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/9780262028912.003.0002
- Subject:
- Biology, Bioethics
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 ...
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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.Less
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.
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/9780262028912.003.0004
- Subject:
- Biology, Bioethics
Good regulation comes from good guidance. IRBs need a coherent and legible ethics but get three principles – respect for persons, justice, and beneficence. A workable ethics is unachievable because ...
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Good regulation comes from good guidance. IRBs need a coherent and legible ethics but get three principles – respect for persons, justice, and beneficence. A workable ethics is unachievable because IRBs regulate too many diverse areas. And such an attempt would encounter a core contradiction: IRB ethics privilege the autonomy principle, but IRBs are “deeply and pervasively paternalistic,” for they tell people whether and how they may participate in research. Yet research subjects are just as competent to make choices as patients contemplating surgery, homeowners choosing a mortgage, or skiers picking a resort. Although IRBs lack a legible ethics, they have a potent ethos. Instead of showing that IRBs’ usefulness, that ethos recites a litany of research scandals. But scandals are evils, not arguments.Less
Good regulation comes from good guidance. IRBs need a coherent and legible ethics but get three principles – respect for persons, justice, and beneficence. A workable ethics is unachievable because IRBs regulate too many diverse areas. And such an attempt would encounter a core contradiction: IRB ethics privilege the autonomy principle, but IRBs are “deeply and pervasively paternalistic,” for they tell people whether and how they may participate in research. Yet research subjects are just as competent to make choices as patients contemplating surgery, homeowners choosing a mortgage, or skiers picking a resort. Although IRBs lack a legible ethics, they have a potent ethos. Instead of showing that IRBs’ usefulness, that ethos recites a litany of research scandals. But scandals are evils, not arguments.
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.
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.
