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Belmont Report
Regulations
has sub items, 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, Decision Charts
Pre-2018 Requirements Decision Charts
2018 Requirements Decision Charts
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
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
Institutional Issues
AIDS Research, Guidance for IRBs (1984)
Clinical Trial Websites: When is IRB Review Required and What Should IRBs Consider with Reviewing? (OHRP Guidance, 2005)
Compliance Oversight Procedures for Evaluating Institutions (2009)
Determining When Institutions are Engaged in Research (January 13, 2009)
Effects of Disasters on Human Research Protections Programs Guidance
Engagement of Institutions in Human Subjects Research (2008)
Engagement: When are Survey Firms Engaged in Research?; Clarification Regarding the Relationship between Institutional Engagement and the Federal Wide Assurance (FWA) (January 13, 2009 OHRP Letter)
Extending an FWA to Cover Collaborating Investigators (2005)
Guidance on Reporting Incidents to OHRP (2011)
Institutional Review Board Written Procedures: Guidance for Institutions and IRBs (2018)
IRB Meetings Convened via Telephone Conference Call: OPRR Memorandum (2000)
IRB Review of Applications for HHS Support (2000)
Minutes of Institutional Review Board (IRB) Meetings Guidance for Institutions and IRBs
Secretarial Waivers
Related Frequently Asked Questions
45 CFR 46 (the HHS Human Research Regulations) FAQ
Assurance Process FAQs
IRB Registration Process FAQ
Quality Improvement Activities FAQ
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