Requiring a Single IRB for Cooperative Research in the Revised Common Rule: What Lessons Can Be Learned from the UK and Elsewhere?

Abstract

One of the most significant revisions to the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”), from an organizational ethics and governance perspective, is the mandated transition towards a single institutional review board (sIRB) system that eschews IRB review at multiple research sites. The sIRB rule is controversial for several reasons. Nevertheless, in this article, I argue in support of the mandated transition towards an sIRB system. I argue that this reform that this is part of a wider principles-based regulatory objective of the revised Common Rule, which itself is part of an emerging international movement in health research regulation. This movement advocates both research participant protection and ethical research promotion. Notwithstanding my general support for the sIRB rule, I draw on my own recent empirical research to highlight several residual weaknesses in the US regulatory structure for research ethics review, and suggest ways in which these weaknesses might be addressed in future regulatory reforms to improve upon the sIRB rule.