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Presented at the IRB Training Trainers Program held at KACST in September 2019 by Omar Hasan Kasule Sr MB ChB (MUK), MPH (MUK), DrPH (MUK) Chairman, Institutional Review Board, King Fahad Medical City, Riyadh
1. PRE-READING
- Articles from the Implementing Regulations of the Law of Research on living creatures:
- Chapter 6: ‘Local Committee for Research Ethics. Article 10.1 to 10.40.
- Articles from the SFDA Requirements and guidelines on clinical trials
- Chapter 3: Institutional Review Board
- Nuremberg Code- read all the document
- Helsinki Declaration – read all the document
- ICH-GCP
- Chapter 2: General Principles
- WHO-GCP,
- CIOMS International Ethical Guidelines for Health-related Research Involving Humans
2. BASIC TERMINOLOGY:
- Institutional Review Board/Research Ethics Committee,
- Research, Clinical Research,
- Informed consent,
- Research subject/participant,
- Risk (low, minimal, moderate, high),
- Types of review (exempt, expedited, full), adverse event, severe
- Adverse event, anticipated/unanticipated, protocol violation
2. GOVERNANCE:
• Independent working under national legislation.
• Has regulatory powers under the law of research on living creatures.
• Reports administratively to the CEO of the hospital and the Monitoring Office of the NCBE
• Decisions are final but can be appealed to the Monitoring Office
3. CORE FUNCTIONS (societal and scientific)
• Primary function is the protection of research participants (link to the policy on human research subject protection)
• Secondary function is the validity of data
• Auxiliary functions: benefit society, protect religion and culture, protect the institution, protect the investigators
• Functions achieved by a review of research proposals, monitoring and auditing research, approval of research manuscripts.
4. CHAIRMAN: QUALIFICATIONS, SELECTION, and RESPONSIBILITIES
• Appointed by the CEO.
• Citizenship: must be Saudi but if non-Saudi the Vice-Chairman must be Saudi
• Breadth of knowledge in medicine to be able to handle all types of research
• Must have time and work either full time or part-time. The job has a lot of administrative responsibilities and not just chairing meetings
• Must make intellectual input into the agenda and minutes
• Legally liable for signed documents
5. MEMBERS: QUALIFICATIONS, SELECTION, and RESPONSIBILITIES
• Membership: Minimal members are 5 but for effectiveness, they should be 10-15. Membership for 3 years renewable 3 times. Membership lost if absent 3 consecutive of 5 non-consecutive times. Diversity: gender, age, ethnicity, discipline/specialty, non-medical, non-institutional. Members represent themselves and not their department.
• Members must register as scientists at KACST and take as well as pass the online ethics examination.
• Members must take extra care to avoid plagiarism because they see many people’s ideas and may unconsciously include them in their research.
6. INVESTIGATOR: QUALIFICATION, and RESPONSIBILITIES
• PI for clinical trials must be a full consultant with clinical privileges in the same hospital, must have training/experience in the specific disease or drug being studied, must have GCP certification, must have protected time for research
• PI either writes the protocol or is trained on it to understand/know all specifics to be able to protect patients
• PI personally communicates with IRB to take full responsibility. He submits the protocol and related documents, amendments, progress/annual reports, continuation requests, adverse events, ensures all records are kept safely,
7. MEETINGS: FREQUENCY, QUORUM, EXCUSES
• Meetings are held in private
• Meeting once a month but special meetings can be held for quicker 5-day approval if the sponsor makes extra payments
• Quorum is 50% and approval is 50% +1 of members present.
• Protocols must be sent to members 2 weeks in advance, but this is not practical?
• PI invited to meeting on clinical trials to test his understanding of the protocol and to answer other queries members may have
• Members with COI (+ve or -ve) excuse themselves
8. MAIN CRITERIA FOR APPROVING PROTOCOLS:
• Full disclosure to participants for purposes of informed consent
• Clear and attainable research objectives
• Methods that will produce valid results
• Favorable risk/benefit ratio based on qawa’id al fiqh
• investigator qualification by training and experience
• Adequate research facilities: human resources, equipment, funds, time
9. SUPPLEMENTARY CRITERIA FOR APPROVING PROTOCOLS:
• Balance care delivery vs research,
• Equity and justice in recruitment
• Source of funding and conflict of interests
• Potential research malpractices such as gift authorship,
10. TYPE OF RESEARCH PROPOSALS HANDLED BY THE COMMITTEE
• Scope of the research: clinical observation, clinical trials, laboratory, epidemiological, genetic, qualitative,
• Proposals can be from the same hospital, other hospitals, and institutions.
11. RESPONSIBILITIES OF THE COMMITTEE SECRETARY
• Receive and acknowledge proposals, check for completeness, check for payment of the IRB review fee, upload to the shared folder, implement chairman’s instructions on sending for review
• Schedule meetings: time, place, invitations of members and non-members
• Prepare agenda and minutes under the direction of the chairman. Send chairman’s follow up after the meeting
• Maintain the database
12. RESPONSIBILITIES OF THE CHAIRMAN
13. RESPONSIBILITIES OF MEMBERS
14. SCENARIO #1
15. SCENARIO #2
16. SCENARIO #3
17. SCENARIO #4
18. SCENARIO #5