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OHRP Compliance Oversight Procedures

This document outlines the compliance oversight procedures followed by OHRP when receiving allegations or indications of non-compliance. It covers the process for reporting, investigating, and resolving compliance concerns, and includes common findings and guidance.

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OHRP Compliance Oversight Procedures

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  1. OHRP Compliance Oversight Procedures

  2. 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

  3. 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

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

  5. 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.

  6. 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

  7. Compliance Concerns

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

  9. 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)

  10. Overarching Concerns 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?

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

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