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HHS.gov
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Breadcrumb

  1. HHS
  2. OHRP
  3. Regulations, Policy & Guidance
  4. Guidance
  5. Protocol Review
  • 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
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    • 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

Protocol Review

Approval of Research with Conditions: OHRP Guidance (2010)
Continuing Review Guidance (2010)
Exempt Research and Research That May Undergo Expedited Review
Exemptions for Public Benefit and Service Programs
Expedited Review Procedures Guidance (2003)
Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998)
Posting Requirement for the Exemption at 45 CFR 46.104(d)(5) of the 2018 Requirements (2022)
Quality Improvement Activities: OHRP Correspondence Regarding Indwelling Catheter Procedures (2008)
Use of a Central Institutional Review Board (OHRP Letter, 2010)

Related Frequently Asked Questions

Exempt Research Determination FAQs
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