Pruning the regulatory tree

How would our proposal affect subject safety? Since only those studies with minimal chance of minimal harm are exempted, the effect on subject welfare would be minimal. Non-medical centre, low-volume IRBs (which review a disproportionate number of minimal-risk-research protocols) do not enjoy econom...

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Bibliographic Details
Published inNature (London) Vol. 457; no. 7229; pp. 534 - 535
Main Authors Kim, Scott, Ubel, Peter, De Vries, Raymond
Format Journal Article
LanguageEnglish
Published London Nature Publishing Group UK 29.01.2009
Nature Publishing Group
Subjects
Behavior
Clinical Trials as Topic - economics
Clinical Trials as Topic - ethics
Clinical Trials as Topic - legislation & jurisprudence
Clinical Trials as Topic - standards
commentary
Cost-Benefit Analysis
Data collection
Humanities and Social Sciences
Humans
Informed consent
Informed Consent - ethics
Medical research
multidisciplinary
Patient Rights - legislation & jurisprudence
Patient Rights - standards
Protocol
Regulation
Review boards
Risk Assessment
Science
Science (multidisciplinary)
Studies
United States
United States
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Summary:How would our proposal affect subject safety? Since only those studies with minimal chance of minimal harm are exempted, the effect on subject welfare would be minimal. Non-medical centre, low-volume IRBs (which review a disproportionate number of minimal-risk-research protocols) do not enjoy economies of scale7. [...] at least half (and probably much more) of all direct IRB costs are devoted to expensive reviews of minimalrisk studies - resources that could be used to improve the oversight of riskier studies.
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ISSN:0028-0836
1476-4687
1476-4687
DOI:10.1038/457534a