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: September 20, 2019
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 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 Additional Resource (A), 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, Additional Resource (A) 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.

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
World Health Organization and The Global Fund
Relevant Sections: 5.01
(B) (Website) LMHRA - Contact (Current as of September 20, 2019)
Liberia Medicines and Health Products Regulatory Authority
Regulatory Authority > Scope of Assessment
Last content review/update: September 20, 2019
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 Appendix 1
(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 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 Additional Resource (B), proposed clinical trials of registered medicines may include changes to indications and clinical use, target populations, routes of administration, and/or dosage. G-LibClinTrial specifies that the scope of the LMHRA’s assessment includes all clinical trials (Phases I-IV). According to Additional Resource (A), the ethics committee (EC) and LMHRA reviews may be conducted in parallel. However, per G-LibClinTrial and G-NREB, EC approval is a prerequisite to the LMHRA’s approval review. G-LibClinTrial, G-NREB, and Additional Resource (B) also indicate 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 Additional Resource (A), LMHRA’s Pharmacovigilance & Medicine Information Office coordinates the clinical trial application review process. Appendix 1 of 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 Additional Resource (A), receipt of the clinical trial application submission shall be acknowledged in five (5) working days. Per Additional Resource (B), 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
(A) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)
(B) (Website) Clinical Trial Application Portal (Current as of September 20, 2019)
Liberia Medicines and Health Products Regulatory Authority
Regulatory Authority > Regulatory Fees
Last content review/update: September 20, 2019
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 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 Additional Resource (A), 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 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: 001-11347210544

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

Additional Resources
(A) (Website) Clinical Trial Application Portal (Current as of September 20, 2019)
Liberia Medicines and Health Products Regulatory Authority
Ethics Committee > Ethics Committee
Last content review/update: September 20, 2019
Requirements
(1) (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
(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, 6.0, and 8.0
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (February 2008)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Institutional Review Board – D & E
(4) (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
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 G-LibClinTrial and G-NREB, ethical clearance is required as part of the Liberia Medicines and Health Products Regulatory Authority (LMHRA) clinical trial approval process.

Additional Resource (C) 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). Per G-UL-PIRE-IRB, the UL-PIRE-IRB is responsible for reviewing all research involving human participants conducted at the UL by any faculty members, staff members, or students located either on or off campus, as well as all research by outside investigators with faculty, staff, or students under the UL auspices.

As explained in 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. G-NREB states that the board oversees all research related protocols within and outside of Liberia in compliance with internationally recognized ethical standards (including the Belmont Report, the Declaration of Helsinki, the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), and the Council for International Organizations of Medical Sciences (CIOMS)’ International Ethical Guidelines for Health-related Research Involving Humans), and with Liberia’s applicable regulations and guidelines. In addition, per G-NREB, 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 G-UL-PIRE-IRB and Additional Resource (B), the UL-PIRE-IRB members are appointed by recommendation from the appropriate UL official. The UL-PIRE-IRB includes:

  • Four (4) faculty members who collectively encompass the relevant professional and scientific expertise necessary to review human subject-based research, and have been recommended by the Faculty Senate Research Publication Committee
  • One (1) student member recommended by the students’ authority
  • One (1) non-university community representative recommended by the Chair
  • Director of the University of Liberia’s Institute of Research or ex-officio designate, who must act as the Institutional Official and the Human Protections Administrator
  • One (1) member who is a non-scientist

The UL-PIRE-IRB Chair is a faculty member elected by the voting committee members.

NREB Composition

According to G-NREB, the NREB is composed of 21 members who jointly represent a diverse community with a range of expertise. G-NREB notes that the majority of the board members are clinicians, scientists, and national subject matter experts. Additional Resource (A) 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 religious elder, community elders, surgeons, clinicians, and public health specialists.

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

As delineated in G-UL-PIRE-IRB, the UL-PIRE-IRB Chair is responsible for convening committee meetings, documenting decisions, providing training to members, assigning protocols to reviewers for expedited review, overseeing the protocol review process, and more. UL-PIRE-IRB members are required to attend meetings, which are convened at least monthly, and review protocols in a timely manner. UL-PIRE-IRB members typically serve for two (2) terms. The IRB composition is reviewed every three (3) years to ensure compliance with internationally accepted standards.

Voting requires a quorum of at least 50 percent of the voting members and the presence of at least one (1) non-scientist. Members may not vote on protocols for which they have conflicts of interest, and they must agree to comply with the committee’s confidentiality policy. For detailed UL-PIRE-IRB procedures and information on other administrative processes, see G-UL-PIRE-IRB.

NREB Terms of Reference, Review Procedures, and Meeting Schedule

Pursuant to G-NREB, 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. 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. All complete applications submitted by the deadline shall be reviewed at the next regularly scheduled meeting if the number of applications meet the threshold. When applicable, the NREB director may also convene ad-hoc meetings. The SOPs 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. 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. Refer to G-NREB for detailed committee requirements.

Additional Resources
(A) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)
(B) NIAID Communication with the Centers for Disease Control (CDC) Liberia Office (not available online) (October-November 2014)
(C) (Website) UL-PIRE AFRICA - The Institutional Review Board (IRB) (Current as of September 20, 2019)
University of Liberia-Pacific Institute for Research and Evaluation
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(E) (WMA Guidance) Declaration of Helsinki (October 19, 2013)
World Medical Association
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Council for International Organizations of Medical Sciences (CIOMS)
Ethics Committee > Scope of Review
Last content review/update: September 20, 2019
Requirements
(1) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (February 2008)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Introduction, Procedures, and Institutional Review Board (G & H), and Appendix A (Frequently Asked Questions)
(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, Administrative Procedures, Researchers, and Intellectual Property
(3) (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
(4) (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)
(5) (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
Summary

Overview

According to G-UL-PIRE-IRB and 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 G-UL-PIRE-IRB, the EC must also pay special attention to reviewing informed consent and protecting the welfare of certain classes of participants deemed to be vulnerable, including children.

G-UL-PIRE-IRB and 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 G-UL-PIRE-IRB and G-NREB for detailed ethical review guidelines.

Role in Clinical Trial Approval Process

As per the LMHRA Act and 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. According to Additional Resource (B), the EC and LMHRA reviews may be conducted in parallel. However, G-LibClinTrial and G-NREB indicate that EC approval is a prerequisite to the LMHRA’s approval. G-LibClinTrial, G-NREB, and Additional Resource (C) 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 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. A full review can take one (1) to two (2) months.

According to G-UL-PIRE-IRB and Additional Resources (A) and (B), the UL-PIRE-IRB review process usually takes two (2) to three (3) weeks if a protocol is exempt or expedited. An exempt study is one in which it is determined that participants are subjected to no risk. An expedited study is one in which it is determined that participants are subject to low risk. Additional information about these categories can be found in G-UL-PIRE-IRB.

According to Additional Resource (A), continuing review must occur 12 months after the commencement of a study, and should occur prior to the study’s expiration date. The expiration date for the UL-PIRE-IRB approval is one (1) calendar year, generally commencing on the date of the approval letter.

NREB

As described in 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. 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 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 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, the NREB must review and approve any protocol amendments prior to implementation. The NREB secretariat must first consult with the board chair to determine the type of review required (full board review or expedited due to risk) and 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 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, 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 G-NREB for detailed application submission requirements.

Delivery Address for UL-PIRE-IRB Submissions:

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

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
(A) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)
(B) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October-November 2014)
(C) (Website) Clinical Trial Application Portal (Current as of September 20, 2019)
Liberia Medicines and Health Products Regulatory Authority
Ethics Committee > Ethics Committee Fees
Last content review/update: September 20, 2019
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
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 G-NREB, the NREB shall 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 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 Additional Resource (A), the UL-PIRE-IRB requires a non-refundable application fee of $500 USD for social, behavioral, and educational research protocol review and $1,000 USD for clinical/biomedical research protocol review.

Additional Resources
University of Liberia, Office of the Institution Review Board
Ethics Committee > Authorizing Body
Last content review/update: September 20, 2019
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 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. G-NREB states 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, the Declaration of Helsinki, International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), and the Council for International Organizations of Medical Sciences (CIOMS)’ International Ethical Guidelines for Health-related Research Involving Humans.

Per the NatResHlthPlcy and G-NREB, the NREB is also responsible for the following:

  • 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

G-NREB further identifies the following NREB duties:

  • 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
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(B) (WMA Guidance) Declaration of Helsinki (October 19, 2013)
World Medical Association
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Council for International Organizations of Medical Sciences (CIOMS)
Clinical Trial Lifecycle > Submission Process
Last content review/update: September 20, 2019
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) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (February 2008)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Institutional Review Board – D & E
(4) (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
(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 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 G-UL-PIRE-IRB and 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 Additional Resource (A), 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. According to Additional Resource (B), the EC and LMHRA reviews may be conducted in parallel. However, per G-LibClinTrial and G-NREB, EC approval is a prerequisite to the LMHRA’s approval.

(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 and Additional Resource (B), 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.

Per the G-UL-PIRE-IRB and Additional Resources (B) and (D), to comply with the UL-PIRE-IRB submission requirements, the PI must submit eight (8) hard copies of the protocol along with additional documentation specified in the Submission Content subtopic.

According to 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 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 Additional Resource (A), the clinical trial application and any accompanying material must be provided in English.

Additional Resources
(A) (Website) Clinical Trial Application Portal (Current as of September 20, 2019)
Liberia Medicines and Health Products Regulatory Authority
(B) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October-November 2014)
(C) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)
(D) (Form) UL-PIRE IRB Submission Form (Date Unavailable)
University of Liberia-Pacific Institute for Research and Evaluation
Clinical Trial Lifecycle > Submission Content
Last content review/update: September 20, 2019
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 and 4.0
(3) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (February 2008)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Institutional Review Board – A, D & E
(4) (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
(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 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 G-UL-PIRE-IRB and 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 Additional Resource (A), the following documentation must be submitted to the LMHRA:

  • 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 G-UL-PIRE-IRB, PIs are required to submit research protocols using the UL-PIRE-IRB submission form (see Additional Resource (C)). G-UL-PIRE-IRB and Additional Resources (C) and (D) state that PIs must submit eight (8) hard copies of the protocol and the following additional documentation for ethics approval:

  • Application letter to the EC Chairperson
  • Copy of protocol
  • Informed consent and/or assent form
  • Questionnaire
  • Investigator(s) CVs
  • Protocol budget
  • Copy of institutional EC approval, if available

NREB Requirements

As indicated in 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/biological materials outside of Liberia (where applicable)
  • 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 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 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 G-UL-PIRE-IRB, the clinical protocol should contain the following elements:

  • Proposed research project title
  • Name(s) and title(s) of the supervisor(s) and/or director(s)
  • Research facility location and projected dates for its commencement and completion
  • Project objective
  • Nature of the investigation to be performed on the participants
  • Investigator(s) qualifications
Additional Resources
(A) (Website) Clinical Trial Application Portal (Current as of September 20, 2019)
Liberia Medicines and Health Products Regulatory Authority
(B) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)
(C) (Form) UL-PIRE IRB Submission Form (Date Unavailable)
University of Liberia-Pacific Institute for Research and Evaluation
(D) NIAID Communication with the Centers for Disease Control (CDC) Liberia Office (not available online) (October-November 2014)
(E) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 6
Clinical Trial Lifecycle > Timeline of Review
Last content review/update: September 20, 2019
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 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) (Policy) National Research for Health Policy and Strategy: 2018 – 2023 (NatResHlthPlcy) (2018)
Ministry of Health
Relevant Sections: 2.5 and Annex 3
(4) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (February 2008)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Institutional Review Board – (D, E and K) and Frequently Asked Questions
Summary

Overview

As delineated in G-LibClinTrial and 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 Additional Resource (A), the EC and LMHRA reviews may be conducted in parallel. However, G-LibClinTrial and G-NREB indicate EC approval is a prerequisite to the LMHRA’s 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).

LMHRA Approval

According to Additional Resource (A) and 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 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 Additional Resource (A), receipt of a clinical trial application submission is acknowledged within five (5) working days.

Per Additional Resource (C), 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 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. A full review can take from one (1) to two (2) months. Investigators will be informed of all UL-PIRE-IRB decisions in writing.

G-UL-PIRE-IRB states that the UL-PIRE-IRB review process usually takes two (2) to three (3) weeks if a protocol is exempt or expedited. An exempt study is one in which it is determined that participants are subjected to no risk. An expedited study is one in which it is determined that participants are subject to low risk. Additional information about these categories can be found in G-UL-PIRE-IRB.

According to Additional Resource (B), continuing review must occur 12 months after the commencement of a study, and should occur prior to the study’s expiration date. The expiration date for the UL-PIRE-IRB approval is one (1) calendar year, generally commencing on the date of the approval letter.

NREB Approval

Pursuant to 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. G-NREB does not specify an approval expiration date.

As indicated in 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 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
(A) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)
(B) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)
(C) (Website) Clinical Trial Application Portal (Current as of September 20, 2019)
Liberia Medicines and Health Products Regulatory Authority
Clinical Trial Lifecycle > Trial Initiation
Last content review/update: September 20, 2019
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) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (February 2008)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Institutional Review Board – (D, E and K) and Frequently Asked Questions
(4) (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
(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 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 G-UL-PIRE-IRB and 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, as per Additional Resource (A), investigators are also required to obtain a research permit from their institution prior to initiating a trial. No waiting period is required following the applicant’s receipt of these approvals.

As per G-LibClinTrial and Additional Resource (C), 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 G-LibClinTrial and G-NREB, the PI must possess appropriate qualifications, training, and experience. 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.

Furthermore, the research should comply with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), which, per Additional Resource (D), Liberia is implementing.

Clinical Trial Agreement

While a signed clinical trial agreement is not an official requirement, 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

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 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 G-LibClinTrial for detailed DSMB documentation requirements.

Additional Resources
(A) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)
(B) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)
Liberia Medicines and Health Products Regulatory Authority
(D) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 6
Clinical Trial Lifecycle > Safety Reporting
Last content review/update: September 20, 2019
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
Summary

Overview

According to G-LibClinTrial and G-LibPV, the following definitions provide a basis for a common understanding of Liberia’s safety reporting requirements:

  • 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
  • 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, or is a congenital anomaly/birth defect
  • 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

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.

According to Additional Resource (A), the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) requires all AEs/ADRs, SAEs/SADRs, and other events to be reported within one (1) week to the UL-PIRE-IRB chairperson.

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 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.

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.

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.

Form Completion & Delivery Requirements

As per G-LibClinTrial and G-LibPV, all SAEs/SADRs and SUSARs must be reported on the LMHRA’s Suspected Adverse Drug Reaction Reporting Form (Table 1 in G-LibPV and Additional Resource (B)), 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)
PO Box 1994 VP Road
Old Road, Sinkor
Monrovia, Liberia
Tel: (+231) (0) 886562019

Additional Resource (B) also provides a platform for 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: +231-886-522-833 or +231-777-583-774
E-mail: morris.caletha@gmail.com and also copy martinbuludi@yahoo.com

Data and Safety Monitoring Board

As per 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 G-LibClinTrial for detailed DSMB documentation requirements.

Additional Resources
(A) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)
(B) (Form) Suspected Adverse Drugs Reaction Reporting (Date Unavailable)
Liberia Medicines and Health Products Regulatory Authority, National Pharmacovigilance Center
(C) (Website) Pharmacovigilance (Current as of September 20, 2019)
Liberia Medicines and Health Products Regulatory Authority
(D) (Website) Instructions for Submitting a Safety Report (Current as of September 20, 2019)
Liberia Medicines and Health Products Regulatory Authority
Clinical Trial Lifecycle > Progress Reporting
Last content review/update: September 20, 2019
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
Summary

Overview

In accordance with G-LibClinTrial and Additional Resource (A), 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 G-LibClinTrial, the sponsor and/or the PI is required to send progress reports to the LMHRA on a quarterly basis.

As per the ICH-GCPs-Addendum, which according to Additional Resource (B) Liberia is implementing, the investigator should promptly provide written reports to the sponsor and the institutional ethics committee on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants.

Final Report

As per 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 Additional Resource (A), a final report must be submitted to the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) within 30 days following completion of the trial.

Additional Resources
(A) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)
(B) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.10 and 4.13
Sponsorship > Definition of Sponsor
Last content review/update: September 20, 2019
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
Summary

Overview

As per 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 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.

As per the ICH-GCPs-Addendum, which according to Additional Resource (A) Liberia is implementing, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality control.

Additional Resources
(A) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.10 and 4.13
Sponsorship > Trial Authorization
Last content review/update: September 20, 2019
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 Appendix 1
(3) (Policy) National Research for Health Policy and Strategy: 2018 – 2023 (NatResHlthPlcy) (2018)
Ministry of Health
Relevant Sections: 2.5 and Annex 3
(4) (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 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 Additional Resource (A), the EC and LMHRA reviews may be conducted in parallel. However, G-LibClinTrial and G-NREB indicate that EC approval is a prerequisite to the LMHRA’s approval.

According to Additional Resource (A) and 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 G-LibClinTrial, G-NREB, and Additional Resource (C), 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
(A) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)
(B) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)
(C) (Website) Clinical Trial Application Portal (Current as of September 20, 2019)
Liberia Medicines and Health Products Regulatory Authority
Sponsorship > Insurance
Last content review/update: September 20, 2019
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 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. G-LibClinTrial does not specify that this is a sponsor requirement.

Additional Resources
No additional resources
Sponsorship > Compensation
Last content review/update: September 20, 2019
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 1
Summary

Overview

As specified in G-LibClinTrial and Additional Resource (A), 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.

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 Additional Resource (A), the LMHRA’s compensation committee must determine participant compensation for trial-related injuries.

In addition, per Additional Resource (B), Liberia is implementing the ICH-GCPs-Addendum, which provides guidance for sponsors on providing compensation to research participants in the event of trial-related injuries or death. The sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

Additional Resources
(A) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)
(B) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8 and 5.8
Sponsorship > Quality, Data & Records Management
Last content review/update: September 20, 2019
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
Summary

Overview

According to 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'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. Per Additional Resource (A), Liberia is implementing the ICH-GCPs-Addendum.

Per the ICH-GCPs-Addendum, 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 the ICH-GCPs-Addendum, 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 the ICH-GCPs-Addendum for additional information.

Record Management

As per G-LibClinTrial, data handling and recordkeeping should be conducted in conformity with the World Health Organization's Good Clinical Practice Guidelines (WHO-GCPs). According to the WHO-GCPs, 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 the WHO-GCPs.

As set forth in the ICH-GCPs-Addendum, 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, the ICH-GCPs-Addendum 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.

Audit Requirements

Per the ICH-GCPs-Addendum, 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

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 PI or the sponsor 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 the ICH-GCPs-Addendum, 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.

Multicenter Studies

As delineated in the ICH-GCPs-Addendum, 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 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 shall assume full responsibilities for all local clinical trial sites.

Additional Resources
(A) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
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
(C) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
Sponsorship > Site/Investigator Selection
Last content review/update: September 20, 2019
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
Summary

Overview

According to 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'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. Per Additional Resource (A), Liberia is implementing the ICH-GCPs-Addendum.

As per 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 shall assume full responsibilities for all local clinical trial sites.

Furthermore, per the ICH-GCPs-Addendum, 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 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 G-LibClinTrial for detailed DSMB documentation requirements.

Additional Resources
(A) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
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: September 20, 2019
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) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (February 2008)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Institutional Review Board – A
(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 G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the International Council for Harmonisation's good clinical practice guidelines. Per Additional Resource (A), Liberia is implementing the ICH-GCPs-Addendum.

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

According to G-LibClinTrial, G-UL-PIRE-IRB, G-NREB, and Additional Resource (C), 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). (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

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). 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.

Re-Consent

According to 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.

Language Requirements

As stated in 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

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 the ICH-GCPs-Addendum, 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
(A) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2, 4.4, 4.8, 8.2, and 8.3
(C) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)
Informed Consent > Required Elements
Last content review/update: September 20, 2019
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) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (February 2008)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Institutional Review Board – A
(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

According to G-LibClinTrial, G-UL-PIRE-IRB, G-NREB, and Additional Resource (A), 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 G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the International Council for Harmonisation's good clinical practice guidelines. Per Additional Resource (B), Liberia is implementing the ICH-GCPs-Addendum.

No Coercion

As per G-LibClinTrial and ICH-GCPs-Addendum, 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

G-LibClinTrial and the ICH-GCPs-Addendum state that the ICF should include the following statements or descriptions, as applicable:

  • 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
  • Compensation and/or medical treatment available to the participant or his/her family or dependents in the event of a trial-related injury
  • Any additional costs to the participant that may result from participation in the research
  • 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
  • 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
Additional Resources
(A) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)
(B) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Compensation Disclosure
Last content review/update: September 20, 2019
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
Summary

Overview

In accordance with G-LibClinTrial, 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 G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the International Council for Harmonisation's good clinical practice guidelines. Per Additional Resource (A), Liberia is implementing the ICH-GCPs-Addendum.

Compensation for Participation in Research

As stated in G-LibClinTrial, 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 G-LibClinTrial, 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 Additional Resource (B), 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
(A) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
(B) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 3.1 and 4.8
Informed Consent > Participant Rights
Last content review/update: September 20, 2019
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
Summary

Overview

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

Also per G-LibClinTrial, the LMHRA complies with the International Council for Harmonisation's good clinical practice guidelines. Per Additional Resource (A), Liberia is implementing the ICH-GCPs-Addendum.

The Right to Participate, Abstain, or Withdraw

As set forth in G-LibClinTrial and the ICH-GCPs-Addendum, 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 G-LibClinTrial and the ICH-GCPs-Addendum, 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 G-LibClinTrial and the ICH-GCPs-Addendum, 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

G-LibClinTrial states 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

G-LibClinTrial, the ICH-GCPs-Addendum, and the Declaration of Helsinki 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
(A) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
(B) (WMA Guidance) Declaration of Helsinki (October 19, 2013)
World Medical Association
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2, 3.1 and 4.8
Informed Consent > Special Circumstances/Emergencies
Last content review/update: September 20, 2019
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
Summary

Overview

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 G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the International Council for Harmonisation's good clinical practice guidelines. Per Additional Resource (A), Liberia is implementing the ICH-GCPs-Addendum.

Medical Emergencies

As delineated in G-LibClinTrial and the ICH-GCPs-Addendum, 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.

Additional Resources
(A) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Vulnerable Populations
Last content review/update: September 20, 2019
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
Summary

Overview

As per G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the ethical principles as specified in the Declaration of Helsinki (Appendix 10, G-LibClinTrial) and the International Council for Harmonisation's good clinical practice guidelines. Per Additional Resource (A), Liberia is implementing the ICH-GCPs-Addendum. According to G-LibClinTrial, the Declaration of Helsinki, and the ICH-GCPs-Addendum, 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
(A) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
(B) (WMA Guidance) Declaration of Helsinki (October 19, 2013)
World Medical Association
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: September 20, 2019
Requirements
(1) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (February 2008)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: Institutional Review Board – B
(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) 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
Summary

Overview

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

As set forth in G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the ethical principles specified in the Declaration of Helsinki (Appendix 10, G-LibClinTrial). As per G-LibClinTrial and the Declaration of Helsinki, 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). 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 G-LibClinTrial, the LMHRA complies with the International Council for Harmonisation's good clinical practice guidelines. Per Additional Resource (B), Liberia is implementing the ICH-GCPs-Addendum, which 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.

Additional Resources
(A) (WMA Guidance) Declaration of Helsinki (October 19, 2013)
World Medical Association
(B) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
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: September 20, 2019
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
Summary

Overview

Per G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the International Council for Harmonisation's good clinical practice guidelines. Per Additional Resource (A), Liberia is implementing the ICH-GCPs-Addendum, which 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.

Additional Resources
(A) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Prisoners
Last content review/update: July 17, 2019
Requirements
No applicable regulatory requirements
Summary

No relevant provisions.

Additional Resources
No additional resources
Informed Consent > Mentally Impaired
Last content review/update: September 20, 2019
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
Summary

Overview

According to G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the ethical principles as specified in the Declaration of Helsinki (Appendix 10, G-LibClinTrial). As per G-LibClinTrial and the Declaration of Helsinki, 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 G-LibClinTrial, the LMHRA complies with the International Council for Harmonisation's good clinical practice guidelines. Per Additional Resource (B), Liberia is implementing the ICH-GCPs-Addendum, which states that when a clinical trial includes subjects 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
(A) (WMA Guidance) Declaration of Helsinki (October 19, 2013)
World Medical Association
(B) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
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: September 20, 2019
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
Summary

Overview

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

Also per G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the International Council for Harmonisation's good clinical practice guidelines. Per Additional Resource (B), Liberia is implementing the ICH-GCPs-Addendum.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.33
(B) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
Investigational Products > Manufacturing & Import
Last content review/update: September 20, 2019
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 Appendix 1
Summary

Overview

As indicated in G-LibClinTrial and Additional Resource (A), 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 per Additional Resource (B), IPs must be manufactured in accordance with the World Health Organization’s (WHO) Good Manufacturing Practice (GMP) Guidelines for IPs and the International Conference on Harmonisation (ICH) Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.

According to G-LibClinTrial and Additional Resource (A), 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
Additional Resources
Liberia Medicines and Health Products Regulatory Authority
(B) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2.12 and 5.13
Investigational Products > IMP/IND Quality Requirements
Last content review/update: September 20, 2019
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
Summary

Overview

In accordance with 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 (WHO-GCPs) when compiling the IB information. G-LibClinTrial also indicates that the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the International Council for Harmonisation's good clinical practice guidelines. Per Additional Resource (B), Liberia is implementing the ICH-GCPs-Addendum, which also provide detailed IB requirements.

IB Content Requirements

As specified in 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

Also, see the WHO-GCPs and ICH-GCPs-Addendum for additional details regarding the IB.

Drug Manufacturing Requirements

As specified in Additional Resource (D), the sponsor or his/her representative must also ensure that the products are manufactured in accordance with the World Health Organization's (WHO) Good Manufacturing Practice (GMP) Guidelines for IPs and the ICH Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.

Per the ICH-GCPs-Addendum, 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
(A) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 5.6 and 8
(B) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.13, 5.14, 7, and 8.2
(D) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Investigational Products > Labeling & Packaging
Last content review/update: September 20, 2019
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
Summary

Overview

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

As delineated in 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 G-LibClinTrial and Additional Resource (A), 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, including the World Health Organization's (WHO) GMP Guidelines for IPs and the International Conference on Harmonisation (ICH) Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.

G-LibClinTrial also indicates that the LMHRA complies with the International Council for Harmonisation's good clinical practice guidelines. Per Additional Resource (B), Liberia is implementing the ICH-GCPs-Addendum, which 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
(A) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)
(B) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.13
Investigational Products > Product Management
Last content review/update: September 20, 2019
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
Summary

Overview

Per G-LibClinTrial, the sponsor or his/her representative must comply with the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) in regard to product management. Per Additional Resource (A), Liberia is implementing the ICH-GCPs-Addendum, which 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 G-LibClinTrial and the ICH-GCPs-Addendum, 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). Also, the sponsor must 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 G-LibClinTrial and the ICH-GCPs-Addendum for detailed sponsor-related IP requirements.

Record Requirements

As per G-LibClinTrial, data handling and recordkeeping should be conducted in conformity with the WHO-GCPs. According to the WHO-GCPs, 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 the WHO-GCPs.

Additional Resources
(A) NIAID Communication with the National Research Ethics Board (NREB) (not available online) (June 2019)
(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
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: September 20, 2019
Requirements
(1) (Guidance) Institutional Review Board (IRB) Policies and Procedures Handbook (G-UL-PIRE-IRB) (February 2008)
University of Liberia-Pacific Institute for Research and Evaluation
Relevant Sections: The IRB Process – B (II)
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 G-UL-PIRE-IRB. As per G-UL-PIRE-IRB and Additional Resource (A), examples of biological specimens include:

  • Hair and nail clippings in a non-disfiguring manner
  • Deciduous teeth at time of exfoliation, or if routine patient care indicates a need for extraction
  • Permanent teeth if routine patient care indicates a need for extraction
  • Excreta and external secretions (including sweat)
  • Uncannulated saliva collected either in an unstimulated fashion, or stimulated by chewing gum base or wax, or by applying a dilute citric solution to the tongue
  • Placenta removed at delivery
  • Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor
  • Supra- and sub-gingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques
  • Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
  • Sputum collected after saline mist nebulization
  • Blood
Additional Resources
(A) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)
Specimens > Specimen Import & Export
Last content review/update: September 20, 2019
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
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, 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)

In addition, according to G-NREB and Additional Resource (A), the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) and the National Research Ethics Board (NREB) require an MTA with the sponsor, local institution, and other related parties to be submitted prior to the transfer or export of biological samples out of Liberia.

Additional Resources
(A) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)
Barchi, Francis and Little, Madison T., BMC Med Ethics
Specimens > Consent for Specimen
Last content review/update: September 20, 2019
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
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, 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 Additional Resources (A) and (B), 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 following information to be provided in the consent process:

  • Material Transfer Agreement (MTA) purpose
  • Signatures of relevant parties
  • Copy of MTA

See the Informed Consent topic, Required Elements and Participant Rights subtopics for additional information on informed consent.

Additional Resources
(A) NIAID Communication with the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)
(B) NIAID Communication with the Centers for Disease Control (CDC) Liberia Office (not available online) (October-November 2014)
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