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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
0. INTRODUCTION: images of major documents on ethics of clinical research
• Nuremberg Declaration
• Helsinki Declaration
• Belmont Report
• ICH-GCP
• WHO-GCP
• Executive Regulations of the Law of Research on Living Creatures
• SFDA Requirements and Guidelines on clinical research
1a. PRE-READING: Chapter 8 from the Executive Regulations of the Law of Research on living creatures
• Article 15: research conducted on humans shall be for clear scientific objectives, and shall be preceded by sufficient laboratory experiments on animals if the research so requires
• Article 16: The expected benefit from the experiment or research to the human subject shall be greater than the possible harm
• Article 17: The researcher may not in any way exploit the conditions of the human subject and shall not expose him to any type of coercion or exploitation
• Article 18: Approval to conduct research on humans shall take into consideration their right to normal life and their safety from all types of harm in accordance with the provisions of the sharia.
1b. PRE-READING: Chapter 8 from the Executive Regulations of the Law of Research on living creatures
• Article 19: The investigator may not exploit the human subject for the purpose of trading in gametes, zygotes, organs, tissues, cells, or any part thereof or genetic data related to human derivatives or products
• Article 20: An organ removed for a purely medical purpose may be used in scientific research upon obtaining the informed consent
• Article 21: No research shall be conducted on human zygotes, gametes, or fetuses except under controls specified by the Regulations
• Article 22: No research may be conducted for the purpose of human cloning
• Article 23: Research may be conducted on tissues, living cells, and separated parts, including stem cells extracted from the umbilical cord or adult stem cells upon obtaining informed consent.
1c. PRE-READING: Chapter 4 (The Investigator) from the SFDA Requirements and guidelines on clinical trials)
• 4.1 Qualifications by education, training, and experience
• 4.2 Adequate resources
• 4.3 Medical care of trial subjects
• 4.5 Communication with IRB
• 4.6 Investigation product
1d. PRE-READING: Chapter 4 (The Investigator) from the SFDA Requirements and guidelines on clinical trials)
• 4.7 Randomization procedures and unblinding
• 4.8 Informed consent of trial subjects
• 4.9 Records and reports
• 4.10 Progress reports
• 4.11 Safety reporting
• 4.12 Premature termination or suspension
• 4.13 Final reports
1e. PRE-READING: Chapter 5 (The Sponsor) from the SFDA Requirements and guidelines on clinical trials)
• 5.1 Responsible for quality assurance and quality control
• 5.2 May delegate functions to Contract Research Organization
• 5.3 Provide medical consultants to the trial
• 5.4 Design the trial
• 5.5 Manage trial management, data handling, record keeping, and independent data monitoring
• 5.6 Appoint the investigator proposed by the Research Center
• 5.7 Duty allocation
• 5.8 Pay research participants and investigators
• 5.9 Finance the trial
1f. PRE-READING: Chapter 5 (The Sponsor) from the SFDA Requirements and guidelines on clinical trials)
• 5.10 Submission to SFDA
• 5.11 Make sure that IRB has reviewed and approved
• 5.12 Provide information about the investigation product
• 5.13 Manufacture, package, label, and code the investigation product
• 5.14 Supply the investigation product
• 5.15 Record access
• 5.16 Safety information and evaluation
• 5.17 Adverse drug reaction reporting
• 5.18 Monitoring
• 5.19 Audit
• 5.20 Non-compliance with the protocol / deviation and violation
• 5.21 Termination or suspension
• 5.22 Study reports
• 5.23 Multi-Center trials
1g. PRE-READING: Chapter 6 (Protocol) from the SFDA Requirements and guidelines on clinical trials)
• 6.1 Frontpage: title, ID, responsible persons
• 6.2 Background information including literature review
• 6.3 Trial objectives and purpose
• 6.4 Trial design
• 6.5 Selection and withdrawal of subjects: sampling, inclusion, and exclusion
• 6.6 Treatment of subjects
• Assessment of efficacy
• Assessment of safety
1h. PRE-READING: Chapter 6 (Protocol) from the SFDA Requirements and guidelines on clinical trials)
• 6.9 Statistics
• 6.10 Direct access to source documents
• 6.11 Quality control and quality assurance
• 6.12 Ethics
• 6.13 Data handling and record-keeping
• 6.14 Financing and insurance
• 6.15 Publication policy
• 6.16 Supplements
o Chapter 8: Essential Documents
• ICH-GCP
o Chapter 5: Design elements for clinical studies
o Chapter 6: Conduct and reporting
2. SOURCE AND TYPES OF PROPOSALS:
• Sources
a. investigator-initiated: major problems
b. Sponsor-initiated
c. Others: required by SFDA or MOH for specific purposes
• Types
a. Exempt review: questionnaires, interviews, chart review, laboratory, case report/series
b. Expedited: minimal risk interventions
c. Randomized controlled clinical trials
d. Semi experimental prospective studies: major problems
e. Single-center vs multicenter
f. Additional site
3. SUBMISSION PROCESS:
• Method of submission
a. Online through a site: requirements, challenges, and problems
b. Email submission
c. Hardcopies:
d. CD or USB
• Purpose of submission:
a. initial approval,
b. renewal, amendment, termination, suspension
c. additional documents,
d. Report of adverse events
e. Request for certificates
3. LIST OF REQUIRED DOCUMENTS AND THE FUNCTION OF EACH
4. LIST OF DOCUMENTS TYPICALLY SUBMITTED BY SPONSORS
5. INVOICE FOR IRB FEE
6. CONFIRMATION OF BANK DEPOSIT
7. INITIAL REVIEW OF THE SUBMISSION
• Secretary’s initial review:
a. check completeness of document list,
b. acknowledge submission,
c. issue invoice for IRB fee,
d. upload to a shared folder,
• Chairman’s initial review:
a. confirm nature of the submission,
b. read the protocol,
c. check the completeness of checklists (PI checklist, informed consent check, full review study checklist),
d. select 2 internal reviewers and 1 external reviewer if necessary,
e. make additional checks: SFDA registration of the drug or device, PI CV, clinical trial clearing houses
8. REVIEW BY MEMBERS
• A structured review form is sent to all members (link to review template).
• Exchange of views by email with cc to all.
• Deeper review by 2 members with a special interest in the subject.
• Chairman passes member comments to the PI and seeks explanations
• PI will be invited to the meeting to respond to member queries and on his departure members discuss and complete the voting paper.
9. CONTINUING REVIEW
• Progress report (6 monthly or annual)
• Policy on auditing and monitoring
• Self-audit form for exempt study
• Self-audit form for expedited and full review studies
• Review of manuscripts before submission to journals
10. POLICY ON SPONSORED RESEARCH
11. CHECK-LIST OF THE RESEARCH CONTRACT
12. FLOW CHART OF THE CLINICAL RESEARCH DEPARTMENT
13. ROLES OF THE SPONSOR / CLINICAL RESEARCH ORGANIZATION
14. ROLES OF THE PRINCIPAL INVESTIGATOR
15. ROLE OF IRB
16. EXERCISE IN REVIEW OF A PROTOCOL using the PROTOCOL REVIEW CJECK LIST
17. CASE SCENARIO #1
18. CASE SCENARIO #2
19. CASE SCENARIO #3
20. CASE SCENARIO #4
21. CASE SCENARIO #5
22. THE RELATION WITH SPONSORS and CLINICAL RESEARCH ORGANIZATIONS
• Communication and feedback between the sponsor/CRO and IRB: report of adverse events (SUSAR, CIOMS), annual progress reports, reports of discoveries at monitoring visits
• Problems of direct contact between IRB members and staff with sponsor/CRO staff
• Sponsor contact with IRB bypassing the PI.
23. CASE SCENARIO #7
24. CASE SCENARIO #8
25. CASE SCENARIO #9
26. CASE SCENARIO #10
27. MEDICAL DATABASES
• Databases for literature review
• SFDA database for registered drugs and devices
• Clearance houses for clinical trials: the US and Saudi databases
• In-hospital database of research projects to ensure data protection
• Research metadata from the hospital database
• Disease registries
• Hospital databases: pharmacy, imaging, laboratory
28. TIPS
• Look for the meat and not the dish in which it is served. Poorly written research proposals can be salvaged
• Do not be a researcher; judge the researcher by what he said he wanted to do not what you want to be done
29. MCQ #1
30. MCQ #2
31. MCQ #3
32. MCQ #4
33. MCQ #5