Women’s Views About a Paternal Consent Requirement for Biomedical Research in Pregnancy

Kristen A. Sullivan, Maggie Little, Nora E. Rosenberg, Tiwonge Mtande, Chifundo Zimba, Elana Jaffe, Jean Anderson, Jenell S. Coleman Fennell, Sappho Gilbert, Marielle S. Gross Wolf, Irving Hoffman, Lisa Rahangdale, Ruth R Faden, Anne Drapkin Lyerly

Research output: Contribution to journalArticle


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’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’s or pregnant woman’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.

Original languageEnglish (US)
JournalJournal of Empirical Research on Human Research Ethics
Publication statusAccepted/In press - Jul 1 2018



  • clinical trials
  • Malawi
  • paternal consent
  • pregnancy
  • qualitative methods
  • research ethics
  • United States
  • women’s views

ASJC Scopus subject areas

  • Social Psychology
  • Education
  • Communication

Cite this

Sullivan, K. A., Little, M., Rosenberg, N. E., Mtande, T., Zimba, C., Jaffe, E., ... Lyerly, A. D. (Accepted/In press). Women’s Views About a Paternal Consent Requirement for Biomedical Research in Pregnancy. Journal of Empirical Research on Human Research Ethics. https://doi.org/10.1177/1556264618783834