Chair, or the designated expedited reviewer. The ACRE IRB reviewer (Chair or designee) may approve the waiver or alteration of informed consent, if the board reviewer can establish that the research is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:

Public benefit or service programs
Procedures for obtaining benefits or services under those programs
Possible changes in or alternatives to those programs or procedures, or
Possible changes in methods or levels of payment for benefits or services under those programs

Per the G-ACRE-IRB, the ACRE IRB reviewer should also be able to ascertain that the research could not practicably be carried out without the waiver or alteration. In cases where the documentation requirement is waived, the IRB may require the investigator to provide participants with a written statement regarding the research, such as an information sheet, instead of an informed consent document.

Additionally, per the G-ACRE-IRB, the ACRE IRB reviewer may approve the waiver or alteration of informed consent, if the reviewer determines the following:

The research involves no more than minimal risk to the participants
The research could not practicably be conducted without the requested waiver or alteration
If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format
The waiver or alteration will not adversely affect the rights and welfare of the participants, and
Whenever appropriate, the participants or legal representative/guardian will be provided with additional pertinent information after participation. The ACRE IRB reviewer will document the findings for waiver or alteration of informed consent. An alteration to informed consent may apply when conducting a study where there is deception or an incomplete disclosure (for example, studies that require deception because the study would be compromised if participants were told the true purpose)

In addition, the G-ACRE-IRB explains that a waiver of a signed ICF may be appropriate for some research studies such as survey or interview studies containing highly sensitive questions (e.g., health status, sexual practices, criminal behavior, etc.), or surveys containing non-sensitive information. To obtain a waiver of documented (signed) informed consent, the investigator must include the request (and provide justification for the waiver or alteration) in the protocol submission process. The request for waiver or alteration will be reviewed by the convened ACRE IRB, the Chair, or the designated expedited reviewer. The ACRE IRB reviewer will consider the investigator’s request and review the request to determine if:

The only record linking the participant and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality
The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context
The participants or legal representative/guardian are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to participants, and provided that there is an appropriate alternative mechanism for documenting that informed consent was obtained. In cases where the documentation requirement is waived, the ACRE IRB may require the investigator to provide participants with a written statement regarding the research, such as an information sheet, instead of an informed consent document

Foreword and 2

Article IX (Sections 9.03 and 9.04), Article XIV (Section 14.03), Article XX, Article XXIII (Section 23.06), and Article XXV (Section 25.04)

Intellectual Property

Part II (Section 1 (a and e (1, 4-6, and 8))

Required Elements

Last content review/update: August 29, 2025

Based on the CTRules, the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (KEN-14), the informed consent form (ICF) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Title of the project and that the study involves research and an explanation of its nature and purpose
The expected duration of the participant’s participation
The participant’s responsibilities in participating in the trial
Experimental aspects of the study
Approximate number of participants involved in the trial
Trial treatment schedule and the probability for random assignment to each treatment
Principal investigator(s), institution, and ethics committee (EC) contact information, the person(s) to contact for further information regarding the trial and the rights of trial participants, and whom to contact in the event of trial-related injury
Any foreseeable risks or discomforts to the participant, and when applicable, to an embryo, fetus, or nursing infant
Any expected benefits or prorated payment to the participant; if no benefit is expected, the participant should also be made aware of this
Alternative procedures or treatment that may be available to the participant, including a statement on disclosure of appropriate alternative procedures or courses of treatment that might be advantageous to participants when the research involves non-validated procedures, devices, or therapies
Compensation and/or medical treatment available to the participant or the family or dependents in the event of a trial-related injury
Any additional costs to the participant that may result from participation in the research
The extent to which confidentiality records identifying the participant will be maintained, and if the results of the trial are published, the participant’s identity will remain confidential
That the Pharmacy and Poisons Board (PPB) will be granted direct access to the participant’s original medical records to verify clinical trial procedures and/or data without violating the participant’s confidentiality
The details on storage and exportation of biological samples, if applicable
The details on storage and ownership of personal data
Information about unblinding, if applicable
The extent of the investigator’s responsibility, if any, to provide medical services to the participant
That therapy will be provided free of charge for specified types of research-related injury, including the investigators’ responsibilities in this regard
That participation is voluntary, the participant may withdraw at any time, and refusal to participate will not involve any penalty or loss of benefits, or reduction in the level of care to which the participant is otherwise entitled
That the participant will be informed about the dissemination of findings and about any publication of the participant’s medical information, including photographs and pedigree charts
Foreseeable circumstances under which the investigator(s) may remove the participant without consent
That the participant or legal representative/guardian will be notified in a timely manner if significant new findings develop during the study which may affect the participant’s willingness to continue
Consent to incomplete disclosure, for example, if it is necessary to inform participants that some information is being withheld deliberately and the reasons for that decision; an offer to disclose the purpose at the conclusion of the study can be made

Note that per the G-KenyaCT, research must be conducted in accordance with requirements set forth in KEN-14.

In addition, the CTRules delineates that if the potential participant is a child, the ICF must also contain these elements:

The pathophysiology of the disease or subject of the clinical trial
The methods of diagnosis
The currently available treatment or prevention strategy in the pediatric population
The incidence and prevalence of the disease or subject of the clinical trial in the overall population and in the pediatric population
The evidence and assumptions on key differences between the disease or subject of the clinical trial in the overall population and the pediatric population

Definitions, 4.1, and 4.2

1.48, 1.63, and 1.188-1.212

Part IV (10 and 11)

4.4 and 4.8

Last content review/update: April 13, 2026

Note: Per LBR-38, the National Research Ethics Board of Liberia (NREB) has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

Liberia Medicines and Health Products Regulatory Authority

As specified in the LibCTReg and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines. Refer to LBR-8 for additional guidance on informed consent.

National Research Ethics Board of Liberia

The following elements are to be included in the NREB’s Exempt Human Research Consent Script Form (LBR-33) and the NREB Short Consent Form (LBR-34) respectively (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Statement indicating that the person is being asked to take part in a research study
Research study purpose and the reason for participant’s eligibility to participate in study
Duration of research study
Participation is voluntary and participant may withdraw at any time
Explanation of study-specific procedures and sample questions provided to participants
Possible risks associated with participating in study
Benefits to the participant or to others from participating in study
Appropriate alternative procedures, or courses of treatment, if any
Explanation of what is experimental vs. routine standard of care
Statement regarding who will have access to the participant’s personal information
Participant’s right to decline participating in any part of the study for any reason, their right to end participation at any time, and that refusal to participate will not be held against the participant
Researcher’s contact information for any questions the participant may have prior to deciding to participate and throughout the participant’s involvement in the study

See LBR-33 and LBR-34 for additional details.

Per LBR-34, if applicable, the following information is also included in the NREB Short Consent Form:

Whether the participant will get treated or paid if injured
The possibility of unknown risks
When the participant may be taken off the research study without the participant’s agreement
Added costs from taking part in the study
What will happen if the participant stops taking part
Steps to safely stop taking part
What new information will be shared with the participant
The number of participants expected to take part in the study
What happens to the participant’s collected data if the participant withdraws from the trial
An explanation of the ClinicalTrials.gov (LBR-40) website

Atlantic Center for Research and Evaluation Institutional Review Board

The G-ACRE-IRB indicates that the principal investigator (PI) is responsible for preparing the informed consent form (ICF) and that the ICF should include the following statements or descriptions:

The study involves research and an explanation of its purpose
The expected duration of a participant’s involvement in the research
A description of the procedures to be followed
Identification of any experimental study procedures
Any foreseeable risks or discomforts to the participant
Any benefits to the subject or to others that may reasonably be expected from the research
Alternative procedures or treatment that may be available to the participant, and if any, which might be advantageous to the participant
A statement describing the extent to which, if any, confidentiality of records identifying the participant will be maintained
A statement noting the possibility that the EC (or its designees) and the study sponsor may inspect the study records, if the research is sponsored by a funding source
For research involving more than minimal risk, an explanation of compensation and/or medical treatment available to the participant, or to the participant’s family or dependents, in the event of a trial-related injury, and if injury occurs, what the medical treatments consist of, or where further information may be obtained
The person(s) to contact for further information regarding the trial and the rights of research participants, and whom to contact in the event of research-related injury
Participation is voluntary, the participant may withdraw at any time, and refusal to participate will not involve any penalty or loss of benefits, or reduction in the level of care to which the participant is otherwise entitled

In addition to the required elements listed above, per the G-ACRE-IRB, for research involving the collection of identifiable private information or identifiable biospecimens, one (1) of the following must be included in the informed consent:

A statement that identifiers will be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies without additional informed consent from the participant or legal representative/guardian
A statement that the participant's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies

See also the Consent for Specimen section for additional information on informed consent relating to specimens.

Foreword

Article IX (Section 9.01), Article XIX (Sections 19.01), and Article XXV (Section 25.03)

Part II (Section 1 (a))

Participant Rights

Last content review/update: August 29, 2025

Overview

In accordance with the Declaration of Helsinki (KEN-33) principles upheld in the CTRules, the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), Kenya’s ethical standards promote respect for all human beings and safeguard the rights of research participants. A participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in KEN-14.

The Right to Participate, Abstain, or Withdraw

As set forth in the CTRules, the G-KenyaCT, the G-ECBiomedRes, and KEN-14, a participant or legal representative/guardian should be informed that participation is voluntary, that the participant may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information

As delineated in the CTRules, the G-KenyaCT, the G-ECBiomedRes, and KEN-14, a potential research participant or legal representative/guardian has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study.

The DPA further indicates that data subjects have a right to:

Be informed of how their personal data is to be used
Access their personal data in custody of the data controller (sponsor) or data processor
Object to the processing of all or part of their personal data
Correct false or misleading data
Delete false or misleading data about them

The Right to Privacy and Confidentiality

As per the G-KenyaCT, the G-ECBiomedRes, and KEN-14, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

The Right of Inquiry/Appeal

The G-KenyaCT, KEN-14, and the G-ECBiomedRes state that the participant or legal representative/guardian should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries. Further, the G-ECBiomedRes requires that the ethics committee contact information also be provided.

The Right to Safety and Welfare

The G-ECBiomedRes and KEN-14 state that a research participant’s right to safety and the protection of the participant’s health and welfare must take precedence over the interests of science and society. KEN-14 upholds the Declaration of Helsinki (KEN-33). (See the Required Elements and Vulnerable Populations sections for additional information regarding requirements for participant rights.)

3.1, 4.1, and 4.2

1.48, 1.63, and 1.188-1.212

Part IV (26) and Part V (46-47)

Part IV (11 and 17)

3.1 and 4.8

Last content review/update: April 13, 2026

Note: Per LBR-38, the National Research Ethics Board of Liberia (NREB) has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

Overview

As specified in the LibCTReg and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines. The G-ACRE-IRB also complies with the Council for International Organizations of Medical Sciences (CIOMS)’ International Ethical Guidelines for Health-related Research Involving Humans (LBR-2) and the national ethical guidelines for research on human participants.

The G-ACRE-IRB states that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process.

The Right to Participate, Abstain, or Withdraw

As set forth in the G-ACRE-IRB, LBR-33, and LBR-34, the participant or legal representative/guardian should be informed that participation is voluntary, that the participant may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information

As per the G-ACRE-IRB, LBR-33, and LBR-34, a potential research participant or legal representative/guardian has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study. (See the Required Elements section for a more detailed list.)

The Right to Privacy and Confidentiality

As per the G-ACRE-IRB, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

The Right of Inquiry/Appeal

The G-ACRE-IRB, LBR-33, and LBR-34, state that the research participant or legal representative/guardian should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries.

The Right to Safety and Welfare

The G-ACRE-IRB states that ethics committees review and approve all research proposals involving research participants with a view to safeguarding their dignity, rights, safety, and well-being. The goals of research, however important, should never be permitted to override the health and well-being of the participants.

(See the Required Elements and Vulnerable Populations sections for additional information regarding requirements for participant rights.)

Foreword

Foreword and Article XIX (Section 19.01)

Part II (Section 1 (a))

Emergencies

Last content review/update: August 29, 2025

The G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by emergencies. Per the G-KenyaCT, research must be conducted in accordance with KEN-14. As delineated in the G-KenyaCT and the G-ECBiomedRes, in an emergency, if the signed informed consent form (ICF) cannot be obtained from the research participant, the consent of the legal representative/guardian should be obtained. If the prior consent of the participant or legal representative/guardian cannot be obtained, the participant’s enrollment should follow measures specified in the protocol, and/or elsewhere, to ensure compliance with ethics committee (EC) and the Pharmacy and Poisons Board (PPB) requirements. The G-ECBiomedRes requires that the principle of clinical equipoise be applied, which essentially means the participant is not any worse off by enrolling.

During a public health emergency, the G-KenyaCT stipulates that the informed consent of participants must be obtained in individuals capable of giving informed consent. The CT-Emrgcy includes safeguards to protect clinical trial participants during a public health emergency, including the recommendation to reconsent if there are amendments as a result of the emergency.

Per KEN-14, in an emergency, if the signed ICF has not been obtained from the participant or legal representative/guardian, or if an effective treatment is lacking but the investigational product could address the participant’s emergency needs, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol, and the EC must approve the protocol in advance. The participant or legal representative/guardian should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.

Participants

4.1 and 4.2

1.48, 1.63, 1.188-1.212, and 1.557-1.574

4.8

Last content review/update: April 13, 2026

As set forth in the LibCTReg, in an emergency situation where consent cannot be obtained, treatment which is necessary without delay to save the life of the trial participant can be started immediately. Such situations must be defined by the Liberia Medicines and Health Products Regulatory Authority (LMHRA) and consent for continued participation must be obtained as soon as possible, and not later than the timeframe specified by the National Research Ethics Board of Liberia (NREB) for a given clinical trial. Additionally, in these cases, the LMHRA may apply an expedited application and review process for clinical trials and make exemptions to the documentation requirements for clinical trial application submissions.

The LibCTReg and the G-LibClinTrial further explain that the LMHRA has adopted the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines. Refer to LBR-8 for additional guidelines on emergency consent requirements.

Per the G-LibClinTrial, examples of emergency situations are epidemics or other urgent public health interests that require fast utilization of new medicines or health products and/or fast gathering of information on products. Information provided to clinical trial participants about the process of obtaining consent must be included in the documents submitted to the LMHRA. Refer to 2.3 of the G-LibClinTrial for additional information on how to submit an expedited clinical trial application package.

Foreword and 2

Part II (Section 1 (a and e(13)) and Section 2 (2))

Vulnerable Populations

Last content review/update: August 29, 2025

Overview

As per the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), in all Kenyan clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. Vulnerable populations include those participants with diminished autonomy whose decision to participate in a clinical trial may be unduly influenced by the expectation of benefits associated with participation or by coercion. This may include, but is not limited to, children/minors, pregnant women, neonates, fetuses, medical students, members of the uniformed forces, prisoners, orphans, homeless populations, unemployed, internally displaced persons, economically or educationally disadvantaged persons, marginalized social groups, individuals with terminal illnesses, and the mentally challenged. KEN-14 also includes members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable participants include persons in nursing homes, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in KEN-14.

Elderly Persons

The G-ECBiomedRes defines an elderly/senior citizen as a person who has attained the age of 65 years. Their physical or mental state may affect their ability to make voluntary decisions regarding their participation in research projects. Such research involving elderly/senior citizens must comply with the following requirements:

Strict adherence to ethical principles
The risk-benefit ratio must be favorable to the research participant
The participants must be protected from gross violation of human rights

Persons in Dependent Groups

Per the G-ECBiomedRes, research involving data collection by superiors on their subordinates involves relationships such as employer-employee, teacher-students, supervisor-staff, sponsor-dependent, and parent-children. This relationship impairs independent consent by the participants leading to complacency. Therefore, research involving the superior/subordinate relationships must fulfill the following requirements:

The superior must strictly follow ethical principles to avoid undue pressure
Subordinates must be protected from gross violation of human rights
The trial design must be based on a need-to-know principle and improve the conditions of the participants

Persons in Low-Resource Communities

The G-ECBiomedRes provides the following requirements related to conducting research on participants in low-resource settings:

Persons in such settings should not be involved in research that could be carried out reasonably well in developed communities
The research should be responsive to the health needs and priorities of the community in which it is to be implemented
Undue inducement to participate in the research must be avoided at all costs

Armed Forces

The G-ECBiomedRes stipulates that research involving the members of the armed forces may be vulnerable because of the conditions of their service, which may affect their ability to make voluntary decisions regarding their participation in research. Such research must be conducted to ensure that:

Participants are protected from gross violations of human rights
There is strict adherence to ethical principles
There is at least one (1) member of the ethics committee approving such research who is an enlisted and authoritative member of the armed forces

Terminally Ill

Per the G-ECBiomedRes, research involving participants who are terminally ill with an incurable medical condition are vulnerable. Their state may affect their ability to make voluntary decisions regarding their participation in research. Such research can only be conducted when:

The objectives of the project(s) cannot be achieved using another non-vulnerable group
There is strict adherence to ethical principles
The risk-benefit ratio should be favorable to the research participant

See the Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired sections for additional information about these vulnerable populations.

4.2

Glossary of Terms, 1.48, and 1.63

1.61, 3.1, and 4.8

Last content review/update: April 13, 2026

Overview

The LibCTReg and the G-LibClinTrial explain that the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines. Refer to LBR-8 for consent guidelines applicable to vulnerable populations.

Persons with Diseases

As indicated in the LibCTReg, in the case of a clinical trial involving a person of legal age who is suffering from a disease for which the investigational product (IP) is to be used, one (1) of the following conditions should be applied along with the general clinical trial requirements delineated in the LibCTReg:

The use of the IP is indicated according to the findings of medical science in order to save the person's life
The IP must be of direct benefit to the group of patients who are suffering from the same disease as this person

Persons Under Legal Disability

As set forth in the LibCTReg, “persons under legal disability” are defined as being under the same category as a minor in terms of the individual’s ability to grant consent, except that the person under disability may be above the age of consent (18 years), but may be too ill to participate in decisions regarding their own health. In this case, priority is not given to parents or next of kin to petition the Probate Court for Guardianship, but priority is given to any natural person who demonstrates best interest in the welfare of the disabled.

The LibCTReg further explains that a person under legal disability may participate in a trial, if their parents/legal guardians have been informed of the nature, significance, and implications of the clinical trial and have given a written voluntary informed consent. If the informed implication is grave, it may be necessary for the guardian to secure the permission from the Probate Court before granting consent, due to the fact that the Decree of Guardianship has a clause that the Court appointed guardian should not release the disabled person to any other body in which case their welfare will be put at peril. Otherwise, it can be argued that the appointed guardian has breached their fiduciary duty to the Court by releasing the disabled person to peril.

See the Children/Minors and Mentally Impaired sections for additional information about these vulnerable populations.

Foreword and 2

Part I (Section 4), Part II (Section 1 (a and e (2)) and Section 2 (1-4))

Children/Minors

Last content review/update: August 29, 2025

According to the G-KenyaCT, a minor is someone under 18 years of age. As set forth in the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), when the research participant is a minor, informed consent should be obtained from the parent/guardian. Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in KEN-14. The informed consent forms, assent forms, and the patient information sheets should be in a language that the parent/guardian clearly understand. All pediatric participants should be fully informed about the trial and its risks and benefits in a language and terms that they are easily able to understand.

Per the G-KenyaCT, a minor should take part in the informed consent procedure in a way tailored to their age and mental maturity. If capable, the participant should sign and personally date the written informed consent. In addition, consent given by pediatric participants should not be considered valid without prior approval by the ethics committee (EC).

The CTRules, the G-ECBiomedRes, and the G-KenyaCT state that a study may only be conducted on minors if several conditions are fulfilled including (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Pediatric participants will not be involved in research that might be equally carried out in adults
The purpose of the research is to generate knowledge relevant to the health needs of children
The parent/guardian must provide proxy consent and ensure assent has been obtained to the extent of the child’s capabilities. However, if the minor refuses to participate after proxy consent is given, the minor’s refusal must be respected unless there is no other medical alternative from which the minor could benefit
The risk presented by interventions not intended to benefit the minor is low and commensurate with the importance of the knowledge to be gained
Interventions that are intended to provide therapeutic benefit are likely to be at least as advantageous to the individual child as any available alternative
No incentives or financial inducements are given to the participant or parent/guardian except to provide compensation for expenses and loss of earnings directly related to the participation in the trial

Additionally, per the G-KenyaCT, the trial should also address the following considerations:

Provide useful answers to the study population
The medicine satisfies a need for the population being studied
Children are adequately monitored and protected
If there is no direct benefit to the child, or there is no more than minimal risk to the participant(s)
Trial results will be published
End-of-trial treatment provisions will be made

Assent Requirements

As delineated in the G-KenyaCT, before undertaking research involving children, the investigator must ensure that the agreement (assent) of each child has been obtained to the extent of the child’s capabilities, and a child’s refusal to participate or continue in the research must be respected. Assent is defined as a child’s affirmative agreement to participate in research, where the child is below the age of the majority but old enough to understand the proposed research in general, its expected risks and possible benefits, and the activities expected of them as participants. The G-ECBiomedRes provides that in children above seven (7) years and below 18 years where the parent(s)/guardian(s) gives proxy consent, assent must be obtained from the child.

For an example of an accredited EC’s assent requirements, see the Kenyatta National Hospital-University of Nairobi (KNH-UoN) Ethics and Research Committee’s sample minor assent form (KEN-17).

4.2

Glossary of Terms, 1.48, 1.63, and 1.131-1.172

Part IV (10)

4.8

Parental Consent for Children and Sample Minor Assent Form

Last content review/update: April 13, 2026

Note: Per LBR-38, the National Research Ethics Board of Liberia (NREB) has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

According to the LibCTReg and the G-NREB, Liberia defines children and minors as those persons under 18 years of age. The G-NREB also defines adolescents as those between the ages of 15 and 17.

The LibCTReg also states that the definition of a legal guardian or “legal representative of a minor” is based on the premise that a minor cannot grant consent or enter into an agreement. The interest of a minor must be firstly protected by the parents (the father, if the parents are married or the child is legitimized), or the mother of the child, if the parents are not married. Where there is no parent alive, especially the mother, if the child is not born out of wedlock or not legitimized, any next of kin, preferably the grandparents first, the siblings second, or any person with interest in the welfare of the child, may petition the Probate Court for Decree of Guardianship. A guardian must be authorized to give consent for the minor child. No institution can serve as guardian and give consent for research on the child. A guardian must be a natural person, not an institution.

Additionally, per the LibCTReg, a minor may participate in a trial if their parents/legal guardians have been informed of the nature, significance, and implications of the clinical trial and have given a written, voluntary informed consent. If the implication of the trial is grave, it may be necessary for the guardian to secure permission from the Probate Court before granting consent, due to the fact that the Decree of Guardianship contains a clause stating that the Court appointed guardian should not release the minor to any other body where their welfare will be put in peril. Otherwise, it can be argued that the appointed guardian has breached their fiduciary duty to the Court by releasing the minor or disabled to peril.

Also, as indicated in LibCTReg, in the case of a clinical trial on a minor who suffers or may suffer from a disease for which the investigational product (IP) is to be used, the following conditions should be applied:

The use of the IP must be indicated according to the findings of medical science in order to save the life of the trial participant, to restore the participant to health, to alleviate suffering, or to prevent a disease
The clinical trial must be of direct benefit to the group of patients suffering from the same disease as the trial participant
The research must be absolutely necessary in order to confirm data obtained in clinical trials on other persons or by means of other research methods
The research must relate to a clinical condition from which the minor concerned is suffering or may suffer
The research may cause only minimal risk and minimal burden to the trial participant

LBR-34 provides a sample NREB informed consent form (ICF) for children that explains the parents’ or guardian’s signatures document their permission for the child to take part in a research study as well as their permission for the use and disclosure of the child’s protected health information. If a second parent’s signature is not obtained, the first parent or guardian needs to choose one (1) of the following options on the form to justify why this is not possible:

The ethics committee (EC) has determined that the permission of one (1) parent is sufficient (this option is only listed on the form if it has been approved by the EC)
Second parent is deceased
Second parent is unknown
Second parent is incompetent
Second parent is not reasonably available
Only one (1) parent has legal responsibility for the care and custody of the child

In addition, per LBR-34, an individual may provide permission as a guardian for a child only if that individual can provide a written document indicating that the individual is legally authorized to consent to the child’s general medical care and this documentation must be attached to the signed ICF. The EC must also approve the consent form, a witness must be present during the consent process, and the witness must sign and date the ICF.

As delineated in the G-ACRE-IRB, the ACRE IRB must classify research involving children into one (1) of four (4) categories and document its discussion of the risks and benefits of the research study in order to approve such research. The risk/benefit categories are as follows:

When the ACRE IRB determines that the risk is no more than minimal to children in a study, it may approve the research only if adequate provisions are made for soliciting the assent of the children and the permission of their parents or legal guardians
When the ACRE IRB determines that more than minimal risk to children is presented by a procedure that holds the prospect of direct benefit to an individual child, or by a monitoring procedure that is likely to contribute to the child’s well-being, the ACRE IRB may approve the research if it is established that: the risk is justified by the anticipated benefit to the children; the relation of the anticipated benefit to the risk is at least as favorable to the children as that presented by available alternative approaches; and adequate provisions are made for soliciting the assent of the children and permission of their parents or legal guardians
When the ACRE IRB determines that the study presents more than minimal risk to children and does not hold out the prospect of direct benefit for the individual child, but is likely to contribute generalizable knowledge about the child’s disorder or condition, the board may approve the research if it established that: the risk represents a minor increase over minimal risk; the study intervention or procedure presents experiences to participants that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; the intervention or procedure is likely to yield generalizable knowledge about the participants’ disorder or condition that is of vital importance for the understanding or improvement of the participants’ disorder or condition; and adequate provisions are made for soliciting the assent of the children and permission of their parents or legal guardians
When the ACRE IRB determines that the research does not meet the requirements in any of the above three (3) categories, the board may only approve the research if it finds that the study presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children

The G-ACRE-IRB further states that the ACRE IRB should ensure that adequate permissions are made for soliciting the permission of each child’s parent/legal guardian. The following provisions are used depending on the category of research:

Research not involving greater than minimal risk to children: Where parental permission is to be obtained, the ACRE IRB may suggest that the permission of one (1) parent is sufficient for research not involving greater than minimal risk
Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual child: Where parental permission is to be obtained, the board may suggest that the permission of one (1) parent is sufficient for research involving greater than minimal risk but presenting the prospect of direct benefit to the individual participants
Research involving greater than minimal risk and no prospect of direct benefit to the individual child, but likely to yield generalizable knowledge about the child’s disorder or condition: When the research is approved under this category, both parents must give their permission unless one (1) parent is deceased, unknown, incompetent, not reasonably available, or when only one (1) parent has legal responsibility for the care and custody of the child

If the ACRE IRB determines that a research study is designed for a participant population for which approval from the parents and/or legal guardian(s) or representative(s) is not reasonably required to protect the participants (e.g., neglected or abused children), the G-ACRE-IRB indicates that the consent requirements may be waived. In order to protect the rights and welfare of children in a research study, the board should consider the involvement of a court appointed guardian.

Assent Requirements

Per the LibCTReg, an assent form must be signed, and, if possible, dated by the minor. Similarly, per the G-LibClinTrial, when the research participant is a minor, the investigator must obtain assent from the child/minor. The G-NREB also indicates that both written parental consent and assent forms should be completed for children less than 18 years of age. Per LBR-34, the child’s assent should also be attained unless this can be justified by one (1) of the following reasons:

The EC determined that assent of the child was not a requirement
The capability of the child is so limited that the child cannot reasonably be consulted

According to LBR-34, the EC must approve the assent form, a witness must be present during the consent process, and the witness must sign and date the ICF.

As indicated in the G-ACRE-IRB, for research reviewed and approved by the ACRE IRB, adequate provisions for the assent of children include the following:

Children capable of assenting: After the ACRE IRB determines that a child is capable of assenting, the proposed research procedures should be explained to the child in a language that is appropriate to the age, experience, maturity, and condition of the child and should include any discomforts and inconveniences the child may experience if the child agrees to participate in the study
The option to withdraw: As they are in the developmental stage, children should be asked if they do or do not wish to participate in the research, especially where the research does not involve interventions likely to be of benefit to the participants but that they will be volunteers for the benefit of others
The signing of assent or consent: When an assent requirement is established, the investigator or the designee and the child (when appropriate) will sign the study consent form. When it is inappropriate for the child to sign the form (due to age or ability), the board requires that the document be signed by the investigator (or the designee) and the parent/legal guardian

Per the G-ACRE-IRB, the ACRE IRB may determine that assent may be waived if the capability of some or all of the children is so limited that they cannot reasonably be consulted; or the intervention or procedure involved in the research has a direct benefit to the health or well-being of the children and is available only in the context of the research. In such instances, a child’s dissent which should normally be respected, may be overruled by the child’s parents at the discretion of the board (for example, when a research study involves providing experimental therapies for life-threatening diseases, such as Ebola Virus Disease, severe COVID-19, or cancer, parents may wish to try anything to help their children, even with the likelihood of success being uncertain). If the child is a mature adolescent, the child’s wishes should be respected.

Foreword and 2

Article XXIV (Sections 24.02-24.03)

Background and Intellectual Property

Part I (Section 4) and Part II (Sections 1 (e (2) and 2 (3 and 9))

Pregnant Women, Fetuses & Neonates

Last content review/update: August 29, 2025

Per the G-KenyaCT, research must be conducted in accordance with the requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14). In accordance with KEN-14, informed consent requirements for conducting clinical trials with pregnant or nursing women or fetuses follow the general requirements listed in the Required Elements section. Specifically, the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant.

As per the G-ECBiomedRes, research involving pregnant, lactating, and breastfeeding women may pose compromised long-term outcomes for the child. In addition, potential parent(s) can make decisions on behalf of the fetus(es), embryo(s), and zygote(s).

For fetal, embryo, and zygote(s) cases, research should be limited as follows:

Cases that present no harm or offer assistance to the life system of the participants
No procedures should be permitted that are likely to harm them
A fetus ex-utero and alive, embryo, and zygote must not be involved in research unless it is intended to enhance the life of that fetus, embryo, and zygote, or unless the research involves no risk to them

Additionally, the following guidelines must be followed for research involving pregnant, lactating, and breastfeeding women:

The research carries no more than minimal risk to the fetuses or nursing infants
Pregnant or nursing women should generally not be clinical trial participants except where such trials are designed to protect or advance the health of the pregnant/nursing women or fetuses/nursing infants, and for which women who are not pregnant or nursing would not be suitable participants
The justification for such research should be that participants must not be arbitrarily deprived of the opportunity to benefit from investigational drugs, vaccines, or other agents that promise therapeutic or preventive benefits

4.2

1.48 and 1.63

4.8

Last content review/update: April 13, 2026

Note: Per LBR-38, the National Research Ethics Board of Liberia (NREB) has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

As set forth in the LibCTReg and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines. Refer to LBR-8 for additional guidance on informed consent applicable to embryos, fetuses, and nursing infants.

As stated in the G-ACRE-IRB, for clinical research studies using the ACRE IRB, pregnant women or fetuses may be involved in research if all the following conditions are met:

Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses
The risk to the fetus is caused solely by the interventions or procedures considered directly beneficial for the woman or the fetus; or, if there is no such prospect of specific benefit, the risk to the fetus is not greater than minimal and the purpose of the research is for the development of important biomedical knowledge which cannot be obtained by any other means
Any risk is the least possible for achieving the objectives of the research
Consent is obtained in accordance with the informed consent provisions in the G-ACRE-IRB if the research holds out the prospect of direct benefit to a pregnant woman; the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit to either the woman or the fetus when risk to the fetus is not greater than minimal; and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means
If the research holds the prospect of direct benefit solely to the fetus, then the consent of the pregnant woman and the father is obtained in accordance with the informed consent provisions in the G-ACRE-IRB, except that the father’s consent need not be obtained if he is unable to consent due to unavailability, incompetence, or temporary incapacity, or, the pregnancy resulted from rape or incest (close relationship)
Each person providing consent is fully informed regarding the foreseeable impact of the research on the fetus and/or resultant child
For children who are pregnant, assent and permission are obtained in accordance with the provisions for children indicated in this guideline
No inducements, monetary or otherwise, will be offered to terminate a pregnancy
Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy
Individuals engaged in the research will have no part in determining the viability of a fetus

Foreword

Article XXIV (Section 24.01)

Part II (Section 1 (a))

Prisoners

Last content review/update: August 29, 2025

Per the G-ECBiomedRes and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in KEN-14. A research study involving prisoners should ensure that these prospective participants are informed and given the opportunity to make their own decisions without any interference or reprisals from a higher authority. The ethics committee must also ensure that the study will be independently monitored to assure the dignity and rights of the prisoners involved in the research.

4.2

1.48 and 1.63

1.61

Last content review/update: April 13, 2026

Note: Per LBR-38, the National Research Ethics Board of Liberia (NREB) has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

Pursuant to the G-ACRE-IRB, for clinical research studies using the ACRE IRB, due to the vulnerability of prisoners, research involving prisoners should be reviewed by a fully convened ACRE IRB. Per the G-ACRE-IRB, the ACRE IRB may only approve research projects involving prisoners if the research falls under one (1) of the following categories:

Study of possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk or inconvenience to the participant
Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the participants
Research on conditions particularly affecting prisoners as a class
Research on practices that are intended and have the probability of improving the health or well-being of the participants

In addition, per the G-ACRE-IRB, the ACRE IRB must review research involving prisoners and approve such research only if it finds that:

The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers
Procedures for the selection of participants within the prison are fair to all prisoners, and free of arbitrary interference by prison authorities or prisoners. Other than the investigator’s justification to the ACRE IRB, the use of other procedures, and the selection of control participants from the available prisoner population for a particular research study should be randomly done
The information is presented in a language that is understandable to the participant population
There is adequate assurance that parole boards will not take into account a prisoner’s participation, withdrawal, or lack of participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that their participation, withdrawal, or lack of participation in the research will have no effect on their parole
The ACRE IRB should ensure that adequate provisions are made where there will be a follow-up examination or care of participants after the end of their participation, considering the variable lengths of individual prisoners’ sentences, and informing participants of this information

Article XXIV (Section 24.03)

Mentally Impaired

Last content review/update: August 29, 2025

As per the G-ECBiomedRes and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), an ethics committee (EC) within the relevant institution must approve the participation of adult research participants who are incapable by reason of physical and mental capacity to give consent. Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in KEN-14.

In addition, as delineated in the G-ECBiomedRes, a research study may involve participants with mental incapacities or behavioral disorders under the following conditions:

Such research could not be carried out equally well with individuals who are in possession of their full mental faculties
The knowledge gained would be relevant to the health needs of persons with mental or behavioral disorders
The participant’s consent has been obtained to the extent of the participant’s capabilities, and a prospective participant’s refusal to participate is always respected
In the case of incompetent individuals, informed consent must be obtained from a legal guardian or other duly authorized person
The degree of risk attached to the intervention not intended to benefit the individual participant is low and commensurate with the importance of knowledge to be gained
Interventions that are intended to provide therapeutic benefit are likely to be at least as advantageous to the individual participant as any alternative

4.2

1.48 and 1.63

1.61 and 3.1

Last content review/update: April 13, 2026

As set forth in the LibCTReg, “persons under legal disability” is defined as being under the same category as a minor in terms of the individual’s ability to grant consent, except that the person under disability may be above the age of consent (18 years) even though the person may lack the mental capacity to reason properly and grant consent. In this case, priority is not given to parents or next of kin to petition the Probate Court for Guardianship, but priority is given to any natural person who demonstrates the best interest in the welfare of the disabled.

The LibCTReg further explains that a person under legal disability may participate in a trial, if their parents/legal guardians have been informed of the nature, significance, and implications of the clinical trial and have given a written voluntary informed consent. If the informed implication is grave, it may be necessary for the guardian to secure permission from the Probate Court before granting consent, due to the fact that the Decree of Guardianship has a clause that the court-appointed guardian should not release the disabled person to any other body where their welfare will be put at peril. Otherwise, it can be argued that the appointed guardian has breached their fiduciary duty to the court by releasing the disabled person to peril.

Also, as indicated in LibCTReg, in the case of a clinical trial on a person of legal age who is incapable of comprehending the nature, significance, and implications of a clinical trial and of determining their will in light of these facts, and who is also suffering from a disease which is to be treated by the investigational product (IP), the following conditions should be applied:

The use of the IP must be indicated, according to the findings of medical science, in order to save the life of the trial participant, to restore the participant to health, or to alleviate suffering
The research must relate directly to a life-threatening or to a highly debilitating clinical condition suffered by the trial participant, and the clinical trial may involve as little burden and other foreseeable risks as possible for the trial participant. Both the degree of burden and the risk threshold must be defined specifically in the trial protocol and monitored constantly by the investigator. The clinical trial may only be conducted if there is a justified expectation that the benefits of using the IP for the trial participant outweigh the risks
Consent should be given by the legal representative/guardian after the participant has been duly informed per the general clinical trial requirements in LibCTReg
The research must be absolutely necessary for the confirmation of data obtained from clinical trials conducted on persons capable of granting informed consent or by means of other research methods
With the exception of adequate compensation, no advantages may be granted

Additionally, as per the LibCTReg and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines.

LBR-34 provides a sample National Research Ethics Board of Liberia (NREB) informed consent form (ICF) for adults unable to consent, which explains that the signature of the legally authorized representative documents their permission for the participant named in the ICF to take part in this research study, as well as their permission for the use and disclosure of the participant’s protected health information. The participant’s assent should also be attained unless this can be justified by one (1) of the following reasons:

The EC determined that assent of the participant was not a requirement
The capability of the participant is so limited that the participant cannot reasonably be consulted

The previously listed options are only available if they have been approved by the ethics committee. A witness must also be present during the consent process and the witness must sign and date the ICF.

Foreword

Part I (Section 4) and Part II (Section 1 (a and e (2-3)) and Section 2 (4))

Definition of Investigational Product

Last content review/update: August 29, 2025

New Info (Not Yet in Profile)

The Pharmacy and Poisons Board issued Revision 5 of Guidelines for the Conduct of Clinical Trials in Kenya, effective January 2, 2026, which includes additional/revised definitions; alignment with ICH, WHO, PIC/S, and GCLP standards; new application process/requirements for multicenter clinical trials; clarification on investigator categories and qualifications; clarification on safety reporting; and alignment of study monitoring requirements to ICH E6(R3).

The G-KenyaCT defines an investigational product (IP) as any pharmaceutical product, including a new product or existing product for a new indication, in the form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

Glossary of Terms, 1.48, and 1.63

Last content review/update: April 13, 2026

Per the LibCTReg and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines. Refer to LBR-8 for detailed investigational product guidelines and definitions.

As delineated in LibCTReg, an investigational product (IP) is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use. In Liberia, IPs are referred to as investigational medicinal products (IMPs).

Foreword

Part I (Section 4) and Part II (Section 1 (a))

Manufacturing & Import

Last content review/update: August 29, 2025

New Info (Not Yet in Profile)

PPB guidelines:

Guideline on Import and Export of Health Products and Technologies (Revision 2, effective February 27, 2026)
Kenya Good Manufacturing Practices Guidelines (Revision 2, effective October 15, 2025)

Manufacturing

According to the PPA and the G-KenyaCT, the Pharmacy and Poisons Board (PPB) is responsible for authorizing the manufacture of all drug products, including investigational products (IPs) in Kenya. Per the CTRules and the G-KenyaCT, an IP must be manufactured in accordance with the requirements of good manufacturing practice (GMP). The CTRules requires a sponsor to immediately notify the PPB in writing when a pharmaceutical or chemical alteration may affect the quality, safety, or efficacy of the IP product during an ongoing clinical trial. The G-KenyaCT states that the sponsor must submit the IP dossier directly to the PPB or may submit it through the principal investigator. The IP dossier must be prepared as per the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), which is required per G-KenyaCT. The manufacture of IPs may be subject to GMP inspection by the PPB in the same way as in the case of marketed drug products. See the G-KenyaCT for detailed chemistry and manufacturing information to be provided to the PPB if the IP has not been registered with the PPB.

KEN-14 also requires IPs to be manufactured, handled, and stored in accordance with applicable GMPs and used in accordance with the approved protocol.

Per the PPA, the PPB is authorized to regulate the manufacturing of medicine, including:

Ensure that all medicinal products manufactured in, imported into, or exported from the country conform to prescribed standards of quality, safety, and efficacy
Ensure that the personnel, premises, and practices employed in the manufacture, storage, marketing, distribution, and sale of medicinal substances comply with the defined codes of practice and other prescribed requirements
Grant or revoke licenses for the manufacture, importation, exportation, distribution, and sale of medicinal substances
Inspect and license all manufacturing premises, importing and exporting agents, wholesalers, distributors, pharmacies (including those in hospitals and clinics), and other retail outlets

See the KenyaGMP, for PPB’s compilation of recommended World Health Organization GMP guidelines to help comply with GMP requirements and prepare for an inspection, including for manufacture of IPs.

Import

Per the PPA and the ImpExp, the PPB is authorized to regulate the import and export of health products and technologies, including IPs. As per the ImpExp and the G-KenyaCT, to obtain an import permit for a clinical trial, the sponsor or investigator must submit an application online to the Kenya Trade Network Agency’s Kenya TradeNet Single Window System (KEN-28). The following documents must be submitted (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

The proforma invoice or invoice
The ethics committee favorable opinion letter
The Expert Committee on Clinical Trials approval letter from the PPB
Registration of the institution where the research is being undertaken

The G-KenyaCT states that the sponsor must submit to the PPB a copy of the endorsed clinical trial import permit and/or evidence of delivery to the approved investigator(s)/trial center(s) on importation and supply of each consignment of the product. The product must only be supplied to the investigator(s) at the trial site(s) named in the clinical trial import license application for the purpose and use as stated in the said application. Prior PPB notification and approval is required for changes in the investigator, trial site, or protocol. The sponsor must inform PPB of any change in information, or any information received that casts doubt on the continued validity of the data, which was submitted with, or in connection with the application for the import permit. The sponsor must also inform the PPB of any decision to discontinue the trial to which the permit relates and state the reason for the decision. See KEN-8 for additional details on the procedures for obtaining an import license.

Per the CTRules, the import of an IP must comply with the applicable regulatory requirements to ensure integrity and accountability of the products. The PPB may revoke or suspend an import permit if the IP was manufactured in conditions not consistent with GMP; if the clinical trial was discontinued; or if the sponsor provided false information.

Please note: Kenya is party to the Nagoya Protocol on Access and Benefit-sharing (KEN-3), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see KEN-15.

Legal Framework, 1.24-1.26, 1.48, 1.63, 1.215-1.240, 1.346-1.354, and 1.542-1.551

Glossary of Terms and 3.1.7

Part 1 (3B), Part IIIA (35A and 35B), and Part IV (44)

Part IV (14)

2.12 and 5.13

Last content review/update: April 13, 2026

Manufacturing

As set forth in the LMHRA-Act, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) is responsible for issuing licenses or permits for premises and personnel to engage in the manufacture of medicinal products in Liberia. The LibCTReg also states that investigational products (IPs) for clinical trials must be manufactured according to internationally accepted good manufacturing practice (GMP) principles.

Per the LibCTReg and the G-LibClinTrial, the LMHRA has also adopted the International Council for Harmonisation (ICH)'s Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines. Refer to LBR-8 for additional IP guidelines. Per LBR-29, the World Health Organization’s (WHO) GMP Guidelines for IPs (LBR-26) and the International Council for Harmonisation (ICH) Harmonised Tripartite GMP Guide for Active Pharmaceutical Ingredients (LBR-9) must also be complied with during the IP manufacturing process.

As explained in G-Inspec-PMS, where pharmaceutical factories have not yet established validated manufacturing processes for pharmaceuticals for use in clinical trials, or have not yet established comprehensive manufacturing control standards, the factories must establish written operational procedures and keep detailed and accurate records for each batch of products manufactured, and each batch of raw material used. Batch manufacturing records must be kept until clinical trials are completed, or until at least two (2) years after the product is completed, whichever period is longer. Additionally, where pharmaceutical factories produce biopharmaceuticals or biotechnology products for use in clinical trials, impurities caused by virus inactivation/removal or other organisms may not exceed the limits imposed on other similar products on the market; where operational procedures for said products have not yet been validated, quality control tests must be performed.

Import

As set forth in the LMHRA-Act, the LibCTReg, and the G-LibClinTrial, the LMHRA is also responsible for issuing licenses or permits for the import/export of medicinal products in Liberia. Pursuant to the G-Inspec-PMS and the LibCTReg, authorization must be obtained from the LMHRA for the importation of medicines to be used in clinical trials. Per LBR-30, the Clinical Trials Unit within the LMHRA’s Pharmacovigilance & Clinical Trials Department is responsible for reviewing importation permits for IPs that are required for the conduct of clinical trials. Per LibCTReg, the LMHRA Managing Director is responsible for receiving application requests to obtain an import permit.

According to the LibCTReg and the G-LibClinTrial, the import permit application must contain the following information and documentation:

Name and address of the sponsor, the sponsor’s legal representative, or the sponsor-investigator (both physical and postal)
Principal investigator’s name, address (both physical and postal), and contact details (e.g., phone number and email)
The clinical trial for which the application is made
The planned clinical trial sites and the planned number of participants at the sites
IP(s) description by name or code, strength, and dosage form
IP(s) unit of issue, total quantity, batch number, manufacture, and expiry dates
Sample labels of the primary and secondary containers
Planned return of unused IP(s) to sponsor or destruction at the clinical trial site
Manufacturer name and address

The LibCTReg also notes that an application letter should be sent to the LMHRA Managing Director along with the required documentation.

In addition, per G-LibClinTrial, a parallel submission for approval of the clinical trial and the import permit application is possible. In this case, the import permit application can be included in the clinical trial application package.

The G-LibClinTrial further explains that if the IP(s), health products, or any auxiliary medicinal product must be imported, the clinical trial must be approved by the LMHRA before the import can be authorized. IPs may only be imported if they are not locally available, or if the need for importation is otherwise justified. The justification must be stated in the import permit application letter.

Please note: Liberia is party to the Nagoya Protocol on Access and Benefit-sharing (LBR-3), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see LBR-17.

Clinical Trials Unit

2.4 and 4.3

Foreword, 2-3

Part IV (Section 2) and Part V (Sections 2 and 4)

Part II (Section 1 (a) and (Section 3))

Quality Requirements

Last content review/update: August 29, 2025

Investigator’s Brochure

In accordance with the CTRules and the G-KenyaCT, the sponsor must provide an up-to-date Investigator’s Brochure (IB). An updated IB and Drug Safety Update Report (DSUR) must be submitted whenever available but at least once a year as a notification to the Pharmacy and Poisons Board (PPB) or when there are substantial changes to the previous version.

Per the G-KenyaCT, research must be conducted in accordance with the requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14). As specified in the G-KenyaCT and KEN-14, the IB must provide coverage of the following areas:

Physical, chemical, and pharmaceutical properties
The pharmacological aspects including its metabolites in all animal species tested
The pharmacokinetics and metabolism including its biological transformation in all animal species tested
Toxicological effects in any animal species tested under a single dose study, a repeated dose study, or a special study
Results of clinical pharmacokinetic studies
Information regarding safety, pharmacodynamics, efficacy, and dose responses that were obtained from previous clinical trials in humans

The G-KenyaCT indicates that the sponsor must also follow the guidance contained in KEN-14.

Quality Management

In accordance with the G-KenyaCT, a good manufacturing practice (GMP) certificate must be provided by a competent authority from the country of manufacture to the PPB in the clinical trial application. At a minimum, the GMP certificate should include the competent authority’s name and contact details, address of the manufacturing site, date of inspection, and validity period. Certificates of Analysis (CoAs) must also be provided to the PPB for all investigational products (IPs) and comparator products. Per KEN-14, the sponsor must maintain a CoA to document the identity, purity, and strength of the IP(s) to be used in the clinical trial.

See the G-KenyaCT for detailed chemistry and manufacturing information to be provided to the PPB if the IP has not been registered with the PPB. In addition, see Cert-Emrgcy for information about good clinical practice (GCP) and GMP certifications during emergencies.

(See Product Management section for additional information on sponsor requirements).

Glossary of Terms, 1.13-1.29, 1.48, 1.63-1.88, 1.213-1.240, 1.340-1.354, and 1.542-1.551

Part III (8)

7

Last content review/update: April 13, 2026

Investigator’s Brochure

Per the LibCTReg and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines. Refer to LBR-8 for sponsor requirements related to compiling the investigator’s brochure (IB).

Quality Management

Per the G-LibClinTrial, the Good Manufacturing Practice (GMP) certificate issued by the national regulatory authority of the country where the investigational product (IP) is manufactured must be included in the clinical trial application submission package, if applicable. If necessary, the certificate must be translated into English.

According to LBR-29, the sponsor or the representative must also ensure that the products are manufactured in accordance with the WHO’s GMP Guidelines for Investigational Products (LBR-26) and the ICH Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (LBR-9).

See also LBR-8 for additional sponsor guidance on quality management requirements. (See Product Management section for additional information on sponsor requirements).

Foreword and 2

Part II (Section 1 (a))

Labeling

Last content review/update: August 29, 2025

Per the G-KenyaCT, investigational products (IPs) used in Kenyan clinical trials must be properly labelled. A final copy/version of the labelling must be submitted to the Pharmacy and Poisons Board (PPB) for approval and should contain the following minimum information:

Statement indicating that the product is for “clinical trial purpose only”
Recommended storage conditions
Protocol code or identification
Name, address, and telephone number of the sponsor, contract research organization, or investigator (the main contact for information on the product, clinical trial, and emergency unblinding)
Pharmaceutical dosage form, route of administration, quantity of dosage units, and in the case of open trials, the name/identifier and strength/potency
The batch and/or code number to identify the contents and packaging operation
A trial reference code allowing identification of the trial, site, investigator, and sponsor, if not given elsewhere
The trial participant identification number/treatment number and, where relevant, the visit number
The name of the investigator (if not included above)
Directions for use (reference may be made to a leaflet or other explanatory document intended for the trial participant or person administering the product)
Period of use (use-by date, expiry date, or re-test date as applicable), in month/year format and in a manner that avoids any ambiguity
The complete physical address of the manufacturing site

As indicated in the G-KenyaCT, it is recommended that an IP is not re-labeled wherever possible. It is, however, accepted that in certain cases it is necessary to re-label and the PPB will review applications for the extension of expiration dates based on sufficient evidence being provided by the applicant that an extended expiration date is warranted. A written justification and evidence should be provided to the PPB. Any re-labelling of remaining IPs from previously manufactured batches must be performed in accordance with good manufacturing practice (GMP) principles and is limited to an extension of the expiration date where sufficient evidence is available to support such extension. Any request for re-labelling should be accompanied by a certificate of analysis of the product from a PPB-recognized laboratory or World Health Organization (WHO) prequalified laboratories (KEN-18). After approval, the re-labelling must be carried out under the supervision of a pharmaceutical inspector on the ground. In case of use-date extension, an additional label should be affixed to the IP to indicate the new use date and repeat the batch number. It may be superposed on the old use date, but not on the original batch number. PPB will not approve re-labelling of a product if the proposed additional label obscures the original labelling. At all times, the original label should be visible. This operation may be performed onsite by the clinical trial monitor(s) or the clinical trial site pharmacist, in accordance with specific and standard operating procedures. The operation should be checked by a second person. Documented evidence of this additional labelling should be available in the trial documentation and in the batch records. KEN-34 indicates that all documents submitted to the PPB in a clinical trial application should be in English, including a pictorial sample of the IP with the labeling text.

The International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (KEN-14), which the G-KenyaCT requires following, states that the IP must be coded and labeled in a manner that protects the blinding, if applicable. The IPs must also be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage.

1.48, 1.63, 1.307-1.317

5.13

Last content review/update: April 13, 2026

Investigational product (IP) labeling in Liberia must comply with the requirements set forth in the LibCTReg, the G-LibClinTrial, and the G-Inspec-PMS. While there is no specified language requirement for IP labeling, English appears to be the preferred language. (Note: IPs are also referred to as investigational medicinal products (IMPs)). Per the LibCTReg and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines. Refer to LBR-8 for additional IP labeling guidelines.

The LibCTReg specifies that IPs to be used in a clinical trial center must be properly labelled and the package must sufficiently identify the following:

The clinical trial to be carried out
The medicine(s) to be used
The trial participant identification number to whom the medicine is to be administered
The name and address of the site where the clinical trial is conducted
The directions regarding the manner in which such medicine should be used
The date of dispensing, if applicable
The storage conditions
The use-by, expiry, or re-test date, as applicable
The reference number, as applicable
Any other information, as may be required by the LMHRA

As delineated in the G-LibClinTrial, if the primary container takes the form of blister packs or small units such as ampoules, the secondary packaging should be provided bearing a label with the required particulars. However, the primary container should bear the following information:

Name of the sponsor, contract research organization (CRO), or investigator
Route of administration (may be excluded for oral solid dosage forms) and in the case of open trials, the name/identifier of the IP and strength/potency
Batch and/or code number to identify the contents and packaging operation
A trial reference code allowing identification of the trial, site, investigator, and sponsor if not given elsewhere
The trial participant identification number/treatment number and where relevant, the visit number

In addition, the G-LibClinTrial explains that if it becomes necessary to change the expiry/use-by date, an additional label should be affixed to the IP which should state the new use-by date and repeat the batch number. It may be superimposed on the old date, but for quality control reasons, not on the original batch number. The operation should be performed at an appropriately authorized manufacturing site. However, when justified, the operation may be performed at the investigational site by or under the supervision of the clinical trial site pharmacist (if available), the principal investigator, or the clinical trial monitor(s), who should be appropriately trained. The provisions listed above may apply for auxiliary medicinal products. An auxiliary medicinal product is a medicinal product used for the needs of a clinical trial as described in the protocol, but not as an IP (e.g., medicinal products used as rescue medication, challenge agents, to assess endpoints in the clinical trial, or background treatment).

As explained in the G-Inspec-PMS, where pharmaceutical factories produce pharmaceuticals for use in clinical trials, the IPs must also be labeled “for use in clinical trials only” and marked with the name of the party that commissioned the clinical trial, as well as a trial code sufficient to identify the trial location and the research personnel involved. However, where pharmaceuticals for use in clinical trials are tested in closed trials (double-blind trials), drug name, potency, and efficacy may be replaced by product codes, serial numbers, and packaging batch numbers.

4.3

1, 2, 3, and 9

Part II (Section 1 (a) and Section 3)

Product Management

Last content review/update: August 29, 2025

Supply, Storage, and Handling Requirements

Per the PPA, the Pharmacy and Poisons Board (PPB) is responsible for the regulation of investigational products (IPs), including all matters relating to the safety, packaging, and distribution of medicines. The PPB must ensure that all medicinal products manufactured in, imported into, or exported from the country conform to prescribed standards of quality, safety, and efficacy. Further, the PPB must ensure that the personnel, premises, and practices employed in the manufacture and storage of IPs complies with prescribed requirements.

Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14). As defined in the G-KenyaCT and KEN-14, the sponsor must ensure the following (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Timely delivery of IPs to the investigator(s)
Records that document shipment, receipt, disposition, return, and destruction of the IPs are maintained
A system for retrieving IPs and documenting that this retrieval is maintained
A system for the disposition of unused IPs is maintained
Steps taken to ensure that the IPs are stable over the period of use
Sufficient quantities of the IPs used in the trials are maintained

To the extent stability permits, samples should be retained either until the analyses of the trial data are complete or as required by the applicable regulatory requirement(s), whichever represents the longer retention period.

As defined in the G-KenyaCT and KEN-14, the sponsor must also supply the investigator(s)/institution(s) with the IPs, including the comparator(s) and placebo, if applicable. The sponsor or the representative should not supply either party with the IP(s) until approval from the PPB and a favorable opinion letter from the local and national ethics committees (ECs) are obtained. In addition, the G-KenyaCT requires the following supply, storage, and handling processes:

Analysis or evaluation of samples is performed in accordance with the protocol and, where applicable, the contract/agreement, the work instruction, and associated methods
Adherence to the laboratories, policies, and standard operating procedures (SOPs)
Prior to the initiation of sample analysis or evaluation, it is often necessary to prepare a work instruction detailing the procedures, which will be used to conduct the analysis or evaluation
Have automated equipment for routine hematology, biochemistry, and serology tests
Have procedures for analyzer calibration and quality control
Regularly maintain all the equipment, including point-of-care equipment
Have a procedure for transporting samples safely and quickly from clinical areas to the laboratory
Have written procedures for all assays, and validate the assays
Have a stock control procedure to make sure that reagents and consumables are used within their expiry dates
Keep records, including source documents and final reports
Have a laboratory information management system, and validate and backup the system
Provide protective clothing and safety equipment for staff
Have a central alarm system for all fridges and freezers
Have an internal audit program

The G-KenyaCT also states that the sponsor must submit to the PPB a copy of the endorsed Clinical Trial Import License and/or evidence of delivery to the approved investigator(s)/institution(s) upon importing and supplying each product consignment. In addition, the IP must only be supplied to the investigator(s)/institution(s) named in the application for the Clinical Trial Import License/Clinical Trial Exemption for the purpose and use specified. The sponsor must inform the PPB in the event of any information changes including:

Information the sponsor receives that casts doubt on the continued validity of the submitted data
Information associated with the Clinical Trial Import License

See the G-KenyaCT for additional information on principal investigator requirements relating to the Clinical Trial Import License.

Record Requirements

As per the G-KenyaCT, the sponsor is required to maintain records that document IP(s) shipment, receipt, disposition, return, and destruction. The sponsor must also maintain a system for retrieving IPs and documenting this retrieval, and maintain a system for the disposition of unused IPs.

According to the G-KenyaCT, IP manufacturers or importers must also retain samples for each batch of bulk product, and the packaging components used for each finished batch, for at least two (2) years following the trial. The sponsor should maintain sufficient samples from each batch and keep a record of their analyses and characteristics for reference so that, if necessary, an independent laboratory could reconfirm the same data.

Glossary of Terms, 1.13-1.29, 1.48, 1.63-1.88, 1.213-1.214, 1.307-1.317, 1.355-1.372, 1.491, 1.507-1.511, and 1.542-1.551

3B

5.5, 5.12-5.14, and 7

Last content review/update: April 13, 2026

Supply, Storage, and Handling Requirements

Per the LibCTReg and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation (ICH)'s Guideline for Good Clinical Practice E6(R2) (LBR-8) for use along with the LMHRA guidelines. According to LBR-29, the World Health Organization's (WHO) Good Manufacturing Practice (GMP) Guidelines for Investigational Products (IPs) (LBR-26) and the ICH Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (LBR-9) must also be complied with during IP product management. In addition, per the LMHRA-Act, the LMHRA is responsible for the supply and storage of medicinal products in Liberia. See LBR-26 and LBR-9 for details.

The LibCTReg specifies that it is the responsibility of the sponsor to supply IPs (also referred to as investigational medicinal products (IMPs)) that are produced in compliance with internationally accepted GMP principles. The LMHRA-Act further states that a person or organization must obtain an LMHRA approval license/permit to supply, store, or distribute or sell any medicinal product. Refer to LBR-8 for detailed, sponsor-related IP supply, storage, and handling guidelines.

In addition, the LibCTReg delineates that destruction operations for IPs should be carried out in such a manner that all operations may be accounted for. Documentation should clearly identify, or allow traceability to, the batches and/or trial participant numbers involved and the actual quantities destroyed. The G-LibClinTrial also states that if the IP(s), health product(s), or auxiliary medicine(s) used in a clinical trial are to be destroyed at any point in time, a respective destruction procedure must be provided to the LMHRA as part of the clinical trial protocol. The sponsor or the contract research organization (CRO) must bear the cost of the disposal.

As per the LibCTReg, if the sponsor or sponsor-investigator would like to export the IP(s) remaining after the clinical trial has been stopped or completed, the sponsor, the legal representative, or the sponsor-investigator must obtain an export authorization from the LMHRA.

Per the G-Inspec-PMS, pharmaceutical factories must determine a suitable expiration date for pharmaceuticals for use in clinical trials based on the product properties, container characteristics, and storage conditions. See the G-Inspec-PMS for additional information.

Record Requirements

Liberia does not have country specific IP record requirements. Refer to LBR-8 for IP record requirements.

4.3

Foreword, 1, and 2

Part IV (Section 2) and Part V (Section 3)

Part II (Section 1 (a) and (Section 3 (1 and 5-6))

Definition of Specimen

Last content review/update: August 29, 2025

Specimens are not defined in the Kenyan regulations. However, per KEN-26, the Kenya Medical Research Institute (KEMRI) identifies biological samples and specimens as including, but not limited to, blood samples, saliva, breast milk samples, mosquito parts samples, biological cultures, tissue and tissue samples, hair samples, human stool, and environmental samples used in human health research.

Submission Forms (Shipping)

Last content review/update: April 13, 2026

While the Liberia Medicines and Health Products Regulatory Authority (LMHRA) does not provide a formal definition for specimens, the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) describes examples of specimens in the G-ACRE-IRB. As per the G-ACRE-IRB, examples of biological specimens include:

Collection of blood via finger or ear stick
Hair and nail clippings collected in a non-disfiguring manner
Excreta and external secretions (including sweat)
Sputum collected through expectoration
Bodily fluids
Tissue biopsies

Article IX (Section 9.04) and Article XVII (Section 17.03)

Specimen Import & Export

Last content review/update: August 29, 2025

New Info (Not Yet in Profile)

The Pharmacy and Poisons Board issued Revision 5 of Guidelines for the Conduct of Clinical Trials in Kenya, effective January 2, 2026, which includes additional/revised definitions; alignment with ICH, WHO, PIC/S, and GCLP standards; new application process/requirements for multicenter clinical trials; clarification on investigator categories and qualifications; clarification on safety reporting; and alignment of study monitoring requirements to ICH E6(R3).

Import/Export

Per the G-ECBiomedRes, biological material must not be imported nor exported without proper justification and authorization, which includes a signed material transfer agreement (MTA) approved by the relevant institutions and deposited with the National Commission for Science, Technology and Innovation (NACOSTI). For exports, a Kenyan investigator must be included in the team that is conducting the research in the recipient country. All biological samples and data collected during research belong to the local participating institutions and country.

In addition, KEN-37 has indicated that Kenya’s Pharmacy and Poisons Board (PPB) will approve of an export for overseas research if the following requirements are met:

PPB initial approval letter or annual approval letter
Ethics committee (EC) approval letter
MTA
Study protocol with a summary justification for the participants' sample exportation
Informed consent form that highlights the areas where study participants are informed about the exportation of their samples

The G-KenyaCT states that in the case of transfer of materials during research involving children, the sponsor or the representative or the principal investigator should provide to the EC an MTA including, but not limited to, the following information:

Identification of the provider and recipient
Definition of the trial and how the material will and will not be used
Maintenance of confidentiality of background of supporting data or information, if any
Indemnification and insurance

In addition, KEN-26 provides an example of the Kenya Medical Research Institute (KEMRI)'s procedures for handling requests to ship biological samples or specimens. KEN-17 also provides an example of an MTA form from the Kenyatta National Hospital-University of Nairobi (KNH-UoN) Ethics and Research Committee.

4.1 and 4.2

Glossary of Terms and 1.172

KNH-UoN ERC Material Transfer Request Form

Submission Forms

Last content review/update: April 13, 2026

Note: Per LBR-38, the National Research Ethics Board of Liberia (NREB) has sole responsibility to review all clinical trial protocols in Liberia. Per LBR-28, due to a Memorandum of Understanding (MOU) between the NREB and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) in 2022, all clinical trial protocols submitted to the ACRE IRB are referred to the NREB. Therefore, the information and requirements from the G-ACRE-IRB described in the ClinRegs Liberia profile only apply to human participants research other than clinical trials.

Import

Information is unavailable regarding the Liberia Medicines and Health Products Regulatory Authority (LMHRA)’s role in approving the import of biological specimens.

Export

As set forth in the LibCTReg and the G-LibClinTrial, the applicant must obtain an authorization from the LMHRA if biological samples are to be exported out of Liberia. Additionally, per the G-LibClinTrial, the applicant must provide an annual progress report on the use, and results obtained from, the biological samples exported out of Liberia. Per LibCTReg, non-refundable fees apply to these requests. Pursuant to LMHRA-Act, the LibCTReg further states that any person(s), institution(s), corporate entity(ies), their designees or legal representatives who are found to be in violation of any provision of the biological sample export requirements delineated in LibCTReg will be liable to fines as prescribed by the LMHRA at the time of the violation.

Material Transfer Agreement

Per the LibCTReg and the G-LibClinTrial, a material transfer agreement (MTA) must also be provided to the LMHRA. The G-LibClinTrial notes that the authorization request and the MTA should be included in the clinical trial application submission package.

The G-NREB indicates that the NREB requires the MTA process be used for the shipment of specimens/biological materials outside of Liberia. The G-NREB also specifies that when a protocol application is submitted for review by the NREB, the accompanying documentation should also include an MTA for the shipment of the specimen/biological materials outside of Liberia (where applicable).

According to the G-ACRE-IRB, the ACRE IRB requires the MTA process be used for the shipment of specimens/biological materials outside of Liberia.

Per the G-ACRE-IRB, for studies using the ACRE IRB, the MTA must detail the type of materials, anticipated use, location of storage outside Liberia, duration of such storage, and limitations on use, transfer, and termination of use of such materials subject to any laws, regulations, and enactments in Liberia. The ACRE IRB also requires an MTA be signed by all parties involved in the research including local and international principal investigators, heads of local institutions, research sponsors, and other relevant entities prior to the transfer or export of biological samples out of Liberia. The following requirements must also be met:

The ACRE IRB (the provider institution) must review the MTA to ensure consistency with the stated objectives of the research, the contents of the informed consent documents, and the principles stated in the G-ACRE-IRB. The ACRE IRB must grant provisional approval pending the submission of the MTA to the ethics committee (EC) (the recipient institution) and the EC’s receipt of acknowledgement
The applicant for research review (the scientist or sponsor at the provider institution) must file a copy of the MTA and provisional approval by the ACRE IRB (the provider institution) with the EC (the recipient institution) for record purposes only
The EC (the recipient institution) must acknowledge receipt of the MTA to the applicant (the scientist or sponsor at the provider institution) who must inform the ACRE IRB (the provider institution)
The ACRE IRB (the provider institution) is required to grant final approval to research involving international transfer of Liberian samples after all the other stated criteria have been met and upon acknowledgement of MTA receipt

2, 6.4, and Annex 4

Article IX (Section 9.01) and Article XXV (Section 25.06)

Intellectual Property

Part VIII

Part II (Section 4)

Consent for Specimen