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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
Informed Consent
Exculpatory Language in Informed Consent Documents: Examples of Acceptable and Unacceptable Language (OPRR Letter, 1996)
Informed Consent Checklist (1998)
Informed Consent of Subjects Who Do Not Speak English (1995)
Informed Consent Requirements for In Vitro Medical Device Clinical Investigations Conducted Under FDA’s Interim Final Rule at 21 CFR 50.23(e) (OHRP Guidance, 2006)
Informed Consent Requirements in Emergency Research (OPRR Letter, 1996)
Informed Consent Tips (1993)
Informed Consent, Legally Effective and Prospectively Obtained (OPRR Letter, 1993)
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)
Student Subject Pools and Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (January 8, 2010)
Use of Electronic Informed Consent: Questions and Answers
Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (January 8, 2010)
Related Frequently Asked Questions
Informed Consent FAQ
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