NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT REPORT MARKS RESEARCH GAPS ON THERAPIES USED BY PREGNANT/LACTATING WOMEN
In a recent report from a task force organized by the National Institute of Child Health and Human Development (NICHD), it underscored research gaps involving the pregnant/breastfeeding population.
With nearly 6 million women who get pregnant in the US yearly and will take medication during pregnancy and lactating, the institution observed that they are often excluded from clinical research.
Completing that research gap is one of the 15 recommendations from the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC). The panel was charged with advising the Secretary of Health and Human Services (HHS) on identifying and addressing gaps in knowledge and research on safe and effective therapies for pregnant and lactating women. The Secretary of HHS has until December 2018 to decide whether action on the PRGLAC recommendations is warranted.
“There is limited scientific knowledge about the effectiveness and optimal dosing of drugs commonly prescribed for pregnant and lactating women,” said NICHD Director Diana W. Bianchi, MD, in a press release. “This needs to change. The theme that resonates clearly throughout the task force recommendations is that we need to emphasize the importance of protecting these populations through research instead of from research.”
Other key recommendations from the PRGLAC taken from four open meetings and a public comment period:
- Including and integrating pregnant and breastfeeding women in the clinical research agenda;
- Expanding the workforce of clinicians and research investigators practicing in obstetric and lactation pharmacology and therapeutics;
- Removing regulatory barriers to research in pregnant women; and
- Optimizing registries for pregnancy and lactation.
With the charter of the PRGLAC expiring in March 2019, the task force calls for a universal consent for pregnancy lactation studies and a revision to the requirement for both maternal and paternal consent before a pregnant woman can participate in a study benefiting only the fetus.
Erudite Nursing Institute™ encourages nurse researchers to include pregnant and breastfeeding women. In this little effort, you can make a difference in integrating their rights and privileges in medicine.
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