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/9780262028912.003.0007
- Subject:
- Biology, Bioethics
Can the IRB system be reformed? Radical pruning might help. But radically pruned is where the system began. It has steadily taken on new topics and new powers while intensifying its review. This ...
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Can the IRB system be reformed? Radical pruning might help. But radically pruned is where the system began. It has steadily taken on new topics and new powers while intensifying its review. This growth is impelled by forces like bureaucratic imperialism, incentives that punish IRBs when researchers seem to err, and the ethos that distrusts researchers and depreciates subjects’ ability to think for themselves. More basically, no system can successfully review all human-subject research in advance, ask amateurs to make expert judgments, forego sound rules and procedures, censor scholarship, and flout accountability. The problem is not regulation, but bad regulation. If IRBs vanished, research would still be regulated — by funders, tort law, and professional sanctions. The regulatory repertoire is rich in yet more tools, including criminal penalties. Severity is not the problem; the problem is ineffective severity. But nothing can justify a system whose burdens must outweigh its benefits.Less
Can the IRB system be reformed? Radical pruning might help. But radically pruned is where the system began. It has steadily taken on new topics and new powers while intensifying its review. This growth is impelled by forces like bureaucratic imperialism, incentives that punish IRBs when researchers seem to err, and the ethos that distrusts researchers and depreciates subjects’ ability to think for themselves. More basically, no system can successfully review all human-subject research in advance, ask amateurs to make expert judgments, forego sound rules and procedures, censor scholarship, and flout accountability. The problem is not regulation, but bad regulation. If IRBs vanished, research would still be regulated — by funders, tort law, and professional sanctions. The regulatory repertoire is rich in yet more tools, including criminal penalties. Severity is not the problem; the problem is ineffective severity. But nothing can justify a system whose burdens must outweigh its benefits.
