Revisions to the Common Rule: A proposal in search of evidence

Abstract

Proposed changes to the Common Rule are proffered to save almost 7,000 reviews annually and consequently vast amounts of investigator and IRB-member time. However, the proposed changes have been subject to criticism. While some have lauded the changes as being imperfect, but nevertheless as improvements, others have contended that ‘neither the scientific community nor the public can be confident that improved practices will emerge from the regulatory changes mandated by the NPRM.’ In the present article, I discuss an important aspect that has been overlooked: the question of whether benefits will emerge is demonstrably empirical, yet data upon which to draw conclusions are conspicuous by their absence. This is thrown into sharp relief when we consider the current environment in which health research is increasingly focused on providing evidence of need or benefit, where there is greater emphasis on evidence-based practice, and when we have the nascent field of implementation science.