@article{a432665669044a2f94a1d48ec87d18b9,
title = "Women{\textquoteright}s Views About a Paternal Consent Requirement for Biomedical Research in Pregnancy",
abstract = "Clinical research to inform the evidence base to guide nonobstetrical care during pregnancy is critically important for the well-being of women and their future offspring. Conversations about regulations for such research, including whether paternal consent should ever be required, should be informed by the perspectives of those most affected, namely, pregnant women. We conducted in-depth interviews with 140 pregnant women living with or at risk of HIV—70 in Malawi, 70 in the United States—exploring their views on requiring paternal consent for pregnant women{\textquoteright}s participation in trials offering the prospect of direct benefit solely to the fetus. The majority of women supported such a requirement; others raised concerns. A trio of themes—the father{\textquoteright}s or pregnant woman{\textquoteright}s rights, fetal protection, and gender/relationship dynamics—characterized views both supporting and against a paternal consent requirement, expanding the range of considerations that should inform approaches to paternal involvement in research with pregnant women.",
keywords = "Malawi, United States, clinical trials, paternal consent, pregnancy, qualitative methods, research ethics, women{\textquoteright}s views",
author = "Sullivan, {Kristen A.} and Maggie Little and Rosenberg, {Nora E.} and Tiwonge Mtande and Chifundo Zimba and Elana Jaffe and Jean Anderson and Coleman, {Jenell S.} and Sappho Gilbert and {Gross Wolf}, {Marielle S.} and Irving Hoffman and Lisa Rahangdale and Ruth Faden and Lyerly, {Anne Drapkin}",
note = "Funding Information: The authors gratefully acknowledge the women who participated in these interviews and shared their time, views, and experiences. We very much appreciate Dr. Francis Martinson at UNC Project Malawi and Dr. Claire Farel at the UNC Infectious Disease Clinic, for their support of this work. Warm thanks are also extended to Bernadette Harley-Boon, Altricia Belk, Patrice Ross-Johns, and Krissa Pecunes at Johns Hopkins University, and Karen Dorman and Katherine Barley at UNC Chapel Hill for their assistance in navigating the clinics and the participant recruitment process. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under award number R01AI108368. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under award number R01AI108368. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Publisher Copyright: {\textcopyright} The Author(s) 2018.",
year = "2018",
month = oct,
day = "1",
doi = "10.1177/1556264618783834",
language = "English (US)",
volume = "13",
pages = "349--362",
journal = "Journal of Empirical Research on Human Research Ethics",
issn = "1556-2646",
publisher = "University of California Press",
number = "4",
}