Clinical Research Involving Pregnant Women

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 inthis 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.

Argues for a new default position whereby pregnant women are included in clinical research unless researchers argue convincingly for their exclusion Builds a framework for the ethical and practical integration of pregnancy in the biomedical research agenda Provides modern examples of the successful inclusion of pregnant women in research and a critique of the challenges encountered, including research on HIV/AIDS, probiotics, uterine transplant, maternal gene transfer to improve foetal growth, and abortion

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TABLE OF CONTENTS ROUTINE EXCLUSION 1. Contemporary history Francoise Baylis & Angela Ballantyne 2. Clinical problems arising from lack of data Jennifer Blake & Graeme Smith 3. Perspectives on the status quo from the R&D pharmaceutical industry Drew Lewis & Russell Orrico 4. Legal factors underlying the exclusion of pregnant women from clinical trials Michelle Oberman 5. The benefits of routine exclusion David Healy 6. Research ethics review Carolyn Ells ETHICAL CHALLENGES 7. When hypothetical vulnerability becomes actual: research participation and the autonomy of pregnant women L. Syd Johnson 8. Vulnerability and exploitation Wendy Rogers, Catriona McKenzie & Angela Ballantyne 9. Equipoise and the ethical management of uncertainty Rebecca Kukla 10. Is information knowledge and is knowledge power? Informed consent for pregnant women participating in biomedical research Mita Giacomini, Meredith Vanstone & Shawn Winsor 11. Pregnant women's views about participating in research Verina Wild A JUST RESEARCH AGENDA 12. Legitimate inclusion/exclusion criteria Christopher Kaposy & Françoise Baylis 13. Assisted human reproduction Abby Lippman 14. Pregnant women seeking abortion Lisa Harris 15. Ethical challenges in research to reduce the risks of prematurity Richard Ashcroft 16. Probiotics Angela Ballantyne, Julian Crane, Kristin Wickens, & Christine Barthow 17. Hypertension and preeclampsia Toby Schonfeld & Jennifer Goedken 18. Vaccines Françoise Baylis & Robyn MacQuarrie 19. HIV prevention: The global context Ruth Macklin 20. Pregnancy, HIV and TB: A perfect storm Anne Lyerly, Ruth Faden & Maggie Little