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The Ethical Analysis of Risk

Published online by Cambridge University Press:  01 January 2021

Extract

The institutional review board (IRB) is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality (142 articles) and considerably fewer on the assessment of risks and potential harms (40), study design (20), and subject-selection procedures (5).

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Article
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Copyright © American Society of Law, Medicine and Ethics 2000

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