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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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IRBs and the Problem of “Local Precedents”

IRBs and the Problem of “Local Precedents”

(p.173) 11 IRBs and the Problem of “Local Precedents”
Human Subjects Research Regulation

Laura Stark

The MIT Press

Regulators have officially recognized what researchers have long known: human subjects review boards request different (sometimes contradictory) modifications to a given study before approval. In doing so, boards inadvertently delay research and create coordination problems, especially for multisite studies. This chapter summarizes an original ethnographic study of the meetings of US institutional review boards and introduces the concept of “local precedents” to explain why multisite research presents such a problem for boards. These ethnographic findings point to the specific shortcomings of the local-review model. To redress these shortcomings, the chapter identifies three types of review mechanisms that are configured differently from the local-review system: study networks, collegial review, and decision repositories. Several institutions are developing these alternative review mechanisms, and their experiences indicate the relative merits of each mechanism.

Keywords:   IRBs, Precedents, Case-based reasoning, Study networks, Multisite-study

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