Clearing Complexity from the Common Rule NPRM

Abstract

On September 8, 2015, the U.S. Department of Health and Human Services proposed major changes to the regulations known as the Common Rule, whose purpose is to protect human subjects in federally funded research. The proposed changes have been criticized as unduly burdening the conduct of research. While some of the proposed changes are supported by legitimate practical, legal, or ethical considerations, we believe that others lack compelling justification. This article addresses those unjustified changes that we view as especially problematic, focusing on the proposed disparate treatment of secondary research involving data and secondary research involving biospecimens across a number of provisions. The primary rationale for this disparate treatment is that individuals have a strong autonomy interest in the research use of their biospecimens that does not extend to their private information. We explain why this and other justifications do not hold up to scrutiny and how the proposed changes will introduce new layers of complexity to the conduct of research while incentivizing behaviors that undermine the Common Rule's effectiveness and integrity. We conclude by recommending the removal of these unjustified complexities from the regulations that ultimately are adopted.

Keywords: NPRM, Common Rule, Research Ethics, Biospecimens, Health Data