1. SOP Melody Lin, Ph.D. Deputy Director, Office for Human Research Protections Director, International Activities Melody.Lin@hhs.gov Santiago, Chile August 2006

2. SOP (This Conference) Value of the implementation Value of the implementation Role of SOP in preparing for Role of SOP in preparing for - Audits - Inspections - Registrations - Accreditations Relations to participant’s rights and protections Relations to participant’s rights and protections

3. Objectives What is SOP What is SOP SOP for Ethics Review Committee SOP for Ethics Review Committee Contribution to International Standards Contribution to International Standards

4. What is SOP A set of instructions or steps someone follows to complete a job A set of instructions or steps someone follows to complete a job Maximizes operational requirements Maximizes operational requirements Makes process, results, consistent, predictable, reproducible Makes process, results, consistent, predictable, reproducible

5. The Benefits of SOPs Staff Staff - Know how things are done - Know who is competent to carry out what tasks - Clarify the roles of support staff Managers Managers - Have confidence the same standard will be carried out during their absence

6. The Benefits of SOPs (2) Useful as a training tool for new staff Useful as a training tool for new staff Assure the quality and consistency of the operation Assure the quality and consistency of the operation Serve as a compliance guide Serve as a compliance guide First line of defense in litigation First line of defense in litigation

7. Human Subject Protections SOP = Written IRB policies and procedures

8. Guidance on Written IRB Procedures “…provide sufficient step-by- step operational details so that an independent observer can understand how an IRB operates and conducts its major functions” OHRP Guidance July 11, 2002

9. Regulatory Requirements IRB must have and follow written policies and procedures to describe - what it does - how it performs the necessary functions and - where it reports the findings

10. Regulatory Requirements (2) The procedures which the IRBs will follow to - Conduct its initial review of research - Conduct its continuing review of research - Report its findings and actions to investigators and the institution - Determine which projects require review more often than annually

11. The procedures which the IRBs will follow to - Determine which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review Regulatory Requirements (3)

12. The procedures which the IRBs will follow to ensure - Prompt reporting to the IRB of proposed changes in a research activity - Such changes may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject. Regulatory Requirements (4)

13. Regulatory Requirements (5) The procedures which the IRBs will follow to - Ensure prompt reporting to the IRB, appropriate institutional officials, any Department or Agency head, and OHRP

14. Reporting Any unanticipated problems involving risks to subjects or others; Any unanticipated problems involving risks to subjects or others; Any serious or continuing noncompliance with regulation or the requirements or determinations of the IRB; and Any serious or continuing noncompliance with regulation or the requirements or determinations of the IRB; and Any suspension or termination of IRB approval Any suspension or termination of IRB approval

15. FDA requirements: 21 CFR 56.115 IRB records Minutes of IRB meetings … Minutes of IRB meetings … Records of continuing review activities Records of continuing review activities Copies of all correspondence between the IRB and the investigators Copies of all correspondence between the IRB and the investigators

16. FDA requirements: 21 CFR 56.115 IRB records A list of IRB members identified by - Name - Expertise - Affiliation

17. - Written procedures for the IRB - Statements of significant new findings provided to subjects - The records shall be retained for at least 3 years after completion of the research, - The records shall be accessible for inspection and copying by authorized representatives of the FDA FDA requirements: 21 CFR 56.115 IRB records

18. Possible Sanctions “The Food and Drug Administration may refuse to consider a clinical investigation in support of an application for a research or marketing permit if the institution or the IRB that reviewed the investigation refuses to allow an inspection under this section.”

19. Top Ten Reasons for SOP Contribution 1. Make review predictable for investigators, so they know what to submit 2. When they submit complete packages, organized the same way reviews can be done more quickly, and everyone is happy

20. To ensure that: 3. IRB operations are performed consistently to maintain quality control of processes and products 4. processes continue uninterrupted and are completed on a prescribed schedule Top Ten Reasons for SOP Contribution

21. To ensure that: 5. no failures occur in processes that would harm anyone 6. approved procedures are followed in compliance with company and government regulations Top Ten Reasons for SOP Contribution

22. To serve as: 7. a training document for teaching new IRB members and investigators 8. a checklist for co-workers who observe job performance to reinforce proper performance Top Ten Reasons for SOP Contribution

23. To serve as: 9. an explanation of steps in a process so they can be reviewed in noncompliance investigations 10. international standards - If procedures are known, it can be compared across borders, harmonized with each other - Also if process is known, it can be evaluated and improved Top Ten Reasons for SOP Contribution