Pregnant women and clinical trials. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023. NLM AIDSLINE Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

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Pregnant women and clinical trials. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

Common Factor. 1995 Apr;(no 10):20. Unique Identifier : AIDSLINE AIDS/95700373
Kuhn D

Abstract: The Food and Drug Administration's (FDA) 1994 policy reversal of allowing pregnant women in NIH-sponsored protocols was the main topic at its FDA-Regulated Products and Pregnant Women conference. More clinical information is needed to determine the effects of trial drugs on HIV-infected pregnant women and fetal development. Ethical considerations are present. It was proposed that in circumstances where potential harm to the fetus exists, the local Institutional Review Board or the investigator would make the decision whether to allow pregnant women to participate, a proposal that was adamantly opposed by many conference participants. The opposing position held that clinical trials should be open to pregnant women and that the choice to participate should be theirs as long as that decision is based on receiving accurate information.
Keywords: Acquired Immunodeficiency Syndrome/*DRUG THERAPY Clinical Trials Disease Transmission, Vertical Ethics, Medical Female Human HIV Infections/*DRUG THERAPY Informed Consent Pregnancy Pregnancy Complications, Infectious/*DRUG THERAPY Professional Staff Committees Teratogens/*TOXICITY NEWSLETTER ARTICLE

KWDacquiredimmunodeficiencysyndrome/KWDdrugtherapyclinicaltrialsdiseasetransmission,verticalethics,medicalfemalehumanhivinfections/KWDdrugtherapyinformedconsentpregnancypregnancycomplications,infectious/KWDdrugtherapyprofessionalstaffcommitteesteratogens/KWDtoxicitynewsletterarticle
951130
M95B0893

Copyright © 1995 - National Library of Medicine. Reproduced under license with the National Library of Medicine, Bethesda, MD.

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