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- Title
No Girls Allowed: A Sponsor's Rejection of One IRB's Contraception Policy.
- Authors
BROWN, JOSEPH S.; SCHONFELD, TOBY L.; AMOURA, N. JEAN; GORDON, BRUCE
- Abstract
The article provides the outcome of a review process used by an institutional review board (IRB) for a drug study involving female participants of childbearing potential. A commercial sponsor decided to withdraw from the study because it disagreed with the involvement of women of childbearing potential. The study examined the efficacy and safety of a drug for the treatment of a chronic disease.
- Subjects
CONTRACEPTION; DRUG design; CLINICAL drug trials; ENDOWMENT of research; MATERNAL age; INSTITUTIONAL review boards; HUMAN research subjects; PREGNANCY
- Publication
IRB: Ethics & Human Research, 2014, Vol 36, Issue 6, p13
- ISSN
0193-7758
- Publication type
Article