A Pregnancy Testing Policy for Women Enrolled in Clinical Trials

The use of contraception hi clinical research is often justified as a compromise between excluding women of childbearing potential completely from clinical trials with unclear fetal risk and including women who have the ability to become pregnant while taking an investigational agent. Here, Schonfel...

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Bibliographic Details
Published inIRB Vol. 35; no. 6; pp. 9 - 15
Main Authors Schonfeld, Toby, Schmid, Kendra K., Brown, Joseph S., Amoura, N. Jean, Gordon, Bruce
Format Journal Article
LanguageEnglish
Published United States The Hastings Center 01.11.2013
Subjects
Abnormalities, Drug-Induced - prevention & control
Adolescent
Adult
Clinical trials
Clinical Trials as Topic - ethics
Clinical Trials as Topic - standards
Contraception
Contraceptive Agents, Female - standards
Drugs, Investigational - adverse effects
Drugs, Investigational - standards
Female
Fetus
Gynecology
Humans
Institutional review boards
Investigational drugs
Maternal-Fetal Exchange - drug effects
Medical tests
Minors
Obstetrics
Pregnancy
Pregnancy tests
Pregnancy Tests - standards
Research Subjects
Risk Assessment
Women
Womens health
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Summary:The use of contraception hi clinical research is often justified as a compromise between excluding women of childbearing potential completely from clinical trials with unclear fetal risk and including women who have the ability to become pregnant while taking an investigational agent. Here, Schonfeld et al investigate practices regarding pregnant women's eligibility to participate in clinical trials, contraception mandates, and pregnancy testing during the course of a study.
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ISSN:0193-7758
2578-2355
2578-2363