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The Ethical Problems of the Open Label Extension Study

Published online by Cambridge University Press:  29 July 2009

Kenneth Craig Micetich
Kenneth Craig Micetich
Affiliation:
Chair of the Institutional Review Board and Associate Professor of Medicine in the Division of Hematology-Oncology, Loyola University Stritch School of Medicine, May wood, Illinois.
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Extract

The institutional review board (IRB) Is charged with assessing the risks and benefits of research projects Involving human subjects. Ethical considerations and federal regulations require that an IRB, in part, must find that the potential risks of participation are proportional to the potential benefits (If any) and to the Importance of the knowledge that may be learned before the IRB can approve the voluntary assumption of risk by a research participant. Adequate assessment of the risks and benefits requires careful scrutiny of the study design In relation to the study objectives.

Type
Special Section: Rejuvenating Research Ethics
Information
Cambridge Quarterly of Healthcare Ethics , Volume 5 , Issue 3 , Summer 1996 , pp. 410 - 414
Copyright
Copyright © Cambridge University Press 1996

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References

Notes

1. 45 CFR 46.111, a-2. Washington, DC: US Government Printing Office, 1991.

2. Minogue, BP, Palmer-Fernandez, G, Udell, L, Waller, BN. Individual autonomy and the double-blind controlled experiment: the case of desperate volunteers. Journal of Medicine and Philosophy 1995;20:43–55.CrossRefGoogle ScholarPubMed

3. Coughlin, SS, Beauchamp, TL. Ethics, scientific validity and the design of epidemiologic studies. Epidemiology 1992;3:343–7.CrossRefGoogle ScholarPubMed