IRB: Ethics & Human Research

Women’s Views about Participating in Research While Pregnant

Pregnant women and their interests have been underrepresented in health research. Little is known about issues relevant to women considering research participation during pregnancy. We performed in-depth interviews with 22 women enrolled in either one of two trials sponsored by the National Institutes of Health to assess the safety and immunogenicity of the H1N1 vaccine during pregnancy. Three themes characterized women’s decisions to participate in research: they valued early access to the vaccine, they perceived a safety advantage when participating in research, and they wanted to help advance scientific knowledge. However, there were also some considerations that would disincline them to participate in research—for instance, a significant risk of maternal or fetal harm, the presence of a placebo arm in a study, or a requirement to significantly change planned therapy or behavior. Pregnant women who participated in the H1N1 vaccine trials viewed research favorably, citing its advantages over standard clinical care. These findings emphasize that access to benefit should guide policy for including pregnant women in research.

Key words/concepts: human subjects research, pregnancy, research ethics, qualitative research, risk/benefit

Anne Drapkin Lyerly, Emily E. Namey, Beverly Gray, Geeta Swamy, and Ruth R. Faden, “Women’s Views about Participating in Research While Pregnant,” IRB: Ethics & Human Research 34, no. 4 (2012): 1-8.