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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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