How should we regulate risk in biomedical research? An ethical analysis of recent policy proposals and initiatives.

The existing regulatory framework for research is increasingly attacked for its "one-size-fits-all" approach. Many stakeholders contend that existing regulations formulate the same regulatory requirements for research involving very different levels of risk, and thereby unnecessarily stifle medical progress. To address this criticism, regulators are currently developing more risk-adapted approaches to regulating research. A key feature of these approaches is that they aim to calibrate subject protections, including ethical review and safety monitoring, to the risks that studies pose to participants. Risk-adapted systems of research oversight are ethically appealing because they have the potential to promote research within the constraints of adequate subject protection. However, this potential can only be realized if the complexities surrounding research risk can be addressed. The present paper offers the first systematic overview and ethical analysis of how European and U.S. regulators approach the development of more risk-adapted regulations. The analysis finds that so-called stratified approaches are ethically preferable because they specify risk categories with corresponding subject protections, and thereby reduce unwarranted variation in how research participants are protected in different studies. But the recent proposals for stratifying risk and subject protections raise various ethical concerns, for example regarding the accuracy of risk categories. Building on this analysis, the paper develops recommendations for future policy.