Preventive ethics for including women of childbearing potential in clinical trials

American Journal of Obstetrics and Gynecology
L B McCulloughF A Chervenak

Abstract

We present a preventive ethics approach for including women of childbearing potential in clinical trials. We explain the concept of preventive ethics and identify its implications for study design, the informed consent process, and study management. We identify and address ethically significant questions for investigators and institutional review boards to address, to responsibly enroll women of childbearing potential in clinical trials. These questions concern preventive ethics for study design, for the informed consent process, and for study management. Distinctive components of this preventive ethics approach include the distinction between directive and nondirective counseling, the recognition of the concept of moral risk for women as research subjects, and the distinction between professional and individual conscience. We identify ethical considerations for physicians considering referral of their patients to clinical trials. A comprehensive, preventive ethics approach to the ethical challenges in clinical trials related to the prevention and occurrence of pregnancy is essential for responsibly enrolling women of childbearing potential.

References

Feb 1, 1990·American Journal of Obstetrics and Gynecology·F A Chervenak, L B McCullough
May 1, 1989·American Journal of Obstetrics and Gynecology·G KorenN H Shear
Sep 1, 1994·Academic Medicine : Journal of the Association of American Medical Colleges·R B Merkatz, S W Junod
Jul 15, 1998·Cambridge Quarterly of Healthcare Ethics : CQ : the International Journal of Healthcare Ethics Committees·H Brody
Apr 1, 1999·Academic Medicine : Journal of the Association of American Medical Colleges·M T NolanR E Gregory
Nov 16, 1999·American Journal of Obstetrics and Gynecology·R RiveraD Grimes
Jan 3, 2004·American Journal of Perinatology·Frank A Chervenak, Laurence B McCullough
Sep 15, 2005·American Journal of Obstetrics and Gynecology·Laurence B McCulloughFrank A Chervenak

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Citations

Jun 19, 2010·Neurocritical Care·Elissa Fory WibleGeorge A Lopez
Apr 14, 2009·Journal of Women's Health·Toby L SchonfeldBruce G Gordon
Jun 30, 2009·Clinics in Perinatology·Frank A Chervenak, Laurence B McCullough
Aug 8, 2007·Seminars in Fetal & Neonatal Medicine·Frank A Chervenak, Laurence B McCullough
Jun 25, 2008·Haemophilia : the Official Journal of the World Federation of Hemophilia·D M DiMichele
Jan 30, 2021·Pacing and Clinical Electrophysiology : PACE·Muhammad Zia KhanMohamad Alkhouli
Apr 7, 2007·Current Opinion in Anaesthesiology

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