2. OHRP Compliance Oversight Procedures

3. Compliance Process OHRP discovers or receives an allegation or indication of non-compliance COMPLAINT(S) – PI, IRB MEMBER, SUBJECT, PRIVATE CITIZEN, ETC. SELF REPORTING – INSTITUTION, PI MEDIA OTHER INCIDENT REPORT – FDA INSPECTION – NIH PSV REPORT – COOPERATIVE GROUP AUDIT

4. Compliance Process OHRP determines if it has jurisdiction OHRP notifies institution and requests institutional response (may include additional documentation, institutional investigation and report, etc.) OHRP may take immediate action if protection of human subjects warrants

5. Compliance Process OHRP evaluates institutional response OHRP requests additional information OR OHRP issues a report of findings OR OHRP performs site visit

6. Compliance Process Most compliance oversight evaluations can be resolved through correspondence with the institution and do not require an on-site review or a formal report of findings.

7. Compliance Investigation Outcomes Institution is in compliance Institution is in compliance, but improvements suggested Assurance restricted Assurance suspended Funding removed (temporarily or permanently) from specific projects* Debarment (institution or individual)* *OHRP Recommendation

8. Compliance Concerns

9. Initial & Continuing Review Expedited Review Procedures Reporting of Problems IRB Review of Changes Application of Exemptions Informed Consent IRB Membership, Support & Workload Documentation OHRP Compliance Activities: Common Findings and Guidance http://ohrp.osophs.dhhs.gov/references/findings.pdf

10. OHRP Compliance Oversight Data 10/98-12/01 A-Initial Review B-Continuing Review C-Expedited Review D-Reporting E-Protocol Changes F-Exemptions G-Informed Consent H-IRB I-Documents J-Written Procedures % Institutions with Deficient IRB Procedures (N=125)

11. Does the institution support and respect the IRB and its mission? Is there a “culture of compliance”? Are IRB members and investigators knowledgeable about regulatory requirements? Is there adequate documentation of IRB findings and actions?

12. Current Climate Reactive Hyper- Protectionism Not the appropriate response!