Scrutinizing ethics as applied to clinical research

Between 1977 and 1993, the US Food and Drug Administration (FDA) did exclude "women of childbearing potential" from participating in phase I and early phase II clinical trials, but retreated from this position in response to issues raised by the Office of Research on Women's Health wi...

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Bibliographic Details
Published in:Journal of allergy and clinical immunology 2008-08, Vol.122 (2), p.429-430
Main Author: Slade, Herbert, MD, FAAAI
Format: Article
Language:English
Subjects:
Allergy and Immunology
Biomedical Research - ethics
Child
Clinical trials
Clinical Trials as Topic - ethics
Drug dosages
Ethics, Research
Female
Humans
Pediatrics
Pharmaceutical industry
Pregnancy
Womens health
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Summary:Between 1977 and 1993, the US Food and Drug Administration (FDA) did exclude "women of childbearing potential" from participating in phase I and early phase II clinical trials, but retreated from this position in response to issues raised by the Office of Research on Women's Health within the Office of the Director at the National Institutes of Health and the findings of an Institute of Medicine committee on inclusion of women in clinical studies (1992, published in 1994).2 The current standard holds that women should be allowed to make informed decisions for themselves, regardless of pregnancy status. In revising the Declaration of Helsinki at the 52nd General Assembly in 2000, the World Medical Association (WMA) revealed its own biases by modifying the Declaration beyond recognized standards of practice.
ISSN:0091-6749
1097-6825
DOI:10.1016/j.jaci.2008.06.018