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HHS > OHRP > Regulations, Policy & Guidance > Guidance > For Investigators

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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 has sub items, about Informed Consent Posting
    • Uploading Informed Consent Documents
    • Informed Consent Posting Guidance
  • 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

For Investigators

Emergency Medical Care and Research: OPRR Letter (1991)
Financial Conflict of Interest: HHS Guidance (2004)
Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: OHRP Guidance (2007)
Withdrawal of Subjects from Research Guidance (2010)

Related Frequently Asked Questions

Investigator Responsibilities FAQs

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