Significant change to the Common Rule proposed in the NPRM: Continuing review
After years of debate and speculation, sixteen federal agencies have collaborated on a notice of proposed rulemaking (NPRM) with the stated purpose of modernizing, strengthening, and making more effective the federal policy for the protection of human subjects. While the NPRM does not tackle as many issues as the Advanced Notice of Proposed Rulemaking (ANPRM) of July 2011, it nevertheless proposes a number of bold moves to streamline the clinical trial process. The U.S. Department of Health and Human Services has identified eight of the proposed changes as “most significant.” The following is the seventh of these significant changes and a brief description prepared by Quorum Review’s regulatory attorneys:
Change proposed in the NPRM
Eliminate the continuing review requirement for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing data or involve only observational follow-up in conjunction with standard clinical care.
Quorum’s description of the proposed change
The proposed rule (NPRM) aims to create additional regulatory flexibility by reducing the need for continuing review (CR) that does not meaningfully enhance protection of subjects. The NPRM reports that CR of protocols comprises 52% of all reviews and estimates that 90% of such reviews would no longer be needed, with an estimated cost savings greater than $100 million.
The NPRM proposes eliminating CR in at least three situations:
- For minimal risk studies that qualify for expedited review, unless a reviewer documents why CR should take place.
- For studies that were reviewed by a convened IRB but have reached a stage of only (1) analyzing data (even if it is identifiable private information); (2) accessing follow-up clinical data from standard care procedures; or (3) doing both.
- For certain secondary research using information and biospecimens, under new limited IRB review provisions.
Administratively, an IRB still must receive annual confirmation that such research is ongoing and that no changes have been made that would require CR. Similarly, the NPRM does not change investigators’ reporting obligations including changes to the protocol and unanticipated problems. The NPRM states that the administrative process could be as simple as an automated electronic communication in which the investigator types “Yes” to indicate that the study is ongoing without change.
To allay liability concerns involving the possibility of increased noncompliance, institutions will have significant flexibility in implementing the requirement. In the event an IRB chooses to conduct CR when it is not required, the IRB will need to document its rationale for doing so.
Ongoing research initiated prior to the effective date of the final rule may—but need not—comply with the CR requirements, and the CR requirements could be voluntarily implemented as soon as 90 days from the publication of the final rule.
Read all the changes
Click here to read all of the significant changes to the Common Rule proposed in the NPRM.