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OHRP’S Annotated Comparison of the Revised Common Rule and the Pre-2018 Requirements

OHRP has added an annotated comparison of the pre-2018 Common Rule with the 2018 regulations. On this page you’ll also find additional information about whether a pre-2018 Common Rule provision has moved to another location in the 2018 Common Rule, and where to find it. While not an official version of the revised Common Rule regulatory text, this resource serves as a quick reference.

Annotated Comparison of the Pre-2018 Common Rule with the Revised Common Rule


CITI Program’s Revised Common Rule Training

Courses

  • Revised Common Rule – This course provides a detailed review of the regulatory changes to 45 CFR 46, Subpart A, “Federal Policy for the Protection of Human Subjects” (the Common Rule).
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  • Single IRB (sIRB) Use and Administration – This course covers relying on a sIRB, serving as a sIRB of record, and authorization agreements.
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Webinars

  • Transitioning Research to the Revised Common Rule: The What, How, and Why – This webinar explores considerations and challenges for transitioning pre-existing research to the revised Common Rule, as well as required documentation and tips for IRB review.
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  • Revised Common Rule: Overview of Revisions – This webinar refreshes on the key revisions to the Common Rule, including why updates were needed, the applicability of the 2018 Rule, which sections were changed, and how they impact the conduct and review of regulated research.
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  • Revised Common Rule: Revisions to Definitions – This webinar covers new terms added, updates to existing definitions, and potential implications for research review and conduct.
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  • Revised Common Rule: Revisions to Informed Consent – This webinar focuses on key changes, new elements, and updates to existing requirements.
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  • Preparing for Single IRB (sIRB) under the Common Rule – This webinar provides a detailed review of the sIRB requirement, including a comparison of Common Rule and NIH Policy.
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  • Understanding Consent Requirements and “Key Information” Under the Revised Rule – This webinar discusses the informed consent requirements related to increasing understandability of information to support good decision-making.
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