“As an increasing number of laws are considered and passed to limit reproductive rights throughout the United States, what impact do you anticipate this political environment will have on research?”

PRIM&R recently asked a panel of thought leaders for their commentary on the article, “Ethical research when abortion access is legally restricted“, published in Science, on June 23, 2023. 

Article Abstract: “Ethical research when abortion access is legally restricted” The legal landscape surrounding abortion in the United States has shifted dramatically since the Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization eliminated a nationwide right to abortion. In the year since, roughly half of US states have expanded abortion restrictions. Some consequences of heightened restrictions—including increased maternal morbidity and mortality and deepening socioeconomic and racial inequities—have quickly come into view. However, little attention has focused on the ethical, legal, and practical implications that such restrictions have for research involving people who could become pregnant during research and research staff. Notably, limited access to abortion can pose risks to clinical research participants and potentially compromise the scientific and social value of some research. As a result, assessments of potential research risks and benefits may be altered. [The authors] outline points for various stakeholders [such as sponsors, investigators, research sites, and IRBs] to consider in addressing these issues.

Below is commentary from thought leaders on this topic. 

Amy Ben-Arieh, JD, MPH, Director of Research Compliance, The Fenway Institute

“I am most concerned about how the laws will affect the applicability of clinical trial data to people assigned female at birth. Already, we are struggling with limited information on how diseases look, progress, and the efficacy of existing therapies in anyone other than cis men. This is the result of decades of myopic science – where cis men were essentially the sole physical standard used to understand human health. It wasn’t until 1994 that there was a policy on the inclusion of “women and minorities” in NIH funded trials. Not until 2015 was there any expectation that the foundational bench science would include an analysis of sex as a biological variable. These Post-Dobbs laws, which create so much fear and uncertainty for people of childbearing potential, can only have a chilling effect on both their willingness and ability to enroll in research. When coupled with the unknown risk and liability they generate for researchers and institutions, as well as the existing challenges of Subpart B, these laws will further exacerbate a dangerous knowledge gap.”

Tonya Ferraro, MeD, Senior IRB QI Consultant at Boston Children’s Hospital, Bioethics Fellow at Harvard Medical School

“As a growing number of US jurisdictions pass laws limiting reproductive rights, the potential repercussions may exacerbate current and introduce new inequities throughout the biomedical and social behavioral research ecosystem. These sociolegal dynamics could foster regional research deserts, as jurisdictions with seemingly inhospitable laws exclude collaborators and research sites, while marginalizing participant populations. Meanwhile, risk-averse, and morally distressed researchers faced with the ambiguity surrounding new legal standards may tend to shift their focus to less ethically contentious and legally restrictive areas of study. In order to minimize these pitfalls, it is crucial that research stakeholders remain attentive to the collective role that research plays in public health and societal well-being, and work to produce generalizable insights that are critical to not only reproductive health but broader societal needs. Given the shifting legal landscape, this will require willingness to conduct research in the face of some uncertainty and measured epistemic humility about interpretation of legal restriction.”

Ann Johnson, PhD, MPH, Director, IRB & HRPP, University of Utah

“The article shows our deep desire—and perhaps our need—for case studies and precedent in this area to better guide our decision making for future study design and IRB determinations. The authors leave a lot in our hands as researchers and IRBs to be not only thoughtful toward the participant experience, but to proactively monitor and collect information that can be used to document precise best practices for including pregnant persons, and those who may become so, in research. It is time for us to pay attention, follow the recommendations, and come up with the unique and ethical solutions that will allow equitable and safe research to continue for this population of people.”

Robert Klitzman, MD, Article Co-Author, Professor and Director of Bioethics Masters and Online Class and Certificate Programs, Columbia University

“The current political environment, in which various states are restricting abortion rights, threatens to hamper important research on the health and well-being of women of child-bearing age – both those that are now pregnant and others. Researchers will likely face increased obstacles in conducting studies on this population, and IRBs will face challenges in ensuring that such research is conducted in ways that protect the rights of such participants. Unfortunately, fears of these difficulties can also dissuade researchers and IRBs from proceeding with certain studies that would nonetheless be permissible to conduct. Given shifts in relevant policies, these stakeholders should thus work with local reproductive health providers, institutional general counsel and legislative affairs offices, and IRBs and investigators elsewhere in their state to share knowledge, experiences and insights regarding the consideration, development, implementation, and enforcement of such policies, to understand whether certain kinds of such studies may nonetheless be possible, and if so, when and how.”

Kim Serpico, Ed.D., CIP, Associate Director of IRB Operations, Harvard T.H. Chan School of Public Health; Post-Doc Fellow, Harvard Medical School Center for Bioethics; Adjunct Faculty, Suffolk University

“Regardless of political environment, any law or standard that differs from state to state in the US poses legitimate challenges to researchers and IRBs alike. State-specific laws concerning topics such as gender-affirming care, use of fetal tissue, audio/visual recordings, and LARs have exemplified how demanding it can be to keep up to date with such laws, as well as the difficulties faced when researchers or IRBs attempt to interpret the law. The Sugarman, et al. article’s (2023) ubiquitous call for education and development of best practices likely won’t suffice when the legal consequences are this serious (e.g., felony charges for aiding abortion). It would be more beneficial for IRBs to collaborate with local legal scholars in these contentious areas. That way, IRBs can provide researchers with options for conducting their work that are practical, compliant, ethical, and present the lowest legal liability possible. IRBs need objective insights to forge lawful research pathways forward, and must expand their circle of advisors to do so.”

Michelle Stickler, DEd, CIP, Associate Vice President for Research & Director, The University of Texas at Austin

  

“In states where abortion has been banned or severely limited, clinical trial sponsors must take additional steps to ensure equitable access to potentially beneficial research rather than avoiding sites or by restricting access among women of childbearing potential. First, an ongoing informed consent process must ensure thorough understanding of the risks to a fetus, as well as the legal restrictions on abortion. If equitable and diverse recruitment of women has any hope of success in such a climate, trials should commit to providing birth control free of charge and consider requiring two forms of birth control. Since local study staff may be legally prohibited from providing information about abortion services, study documentation should refer women to sponsor websites to access abortion support information. Finally, sponsors should commit to providing financial support to women participants who accidentally become pregnant and elect to pursue an abortion. Without measures such as these, the ability to enroll women in research with increased risk to a fetus will be severely limited and potentially unethical across nearly half of the United States.”

At the 2022 PRIM&R Annual Conference, PRIM&R held a session entitled, “When Research Context Changes-Politics, Legislation, the Culture Wars impact on Independent Ethics Oversight.” Given the rapidly changing landscape of reproductive freedoms in the United States, this session recording has been released for free for PRIM&R members.

For your convenience, we have also listed the sessions that will be offered during the 2023 SBER Conference on December 3 and the 2023 PRIM&R Annual Conference, December 4-6 both in Washington, DC. 

• SBER23 Breakout Session A1: When Politics Collide With Research (December 3)

• PRIMR23 Plenary Session: Beyond Evaluating Risk: Now We Must Navigate Sociopolitical Events in Research (December 4)

• PRIMR23 Networking Session D24: Public Policy Roundtable (December 5)

• PRIMR23 Plenary Session: It’s About Time: Inclusion of Sexual and Gender Minorities in Clinical Research (December 5)

Editor’s Note: We rely on experts in the PRIM&R community to provide insight and commentary on substantial issues and changes within the research ethics and oversight field. If you would like volunteer to be on our source list for future articles, please fill out this form.

This article was originally published in the August 2023 PRIM&R Member Newsletter. Click here to become a PRIM&R member and join our supportive membership community that provides resources and connections with colleagues from more than 1,000 institutions in more than 40 countries.