Most requirements of the revised Common Rule go into effect January 21, 2019*. While many US researchers are aware of the coming changes, not everyone is sure whether they will need to comply with the revised regulations.
For those uncertain researchers, consider the following:
In this decision tree and throughout this blog, we refer to the Common Rule in effect before January 21, 2019, as the “old Common Rule” and the Common Rule in effect on or after January 21, 2019, as the “revised Common Rule.”
Note: Studies subject to both the Common Rule and FDA regulations must include the Revised Common Rule consent requirements in their ICFs.
Here is a brief outline of the revised Common Rule’s key changes. For the complete updated regulations and additional guidance from OHRP, please refer to OHRP’s revised Common Rule resources. Additional guidance materials are also available to Advarra clients.
- Definition of human subject research expanded
- New and revised exemptions
- New “limited review” required for some exemption categories
- New 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 (except for Department of Justice)
- Waiver of consent is no longer needed for screening and recruitment purposes
- When state law does not define who can be a LAR, institutional policy must be followed
- Option to apply OHRP regulations to non-federally funded research (aka “checking the box” on the FWA) no longer available
We’ve assembled the following frequently asked questions to provide further detail on applying the various regulations. It is up to each IRB to determine how they will apply certain aspects of the revised Common Rule, and in the FAQs we explain how Advarra has chosen to proceed. Be sure to consult with your IRB of record to understand your specific compliance requirements.
1. When does the revised Common Rule apply?
It applies to federally funded research approved on or after January 21, 2019 (exception: DOJ-funded research). The revised Common Rule does not apply to FDA-regulated research. However, sponsors of FDA-regulated research may want to include the new key information and consent elements in their ICFs. Including this information does not transition the study to the revised Common Rule. Advarra’s IRB permits this ICF approach.
2. When does the old Common Rule apply?
It applies to research approved prior to January 21, 2019, and DOJ-funded research. Advarra also applies it to non-federally funded research. At Advarra, changes to those pre-January 21 studies and additional sites will continue to be reviewed under the old Common Rule rather than the revised Common Rule.
3. What rules apply if a study is not federally funded or FDA-regulated?
Advarra’s approach is to apply the old Common Rule for this type of study. Exemption determinations are the exception to this rule, as they are reviewed under the revised Common Rule.
4. When both FDA and the revised Common Rule regulations are governing, which should we follow?
In this situation, Advarra’s approach is to apply the revised Common Rule, which is the more stringent governing regulation.
5. 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.
6. Can a study or site that is not subject to the revised Common Rule add the Key Information section and new elements to their ICF?
Yes, studies that are FDA-regulated or approved under the Old Common Rule can add the Key Information and new consent elements to their ICFs. Making these revisions to the ICF will not transition the study to the revised Common Rule.
7. Can a study approved under the old Common Rule transition to the revised Common Rule?
Research that is not FDA-regulated may be transitioned to the revised Common Rule. However, following the advice of OHRP, Advarra and many other IRBs do not plan to transition research approved under the old Common Rule to the revised Common Rule.
Need more information on complying with the revised Common Rule? View our webinar Making a List, Checking It Twice… The Revised Common Rule Is Coming to Town!
For assistance in implementing these requirements for a new study submission, contact Business Development.
*The revised Common Rule’s requirement for single IRB review of multisite research goes into effect January 19, 2020.