50 Pages Posted: 2 Dec 2012 Last revised: 2 Jul 2014
Date Written: 2013
Information-based studies that use people’s health data and biospecimens are set to play an important role in 21st-century biomedical discovery, public health, and healthcare system improvement. There is wide agreement that the Common Rule needs to be modernized to provide better protection for people whose data and biospecimens are used in such studies. Unfortunately, the Secretary of Health and Human Services (HHS) is in the position of trying to keep the Common Rule up-to-date using authorities granted by an outdated statute. This article explores statutory constraints that appear to limit the Secretary’s authority to make some of the changes proposed in the July 2011 ANRPM. Some of the proposed revisions to the Common Rule seemingly would require legislative action to alter the Secretary’s rulemaking authority. This does not, however, mean that it will be impossible to modernize the Common Rule in the absence of legislative action. As noted at the end of this article, the Secretary of HHS has significant discretion to make the Common Rule function better without amending the regulatory text itself. The Common Rule is hard to amend, but there are promising pathways for implementing improved policies within the framework of the existing regulation. Skillful use of these other approaches may avoid the need for hasty regulatory amendments that may, in the end, prove unlawful.
Keywords: Common Rule, Human-subject protections, Common Rule ANPRM, administrative law
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