Skip to main content
Log in

Ethics of Studies of Drugs in Pregnancy

  • Review Article
  • Published:
Pediatric Drugs Aims and scope Submit manuscript

Abstract

Pregnant women with illness require efficacious and safe drug therapy during pregnancy; however, their treatment is often hindered by a lack of information regarding the use of medications during pregnancy. Ethical challenges are encountered in conducting drug trials in pregnant women, who are often excluded from participation due to fear of harm to the fetus. However, as the health of the fetus is ultimately affected by that of the pregnant woman, inclusion of pregnant women in studies of medications that they may require for their own benefit may also benefit the unborn child. The principle of autonomy argues for the pregnant woman being able to make an informed choice to take part in a clinical trial, and the principle of justice dictates that she not be denied the benefits of drug research.

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

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Baylis F. Pregnant women deserve better. Nature. 2010;465:689–90.

    Article  CAS  PubMed  Google Scholar 

  2. Lyerly AD, Little MO, Faden R. The second wave: toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth. 2008;1:5–22.

    Article  PubMed Central  PubMed  Google Scholar 

  3. Schonfeld T, Schmid KK, Brown JS, Amoura NJ, Gordon B. A pregnancy testing policy for women enrolled in clinical trials. IRB. 2013;35:9–15.

    PubMed  Google Scholar 

  4. Casey MJ, O’Brien R, Rendell M, Salzman T. Ethical dilemma of mandated contraception in pharmaceutical research at Catholic medical institutions. Am J Bioeth. 2012;12:34–7.

    Article  PubMed  Google Scholar 

  5. Shields KE, Lyerly AD. Exclusion of pregnant women from industry-sponsored clinical trials. Obstet Gynecol. 2013;122:1077–81.

    Article  PubMed  Google Scholar 

  6. Dominguez V, Ramos N, Torrents A, Garcia D, Carné X. Clinical trials during pregnancy: what has been done. Eur J Clin Pharmacol. 2012;68:455–8.

    Article  PubMed  Google Scholar 

  7. Blehar MC, Spong C, Grady C, Goldkind SF, Sahin L, Clayton JA. Enrolling pregnant women: issues in clinical research. Womens Health Issues. 2013;23:e39–45.

    Article  PubMed Central  PubMed  Google Scholar 

  8. Allesee L, Gallagher CM. Pregnancy and protection: the ethics of limiting a pregnant woman’s participation in clinical trials. J Clin Res Bioeth. 2011;. doi:10.4172/2155-9627.1000108.

    PubMed Central  PubMed  Google Scholar 

  9. Department of Health and Human Services. Code of Federal Regulations Title 45 Part 46 Protection of Human Subjects. 2009. http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf. Accessed 10 April 2014.

  10. Chervenak FA, McCullough LB. An ethically justified framework for clinical investigation to benefit pregnant and fetal patients. Am J Bioeth. 2011;11:39–49.

    Article  PubMed  Google Scholar 

  11. Canadian Institutes of Health Research. Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans; 2010.

    Google Scholar 

  12. Health Canada. Guidance Document: Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex Differences. 2013. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/womct_femec-eng.php. Accessed 10 April 2014.

  13. Regulation (EU) No. 536/2014 of the European Parliament and of the Council Of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Off J Eur Union 2014;57:1–76.

  14. DiGiovanni LM. Ethical issues in obstetrics. Obstet Gynecol Clin N Am. 2010;37:345–57.

    Article  Google Scholar 

  15. Lyerly AD, Little MO, Faden RR. Reframing the framework: toward fair inclusion of pregnant women as participants in research. Am J Bioeth. 2011;11:50–2.

    Article  PubMed  Google Scholar 

  16. Strong C. Moral status and the fetus: continuation of a dialogue. Am J Bioeth. 2011;11:52–4.

    Article  PubMed  Google Scholar 

  17. Shalowitz DI, Ecker JL. Research in pregnancy: back to first principles. Am J Bioeth. 2011;11:56–7.

    Article  PubMed  Google Scholar 

  18. Minkoff H, Marshall MF, Liaschenko J. The fetus, the “potential child”, and the ethical obligations of obstetricians. Obstet Gynecol. 2014;123:1100–3.

    Article  PubMed  Google Scholar 

  19. Shivakumar G, Inrig S, Sadler JZ. Community, constituency, and morbidity: applying Chervenak and McCullough’s criteria. Am J Bioeth. 2011;11:57–60.

    Article  PubMed  Google Scholar 

  20. Townsend SF. Ethics for the pediatrician: obstetric conflict: when fetal and maternal interests are at odds. Pediatr Rev. 2012;33:33–7.

    Article  PubMed  Google Scholar 

  21. Daw JR, Hanley GE, Greyson DL, Morgan SG. Prescription drug use during pregnancy in developed countries: a systematic review. Pharmacoepidemiol Drug Saf. 2011;20:895–902.

    PubMed Central  PubMed  Google Scholar 

  22. Adam MP, Polifka JE, Friedman JM. Evolving knowledge of the teratogenicity of medications in human pregnancy. Am J Med Genet C Semin Med Genet. 2011;157:175–82.

    Article  Google Scholar 

  23. Baylis F, Kaposy C. Wanted: inclusive guidelines for research involving pregnant women. J Obstet Gynaecol Can. 2010;32:473–6.

    PubMed  Google Scholar 

  24. Lyerly AD, Faden RR. Mothers matter: ethics and research during pregnancy. Virtual Mentor. 2013;15:775–8.

    Article  PubMed  Google Scholar 

  25. van Trigt AM, Waardenburg CM, Haaijer-Ruskamp FM, de Jong-van de Berg LT. Questions about drugs: how do pregnant women solve them? Pharm World Sci. 1994;16:254–9.

    CAS  PubMed  Google Scholar 

  26. Olesen C, Søndergaard C, Thrane N, Nielsen GL, de Jong-van den Berg L, Olsen J. L. Epidemiology. 2001;12:497–501.

    Article  CAS  PubMed  Google Scholar 

  27. Nielsen MJ, Nørgaard M, Holland-Fisher P, Christensen LA. Self-reported antenatal adherence to medical treatment among pregnant women with Crohn’s disease. Aliment Pharmacol Ther. 2010;32:49–58.

    CAS  PubMed  Google Scholar 

  28. Julsgaard M, Nørgaard M, Hvas CL, Buck D, Christensen LA. Self-reported adherence to medical treatment prior to and during pregnancy among women with ulcerative colitis. Inflamm Bowel Dis. 2011;17:1573–80.

    Article  PubMed  Google Scholar 

  29. Macklin R. Enrolling pregnant women in biomedical research. Lancet. 2010;375:632–3.

    Article  PubMed  Google Scholar 

  30. Lyerly AD, Namey EE, Gray B, Swamy G, Faden RR. Women’s views about participating in research while pregnant. IRB. 2012;34:1–8.

    PubMed  Google Scholar 

  31. Rodger MA, Makropoulos D, Walker M, Keely E, Karovitch A, Wells PS. Participation of pregnant women in clinical trials: will they participate and why? Am J Perinatol. 2003;20:69–76.

    Article  PubMed  Google Scholar 

  32. Mohanna K, Tunna K. Withholding consent to participate in clinical trials: decisions of pregnant women. Br J Obstet Gynaecol. 1999;106:892–7.

    Article  CAS  PubMed  Google Scholar 

  33. Haas DM, Wunder K, Wolf JG, Denne SC. Women’s health care providers’ attitudes toward research in pregnancy. J Reprod Med. 2010;55:108–14.

    PubMed  Google Scholar 

  34. Schonfeld T. The perils of protection: vulnerability and women in clinical research. Theor Med Bioeth. 2013;34:189–206.

    Article  PubMed  Google Scholar 

  35. Liaschenko J, DeBruin D, Marshall MF. The two-patient framework for research during pregnancy: a critique and a better way forward. Am J Bioeth. 2011;11:66–8.

    Article  PubMed  Google Scholar 

  36. Baylis F, Halperin SA. Research involving pregnant women: trials and tribulations. Clin Invest. 2012;2:139–46.

    Article  Google Scholar 

  37. Koren G. Ethical framework for observational studies of medicinal drug exposure in pregnancy. Teratology. 2002;65:191–5.

    Article  CAS  PubMed  Google Scholar 

  38. Strong C. How should risks and benefits be balanced in research involving pregnant women and fetuses? IRB. 2011;33:1–5.

    PubMed Central  PubMed  Google Scholar 

  39. American College of Obstetricians and Gynecologists. Committee on Ethics; American Academy of Pediatrics, Committee on Bioethics. Maternal-fetal intervention and fetal care centers. Pediatrics. 2011;128:e473–8.

    Article  Google Scholar 

  40. Gedeon C, Nava-Ocampo AA, Koren G. Ethical issues in pharmacologic research in women undergoing pregnancy termination: a systemic review and survey of researchers. Obstet Gynecol Int. 2012;. doi:10.1155/2012/724591.

    PubMed Central  PubMed  Google Scholar 

  41. Ward RM, Sherwin CM. Ethics of drug studies in the newborn. Pediatr Drugs. 2015;17(1)

  42. Noel-Weiss J, Woodend AK, Kujawa-Myles S. Lactation and breastfeeding research studies: who should provide consent for the neonate? J Hum Lact. 2010;26:180–2.

    Article  PubMed  Google Scholar 

  43. Kaposy C, Baylis F. The common rule, pregnant women, and research: no need to “rescue” that which should be revised. Am J Bioeth. 2011;11:60–2.

    Article  PubMed  Google Scholar 

Download references

Acknowledgment

The author has no relevant conflicts of interest to declare. No sources of funding were used to support the writing of this manuscript.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Doreen Matsui.

Additional information

This article is part of the topical collection on Ethics of Pediatric Drug Research.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Matsui, D. Ethics of Studies of Drugs in Pregnancy. Pediatr Drugs 17, 31–35 (2015). https://doi.org/10.1007/s40272-014-0104-2

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40272-014-0104-2

Keywords

Navigation