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Presentation at a Course on IRB held on July 17-18, 2017 at MOH Jeddah by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Institutional Review Board / Research Ethics Committee at King Fahad Medical City, Riyadh.
FUNCTIONS OF REC:
• Initial evaluation and approval of research proposals to make sure they fulfill the requirements of the Saudi regulations on human research and the international consensus Good Clinical Practice Guidelines. Above these regulations REC must ensure the highest ethical standards in any research.
• Follow up evaluation and approval of matters arising in the course of the research: protocol amendments, study termination / completion.
• Monitoring of study execution by checking on vital issues such as proper consenting procedures, confidentiality of the data, and complete and up to date documentation, completeness and quality of AE reporting[1], and any ethical violations / protocol deviations.
MEMBERSHIP OF IRB - 1:
• Membership of the REC must have a diversity of medical professional competencies (clinical and non-clinical) to make sure that for every project reviewed there is a member from the relevant discipline and not necessarily the sub-discipline. Physicians tend to dominate RECs[2].
• Membership should comprise representatives of the major medical and surgical specializations practiced in the hospital or region, hospital physicians, hospital nursing staff, general practitioners, pharmacists, statisticians, ethicists, and lay persons from the community.
• At least one of the members must be a normal community representative with no affiliation to the institution. This member should not have any connection with medical work.
MEMBERSHIP OF IRB - 2:
• In selecting members attempts should be made to make sure that all genders and age groups are well represented.
• Members should be selected on their own personal merit as people with knowledge, skills, and sound judgment. They should discuss the proposals as individuals and not representatives of any department, unit, organization or profession.
• Members are appointed by the hospital, the health authority in the region or the government.
• The period of service on the committee is usually three years. Membership may be renewed. Staggered renewal of membership. A member should serve 2-3 terms.
SCOPE OF RESEARCH REVIEW BY REC:
• The committee assesses research proposals and protocols that have ethical implications: (a) research on patients, volunteers, the recently dead, fetal or embryological tissues (b) research with potential to breach confidentiality.
• All research however must be submitted to the REC Chairman because the researcher cannot be trusted to determine the classification.
• The Chairman will determine which proposals are exempt (no risk no ethical issues) and which are expedited (minimal risk) and approve them immediately.
• The chairman will determine and approve expedited proposals (minimal patient risk) and if need be can consult one or more members of the committee.
• Full review is done for research with human intervention.
DOCUMENTS SUBMITTED FOR REC REVIEW:
• Exempt proposals submitted on a special form with the proposal attached. The form must be signed by the PI and HOD.
• Full and expedited: Protocols, investigator brochures, and consent documents of proposals with potentially significant patient risk are sent to all REC members at least 2 weeks in advance for review with those from the relevant disciplines being asked to make a more detailed analysis and make a presentation to the REC.
• The CVs of investigators and certification of GCP must be attached.
REC MEETING:
• The committee must be provided with adequate secretarial and logistic assistance to carry out its functions well.
• A quorum of at least half of the members will be necessary for holding a meeting. Members who cannot attend can send written comments and may/may not vote.
• The committee meets in private to preserve confidentiality. Others argue that they should meet in public for more transparency.
• If the issues are complicated the investigator may be invited to the meeting to explain.
• Any member of the committee involved in a project will recluse himself when that project comes up for discussion.
CRITERIA OF REC APPROVAL - 1:
• The two main considerations in REC decisions are: informed consent and patient safety.
• Informed and voluntary consent following full disclosure of objectives, risks and benefits of the research, the right to abstain or withdraw from the study. Special scrutiny of proxy consent for the vulnerable will be made to ensure there is no abuse[4,5,6]. The investigator must submit reasons in writing in cases in which full disclosure is deemed inappropriate.
• Patient safety based on careful weighing of benefits and risks.
• Confidentiality (use of certificates of confidentiality[7]) and security of the data.
CRITERIA OF REC APPROVAL - 2:
• Scientific merit: objectives clearly states and attainable, research design and statistical methods are adequate to produce clinically and scientifically useful results. Outside experts may be consulted. The committee will compare the scientific merit and benefit of the research against risks and costs to patients. Decision making procedures may improve the risk-benefit discourse[8].
• Qualification of the researchers based on study of their detailed resumes.
• Adequacy of research facilities.
• No conflicts of interest.
DECISIONS OF IRB:
• REC decisions are best taken by consensus but if this is not possible the decision will be based on a simple majority of the members attending if the quorum is assured. Minority views should be recorded.
• The decision of the committee may be full approval, conditional approval, deferment, or rejection. Reasons should be provided for projects approved conditionally or those that are rejected. If the investigator fulfills the missing information the chairman may approve a conditional approval without returning to the full committee.
FOLLOW-UP OF RESEARCH:
• The committee must monitor progress of the research project and must receive reports of all adverse reactions whether related to the drug tested or not. AE reports from all sites of multi-center trials must be submitted.
• Members of the committee can make on-site inspections to make sure that the approved protocol is adhered to and to inspect research documents and records.
• Regular monitoring meetings are held to review the following: progress of recruitment of research subjects, changes to the protocol, adverse reactions, the process of informed consent, refusals and withdrawals, and case record forms.
• Warning letters[9]
• Audits
OVERSIGHT OF IRB
• The committee keeps full records of all its actions. Records are not privileged if a suit arises.
• It submits an annual report listing all proposals considered in the past year, the number approved, and any matters that deserve attention from higher authorities.
• The Chairman of IRB reports to the highest official in the institution.
• Tool for REC self-assessment[10].
• Researchers have a right of appeal.
REFERENCES:
[1] Clin Cancer Res. 2009 Jun 1;15(11):3850-5.
[2] BMC Med Ethics. 2010 Jun 28;11:12.
[3] J Med Ethics. 2008 Aug;34(8):631-5.
[4] Arch Dis Child. 2010 Nov;95(11):915-7.
[5] J Med Ethics. 2009 Jun;35(6):377-81.
[6] Crit Care Med. 2010 Nov;38(11):2146-54.
[7] PLoS One. 2012;7(9):e44050.
[8] BMC Med Ethics. 2012 Apr 20;13:6.
[9] Indian J Med Ethics. 2011 Oct-Dec;8(4):211-4.
[10] J Empir Res Hum Res Ethics. 2010 Sep;5(3):85-96; quiz 97-8. 13