Advancing Inclusion: Integrating Pregnant and Lactating People in Research

Meeting Summary

Presented on: March 8, 2024

Abstract:

There is widespread recognition, including among pregnant and lactating people, of the need for better evidence on which to base medical treatment decisions during pregnancy and the post-partum period. Despite this, pregnant and lactating people continue to be left out of clinical trials that test drugs, vaccines, devices, and other medical products for safety and efficacy. Study eligibility criteria routinely exclude both pregnant and lactating individuals, even though the biological bases for exclusion of the two populations differ; the effects of exposure of medicinal products to the fetus at the varying stages of development differ from the effects on the neonate or newborn of medicinal products possibly transferred through breast milk Eligibility often requires negative pregnancy tests prior to enrollment and effective methods of contraception for the duration of the study. Further, people who become pregnant while on an interventional trial protocol are typically withdrawn from further participation. Explanations for this are likely to involve perceived ethical, regulatory, and/or legal considerations, reflecting primarily a concern to avoid harming the developing fetus. In the United States, the regulatory framework requires special protections that must be met before pregnant people may participate in clinical research, including limits on the risks they may be asked to undertake. And there are no federal regulations on the exclusion of or additional safeguards for lactating people, despite their common exclusion. In addition, concerns about potential liability and negative public perception are likely to loom large for sponsors, funders, and investigators, motivating them toward the perceived safer strategy of excluding pregnant people from research in many situations.    

At the March 2024 meeting of the Bioethics Collaborative, we examined ethical issues that bear on determining the proper scope of efforts to further the inclusion of people who are pregnant or lactating in clinical research. Discussion sought to build on prior workshops and recommendations asking such questions as: Is the current default of excluding pregnant and lactating people from interventional clinical trials justifiable? Do pregnant people have the right to autonomously choose what level of risk is acceptable for themselves and the fetus they carry? How do clinical research entities circumscribe a reasonable range of, and limits on, risk for pregnant people in research, and does this definition align with the views of pregnant and lactating people? Are there alternatives to including pregnant people in clinical trials that can yield the data needed to improve the care of pregnant and lactating people and avoid the well-known problems that arise with seeking to protect groups by excluding them? What are the justice-based implications of placing restrictions on pregnancy? Might requirements for effective contraception, for example, inadvertently function to discourage or even preclude participation from people who are unable to afford contraception? Could these requirements, which are likely to be perceived as burdensome by some, hinder the participation of people of childbearing potential generally and further exacerbate gender inequities in clinical research? 

Reciprocity in Research: Does the Principle of Justice Support Community Investment

Meeting Summary

Presented on: June 18, 2024

This meeting was presented to the Bioethics Collaborative. The Bioethics Collaborative is a forum to propose, share, and discuss ethical challenges in multi-national clinical trials. Meetings convene individuals from academia, industry, patient/participant groups, ethics committees, government, and others.

Abstract:  It is generally agreed that sponsors and other entities undertaking research in limited-resource settings incur certain duties of reciprocity. These obligations ensure that host communities are treated fairly and not exploited, given the burdens and risks of research undertaken by community members. However, the expectations, content, and limitations of these obligations are not defined. The next Bioethics Collaborative will be devoted to understanding and assessing different approaches to satisfying the ethical contorts of reciprocity for research undertaken in these settings.

Gene Therapies: Probing the Ethics

Meeting Summary

Presented on: December 14, 2023

Presented at: Cambridge, MA and online

The MRCT Center recently initiated a project on cell and gene therapies (CGTs), led by Carolyn Riley Chapman, PhD MS, Lead Investigator in the Division of Global Health Equity at Brigham and Women’s Hospital and Member of the Faculty at Harvard Medical School. In collaboration with diverse stakeholders, the project will identify and characterize the unique ethical, regulatory, and logistical challenges related to CGT research and development; we will then develop potential solutions or approaches to help address those issues.  This meeting, held in conjunction with the Bioethics Collaborative, served, in part, as the project launch.

While the MRCT Center Bioethics Collaborative meetings are usually open only to invited guests and individuals from the organizations that sponsor the forum, this session was presented in conjunction with the 2023 MRCT Center Annual Meeting and was open to the public.

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