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Belmont Report
Regulations
has sub items, Regulations
Regulatory Text
Annotated 2018 Requirements
Pre-2018 Requirements
2018 Requirements
Common Rule Departments and Agencies
FDA
HHS Statutory Authority
Revised Common Rule
2018 Req. Preamble
Terminology
Guidance
has sub items, 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
Decision Charts
has sub items, Decision Charts
Pre-2018 Requirements Decision Charts
2018 Requirements Decision Charts
Informed Consent Posting
Single IRB Exception Determinations
has sub items, 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)
Human Subject Regulations Decision Charts
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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