PIRE-AFRICA CENTER
Ground Floor, GD Building
University Of Liberia
Monrovia, Liberia
E-mail:
INSTITUTIONAL REVIEW BOARD
(IRB)
STANDARD OPERATING PROCEDURES
FOR
INSTITUTIONAL RESEARCH BOARD
University of Liberia (UL) Pacific Institute for Research
& Evaluation (PIRE)
February 2008
Foreword
The objective of this Standard Operating Procedure (SOP) is to ensure quality and consistency in the review of social, behavioral, clinical and biomedical research protocols to be in consistent with theCouncil for International Organizations of Medical Sciences (CIOMS) and national ethical guidelines for research on human subjects. Institutional Review Boards (IRBs) should provide independent, competent and timely review of ethical issues prior to the commencement of research studies, including the regular monitoring and evaluating of ongoing studies.
IRBs review and approve all research proposals involving human participants with a view to safeguard the dignity, rights, safety and well being of research participants, irrespective of the funding source. The goals of research, however important, should never be permitted to override the health and well being of research subjects.
The University of Liberia-Pacific Institute for Research & Evaluation (UL-PIRE) Africa Center Institutional Review Board was therefore instituted to tackle social, cultural and other ethical issues in human subject research by instituting internationally acceptable principles and practices. The IRB will ensure that all cardinal principles of research ethics (i.e., autonomy, beneficence, non–malfeasance and justice) are considered during project-related planning, implementation and reporting. It examines the informed consent process, the risk-benefit ratio, the distribution of burden/benefit and the provisions for appropriate compensations, wherever required. It reviews proposals prior to the commencement of research studies, as well as, monitors research projects through site visits and periodic reports, etc. The IRB also ensures compliance with all regulatory requirements, applicable guidelines and laws.
With an increasing trend in international collaborative research between external and local institutions, interpretations of ethical issues may vary. As such, there is a need for standardized regulations of research activities through established IRBs at recognized institutions, including emerging IRBs in post-conflict settings.
Most importantly, the need for Standard Operating Procedures (SOPs) cannot be overemphasized to ensure consistency in regulatory requirements. While emerging ethical issues in post-conflict environments will require updates to SOPs, it is essential that changes are consistent with internationally acceptable best practices in human subject research.
Stephen B. Kennedy, MD, MPH
Principal Investigator (PI)
UL-PIRE Africa Center
University of Liberia
Monrovia, Liberia
TABLE OF CONTENTS
PAGE
FOREWORD ………………………………………………………………………… i
TABLE OF CONTENT ………………………………………………………………. ii
1.0 ROLE OF UL-PIRE IRB …………………………………………………….. 1
2.0 MEMBERSHIP ………………………………………………………………. 1
3.0 TERMS OF REFERENCE …………………………………………………. 3
4.0 THE EXECUTIVE COMMITTEE …………………………………………… 4
5.0 THE IRB SECRETARIAT …………………………………………………… 4
6.0 FUNCTIONS AND RESPONSIBILITIES ………………………………….. 4
7.0 REGULAR IRB MEETING ………………………………………………….. 5
8.0 CONDUCT OF THE MEETING ……………………………………………. 5
9.0 COMMUNICATION OF REVIEW DECISIONS …………………………… 6
10.0 EXPEDITED REVIEW ………………………………………………………. 6
11.0 DECISION MAKING ………………………………………………………… 7
12.0 MONITORING AND EVALUATION OF RESEARCH …………………… 8
13.0 REFERENCES ………………………………………………………………. 9
STANDARD OPERATING PROCEDURES (SOPs)
1.0 ROLE OF UL-PIRE IRB
The University of Liberia-Pacific Institute for Research & Evaluation (UL-PIRE) Institutional Research Board, hereinafter called The Board, was constituted through a collaborative initiative between the University of Liberia (UL) and the Pacific Institute for Research & Evaluation (PIRE). It shall serve as the regulatory body for human subject protection research at the University of Liberia and UL-PIRE Africa Center. It shall serve as an independent entity with the authority to receive, review, evaluate and decide on the bases of scientific and ethical merits of human subject research protocols. It is committed to ensuring and guaranteeing the rights, dignity, safety and protection of all individuals and communities who participate in research activities. The respect for research participants shall extend to non-human subjects, plants and the environment. The Board governs health research as guided by the applicable laws and regulations of the Liberian Government and relevant international conventions.
2.0 MEMBERSHIP
The Board shall comprise core members from various disciplines including social sciences, clinical, biostatistics, law, and a lay person. The Program Director of UL-PIRE Africa Center shall also be an ex-officio member.
The IRB shall be multidisciplinary and multi-sectorial in composition. The number of members on the Board shall be between 5-11 members from diverse social and educational backgrounds. The external members shall be in majority to ensure the independence of the Board.
The Chairperson of the Board shall be from outside the institution and not the Director or former Director of UL-PIRE Africa Center. The Board Coordinator (or Administrator), recruited from UL-PIRE Africa Center, shall conduct the business of the Board. Other members shall be a mix of medical and non-medical, scientific and non-scientific persons, including the general public to reflect diverse viewpoints.
The composition shall be as follows:
1. Chairperson
2. Basic medical scientist(s)
3. Clinician(s)
4. Legal expert(s)
5. Social scientist(s)/representative of non-governmental voluntary agencies
6. Non-scientific individual(s) from the communities/disadvantaged population(s)
7. Administrator/Coordinator
The IRB shall have a majority of its members from other institutions. They could be drawn from any public or private institute from anywhere within the country. There shall be adequate representation by age, gender, community, etc., on the Board to safeguard the interests and welfare of all segments of the society. The Board shall have gender balance.
2.1 Appointments
The Board members shall be appointed by the President of the University herein referred to as the Appointing Authority.
2.2 Tenure and Conditions of Appointment
Members shall be appointed initially for a period of three (3) years, and renewable. To maintain continuity in the operations of the Board, at least 1/3 of the membership shall be retained at any given time.. The outgoing Chairperson shall be an ex-officio member on the incoming Board.
2.3 Resignation
A member may resign after giving at least one month notice to the Appointing Authority. The Board shall recommend to the Appointing Authority a nominee for replacement.
2.4 Allowances
Allowances for IRB membership shall be considered by the Board.
2.5 Review Fees
The Board may recommend levy of fees to cover administrative costs associated with the review of research protocols.
3.0 TERMS OF REFERENCE
3.1 Review and Approvals of Research Proposals
The Board shall provide independent, competent and ethical review of research protocols.
3.1.1 The Board shall review health research proposals submitted to it within a reasonable time and document its views/findings in writing to the applicant(s) or investigator(s).
3.1.2 The Board shall safeguard the dignity, rights, safety, and well being of all study participants/subjects and communities paying special attention to studies that involve vulnerable participants.
3.1.3 The Board may request the investigator(s) to explain any aspect of the study that may require personal appearance at its meeting.
3.1.4 The Board will provide standardized guidelines for the submissions of research proposals.
3.1.5 The Board shall request relevant documents from applicant(s) or investigator(s), including but not limited to the following:
Ø Summary of proposal
Ø Study proposal(s) and/or amendment(s)
Ø Written informed consent form(s) and questionnaire(s) that the investigator(s) propose(s) to use in the study
Ø Safety information, if required
Ø Information about benefits and protections to participants
Ø Any other relevant documents as may be desired.
3.1.6 The Board shall consider the suitability of the investigator(s) for the proposed study with respect to relevant qualification, training and/or experience, as documented by a current curriculum vitae and/or any other relevant documentation.
3.1.7 The Board shall review both the amount and type of benefit to participants to ensure that it does not presents problems, coercion or undue influence on study participants.
3.1.8 Submitted proposals that have been reviewed elsewhere shall be reviewed afresh by the Board.
3.1.9 The date of meetings will be provided to applicant(s)/investigator(s) who should be available to offer clarifications, if necessary.
3.1.10 The SOPs shall be reviewed and revised every three years.
3.2 Facilitating, Sourcing and Coordinating Approvals of Research Grants / Funds
The Board endeavor explore all available avenues to secure funding for ethical research projects as deemed necessary for capacity building and collaboration with other donor institutions.
3.2 Coordinate the Dissemination and Publicity of Research Information and
Findings
The Board shall endeavor to disseminate information to the general public as it relates to ethical education in health research studies.
4.0 THE EXECUTIVE COMMITTEE
There shall be an Executive Committee consisting of the Chairperson, the Coordinator (or Administrator) and a maximum of two additional members.
5.0 THE IRB SECRETARIAT
The Secretariat shall consist of the Coordinator/Administrator, and support staff.
6.0 FUNCTIONS AND RESPONSIBILITIES
6.1 Chairperson
Ø Shall be the head and chief spokesperson of the Board and shall conduct meetings in accordance with the policies and regulations and timetable approved by the Board.
Ø Shall facilitate training for new Board members and continuing education for regular members.
Ø Shall oversee the functions and activities of the Secretariat.
Ø Shall assign responsibilities and duties to any member of the Board.
6.2 Coordinator/Administrator
Ø Shall call meetings in consultation with the Chair.
Ø Shall receive proposals/protocols.
Ø Shall dispatch proposals for scientific review to selected reviewers.
Ø Shall prepare proposal review documents for discussions at regular Board meetings.
Ø Shall undertake all other administrative duties as assigned.
7.0 REGULAR IRB MEETING
7.1 Frequency
The Chairperson will conduct all meetings of the Board. If the Chairperson is not available; an alternate Chairperson will be elected by the members present to chair the meeting(s). The IRB Coordinator/Administrator will be responsible to organize meetings, maintain records and communicate with applicant(s), investigator(s), and concerned individual(s). He/she will prepare minutes of meetings and secure approval from the Chairperson before communicating with applicant(s)/investigator(s).
7.2 The Board shall convene a meeting every two months or when deemed necessary.
7.3 Quorum
Three-quarter (3/4) of the IRB membership shall constitute a quorum for a regular meeting.
7.4 Operation
Except when an expedited review procedure is used, the Board shall review and act upon proposed research applications at convened meetings at which a quorum is present. In order for a research protocol to be approved, it shall receive the approval of a majority of those members present at the meeting.
8.0 CONDUCT OF THE MEETING
8.1 IRB Meeting Schedule and Distribution of Agenda
8.1.1 Except for emergency or special meetings, the Board shall meet on the last Friday of the second month at the University of Liberia at 1:00 PM.
8.1.2 The Coordinator shall notify all Board members of an upcoming meeting at least one week in advance.
8.1.3 The Coordinator shall notify all Board members of any changes to the meeting time, date or agenda within 24 hours prior to the schedule meeting.
8.1.4 The Board Secretariat shall keep and archive all original copies of the Board’s documents.
8.2 Meeting Procedure
8.2.1 Opening Prayers.
8.2.2 Call the meeting to order.
8.2.3 Request for adoption of the agenda.
8.2.4 The agenda items and Any Other Business (AOB) shall be discussed.
8.2.5 Closing Prayers.
8.2.6 Board members with conflict of interests (COI) on any research proposal shall declare same and shall not participate in the deliberations of said proposal.
8.3 Meeting Minutes
8.3.1 The Chair shall perfect the minutes for accuracy and completeness and approve same for circulation.
8.3.2 The minutes of the prior meeting shall be approved at the next or subsequent meeting.
8.4 Independent Consultants
The Board shall call upon subject experts as consultants for review of selected research protocols. These experts may be specialists in ethical or legal aspects, specific diseases or methodologies, or represent specific communities; patient groups or special interest groups, e.g. cancer patients, HIV/AIDS positive persons or ethnic minorities.
9.0 COMMUNICATION OF REVIEWED DECISIONS
The Secretariat shall communicate to the Applicant (Principal Investigator) all reviewed decisions through standardized IRB documents. Three forms currently exist: “Approval”, “Provisional Approval” and “Not Approved”. Reviewer comments shall be attached as part of the communication of the reviewer decisions when a research proposal requires adjustments and/or revisions. These documents shall be reviewed and revised at the discretion of the Board.
10.0 EXPEDITED REVIEW
An expedited review shall be conducted by the IRB Chairman, Coordinator/Administrator and one other reviewer designated by the Chairperson.
The following categories of research proposals shall qualify for an expedited review and/or approval:
Ø Research investigations that present no more than minimal risk to study participants.
Ø Minor amendment in previously approved research protocols during the period for which approval was granted.
Definitions of “minimal risk” and “minor amendment” will be based upon accepted guidelines/categories and/or employed at the discretion of the Board.
11.0 DECISION MAKING
1. A member shall withdraw from the meeting during the decision process on an application wherein a conflict of interest (COI) exists. This shall be indicated to the chairperson prior to the review of the application and recorded in the minutes.
2. The decisions shall be taken in the absence of the investigator(s), representatives of sponsor(s), consultant(s), etc.
3. Decisions may be to approve, reject or revise the proposals. Specific suggestions for modifications and reasons for rejection should be given.
4. Revised proposals may be subjected to an expedited review.
5. All approved proposals will be subject to the following conditions.
i. The Applicant/Principal Investigator (PI) should submit annual report of the ongoing project to the IRB based on formats prescribed by the Board.
ii. The final report of the completed study should be submitted by the Applicant (PI).
iii. The Applicant (PI) should highlight the changes in the protocols, brochures, and/or informed consent forms, etc., that are being amended from the previous documents when submitting an amended documents to the IRB.
iv. Additional conditions may be added by the IRB.
12.0 MONITORING AND EVALUATION OF RESEARCH
12.1 The Board shall monitor and evaluate all approved research studies at a
frequency deemed necessary, but at a frequency no greater than once yearly