Institutional Issues

Clinical Trial Websites: When is IRB Review Required and What Should IRBs Consider with Reviewing? (OHRP Guidance, 2005)

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)

Institutional Review Board Written Procedures: Guidance for Institutions and IRBs (2025)

Minutes of Institutional Review Board (IRB) Meetings Guidance for Institutions and IRBs

OHRP Guidance on Elimination of IRB Review of Research Applications and Proposals (2020)

OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements (2020)

OHRP’s Compliance Oversight Assessments (2024)

Reporting Incidents to OHRP (2022)

Secretarial Waivers