The Common Rule: Updating Human Subject Research Protections for a New Era of Research

Abstract:     
This paper details and analyzes DHHS’s response to these concerns, the Advanced Notice for Proposed Rulemaking (ANPRM): “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” The ANPRM was announced with the goal of “delineat[ing] options for simultaneously enhancing protections for research subjects and improving the effectiveness of the federal oversight system.” In particular, the ANPRM is designed to “better focus oversight resources on higher-risk research studies,” while at the same time modifying regulations to keep pace with “the proliferation of multi-site trials” and research involving the use of biological specimens. This paper will demonstrate that while the reforms are timely and productive, they remain both under and over inclusive in certain respects and ultimately substitute substantive clarity for procedural efficiency. While each of the proposed reforms will be addressed in turn, this paper will focus its critical analysis on the two most impactful reforms: amending the risk-based regulatory framework to ensure research that poses minimal risk to subjects is not overly burdened by IRB review and updating the regulatory framework surrounding biospecimen research, particularly as it concerns the consent requirements for human subjects who volunteer biological material.

Number of Pages in PDF File: 31

Keywords: Common Rule, Human Subject, Human Subject Research, FDA, OHRP, Advanced Notice for Proposed Rulemaking, ANPRM, Institutional Review Board, IRB

working papers series