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  1. HHS
  2. OHRP
  3. Regulations, Policy & Guidance
  4. Guidance
  5. Informed Consent
  • 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)
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      • Preamble to the Revised Common Rule (2018 Requirements)
      • Path to Revising the Common Rule (2011–2018)
      • Explanation of Terminology
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  • 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
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    • Informed Consent
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    • Alphabetical List
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    • Uploading Informed Consent Documents
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  • Single IRB Exception Determinations
    • Background
    • November 2019 Exception Determination
    • October 2020 Exception Determination
  • Subpart C Certification Request to OHRP
  • Regulations & Policy Archived Materials

Informed Consent

Exculpatory Language in Informed Consent Documents: Examples of Acceptable and Unacceptable Language (OPRR Letter, 1996)
Informed Consent Checklist (1998)
Informed Consent of Subjects Who Do Not Speak English (1995)
Informed Consent Posting Instructions (2022)
Informed Consent Requirements for In Vitro Medical Device Clinical Investigations Conducted Under FDA’s Interim Final Rule at 21 CFR 50.23(e) (OHRP Guidance, 2006)
Informed Consent Requirements in Emergency Research (OPRR Letter, 1996)
Informed Consent Tips (1993)
Informed Consent, Legally Effective and Prospectively Obtained (OPRR Letter, 1993)
IRB Review of Protocol and Informed Consent Changes for NCI/CTEP-Sponsored Clinical Trials
IRB Review of Protocol and Informed Consent Changes in Cooperative Group Protocols (OHRP Memo to the National Cancer Institute, 2008)
Student Subject Pools and Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (January 8, 2010)
Use of Electronic Informed Consent: Questions and Answers
Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (January 8, 2010)

Related Frequently Asked Questions

Informed Consent FAQ
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