By Elisa A. Hurley, PhD, executive director

It has been nearly four years since the Department of Health and Human Services (DHHS) released for public comment an Advance Notice of Proposed Rulemaking (ANPRM), titled Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. The ANPRM, which proposed the first changes to the “Common Rule” since it was published in 1991, catalyzed considerable debate and discussion about the appropriate regulation of human subjects research.

In the Federal rulemaking process, the issuance of an ANPRM is an optional step that can be used by agencies to collect information to help inform the development of a proposed rule, which is issued as a Notice of Proposed Rulemaking (NPRM). Many in the research community, including PRIM&R, weighed in and submitted comments on the ANPRM, and over the last four years, the community has remained in a state of watchful waiting, with speculation about the status and shape of the proposed new rule—including if it will ever see the light of day—running rampant.

Recently, however, there was a sign that the process is indeed still moving forward. On February 24, 2015, a draft of a proposed rule, titled Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, was submitted to the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA). Under Executive Order 12866, OIRA is responsible for reviewing “significant regulatory actions” to ensure that they don’t introduce “inconsistencies, incompatibilities, or duplicative processes” with regulations promulgated by other agencies, and that any potential consequences associated with implementing a rule (including cost/benefit) have been thoroughly considered by the submitting agency. OIRA has 90 days to review a draft regulation, and the review period can be extended up to 30 days beyond that by the director of OMB. Alternatively, the submitting agency—in the case of the NPRM, DHHS—can elect to extend the review period indefinitely or withdraw a draft rule from review. With respect to the NPRM, once review by OIRA is complete, there are two potential outcomes: (1) the proposed rule will be published in the Federal Register as an NPRM, or (2) the proposed rule will be returned to DHHS for further consideration. In any case, the Federal rulemaking process requires that a NPRM be published for public comment before the issuance of any final rule.

Once a proposed rule is published in the Federal Register, the public is encouraged to comment on the draft, as the proposed rule and the public comments received on it will form the basis of the final rule. However, before that, while a regulation is under review by OIRA, outside parties can request a meeting with the agency to share their views on issues related to a regulation. Given the significance of the NPRM for the human subject protections community, PRIM&R took advantage of this opportunity, and requested a meeting with OIRA.

On May 19, members of PRIM&R’s Public Policy Committee met with representatives from OIRA, and highlighted four central points from PRIM&R’s comments on the ANPRM and other recent public policy work:

1. the need for harmonization among regulatory requirements around research protections;
2. objections to requiring institutions to register with OHRP protections that go beyond those required by the regulations;
3. concerns about mandating a single IRB of record for all multi-site studies; and
4. the need to provide a framework for delineating the types of activities subject to IRB review, given the current proliferation of health-related activities that share blurry “boundaries” with research (e.g., quality improvement activities, clinical innovations, pragmatic clinical trials). 

To support and give further context to our positions, we provided OIRA with a summary handout, and copies of the following PRIM&R public policy documents: comments to DHHS on the ANPRM; comments to DHHS on research on standard of care interventions; comments to DHHS in response to the agency’s “Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care; comments to NIH on the use of single IRBs for multi-site research; and a white paper on the boundary between research and practice.

The OIRA representatives with whom we met were very receptive to PRIM&R’s input and perspective, and made it clear that constructive comments from PRIM&R on the proposed rule, when published, will be invaluable. While our allotted time with OIRA was only 30 minutes, OIRA allowed the meeting to go on for over 60, and we left with the impression that our feedback would be taken seriously and that OIRA is thinking very carefully about some of the key issues raised by the proposed rule.

Since our May 19 meeting with OIRA, OMB announced that the review period for the proposed rule has been extended, meaning it is still not clear if and when we will see a NPRM. However, for those interested, this also means there may still be time for you to schedule a meeting with OIRA to share your concerns about the proposed changes to the “Common Rule.” Information about scheduling a meeting with OIRA can be found on their webpage. We encourage you to investigate this possibility, and we look forward to keeping you apprised of any further developments.