Carl E. Schneider
- Published in print:
- 2015
- Published Online:
- September 2015
- ISBN:
- 9780262028912
- eISBN:
- 9780262328784
- Item type:
- chapter
- Publisher:
- The MIT Press
- DOI:
- 10.7551/mitpress/9780262028912.003.0003
- Subject:
- Biology, Bioethics
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. ...
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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.Less
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.
Carl E. Schneider
- Published in print:
- 2015
- Published Online:
- September 2015
- ISBN:
- 9780262028912
- eISBN:
- 9780262328784
- Item type:
- chapter
- Publisher:
- The MIT Press
- DOI:
- 10.7551/mitpress/9780262028912.003.0006
- Subject:
- Biology, Bioethics
Censors notoriously err, and IRBs are censors. They tell researchers what they may study, how they may structure and conduct inquiries, what they may say to subjects, and how they may report results. ...
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Censors notoriously err, and IRBs are censors. They tell researchers what they may study, how they may structure and conduct inquiries, what they may say to subjects, and how they may report results. First-amendment jurisprudence has learned that censors’ incentives and psychology make them poor and repressive decision-makers. Predictably, then, IRBs underweight interests in free inquiry, unfettered speech, and academic freedom while favoring orthodoxy in scholarship and ideology. First-amendment jurisprudence stringently limits administrative agencies that attempt to license expression. IRBs have assumed they are subject to none of these limits.Less
Censors notoriously err, and IRBs are censors. They tell researchers what they may study, how they may structure and conduct inquiries, what they may say to subjects, and how they may report results. First-amendment jurisprudence has learned that censors’ incentives and psychology make them poor and repressive decision-makers. Predictably, then, IRBs underweight interests in free inquiry, unfettered speech, and academic freedom while favoring orthodoxy in scholarship and ideology. First-amendment jurisprudence stringently limits administrative agencies that attempt to license expression. IRBs have assumed they are subject to none of these limits.