Carl E. Schneider
- Published in print:
- 2015
- Published Online:
- September 2015
- ISBN:
- 9780262028912
- eISBN:
- 9780262328784
- Item type:
- book
- Publisher:
- The MIT Press
- DOI:
- 10.7551/mitpress/9780262028912.001.0001
- Subject:
- Biology, Bioethics
Medical and social progress depend on research with human subjects. When that research is done in institutions getting federal money, it is regulated by federally required and supervised ...
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Medical and social progress depend on research with human subjects. When that research is done in institutions getting federal money, it is regulated by federally required and supervised bureaucracies called “institutional review boards” (IRBs) expected to apply bioethical principles in making decisions. Do — can — these administrative agencies do more harm than good? The Censor’s Hand addresses this fundamental but long-unasked question. The book answers the question by consulting a critical experience — the law’s learning about regulation — and by amassing the empirical evidence scattered around many literatures. The book concludes that IRBs are fundamentally misconceived. Their usefulness to human subjects is doubtful, but they delay, distort, and deter research that can save lives, soothe suffering, and enhance welfare. IRBs make decisions poorly. They cannot be expected to make decisions well, for they lack the expertise, ethical principles, legal rules, effective procedures, and accountability essential to good regulation. And IRBs are censors in the place censorship is most damaging — universities in which academic freedom is essential. In sum, IRBs are bad regulation that cannot survive cost-benefit analysis. They were an irreparable mistake that should be abandoned so that research can be conducted properly and regulated sensibly.Less
Medical and social progress depend on research with human subjects. When that research is done in institutions getting federal money, it is regulated by federally required and supervised bureaucracies called “institutional review boards” (IRBs) expected to apply bioethical principles in making decisions. Do — can — these administrative agencies do more harm than good? The Censor’s Hand addresses this fundamental but long-unasked question. The book answers the question by consulting a critical experience — the law’s learning about regulation — and by amassing the empirical evidence scattered around many literatures. The book concludes that IRBs are fundamentally misconceived. Their usefulness to human subjects is doubtful, but they delay, distort, and deter research that can save lives, soothe suffering, and enhance welfare. IRBs make decisions poorly. They cannot be expected to make decisions well, for they lack the expertise, ethical principles, legal rules, effective procedures, and accountability essential to good regulation. And IRBs are censors in the place censorship is most damaging — universities in which academic freedom is essential. In sum, IRBs are bad regulation that cannot survive cost-benefit analysis. They were an irreparable mistake that should be abandoned so that research can be conducted properly and regulated sensibly.
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/9780262028912.003.0001
- Subject:
- Biology, Bioethics
How much good IRB regulation can do depends on how much risk research subjects run. Biomedical research can harm subjects, but much of it needs no physical contact with patients, and most contact ...
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How much good IRB regulation can do depends on how much risk research subjects run. Biomedical research can harm subjects, but much of it needs no physical contact with patients, and most contact cannot cause serious injury. Even truly ill patients are, if anything, safer in than out of research. Social-science research cannot injure people physically, and its risks are trivial compared with the chances free people take daily In short, research harm “has been far less than the harm arising from many entirely ordinary activities” like walking. So the IRB system has less scope to do good than its severity suggests because research is safer than its rhetoric implies.Less
How much good IRB regulation can do depends on how much risk research subjects run. Biomedical research can harm subjects, but much of it needs no physical contact with patients, and most contact cannot cause serious injury. Even truly ill patients are, if anything, safer in than out of research. Social-science research cannot injure people physically, and its risks are trivial compared with the chances free people take daily In short, research harm “has been far less than the harm arising from many entirely ordinary activities” like walking. So the IRB system has less scope to do good than its severity suggests because research is safer than its rhetoric implies.
