Laura Stark
- Published in print:
- 2014
- Published Online:
- January 2015
- ISBN:
- 9780262027465
- eISBN:
- 9780262320825
- Item type:
- chapter
- Publisher:
- The MIT Press
- DOI:
- 10.7551/mitpress/9780262027465.003.0015
- Subject:
- Biology, Bioethics
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 ...
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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.Less
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.
