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.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.