OHRP Compliance Oversight Procedures. 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
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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.
Expedited Review Procedures
Reporting of Problems
IRB Review of Changes
Application of Exemptions
IRB Membership, Support & Workload
OHRP Compliance Activities: Common Findings and Guidance
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?
Not the appropriate response!