Skip to main content

Clinical Research Involving Pregnant Women Seeking Abortion Services: United States Perspectives

  • Chapter
  • First Online:
Book cover Clinical Research Involving Pregnant Women

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

Abstract

Many pregnant women have induced abortions. Women seeking abortion are appropriate participants in clinical research requiring embryonic or foetal tissue, research with known risks to a foetus, and research designed to improve induced abortion methods. Critics of clinical research at the time of abortion are concerned that research opportunities will influence women’s abortion decisions, help women ‘rationalise’ their abortion, or exploit their vulnerability. I reject these arguments because they are largely based on stigma and negative stereotypes about women and abortion providers. However, economic and racial justice issues must be considered, since low-income women and women of colour disproportionately experience unintended pregnancy and abortion. I conclude that research regulations, and Institutional Review Board interpretations of them, should reflect knowledge gaps and reproductive justice values, rather than stigma, stereotypes and politics. Concerns about clinical research at the time of abortion must be considered alongside the potential harms of not doing such research.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 139.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 179.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 179.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  • AAMC (Association of American Medical Colleges). 18 March 2016. Correspondence in support of fetal tissue research. https://www.aamc.org/download/444248/data/statementinsupportoffetaltissueresearch.pdf. Accessed 1 Apr 2016.

  • ACOG (American College of Obstetricians and Gynecologists). 2007. ACOG committee opinion no. 377: Research involving women. Obstetrics and Gynecology 110(3): 731–736 [At the time of writing, ACOG committee opinion no. 377 was in effect. It has since been withdrawn and replaced with American College of Obstetricians and Gynecologists. 2015. ACOG committee opinion no. 646: Ethical considerations for including women as research participants. Obstetrics and Gynecology 126: e100–e107].

    Google Scholar 

  • ACOG (American College of Obstetricians and Gynecologists). 2014a. ACOG practice bulletin no.143: Medical management of first-trimester abortion. Obstetrics and Gynecology 123(3): 676–692.

    Google Scholar 

  • ACOG (American College of Obstetricians and Gynecologists). 2014b. ACOG College statement of policy: Abortion policy. http://www.acog.org/-/media/Statements-of-Policy/Public/sop069.pdf?dmc=1&ts=20150622T0902260211. Accessed 1 Apr 2016.

  • ACOG (American College of Obstetricians and Gynecologists). 2016. ACOG statement in support of fetal tissue research. http://www.acog.org/About-ACOG/News-Room/Statements/2016/ACOG-Statement-In-Support-of-Fetal-Tissue-Research. Accessed 1 Apr 2016.

  • Anderson, F., A. Glasier, J. Ross, and D.T. Baird. 1994. Attitudes of women to fetal tissue research. Journal of Medical Ethics 20(1): 36–40.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Ballantyne, A. 2008. Benefits to research subjects in international trials: Do they reduce exploitation or increase undue inducement? Developing World Bioethics 8(3): 178–191.

    Article  PubMed  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 

  • 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.

    Google Scholar 

  • Beardsley, T. 1992. Aborting research. Scientific American 276(2): 17–18.

    Google Scholar 

  • Berer, M. 2004. Abortion law, policy and practice in transition. Reproductive Health Matters 12(24): 1–8.

    Article  PubMed  Google Scholar 

  • Boonstra, H. 2001. Human embryo and fetal research: Medical support and political controversy. The Guttmacher Report on Public Policy (4)1: 3–4, 14.

    Google Scholar 

  • Boonstra, H., and E. Nash. 2014. A surge of state abortion restrictions puts providers – And the women they serve – In the crosshairs. Guttmacher Policy Review 17(1): 9–15.

    Google Scholar 

  • Breeze, A.C., H. Statham, G. Hackett, F. Jessop, and C. Lees. 2011. Attitudes to perinatal postmortem: Parental views about research participation. Journal of Medical Ethics 37(6): 364–367.

    Article  PubMed  Google Scholar 

  • Bryant, A., D. Grimes, J. Garrett, and G. Stuart. 2011. Second-trimester abortion for fetal anomalies or fetal death: Labor induction compared with dilation and evacuation. Obstetrics and Gynecology 117(4): 788–792.

    Article  PubMed  Google Scholar 

  • Childress, J. 1991. Deliberations of the human fetal tissue transplantation research panel. In Biomedical politics, ed. K.E. Hanna, 215–248. Washington, DC: National Academies Press.

    Google Scholar 

  • Cohen, S. 2009. Facts and consequences: Legality, incidence and safety of abortion worldwide. Guttmacher Policy Review 12(4): 2–6.

    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). 2011. Federal wide assurance (FWA) for the protection of human subjects. http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html. Accessed 1 Apr 2016.

  • Driggers R.W., C-Y. Ho, E.M. Korhonen, S. Kuivanen, A.J. Jääskeläinen, and T. Smura, et al. 2016. Zika virus infection with prolonged maternal viremia and fetal brain abnormalities. The New England Journal of Medicine 374(22): 2142–2151.

    Google Scholar 

  • Ells, C., and C. Lyster. 2016. Research ethics review of drug trials targeting medical conditions of pregnant women. In Clinical research involving pregnant women, eds. F. Baylis and A. Ballantyne, 95–118. Cham: Springer.

    Google Scholar 

  • FDA (U.S. Food and Drug Administration). 2016. Mifeprex (mifepristone) information. U.S. Department of Health and Human Services, 30 March. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm. Accessed 8 Apr 2016.

  • Finer, L.B., L.F. Frohwirth, L.A. Dauphinee, S. Singh, and A.M. Moore. 2005. Reasons U.S. women have abortions: quantitative and qualitative perspectives. Perspectives on Sexual and Reproductive Health 37(3): 110–118.

    Article  PubMed  Google Scholar 

  • Fletcher, J.C. 1992. Abortion politics, science, and research ethics: Take down the wall of separation. The Journal of Contemporary Health Law and Policy 8: 95–121.

    PubMed  Google Scholar 

  • Grimes, D. 2008. The choice of second trimester abortion method: Evolution, evidence and ethics. Reproductive Health Matters 16(31): 183–188.

    Article  PubMed  Google Scholar 

  • Grimes, D., K. Schulz, W. Cates, and C. Tyler. 1977. Mid-trimester abortion by dilation and evacuation: A safe and practical alternative. The New England Journal of Medicine 296(20): 1141–1145.

    Article  CAS  PubMed  Google Scholar 

  • Grossman, D., K. White, L.H. Harris, M. Reeves, P. Blumenthal, B. Winikoff, and D. Grimes. 2015. Continuing pregnancy after mifepristone and “reversal” of first-trimester medical abortion: A systematic review. Contraception 92(3): 206–211.

    Article  PubMed  Google Scholar 

  • Haddad, L.B., and N. Nour. 2009. Unsafe abortion: Unnecessary maternal mortality. Reviews in Obstetrics and Gynecology 2(2): 122–126.

    PubMed  PubMed Central  Google Scholar 

  • Harris, L.H. 2013. Abortion politics and the production of knowledge. Contraception 88(2): 200–203.

    Article  PubMed  Google Scholar 

  • Harris, L.H., and T. Wolfe. 2014. Stratified reproduction and the double edge of history. Current Opinion in Obsetrics and Gynecology 26(6): 539–544.

    Article  Google Scholar 

  • Johnson, L.S.M. 2016. When hypothetical vulnerability becomes actual: Research participation and the autonomy of pregnant women. In Clinical research involving pregnant women, eds. F. Baylis and A. Ballantyne, 161–178. Cham: Springer.

    Google Scholar 

  • Jones, R.K., and J. Jerman. 2014. Abortion incidence and service availability in the United States, 2011. Perspectives on Sexual and Reproductive Health 46(1): 3–14.

    Article  PubMed  Google Scholar 

  • Jones, R.K., and M.L. Kavanaugh. 2011. Changes in abortion rates between 2000 and 2008 and lifetime incidence of abortion. Obstetrics and Gynecology 117(6): 1358–1366.

    Article  PubMed  Google Scholar 

  • Jones, R.K., and K. Kooistra. 2011. Abortion incidence and access to services in the United States, 2008. Perspectives on Sexual and Reproductive Health 43(1): 41–50.

    Article  PubMed  Google Scholar 

  • Jones, R.K., L.B. Finer, and S. Singh. 2010. Characteristics of U.S. abortion patients, 2008. New York: Guttmacher Institute.

    Google Scholar 

  • Jones, R.K., U. Upadhyay, and T. Weitz. 2013. At what cost? Payment for abortion care by U.S. women. Womens Health Issues 23(3): e173–e178.

    Article  PubMed  Google Scholar 

  • 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.

    Google Scholar 

  • Kumar, A., L. Hessini, and E.M.H. Mitchell. 2009. Conceptualising abortion stigma. Culture, Health and Sexuality 11(6): 625–639.

    Article  PubMed  Google Scholar 

  • 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.

    Google Scholar 

  • Lepore, A.C., J. O’Donnell, A.S. Kim, T. Williams, A. Tuteja, M.S. Rao, et al. 2011. Human glial-restricted progenitor transplantation into cervical spinal cord of the SOD1G93A mouse model of ALS. PloS One 6(10): e25968.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Lyerly, A., M. Little, and R. Faden. 2011. Reframing the framework: Toward fair inclusion of pregnant women as participants in research. The American Journal of Bioethics 11(5): 50–52.

    Article  PubMed  Google Scholar 

  • Magyar, Z., J. Schönleber, M. Romics, E. Hruby, B. Nagy, B. Sulya, et al. 2015. Expression of VEGF in neonatal urinary obstruction: Does expression of VEGF predict hydronephrosis? Medical Science Monitor 21: 1319–1323.

    Article  PubMed  PubMed Central  Google Scholar 

  • Major, B., and R.H. Gramzow. 1999. Abortion as stigma: Cognitive and emotional implications of concealment. Journal of Personality and Social Psychology 77(4): 735–745.

    Article  CAS  PubMed  Google Scholar 

  • McCarthy, C. 1994. Historical background of clinical trials involving women and minorities. Academic Medicine 69(9): 695–698.

    Article  CAS  PubMed  Google Scholar 

  • McCullough, L., J. Coverdale, and F. Chervenak. 2006. Preventive ethics for including women of childbearing potential in clinical trials. American Journal of Obstetrics Gynecology 194(5): 1221–1227.

    Article  PubMed  Google Scholar 

  • Mlakar, J., M. Korva, N. Tul, M. Popović, M. Poljšak, J. Mraz, et al. 2016. Zika virus associated with microcephaly. New England Journal of Medicine 374: 951–958.

    Article  CAS  PubMed  Google Scholar 

  • Norris, A., D. Bessett, J. Steinberg, M. Kavanaugh, S. Zordo, and D. Becker. 2011. Abortion stigma: A reconceptualization of constituents, causes, and consequences. Women’s Health Issues 21(3): 49–54.

    Article  Google Scholar 

  • Reverby, S. 2011. “Normal exposure” and inoculation syphilis: A PHS “Tuskegee” doctor in Guatemala, 1946–1948. Journal of Policy History 23(1): 6–28.

    Article  Google Scholar 

  • Roberts, D.E. 1997. Killing the black body: Race, reproduction, and the meaning of liberty. New York: Random House.

    Google Scholar 

  • Sedgh, G., S. Singh, I. Shah, E. Ahman, S. Henshaw, and A. Bankole. 2012. Induced abortion: Incidence and trends worldwide from 1995 to 2008. Lancet 379(9816): 625–632.

    Article  PubMed  Google Scholar 

  • Smith, R. 2006. Family caps in welfare reform: Their coercive effects and damaging consequences. Harvard Journal of Law and Gender 29(1): 151–200.

    Google Scholar 

  • Steinbock, B. 1999. Ethical issues related to the inclusion of pregnant women in clinical trials (II). In Women and health research: Ethical and legal issues of including women in clinical studies: Volume 2: Workshop and commissioned papers, eds. A.C. Mastroianni, R. Faden, and D. Federman, 23–28. Washington, DC: The National Academies Press.

    Google Scholar 

  • Strong, C. 2012. Abortion decisions as inclusion and exclusion criteria in research involving pregnant women and fetuses. Journal of Medical Ethics 38(1): 43–47.

    Article  PubMed  Google Scholar 

  • Stulberg, D.B., A.M. Dude, I. Dahlquist, and F.A. Curlin. 2011. Abortion provision among practicing obstetrician-gynecologists. Obstetrics and Gynecology 118(3): 609–614.

    Article  PubMed  PubMed Central  Google Scholar 

  • Su, L.L., A. Biswas, M. Choolani, V. Kalaichelvan, and K. Singh. 2005. A prospective, randomized comparison of vaginal misoprostol versus intra-amniotic prostaglandins for midtrimester termination of pregnancy. American Journal of Obstetrics and Gynecology 193(4): 1410–1414.

    Article  CAS  PubMed  Google Scholar 

  • Swetlitz, I. 2016. This scientist works with tissue from aborted fetuses. Congress has come calling. STAT. https://www.statnews.com/2016/03/31/fetal-tissue-congress/. Accessed 11 Apr 2016.

  • Thelen, T., Y. Hao, A.I. Medeiros, J.L. Curtis, C.H. Serezani, L. Kobzik, et al. 2010. The class A scavenger receptor, macrophage receptor with collagenous structure, is the major phagocytic receptor for Clostridium sordellii expressed by human decidual macrophages. The Journal of Immunology 185(7): 4328–4335.

    Article  CAS  PubMed  Google Scholar 

  • Torres, A., and J.D. Forrest. 1988. Why do women have abortions? Family Planning Perspectives 20(4): 169–176.

    Article  CAS  PubMed  Google Scholar 

  • United States 104th Congress. 1996. The balanced budget downpayment act, I: Public law 104–99. January 26: Section 128. http://history.nih.gov/research/downloads/PL104.99.pdf. Accessed 1 Apr 2016.

  • Ward, R.H., B. Modell, M. Petrou, F. Karagozlu, and E. Douratsos. 1983. Method of sampling chorionic villi in first trimester of pregnancy under guidance of real time ultrasound. British Medical Journal 286(6377): 1542–1544.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Weitz, T. 2010. Rethinking the mantra that abortion should be “safe, legal, and rare.”. Journal of Womens History 22(3): 161–172.

    Article  Google Scholar 

  • Wertz, D. 2002. Embryo and stem cell research in the USA: A political history. Trends in Molecular Medicine 8(3): 143–146.

    Article  PubMed  Google Scholar 

  • Westin, B. 1954. Hysteroscopy in early pregnancy. Lancet 264(6843): 872.

    Article  Google Scholar 

  • Winikoff, B., and W. Sheldon. 2012. Use of medicines changing the face of abortion. International Perspectives on Sexual and Reproductive Health 38(3): 164–166.

    Article  PubMed  Google Scholar 

  • Winikoff, B., I. Dzuba, E. Chong, A. Goldberg, E. Lichtenberg, C. Ball, et al. 2012. Extending outpatient medical abortion services through 70 days of gestational age. Obstetrics and Gynecology 120(5): 1070–1076.

    PubMed  Google Scholar 

Download references

Acknowledgements

Sincere thanks are owed to Meghan Seewald for assistance with the literature search and references. As well, I would like to thank Stephen Harris for comments on an earlier draft.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Lisa H. Harris MD, PhD .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2016 Springer International Publishing Switzerland

About this chapter

Cite this chapter

Harris, L.H. (2016). Clinical Research Involving Pregnant Women Seeking Abortion Services: United States Perspectives. 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_15

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-26512-4_15

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-26510-0

  • Online ISBN: 978-3-319-26512-4

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics