Group to help enhance inclusion of pregnant women and nursing mothers in clinical research
The Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), established in 2016 by the 21st Century Cures Act, has been renewed for an additional two years by the Secretary of Health and Human Services (HHS).
In September 2018, PRGLAC submitted to the HHS Secretary and Congress its report and 15 recommendations. The reconvened task force will now provide advice and guidance to the HHS Secretary on the implementation of these recommendations, which include the following:
- Design research studies to include pregnant women and nursing mothers, unless a scientific justification exists not to
- Expand the workforce of clinicians and researchers with expertise in obstetric and lactation pharmacology and therapeutics
- Remove regulatory barriers that prohibit pregnant women and nursing mothers from participating in research
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health, will continue to lead PRGLAC, a group that includes a wide range of federal health agencies, professional societies, patient organizations, and representatives from the pharmaceutical industry. NICHD Director Diana W. Bianchi, M.D., will serve as chair.
Diana W. Bianchi, M.D. , NICHD Director and chair of PRGLAC, is available for comment.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD conducts and supports research in the United States and throughout the world on fetal, infant and child development; maternal, child and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit NICHD’s website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.