Research in Pregnancy

Author:

Little Margaret Olivia1,Wickremsinhe Marisha N.2,Lyerly Anne Drapkin3

Affiliation:

1. Institute of Ethics, Georgetown University

2. Population Health, University of Oxford

3. Bioethics, University of North Carolina School of Medicine

Abstract

Abstract While pregnant people are among those most in need of access to effective treatment and preventive drugs and vaccines, evidence to inform use of pharmaceuticals in pregnancy is sorely lacking. Recent years have seen growing recognition of the urgent need to increase responsible research in pregnancy. This chapter outlines the state of play on key issues regarding such research. First, it describes evidence gaps, their systemic causes, and their human and moral costs. Next, it addresses conditions under which pregnant people may ethically be included in studies, highlighting issues of allowable risk, consent, and abortion. Finally, it turns to the important issue of fair inclusion of pregnant participants in research, at the levels of both agenda-setting structures and individual trials. Together these considerations point to the collective responsibility of the global research community to identify and pursue research that meets the needs and honors the interests of pregnant people.

Publisher

Oxford University Press

Reference104 articles.

1. Evolving Knowledge of the Teratogenicity of Medications in Human Pregnancy.;American Journal of Medical Genetics Part C: Seminars in Medical Genetics,2011

2. Pharmacokinetic Studies in Pregnant Women.;Clinical Pharmacology & Therapeutics,2008

3. Ballantyne, Angela, and Wendy Rogers. 2016. “Pregnancy, Vulnerability, and the Risk of Exploitation in Clinical Research.” In Clinical Research Involving Pregnant Women, edited by Francoise Baylis and Angela Ballantyne, 139–159. Cham, Switzerland: Springer.

4. Pregnant Women Deserve Better.;Nature,2010

5. Pharmacokinetics of oseltamivir among pregnant and nonpregnant women.;American Journal of Obstetrics and Gynecology,2011

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