In July 2011, the Department of Heath and Human Services (DHHS) issued an “advanced notice of proposed rulemaking” (ANPRM), which is a proposal to begin the formal process of making significant changes to the regulatory oversight of research involving human subjects. A review of the proposed rules by Second Wave Initiative leaders Maggie Little and Ruth Faden of the KIE as well as Anne Drapkin Lyerly of the Center for Bioethics at UNC-Chapel Hill found no serious attempt to address the under-representation of pregnant women and their interests in medical research.
While over 500,000 women in the United States face serious medical illness during pregnancy, there is limited information on how to safely and effectively treat them, in part because of the insufficiency of current regulations for providing guidance to researchers and institutional review boards. The current practice of summarily excluding all pregnant women from clinical research trials (even where there is minimal concern regarding fetal safety) is a dangerous one, and improved inclusion guidelines from the DHHS are crucial for improving the health of women and their newborns.
Members of the Second Wave Initiative have drafted, signed, and formally submitted public comments imploring the DHHS to consider five proposed recommendations that fit within the approach of the ANPRM and would make a substantial contribution to improving guidance on research with pregnant women.