Protected from Harm, Harmed by Protection: Ethical Consequences of the Exclusion of Pregnant Participants from Clinical Trials

Autor/in	Zur, Rebecca L.
Titel	Protected from Harm, Harmed by Protection: Ethical Consequences of the Exclusion of Pregnant Participants from Clinical Trials
Quelle	In: Research Ethics, 19 (2023) 4, S.536-545 (10 Seiten)Infoseite zur Zeitschrift PDF als Volltext Verfügbarkeit
Zusatzinformation	ORCID (Zur, Rebecca L.)
Sprache	englisch
Dokumenttyp	gedruckt; online; Zeitschriftenaufsatz
ISSN	1747-0161
DOI	10.1177/17470161231189843
Schlagwörter	Experimental Groups; Control Groups; Research Methodology; Pregnancy; Participation; Ethics; Safety; Selection; Individual Characteristics + Suchen Sie Ihr Suchwort? Research method; Forschungsmethode; Schwangerschaft; Teilnahme; Ethik; Sicherheit; Auslese; Personality characteristic; Personality traits; Persönlichkeitsmerkmal
Abstract	Pregnancy is a frequently applied exclusion criteria for many forms of research. Common justifications for this exclusion include the potential for teratogenicity, as well as the potential for physiologic changes in pregnancy to impact the research itself. The systematic exclusion of pregnant persons from clinical studies has created a significant gap in knowledge regarding medication safety and efficacy in pregnancy, which continues to cause significant harm to pregnant persons in need of medical therapy. To produce meaningful data and facilitate effective knowledge translation to the clinical setting, special consideration to the pharmacology of pregnancy, as well as to outcomes of concern for this population is essential. The exclusion of pregnant participants from research is not ethically justifiable, as it violates the principles of autonomy, justice and nonmaleficence. While the inclusion of pregnant patients in research presents it's own challenges, with appropriate methodological, ethical, and clinical considerations, we may be able to narrow the knowledge gap and improve drug availability and safety for pregnant patients and their children. (As Provided).
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Erfasst von	ERIC (Education Resources Information Center), Washington, DC
Update	2024/1/01