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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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Three Challenges for Risk-Based (Research) Regulation: Heterogeneity among Regulated Activities, Regulator Bias, and Stakeholder Heterogeneity

Three Challenges for Risk-Based (Research) Regulation: Heterogeneity among Regulated Activities, Regulator Bias, and Stakeholder Heterogeneity

Chapter:
(p.313) 20 Three Challenges for Risk-Based (Research) Regulation: Heterogeneity among Regulated Activities, Regulator Bias, and Stakeholder Heterogeneity
Source:
Human Subjects Research Regulation
Author(s):

Michelle N. Meyer

Publisher:
The MIT Press
DOI:10.7551/mitpress/9780262027465.003.0026

The ANPRM seeks to shift scarce regulatory resources from “low risk” studies, where they unnecessarily burden research, to studies that “pose risks of serious physical or psychological harm,” which currently suffer from insufficiently rigorous review, thereby endangering participant welfare. This chapterthree challenges for governing human subjects research by such “risk-based regulation.” First, because a study’s riskiness does not depend on the research method, discipline, or type of risk it involves, it is difficult to designate low- and high-risk studies in advance, at the level of statute or regulation. This means that most risk-based research regulation will occur by IRBs reviewing individual protocols. A second challenge, however, is that IRBs suffer from various biases in assessing risks and potential benefits, including asymmetric incentives to avoid Type I and II errors and double risk aversion. Third, even if IRBs could be rid of their biases, because prospective research participants are heterogeneous in their preferences and other circumstances, the same protocol will offer a different risk-benefit profile for different participants, further frustrating attempts at risk-based regulation. The chapter concludes by suggesting an alternative way to redistribute scarce regulatory resources that embraces, rather than ignores, all three challenges.

Keywords:   Risk-based regulation, Risk-benefit analysis, Preference heterogeneity, Type I and II errors, Risk aversion

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