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Presentation at King Abdullah Medical City (Makkah) held on 13 February 2018 by Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman of the KFMC IRB
PRIMARY ROLE OF IRB: PATIENT SAFETY AND SCIENTIFIC VALIDITY:
- The primary role of the IRB is protecting the rights, safety, and welfare of the subject/patient. This is achieved by the following measures: independent review and monitoring of the protocol to ensure a favourable risk-benefit ratio, putting the patient interest before public interest, assuring informed consent, conducting the study according to the protocol. Making sure that the study is carried out by qualified personnel.
- Validity of the results: approval of the scientific methodology, follow up of data collection and analysis, approval of the manuscript
SECONDARY ROLE OF IRB:
- The secondary role is assuring that data from a study will be accurate, reliable, and accurate.
- Data accuracy is ensured by review of monitoring, auditing, and inspection reports where applicable.
- Approval of the manuscript before submission to the journal
ACTIVITIES OF IRB:
• Review and approval of the protocol: No research shall start before IRB approval
• Assessing the qualifications of the investigator
• Assuring those methods and materials for informed consent are appropriate
• Reviewing financial aspects to ensure no conflicts of interest and monitoring the conduct of the study.
IRB PERSONNEL:
• The IRB Chair and Membership are appointed by and reports to the KFMC CEO.
• IRB is not just a committee; it is a board (has legal authority) and an administration
• The IRB Chair is responsible for day-to-day operations of the IRB, including IRB regular meetings.
IRB PERSONNEL, Con’t.:
• Authority CPP - Slide 5\1432-91 CPP Institutional Review Board_V.4.0.pdf
• IRB CFO - Slide 5\2017 CFO KFMC Institutional Review Board.pdf
• IRB CPP on Standard Operating Procedures - Slide 5\1436-08 CPP Institutional Review Board Committee Operating Procedures_V.2.0.pdf
• Report to CEO - Slide 6\180103 Report to CEO July-December 2017.pdf
• Report to KACST - Slide 6\Report to KACST_July 1 - December 31, 2017.pdf
• Members: (a) At least five members (b) Representatives of varying racial, cultural, and professional backgrounds. (c) Both genders (d) At least one member whose primary concern is a non-scientific area. (e ) At least one member who is not otherwise affiliated with KFMC himself or through his immediate family.(e) At least one member from the community. (f) Professionally qualified members
IRB GOVERNANCE:
• CEO is the Institutional Officer (IO) ie head of IRB
• IO appoints the chairman and members and confirms member termination of members
• Chair of IRB reports to IO in administrative matters: a 6 month report and adverse events
• Chair of IRB reports to the monitoring office of the National Council on Bioethics; 6 month report and Aes
• IRB acts independently in professional matters
DOCUMENTS SUBMITTED TO IRB by email to irb1@kfmc.med.sa - 1:
• All documents submitted by the PI, IRB correspondence, and IRB minutes are part of IRB official records that must be kept for a minimum of 3 years post-study completion.
• Initial application forms: (a) Exempt form (b) Expedited form (c) Full review form
• Consent form and information forms: survey cover for questionnaires, minimal risk, and full
• Follow up forms: annual progress, continuing review, amendment
• Proposal/protocol
• Questionnaire/CRF
• Investigators: CV and evidence of research ethics training (NIH and NCBE)
DOCUMENTS SUBMITTED TO IRB - 2:
• Subject recruitment procedures (e.g., advertisements)
• Written information to be provided to subjects
• Investigational product brochure (IB)
• Available safety information
• Information about payments and compensation available to subject
DOCUMENTS SUBMITTED TO IRB - 2, Con’t.:
• Exempt Form Slide 8\Request for Exempt Status 5 April 2016.pdf
• Expedited Form Slide 8\Request for Expedited Review Form - Systematic Review Feb 18 2014.pdf
• Full Review Form Slide 8\Continuing Review Checklist For Full and Expedited Projects Feb 20, 2014.pdf
• Survey Cover Page Slide 8\(A) Survey Cover Page Consent.pdf
• Minimal Risk Consent Slide 8\(C) Consent Form for Participation (Minimal Risk) - Original Study.pdf
• Assent Slide 8\Consent Form for Participation (Assent for Minor).pdf
• Full Consent Slide 8\Consent Form for Participation (Adult).pdf
• Progress/Status Form Slide 8\IRB Study Status Report Form Feb 18 2014.pdf
• Protocol ..\Slide 8\Protocol.pdf
• NIH or KACST Ethics Certificate Slide 8\NIH or KACST Certificate.pdf
ROLE OF THE IRB CHAIRMAN - 1:
• Receives research application submission materials, determining their appropriateness for review, and assigning research review to IRB member(s).
• Prepares the IRB committee agenda.
• Ensuring reviewers are qualified to perform the review. The chairman will designate 1-2 members to make a detailed analysis of each submission and report to the meeting.
• Supervises the IRB Administrative Coordinator and assuring that tasks are performed accurately and according to timelines, including but not limited to: (a)
• Maintenance of IRB Administrative and Research Study Files and other IRB documentation
• Chairs IRB meeting every 2 weeks.
ROLE OF THE IRB CHAIRMAN - 2:
• Addresses any conflict of interest at the beginning of the committee meeting.
• Issues letters of approval or rejection of submissions within 45 days for full review studies and within 5 days for exempt and expedited studies.
• Decision shall be sent by email to the principal investigator with a copy to the study coordinator; original can be collected from the IRB office
DECISIONS OF THE IRB:
• Approval
• Conditional approval
• Modifications required prior to its approval;
• Disapproval; and
• Termination/suspension of any prior approval.
IRB APPROVAL LETTERS CONTENTS - 1:
• IRB registration number with the National Bioethics Commission,
• IRB registration number with NIH and FWA,
• IRB log number,
• Date of the letter
• Date of submission, any conditions
• Exempt Approval Letter Slide 15\IRB Exempt Approval letter-internal.pdf
• Expedited Approval Letter Slide 15\IRB Expedited Approval Letter.pdf
• Full Review Approval Letter Slide 15\IRB Full Approval Letter.pdf
• Conditional Approval Letter Slide 15\IRB Expedited Conditional Approval.pdf
• Amendment Approval Letter Slide 15\IRB Exempt IB Amendment Approval.pdf
• Termination or Suspension Letter Slide 15\IRB Full Study Termination Acknowledgement.pdf
IRB APPROVAL LETTERS CONTENTS - 2:
• Listing of documents submitted for approval,
• Date by which a progress report shall be submitted,
• Date by which the approval will be voided if the progress report is not received,
• Statement that the IRB is in compliance with the guidelines such as ICH-GCP,
• Statements about privacy and confidentiality, reporting suspected adverse effects promptly,
• Statement about keeping the IDS form in the patient files
PROCESS OF IRB REVIEW:
• Exempt proposals reviewed by the chairman or 1-2 members and are approved within 2 business days if no queries. The IRB endorses the approval at its next scheduled meeting
• Expedited proposals are reviewed by the chairman and or 1-2 members and are approved within 5 business days if no queries. The IRB endorses the approval at its next scheduled meeting
• Full proposals are distributed to all members and 1-2 members are assigned to make a special study and report to the IRB meeting. The PI is usually invited to attend the meeting. Approval is based on 51% vote - Slide 18\171120 Minutes of 72nd IRB Meeting 25 Oct. 2017 & 15 Nov. 2017.pdf
APPROVAL OF AMENDMENTS:
• No deviations from, or changes of, the protocol should be initiated without prior written IRB approval of an appropriate amendment, except when necessary to eliminate immediate hazards to the subjects
• Any change even administrative or grammatical have to be reported
• Amendment Approval Form - Slide 19\Amendment Submission Request Form Apr 9, 2015.pdf - Slide 19\Amendment Request Form Apr 9, 2015.pdf
• Adverse Event Protocol Deviation Report Form - Slide 19b\Adverse Events, Protocol Deviations and Protocol Violations Report Form2.pdf