Clinical Research Involving Pregnant Women

  • Françoise Baylis
  • Angela Ballantyne

Part of the Research Ethics Forum book series (REFF, volume 3)

Table of contents

  1. Front Matter
    Pages i-xv
  2. Françoise Baylis, Angela Ballantyne
    Pages 1-13
  3. Part I

  4. Part II

    1. Front Matter
      Pages 63-63
    2. Indira S. E. van der Zande, Rieke van der Graaf, Joyce L. Browne, Johannes J. M. van Delden
      Pages 65-94
    3. Verina Wild, Nikola Biller-Andorno
      Pages 119-136
  5. Part III

  6. Part IV

    1. Front Matter
      Pages 209-209
    2. Angela Ballantyne, Christine Barthow, Kristin Wickens
      Pages 211-225
    3. Margaret Olivia Little, Anne Drapkin Lyerly, Anna C. Mastroianni, Ruth R. Faden
      Pages 227-246
    4. Ruth M. Farrell, Rebecca Flyckt
      Pages 285-297
  7. Back Matter
    Pages 299-301

About this book


This book discusses ‘how’ to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons ‘why’ the inclusion of pregnant women in clinical research is necessary – viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift to a new default position, whereby pregnant women are included in clinical research unless researchers argue convincingly for their exclusion. This shift raises many as yet unexplored ethical and policy questions about existing barriers to the equitable inclusion of pregnant women in research.

This book is original in three key ways. First, it presents an unparalleled depth of analysis of the ethics of research with pregnant women, bringing together many of the key authors in this field as well as experts in research ethics and in vulnerability who have not previously applied their work to pregnant women. Second, it includes innovative theoretical work in ethics and disease specific case studies that highlight the current complexity and future challenges of research involving pregnant women. Third, the book brings together authors who argue both for and against including more pregnant women in formal clinical trials. 


clinical research involving pregnant women clinical trials exclusion from research participation innovative clinical trial designs pregnant women in medical research risk intepretation

Editors and affiliations

  • Françoise Baylis
    • 1
  • Angela Ballantyne
    • 2
  1. 1.Faculty of MedicineDalhousie UniversityHalifaxCanada
  2. 2.University of OtagoWellingtonNew Zealand

Bibliographic information

  • DOI
  • Copyright Information Springer International Publishing Switzerland 2016
  • Publisher Name Springer, Cham
  • eBook Packages Medicine Medicine (R0)
  • Print ISBN 978-3-319-26510-0
  • Online ISBN 978-3-319-26512-4
  • Series Print ISSN 2212-9529
  • Series Online ISSN 2212-9537
  • Buy this book on publisher's site