Protection of Human Subjects
Revised Common Rule
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). A final rule was published in the Federal Register (FR) on January 19, 2017, and was amended to delay the effective and compliance dates on January 22, 2018, and June 19, 2018. The revised Common Rule is effective July 19, 2018.
The general compliance date of the revised Common Rule remains January 21, 2019. This means that HHS-conducted or supported research initiated on or after January 21, 2019, 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.
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)).
Single IRB Requirement
The Revised Common Rule, at 45 CFR 46.114 (b) (cooperative research), requires that any institution located in the United States that is engaged in cooperative research as defined under 45 CFR 46.114 (a) must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The compliance date for 45 CFR 46.114 (b) (cooperative research) of the Final Rule is January 20, 2020.