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The Censor's HandThe Misregulation of Human-Subject Research$
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Carl E. Schneider

Print publication date: 2015

Print ISBN-13: 9780262028912

Published to MIT Press Scholarship Online: September 2015

DOI: 10.7551/mitpress/9780262028912.001.0001

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Arbitrary and Capricious Decisions

Arbitrary and Capricious Decisions

Chapter:
(p.71) 3 Arbitrary and Capricious Decisions
Source:
The Censor's Hand
Author(s):

Carl E. Schneider

Publisher:
The MIT Press
DOI:10.7551/mitpress/9780262028912.003.0003

Much evidence suggests that IRBs make decisions badly. For example, when multiple IRBs review the same research protocols, they treat them inconsistently. The IRB system makes error inevitable. First, bureaucratized event-licensing overtaxes IRBs with too much work to handle and too much paperwork to manage. Second, IRBs necessarily lack the expertise to understand the hyper-specialized studies they license. Third, IRB incentives distort decisions. Unlike the FDA, which weighs a drug’s benefits against its costs, IRBs just protect research subjects. Also, IRBs that say no to research are safe; if they say yes, they risk trouble like institutional disgrace, lawsuits, and federal sanctions that have included (briefly but unforgettably) closing down research at distinguished universities.

Keywords:   IRBs, IRB decisions, IRB bureaucracy, Research subjects, IRB incentives, IRB inconsistency, Research protocols, IRB expertise, Universities, Research

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