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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
Biological Materials and Data
Clinical Data Registries - OHRP Correspondence (2015)
Coded Private Information or Biospecimens Used in Research
Coded Private Information or Specimens Use in Research, Guidance (2008)
Fetal Tissue Transplantation Research Guidance (2003)
Genetic Information Nondiscrimination Act (GINA): OHRP Guidance (2009)
Human Embryonic Stem Cells, Germ Cells, and Cell-Derived Test Articles: OHRP Guidance (2002)
Issues to Consider in the Research Use of Stored Data or Tissues (1996, 1997)
National Health Registry Activities and 45 CFR part 46 (2011)
Statute on Fetal Tissue Transplantation Research (1993)
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This is archived HHS content.