Institutional Issues
- 45 CFR 46 (the HHS Human Research Regulations) FAQ [PDF - 38KB]
- AIDS Research, Guidance for IRBs (1984)
- Assurance Process FAQs [PDF - 68KB]
- Belmont Report
- Clinical Trial Websites: When is IRB Review Required and What Should IRBs Consider with Reviewing? (OHRP Guidance, 2005) [PDF - 33.5KB]
- Compliance Oversight Procedures Used by OHRP (2009) [PDF - 47KB]
- Correspondence
- Engagement of Institutions in Human Subjects Research: OHRP Guidance (2008) [PDF - 66KB]
- 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 - 43.9KB]
- 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 - 34KB]
- IRB Review of Applications for HHS Support: OPRR Memorandum (2000)
- Quality Improvement Activities FAQ [PDF - 37KB]
- Reporting Incidents to OHRP: Guidance on When and How to File Incident Reports (2011) [PDF - 51.6KB]
- Written Institutional Review Board (IRB) Procedures: OHRP Guidance (2011) [PDF - 58KB]