By Bria Fitz, MA, SWHR Public Policy Fellow
The National Academies of Sciences, Engineering, & Medicine (NASEM) released a new report this week, titled “Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks.”
This report, developed by the NASEM Committee on Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons, is the result of a call from Congress for NASEM to convene a committee to examine the real or perceived liability risk arising from research conducted with pregnant and lactating women. Today, approximately 90% of women take at least one medication during pregnancy. Yet, many medications that are prescribed don’t have pregnancy or lactation data available, leaving patients and doctors to make decisions about medications with limited information. This lack of data has stemmed from the exclusion of pregnant and lactating people in many research studies.
Legal liability has been cited as a major reason for exclusion of these populations in research, including in a 2018 document released by the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC). The recent National Academies report investigated the legal liability landscape in the United States regarding research on pregnant and lactating people and made recommendations on how to include these populations in ways that could mitigate or help avoid liability concerns. Additionally, the report proposed strategies to minimize harm and address other dissuasive factors.
In an article from The Fuller Project about the report’s launch, SWHR Chief Science Officer Dr. Irene Aninye said NASEM’s report is unique because it addresses the unknown liability concern in this type of research:
“Every trial has its unknowns — it has its benefits and risks. But you plan and strategize for it to be as safe as possible for everyone involved and this should be applied to diverse populations as well.”
In total, the NASEM report made nine recommendations. These recommendations included, but were not limited to, the following:
- Proposing that the U.S. Department of Health and Human Services (HHS), the Office for Human Research Protections (OHRP), and the Food and Drug Administration (FDA) to clarify guidance on the inclusion of pregnant and lactating people in studies
- Calling on the National Institutes of Health (NIH) to aid with the cost of clinical trial insurance for research that includes pregnant and lactating people and to create an action plan that prioritizes research that includes pregnant and lactating people
- Recommending that Congress should pass legislation modeled on the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
A full list of recommendations can be found in the report here.
Coinciding with the release of the report, NASEM hosted a webinar on April 10 to highlight key conclusions and recommendations. That webinar and accompanying slide deck can be viewed here.