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
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Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
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Required Elements
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Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
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Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
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Specimens
Definition of Specimen
Import & Export
Consent for Specimens
Liberia
QUICK FACTS
Clinical trial application languageEnglish
Parallel regulatory and ethical review permittedYes
Clinical trial registration requiredNo
In-country sponsor presence/representation requiredNo
Age of minorsUnder 18
Specimens export allowedUnspecified
Regulatory Authority > Regulatory Authority
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Last content review/update: December 01, 2016. Submit updates or comments.
SUMMARY

Overview
As per the LMHRA Act and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections. According to the LMHRA Act and Additional Resource (A), the LMHRA was established as the drug regulatory authority in 2010, and 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.

Contact Information
Liberia Medicines and Health Products Regulatory Authority (LMHRA)
VP Road, Tubman Boulevard
Old Road, Sinkor
1000 Monrovia, 10 Liberia
West Africa

Phone: (+231) (0) 886562019
Email: libmhra@gmail.com or d.sumo2013@gmail.com

ADDITIONAL RESOURCES

(A) (Document) Pharmaceutical Sector Country Profile Questionnaire – Liberia (2011)
World Health Organization and The Global Fund, Geneva, Switzerland

Relevant Section: 5.01 – Regulatory Framework

REQUIREMENTS

(1) (Legislation) An Act to Establish the Liberia Medicines and Health Products Regulatory Authority of 2010 (LMHRA Act) (September 29, 2010)
Government of the Republic of Liberia

Relevant Sections: Part IV (Sections 1 and 2) and Part V (Section 5)

(2) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: 1.0 and 2.0

Regulatory Authority > Scope of Assessment
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SUMMARY

Overview
In accordance with the LMHRA Act and the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) is responsible for reviewing, evaluating, and approving applications for clinical trials using registered or unregistered investigational products (IPs). The 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, EC approval is a prerequisite to the LMHRA’s approval review. The G-LibClinTrial also indicates 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), the Pharmacovigilance & Medicine Information Office within the LMHRA coordinates the clinical trial application review process. Appendix 1 of the G-LibClinTrial indicates that upon receipt of a clinical trial application, the Pharmacovigilance & Medicine Information Office screens the application package for completeness. If complete, the sponsor or his/her representative is issued an acknowledgement of receipt via a cover sheet and an LMHRA application/reference number is assigned to the application. The sponsor or his/her representative must reference the LMHRA reference number in all future application-related correspondence. According to Additional Resource (A), the process of acknowledging receipt of clinical trial application submission shall be done in five (5) working days.

Additional information on the review and approval process is not available at this time.

(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)

REQUIREMENTS

(1) (Legislation) An Act to Establish the Liberia Medicines and Health Products Regulatory Authority of 2010 (LMHRA Act) (September 29, 2010)
Government of the Republic of Liberia

Relevant Sections: Part IV (Sections 1 and 2) and Part V (Section 5)

(2) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: 1.0, 1.2, 2.0, and Appendix 1

Regulatory Authority > Regulatory Fees
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SUMMARY

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

Instructions for Payment of Clinical Trial Application Fee
As stated in the G-LibClinTrial, payment is to be made directly into the LMHRA’s bank account:

Liberia Medicines and Health Products Regulatory Authority (LMHRA)
Bank: ECOBANK, Liberia Ltd.
Account Number: 001-11347210544

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

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: 2.0 and Appendix 11

Ethics Committee > Ethics Committee
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Last content review/update: December 01, 2016. Submit updates or comments.
SUMMARY

Overview
According to the G-UL-PIRE-IRB and the G-LIBR/NHSREC, Liberia requires the principal investigator (PI) to obtain institutional and national level ethics committee (EC) approval for each clinical trial. As per the G-UL-PIRE-IRB, the G-LIBR/NHSREC, and Additional Resource (A), for the initial review, the PI is required to obtain ethics approval from his/her institution followed by national review and approval by the Liberia Institute of Biomedical Research/National Health Science Research EC (LIBR/NHSREC), the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB), or the National Research Ethics Board (NREB).

As per Additional Resource (B), the LIBR/NHSREC was established by the Ministry of Health (MoH) in the 1980s. 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).

According to Additional Resource (A), the NREB reports to the MoH and its members are appointed by the Minister of Health. The NREB also registered with the U.S. Department of Health and Human Services’ Office for Human Subjects Protection (OHRP) on January 20, 2015. As per Additional Resource (A), the LIBR/NHSREC transferred its national ethics oversight responsibilities as well as the majority of its membership to the NREB. It is not yet known how these developments will impact the LIBR/NHSREC as it restructures its own EC.

LIBR/NHSREC Composition
No information is currently available on LIBR/NHSREC composition requirements.

UL-PIRE-IRB Composition
As specified in the 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 UL’s Institute of Research or designate, ex-officio, 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 Additional Resource (A), the NREB is composed of 21 members who jointly represent a diverse community with a range of expertise. 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.

LIBR/NHSREC Terms of Reference, Review Procedures, and Meeting Schedule
The G-LIBR/NHSREC states that the LIBR/NHSREC must operate within written standard operating procedures (SOPs) to fulfill its budgetary and administrative responsibilities. The quorum for meetings is one third of the LIBR/NHSREC members. Decisions are reached by general agreement and must be based on the LIBR/NHSREC SOPs. The committee may seek specialist(s) advice on particular protocols as long as the experts have no conflict of interest with the study. The committee meets on a bi-monthly basis on the third Friday of the month. The agenda and protocols are distributed to committee members no later than four (4) weeks prior to the next meeting. See the G-LIBR/NHSREC for detailed committee requirements.

UL-PIRE-IRB Terms of Reference, Review Procedures, and Meeting Schedule
As delineated in the 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 regularly convened 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 the G-UL-PIRE-IRB.

NREB Terms of Reference, Review Procedures, and Meeting Schedule
As per Additional Resource (A), the NREB is presently using the SOPs created by the LIBR/NHSREC.

Note: The ClinRegs team will update this subtopic as additional information becomes available regarding new developments within the LIBR/NHSREC, the UL-PIRE-IRB, and the NREB.

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) University of Liberia (UL) – Atlantic Center for Research and Evaluation (ACRE) Africa Center – The Institutional Review Board (IRB) (Current as of November 22, 2016)
UL-ACRE Africa Center, University of Liberia, Monrovia, Liberia

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, Monrovia, Liberia

Relevant Sections: Institutional Review Board – D & E

(2) (Guidance) Liberia Institute of Biomedical Research/National Health Science Research (LIBR/NHSR) Ethics Committee Guidelines: Procedures for Researchers (G-LIBR/NHSREC) (September 23, 2011)
Liberia Institute of Biomedical Research, Monrovia, Liberia

Relevant Section: 1

(3) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: 1.2, 2.0, and 4.12

Ethics Committee > Scope of Review
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SUMMARY

Overview
According to the G-LIBR/NHSREC, the G-UL-PIRE-IRB, and Additional Resource (A), the primary scope of information assessed by the Liberia Institute of Biomedical Research/National Health Science Research Ethics Committee (LIBR/NHSREC), the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB), and the National Research Ethics Board (NREB) relate to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial.

As per the G-UL-PIRE-IRB, the ethics committee (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.

The G-UL-PIRE-IRB also states that the EC is responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. They 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 they must verify the adequacy of confidentiality and privacy safeguards. See the G-UL-PIRE-IRB for detailed ethical review guidelines.

Role in Clinical Trial Approval Process
As per the LMHRA Act, the G-LibClinTrial, and Additional Resources (A) and (B), the Liberia Medicines and Health Products Regulatory Authority (LMHRA) and the LIBR/NHSREC, the UL-PIRE-IRB, or the NREB 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, EC approval is a prerequisite to the LMHRA’s approval. The G-LibClinTrial also indicates that EC clearance or a copy of acknowledgement of study protocol submission must be included in the clinical trial application submission.

According to the G-LIBR/NHSREC, the G-UL-PIRE-IRB, and Additional Resource (A), the principal investigator (PI) is responsible for submitting an application to his/her institution and to LIBR/NHSREC, the UL-PIRE-IRB, or the NREB for review and approval.

LIBR/NHSREC
According to the G-LIBR/NHSREC, PIs are required to submit proposals to be reviewed at the next bi-monthly meeting. The G-LIBR/NHSREC indicates that all submissions must be received by the LIBR/NHSREC no later than six (6) weeks prior to each meeting. Also, the G-LIBR/NHSREC does not specify an approval expiration date.

UL-PIRE-IRB
As per the G-UL-PIRE-IRB, PIs are required to submit all applications four (4) weeks in advance of the date that a decision is requested. In the case of proposals 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 the 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 proposal 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
According to Additional Resource (A), the NREB is presently using the LIBR/NHSREC submission, review, and approval guidelines.

Note: The ClinRegs team will update this subtopic as additional information becomes available regarding new developments within the LIBR/NHSREC, the UL-PIRE-IRB, and the NREB.

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:
The Chairperson
National Research Ethics Board (NREB)
Ministry of Health
Congo Town
Monrovia, 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)

(B) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October-November 2014)



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, Monrovia, Liberia

Relevant Section: Introduction, Procedures, and Institutional Review Board (G & H), and Appendix A (Frequently Asked Questions)

(2) (Guidance) Liberia Institute of Biomedical Research/National Health Science Research (LIBR/NHSR) Ethics Committee Guidelines: Procedures for Researchers (G-LIBR/NHSREC) (September 23, 2011)
Liberia Institute of Biomedical Research, Monrovia, Liberia

Relevant Sections: 1.5, 2.1, 2.4, and 2.13

(3) (Legislation) An Act to Establish the Liberia Medicines and Health Products Regulatory Authority of 2010 (LMHRA Act) (September 29, 2010)
Government of the Republic of Liberia

Relevant Sections: Part IV (Sections 1 and 2) and Part V (Section 5)

(4) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: 1.0 and 2.0

Ethics Committee > Ethics Committee Fees
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SUMMARY
Overview
According to the G-LIBR/NHSREC and Additional Resource (A), the Liberia Institute of Biomedical Research/National Health Science Research EC (LIBR/NHSREC) and the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) require the principal investigator (PI) to pay a nonrefundable fee to submit a research proposal for ethics committee (EC) review and approval. As per Additional Resource (B), the National Research Ethics Board (NREB) is also developing a review fee schedule for various types of research studies.

The G-LIBR/NHSREC states that the LIBR/NHSREC charges a minimum fee of 3 percent of a research budget to review all proposals other than academic ones. Proposals that meet academic requirements are levied a minimum fee of 1 percent of the research budget.

As per Additional Resource (B), the UL-PIRE-IRB requires a non-refundable application fee of $500 USD for social, behavioral and educational research proposal review and $1,000 USD for clinical/biomedical research proposal review.
 
ADDITIONAL RESOURCES
(A) NIAID Communication with the Centers for Disease Control (CDC) Liberia Office (not available online) (October-November 2014)

(B) University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) Fees Memo (October 1, 2014)
University of Liberia, Office of the Institution Review Board
 
 
REQUIREMENTS

(1) (Guidance) Liberia Institute of Biomedical Research/National Health Science Research (LIBR/NHSR) Ethics Committee Guidelines: Procedures for Researchers (G-LIBR/NHSREC) (September 23, 2011)
Liberia Institute of Biomedical Research, Monrovia, Liberia

Relevant Section: 1.10

Ethics Committee > Authorizing Body
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SUMMARY

Overview
According to Additional Resource (A), the National Research Ethics Board (NREB) reports to the Ministry of Health (MoH) and its members are appointed by the Minister of Health. The NREB also registered with the U.S. Department of Health and Human Services’ Office for Human Subjects Protection (OHRP) on January 20, 2015. As per Additional Resource (A), the Liberia Institute of Biomedical Research/National Health Science Research Ethics Committee (LIBR/NHSREC) transferred its national ethics oversight responsibilities as well as the majority of its membership to the NREB. It is unclear at this time whether the NREB will also be responsible for accrediting other ethics committees (ECs).

As stated in the Ethics Committee topic, Ethics Comittee subtopic, the LIBR/NHSREC, the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB), and the NREB are the three (3) ECs responsible for reviewing and approving clinical research protocols at the national level.

Note: The ClinRegs team will update this subtopic as additional information becomes available regarding new developments within the LIBR/NHSREC, the UL-PIRE-IRB, and the NREB.

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)

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, Monrovia, Liberia

(2) (Guidance) Liberia Institute of Biomedical Research/National Health Science Research (LIBR/NHSR) Ethics Committee Guidelines: Procedures for Researchers (G-LIBR/NHSREC) (September 23, 2011)
Liberia Institute of Biomedical Research, Monrovia, Liberia

Clinical Trial Lifecycle > Submission Process
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SUMMARY

Overview
In accordance with the LMHRA Act, the G-LibClinTrial, the G-UL-PIRE-IRB, the G-LIBR/NHSREC, and Additional Resources (A) and (B), Liberia requires the sponsor or his/her representative to obtain clinical trial authorization from the Liberia Medicines and Health Products Regulatory Authority (LMHRA). The sponsor must also ensure the principal investigator (PI) obtains ethics committee (EC) approval from his/her institution followed by national approval from the Liberia Institute of Biomedical Research/National Health Science Research EC (LIBR/NHSREC), the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB), or the National Research Ethics Board (NREB) prior to initiating a study. According to Additional Resource (A), the EC and LMHRA reviews may be conducted in parallel. However, EC approval is a prerequisite to the LMHRA’s approval.

Note: The ClinRegs team will update this subtopic as additional information becomes available regarding new developments within the LIBR/NHSREC, the UL-PIRE-IRB, and the NREB.

(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)
VP Road, Tubman Boulevard
Old Road, Sinkor
1000 Monrovia, 10 Liberia
West Africa

Phone: (+231) (0) 886562019
Email: libmhra@gmail.com or mail to: d.sumo2013@gmail.com

Assembly and Number of Copies
Based on information provided in the G-LibClinTrial and Additional Resource (A), the sponsor or his/her representative should submit printed and electronic copies of the clinical trial application. 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.

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) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October-November 2014)

(B) NIAID Communication with University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)


REQUIREMENTS

(1) (Legislation) An Act to Establish the Liberia Medicines and Health Products Regulatory Authority of 2010 (LMHRA Act) (September 29, 2010)
Government of the Republic of Liberia

Relevant Sections: Part IV (Sections 1 and 2) and Part V (Section 5)

(2) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

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, Monrovia, Liberia

Relevant Sections: Institutional Review Board – D & E

(4) (Guidance) Liberia Institute of Biomedical Research/National Health Science Research (LIBR/NHSR) Ethics Committee Guidelines: Procedures for Researchers (G-LIBR/NHSREC) (September 23, 2011)
Liberia Institute of Biomedical Research, Monrovia, Liberia

Relevant Sections: 1 and 2

Clinical Trial Lifecycle > Submission Content
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SUMMARY

Overview
As set forth in the LMHRA Act, the G-LibClinTrial, the G-UL-PIRE-IRB, the G-LIBR/NHSREC, and Additional Resources (A) and (B), Liberia requires the sponsor or his/her representative to obtain clinical trial authorization from the Liberia Medicines and Health Products Regulatory Authority (LMHRA). The principal investigator (PI) must obtain ethics committee (EC) approval from his/her institution followed by national approval from the Liberia Institute of Biomedical Research/National Health Science Research EC (LIBR/NHSREC), the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB), or the National Research Ethics Board (NREB).

LMHRA Requirements
As per the G-LibClinTrial, the following documentation must be submitted to the LMHRA:

  • Cover letter
  • 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 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
  • For multicenter trials, a coordinating investigator must sign the application form
  • When the trial is part of an international study, provide sufficient information regarding the other participating countries, including the part of the trial to be conducted locally
  • Payment of application fee

Refer to the G-LibClinTrial for detailed application requirements.

UL-PIRE-IRB Requirements
As indicated in the G-UL-PIRE-IRB, PIs are required to submit research proposals using the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) submission form (see Additional Resource (C)). The 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 proposal
  • Informed consent and/or assent form
  • Questionnaire
  • Investigator(s) curriculum vitaes (CVs)
  • Protocol budget
  • Copy of institutional EC approval, if available


LIBR/NHSREC Requirements
According to the G-LIBR/NHSREC, the LIBR/NHSREC requires the PIs to provide typed, dated, and signed submissions that may be sent electronically or by hard copy. Submissions must also include all the documents and materials used to inform potential research participants including information sheets, consent forms, questionnaires, letters of invitation, and internet content. The number of copies required to be submitted is not specified in the G-LIBR/NHSREC.

Note: According to Additional Resource (E), the LIBR/NHSREC has no submission forms. Those seeking review may adapt their own forms in order to address submission guidelines.

NREB Requirements
According to Additional Resource (B), the NREB is presently using the LIBR/NHSREC submission, review, and approval guidelines.

LMHRA Clinical Protocol Requirements
For detailed information on LMHRA protocol requirements, see Section 4.0 of the G-LibClinTrial.

UL-PIRE-IRB Clinical Protocol Requirements
According to the 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

LIBR/NHSREC Clinical Protocol Requirements
Protocol submission requirements are currently unavailable for the LIBR/NHSREC.

NREB Clinical Protocol Requirements
Protocol submission requirements are currently unavailable for the NREB.

Note: The ClinRegs team will update this subtopic as additional information becomes available regarding new developments within the LIBR/NHSREC, the UL-PIRE-IRB, and the NREB.

ADDITIONAL RESOURCES

(A) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October-November 2014)

(B) NIAID Communication with University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)

(C) (Form) UL-PIRE IRB Submission Form (Date Unavailable)
University of Liberia-Pacific Institute for Research and Evaluation, Monrovia, Liberia

(D) NIAID Communication with the Centers for Disease Control (CDC) Liberia Office (not available online) (October-November 2014)

(E) NIAID Communication with Liberia Institute for Biomedical Research/National Health Science Research Ethics Committee (LIBR/NHSREC) (not available online) (October-November 2014)


REQUIREMENTS

(1) (Legislation) An Act to Establish the Liberia Medicines and Health Products Regulatory Authority of 2010 (LMHRA Act) (September 29, 2010)
Government of the Republic of Liberia

Relevant Sections: Part IV (Sections 1 and 2) and Part V (Section 5)

(2) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

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, Monrovia, Liberia

Relevant Section: Institutional Review Board – D & E

(4) (Guidance) Liberia Institute of Biomedical Research/National Health Science Research (LIBR/NHSR) Ethics Committee Guidelines: Procedures for Researchers (G-LIBR/NHSREC) (September 23, 2011)
Liberia Institute of Biomedical Research, Monrovia, Liberia

Relevant Sections: 1 and 2

Clinical Trial Lifecycle > Timeline of Review
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SUMMARY

Overview
Based on the G-LibClinTrial, G-UL-PIRE-IRB, the G-LIBR/NHSREC, and Additional Resources (A) and (B), 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 from his/her institution followed by national approval from the Liberia Institute of Biomedical Research/National Health Science Research EC (LIBR/NHSREC), the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB), or the National Research Ethics Board (NREB).

According to Additional Resource (A), the EC and LMHRA reviews may be conducted in parallel. However, EC approval is a prerequisite to the LMHRA’s approval.

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

Additional information on the review and approval process is not available at this time.

Ethics Committee (EC) Approval
UL-PIRE-IRB Approval
As specified in the G-UL-PIRE-IRB, PIs are required to submit all application materials four (4) weeks in advance of the date that a decision is requested. In the case of full review studies, submission is required four (4) weeks prior to the next scheduled UL-PIRE-IRB meeting. A full review can take from one (1) to two (2) months. Investigators will be informed of all UL-PIRE-IRB decisions in writing.

According to the G-UL-PIRE-IRB, the UL-PIRE-IRB review process usually takes two (2) to three (3) weeks if a proposal 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.

LIBR/NHSREC Approval
According to the G-LIBR/NHSREC, PIs are required to submit proposals to be reviewed at the next bi-monthly meeting. The G-LIBR/NHSREC indicates that all submissions must be received by the LIBR/NHSREC no later than six (6) weeks prior to each meeting. The PI, and where applicable, the sponsor or his/her representative should be notified in writing of the committee’s decision at least one (1) month after the meeting at which the protocol is reviewed. The G-LIBR/NHSREC does not specify an approval expiration date.

NREB Approval
According to Additional Resource (B), the NREB is presently using the LIBR/NHSREC submission, review, and approval guidelines.

Note: The ClinRegs team will update this subtopic as additional information becomes available regarding new developments within the LIBR/NHSREC, the UL-PIRE-IRB, and the NREB.

ADDITIONAL RESOURCES

(A) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October-November 2014)

(B) NIAID Communication with University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: 1.0, 2.0, and Appendices 1 and 11

(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, Monrovia, Liberia

Relevant Section: Institutional Review Board – (D, E and K) and Frequently Asked Questions

(3) (Guidance) Liberia Institute of Biomedical Research/National Health Science Research (LIBR/NHSR) Ethics Committee Guidelines: Procedures for Researchers (G-LIBR/NHSREC) (September 23, 2011)
Liberia Institute of Biomedical Research, Monrovia, Liberia

Relevant Sections: 1 and 2

Clinical Trial Lifecycle > Trial Initiation
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SUMMARY

Overview
In accordance with the LMHRA Act, the G-LibClinTrial, the G-UL-PIRE-IRB, the G-LIBR/NHSREC, and Additional Resources (A) and (B), 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) and the principal investigator (PI) obtains ethics committee (EC) approval from his/her institution followed by national approval from the Liberia Institute of Biomedical Research/National Health Science Research EC (LIBR/NHSREC), the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB), or the National Research Ethics Board (NREB).

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 the 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 the G-LibClinTrial, the PI must possess 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. 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.

Note: The ClinRegs team will update this subtopic as additional information becomes available regarding new developments within the LIBR/NHSREC, the UL-PIRE-IRB, and the NREB.

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

EC Confirmation of Review and Approval
The G-LibClinTrial indicates that the sponsor must ensure that the PI obtains EC clearance.

Note: The ClinRegs team will update this subtopic as additional information becomes available regarding new developments within the LIBR/NHSREC, the UL-PIRE-IRB, and the NREB.

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

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

ADDITIONAL RESOURCES

(A) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October-November 2014)

(B) NIAID Communication with University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)

(C) (Document) Standard Operating Procedure (SOP) for the Submission of Dossiers for Investigational Products (Date Unavailable)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

REQUIREMENTS

(1) (Legislation) An Act to Establish the Liberia Medicines and Health Products Regulatory Authority of 2010 (LMHRA Act) (September 29, 2010)
Government of the Republic of Liberia

Relevant Sections: Part IV (Sections 1 and 2) and Part V (Section 5)

(2) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

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, Monrovia, Liberia

Relevant Section: Institutional Review Board – (D, E and K) and Frequently Asked Questions

(4) (Guidance) Liberia Institute of Biomedical Research/National Health Science Research (LIBR/NHSR) Ethics Committee Guidelines: Procedures for Researchers (G-LIBR/NHSREC) (September 23, 2011)
Liberia Institute of Biomedical Research, Monrovia, Liberia

Relevant Sections: 1 and 2

Clinical Trial Lifecycle > Safety Reporting
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SUMMARY

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

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

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.

Form Completion & Delivery Requirements
As per the G-LibClinTrial and G-LibPV, all SAEs/SADRs and SUSARs must be reported on the LMHRA’s Serious Adverse Event (SAE) Reporting Form (Appendix 8 in the G-LibClinTrial 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)
VP Road, Tubman Boulevard
Old Road, Sinkor
1000 Monrovia, 10 Liberia
West Africa

Tel: +231 (0) 886 530270/886 562019

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

ADDITIONAL RESOURCES

(A) NIAID Communication with 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, Government of the Republic of Liberia

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: 1.0, 1.2, 2.0, 3.0, 9.0, 10.0, and Appendix 8

(2) (Draft Guidance) Draft Guideline for the Pharmacovigilance System in Liberia (G-LibPV) (April 15, 2012)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: Interpretation and 1.6

Clinical Trial Lifecycle > Progress Reporting
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SUMMARY

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

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

According to 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-December 2014)

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: 11.0 and 12.3

Sponsorship > Definition of Sponsor
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SUMMARY

Overview
As per the G-LibClinTrial, the sponsor is defined as an individual, company, institution, or organization which takes responsibility for the initiation, management and/or financing of a clinical trial.

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

A sponsor may be domestic or foreign.

ADDITIONAL RESOURCES

No additional resources

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, Government of the Republic of Liberia

Relevant Section: 1.2

Sponsorship > Trial Authorization
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SUMMARY

Overview
In accordance with the LMHRA Act, the G-LibClinTrial, the G-UL-PIRE-IRB, the G-LIBR/NHSREC, and Additional Resources (A) and (B), 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. The sponsor must also ensure that the principal investigator (PI) obtains ethics committee (EC) approval from his/her institution, followed by national approval from the Liberia Institute of Biomedical Research/National Health Science Research EC (LIBR/NHSREC), the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB), or the National Research Ethics Board (NREB).

Note: The ClinRegs team will update this subtopic as additional information becomes available regarding new developments within the LIBR/NHSREC, the UL-PIRE-IRB, and the NREB.

According to Additional Resource (A), the EC and LMHRA reviews may be conducted in parallel. However, EC approval is a prerequisite to the LMHRA’s approval review.

According to Additional Resource (A) and the G-LibClinTrial, the sponsor or his/her representative must use the LMHRA’s application form (see Appendix 1 of the G-LibClinTrial). In addition to the completed application, the sponsor or his/her representative must provide the EC clearance or 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-November 2014)

(B) NIAID Communication with University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)

REQUIREMENTS

(1) (Legislation) An Act to Establish the Liberia Medicines and Health Products Regulatory Authority of 2010 (LMHRA Act) (September 28, 2010)
Government 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, Government of the Republic of Liberia

Relevant Sections: 1.0, 1.2, 2.0, and Appendix 1

(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, Monrovia, Liberia

Relevant Sections: Institutional Review Board – D & E

(4) (Guidance) Liberia Institute of Biomedical Research/National Health Science Research (LIBR/NHSR) Ethics Committee Guidelines: Procedures for Researchers (G-LIBR/NHSREC) (September 23, 2011)
Liberia Institute of Biomedical Research, Monrovia, Liberia

Relevant Sections: 1 and 2

Sponsorship > Insurance
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SUMMARY

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

ADDITIONAL RESOURCES

No additional resources

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, Government of the Republic of Liberia

Relevant Sections: 1.0, 1.2, 2.0, and Appendix 1

Sponsorship > Compensation
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SUMMARY

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

ADDITIONAL RESOURCES

(A) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October-November 2014)

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Section: Appendix 1

Sponsorship > Quality, Data & Records Management
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SUMMARY

Overview
According to the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) requires the sponsor or his/her representative to comply with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) 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.

As per the ICH-GCPs, the sponsor is required to obtain agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities. The sponsor and investigator(s) agreement should be confirmed in writing prior to the trial. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed.

The sponsor must also obtain agreement from the investigator(s) and the institution(s) to:

  • conduct the trial in compliance with the ICH-GCPs, and the protocol agreed to by the sponsor and approved by the ethics committee (EC)
  • comply with data recording and reporting procedures  
  • permit monitoring, auditing, and inspection
  • retain essential documents until the sponsor informs them that they are no longer needed

Electronic Data Processing System
According to the ICH-GCPs, 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, and that he/she maintains SOPs for using these systems. Refer to the ICH-GCPs for detailed information on electronic trial data systems.

Record Management
As per the G-LibClinTrial, data handling and recordkeeping should be conducted in conformity with the World Health Organization’s good clinical practice guidelines (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.

Audit Requirements
As part of its QA system, the ICH-GCPs state that the sponsor may choose to perform a clinical trial audit to evaluate trial conduct and compliance with the protocol, SOPs, and other applicable regulatory requirements. The sponsor must also ensure that the audit is conducted in accordance with his/her own SOPs, the auditor observations are documented, and data are available as needed for the LMHRA. No specific timeframe is provided for the audit process.

Premature Study Termination/Suspension
The G-LibClinTrial states that if the sponsor or the principal investigator (PI) terminates a trial, the sponsor or the PI must inform the LMHRA no later than 15 days after the termination date. The 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.

Multicenter Studies
As delineated in the ICH-GCPs, in the event of a multicenter clinical trial, the sponsor must ensure that:

  • All investigators conduct the trial in strict compliance with the protocol
  • 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 between investigators is facilitated

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

ADDITIONAL RESOURCES

(A) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 5.1, 5.5, 5.6, 5.19, 5.21, and 5.23

(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, Geneva, Switzerland

Relevant Section: 8

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: Foreword,  10.0, 12.1, and Appendices 2, 3, 4, and 9

Sponsorship > Site/Investigator Selection
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SUMMARY

Overview
According to the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) requires the sponsor or his/her representative to comply with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) 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.

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

Foreign Sponsor Responsibilities
No information is currently available specifying requirements for foreign sponsors.

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

ADDITIONAL RESOURCES

(A) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Section: 5.6

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: Foreword, 2.0, 3.0, 5.0, 10.0, and Appendix 1

(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, Monrovia, Liberia

Relevant Sections: Institutional Review Board – D & E

(3) (Guidance) Liberia Institute of Biomedical Research/National Health Science Research (LIBR/NHSR) Ethics Committee Guidelines: Procedures for Researchers (G-LIBR/NHSREC) (September 23, 2011)
Liberia Institute of Biomedical Research, Monrovia, Liberia

Relevant Sections: 1 and 2

Informed Consent > Documentation Requirements
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SUMMARY

Overview
In accordance with the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs). As per the G-LibClinTrial and the ICH-GCPs, a freely given informed consent must be obtained from every study participant prior to clinical trial participation.

According to the G-LibClinTrial and Additional Resource (B), the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by the Liberia Institute of Biomedical Research)/National Health Science Research EC (LIBR/NHSREC), the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB), or the National Research Ethics Board (NREB). The ICF must be provided to the LMHRA with the clinical trial application. (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

Note: The ClinRegs team will update this subtopic as additional information becomes available regarding new developments within the LIBR/NHSREC, the UL-PIRE-IRB, and the NREB.

The G-LibClinTrial states that the investigator or his/her designated representative must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). The G-LibClinTrial also specifies that the oral and written information concerning the trial, including the ICF, should be easy to understand and presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. The participant, and/or his/her legal representative(s) or guardian(s), should also be given adequate time to consider whether to participate.

Re-Consent
According to the G-LibClinTrial, any change in the ICF due to a protocol modification should be approved by the LMHRA and either the LIBR/NHSREC or the UL-PIRE-IRB 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 may 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 the G-LibClinTrial, the ICF content should be presented in English, and all written and oral information given to participants must be in English.

Documentation Copies
The G-LibClinTrial states that the participant and/or the participant’s legal representative(s) or guardian(s), and the person who conducted the informed consent discussion should sign and personally date the ICF. Where the participant is illiterate, and/or his/her legal representative(s) or guardian(s) is illiterate, verbal consent should be obtained in the presence of and countersigned by an impartial witness.

ADDITIONAL RESOURCES

(A) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 2 and 4.8

(B) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October-December 2014)

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: Foreword, 6, and Appendix 9

Informed Consent > Required Elements
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SUMMARY

Overview
As set forth in the G-LibClinTrial, prior to beginning a clinical trial, the principal investigator (PI) is required to obtain approval from the Liberia Medicines and Health Products Regulatory Authority (LMHRA) and ethics committee (EC) approval from his/her institution, followed by national approval from the Liberia Institute of Biomedical Research)/National Health Science Research EC (LIBR/NHSREC), the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB), or the National Research Ethics Board (NREB).

Note: The ClinRegs team will update this subtopic as additional information becomes available regarding new developments within the LIBR/NHSREC, the UL-PIRE-IRB, and the NREB.

No Coercion
As per the G-LibClinTrial, none of the oral and written information concerning the research study, including the written informed consent form (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
Based on the G-LibClinTrial, the LMHRA complies with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs). As per the G-LibClinTrial and the ICH-GCPs, the ICF should include the following statements or descriptions, as applicable:

  • That 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
  • That records identifying the participant will be maintained, and if the results of the trial are published, the participant’s identity will remain confidential
  • That the 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
  • That participation is voluntary, the participant may withdraw at any time, and refusal to participate will not involve any penalty or loss of benefits, or reduction in the level of care to which the participant is otherwise entitled
  • Foreseeable circumstances under which the investigator(s) may remove the participant without his/her consent
  • That 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-December 2014)

(B) NIAID Communication with University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) (not available online) (October 2014-February 2015)

(C) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Section: 2

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: Foreword, 6, and Appendix 9

Informed Consent > Compensation Disclosure
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SUMMARY

Overview
In accordance with the 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.

Compensation for Participation in Research
As stated in the 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 Liberia Medicines and Health Products Regulatory Authority (LMHRA).

Compensation for Injury
As per the 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 (A), compensation for trial-related injuries to participants must be determined by the LMHRA’s compensation committee. (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 Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October-December 2014)

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: 6 and Appendix 1

Informed Consent > Participant Rights
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SUMMARY

Overview
According to the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the ethical principles as specified in the Declaration of Helsinki (Appendix 10, G-LibClinTrial). As per the 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.

The Right to Participate, Abstain, or Withdraw
As set forth in the G-LibClinTrial, 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
Based on the G-LibClinTrial, the LMHRA complies with the good clinical practice (GCP) guidelines as specified in the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs). As per the G-LibClinTrial and the ICH-GCPs, a potential research participant and/or his/her legal representative(s) or guardian(s) has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study. (See the Informed Consent topic, Required Elements subtopic for a more detailed list.)

The Right to Privacy and Confidentiality
As per the G-LibClinTrial and the ICH-GCPs, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

The Right of Inquiry/Appeal
The G-LibClinTrial 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
The G-LibClinTrial, the ICH-GCPs, 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) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 2 and 4.8

(B) (WMA Guidance) Declaration of Helsinki (October 19, 2013)
World Medical Association

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: Foreword, 6, and Appendices 9 and 10

Informed Consent > Special Circumstances/Emergencies
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SUMMARY

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

Medical Emergencies
As delineated in the G-LibClinTrial, 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 Liberia Medicines and Health Products Regulatory Authority (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

No additional resources

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Section: 6

Informed Consent > Vulnerable Populations
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SUMMARY

Overview
As per the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the ethical principles as specified in the Declaration of Helsinki (Appendix 10, G-LibClinTrial). As per the G-LibClinTrial and the Declaration of Helsinki, 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) (WMA Guidance) Declaration of Helsinki (October 2013)
World Medical Association

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: 1.2 and Appendix 10

Informed Consent > Children/Minors
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SUMMARY

Overview
According to the G-UL-PIRE-IRB, children and minors are defined by the Republic of Liberia as those persons under 18 years of age. As set forth in the G-LibClinTrial, 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 the 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).

ADDITIONAL RESOURCES

(A) (WMA Guidance) Declaration of Helsinki October 2013)
World Medical Association, Ferney-Voltaire, France

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, Monrovia, Liberia

Relevant Sections: Institutional Review Board – B

(2) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Section: Appendix 10

Informed Consent > Pregnant Women, Fetuses & Neonates
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SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Informed Consent > Prisoners
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SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Informed Consent > Mentally Impaired
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SUMMARY

Overview
According to the G-LibClinTrial, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with the ethical principles as specified in the Declaration of Helsinki (Appendix 10, G-LibClinTrial). As per the 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
ADDITIONAL RESOURCES

(A) (WMA Guidance) Declaration of Helsinki (October 2013)
World Medical Association

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Section: Appendix 10

Investigational Products > Definition of Investigational Product
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SUMMARY

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

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Section: 1.2

Investigational Products > Manufacturing & Import
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SUMMARY

Overview
As indicated in the 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 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 the 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 the 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


No information is currently available on authorizing the import of IPs.

ADDITIONAL RESOURCES

(A) (Document) Standard Operating Procedure (SOP) for the Submission of Dossiers for Investigational Products (Date Unavailable)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

(B) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)

(C) (WHO Guidance) Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Investigational Pharmaceutical Products for Clinical Trials in Humans (Technical Report Series No. 863, Annex 7) (1996) World Health Organization, Geneva, Switzerland

(D) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) (Step 4 Version) (November 10, 2000)
International Conference on Harmonisation
Geneva, Switzerland

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: 1.2, 2.0, 7.0, and Appendix 1


Investigational Products > IMP/IND Quality Requirements
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SUMMARY

Overview
In accordance with the G-LibClinTrial and the World Health Organization’s good clinical practice guidelines (WHO-GCPs) which the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with, the sponsor or his/her representative is responsible for providing the investigators with an Investigator’s Brochure (IB).

IB Content Requirements
As specified in the G-LibClinTrial and the WHO-GCPs, 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

In accordance with the G-LibClinTrial, the LMHRA complies with the good clinical practice (GCP) guidelines specified in the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs). As delineated in the G-LibClinTrial, the WHO-GCPs, the ICH-GCPs, and Additional Resources (C) and (D), the sponsor or his/her representative must also supply the investigator(s) with the IP(s), including the comparator(s) and placebo, if applicable. As per Additional Resources (B) and (C), the sponsor or his/her representative should not supply either party with the IP(s) until he/she obtains approval from the LMHRA.

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 International Conference on Harmonisation (ICH) Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.

(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, Geneva, Switzerland

Relevant Sections: 5.6 and 8

(B) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 1, 5.6.2, 5.12.2, 5.14, 5.15, and 7

(C) (Document) Standard Operating Procedure (SOP) for the Submission of Dossiers for Investigational Products (Date Unavailable)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

(D) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)

(E) (WHO Guidance) Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Investigational Pharmaceutical Products for Clinical Trials in Humans (Technical Report Series No. 863, Annex 7) (1996) World Health Organization, Geneva, Switzerland

(F) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) (Step 4 Version) (November 10, 2000)
International Conference on Harmonisation
Geneva, Switzerland

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: 1.2, 2.0, 5.0, and 7.0

Investigational Products > Labeling & Packaging
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SUMMARY

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

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

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

In addition, as per the 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) good manufacturing practice (GMP) guidelines for IPs and the International Conference on Harmonisation (ICH) Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.

ADDITIONAL RESOURCES

(A) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October 2014-January 2015)

(B) (WHO Guidance) Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Investigational Pharmaceutical Products for Clinical Trials in Humans (Technical Report Series No. 863, Annex 7) (1996) World Health Organization, Geneva, Switzerland

(C) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) (Step 4 Version) (November 10, 2000)
International Conference on Harmonisation
Geneva, Switzerland


REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: 2.0, 7.2, and Appendix 1

Investigational Products > Product Management
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SUMMARY

Overview
In accordance with the G-LibClinTrial and the World Health Organization’s good clinical practice guidelines (WHO-GCPs), which the Liberia Medicines and Health Products Regulatory Authority (LMHRA) complies with, the sponsor or his/her representative is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The sponsor should also update the IB as significant new information becomes available.

Investigational Product Supply, Storage, and Handling Requirements
According to the G-LibClinTrial and the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs), which the LMHRA complies with, the sponsor or his/her representative must also supply the investigator(s)/institution(s) with the IPs. As per the G-LibClinTrial and Additional Resources (C) and (D), the sponsor or his/her representative should not supply either party with the IP(s) until he/she obtains approval from the LMHRA. As delineated in the G-LibClinTrial and ICH-GCPs, the sponsor must also ensure the following:

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

Refer to the G-LibClinTrial and the ICH-GCPs for detailed sponsor-related IP requirements.

Record Requirements
As per the 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) (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, Geneva, Switzerland

Relevant Section: 8

(B) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 1, 5.6.2, 5.12.2, 5.14, 5.15, and 7

(C) (Document) Standard Operating Procedure (SOP) for the Submission of Dossiers for Investigational Products (Date Unavailable)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

(D) NIAID Communication with Liberia Medicines and Health Products Regulatory Authority (LMHRA) (not available online) (October-November 2014)

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Sections: Foreward, 2.0, 4.10, 4.11, 4.12, 5.0, 7.0, and Appendix 1

Specimens > Definition of Specimen
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Last content review/update: December 01, 2016. Submit updates or comments.
SUMMARY

Overview
While the Liberia Medicines and Health Products Regulatory Authority (LMHRA) does not provide a formal definition for specimens, the
University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) describes examples of specimens in the G-UL-PIRE-IRB. As per the G-UL-PIRE-IRB and Additional Resource (A), examples of biological specimens include:

  • Hair and nail clippings in a nondisfiguring 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)

(B) NIAID Communication with the Centers for Disease Control (CDC) Liberia Office (not available online) (October-November 2014)

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, Monrovia, Liberia

Relevant Sections: The IRB Process – B (II)

Specimens > Import & Export
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SUMMARY

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

  • Identification of the provider and recipient
  • Identification of the material and volume of material
  • Definition of the trial and how the material will and will not be used
  • Maintenance of confidentiality of background of supporting data or information, if any
  • Indemnification and warranties (where applicable)


In addition, according to Additional Resource (A), the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) requires 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)

(B) (Article) National Ethics Guidance in Sub-Saharan Africa on the Collection and Use of Human Biological Specimens: A Systematic Review (October 22, 2016)
Barchi, Francis and Little, Madison T., BMC Med Ethics

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Section: 4.12

Specimens > Consent for Specimens
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Last content review/update: December 01, 2016. Submit updates or comments.
SUMMARY

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

According to Additional Resources (A) and (B), the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB) requires 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)

REQUIREMENTS

(1) (Draft Guidance) Guideline for Application to Conduct Clinical Trials in Liberia (G-LibClinTrial) (1st Edition) (February 2014)
Liberia Medicines and Health Products Regulatory Authority, Government of the Republic of Liberia

Relevant Section: 4.12

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Expiration Date: 2/28/2019