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Human Subjects Research RegulationPerspectives on the Future$
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I. Glenn Cohen and Holly Fernandez Lynch

Print publication date: 2014

Print ISBN-13: 9780262027465

Published to MIT Press Scholarship Online: January 2015

DOI: 10.7551/mitpress/9780262027465.001.0001

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Getting Past Protectionism: Is It Time to Take off the Training Wheels?

Getting Past Protectionism: Is It Time to Take off the Training Wheels?

(p.341) 22 Getting Past Protectionism: Is It Time to Take off the Training Wheels?
Human Subjects Research Regulation

Greg Koski

The MIT Press

The current protectionist paradigm for ethical review of human subjects research is based on an implicit assumption that scientists, left on their own, are either unable or unwilling to fulfil their personal responsibilities to ensure the safety and well-being of individuals participating in their studies. A sound ethical framework exists, but a well-intended effort to implement its principles through rules, regulation and guidance has failed to achieve its intended goals. The resulting process itself is excessively focused on achieving regulatory compliance at the expense of meaningful ethical consideration. Calls for reform focus on relieving regulatory burdens and expediting review and approval without substantively changing the underlying protectionist assumptions. Consistent with modern regulatory science, a pragmatic alternative paradigm based on existing and proven models of professionalism is proposed to address these challenges with greater effectiveness and efficiency. This new approach would require that investigators and research teams be appropriately qualified, assume responsibility for their actions, and aspire to the values delineated by Henry Beecher more than half a century ago—a reasonable and achievable, although so far elusive, goal.

Keywords:   Ethical review, Protectionism, Regulation, Regulatory science, Responsibility, Compliance

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