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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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Cost Is No Object

Cost Is No Object

(p.33) 2 Cost Is No Object
The Censor's Hand

Carl E. Schneider

The MIT Press

High costs are built into IRB regulation of research. Prior licensing of each study requires searching mountains of innocuous studies to find molehills of baneful ones. The bioethical ethos drives IRB scrutiny ever stricter. Bureaucratized IRBs need thousands of members and burgeoning staffs just to manage paperwork, and researchers are similarly taxed (in some multi-site studies, 15% of the research budget pays for dealing with IRBs). Because this research “is how we produce the innovations that improve health, reduce morbidity or mortality, and alleviate human suffering, preventing or delaying research results in vastly more suffering and death than occurs from researchers’ ethical lapses.” Chapter 2 amasses and assesses evidence that IRBs delay, distort, derail, and deter research; hobble research training; and repel researchers from fields IRBs regulate.

Keywords:   Research regulation, Regulatory costs, Bureaucratization, Licensing, Prior licensing, IRBs, Multi-site studies, IRB delay, Bioethical ethos

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