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Ethical and Legal Obligations for Research Involving Pregnant Persons in a Post-Dobbs Context

Published online by Cambridge University Press:  13 December 2023

Richard M. Weinmeyer Open the ORCID record for Richard M. Weinmeyer [Opens in a new window] ,
Seema K. Shah  and
Michelle L. McGowan
Richard M. Weinmeyer
Affiliation:
DEPAUL UNIVERSITY COLLEGE OF LAW, CHICAGO, IL, USA NORTHWESTERN UNIVERSITY, CHICAGO, IL, USA
Seema K. Shah
Affiliation:
NORTHWESTERN UNIVERSITY, CHICAGO, IL, USA LURIE CHILDREN’S HOSPITAL, CHICAGO, IL, USA
Michelle L. McGowan
Affiliation:
MAYO CLINIC, ROCHESTER, MN, USA.
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Abstract

In light of a history of categorical exclusion, it is critical that pregnant people are included in research to help improve the knowledge base and interventions needed to address public health. Yet the volatile legal landscape around reproductive rights in the United States threatens to undue recent progress made toward the greater inclusion of pregnant people in research. We offer ethical and practical guidance for researchers, sponsors, and institutional review boards to take specific steps to minimize legal risks and ensure the ethical conduct of research with pregnant people in an evolving legal environment.

Keywords

Research Ethics and RegulationAbortionPregnancyHuman Subjects ResearchHealth Law
Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 51 , Issue 3: Seeking Reproductive Justice in the Next 50 Years , Fall 2023 , pp. 504 - 510
Copyright
© 2023 The Author(s)

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References

Aspinwall, C. et al., “They Lost Pregnancies for Unclear Reasons. Then They were Prosecuted.” Washington Post, September 1, 2022.Google Scholar
Transcript of Oral Argument at 49, Dobbs v. Jackson, Women’s Health Org., 597 U.S. ___ (No. 19-1392).Google Scholar
Fowler, L. R. and Ulrich, M., “Femtechnodystopia,” Stanford Law Review 75 (forthcoming 2023), available at <https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4099764> (last visited November 9, 2022).Google Scholar
Lyerly, A.D. et al., “The Second Wave: Toward Responsible Inclusion of Pregnant Women in Research,” International Journal of Feminist Approaches to Bioethics 1, no. 2 (2008): 5–22.CrossRefGoogle ScholarPubMed
Mitchell, A. A. et al., “Medication use During Pregnancy, with Particular Focus on Prescription Drugs: 1976-2008,” American Journal of Obstetrics and Gynecology 205, no. 1 (2008): 51.e1–51.e8.Google Scholar
Food and Drug Administration, “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials,” (Rockville, MD, April 2018), available at <https://www.fda.gov/media/112195/download> (last visited February 15, 2022).+(last+visited+February+15,+2022).>Google Scholar
Adam, M. P. et al., “Evolving Knowledge of the Teratogenicity of Medications in Human Pregnancy,” American Journal of Medical Genetics 157C, no. 3 (2011): 175–182.Google Scholar
Lyerly et al., supra note 4.Google Scholar
National Academies of Sciences, Engineering, and Medicine, “Women’s Health Research: Progress, Pitfalls, and Promise,” (Washington, DC: The National Academies Press, 2010): at 16Google Scholar
Franks, M. E. et al., “Thalidomide,” The Lancet 363 (2004): 1802–1811.CrossRefGoogle ScholarPubMed
Id. Google Scholar
Hoover, R. N. et al., “Adverse Health Outcomes in Women Exposed in Utero to Diethylstilbestrol,” New England Journal of Medicine 365, no. 14 (2011): 1304–1314.CrossRefGoogle ScholarPubMed
“ACOG Committee Opinion No. 268: Management of Asymptomatic Pregnancy or Lactating Women Exposed to Anthrax,” Obstetrics and Gynecology 99, no. 2 (2002): 366–368.Google Scholar
Andrew, M. A. et al., “Amoxicillin Pharmacokinetics in Pregnant Women: Modeling and Simulations of Dosage Strategies,” Clinical Pharmacology and Therapeutics 81, no. 4 (2007): 547–556.CrossRefGoogle ScholarPubMed
Bianchi, D. W. et al., “Involving Pregnant Individuals in Clinical Research on COVID-19 Vaccines,” JAMA 325, no. 11 (2021): 1041–1042.CrossRefGoogle ScholarPubMed
See National Institutes of Health, NIH Begins Study of COVID-19 Vaccination During Pregnancy and Postpartum, National Institutes of Health New Releases, June 23, 2021, available at <https://www.nih.gov/news-events/news-releases/nih-begins-study-covid-19-vaccination-during-pregnancy-postpartum> (last visited November 10, 2022).+(last+visited+November+10,+2022).>Google Scholar
Krubiner, C. B. et al., “Pregnant Women & Vaccines against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research, and Response,” Vaccine 39 (2021): 85–120,.CrossRefGoogle ScholarPubMed
Lyerly, D. et al., “Ending the Evidence Gap for Pregnancy, HIV and Co-Infections: Ethics Guidance from the PHASES Project,” Journal of the International AIDS Society 24, no. 12 (2021): 1–7.CrossRefGoogle ScholarPubMed
Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Health-related Research Involving Humans, CIOMS website, available at <https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf> (last visited November 10, 2022).+(last+visited+November+10,+2022).>Google Scholar
Pub. L. 114–255, div. A, title II, §2041, Dec. 13, 2016, 130 Stat. 1070; National Institute for Child Health and Human Development, Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), PRGLAC Task Force website, available at <https://www.nichd.nih.gov/about/advisory/PRGLAC> (last visited November 10, 2022).+(last+visited+November+10,+2022).>Google Scholar
Task Force on Research Specific to Pregnant Women and Lactating Women, “Report to the Secretary of Health and Human Services and Congress,” September 2018, available at <https://www.nichd.nih.gov/sites/default/files/2018-09/PRGLAC_Report.pdf> (last visited November 10, 2022).+(last+visited+November+10,+2022).>Google Scholar
45 C.F.R. 46 § 46.204 (2018).CrossRefGoogle Scholar
Beauchamp, T. L. and Childress, J. F., Principles of Biomedical Ethics (New York: Oxford University Press, 2009).Google Scholar
Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Subjects in Human Subjects Research (December 2011), available at <https://bioethicsarchive.georgetown.edu/pcsbi/sites/default/files/Moral%20Science%20June%202012.pdf> (last visited February 16, 2023).+(last+visited+February+16,+2023).>Google Scholar
Emanuel, E. J. et al., “What Makes Clinical Research Ethical?” JAMA 283, no. 20 (2000): 2701–2711.CrossRefGoogle ScholarPubMed
International Ethical Guidelines for Health-related Research Involving Humans, supra note 19.Google Scholar
A. Brennan, “Subject, not Suspect: The New Hazards of Conducting Clinical Research in the Dobbs Era,” STAT Plus, September 26, 2022, available at <https://www.statnews.com/2022/09/26/new-hazards-conducting-clinical-research-dobbs-era/ > (last visited February 17, 2023). +(last+visited+February+17,+2023).>Google Scholar
Id.; C. M. Klapperich, “How the Dobbs Decision Changed my Research on Reproductive Health Technology,” STAT, June 30, 2022, available at <https://www.statnews.com/2022/06/30/dobbs-decision-changing-research-reproductive-health-technology/> (last visited February 17, 2023).+(last+visited+February+17,+2023).>Google Scholar
National Institutes of Health, HEALthy Brain and Child Development Study (HBCD), HBCD website, available at <https://heal.nih.gov/research/infants-and-children/healthy-brain> (last visited February 17, 2023).+(last+visited+February+17,+2023).>Google Scholar
National Institutes of Health, Information Protected by a CoC, National Institutes of Health Grants and Funding website, available at <https://grants.nih.gov/policy/humansubjects/coc/information-protected-coc.htm> (last visited February 17, 2023).+(last+visited+February+17,+2023).>Google Scholar
Olson, N. W., “Medical Researchers’ Ancillary Care Obligations: The Relationship-Based Approach,” Bioethics 30, no. 5 (2016): 317–324.CrossRefGoogle ScholarPubMed
University of Wisconsin Law School, Pilar Ossorio, Faculty Profile website, available at <https://secure.law.wisc.edu/profiles/pnossorio@wisc.edu> (last visited February 17, 2023).+(last+visited+February+17,+2023).>Google Scholar
Morgridge Institute for Research, Infants with Prenatal Substance Exposure, Morgridge Institute for Research website, available at <https://morgridge.org/research/bioethics/prenatal-substance-exposure/> (last visited February 16, 2023).+(last+visited+February+16,+2023).>Google Scholar
National Institutes of Health, Information Protected by a CoC, National Institutes of Health Grants and Funding website, available at <https://grants.nih.gov/policy/humansubjects/coc/information-protected-coc.htm> (last visited February 17, 2023).+(last+visited+February+17,+2023).>Google Scholar
Wolf, L. E. et al., “Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice,” Journal of Law, Medicine & Ethics 43, no. 3 (2016): 594–609.CrossRefGoogle Scholar
Marshall, M. F. et al., “Perinatal Substance Abuse and Human Subjects Research: Are Privacy Protections Adequate?” Mental Retardation and Developmental Disabilities Research Reviews 9, no. 1 (2003): 54–59.CrossRefGoogle ScholarPubMed
Hui, K. et al., “Criminalizing Substance use in Pregnancy: Misplaced Priorities,” Addiction 112, no. 7 (2017): 1123–1125.CrossRefGoogle ScholarPubMed
Gerdts, C. et al., “Side Effects, Physical Health Consequences, and Mortality Associated with Abortion and Birth after an Unwanted Pregnancy,” Women’s Health Issues 26, no. 1 (2016): 55–59.CrossRefGoogle ScholarPubMed
Foster, D. G. et al., “Effects of Carrying an Unwanted Pregnancy to Term on Women’s Existing Children,” Journal of Pediatrics 205 (2019): 183–189.CrossRefGoogle ScholarPubMed