Protection of Human Subjects

Revised Common Rule

As of January 21, 2019, studies initiated on or after that date, ongoing studies that voluntarily transitioned to the Revised Common Rule, and studies that voluntarily implemented the three burden-reducing provisions during the delay period (July 19, 2018 through January 20, 2019), are expected to comply with all Revised Common Rule requirements for the remainder of the study.

View an official version of the 2018 Requirements in 45 CFR 46 of the July 19, 2018 edition of the e-Code of Federal Regulations.

2018 Requirements FAQs

Posting Clinical Trial Informed Consent Form (45 CFR 46.116(h))

The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available Federal website within a specific time frame. The consent form must have been used in enrolling participants in order to satisfy this new provision.

Refer to the Office for Human Research Protections (OHRP)’s guidance on Clinical Trial Informed Consent Form Posting (45 CFR 46.116(h))

NIH Guide Notice

AHRQ Implementation of Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule)

AHRQ Implementation of the Burden-Reducing Provisions of the 2018 Common Rule

Pre-2018 Requirements

Pre-2018 Requirements

Page last reviewed May 2019
Page originally created May 2019
Internet Citation: Protection of Human Subjects. Content last reviewed May 2019. Agency for Healthcare Research and Quality, Rockville, MD.
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