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.
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))