Revised Common Rule

Reference Guide

Key Changes

Definition of human subject research expanded
New and revised exemptions
New “limited institutional review board (IRB) review” required for some exemption categories
New informed consent form (ICF) elements
Continuing review is not required for minimal risk studies, and they will not have an expiration date
Grant reviews are no longer required

Waiver of consent is no longer needed for screening and recruitment purposes
When state law does not define who can be a legally authorized representative (LAR), institutional policy may be followed
Single IRB requirement for multisite research is effective in 2020 (already required by National Institutes of Health [NIH])
Option to apply Office of Human Research Protections (OHRP) regulations to non-federally funded research removed (i.e., option to “check the box” on the Federalwide Assurance (FWA) no longer exists)

The revised Common Rule does not apply to research that is:

FDA-regulated

Department of
Justice (DOJ)-funded

Non-federally
funded

Not funded

Health Canada-only regulated

Frequently Asked Questions

Can a study approved under the FDA regulations elect to follow the revised Common Rule?

FDA-regulated research that is not federally funded may incorporate the consent provisions in the revised Common Rule. Other provisions such as the new exemptions, changes in continuing review, and the new waiver criteria cannot be voluntarily applied to FDA-regulated research.

Can a study or site that is not subject to the revised Common Rule add the key information and new elements to their ICF?

Yes, FDA-regulated studies or ones approved under the old Common Rule can add the key information and consent elements to their ICFs. However, making these revisions to the ICF will not transition the study to the revised Common Rule.

Can a study approved under the old Common Rule transition to the revised Common Rule?

Non-FDA-regulated research may be transitioned to the revised Common Rule.