Abstract
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).
Publisher
Cambridge University Press (CUP)
Subject
Health Policy,General Medicine,Issues, ethics and legal aspects
Reference95 articles.
1. 34. 45 C.F.R. § 46.306(a)(2)(A); 45 C.F.R. § 46.303(d).
2. “A Placebo-Controlled Clinical Trial of Remoxipride and Chlorpromazine in Newly Admitted Schizophrenia Patients with Acute Exacerbation,”;Chouinard;Acta Psychiatrica Scandinavica,1990
3. 75. 45 C.F.R. § 46.102(d).
4. 35. National Commission, Research Involving Children, supra note 19.
5. 50. National Commission, Research Involving Children, supra note 19, at 2.
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