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HHS.gov
  • About HHS
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  • Regulations, Policy & Guidance
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Breadcrumb

  1. HHS
  2. OHRP
  3. Regulations, Policy & Guidance
  4. Regulations & Policy Archived Materials
  • Belmont Report
  • 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
    • Pre-2018 Requirements Decision Charts
    • 2018 Requirements Decision Charts
  • 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
    • Uploading Informed Consent Documents
    • Informed Consent Posting Guidance
  • Single IRB Exception Determinations
    • Background
    • November 2019 Exception Determination
    • October 2020 Exception Determination
  • Subpart C Certification Request to OHRP
  • Regulations & Policy Archived Materials

Regulations & Policy Archived Materials

  • Foundational and Historical Documents, including
    • Nuremberg Code
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978)
      • Reports of the National Commission
      • Belmont Archive
        • Celebration of 25th Anniversary of the Belmont Report  (waiting for new archive link)
        • Belmont Oral History Archive of interviews with National Commission members and staff  (waiting for new archive link)
    • Henry Beecher 1966 NEJM Article "Ethics and Clinical Research"
  • Guidance Documents No Longer in Effect
  • Requests for Public Comment
  • Children in Research
  • Special Protections for Children as Research Subjects
  • Conflicts of Interest
  • Alternative Models of IRB Review
Content created by Office for Human Research Protections (OHRP)
Content last reviewed March 17, 2016
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  • The White House
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  • Vulnerability Disclosure Policy

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