Clinical Research Regulation For Liberia
Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Specimen Import & Export
QUICK FACTS
Clinical trial application language English
Regulatory authority & ethics committee review may be conducted at the same time Yes
Clinical trial registration required No
In-country sponsor presence/representation required No
Age of minors Under 18
Specimens export allowed Yes
Regulatory Authority > Regulatory Authority
Last content review/update: July 23, 2020
Requirements
(1) (Legislation) An Act to Establish the Liberia Medicines and Health Products Regulatory Authority of 2010 (LMHRA Act) (September 29, 2010)
Senate and House of Representatives of the Republic of Liberia
Relevant Sections: Part IV (Sections 1 and 2) and Part V (Section 5)
(2) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 1.0 and 2.0
(3) (Guidance) Guidelines for Registration of Medicines and Health Products in Liberia (G-MedProdReg) (April 15, 2012)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Legal Basis and Registration (2.1)
Summary

Overview

As per the LMHRA Act and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections. According to the LMHRA Act and LBR-4, the LMHRA operates as an autonomous government agency that reports to the President of the Republic of Liberia. In addition to its role in authorizing clinical trials, LBR-4 indicates that the LMHRA is also responsible for drug and health care product marketing authorization and registration, inspections, import control, licensing, market and quality control, advertising and promotion, and pharmacovigilance. Per G-MedProdReg, applicants are responsible for registering all locally manufactured or imported drugs with the LMHRA.

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

Contact Information

Liberia Medicines and Health Products Regulatory Authority (LMHRA)
PO Box 1994 VP Road
Old Road, Sinkor
Monrovia, Liberia

Phone: (+231) (0) 886562019
Email: info@lmhra.org or lmhra2010@gmail.com

Additional Resources
(1) (Document) Nagoya Protocol on Access and Benefit-sharing (LBR-3) (2011)
Convention on Biological Diversity, United Nations
(2) (Document) Pharmaceutical Sector Country Profile Questionnaire - Liberia (LBR-4) (2011)
World Health Organization and The Global Fund
Relevant Sections: 5.01
(3) (Webpage) Country Profile: Liberia (LBR-17) (Current as of December 22, 2020)
Access and Benefit-sharing Clearing-house, Convention on Biological Diversity, United Nations
(4) (Webpage) LMHRA - Contact (LBR-19) (Current as of December 22, 2020)
Liberia Medicines and Health Products Regulatory Authority
Regulatory Authority > Scope of Assessment
Last content review/update: July 01, 2020
Requirements
(1) (Legislation) An Act to Establish the Liberia Medicines and Health Products Regulatory Authority of 2010 (LMHRA Act) (September 29, 2010)
Senate and House of Representatives of the Republic of Liberia
Relevant Sections: Part IV (Sections 1 and 2) and Part V (Section 5)
(2) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 1.0, 1.2, 2.0, and Appendices 1, 2, and 9
(3) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Intellectual Property
Summary

Overview

In accordance with the LMHRA Act 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 LBR-18, proposed clinical trials of registered medicines may include changes to indications and clinical use, target populations, routes of administration, and/or dosage. The G-LibClinTrial specifies that the scope of the LMHRA’s assessment includes all clinical trials (Phases I-IV). In addition, per the G-LibClinTrial and LBR-18, the ethics committee (EC) 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 EC approval is obtained. The G-LibClinTrial, the G-NREB, and LBR-18 also specify that EC clearance or a copy of acknowledgement of study protocol submission must be included in the clinical trial application submission.

Clinical Trial Review Process

According to LBR-29, LMHRA’s Pharmacovigilance & Medicine Information Office coordinates the clinical trial application review process. Appendix 1 of the G-LibClinTrial indicates that upon receipt of a clinical trial application, the Pharmacovigilance & Medicine Information Office screens the application package for completeness. If complete, the sponsor or his/her representative is issued an acknowledgement of receipt via a cover sheet, and an LMHRA application/reference number is assigned to the application. The sponsor or his/her representative must reference the LMHRA reference number in all future application-related correspondence. According to LBR-29, receipt of the clinical trial application submission must be acknowledged in five (5) working days. Per the G-LibClinTrial and LBR-18, LMHRA will only process an application upon receipt of a completed application and the prescribed fees.

(See the Clinical Trial Lifecycle topic, Submission Process and Submission Content subtopics for detailed submission requirements)

Additional Resources
(1) (Not Available Online) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (October 2014-January 2015) (LBR-29)
(2) (Webpage) Clinical Trial Application Portal (LBR-18) (Current as of December 22, 2020)
Liberia Medicines and Health Products Regulatory Authority
Regulatory Authority > Regulatory Fees
Last content review/update: July 01, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 2.0 and Appendix 11
Summary

Overview

As per the G-LibClinTrial, the sponsor or his/her representative is responsible for paying a fee to the Liberia Medicines and Health Products Regulatory Authority (LMHRA) to submit a clinical trial application. The LMHRA requires a non-refundable application fee of $3,000 USD. If the sponsor or his/her representative would like to fast track the application review process, the fee is $6,000 USD. In addition, there is a fee of $500 USD for the LMHRA to review major application amendments and a fee of $250 USD to review minor amendments.

Per the G-LibClinTrial and LBR-18, the LMHRA will only process an application upon receipt of a completed application and the prescribed fees.

Instructions for Payment of Clinical Trial Application Fee

As stated in the G-LibClinTrial, payment is to be made directly into the LMHRA’s bank account:

Liberia Medicines and Health Products Regulatory Authority (LMHRA)
Bank: ECOBANK, Liberia Ltd.
Account Number: 001-113472105440

Additional payment details should be obtained from the LMHRA prior to initiating such a transaction.

Additional Resources
(1) (Webpage) Clinical Trial Application Portal (LBR-18) (Current as of December 22, 2020)
Liberia Medicines and Health Products Regulatory Authority
Ethics Committee > Ethics Committee
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 1.0, 1.2, 2.0, 6.0, and 8.0
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Forward, Background, and Intellectual Property
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Foreword, Article V, Article VI (Section 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)
(4) (Policy) National Research for Health Policy and Strategy: 2018 – 2023 (NatResHlthPlcy) (2018)
Ministry of Health
Relevant Sections: 2.5, 5.1.3 and Annex 3
Summary

Overview

According to the NatResHlthPlcy, Liberia has two (2) ethics committees (ECs): the National Research Ethics Board (NREB) and the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB). Per the G-LibClinTrial and the G-NREB, ethical clearance is required as part of the Liberia Medicines and Health Products Regulatory Authority (LMHRA) clinical trial approval process.

LBR-22 states that the UL-PIRE-IRB was created in 2005 through a collaborative agreement between the U.S.-based Pacific Institute for Research and Evaluation (PIRE) and the University of Liberia (UL). As noted in the G-UL-PIRE-IRB, the UL-PIRE-IRB is mandated by the Board of Directors of the University of Liberia-Pacific Institute for Research Evaluation (UL-PIRE) Africa Center. The UL-PIRE-IRB’s purpose is to review and certify the ethical acceptability of all research involving human participants conducted in Liberia. All studies submitted to the UL-PIRE must be approved by the UL-PIRE-IRB. This includes all studies conducted by UL-PIRE investigators as well as all research conducted by outside investigators or students and faculty of universities in Liberia. The G-UL-PIRE-IRB is intended to ensure quality and consistency in the UL-PIRE-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 subjects.

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 and LBR-13 state that the board oversees all research related protocols within and outside of Liberia 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 CIOMS’ guidelines (LBR-2)), and with Liberia’s applicable regulations and guidelines. In addition, per the G-NREB and LBR-13, the NREB is responsible for reviewing all research protocols involving human participants submitted by individual investigators affiliated with nationally and internationally recognized institutions. Please refer to the Authorizing Body subtopic for additional information.

UL-PIRE-IRB Composition

As specified in the G-UL-PIRE-IRB, the UL-PIRE-IRB members (full, regular, and ad-hoc) must be recommended by the UL-PIRE-IRB Chair and appointed by the UL-PIRE Board of Directors. The UL-PIRE-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 membership must include both scientists and non-scientists from diverse backgrounds to undertake an impartial and adequate review of research proposals. The UL-PIRE-IRB membership must include the following:

  • 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 UL-PIRE-IRB must ensure social inclusivity and gender sensitivity in its membership and recruitment of ad-hoc reviewers. There must be adequate representation by age, gender, community, etc., on the board to safeguard the interests and welfare of all segments of society. UL-PIRE-IRB members must be drawn from both public and private institutions within the country.

NREB Composition

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. LBR-28 also specifies 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 religious elder, community elders, surgeons, clinicians, and public health specialists.

UL-PIRE-IRB Terms of Reference, Review Procedures, and Meeting Schedule

As delineated in the G-UL-PIRE-IRB, the UL-PIRE-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. UL-PIRE-IRB members must be appointed initially for a term of three (3) years, which must be renewable and is subject to the UL-PIRE Board of Directors’ decision. To maintain continuity in UL-PIRE-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 UL-PIRE-IRB. UL-PIRE-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. UL-PIRE-IRB members are required to review, discuss, and consider protocols submitted to the board for evaluation in order 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.

The UL-PIRE-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 member(s) who is/are unavailable during a meeting), and 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 UL-PIRE-IRB members in attendance is required for a protocol to be approved.

The UL-PIRE-IRB Chair may 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.

Regular-voting, UL-PIRE-IRB members, as well as independent consulting members, may be modestly compensated for the time spent on board-related activities. The amount of such compensation will be determined by the Coordinator in consultation with the Chair.

Refer to the G-UL-PIRE-IRB for detailed information on UL-PIRE-IRB administrative processes.

NREB Terms of Reference, Review Procedures, and Meeting Schedule

Pursuant to the G-NREB and LBR-15, the NREB follows standard operating procedures (SOPs) as well as relevant 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 issues, as long as 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. Per the G-NREB and LBR-14, 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. The G-NREB and LBR-16 explain that all complete applications submitted by the deadline must be reviewed at the next regularly scheduled meeting if the number of applications meet the threshold. The G-NREB SOPs and LBR-14 further specify that 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, LBR-13, LBR-15, LBR-14, and LBR-16 for detailed committee requirements.

Additional Resources
(1) (Document) The Belmont Report: Ethical Principals and Guidelines for the Protection of Human Subjects of Research (LBR-11) (September 30, 1978)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(2) (International Guidance) Declaration of Helsinki (LBR-27) (October 19, 2013)
World Medical Association
(3) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(4) (International Guidance) International Ethical Guidelines for Health-related Research Involving Humans (LBR-2) (2016)
Council for International Organizations of Medical Sciences (CIOMS)
(5) (Not Available Online) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (October 2014-February 2015, June and December 2020) (LBR-28)
(6) (Webpage) National Research Ethics Board of Liberia - About (LBR-13) (Current as of January 5, 2020)
National Research Ethics Board of Liberia
(7) (Webpage) National Research Ethics Board of Liberia - Review Type (LBR-16) (Current as of December 22, 2020)
National Research Ethics Board of Liberia
(8) (Webpage) National Research Ethics Board of Liberia – Administrative Procedures (LBR-14) (Current as of December 22, 2020)
National Research Ethics Board of Liberia
(9) (Webpage) National Research Ethics Board of Liberia – Method of Decision Making (LBR-15) (Current as of December 22, 2020)
National Research Ethics Board of Liberia
(10) (Webpage) UL-PIRE AFRICA - The Institutional Review Board (IRB) (LBR-22) (Current as of December 14, 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Ethics Committee > Scope of Review
Last content review/update: December 22, 2020
Requirements
(1) (Legislation) An Act to Establish the Liberia Medicines and Health Products Regulatory Authority of 2010 (LMHRA Act) (September 29, 2010)
Senate and House of Representatives of the Republic of Liberia
Relevant Sections: Part IV (Sections 1 and 2) and Part V (Section 5)
(2) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 1.0, 2.0, and Appendices 1, 2, and 9
(3) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Forward, Background, Administrative Procedures, Researchers, and Intellectual Property
(4) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Foreword, Article I, Article II, Article IV, Article V, Article VI (Section 6.04), Article XIV (Sections 14.01 and 14.05), Article XV, Article XVI, Article XVII (Sections 17.01 and 17.02), Article XXII, Article XXIII (Section 23.01), and Article XXV (Sections 25.02, 25.04, and 25.05)
(5) (Policy) National Research for Health Policy and Strategy: 2018 – 2023 (NatResHlthPlcy) (2018)
Ministry of Health
Relevant Sections: 2.5, 5.1.3, and Annex 3
Summary

Overview

According to the G-UL-PIRE-IRB and the G-NREB, the primary scope of information assessed by the ethics committee (EC) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. According to the NatResHlthPlcy, Liberia has two (2) ECs: the National Research Ethics Board (NREB) and the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB). As per the G-UL-PIRE-IRB, the UL-PIRE-IRB must also pay special attention to reviewing informed consent and protecting the welfare of certain classes of participants deemed to be vulnerable, including children.

The G-UL-PIRE-IRB and the G-NREB also state that the EC is responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. It must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants, and it must verify the adequacy of confidentiality and privacy safeguards. See the G-UL-PIRE-IRB and the G-NREB for detailed ethical review guidelines.

Role in Clinical Trial Approval Process

As per the LMHRA Act and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) and the EC must approve a clinical trial application prior to the sponsor or his/her representative initiating the clinical trial. Per the G-LibClinTrial and LBR-18, the EC 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 EC approval is obtained. The G-LibClinTrial, the G-NREB, and LBR-18 also indicate that EC clearance or a copy of acknowledgement of study protocol submission must be included in the clinical trial application submission.

UL-PIRE-IRB

As per the G-UL-PIRE-IRB, principal investigators (PIs) are required to submit all applications four (4) weeks in advance of the date that a decision is requested. In the case of protocols requiring full review, submission is required four (4) weeks prior to the next scheduled UL-PIRE-IRB meeting. The UL-PIRE-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.

On receipt of a proposal for review, the UL-PIRE-IRB Secretariat will preliminarily assess the completeness of the submission. If the submission is incomplete, the Secretariat will inform the PI accordingly and request the additional materials. Once the submission is deemed complete, the Secretariat will notify the PI and distribute the materials to the assigned UL-PIRE-IRB members. Exempt studies will be reviewed by all board members; expedited studies will be reviewed by all board members; full review studies will be sent to the entire UL-PIRE-IRB membership for review. In addition, the G-UL-PIRE-IRB defines an expedited study as one which does not require review by a convened UL-PIRE-IRB quorum because it has been determined that participants are subject to low risk. Additional information about the various review types can be found in the G-UL-PIRE-IRB.

The G-UL-PIRE-IRB explains that the PI must check the level at which the protocol will be reviewed and confirm the required documents before submitting it for review. Please refer to the G-UL-PIRE-IRB for additional information on the administrative processes relating to proposal submission.

As specified in the G-UL-PIRE-IRB, the UL-PIRE-IRB approval will commence on the day the study is approved and will expire within a defined time period based on the 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-UL-PIRE-IRB also states that the UL-PIRE-IRB must review and approve any protocol amendments prior to those changes being implemented. The protocol submission is reviewed either via expedited procedures (for minor changes) or via full UL-PIRE-IRB review (for all other changes). The criteria for approval are the same as for initial review. In addition, per the G-UL-PIRE-IRB, UL-PIRE-IRB has a continuing responsibility to monitor the approved trial(s) to ensure ethical compliance throughout the study duration. A continuing review is conducted to review progress of an ongoing study, and not just changes made in the study, in order to ensure continued protection of the rights and welfare of research participants. Refer to the G-UL-PIRE-IRB for protocol amendment and continuing review documentation submission and procedural requirements.

As described in the G-UL-PIRE-IRB, the UL-PIRE-IRB is also authorized to suspend or terminate an approved research study for a variety of reasons, including but not limited to:

  • Failure to obtain appropriate consent or keep appropriate study-related paperwork
  • Conduct of research activities without prior UL-PIRE-IRB approval
  • Serious adverse event(s)
  • Detrimental change in the risk-benefit ratio of the study
  • Failure of investigators to complete required training

The convened board is specifically authorized to suspend or terminate approval of research protocols that are not being conducted in accordance with the UL-PIRE-IRB’s requirements or that has been associated with serious harm to the participants. The UL-PIRE-IRB Chair, or his/her designee, is authorized to suspend research protocols in emergency situations, such as when the rights, safety, or welfare of research participants are at immediate risk. Please refer to the G-UL-PIRE-IRB for detailed information on the board’s process for study suspension/termination, notification of the investigator, the consequences of study suspension/termination, and UL-PIRE-IRB requirements for permitting study reinstatement.

NREB

As described in the G-NREB, PIs are required to submit new research protocols to the NREB Secretariat no later than three (3) weeks prior to the next bi-monthly board meeting. Any protocols submitted following the stipulated timeline should be re-routed for the next review. 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. Per the G-NREB and LBR-16, a PI will be contacted by written communication (letter or email) if the NREB determines that additional materials are required to complete its review. PIs may also be asked to be available for presentations and/or contacted during the meetings.

The G-NREB and LBR-16 explain that 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 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. 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. If the NREB has not reviewed and approved a study’s request by the current expiration date, study activities should cease until the board determines whether continuing the research is in the best interests of all previously enrolled participants.

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 due to risk). The G-NREB further states that the secretariat will then notify the PI of the board’s decision within three (3) weeks from the date of protocol submission. 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 the decision types and various review processes the NREB uses to consider protocol submissions.

In addition to protocol submission requirements, the G-NREB also specifies that the complete application for ethical review and approval of a proposed health research study should be submitted by a PI to the NREB Secretariat. Applicants should submit the application 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.

Delivery Address for UL-PIRE-IRB Submissions:

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

The IRB Coordinator
UL-PIRE Africa Center
Ground Floor
Graduate School Building
University of Liberia
Capitol Hill
Monrovia, Liberia

Phone: +231 (0) 886-522833 or +231(0) 777-583774 (per LBR-28)
Email: jktegli@yahoo.com and ulpireirb@gmail.com

Note: Proposals submitted electronically should be sent to the email addresses listed above. Details concerning the number of copies to submit can be found in the application package.

Delivery Address for NREB Submissions:

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

Additional Resources
(1) (Not Available Online) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (October 2014-February 2015, June and December 2020) (LBR-28)
(2) (Webpage) Clinical Trial Application Portal (LBR-18) (Current as of December 22, 2020)
Liberia Medicines and Health Products Regulatory Authority
(3) (Webpage) National Research Ethics Board of Liberia - Review Type (LBR-16) (Current as of December 22, 2020)
National Research Ethics Board of Liberia
(4) (Webpage) National Research Ethics Board of Liberia – Method of Decision Making (LBR-15) (Current as of December 22, 2020)
National Research Ethics Board of Liberia
(5) (Webpage) National Research Ethics Board of Liberia – Notification of Decision (LBR-23) (Current as of December 22, 2020)
National Research Ethics Board of Liberia
Ethics Committee > Ethics Committee Fees
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Administrative Procedures
(2) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article VI (Section 6.14) and Article XXV (Section 25.01)
Summary

Overview

The National Research Ethics Board (NREB) and the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) both charge fees to conduct ethical reviews.

NREB

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 is 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

UL-PIRE-IRB

As per the G-UL-PIRE-IRB, the UL-PIRE-IRB requires applicants to pay a fee for protocol review. Additional fees may be charged for amendments, particularly those of a substantive nature. The Coordinator and the Chair of the board must determine the amount for protocol review. A relatively minimum submission fee will be required for non-sponsored research conducted by individual investigators (50% of sponsored research). The UL-PIRE-IRB fees are as follows:

  • Health, Behavioral and Education Research: $500 USD
  • Clinical Trial: $5,000 USD
  • Re-Submission: $500 USD
  • Continuing Review: $500 USD
  • Amendment: $250 USD
  • Foreign Student: $300 USD
  • Liberian Student: $100 USD
Additional Resources
(1) (Document) University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) Fees Memo (LBR-10) (October 1, 2014)
University of Liberia, Office of the Institution Review Board
(2) (Webpage) National Research Ethics Board of Liberia (LBR-12) (Current as of December 22, 2020)
National Research Ethics Board of Liberia
Ethics Committee > Authorizing Body
Last content review/update: July 01, 2020
Requirements
(1) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Forward, Acknowledgements, Background, and Administrative Procedures
(2) (Policy) National Research for Health Policy and Strategy: 2018 – 2023 (NatResHlthPlcy) (2018)
Ministry of Health
Relevant Sections: 5.1
Summary

Overview

As explained in the G-NREB, the National Research Ethics Board (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 and LBR-13 state that the NREB is responsible for overseeing all research related protocols within and outside of Liberia in compliance with internationally recognized ethical standards including the Belmont Report (LBR-11), the Declaration of Helsinki (LBR-27), 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).

Per the NatResHlthPlcy, the G-NREB, and LBR-13, the NREB is also responsible for the following (Note: The sources provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

  • Establishing guidelines for the review of research for health protocols for use by other review boards
  • Reviewing and approving protocols in line with established ethics guidelines
  • Giving advice on ethical research issues to the MoH and related government ministries and agencies
  • Monitoring the conduct of research for health to ensure compliance with approved protocols
  • Establishing and maintaining a repository of all protocols reviewed in the country along with finished research/study reports
  • Supporting research ethics capacity building

The G-NREB and LBR-13, further identify the following NREB duties (Note: The sources provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

  • Maintaining a registry of health research ethics committees (ECs)
  • Setting norms and standards for conducting research on humans and animals, including clinical trials
  • Mitigating conflicts among ECs, researchers, and research entities
  • Informing professional bodies of any breaches of professional ethical standards
  • Recommending disciplinary action(s), where appropriate

No information is available on registration, auditing, and accreditation responsibilities by the NREB.

Additional Resources
(1) (Document) The Belmont Report: Ethical Principals and Guidelines for the Protection of Human Subjects of Research (LBR-11) (September 30, 1978)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(2) (International Guidance) Declaration of Helsinki (LBR-27) (October 19, 2013)
World Medical Association
(3) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(4) (International Guidance) International Ethical Guidelines for Health-related Research Involving Humans (LBR-2) (2016)
Council for International Organizations of Medical Sciences (CIOMS)
(5) (Webpage) National Research Ethics Board of Liberia - About (LBR-13) (Current as of January 5, 2020)
National Research Ethics Board of Liberia
Clinical Trial Lifecycle > Submission Process
Last content review/update: December 22, 2020
Requirements
(1) (Legislation) An Act to Establish the Liberia Medicines and Health Products Regulatory Authority of 2010 (LMHRA Act) (September 29, 2010)
Senate and House of Representatives of the Republic of Liberia
Relevant Sections: Part IV (Sections 1 and 2) and Part V (Section 5)
(2) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 1.0, 2.0, and Appendices 1, 2, and 9
(3) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Forward, Background, Administrative Procedures, Researchers, and Intellectual Property
(4) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article V, Article IX (Section 9.01), and Article XXV (Section 25.02)
(5) (Policy) National Research for Health Policy and Strategy: 2018 – 2023 (NatResHlthPlcy) (2018)
Ministry of Health
Relevant Sections: 2.5 and Annex 3
Summary

Overview

In accordance with the LMHRA Act and the G-LibClinTrial, Liberia requires the sponsor or his/her representative to obtain clinical trial authorization from the Liberia Medicines and Health Products Regulatory Authority (LMHRA). Per the G-UL-PIRE-IRB and the G-NREB, the principal investigator (PI) must also obtain ethics committee (EC) approval. The NatResHlthPlcy states that Liberia has two (2) ECs: the National Research Ethics Board (NREB) and the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB).

Per the G-LibClinTrial and LBR-18, the sponsor’s representative must also submit a power of attorney attesting that he/she is a duly appointed agent. The sponsor must also ensure the PI obtains EC approval. Per the G-LibClinTrial and LBR-18, the EC and LMHRA reviews may be conducted in parallel. However, per the G-LibClinTrial and the G-NREB, the LMHRA will only issue final approval once EC approval is obtained. (See Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission requirements).

Delivery Address for Clinical Trial Application
Liberia Medicines and Health Products Regulatory Authority (LMHRA)
PO Box 1994 VP Road
Old Road, Sinkor
Monrovia, Liberia
Phone: (+231) (0) 886562019
Email:
info@lmhra.org; lmhra2010@gmail.com

Assembly and Number of Copies

Based on information provided in the G-LibClinTrial, the sponsor or his/her representative should submit printed and electronic copies of the clinical trial application to the LMHRA. The LMHRA will only begin processing the application upon receipt of four (4) printed copies arranged in spring form file folders formatted using Microsoft Word, Times New Roman, font size 12. The electronic file should also be formatted using Microsoft Word, Times New Roman, font size 12. See Appendix 1 in the G-LibClinTrial for detailed clinical trial application formatting requirements.

As indicated in the G-UL-PIRE-IRB, PIs are required to a submit research protocol as part of an application packet that includes the documentation specified by the UL-PIRE-IRB submission form (see Article XXV in the G-UL-PIRE-IRB and LBR-7). According to LBR-28, PIs must submit eight (8) hard copies of the protocol with additional documentation as specified in the Submission Content subtopic.

According to the G-NREB, PIs must submit typed, dated, and signed submissions electronically and by hard copy to the NREB. The documents should be formatted in standard font size 12, double-spaced, with the pages printed on one (1) side only. The NREB requires 15 comb-bound copies of the full 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. In addition, all protocols must 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.

Clinical Trial Application Language Requirements

As delineated in the G-LibClinTrial and LBR-18, the clinical trial application and any accompanying material must be provided in English.

Additional Resources
(1) (Form) UL-PIRE IRB Submission Form (LBR-7) (Date Unavailable)
University of Liberia-Pacific Institute for Research and Evaluation
(2) (Not Available Online) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (October 2014-February 2015, June and December 2020) (LBR-28)
(3) (Webpage) Clinical Trial Application Portal (LBR-18) (Current as of December 22, 2020)
Liberia Medicines and Health Products Regulatory Authority
(4) (Webpage) National Research Ethics Board of Liberia (LBR-12) (Current as of December 22, 2020)
National Research Ethics Board of Liberia
Clinical Trial Lifecycle > Submission Content
Last content review/update: December 22, 2020
Requirements
(1) (Legislation) An Act to Establish the Liberia Medicines and Health Products Regulatory Authority of 2010 (LMHRA Act) (September 29, 2010)
Senate and House of Representatives of the Republic of Liberia
Relevant Sections: Part IV (Sections 1 and 2) and Part V (Section 5)
(2) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 1.0, 2.0, and 4.0
(3) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Forward, Background, Administrative Procedures, Researchers, and Intellectual Property
(4) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article V, Article IX (Sections 9.01 and 9.03), and Article XXV (Section 25.02)
(5) (Policy) National Research for Health Policy and Strategy: 2018 – 2023 (NatResHlthPlcy) (2018)
Ministry of Health
Relevant Sections: 2.5, Annex 2, and Annex 3
Summary

Overview

As set forth in the LMHRA Act and the G-LibClinTrial, Liberia requires the sponsor or his/her representative to obtain clinical trial authorization from the Liberia Medicines and Health Products Regulatory Authority (LMHRA). Per the G-UL-PIRE-IRB and the G-NREB, the principal investigator (PI) must also obtain ethics committee (EC) approval. The NatResHlthPlcy states that Liberia has two (2) ethics committees (ECs): the National Research Ethics Board (NREB) and the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB).

LMHRA Requirements

As per the G-LibClinTrial and LBR-18, the following documentation must be submitted to the LMHRA (Note: The sources provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

  • Cover letter (signed, witnessed, and notarized)
  • Power of attorney, if applicable
  • Clinical trial application form (See Appendix 1, G-LibClinTrial)
  • General investigational plan
  • Capacity building plans
  • Protocol (see below for detailed protocol requirements)
  • Investigator’s Brochure (IB) or prescribing information data sheet
  • Declarations by sponsor, investigators, and monitor(s) (See Appendices 2-4, G-LibClinTrial)
  • Financial declaration by sponsor and/or PI (See Appendix 5, G-LibClinTrial)
  • Certified copy of insurance for participants
  • Ethics clearance or copy of acknowledgement of protocol submission
  • Investigator(s) curriculum vitae(s) (CVs) (See Appendix 6, G-LibClinTrial)
  • Investigational medicinal product dossier
  • Statement indicating application information is complete, accurate, and not misleading (may be provided in the cover letter)
  • For multicenter trials, a coordinating investigator must sign the application form
  • When the trial is part of an international study, provide sufficient information regarding the other participating countries, including the part of the trial to be conducted locally
  • Payment of application fee

Refer to the G-LibClinTrial for detailed application requirements.

UL-PIRE-IRB Requirements

As indicated in the G-UL-PIRE-IRB, PIs are required to a submit research protocol as part of an application packet that includes the documentation specified by the UL-PIRE-IRB submission form (see Article XXV in the G-UL-PIRE-IRB and LBR-7). According to LBR-28, PIs must submit eight (8) hard copies of the protocol and, per the G-UL-PIRE-IRB, the following additional documentation for an initial application review:

  • Cover letter
  • Protocol summary (Article XXV (Section 25.02) in the G-UL-PIRE-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
  • Informed consent forms (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-UL-PIRE-IRB)
  • Data Safety and Monitoring Board (DSMB) and Institutional Biosafety Committee (IBC) records, if applicable
  • Material Transfer Agreement (MTA), if applicable (See also Specimens topic, Specimen Import & Export and Consent for Specimen subtopics)
  • 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

NREB Requirements

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
  • 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
  • Material Transfer Agreement (MTA) for shipment of specimen(s)/biological material(s) outside of Liberia (where applicable) (See also Specimens topic, Specimen Import & Export and Consent for Specimen subtopics)
  • Data Sharing Agreement (where applicable)
  • Administrative information on sponsors of the study
  • 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 informed consent form (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 for 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 Good Clinical Practice (GCP) for PI(s)
  • Data Safety Monitoring Board (DSMB) membership and charter of work/current member CVs
  • Insurance coverage for study participants
  • Scientific review approval
  • LMHRA approval letter for use of the investigational products (IPs)/ devices and clinical trial approval (this should be submitted after the NREB approval)

Clinical Trial Protocol Requirements

Per the G-LibClinTrial, the following must be included in the protocol:

  • General information (title, identification, date, names, and contact information for sponsor, monitor, investigators, and institutions involved in the trial)
  • Background information (details of investigational products, pre-clinical studies, potential risks and benefits, dosage, population, reference literature)
  • Trial objective and purpose
  • Trial design
  • Selection and withdrawal of study participants
  • Treatment of study participants
  • Assessment of efficacy
  • Assessment of safety
  • Statistics
  • Granting LMHRA direct access to source data/documents
  • Quality control and quality assurance
  • Description of ethical considerations
  • Publication policy

For more details, see section 4 of the G-LibClinTrial.

Per the NatResHlthPlcy, the protocol should be structured as follows:

  • Title
  • Investigators/Researchers 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.

UL-PIRE-IRB Clinical Protocol Requirements

According to the G-UL-PIRE-IRB, the clinical protocol should contain the elements included in the UL-PIRE-IRB submission form (see Article XXV in the G-UL-PIRE-IRB and LBR-7). Per the G-UL-PIRE-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 UL-PIRE-IRB approval, if available
  • Study design
  • Study participation (including informed consent procedures and content/language and participant information sheet content) (See also Informed Consent topic, Documentation Requirements subtopic)

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

Additional Resources
(1) (Form) UL-PIRE IRB Submission Form (LBR-7) (Date Unavailable)
University of Liberia-Pacific Institute for Research and Evaluation
(2) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 6
(3) (Not Available Online) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (October 2014-February 2015, June and December 2020) (LBR-28)
(4) (Webpage) Clinical Trial Application Portal (LBR-18) (Current as of December 22, 2020)
Liberia Medicines and Health Products Regulatory Authority
(5) (Webpage) National Research Ethics Board of Liberia (LBR-12) (Current as of December 22, 2020)
National Research Ethics Board of Liberia
Clinical Trial Lifecycle > Timeline of Review
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 1.0, 2.0, and Appendices 1, 2, 9, and 11
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Administrative Procedures, Researchers, and Intellectual Property
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: 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)
(4) (Policy) National Research for Health Policy and Strategy: 2018 – 2023 (NatResHlthPlcy) (2018)
Ministry of Health
Relevant Sections: 2.5 and Annex 3
Summary

Overview

As delineated in the G-LibClinTrial and the G-NREB, the Liberia Medicines and Health Products Regulatory Authority (LMHRA)’s approval of a clinical trial application is dependent upon the principal investigator (PI) obtaining ethics committee (EC) approval. According to the G-LibClinTrial and LBR-18, the EC and LMHRA reviews may be conducted in parallel. However, per the G-LibClinTrial and the G-NREB, the LMHRA will only issue final approval once EC approval is obtained. The NatResHlthPlcy states that Liberia has two (2) ECs: the National Research Ethics Board (NREB) and the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB).

LMHRA Approval

According to LBR-29 and the G-LibClinTrial, the LMHRA’s Pharmacovigilance & Medicine Information Office review and approval process for a clinical trial application takes five (5) months following receipt of the submission, and fast tracked review and approvals take two and half (2.5) months. Appendix 1 of the G-LibClinTrial indicates that upon receipt of a clinical trial application, the Pharmacovigilance & Medicine Information Office screens the application package for completeness. If complete, the sponsor or his/her representative is issued an acknowledgement of receipt via a cover sheet and an LMHRA application/reference number is assigned to the application. The sponsor or his/her representative must reference the LMHRA reference number in all future application-related correspondence. According to LBR-29, receipt of a clinical trial application submission is acknowledged within five (5) working days.

Per the G-LibClinTrial and LBR-12, LMHRA will only process an application upon receipt of a completed application and the prescribed fees.

Ethics Committee (EC) Approval

UL-PIRE-IRB Approval

As specified in the G-UL-PIRE-IRB, PIs are required to submit all application materials 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 UL-PIRE-IRB meeting. The UL-PIRE-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.

On receipt of a proposal for review, the UL-PIRE-IRB Secretariat will preliminarily assess the completeness of the submission. If the submission is incomplete, the Secretariat will inform the PI accordingly and request the additional materials. Once the submission is deemed complete, the Secretariat will notify the PI and distribute the materials to the assigned members of the UL-PIRE-IRB. Exempt studies will be reviewed by all UL-PIRE-IRB members; expedited studies will be reviewed by all UL-PIRE-IRB members; full review studies will be sent to the entire UL-PIRE-IRB membership for review. Per the G-UL-PIRE-IRB, an expedited study is one which does not require review by a convened UL-PIRE-IRB quorum because it has been determined that participants are subject to low risk. Additional information about the various review types can be found in the G-UL-PIRE-IRB.

The G-UL-PIRE-IRB explains that the PI must check the level at which the protocol will be reviewed and confirm the required documents before submitting a proposal for review. Please refer to the G-UL-PIRE-IRB for additional information on the administrative processes relating to proposal submission. 

As specified in the G-UL-PIRE-IRB, the UL-PIRE-IRB approval will commence on the day the study is approved and 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-UL-PIRE-IRB also states that the UL-PIRE-IRB must review and approve any protocol amendments prior to those changes being implemented. The protocol submission is reviewed either via expedited procedures (for minor changes) or via full board review (for all other changes). The criteria for approval are the same as for initial review. In addition, per the G-UL-PIRE-IRB, UL-PIRE-IRB has a continuing responsibility to monitor the approved trial(s) to ensure ethical compliance throughout the study duration. A continuing review is conducted to review progress of an ongoing study and not just changes made in the study in order to ensure continued protection of the rights and welfare of research subjects. Refer to the G-UL-PIRE-IRB for protocol amendment and continuing review documentation submission and procedural requirements.

As described in the G-UL-PIRE-IRB, the EC is also authorized to suspend or terminate an approved research study for a variety of reasons, including but not limited to:

  • Failure to obtain appropriate consent or keep appropriate study-related paperwork
  • Conduct of research activities without prior UL-PIRE-IRB approval
  • Serious adverse event(s)
  • Detrimental change in the risk-benefit ratio of the study
  • Failure of investigators to complete required training

See the Ethics Committee topic, Scope of Review subtopic for detailed study suspension/termination information.

NREB Approval

Pursuant to the G-NREB, 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.

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. If the NREB has not reviewed and approved a study’s request by the current expiration date, study activities should cease until the board determines whether continuing the research is in the best interests of all previously enrolled participants. 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.

Additional Resources
(1) (Not Available Online) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (October 2014-January 2015) (LBR-29)
(2) (Webpage) Clinical Trial Application Portal (LBR-18) (Current as of December 22, 2020)
Liberia Medicines and Health Products Regulatory Authority
(3) (Webpage) National Research Ethics Board of Liberia (LBR-12) (Current as of December 22, 2020)
National Research Ethics Board of Liberia
Clinical Trial Lifecycle > Trial Initiation
Last content review/update: December 22, 2020
Requirements
(1) (Legislation) An Act to Establish the Liberia Medicines and Health Products Regulatory Authority of 2010 (LMHRA Act) (September 29, 2010)
Senate and House of Representatives of the Republic of Liberia
Relevant Sections: Part IV (Sections 1 and 2) and Part V (Section 5)
(2) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 1.0, 1.2, 2.0, 3.0, 7.0, 10.0, and Appendices 1, 2, and 9
(3) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Forward, Background, Administrative Procedures, Researchers, and Intellectual Property
(4) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article V and Article IX (Section 9.01)
(5) (Policy) National Research for Health Policy and Strategy: 2018 – 2023 (NatResHlthPlcy) (2018)
Ministry of Health
Relevant Sections: 2.5 and Annex 3
Summary

Overview

In accordance with the LMHRA Act and the G-LibClinTrial, a clinical trial can only commence after the sponsor or his/her representative receives authorization from the Liberia Medicines and Health Products Regulatory Authority (LMHRA). Per the G-UL-PIRE-IRB and the G-NREB, the principal investigator (PI) must also obtain ethics committee (EC) approval. The NatResHlthPlcy states that Liberia has two (2) ECs: the National Research Ethics Board (NREB) and the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB).

In addition, per the G-LibClinTrial, in the case of multi-center studies where the PI is not a resident of Liberia, the appointed national PI must be the resident and must assume full responsibilities for all local clinical trial sites.

As per the G-LibClinTrial and LBR-5, the sponsor or his/her representative is required to obtain an import license for the shipment of an investigational product to be used in the trial from the LMHRA.

As stated in the G-LibClinTrial and the G-NREB, the PI must possess appropriate qualifications, training, and experience. The G-LibClinTrial further notes that the PI must have had previous experience as a co-investigator in at least two (2) trials in the relevant professional area, and is responsible for the conduct of the trial at the clinical trial site. For multisite studies in Liberia, where the PI is not a Liberian resident, the appointed national PI must be a resident and must assume full responsibility for the local clinical trial sites. All investigators involved in the trial must have had formal training in good clinical and laboratory practices (GCLPs) within the last two (2) years and submit proof that a GCLPs course was attended.

In addition, per the G-NREB, the research should comply with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8).

Clinical Trial Agreement

While a signed clinical trial agreement is not an official requirement, the G-LibClinTrial states that before the trial begins, the sponsor or his/her representative, the national PI, and the national coordinator (for a multi-center study) should sign a declaration confirming that the application is complete and accurate.

EC Confirmation of Review and Approval

The G-LibClinTrial indicates that the sponsor must ensure that the PI obtains EC clearance.

Clinical Trials Registry

No clinical trials registry exists at this time and there is no stated requirement to register in an international registry.

Data and Safety Monitoring Board (DSMB)

As per the G-LibClinTrial, the sponsor may establish an independent data monitoring committee to assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. See section 10.0 of the G-LibClinTrial for detailed DSMB documentation requirements.

Additional Resources
(1) (Document) Standard Operating Procedure (SOP) for the Submission of Dossiers for Investigational Products (LBR-5) (Date Unavailable)
Liberia Medicines and Health Products Regulatory Authority
(2) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 6
(3) (Webpage) National Research Ethics Board of Liberia (LBR-12) (Current as of December 22, 2020)
National Research Ethics Board of Liberia
Clinical Trial Lifecycle > Safety Reporting
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 1.0, 1.2, 2.0, 3.0, 9.0, 10.0, and Appendix 8
(2) (Guidance) Guideline for the Pharmacovigilance System in Liberia (G-LibPV) (March 2013)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Interpretation,1.6, and Table 1, Table 2, and Table 3
(3) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Researchers
(4) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article XXII
Summary

Overview

According to the G-LibClinTrial,  the G-LibPV, and the G-UL-PIRE-IRB, the following definitions provide a basis for a common understanding of Liberia’s safety reporting requirements (Note: the regulations provide overlapping and unique elements, so each of the items listed below will not necessarily be in each source.):

  • 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, 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 response in a participant to an investigational medicinal product which is related to any dose administered to that participant
  • 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)
  • Unexpected Adverse Drug Reaction – An adverse reaction where the nature or severity is inconsistent with the applicable product information

Reporting Requirements for AEs/ADRs

Investigator Responsibilities

The G-LibClinTrial requires the investigator report all SAEs to the sponsor by telephone within 24 hours of the event. The initial phone report should provide the following information:

  • Study identifier
  • Study center
  • Subject number
  • A description of the event
  • Date of onset
  • Current status
  • Whether study treatment was discontinued
  • The reason why the event is classified as serious
  • Investigator assessment of the association between the event and study treatment

Furthermore, within the following 48 hours, the investigator must provide the sponsor with the completed SAE form or ADR form and any other diagnostic information that will assist the sponsor in understanding the event. The investigator should also promptly provide the sponsor with any significant new information related to the SAEs.

As indicated in the G-UL-PIRE-IRB, the investigator must promptly report any unanticipated problems to the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) in accordance with the following guidelines:

  • Unanticipated problems that are SAEs must be reported to the UL-PIRE-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 UL-PIRE-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
  • In addition, per the G-UL-PIRE-IRB, when making a report to the UL-PIRE-IRB, the investigator should include the following information:
  • The appropriate identifying information for the research protocol, such as the title, the investigator’s name, and the ethics committee (EC) project number
  • A detailed description of the AE, incident, experience, or outcome; however, to maintain confidentiality, participants’ names and identifiable information should not be included in the report
  • An explanation of the basis for determining that the AE, incident, experience, or outcome represents an unanticipated problem, and
  • A description of any changes to the protocol or other corrective actions that have been taken or are proposed in response to the unanticipated problem

The G-NREB also indicates that investigators are required to submit a report to the National Research Ethics Board (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

Sponsor Responsibilities

As stated in the G-LibClinTrial, the sponsor or his/her representative or the principal investigator (PI) must report all AEs/ADRs, SAEs/SADRs, and Suspected Unexpected Serious Adverse Reactions (SUSARs) to the Liberia Medicines and Health Products Regulatory Authority (LMHRA) within eight (8) working days from the occurrence of the incident. Fatal incidents should be reported within 24 hours of their occurrence. For reported deaths, additional information (e.g., autopsy reports and terminal medical reports) should be submitted.

In addition, AEs/ADRs and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should also be reported. The relationship between SAE(s)/SUSARs and the investigational product must also be established, evaluated, clarified, and submitted to the LMHRA for further assessment.

The G-LibPV provides the following scale by which to assess the severity of AEs/ADRs: Mild, Moderate, Severe, or Fatal. For more details, see Table 2.

The G-LibPV also provides criteria for determining the link between the intervention and the AEs/ADRs as either certain, probably/likely, possible, unlikely, conditional/unclassified, or un-assessable/unclassified. For more details, see Table 3.

Ethics Committee Responsibilities

As explained in the G-UL-PIRE-IRB, the UL-PIRE-IRB Executive Committee conducts the initial review of unanticipated problems. This committee is authorized to take the following actions in response to any incident report:

  • Conduct an administrative review of the report, including assessing whether the incident constitutes an unanticipated problem
  • If a convened UL-PIRE-IRB review is needed, the Chair assigns the incident report for review at the next available regularly scheduled UL-PIRE-IRB meeting
  • Alternately, the UL-PIRE-IRB Executive Committee may convene an emergency meeting of the UL-PIRE-IRB to review the report
  • If the UL-PIRE-IRB Executive Committee finds that the rights, safety, and welfare of the participants are jeopardized by the research, the Chair may suspend the research until such time when the full UL-PIRE-IRB can convene to review the report. When reviewing a particular incident, experience, or outcome reported as an unanticipated problem by the investigator, the board may determine that the incident, experience, or outcome does not meet the criteria for an unanticipated problem

Following a review of the unanticipated problem report, per the G-UL-PIRE-IRB, the UL-PIRE-IRB may require the following actions, in order to protect the ongoing safety of the research participants:

  • Modification of participant inclusion or exclusion criteria to mitigate the newly identified risks
  • Implementation of additional procedures for monitoring participants
  • Modification of informed consent documents to include a description of newly recognized risks
  • Provision of additional information about newly recognized risks to previously enrolled participants
  • Suspension of enrollment of new participants
  • Suspension of research procedures in currently enrolled participants
  • Suspension of the entire study, or
  • Termination of approval for the entire study

If the solution to an unanticipated problem is to amend the research protocol and/or informed consent forms, then an amendment request must be made to the UL-PIRE-IRB. If the changes are minor, they may be reviewed by expedited review procedures. If the changes are major, they must be reviewed and approved by the convened board. Changes made in response to an unanticipated problem must be reviewed and approved by the UL-PIRE-IRB before being implemented, except where implementation is necessary to eliminate immediate hazards to research participants.

Form Completion & Delivery Requirements

As per the G-LibClinTrial and the G-LibPV, all SAEs/SADRs and SUSARs must be reported on the LMHRA’s Suspected Adverse Drug Reaction Reporting Form (Table 1 in the G-LibPV and LBR-6), and be emailed to: libmhra@gmail.com or jgoteh@gmail.com; d.sumo2013@gmail.com or mailed to the following address:

The National Pharmacovigilance Centre
Liberia Medicines & Health Products Regulatory Authority (LMHRA)
VP Road, Tubman Boulevard
Old Road, Sinkor
1000 Monrovia, 10 Liberia
West Africa
Tel: (+231) (0) 886 530270 or (+231) (0) 886 562019

LBR-6 also provides a platform on the Pharmacovigilance website (LBR-20) that may be used to complete an online submission of the Suspected Adverse Drug Reaction Reporting Form.

Delivery Address for AEs/ADRs and SAEs/SADRs to the UL-PIRE-IRB:

Ms. Cecelia Morris
Chairperson
UL-PIRE IRB
Ground Floor, GD Bldg.
University of Liberia
Capitol Hill
Monrovia, Liberia
Phone: +(231) (0) 886-522-833 or +(231) (0) 777-583-774
E-mail: morris.caletha@gmail.com and also copy martinbuludi@yahoo.com

Data and Safety Monitoring Board

As per the G-LibClinTrial, the sponsor may establish an independent data monitoring committee to assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. See section 10.0 of the G-LibClinTrial for detailed DSMB documentation requirements.

Additional Resources
(1) (Form) Suspected Adverse Drugs Reaction Reporting (LBR-6) (Date Unavailable)
Liberia Medicines and Health Products Regulatory Authority, National Pharmacovigilance Center
(2) (Webpage) Instructions for Submitting a Safety Report (LBR-21) (Current as of December 22, 2020)
Liberia Medicines and Health Products Regulatory Authority
(3) (Webpage) Pharmacovigilance (LBR-20) (Current as of December 22, 2020)
Liberia Medicines and Health Products Regulatory Authority
Clinical Trial Lifecycle > Progress Reporting
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 11.0 and 12.3
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article XVI and Article XXV (Sections 25.02 and 25.05)
Summary

Overview

In accordance with the G-LibClinTrial, the sponsor and/or principal investigator (PI) must submit progress reports on the status of a clinical trial and a final study report upon the trial’s completion to the Liberia Medicines and Health Products Regulatory Authority (LMHRA).

Interim/Progress Reports

As stated in the G-LibClinTrial, the sponsor and/or the PI is required to send progress reports to the LMHRA on a quarterly basis.

In addition, per the G-NREB, research in Liberia should comply with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (LBR-8). As part of the country’s compliance with LBR-8, the investigator should submit written summaries of the trial status to the National Research Ethics Board (NREB) annually, or more frequently, if requested by the board. The investigator should also promptly provide written reports to the sponsor, the NREB, and where applicable, the institution on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants.

The G-UL-PIRE-IRB also requires PI(s) to submit progress reports (also referred to as continuing review submissions in Liberia) to the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB)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.

As indicated in the G-UL-PIRE-IRB, the following list provides the required documentation to submit a continuing review to the UL-PIRE-IRB:

  • A completed Continuing Review form
  • A copy of the current informed consent document(s) or any newly proposed consent document(s) if enrollment is ongoing
  • A copy of current recruitment material(s) or any newly proposed recruitment material(s) if enrollment is ongoing
  • A summary of adverse events and any unanticipated problems involving risks to participants
  • Numbers of and reason for withdrawal of participants from the research
  • A summary of any relevant information about risks associated with the research
  • Number and demographics of participants enrolled
  • Changes in the principal and/or associate investigator(s)
  • A summary description of participant experiences
  • Research results obtained thus far
  • A current risk-benefit assessment based on the study results, and
  • Any new information since the UL-PIRE-IRB’s last review

After the Secretary and the Coordinator have determined that the continuing review submission is complete, the documentation must be submitted to the UL-PIRE-IRB and reviewed by the convened board, or by the expedited reviewer(s), if necessary, for an expedited review.

Final Report

As per the G-LibClinTrial, after a trial has been completed, the sponsor and/or the PI must submit a closing report within 30 business days. This should be followed by a final study report within six (6) months after trial closure.

According to LBR-29, a final report must be submitted to the UL-PIRE-IRB within 30 days following completion of the trial.

Per LBR-8, the investigator, where applicable, should inform the institution; the investigator/institution should provide the EC with a summary of the trial’s outcome, and the regulatory authority (LMHRA) with any reports required.

In addition, per the G-UL-PIRE-IRB, PI(s) should complete Section 12 (Disposition of Project) of the UL-PIRE-IRB Submission Form (Section 25.02 in Article XXV of the G-UL-PIRE-IRB and LBR-7) for the final UL-PIRE-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 provide a brief summary of their findings.

Additional Resources
(1) (Form) UL-PIRE IRB Submission Form (LBR-7) (Date Unavailable)
University of Liberia-Pacific Institute for Research and Evaluation
(2) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.10 and 4.13
(3) (Not Available Online) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (October 2014-January 2015) (LBR-29)
Sponsorship > Definition of Sponsor
Last content review/update: July 01, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 1.2
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
Summary

Overview

As per the G-LibClinTrial, 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.

According to the G-LibClinTrial, a sponsor can also authorize a contract research organization (CRO) to perform one (1) or more of his/her trial-related duties and functions.

Per the G-NREB, research in Liberia should comply with the International Council for Harmonisation (ICH)'s Guideline for Good Clinical Practice E6(R2) (LBR-8). As delineated in LBR-8, the sponsor is ultimately always responsible for the trial data’s quality and integrity. Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality control.

Additional Resources
(1) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.2
Sponsorship > Trial Authorization
Last content review/update: July 01, 2020
Requirements
(1) (Legislation) An Act to Establish the Liberia Medicines and Health Products Regulatory Authority of 2010 (LMHRA Act) (September 29, 2010)
Senate and House of Representatives of the Republic of Liberia
Relevant Sections: Part IV (Sections 1 and 2) and Part V (Section 5)
(2) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 1.0, 1.2, 2.0, and Appendices 1, 2, and 9
(3) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Intellectual Property
(4) (Policy) National Research for Health Policy and Strategy: 2018 – 2023 (NatResHlthPlcy) (2018)
Ministry of Health
Relevant Sections: 2.5 and Annex 3
Summary

Overview

In accordance with the LMHRA Act and the G-LibClinTrial, Liberia requires the sponsor or his/her representative to submit a clinical trial authorization to the Liberia Medicines and Health Products Regulatory Authority (LMHRA) to obtain authorization to conduct a clinical trial, and an ethics committee (EC) must approve the clinical trial application prior to the sponsor or his/her representative initiating the clinical trial. The NatResHlthPlcy states that Liberia has two (2) ECs: the National Research Ethics Board (NREB) and the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB).

According to the G-LibClinTrial and LBR-18, the EC and LMHRA reviews may be conducted in parallel. However, per the G-LibClinTrial and the G-NREB, the LMHRA will only issue final approval once EC approval is obtained. As indicated in the G-LibClinTrial, the sponsor or his/her representative must use the LMHRA’s application form (see Appendix 1 of G-LibClinTrial). In addition to the completed application, per the G-LibClinTrial, the G-NREB, and LBR-18, the sponsor or his/her representative must provide the EC clearance or a copy of acknowledgement of protocol submission, the clinical protocol, the Investigator’s Brochure or prescribing information data sheet, the declarations by sponsor, investigators, and monitor(s), and other documentation covered in the Clinical Trial Lifecycle topic, Submission Content subtopic.

Additional Resources
(1) (Webpage) Clinical Trial Application Portal (LBR-18) (Current as of December 22, 2020)
Liberia Medicines and Health Products Regulatory Authority
(2) (Webpage) National Research Ethics Board of Liberia (LBR-12) (Current as of December 22, 2020)
National Research Ethics Board of Liberia
Sponsorship > Insurance
Last content review/update: July 01, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 1.0, 1.2, 2.0, and Appendix 1
Summary

Overview

As set forth in the G-LibClinTrial, an insurance and indemnity provision must be made to cover the liability of the investigator and sponsor for injuries that may occur during a clinical trial. Detailed requirements on the scope of coverage and the period of validity are not currently available. The G-LibClinTrial does not specify that this is a sponsor requirement.

Additional Resources
No additional resources
Sponsorship > Compensation
Last content review/update: July 01, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 6.0 and Appendix 1
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
Summary

Overview

As specified in the G-LibClinTrial, the sponsor or his/her representative is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death.

The G-LibClinTrial states that the sponsor or his/her representative must provide a breakdown of costs to be covered, and indicate compensation to be received by participants for travel and incidental expenses. The compensation amount is subject to discussion with agreement by the Liberia Medicines and Health Products Regulatory Authority (LMHRA). According to LBR-29, the LMHRA’s compensation committee must determine participant compensation for trial-related injuries.

In addition, per the G-NREB, research in Liberia complies with the International Council for Harmonisation (ICH)'s Guideline for Good Clinical Practice E6(R2) (LBR-8). As delineated in LBR-8, the sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

Additional Resources
(1) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8 and 5.8
(2) (Not Available Online) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (October 2014-January 2015) (LBR-29)
Sponsorship > Quality, Data & Records Management
Last content review/update: December 29, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword, 4.12, 10.0, 12.1, and Appendices 2, 3, 4, and 9
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Articles X (Section 10.016) and XI (Sections 11-01, 11.02, and 11.05)
Summary

Overview

As stated in the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) requires the sponsor or his/her representative to comply with the International Council for Harmonisation (ICH)'s guidelines to manage 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. Furthermore, per the G-NREB, Liberia complies with the ICH's Guideline for Good Clinical Practice E6(R2) (LBR-8).

Per LBR-8, 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

Electronic Data Processing System

As per LBR-8, 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. 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 SOPs for the systems that cover system 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 LBR-8 for additional information.

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). According to LBR-25, the allocation of recordkeeping and data handling responsibilities should be specified in the protocol or other written agreement(s) between the sponsor and the investigator(s). For detailed recordkeeping and data handling information, please refer to section 8 of LBR-25.

As set forth in LBR-8, sponsor-specific essential documents should be retained for at least two (2) years after the last approval of a marketing application, until there are no pending or contemplated marketing applications, or at least two (2) years have elapsed since the formal discontinuation of the investigational product’s clinical development. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

In addition, LBR-8 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.

Per the G-UL-PIRE-IRB, the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) must retain all relevant records (e.g., study documents specific to board activities and administrative documents related to UL-PIRE-IRB internal operations) per the following timelines:

  • All records regarding a research application (regardless of whether it is approved) must be retained for at least three (3) years
  • All records regarding all applications that are approved, and the research initiated shall be retained for at least three (3) years after completion of the research
  • Denied applications will be treated as terminated files and records shall be retained for three (3) years after the denial of the research

For detailed UL-PIRE-IRB recordkeeping requirements, refer to the G-UL-PIRE-IRB.

In addition, per the G-UL-PIRE-IRB, investigator(s) may close a protocol for board reviewed research by submitting study closure materials electronically before the expiration of board approval. According to LBR-28, an email should be sent to one (1) of the following addresses to close a study: jktegli@yahoo.com and ulpireirb@gmail.com. The 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.

In addition, 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 of the data. They must also honor any other commitments agreed to as part of the approved research, for example, providing information about the study results to research participants, commitment to research participants for use of sample or data in future research, and commitments for compensation to research subjects for research participation. Refer to the Informed Consent topic for additional information on documentation requirements and research participant rights during the informed consent process.

Audit Requirements

Per LBR-8, 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 on-site monitoring, a combination of on-site 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).

Premature Study Termination/Suspension

The G-LibClinTrial states that if the sponsor or the principal investigator (PI) terminates a trial, the sponsor or the PI must inform the LMHRA no later than 15 days after the termination date. The sponsor or the PI must also provide the LMHRA with the reason(s) for the termination and its impact on the proposed or ongoing trials. They must also inform all co-investigators of the termination, the reasons for the termination, and advise them in writing of potential risks to trial participants.

According to LBR-8, 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 sponsor should promptly inform the ethics committee (EC) and provide the reason(s) for the termination or suspension.

Per the G-UL-PIRE-IRB, investigator(s) may close a research study for UL-PIRE-IRB reviewed research under the following circumstances:

  • When further interventions/interactions with participants, follow-ups, or access to personal identifiable information for research purposes are no longer place
  • When all data analysis of the study is complete, or data have been de-identified and no direct identifiers or code keys (if data are coded) exist that would allow for potential identification of participants, and
  • Grant funds associated with the protocol are no longer being accessed; or an associated grant remains active, but the human participant research activities have ended

See the G-UL-PIRE-IRB for additional investigator instructions on closing a research study.

Multicenter Studies

As delineated in LBR-8, in the event of a multicenter clinical trial, the sponsor must ensure that:

  • All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and are 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

As per the G-LibClinTrial, in the case of multi-center studies where the PI is not a resident of Liberia, the appointed national PI must be a resident and must assume full responsibilities for all local clinical trial sites.

Additional Resources
(1) (International Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (LBR-25) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
(2) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.65, 5.0, 5.1, 5.2, 5.5, 5.18, 5.19, 5.21, 5.23, 6.10, and 8
(3) (Not Available Online) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (October 2014-February 2015, June and December 2020) (LBR-28)
Sponsorship > Site/Investigator Selection
Last content review/update: July 01, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword, 2.0, 3.0, 5.0, 10.0, and Appendix 1
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
Summary

Overview

According to the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) requires the sponsor or his/her representative to comply with the International Council for Harmonisation (ICH)'s good clinical practice guidelines to select the investigator(s) and the institution(s) for the clinical trial, taking into account the appropriateness and availability of the study site and facilities. Furthermore, per the G-NREB, Liberia is in compliance with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8).

As per the G-LibClinTrial, the sponsor must ensure that the principal investigator (PI) possesses appropriate qualifications, training, and experience. The PI must have had previous experience as a co-investigator in at least two (2) trials in the relevant professional area, and is responsible for the conduct of the trial at the clinical trial site. All investigators involved in the trial must also have had formal training in good clinical and laboratory practices (GCLPs) within the last two (2) years and submit proof that a GCLP course was attended. In addition, prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor or his/her representative should provide the investigator(s) with the protocol and an investigator’s brochure. In addition, in the case of multi-center studies where the PI is not a resident of Liberia, the appointed national PI must be a resident and must assume full responsibilities for all local clinical trial sites.

Furthermore, per LBR-8, the sponsor should obtain the investigator's/institution's agreement to:

  • Conduct the trial in compliance with Good Clinical Practices (GCPs), with the applicable regulatory requirement(s), and with the approved protocol
  • Comply with procedures for data recording/reporting
  • Permit monitoring, auditing, and inspection
  • Retain the trial related essential documents until the sponsor informs the investigator/institution these documents are no longer needed

The sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm this agreement.

Foreign Sponsor Responsibilities

No information is currently available specifying requirements for foreign sponsors.

Data and Safety Monitoring Board (DSMB)

As per the G-LibClinTrial, the sponsor may establish an independent data monitoring committee to assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. See section 10.0 of the G-LibClinTrial for detailed DSMB documentation requirements.

Additional Resources
(1) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 5.5, and 5.6
Informed Consent > Documentation Requirements
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword, 6, and Appendix 9
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background and Intellectual Property
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article IX (Sections 9.03 and 9.04), Article XI (Section 11.05), Article XIV (Section 14.03), Article XXIII (Section 23.06), and Article XXV (Section 25.04)
(4) (Policy) National Research for Health Policy and Strategy: 2018 – 2023 (NatResHlthPlcy) (2018)
Ministry of Health
Relevant Sections: 2.5 and Annex 3
Summary

Overview

In accordance with the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the International Council for Harmonisation (ICH)'s good clinical practice guidelines. Furthermore, per the G-NREB, Liberia complies with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8).

As per the G-LibClinTrial, a freely given informed consent must be obtained from every study participant prior to clinical trial participation.

According to the G-LibClinTrial, the G-UL-PIRE-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). The NatResHlthPlcy states that Liberia has two (2) ECs: the National Research Ethics Board (NREB) and the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB). Per the G-UL-PIRE-IRB, the UL-PIRE-IRB must assess the study to ensure voluntary, non-coercive recruitment of research participants. The board must ensure that they have adequately considered the following in the protocol:

  • Procedures for obtaining informed consent
  • Content of the participant information sheet
  • Content and language of the informed consent document
  • Translation of the informed consent document into the local language
  • The language used in the documents should be simple relative to the general public’s level of understanding
  • Contact persons with their addresses and telephone numbers (for both the study team and the EC)
  • Privacy and confidentiality
  • Risks (physical, mental, social)
  • Benefits to participants and to others
  • Compensation (reasonable/unreasonable)
  • Involvement of vulnerable participants
  • Provision for medical/psychosocial support
  • Treatment for study-related injuries
  • Use of biological materials

(See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

The G-LibClinTrial states that the investigator or his/her designated representative must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). The G-LibClinTrial also specifies 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. The participant, and/or his/her legal representative(s) or guardian(s), should also be given adequate time to consider whether to participate.

In addition, per the G-UL-PIRE-IRB, if 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 UL-PIRE-IRB-approved protocol and participant consent requirements. The investigator(s) must continue to honor any confidentiality protections of the data. They must also honor any other commitments agreed to as part of the approved research, for example, providing information about the study results to research participants, commitment to research participants for use of samples or data in future research, and commitments for compensation to research subjects for research participation.

Re-Consent

According to the G-LibClinTrial, the LMHRA and an EC should approve any change in the ICF due to a protocol modification before such changes are implemented. The participant and/or the participant’s legal representative(s) or guardian(s) should be informed in a timely manner if new information becomes available that might be relevant to the participant’s willingness to continue participation in the trial. The participant and/or his/her legal representative(s) or guardian(s) will also be required to re-sign the revised ICF and receive a copy of any amended documentation.

In addition, per the G-UL-PIRE-IRB, in the case that UL-PIRE-IRB approval is reinstated, the UL-PIRE-IRB may require previously enrolled participants to re-consent.

Language Requirements

As stated in the G-LibClinTrial, the ICF content should be presented in English, and all written and oral information given to participants must be in English.

Documentation Copies

The G-LibClinTrial states that the participant and/or the participant’s legal representative(s) or guardian(s), and the person who conducted the informed consent discussion should sign and personally date the ICF. Where the participant is illiterate, and/or his/her legal representative(s) or guardian(s) is illiterate, verbal consent should be obtained in the presence of and countersigned by an impartial witness. Per LBR-8, 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 provided to the participant is read and explained to the participant and his/her legal representative(s) and/or guardian(s)
  • The participant and his/her legal representative(s) and/or guardian(s), 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 his/her legal representative(s) and/or guardian(s) should receive a copy of the signed and dated ICF.

Additional Resources
(1) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2, 4.4, 4.8, 8.2, and 8.3
Informed Consent > Required Elements
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword, 6, and Appendix 9
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background and Intellectual Property
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article IX (Section 9.03), Article XI (Section 11.05), Article XIX (Sections 19.01 and 19.02), and Article XXV (Section 25.03)
(4) (Policy) National Research for Health Policy and Strategy: 2018 – 2023 (NatResHlthPlcy) (2018)
Ministry of Health
Relevant Sections: 2.5 and Annex 3
Summary

Overview

According to the G-LibClinTrial, the G-UL-PIRE-IRB, and the G-NREB, prior to beginning a clinical trial, the principal investigator (PI) is required to obtain ethics committee (EC) approval for the informed consent form (ICF). The NatResHlthPlcy states that Liberia has two (2) ethics committees (ECs): the National Research Ethics Board (NREB) and the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB).

Per the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the International Council for Harmonisation (ICH)'s good clinical practice guidelines. Furthermore, per the G-NREB, Liberia complies with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8).

No Coercion

As per the G-LibClinTrial and LBR-8, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant and/or his/her legal representative(s) and/or guardian(s) to waive or to appear to waive his/her legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence.

ICF Required Elements

The G-UL-PIRE-IRB specifically indicates that the PI is responsible for preparing the ICF. The G-LibClinTrial, the LBR-8, and the G-UL-PIRE-IRB similarly state that the ICF should include the following statements or descriptions, as applicable. (Note: the regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source.):

  • The study involves research and an explanation of its nature and purpose
  • Trial procedures to be followed, including all invasive procedures
  • 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
  • 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, and if any, which might be advantageous to the participant
  • Compensation and/or medical treatment available to the participant or his/her 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
  • Any additional costs to the participant that may result from participation in the research
  • A statement describing the extent to which, if any, confidentiality of records identifying the participant will be maintained, and if the results of the trial are published, the participant’s identity will remain confidential
  • The LMHRA 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
  • 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
  • Foreseeable circumstances under which the investigator(s) may remove the participant without his/her consent
  • 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
  • Foreseeable circumstances under which the investigator(s) may remove the participant without his/her consent
  • The participant and/or his/her legal representative(s) or guardian(s) will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue

For research involving the collection of identifiable private information or identifiable biospecimens, the G-UL-PIRE-IRB states 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 the legal representative(s) or guardian(s); or
  • 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 Specimens topic, Consent for Specimen subtopic for additional information on informed consent relating to specimens.

Per the G-UL-PIRE-IRB, if the informed consent procedures and consent document(s) are reviewed by the UL-PIRE-IRB Secretariat and found to be complete, the documentation is then submitted to the board for review. If the documentation qualifies for expedited review, the Chair person or a designated expedited reviewer will evaluate the materials. After the investigator makes the required changes suggested by the UL-PIRE-IRB, the application may be approved by the Chair.

Additional Resources
(1) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Compensation Disclosure
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword, 6, and Appendix 1
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article XIX (Section 19.01)
Summary

Overview

In accordance with the G-LibClinTrial and the G-UL-PIRE-IRB, the informed consent form (ICF) should contain a statement describing the compensation and medical treatment a participant can receive for participating in a clinical trial.

Per the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the International Council for Harmonisation (ICH)'s good clinical practice guidelines. Furthermore, per the G-NREB, Liberia complies with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8). The G-UL-PIRE-IRB 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 subjects.

Compensation for Participation in Research

As stated in the G-LibClinTrial and the G-UL-PIRE-IRB, trial participants may be compensated for travel and incidental expenses incurred while participating in the trial. The compensation amount is subject to discussion with agreement by the LMHRA.

Compensation for Injury

As per the G-LibClinTrial and the G-UL-PIRE-IRB, the ICF should include a statement advising the participant that compensation and medical treatment is available in the event of any trial-related injury. According to LBR-29, the LMHRA’s compensation committee must determine compensation for trial-related injuries to participants. (See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF.)

Additional Resources
(1) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 3.1 and 4.8
(2) (International Guidance) International Ethical Guidelines for Health-related Research Involving Humans (LBR-2) (2016)
Council for International Organizations of Medical Sciences (CIOMS)
(3) (Not Available Online) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (October 2014-January 2015) (LBR-29)
Informed Consent > Participant Rights
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword, 6, and Appendices 9 and 10
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article XIX (Section 19.01)
Summary

Overview

According to the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the ethical principles as specified in the Declaration of Helsinki (LBR-27) (Appendix 10, G-LibClinTrial). As per the G-LibClinTrial and LBR-27, Liberia’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The G-LibClinTrial, LBR-27, and the G-UL-PIRE-IRB state that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process.

Also per the G-LibClinTrial, the LMHRA complies with the International Council for Harmonisation (ICH)’s good clinical practice guidelines. Furthermore, per the G-NREB, Liberia complies with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8). The G-UL-PIRE-IRB 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 subjects.

The Right to Participate, Abstain, or Withdraw

As set forth in the G-LibClinTrial, LBR-8, and the G-UL-PIRE-IRB, the participant and/or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, that he/she 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-LibClinTrial, LBR-8, and the G-UL-PIRE-IRB, a potential research participant and/or his/her legal representative(s) or guardian(s) 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 Informed Consent topic, Required Elements subtopic for a more detailed list.)

The Right to Privacy and Confidentiality

As per the G-LibClinTrial, LBR-8, and the G-UL-PIRE-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-LibClinTrial and the G-UL-PIRE-IRB state that the research participant and/or his/her legal representative(s) or guardian(s) 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-LibClinTrial, LBR-8, and LBR-27 state that the research participant’s right to safety and the protection of his/her health and welfare must take precedence over the interests of science and society.

(See the Informed Consent topic, and the subtopics of Required Elements and Vulnerable Populations for additional information regarding requirements for participant rights.)

Additional Resources
(1) (International Guidance) Declaration of Helsinki (LBR-27) (October 19, 2013)
World Medical Association
(2) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2, 3.1, and 4.8
(3) (International Guidance) International Ethical Guidelines for Health-related Research Involving Humans (LBR-2) (2016)
Council for International Organizations of Medical Sciences (CIOMS)
Informed Consent > Special Circumstances/Emergencies
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword and 6
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article XX
Summary

Overview

The G-LibClinTrial makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by special circumstances. Special circumstances include medical emergencies when prior consent from the participant is not possible.

Also per the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the International Council for Harmonisation (ICH)’s good clinical practice guidelines. Furthermore, per the G-NREB, Liberia complies with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8).

Medical Emergencies

As delineated in the G-LibClinTrial and LBR-8, in an emergency, if the signed informed consent form (ICF) cannot be obtained from the research participant, the consent of his/her legal representative(s) or guardian(s) should be obtained. If the prior consent of the participant and/or his/her legal representative(s) or guardian(s) cannot be obtained, the participant’s enrollment should follow measures specified in the protocol, and/or elsewhere, with documented LMHRA approval to protect the rights, safety, and well-being of the participant, and to ensure compliance with ethics committee (EC) and LMHRA requirements. The participant and/or the participant’s legal representative(s) or guardian(s) should be informed about the trial and provide consent as soon as possible.

Waiver of Consent

As specified in the G-UL-PIRE-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 University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB). The request for waiver or alteration will be reviewed by the convened board, the UL-PIRE-IRB Chair, or the designated expedited reviewer. The UL-PIRE-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

The UL-PIRE-IRB reviewer should also be able to ascertain that the research could not practicably be carried out without the waiver or alteration.

Per the G-UL-PIRE-IRB, the board reviewer (Chair or designee) may approve the waiver or alteration of informed consent, if he/she 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 his/her legal representative(s) or guardian(s) will be provided with additional pertinent information after participation. The UL-PIRE-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-UL-PIRE-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 UL-PIRE-IRB or by the Chair or the designated expedited reviewer. The UL-PIRE-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, or
  • The participants or their legal representative(s) or guardian(s) 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 UL-PIRE-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
Additional Resources
(1) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Vulnerable Populations
Last content review/update: July 01, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword, 1.2, and Appendix 10
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
Summary

Overview

As per the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the ethical principles as specified in the Declaration of Helsinki (LBR-27) (Appendix 10, G-LibClinTrial) and the International Council for Harmonisation (ICH)'s good clinical practice guidelines. Furthermore, per the G-NREB, Liberia complies with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8). According to G-LibClinTrial, LBR-27, and LBR-8, 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 who cannot give or refuse consent for themselves, those who may be giving consent under duress, those who will not benefit personally from the research, and those for whom the research is combined with medical care. This may include, but is not limited to, 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 study participants include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

See the Informed Consent topic and the subtopics of Children/Minors and Mentally Impaired for additional information about these vulnerable populations.

Additional Resources
(1) (International Guidance) Declaration of Helsinki (LBR-27) (October 19, 2013)
World Medical Association
(2) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.61, 3.1 and 4.8
Informed Consent > Children/Minors
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword and Appendix 10
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background and Intellectual Property
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article XXIV (Sections 24.02-24.04)
Summary

Overview

According to 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.

As set forth in the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the ethical principles specified in the Declaration of Helsinki (LBR-27) (Appendix 10, G-LibClinTrial). As per the G-LibClinTrial and LBR-27, when the research participant is a minor, the investigator must obtain assent from the child/minor in addition to the consent of his/her legal representative(s) or guardian(s). The G-NREB also indicates that both written parental consent and assent forms should be completed for children less than 18 years of age. Also per the G-LibClinTrial, the LMHRA complies with the International Council for Harmonisation (ICH)'s good clinical practice guidelines. Furthermore, per the G-NREB, Liberia complies with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8). LBR-8 states that when a clinical trial includes minors, the minor should be informed about the trial to the extent compatible with his or her understanding and, if capable, he or she should sign and personally date the written informed consent.

As delineated in the G-UL-PIRE-IRB, the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-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 UL-PIRE-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 permission of their parents or legal guardians
  • When the UL-PIRE-IRB determines that more than minimal risk to children is presented by a procedure that indicates 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 UL-PIRE-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 UL-PIRE-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 which 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 UL-PIRE-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

In addition, the G-UL-PIRE-IRB explains that adequate provisions for the assent of children include the following:

  • Children capable of assenting: After the UL-PIRE-IRB determines that a child is capable of assenting, the proposed research procedures should be explained to him/her in language that is appropriate to his/her age, experience, maturity, and condition and should include any discomforts and inconveniences the child may experience if he/she 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 his/her designee and the child (when appropriate) will sign the study consent form. When it is inappropriate for the signature of the child (due to age or ability), the board requires that the document be signed by the investigator (or his/her designee) and the parent(s)/legal representative(s)

Per the G-UL-PIRE-IRB, the UL-PIRE-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 his/her 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 matured adolescent, his/her wishes should be respected.

The G-UL-PIRE-IRB further states that the UL-PIRE-IRB should ensure that adequate permissions are made for soliciting the permission of each child’s parents and/or his/her legal representative(s) or guardian(s). 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 UL-PIRE-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 UL-PIRE-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-UL-PIRE-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.

Additional Resources
(1) (International Guidance) Declaration of Helsinki (LBR-27) (October 19, 2013)
World Medical Association
(2) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Pregnant Women, Fetuses & Neonates
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article XXIV (Section 24.01)
Summary

Overview

Per the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the International Council for Harmonisation (ICH)'s good clinical practice guidelines. Furthermore, per the G-NREB, Liberia complies with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8). LBR-8 states that 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 stated in the G-UL-PIRE-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 this guideline 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 for 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 this guideline, 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, and
  • Individuals engaged in the research will have no part in determining the viability of a fetus
Additional Resources
(1) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Prisoners
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article XXIV (Section 24.03)
Summary

Overview

Pursuant to the G-UL-PIRE-IRB, due to the vulnerability of prisoners, research involving prisoners should be reviewed by a fully convened University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB). The UL-PIRE-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 (for example, vaccine trials and other research on Ebola, COVID-19, hepatitis, as well as social and psychological research such as alcoholism, drug addiction, and sexual assaults), or
  • 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-UL-PIRE-IRB, the UL-PIRE-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 UL-PIRE-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 his or her parole, and
  • The UL-PIRE-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
Additional Resources
No additional resources
Informed Consent > Mentally Impaired
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword and Appendix 10
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
Summary

Overview

According to the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the ethical principles as specified in the Declaration of Helsinki (LBR-27) (Appendix 10, G-LibClinTrial), International Council for Harmonisation (ICH)'s good clinical practice guidelines. As per the G-LibClinTrial and LBR-27, the following conditions must be met for clinical trials involving participants who are mentally incapable of giving consent:

  • Informed consent must be obtained from the legal representative(s) or guardian(s)
  • This group should not be included in research unless the research is necessary to promote the health of the population represented, and this research cannot instead be performed on legally competent persons
  • The specific reason for involving research study participants with a condition that renders them unable to give informed consent should be stated in the experimental protocol for consideration and approval of the ethics committee

Per the G-LibClinTrial, the LMHRA complies with the International Council for Harmonisation (ICH)'s good clinical practice guidelines. Furthermore, per the G-NREB, Liberia complies with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8). LBR-8 states that when a clinical trial includes participants with mental impairment (e.g., those with severe dementia), the participant should be informed about the trial to the extent compatible with his or her understanding and, if capable, he or she should sign and personally date the written informed consent.

Additional Resources
(1) (International Guidance) Declaration of Helsinki (LBR-27) (October 19, 2013)
World Medical Association
(2) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.61, 3.1, and 4.8
Investigational Products > Definition of Investigational Product
Last content review/update: July 01, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword and 1.2
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
Summary

Overview

As delineated in the G-LibClinTrial, an investigational product (IP) (also referred to as an investigational medicinal product (IMP)) 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.

Per the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) also complies with the International Council for Harmonisation (ICH)'s good clinical practice guidelines. Furthermore, per the G-NREB, Liberia complies with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8).

Additional Resources
(1) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.33
Investigational Products > Manufacturing & Import
Last content review/update: July 23, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 1.2, 2.0, 7.0, and Appendices 1 and 9
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
Summary

Overview

As indicated in the G-LibClinTrial and LBR-5, the Pharmacovigilance & Medicine Information Office within the Liberia Medicines and Health Products Regulatory Authority (LMHRA) is responsible for authorizing the manufacture of all drug products, including investigational products (IPs) in Liberia. The Pharmacovigilance & Medicine Information Office is responsible for receiving the IP dossiers and coordinates with the LMHRA’s Clinical Trial Team to ensure the safety and efficacy of the IPs to be used in clinical trials. The LMHRA will approve the manufacture of an IP after the clinical trial application has been approved.

As part of the agency’s compliance with the International Council for Harmonisation (ICH)'s good clinical practice guidelines, per the G-LibClinTrial, IPs must be manufactured in accordance with applicable good manufacturing practices (GMPs) and be used in accordance with the approved protocol. Furthermore, per the G-NREB, Liberia complies with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8). In addition, per LBR-29, the World Health Organization’s (WHO) GMP Guidelines for IPs (LBR-26) and the International Conference on Harmonisation (ICH) Harmonised Tripartite GMP Guide for Active Pharmaceutical Ingredients (LBR-9) must also be complied with during the IP manufacturing process.

According to G-LibClinTrial and LBR-5, the IP dossier documentation requirements for the LMHRA’s approval are as follows:

  • Submit typewritten application as per Appendix 1 (Section 2, Part 2) of G-LibClinTrial
  • Pay the required fee into the LMHRA bank account
  • Submit payment slip to the Finance Department to obtain an official LMHRA receipt
  • Present the IP dossier(s) along with the official receipt and product samples to the LMHRA

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

Additional Resources
(1) (Document) Nagoya Protocol on Access and Benefit-sharing (LBR-3) (2011)
Convention on Biological Diversity, United Nations
(2) (Document) Standard Operating Procedure (SOP) for the Submission of Dossiers for Investigational Products (LBR-5) (Date Unavailable)
Liberia Medicines and Health Products Regulatory Authority
(3) (International Guidance) Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Investigational Pharmaceutical Products for Clinical Trials in Humans (Technical Report Series No. 863, Annex 7) (LBR-26) (1996)
World Health Organization
(4) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2.12 and 5.13
(5) (International Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) (LBR-9) (Step 4 Version) (November 10, 2000)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(6) (Not Available Online) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (October 2014-January 2015) (LBR-29)
(7) (Webpage) Country Profile: Liberia (LBR-17) (Current as of December 22, 2020)
Access and Benefit-sharing Clearing-house, Convention on Biological Diversity, United Nations
Investigational Products > IMP/IND Quality Requirements
Last content review/update: July 01, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword, 1.2, 2.0, 5.0, and 7.0
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
Summary

Overview

In accordance with the G-LibClinTrial, the sponsor or his/her representative is responsible for providing the investigators with an Investigator’s Brochure (IB) and may follow the World Health Organization's Good Clinical Practice Guidelines (LBR-25) when compiling the IB information. The G-LibClinTrial also indicates that the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the International Council for Harmonisation (ICH)'s good clinical practice (GCP) guidelines. Furthermore, per the G-NREB, Liberia complies with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8). Refer to LBR-8 for detailed IB requirements.

IB Content Requirements

As specified in the G-LibClinTrial, the IB must provide coverage of the following areas:

  • Physical, chemical, and pharmaceutical properties
  • Pharmaceutical aspects
  • Pharmacokinetics and metabolism
  • 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 obtained from prior clinical trials in humans

See also LBR-25 and LBR-8 for additional details regarding the IB.

Drug Manufacturing Requirements

As part of the agency’s compliance with the ICH's GCPs, per the G-LibClinTrial, IPs must be manufactured in accordance with applicable good manufacturing practices (GMPs) and be used in accordance with the approved protocol. According to LBR-29, the sponsor or his/her representative must also ensure that the products are manufactured in accordance with the WHO’s GMP Guidelines for IPs (LBR-26) and the ICH Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (LBR-9).

Per LBR-8, the sponsor must maintain a Certificate of Analysis to document the identity, purity, and strength of the IP(s) to be used in the clinical trial.

(See Investigational Products topic, Product Management subtopic for additional information on sponsor requirements).

Additional Resources
(1) (International Guidance) Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Investigational Pharmaceutical Products for Clinical Trials in Humans (Technical Report Series No. 863, Annex 7) (LBR-26) (1996)
World Health Organization
(2) (International Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (LBR-25) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 5.6 and 8
(3) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.13, 5.14, 7, and 8.2
(4) (International Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) (LBR-9) (Step 4 Version) (November 10, 2000)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(5) (Not Available Online) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (October 2014-January 2015) (LBR-29)
Investigational Products > Labeling & Packaging
Last content review/update: July 01, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword, 2.0, 7.2, and Appendix 1
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
Summary

Overview

Investigational product (IP) labeling in Liberia must comply with the requirements set forth in the G-LibClinTrial. While there is no specified language requirement for IP labeling, English appears to be the preferred language.

As delineated in the G-LibClinTrial, a prototype of the labeling must also be submitted to the Liberia Medicines and Health Products Regulatory Authority (LMHRA) for approval, and the following information must be included as a minimum on the product label:

  • Statement indicating that the product is for “clinical trial purposes only”
  • Name, number, or identifying mark
  • Recommended storage conditions
  • Manufacturer’s address
  • Protocol code or identification

In addition, as per the G-LibClinTrial, the re-labeling of any remaining IPs from previously manufactured batches must be performed in accordance with established written procedures and good manufacturing practice (GMP) principles. According to LBR-29, the World Health Organization's (WHO) GMP Guidelines for IPs (LBR-26) and the International Conference on Harmonisation (ICH) Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (LBR-9) must also be complied with during the IP manufacturing process.

The G-LibClinTrial also indicates that the LMHRA complies with the ICH's good clinical practice guidelines. Furthermore, per the G-NREB, Liberia complies with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8). LBR-8 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.

Additional Resources
(1) (International Guidance) Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Investigational Pharmaceutical Products for Clinical Trials in Humans (Technical Report Series No. 863, Annex 7) (LBR-26) (1996)
World Health Organization
(2) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.13
(3) (International Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) (LBR-9) (Step 4 Version) (November 10, 2000)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(4) (Not Available Online) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (October 2014-January 2015) (LBR-29)
Investigational Products > Product Management
Last content review/update: July 01, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: Foreword, 2.0, 4.10, 4.11, 4.12, 5.0, 7.0, and Appendix 1
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Background
Summary

Overview

Per the G-LibClinTrial, the sponsor or his/her representative must comply with the International Council for Harmonisation (ICH)’s guidelines and the World Health Organization (WHO)’s Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (LBR-25) in regards to product management. Furthermore, per the G-NREB, Liberia complies with the ICH’s Guideline for Good Clinical Practice E6(R2) (LBR-8). LBR-8 states that the Investigator’s Brochure (IB) must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The sponsor should also update the IB as significant new information becomes available.

Investigational Product Supply, Storage, and Handling Requirements

According to the G-LibClinTrial and LBR-8, the sponsor or his/her representative must also supply the investigator(s)/institution(s) with the IPs. The sponsor or his/her representative should not supply either party with the IP(s) until he/she obtains approval from the Liberia Medicines and Health Products Regulatory Authority (LMHRA).The sponsor must also ensure the following:

  • IP manufactured according to good manufacturing practices (GMPs)
  • Timely delivery of the IP(s)
  • Written procedures including instructions for handling and storage of the IP(s), adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor
  • IP product quality and stability over the period of use
  • Maintain sufficient quantities of the IP(s) to reconfirm specifications, should this become necessary

Refer to the G-LibClinTrial and LBR-8 for detailed sponsor-related IP requirements.

Record Requirements

As per the G-LibClinTrial, data handling and recordkeeping should be conducted in conformity with LBR-25. According to LBR-25, the allocation of recordkeeping and data handling responsibilities should be specified in the protocol or other written agreement(s) between the sponsor and the investigator(s). For detailed recordkeeping and data handling information, please refer to section 8 of LBR-25.

Additional Resources
(1) (International Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (LBR-25) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
(2) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (LBR-8) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2.12, 5.5, 5.12, 5.13, 5.14, and 7
Specimens > Definition of Specimen
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article IX (Section 9.04) and Article XVII (Section 17.03)
Summary

Overview

While the Liberia Medicines and Health Products Regulatory Authority (LMHRA) does not provide a formal definition for specimens, the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) describes examples of specimens in the G-UL-PIRE-IRB. As per the G-UL-PIRE-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
Additional Resources
No additional resources
Specimens > Specimen Import & Export
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 4.12
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Intellectual Property
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article IX (Section 9.01) and Article XXV (Section 25.06)
Summary

Overview

Information is currently unavailable regarding the Liberia Medicines and Health Products Regulatory Authority’s (LMHRA) role in approving the import and export of biological specimens. However, the G-LibClinTrial does state that in the case of the transfer of materials, the sponsor or his/her representative should provide to the LMHRA a Material Transfer Agreement (MTA) including, but not limited to, the following information:

  • Identification of the provider and recipient
  • Identification of the material and volume of material
  • 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 warranties (where applicable)

The G-NREB also specifies that when a protocol application is submitted for review by the National Research Ethics Board (NREB), the accompanying documentation should also include an MTA for the shipment of the specimen/biological materials outside of Liberia (where applicable).

In addition, per the G-UL-PIRE-IRB, the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) 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. (Note: The G-UL-PIRE-IRB uses the Nigerian MTA included National Code for Health Research as a prototype for its own MTA.) The G-UL-PIRE-IRB states that the MTA must detail the type of materials, anticipated use, location of storage outside Liberia, duration of such storage, limitations on use, transfer, and termination of use of such materials, subject to any law, regulations, and enactment in Liberia. The following requirements must also be met:

  • The UL-PIRE-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-UL-PIRE-IRB. The UL-PIRE-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 UL-PIRE-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 UL-PIRE-IRB (the provider institution)
  • The UL-PIRE-IRB (the provider institution) is required to grant final approval to research involving international transfer of Liberian samples after all the other stated criteria has been met and upon acknowledgement of MTA receipt
Additional Resources
(1) (Article) National Ethics Guidance in Sub-Saharan Africa on the Collection and Use of Human Biological Specimens: A Systematic Review (LBR-1) (October 22, 2016)
Barchi, Francis and Little, Madison T., BMC Med Ethics
(2) (Not Available Online) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (October 2014-February 2015, June and December 2020) (LBR-28)
Specimens > Consent for Specimen
Last content review/update: December 22, 2020
Requirements
(1) (Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority
Relevant Sections: 4.12
(2) (Guidance) Operational Guidelines (Amended Version 2019) National Research Ethics Board of Liberia (NREB) Republic of Liberia (G-NREB) (Amended 2019)
National Research Ethics Board of Liberia
Relevant Sections: Intellectual Property
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (June 2020)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Article IX (Sections 9.01 and 9.04), Article XXVII (Section 17.03), Article XIX (Article 19.01), and Article XXV (Section 25.06)
Summary

Overview

Detailed information is currently unavailable regarding the Liberia Medicines and Health Products Regulatory Authority’s (LMHRA) requirements for obtaining informed consent from participants prior to collecting, storing, or using his/her biological sample(s). However, the G-LibClinTrial does state that the sponsor or his/her representative should provide examples of patient information leaflets and informed consent forms to the LMHRA for any proposed archiving of biological specimens for later research, or for genetics research.

According to the G-UL-PIRE-IRB and the G-NREB, the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) and the National Research Ethics Board (NREB) require the Material Transfer Agreement (MTA) process be used for the shipment of specimens/biological materials outside of Liberia. The G-UL-PIRE-IRB further explains that the purpose of an MTA is to protect the interests of local researchers and Liberia’s human and natural resources in all its biodiversity as well as how they can be legitimately used. It ensures that the interests of all relevant parties, human, and community participants in research and the Liberian nation are protected from exploitation and egregious harm.

Per the G-UL-PIRE-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 law, regulations, and enactment in Liberia. For detailed UL-PIRE-IRB MTA requirements, please refer to the Specimens topic, Specimen Import & Export subtopic.

The G-UL-PIRE-IRB also notes that the MTA does not vitiate the right of research participants or communities to request that their samples be withdrawn from research according to the terms of the informed consent process.

As delineated in the G-UL-PIRE-IRB, the following information must be provided for the review of a research protocol involving specimens:

  • A full description of any specimens that will be collected (blood, bodily fluids, tissue biopsies, etc.)
  • Plans for obtaining consent and clearance from participants and the UL-PIRE-IRB, for long-term storage, export, and future research
  • Arrangements for transfer and disposal
  • Community considerations
  • The impact and relevance of the research on the local community from where the research participants are recruited as well as the wider communities and the environment of concern
  • The consultation procedures with the concerned communities at the time of the planning and designing the research
  • The influence of the community on the consent of the research participants/individuals
  • Proposed community consultation during the course of the research
  • The extent to which the research contributes to capacity-building, such as the improvement of local healthcare, research, and the ability to respond to public health needs
  • Description of how the research results will be made available to the research participants and the concerned communities

Per the G-UL-PIRE-IRB, in the event of a request to amend the study, the following study procedures will not require review:

  • Rescheduling of a data collection as a result of a research participant missing an appointment or incomplete data collection due to unforeseen circumstances that do not increase risk to the participants
  • Rescheduling of specimen collections as a result of a research participant missing an appointment or incomplete specimen collection due to unforeseen circumstances that do not increase risks to the participant. The following specimen collections qualify for this category: collection of blood via finger, or ear stick; hair and nail clippings collected in a non-disfiguring manner; excreta and external secretions (including sweat); and sputum collected through expectoration, etc.

Pursuant to the G-UL-PIRE-IRB, for research that involves 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 the legal representative(s) or guardian(s); or
  • 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 the Informed Consent topic, Required Elements and Participant Rights subtopics for additional information on informed consent.

Additional Resources
No additional resources
Sections Country Announcement
Country Announcement
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COVID-19 Guidance

African regulatory agencies, ethics committees to expedite COVID-19 clinical trial reviews (April 20, 2020)

Country Profile Update

The Liberia profile was updated on December 22, 2020, with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE IRB)’s revised Policies and Procedures Handbook.

The updated handbook has been significantly revised from the 2008 version. The 2020 edition provides information on a structured approach to evaluating the ethics of research protocols and a clear understanding of the fundamental principles that should be used to determine or accept research proposals. (See the Ethics Committee, Clinical Trial Lifecycle, Informed Consent, and Specimens topics)

This message was updated on January 11, 2021
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