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  1. HHS
  2. OHRP
  3. Regulations, Policy & Guidance
  • Belmont Report
  • Regulations
    • 45 CFR 46
      • Subpart B
      • Subpart C
      • Subpart D
      • Subpart E
      • List of Expedited Categories (1998)
    • Revision of the Common Rule
      • Preamble to the Revised Common Rule (2018 Requirements)
      • Path to Revising the Common Rule (2011–2018)
      • Explanation of Terminology
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    • Pre-2018 Requirements Decision Charts
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  • Guidance
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    • 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 & Guidance

OHRP has published a variety of policy and regulatory guidance materials to assist the research community in conducting ethical research that is in compliance with the HHS regulations. These include guidance documents and frequently asked questions (FAQs) addressing various topics, findings in the form of OHRP letters addressing regulatory issues, and other media including decision tree graphics and educational videos.

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  • The documents that are open for public comment
  • Human Subject Regulations Decision Charts

Belmont Report

Read the Belmont Report and learn about its history.

Regulations

Access the regulations issued by federal agencies that pertain to the protection of human subjects in research.

Decision Charts

Access human subjects protection regulations decision charts.

Guidance

Find a variety of OHRP policy and guidance documents to support ethical human subjects research that complies with HHS regulations.

Informed Consent Posting

Learn more about the posting requirement for clinical trial informed consent documents.

Subpart C Certification Request to OHRP

Submit a subpart C certification request to OHRP.

Request for Comments

Submit public comments on any OHRP guidance document.

Regulations & Policy Archived Materials

Find archived OHRP guidance materials that are maintained for reference.

Contact Us

Contact OHRP about our policies on protecting human subjects in research.

Content created by Office for Human Research Protections (OHRP)
Content last reviewed June 30, 2020
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