Skip to main content
View expanded cover

Clinical Research Involving Pregnant Women pp 161–178Cite as

When Hypothetical Vulnerability Becomes Actual: Research Participation and the Autonomy of Pregnant Women

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

Abstract

Various national and international research guidelines and regulations limit the inclusion of pregnant women in clinical research by classifying them as vulnerable. This exclusion has widely acknowledged negative consequences for the health of women, foetuses, and future children. Another negative consequence is the threat to a pregnant woman’s autonomy and agency when she is treated as a ‘vulnerable’ person without cause. Research guidelines and regulations around the world continue to be overly protectionist. The limitations on autonomy they imply (and create) infantilise pregnant women, treating them ‘as if’ they are vulnerable – as if they, in fact, lack autonomy and the capacity to make informed choices about their own research participation. The hypothetical ‘as if’ becomes actual as research guidelines and regulations effectively reduce the autonomy and agency of pregnant women, making them unable to protect their own interests, including their interests in protecting their future children.

Keywords

  • Pregnant women
  • Clinical research
  • Research ethics
  • Autonomy
  • Decision making
  • Vulnerability
  • Exclusion
  • Paternalism

This is a preview of subscription content, access via your institution.

Chapter
USD   29.95
Price excludes VAT (USA)
  • DOI: 10.1007/978-3-319-26512-4_9
  • Chapter length: 18 pages
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
eBook
USD   149.00
Price excludes VAT (USA)
  • ISBN: 978-3-319-26512-4
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
Softcover Book
USD   199.99
Price excludes VAT (USA)
Hardcover Book
USD   199.99
Price excludes VAT (USA)
Learn about institutional subscriptions

Notes

  1. 1.

    The use of the term ‘subject’ has been widely replaced by ‘participant’ in recent years. Both the Common Rule and the Belmont Report use ‘subject,’ while CIOMS guidelines, TCPS2, and the guidelines of South Africa and India usually refer to ‘participant.’ ‘Participant’ will be the preferred terminology used in this chapter.

  2. 2.

    The CIOMS guidelines are currently under revision, and the guidelines concerning women and pregnant women are expected to be substantially changed. This may result in greater clarity on this point.

  3. 3.

    For a detailed discussion of types of vulnerability that can be experienced by pregnant women , see Ballantyne and Rogers (2016). Notably, Ballantyne and Rogers argue that while pregnant women can be vulnerable in a number of ways, that vulnerability does not create incentives or opportunities for them to be exploited in research, because involving pregnant women in research does not make research easier, quicker, or cheaper.

  4. 4.

    Existing research guidelines do not take a stand on the alleged personhood or moral status of the foetus. For example, CIOMS refers to “the person the fetus is destined to become” (CIOMS 2002, Guideline 17), while explicitly noting that discussion of the moral status of foetuses and embryos proved a sticking point in considering research on the products of conception (CIOMS 2002, Introduction). TCPS2 defines the foetus as “a human organism during the period of its development beginning on the 57th day following fertilization or creation, excluding any time during which its development has been suspended, and ending at birth” (Canada 2014, 183). The definition of a “participant” in TCPS2 plausibly encompasses foetuses, but without defining participants as necessarily being persons: “An individual whose data, or responses to interventions, stimuli, or questions by a researcher are relevant to answering a research question; also referred to as “human participant,” and in other policies/guidance as “subject” or “research subject” (Canada 2014, 215). The Common Rule defines a foetus as “the product of conception from implantation until delivery” (DHHS 2009, 45 CFR 46 Subpart B 46.202) without making reference to its personhood. India and South Africa do not define persons or foetuses in their guidelines, and are silent on the matter of foetal personhood.

  5. 5.

    There are rare situations in which a woman’s health or life might be endangered by pregnancy or pregnancy-related conditions, such as pre-eclampsia, HELLP Syndrome, and amniotic fluid embolism. In such cases, however, the pregnant woman’s health is not dependent on the foetus’ health, per se. Rather, being pregnant adversely affects the woman’s health, regardless of the condition of the foetus.

References

  • ACOG (American College of Obstetricians and Gynecologists). 2005. Maternal decision making, ethics, and the law. ACOG committee opinion no. 321. Obstetrics and Gynecology 106(5 Pt 1): 1127–1137.

    Google Scholar 

  • 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.

    Google Scholar 

  • 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.

    Google Scholar 

  • Brunner, E., D.M. Falk, M. Jones, D.K. Dey, and C.C. Shatapathy. 2013. Olanzapine in pregnancy and breastfeeding: A review of data from global safety surveillance. BMC Pharmacology and Toxicology 14(38). doi:10.1186/2050-6511-14-38.

  • Canada (Canadian Institutes of Health Research, Natural Sciences and Engineering Council of Canada, and Social Sciences and Humanities Research Council of Canada). 2014. Tri-Council Policy Statement: Ethical conduct for research involving humans (TCPS2). http://www.pre.ethics.gc.ca/pdf/eng/tcps2-2014/TCPS_2_FINAL_Web.pdf. Accessed 3 Oct 2016.

  • 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.

  • Denny, C., and C. Grady. 2008. Research involving women. In The Oxford textbook of clinical research ethics, eds. E.J. Emanuel, C. Grady, R.A. Crouch, R.L. Kie, F.G. Miller, and D. Wendler, 407–422. Oxford: Oxford University Press.

    Google Scholar 

  • DHHS (US Department of Health and Human Services). 2009. Code of Federal Regulations: Title 45, Part 46, Protection of Human Subjects. http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html. Accessed 3 Oct 2016.

  • DHHS (US Department of Health and Human Services, Office for Human Research Protections). 2012. International compilation of human research standards. http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html. Accessed 3 Apr 2015.

  • FDA (US Food and Drug Administration). 2011. Science and research: Pregnancy registries (last updated 22 July 2011). http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm251314.htm. Accessed 27 Feb 2015.

  • Healy, D., and D. Mangin. 2016. Does my bias look big in this? In Clinical research involving pregnant women, eds. F. Baylis and A. Ballantyne, 197–208. Cham: Springer.

    Google Scholar 

  • India (Indian Council of Medical Research, Director-General). 2006. Ethical guidelines for biomedical research on human participants. New Delhi. http://icmr.nic.in/ethical_guidelines.pdf. Accessed 8 Apr 2015.

  • Kukla, R. 2005. Conscientious autonomy: Displacing decisions in health care. Hastings Center Report 35(2): 34–44.

    CrossRef  PubMed  Google Scholar 

  • Kukla, R. 2016. Equipoise, uncertainty, and inductive risk in research involving pregnant women. In Clinical research involving pregnant women, eds. F. Baylis and A. Ballantyne, 179–196. Cham: Springer.

    Google Scholar 

  • Little, M.O. 1999. Abortion, intimacy, and the duty to gestate. Ethical Theory and Moral Practice 2(3): 295–312.

    CAS  CrossRef  PubMed  Google Scholar 

  • Lupton, M.G.F., and D.J. Williams. 2004. The ethics of research on pregnant women: Is maternal consent sufficient? International Journal of Obstetrics and Gynaecology 111(12): 1307–1312.

    CrossRef  Google Scholar 

  • Mackenzie, C. 2010. Conceptions of autonomy and conceptions of the body in bioethics. In Feminist bioethics: At the center, on the margins, eds. Jackie L. Scully, Laurel E. Baldwin-Ragaven, and Petya Fitzpatrick, 71–90. Baltimore: Johns Hopkins University Press.

    Google Scholar 

  • Mastroianni, A.C., and J.P. Kahn. 2002. Risk and responsibility: Ethics, Grimes v Kennedy Krieger, and public health research involving children. American Journal of Public Health 92(7): 1073–1076.

    CrossRef  PubMed  PubMed Central  Google Scholar 

  • Miller, F.G., and A. Wertheimer. 2007. Facing up to paternalism in research ethics. Hastings Center Report 37(3): 24–34.

    CrossRef  PubMed  Google Scholar 

  • NIH-ORWH (United States. Department of Health and Human Services, Public Health Service, National Institutes of Health, Office of Research on Women’s Health). 2011. Enrolling pregnant women: Issues in clinical research. Bethesda: National Institutes of Health. http://orwh.od.nih.gov/resources/policyreports/pdf/ORWH-EPW-Report-2010.pdf. Accessed 8 Apr 2015.

  • Robinson, W.M., and B.T. Unruh. 2008. The Hepatitis experiments at the Willowbrook State School. In The Oxford textbook of clinical research ethics, eds. E.J. Emanuel, C. Grady, R.A. Crouch, R.L. Kie, F.G. Miller, and D. Wendler, 80–85. Oxford: Oxford University Press.

    Google Scholar 

  • South Africa (South African Medical Research Council). 2000. Guidelines on ethics for medical research: General principles, including research on vulnerable groups, international collaboration and epidemiology. http://www.kznhealth.gov.za/research/ethics1.pdf. Accessed 26 Mar 2015.

  • United States (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research). 1979. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html. Accessed 26 Mar 2015.

  • Wild, V., and N. Biller-Andorno. 2016. Pregnant women’s views about participation in clinical research. In Clinical research involving pregnant women, eds. F. Baylis and A. Ballantyne, 119–136. Cham: Springer.

    Google Scholar 

  • World Medical Association. 2013. WMA Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. http://www.wma.net/en/30publications/10policies/b3/. Accessed 3 Oct 2016.

Download references

Author information

Authors and Affiliations

  1. Humanities, Kinesiology and Integrative Physiology, Michigan Technological University, Houghton, MI, USA

    L. Syd M. Johnson PhD

Authors
  1. L. Syd M. Johnson PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to L. Syd M. Johnson PhD .

Editor information

Editors and Affiliations

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

    Françoise Baylis

  2. University of Otago, Wellington, New Zealand

    Angela Ballantyne

Rights and permissions

Reprints and Permissions

Copyright information

© 2016 Springer International Publishing Switzerland

About this chapter

Cite this chapter

Johnson, L.S.M. (2016). When Hypothetical Vulnerability Becomes Actual: Research Participation and the Autonomy of Pregnant Women. 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_9

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-26512-4_9

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-26510-0

  • Online ISBN: 978-3-319-26512-4

  • eBook Packages: MedicineMedicine (R0)