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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.
OVERVIEW OF IRB POLICIES, FORMS AND STANDARD LETTERS:
• Documentation and Accreditation Subcommittee
o Objective; To provide guidance to the IRB Committee on streamlining and clarifying IRB documentation
LIST OF IRB FORMS:
• Principal Investigator IRB Submission Checklist: Initial Review
• Request for Exempt Status
• Request for Expedited Review
• Risk Determination
• External Investigators’ Statement
• Template for Reviewer’s Report (Optional)
• Adverse Events Report
• Study Status Report
• Continuing Review Checklist For Full and Expedited Projects
• Continuing Review Checklist For Exempt Status Projects
• Progress Report Protocols Approved by Expedited Review
• Final Report for IRB Study Completion or Study Termination
• Survey Cover Page Consent
• Conflict of Interest Declaration Form
• Consent Form for Participation (Assent for Minor)
• Consent Form for Participation (Adult)
• Short Audit Form
• IRB Participant Concern or Complaint Form
• Amendment Submission Request Form
• IRB Material Transfer Agreement
• IRB Investigator Self-Assessment Checklists for Exempt, Expedited and Full Board IRB Approved Research Studies
LIST OF IRB POLICIES AND PROCEDURES:
• Institutional Review Board
• Provision of Information to Patients and Families on Participation in Clinical Research
• Regulations on Sending Human Tissue Abroad for Research Progress
• Guidelines and Procedures for Informed Consent for Clinical Research
• Eligibility as Principal Investigator
• Protected Health Information PHI for Research subjects
• Institutional Review Board Committee Operating Procedures
• IRB Informed Consent for Vulnerable participants in Approved Research Projects
• Institutional Review Board Committee Operating Procedures
• IRB Audit and Monitoring Processes for Approved IRB Research Studies
• IRB Auditing and Monitoring Follow-Up Procedures
• IRB Concern or Complaint Process
• Monitoring the Informed Consent Process
• IRB Determination Regarding Research Versus Quality Improvement Projects
• IRB Patient Safety and Quality Program
• Registration of Clinical Trials with the Saudi Food and Drug Administration
• Principal Investigators Taking Leave of Absence, Sabbatical or Moving to Another Institution
• Conflict of Interest in IRB Approved Research
• Re-Consenting in Research Studies
• Informed Consent and Confidentiality in Genetic Research
• Payment of IRB Reviewers
• Use of Placebos and Washout Periods in Research
• IRB Intellectual Property
ADDITIONAL CPPS USED BY IRB
• Informed Consent
• Handling of investigational drugs
• Confidentiality Policy
• PLAGIARISM IN CLINICAL RESEARCH
• Industry-Sponsored Research
LIST OF STANDARD LETTERS: Exempt Forms
1. Annual Continuation Report Acknowledgement
2. Approval Letter-Internal
3. Approval Letter-External
4. Approval of Research Report for Publication
5. Cancellation Acknowledgement
6. Completion Report Acknowledgement
7. Conditional Approval
8. CRF Amendment Approval
9. IB Amendment Approval
10. ICF Amendment Approval
11. Letter to the Security Department Asking for Temporary ID Badge
12. Protocol Amendment Approval
13. Renewal Approval
14. Study Status Report Acknowledgement
15. Suspension of a Study
16. Cancellation of Suspension of a Study
17. Termination Acknowledgement
LIST OF STANDARD LETTERS: Expedited Forms
1. Annual Continuation Report Acknowledgement
2. Approval Letter
3. Approval of Research Report for Publication
4. Cancellation Acknowledgement
5. Completion Report Acknowledgement
6. Conditional Approval
7. CRF Amendment Approval
8. IB Amendment Approval
9. ICF Amendment Approval
10. Protocol Amendment Approval
11. Renewal Approval
12. Suspension of a Study
13. Cancellation of Suspension of a Study
14. Termination Acknowledgement
LIST OF STANDARD LETTERS: Full Review Forms
1. Approval Letter
2. Approval of Research Report for Publication
3. Approval to Send Material Overseas
4. Cancellation Acknowledgement
5. CIOMS Acknowledgement
6. Completion Acknowledgement
7. Conditional Approval
8. CRF Amendment Approval
9. Document Acknowledgement
10. IB Amendment Approval
11. ICF Amendment Approval
12. Progress Report Acknowledgement
13. Protocol Amendment Approval
14. Protocol Violation Acknowledgement
15. Publication Acknowledgement
16. Renewal
17. Study Certification of Compliance with Regulations and Guidelines
18. Safety Report Acknowledgement
19. Study Coordinator Handover Acknowledgement
20. Study Resumption Acknowledgement
21. Study Suspension Acknowledgement
22. Study Termination Acknowledgement
23. Suspect Adverse Effect Acknowledgement
LIST OF STANDARD LETTERS: Other Forms
1. Letter Commissioning Reviewers
2. Letter to Section Heads for External Projects
3. Rejection Letter
4. Reminder Expiry Date of Approval