Anne Drapkin Lyerly

University of North Carolina at Chapel Hill

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Ruth Faden

Johns Hopkins Berman Institute of Bioethics

Margaret Olivia Little

Georgetown University

Kristen Sullivan

Bristol-Myers Squibb (United States)

Elana Jaffe

University of North Carolina at Chapel Hill

Neeta L. Vora

University of North Carolina at Chapel Hill

Kelly L. Gilmore

University of North Carolina at Chapel Hill

Lisa H. Harris

University of Michigan–Ann Arbor

Marisha N. Wickremsinhe

University of London

Carleigh Krubiner

Wellcome Trust

Asha N. Talati

University of North Carolina at Chapel Hill

Cooperative Institutions

Johns Hopkins University

146

Harvard University

122

University of North Carolina at Chapel Hill

122

United States Food and Drug Administration

108

University of Washington

105

National Institutes of Health

University of California, San Francisco

University College London

University of the Witwatersrand

University of Cape Town

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Research in Pregnancy

Oxford University Press eBooks (2022)

Margaret Olivia Little Marisha N. Wickremsinhe Anne Drapkin Lyerly

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.

10.1093/oxfordhb/9780190947750.013.49

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Citations (2)

Clinical trials in pregnancy and the “shadows of thalidomide”: Revisiting the legacy of Frances Kelsey

Contemporary Clinical Trials (2022)

Miranda R. Waggoner Anne Drapkin Lyerly

Safeguarding

10.1016/j.cct.2022.106806

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Citations (13)

Dolutegravir: advancing ethical research in pregnancy

The Lancet (2019)

Anne Drapkin Lyerly

Dolutegravir

Interim

10.1016/s0140-6736(19)32638-8

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Pregnant women's perceptions of types and levels of evidence when considering participation in hypothetical Zika virus vaccine trials

American Journal of Obstetrics and Gynecology (2019)

Elana Jaffe Ilona T. Goldfarb Anne Drapkin Lyerly

Zika Virus

Affect

10.1016/j.ajog.2019.10.055

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Pregnant women & medical research: a moral imperative

Bioethica Forum (2009)

Anne Drapkin Lyerly Ruth Faden Margaret Olivia Little

10.24894/bf.2009.02020

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Citations (13)

The second wave: Toward responsible inclusion of pregnant women in research

International Journal of Feminist Approaches to Bioethics (2008)

Anne Drapkin Lyerly Margaret Olivia Little Ruth Faden

Though much progress has been made on inclusion of non-pregnant women in research, thoughtful discussion about including pregnant women has lagged behind. We outline resulting knowledge gaps and their costs and then highlight four reasons why ethically we are obliged to confront the challenges of including pregnant women in clinical research. These are: the need for effective treatment for women during pregnancy, fetal safety, harm from the reticence to prescribe potentially beneficial medication, and the broader issues of justice and access to benefits of research participation. Going forward requires shifting the burden of justification from inclusion to exclusion and developing an adequate ethical framework that specifies suitable justifications for excluding pregnant women from research.

Inclusion–exclusion principle

10.2979/fab.2008.1.2.5

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Citations (58)

Clinical Research with Pregnant Adolescents: The Ethics of Risk Standards, Emancipation, and Consent

Journal of Adolescent Health (2018)

Marisha N. Wickremsinhe Maggie Little Anne Drapkin Lyerly

Clinical Research

Research Ethics

10.1016/j.jadohealth.2017.11.120

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Ethics in Academic Medicine

International library of ethics, law, and the new medicine/The international library of ethics, law, and the new medicine (2011)

Anne Drapkin Lyerly

Academic Medicine

10.1007/978-94-007-0931-7_9

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The meaning of “control” for childbearing women in the US

Social Science & Medicine (2010)

Emily Namey Anne Drapkin Lyerly

Ambivalence

Birth control

10.1016/j.socscimed.2010.05.024

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“Therapeutic” Bed Rest in Pregnancy

Obstetrics and Gynecology (2013)

Christina A. McCall David A. Grimes Anne Drapkin Lyerly

"Therapeutic" bed rest continues to be used widely, despite evidence of no benefit and known harms. In this commentary, we summarize the Cochrane reviews of bed rest and propose an ethical argument for discontinuing this practice. Cochrane systematic reviews do not support "therapeutic" bed rest for threatened abortion, hypertension, preeclampsia, preterm birth, multiple gestations, or impaired fetal growth. This assessment has been echoed in other comprehensive reviews. Prescribing bed rest is inconsistent with the ethical principles of autonomy, beneficence, and justice. Hence, if bed rest is to be used, it should be only within a formal clinical trial.

Rest (music)

Therapeutic abortion

10.1097/aog.0b013e318293f12f

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Citations (61)