© 2002 by Oxford University Press
Journal of the National Cancer Institute, Vol. 94, No. 20, 1518-1520,
October 16, 2002
© 2002 Oxford University Press
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For Institutional Review Boards, Decisions Can Be Subjective
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When evaluating a clinical trial protocol, institutional review boards (IRBs) must determine whether the likely benefits to patients outweigh the risks. How do IRBs sort through the complexity of medical, scientific, and ethical considerations to reach these decisions?
In a new study, researchers in the Netherlands interviewed 53 IRB members from six research hospitals and cancer centers to find out how they make risk/benefit assessments for phase II cancer clinical trials. The results suggest that they use a range of approaches but rarely employ a formal, systematic analysis. In an article published in the Aug. 1 Annals of Oncology, Heleen van Luijn, Ph.D., of the Institute for Ethics, Vrije Universiteit, Amsterdam, and colleagues describe findings from the first phase of a four-part study in which they
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