OHRP Compliance Oversight Procedures Compliance Process l OHRP
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OHRP Compliance Oversight Procedures
Compliance Process l OHRP discovers or receives an allegation or indication of non-compliance l COMPLAINT(S) – l SELF REPORTING – l l PI, IRB MEMBER, SUBJECT, PRIVATE CITIZEN, ETC. INSTITUTION, PI MEDIA OTHER INCIDENT REPORT FDA INSPECTION – NIH PSV REPORT – COOPERATIVE GROUP AUDIT –
Compliance Process l l l 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
Compliance Process l OHRP evaluates institutional response l OHRP requests additional information OR OHRP issues a report of findings OR OHRP performs site visit l l
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.
Compliance Investigation Outcomes l l l 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
Compliance Concerns
Compliance Concerns OHRP Compliance Activities: Common Findings and Guidance http: //ohrp. osophs. dhhs. gov/references/findings. pdf l l Initial & Continuing Review Expedited Review Procedures Reporting of Problems IRB Review of Changes l l Application of Exemptions Informed Consent IRB Membership, Support & Workload Documentation
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)
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?
Current Climate Reactive Hyper. Protectionism Not the appropriate response!
