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HHS > OHRP > Regulations, Policy & Guidance > Guidance > Institutional Issues

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  • Belmont Report
  • Regulations has sub items, about Regulations
    • 45 CFR 46
      • 2018 Requirements (2018 Common Rule)
      • Exemptions (2018 Requirements)
      • Subpart B
      • Subpart C
      • Subpart D
      • Subpart E
      • List of Expedited Categories (1998)
      • Annotated version of 2018 Requirements
      • Pre-2018 Common Rule
      • Exemptions (Pre-2018 Requirements)
    • Revision of the Common Rule
      • Preamble to the Revised Common Rule (2018 Requirements)
      • Path to Revising the Common Rule (2011–2018)
      • Explanation of Terminology
  • Decision Charts has sub items, about Decision Charts
    • Pre-2018 Requirements Decision Charts
    • 2018 Requirements Decision Charts
  • Guidance has sub items, about Guidance
    • OHRP Guidance on COVID-19
    • OHRP Guidance on Elimination of IRB Review of Research Applications and Proposals
    • OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements
    • Frequently Asked Questions
      • 2018 Requirements FAQs
      • 45 CFR 46 FAQs
      • Assurance Process FAQs
      • Children: Research with Children FAQs
      • Exempt Research Determination FAQs
      • Informed Consent FAQs
      • Investigator Responsibilities FAQs
      • IRB Registration Process FAQs
      • Prisoner Research FAQs
      • Quality Improvement Activities FAQs
    • Informed Consent
    • Institutional Issues
    • For Investigators
    • Vulnerable Populations
    • Protocol Review
    • Biological Materials & Data
    • Correspondence
    • Alphabetical List
  • Requests for Comments
  • Informed Consent Posting
  • Single IRB Exception Determinations has sub items, about Single IRB Exception Determinations
    • Background
    • November 2019 Exception Determination
    • October 2020 Exception Determination
  • Subpart C Certification Request to OHRP
  • Regulations & Policy Archived Materials

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

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This is archived HHS content.