Institutional Issues

AIDS Research, Guidance for IRBs (1984)
Clinical Trial Websites: When is IRB Review Required and What Should IRBs Consider with Reviewing? (OHRP Guidance, 2005)
Compliance Oversight Procedures for Evaluating Institutions (2009)
Determining When Institutions are Engaged in Research (January 13, 2009)
Effects of Disasters on Human Research Protections Programs Guidance
Engagement of Institutions in Human Subjects Research (2008)
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)
Extending an FWA to Cover Collaborating Investigators (2005)
Guidance on Reporting Incidents to OHRP (2011)
Institutional Review Board Written Procedures: Guidance for Institutions and IRBs (2018)
IRB Meetings Convened via Telephone Conference Call: OPRR Memorandum (2000)
IRB Review of Applications for HHS Support (2000)
Minutes of Institutional Review Board (IRB) Meetings Guidance for Institutions and IRBs
Secretarial Waivers

Related Frequently Asked Questions

45 CFR 46 (the HHS Human Research Regulations) FAQ
Assurance Process FAQs
IRB Registration Process FAQ
Quality Improvement Activities FAQ