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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 Form
Regulations & Policy Archived Materials
Correspondence
Clinical Data Registries - OHRP Correspondence (2015)
Correspondence on "Non-engaged" Scenarios
Determining When Institutions are Engaged in Research (January 13, 2009)
Indwelling Catheter QI Procedures: (July 30, 2008)
Indwelling Catheter QI Procedures: Letter, July 30, 2008
IRB Review of Protocol and Informed Consent Changes for NCI/CTEP-Sponsored Clinical Trials
IRB Review of Protocol and Informed Consent Changes in Cooperative Group Protocols (OHRP Memo to the National Cancer Institute, 2008)
National Health Registry Activities and 45 CFR part 46 (2011)
National Health Registry Activities, OHRP August 11, 2011
National Health Registry Activities, OHRP December 29, 2011
OHRP’s Viewpoint on Conflicting Interests of PedCIRB Members
Use of a Central IRB: Announcement (2010)
Use of a Central IRB: McDeavitt to Menikoff, April 13, 2010
Use of a Central IRB: Menikoff to McDeavitt, April 30, 2010
Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (January 8, 2010)
Use of Penalties for Students Who Fail to Show up: Letter to SONA SYSTEMS, (January 8, 2010)
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This is archived HHS content.