Institutional Issues
- 45 CFR 46 (the HHS Human Research Regulations) FAQ (PDF - 38 KB)
- AIDS Research, Guidance for IRBs (1984)
- Assurance Process FAQs (PDF - 68 KB)
- Belmont Report
- Clinical Trial Websites: When is IRB Review Required and What Should IRBs Consider with Reviewing? (OHRP Guidance, 2005) (PDF - 33.5 KB)
- Compliance Oversight Procedures Used by OHRP (2009) (PDF - 47 KB)
- Correspondence
- Engagement of Institutions in Human Subjects Research: OHRP Guidance (2008) (PDF - 66 KB)
- Engagement: When are Survey Firms Engaged in Research?; Clarification Regarding the Relationship between Institutional Engagement and the Federal Wide Assurance (FWA) (January 13, 2009 OHRP Letter)
- Extension of an Institutional FWA via an Individual Investigator Agreement: OHRP Guidance (2005) (PDF - 43.9 KB)
- IRB Meetings Convened via Telephone Conference Call: OPRR Memorandum (2000) (PDF)
- IRB Membership (Video)
- IRB Records, Part One (Video)
- IRB Records, Part Two (Video)
- IRB Registration Process FAQ (PDF - 34 KB)
- IRB Review of Applications for HHS Support: OPRR Memorandum (2000)
- Quality Improvement Activities FAQ (PDF - 37 KB)
- Reporting Incidents to OHRP: Guidance on When and How to File Incident Reports (2011) (PDF - 51.6 KB)
- Written Institutional Review Board (IRB) Procedures: OHRP Guidance (2011) (PDF - 58 KB)