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Pregnant Women’s Views About Participation in Clinical Research

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Clinical Research Involving Pregnant Women

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

Abstract

In this chapter we first discuss the impact of thalidomide on the approach to drug use and clinical research with pregnant women in Germany. We then present results from a qualitative interview study conducted in Göttingen, Germany, in 2003. The interviews provide insights into women’s thoughts and experiences in relation to decision-making during pregnancy, illness and treatment during pregnancy, their maternal-foetal relationship, and how they assess different types of clinical research scenarios. The results reveal the shortcomings of the current restrictive approach to drug therapy during pregnancy. They also help answer some conceptual questions about clinical research with pregnant women. The ultimate aim is to work towards a balanced approach that respects the autonomy and decision-making capacity of pregnant women, protects the foetus from preventable harm, and generates well-researched and officially approved drugs for use during pregnancy.

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Notes

  1. 1.

    The Additional Protocol to the European Convention on Human Rights and Biomedicine regulates clinical research on pregnant women , but Germany did not sign and ratify the Protocol so far (Council of Europe 2005).

  2. 2.

    Questions per category: (1) General questions: (expected) date of birth, previous pregnancies, course of current pregnancy (disease, complications, etc.), professional background, and current job situation. (2) Experience with medical care during pregnancy: How did the clinical research participant experience drug intake? How well did she feel informed? Who or what helped to make decisions? How was the physician-patient-relationship? Did she change certain habits and if so, why? (3) Participation in clinical research in general: Did the interview partner ever participate in clinical research? Would the woman participate in clinical research that tests a new drug for a certain disease from which she suffers? Would the woman participate in clinical research as a healthy participant that tests a new drug, involves blood taking, and for which she receives a financial reward? (4) Participation in clinical research during pregnancy: What is the general opinion about clinical research involving pregnant women ? Would the woman participate in certain types of clinical research? (5) General issues on how to perform clinical research: Involvement of the partner, decision-making procedure, role of the researcher. (6) The maternal-foetal relationship: How do women perceive the relationship?

  3. 3.

    All interview passages quoted here have been translated from German to English by the authors.

  4. 4.

    The women received code-letters for the purpose of anonymisation.

  5. 5.

    Quantitative numbers that are presented in qualitative studies do not result in generalizable data, but we provide the numbers as additional, orienting information.

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Authors and Affiliations

  1. Institute of Biomedical Ethics and History of Medicine, University of Zurich, Zurich, Switzerland

    Verina Wild MD, PhD & Nikola Biller-Andorno MD, PhD

  2. Department of Philosophy, Ludwig-Maximilians-University Munich, Munich, Germany

    Verina Wild MD, PhD

Authors
  1. Verina Wild MD, PhD
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  2. Nikola Biller-Andorno MD, PhD
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Correspondence to Verina Wild MD, PhD .

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Editors and Affiliations

  1. Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada

    Françoise Baylis

  2. University of Otago, Wellington, New Zealand

    Angela Ballantyne

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Wild, V., Biller-Andorno, N. (2016). Pregnant Women’s Views About Participation in Clinical Research. In: Baylis, F., Ballantyne, A. (eds) Clinical Research Involving Pregnant Women. Research Ethics Forum, vol 3. Springer, Cham. https://doi.org/10.1007/978-3-319-26512-4_7

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  • DOI: https://doi.org/10.1007/978-3-319-26512-4_7

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