The Revised and Final Common Rule: An Unfinished Story.

Abstract

The revised Common Rule, published in January 2017, was the result of an arduous and lengthy process and of missed opportunities to rebalance foundational ethical principles and thereby to invigorate engagement in clinical research. The revision's shortcomings include a failure to substantively amend the definition of research even though generalizable knowledge is not the appropriate criterion by which to distinguish research from clinical care. The revised Common Rule does little to advance the oversight and governance of the continuum between research and clinical care, in which a central question is the balance between research in the service of public health and individual autonomy and privacy. In addition, the framers of the revised Common Rule had promised a risk-based approach to oversight, but the revision failed to develop the theme adequately for implementation. This is disappointing as a risk-based framework remains a tenable approach and the specifics need to be articulated. The patchwork of federal regulations of which the revised Common Rule is a piece renders the clinical trial ecosystem inefficient and costly, without diminishing administrative burden or enhancing participant protections. We should engage all stakeholders to reframe standards for clinical research that are applicable nationally and internationally.