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.
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.
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.
All interview passages quoted here have been translated from German to English by the authors.
- 4.
The women received code-letters for the purpose of anonymisation.
- 5.
Quantitative numbers that are presented in qualitative studies do not result in generalizable data, but we provide the numbers as additional, orienting information.
References
Anderson, C. 1994. Panel backs pregnant women in trials. Science 263(5151): 1216.
Ashcroft, R. 2016. Ethical issues in a trial of maternal gene transfer to improve foetal growth. In Clinical research involving pregnant women, eds. F. Baylis and A. Ballantyne, 247–263. Cham: Springer.
Ballantyne, A., and W. Rogers. 2016. Pregnancy, vulnerability, and the risk of exploitation in clinical research. In Clinical research involving pregnant women, eds. F. Baylis and A. Ballantyne, 139–159. Cham: Springer.
Baylis, F., and R. MacQuarrie. 2016. Why physicians and women should want pregnant women included in clinical trials. In Clinical research involving pregnant women, eds. F. Baylis and A. Ballantyne, 17–31. Cham: Springer.
Biller-Andorno, N., and V. Wild. 2003a. Arzneimittelforschung an Schwangeren: Besonderer Schutz – aber kein Ausschluss aus der Forschung. Deutsches Ärzteblatt 100(15): A-970/B-814/C-760.
Biller-Andorno, N., and V. Wild. 2003b. Zwischen Protektion und Protektionismus – medizinethische Überlegungen zur Teilnahme schwangerer Frauen an klinischen Studien. In Das Kind als Patient, eds. C. Wiesemann, A. Dörries, G. Wolfslast, and A. Simon, 302–320. Frankfurt am Main: Campus Verlag.
Bobbert, M. 2004. Frauenheilkunde und Geburtshilfe. In Gutachten “Probanden- und Patientenschutz in der medizinischen Forschung”, eds. M. Bobbert, U.B. Brückner, and H. Lilie, 55–69. Erstellt im Auftrag der Enquête-Kommission ›Ethik und Recht der modernen Medizin‹ des Deutschen Bundestages. http://webarchiv.bundestag.de/archive/2005/0718/parlament/kommissionen/ethik_med/gutachten/gutachten_03_probandenschutz.pdf. Accessed 13 Nov 2014.
Caschetta, M.B., and W. Chavkin. 1994. FDA policy on women in drug trials. The New England Journal of Medicine 329(24): 1815–1816.
Che Yaakob, C.A., A.A. Dzarr, A.A. Ismail, N.A. Zuky Nik Lah, and J.J. Ho. 2010. Anticoagulant therapy for deep vein thrombosis (DVT) in pregnancy. Cochrane Database of Systematic Reviews. 6: CD007801.
CIOMS (Council for International Organizations of Medical Sciences). 2002. International ethical guidelines for biomedical research involving human subjects. Geneva: World Health Organization. http://www.cioms.ch/publications/layout_guide2002.pdf. Accessed 3 Oct 2016.
Council of Europe. 2005. Additional protocol to the Convention on Human Rights and Biomedicine, concerning biomedical research. CETS No.: 195. http://conventions.coe.int/Treaty/en/Treaties/html/195.htm. Accessed 6 Apr 2016.
Czeizel, A.E. 1999. The role of pharmacoepidemiology in pharmacovigilance: Rational drug use in pregnancy. Pharmacoepidemiology and Drug Safety 8(Suppl 1): S55–S61.
DHHS (US Department of Health and Human Services). 2009. Code of Federal Regulations: Title 45, part 46, Protection of Human Subjects. See Subpart 46.111(b) (vulnerability) and Subpart 46.204 (research on pregnant women). http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html. Accessed 3 Oct 2016.
Estler, C.-J. 1995. Pharmakologische Grundlagen der Arzneimittelverordnung in der Schwangerschaft. Zeitschrift für ärztliche Fortbildung (ZaeF) 89: 743–748.
Garland, M. 1998. Pharmacology of drug transfer across the placenta. Obstetrics and Gynecology Clinics of North America 25(1): 21–42.
Harris, L.H. 2016. Clinical research involving pregnant women seeking abortion services: United States perspectives. In Clinical research involving pregnant women, eds. F. Baylis and A. Ballantyne, 265–284. Cham: Springer.
Iberogast. 2013. Frequently asked questions. http://www.iberogast.de/infothek/haeufige-fragen-faq/darf-iberogast-auch-waehrend-der-schwangerschaft-oder-in-der-stillzeit-eingenommen-werden.html#12. Accessed 6 Apr 2016.
Imhof, C. 2005. Antibiotika-Therapie in der Schwangerschaft: Teratogene Risiken von Makroliden, Doxycyclin und Cotrimoxazol. Dissertation zur Erlangung des Doktorgrades der Medizin. Universität Ulm. http://vts.uni-ulm.de/doc.asp?id=5696. Accessed 6 Apr 2016.
Kaposy, C. 2016. Presumptive inclusion and legitimate exclusion criteria. In Clinical research involving pregnant women, eds. F. Baylis and A. Ballantyne, 51–62. Cham: Springer.
Kasilo, O., M. Romero, M. Bonati, and G. Tognoni. 1988. Information on drug use in pregnancy from the viewpoint regional drug information centre. European Journal of Clinical Pharmacology 35(5): 447–453.
Koren, G., A. Pastuszak, and S. Ito. 1998. Drugs in pregnancy. New England Journal of Medicine 338(16): 1128–1137.
Langston, L. 2016. Better safe than sorry: Risk, stigma, and research during pregnancy. In Clinical research involving pregnant women, eds. F. Baylis and A. Ballantyne, 33–50. Cham: Springer.
Lyerly, A.D., M. Little, and R. Faden. 2008. The second wave: Toward responsible inclusion of pregnant women in research. International Journal of Feminist Approaches to Bioethics 1(2): 5–22.
Mackenzie, C. 1992. Abortion and embodiment. Australasian Journal of Philosophy 70(2): 136–155.
Macklin, R. 1994. Reversing the presumption: The IOM report on women in health research. Journal of the American Medical Women’s Association 49(4): 13–16. 21.
Marquardt, E. 1994. Die Contergankatastrophe 1961 – Schock und erste Reaktionen. In Contergan – 30 Jahre danach, ed. Fritz U. Niethard, 79–84. Stuttgart: Enke.
Mastroianni, A.C., R. Faden, and D. Federman. 1994. Women and health research: Ethical and legal issues of including women in clinical studies. Washington, DC: National Academy Press.
Matthews, A., T. Dowswell, D.M. Haas, M. Doyle, and D.P. O’Mathúna. 2010. Interventions for nausea and vomiting in early pregnancy. Cochrane Database of Systematic Reviews 9: CD007575.
Mayring, P.A.E. 2008. Qualitative Inhaltsanalyse: Grundlagen und Technik, 10th ed. Weinheim/Basel: Beltz.
Merkatz, R.B., R. Temple, S. Sobel, K. Feiden, and D.A. Kessler. 1993. Women in clinical trials of new drugs – A change in Food and Drug Administration policy. New England Journal of Medicine 329(4): 292–296.
Meuser, M., and U. Nagel. 1991. ExpertInneninterviews – vielfach erprobt, wenig bedacht. In Qualitativ-empirische Sozialforschung. Konzepte, Methoden, Analysen, eds. D. Garz and K. Kraimer, 441–471. Opladen: Westdt. Verl.
Mohanna, K. 1997. Informed consent: Research in pregnancy brings special considerations. British Medical Journal 315(7102): 249–250.
Müller, W.C. 1969. Arzneimittelgaben während der Schwangerschaft. Münchener Medizinische Wochenschrift 111(34): 1687–1692.
Müller-Oerlinghausen, B. 2005. Die Rolle der Ärzteschaft bei der Aufklärung der Contergannebenwirkungen und die Auswirkung auf die deutsche Arzneimittelgesetzgebung. In Die Contergankatastrophe – Eine Bilanz nach 40 Jahren, eds. L. Zichner, M.A. Rauschmann, and K.-D. Thomann, 33–38. Darmstadt: Steinkopff Verlag.
Murphy, J.F. 1984. Drugs and pregnancy. Irish Medical Journal 77(2): 52–56.
Paulus, W.E. 1999. Pharmakotherapie in der Schwangerschaft. Therapeutische Umschau. Revue thérapeutique 56(10): 602–607.
Schaefer, C., H. Spielmann, and K. Vetter. 2004. Liberalisierung nicht erforderlich. Deutsches Ärzteblatt 101(4): A165–A166.
Schaefer, C., H. Spielmann, and K. Vetter. 2006. Arzneiverordnung in Schwangerschaft und Stillzeit. München/Jena: Elsevier (Urban & Fischer).
Scott, A. 1974. Drugs and pregnancy. Journal of the Irish Medical Association 67(5): 123–126.
Sherwin, S. 2000. Abortion through a feminist ethics lens. In Ethical theory: A concise anthology, eds. H. Geirsson and M.R. Holmgren, 374–390. Peterborough: Broadview Press.
Therapontos, C., L. Erskine, E.R. Gardner, W.D. Figg, and N. Vargesson. 2009. Thalidomide induces limb defects by preventing angiogenic outgrowth during early limb formation. Proceedings of the National Academy of Sciences of the United States of America 106(21): 8573–8578.
Thürmann, P.A., and A. Steioff. 2001. Drug treatment in pregnancy. International Journal of Clinical Pharmacology and Therapeutics 39(5): 185–191.
Vazquez, J.C., and E. Abalos. 2011. Treatments for symptomatic urinary tract infections during pregnancy. Cochrane Database of Systematic Reviews 1: CD002256.
Wild, V. 2010. Arzneimittelforschung an schwangeren Frauen: Dilemma, Kontroversen und ethische Diskussion. Frankfurt am Main: Campus Verlag.
Wild, V. 2012. How are pregnant women vulnerable research participants? International Journal of Feminist Approaches to Bioethics 5(2): 82–104.
Wilson, J.G. 1979. The evolution of teratological testing. Teratology 20(2): 205–211.
Winkelheide, M. 2009. Schutz auf dem Prüfstand. Deutschlandfunk – Wissenschaft im Brennpunkt. http://www.dradio.de/dlf/sendungen/wib/1025132/. Accessed 6 Apr 2016.
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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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