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

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  • Rid, Annette

Abstract

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.

Suggested Citation

  • Rid, Annette, 2014. "How should we regulate risk in biomedical research? An ethical analysis of recent policy proposals and initiatives," Health Policy, Elsevier, vol. 117(3), pages 409-420.
    • Handle: RePEc:eee:hepoli:v:117:y:2014:i:3:p:409-420
    DOI: 10.1016/j.healthpol.2014.04.011
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