The role of HRECs in regulating medical research: from peer review to regulation.

In Australia, Human Research Ethics Committees (HRECs) play a ubiquitous role reviewing human subjects research, as do Institutional Review Boards in the US and elsewhere. While HRECs were established as peer review bodies, we argue they should now be characterised a 'devolved regulator' within the broader context of the regulatory state. We evidence HRECs' regulatory role through three examples of current responsibilities. By categorising HRECs as a regulator, we are able to assess their role through a regulatory lens. Drawing on Reeve and Magnusson's 'regulatory scaffolding' approach, we suggest key ways in which the role provided by HRECs could be improved. These include setting clear roles and responsibilities HREC review; ensuring HREC accountability for the substantive aspects of their decision making; and accountability for trial sponsors who seek review of trials under the Clinical Trials Notification Scheme. Deficits in the above must incur a credible expectation of escalation and review.