(Garrison, NY) A new study involving pregnant women who enrolled in randomized vaccine trials challenges the longstanding reluctance to conduct research with pregnant women because of ethical concerns about the risk it poses. The study, which appears in IRB: Ethics & Human Research, points the way toward reforming current practices and policies so that they benefit pregnant women and provide information that is lacking about the safety and efficacy of medications during pregnancy.“Broad-based exclusion of pregnant women from biomedical research studies endangers both women and children,” write the authors. “More than 400,000 women each year face serious medical illness during pregnancy, yet there are inadequate data to guide treatment decisions.”

This problem was brought into sharp relief by the H1N1 influenza pandemic in 2009, in which a disproportionate number of those who became ill or died were pregnant women. Among the many contributing factors, the authors write, were “delays in treatment with antiviral medications, whose safety and efficacy during pregnancy were unknown.”

For the new study, the researchers sought to find out women’s views about participating in research while pregnant. “It was one of the first studies of pregnant women’s attitudes about participating in a randomized trial of an intervention aimed at preventing a nonobstetrical illness during pregnancy,” they state.

They conducted in-depth interviews with 22 women who participated while pregnant in either of two H1N1 vaccine studies conducted by the National Institutes of Health. The women were randomized to receive one of two different doses of the vaccine. Three considerations influenced the women’s decisions about entering the trial:

• Early access to the vaccine. More than half of the respondents said that they enrolled in the study in order to receive the vaccine before they could have received it otherwise. Fueling their desire for early vaccination were concerns that the pandemic might lead to a scarcity of vaccine supplies.
• Vaccine safety. Most respondents indicated they would have enrolled in the H1N1 vaccine trial even if the vaccine had been available outside the study, with several indicating that they felt safer being part of a research study than not. Some women reasoned that they would get better care in the trial than they would as ordinary patients because they would get more detailed information and closer monitoring.
• Altruism. Many women said that altruistic considerations motivated them to participate in the vaccine trial. Some focused in particular on the dearth of evidence for therapeutics in pregnancy and how their participation could help document evidence. One respondent said that because she was hearing a lot of well-educated people expressing uninformed opinions abut the vaccine, she “was glad to be in a trial that would hopefully get rid of those fears.”

The women in the study also cited considerations that might have made them decide against participating in research — for instance, a significant risk of harm to them or to their fetuses or the presence of a placebo arm of the study, which would have left them uncertain about whether they would receive an intervention perceived as beneficial.

But one of the most surprising findings was that many of the women viewed research participation as “safer” than care they would have received as patients. “The presumption that research participation is riskier than clinical care is often questionable,” the authors write. “This is particularly so in pregnancy where the opposite may be true: because our evidence base for current treatments is so weak, standard practice can be more like experiment than validated treatment.”

The authors conclude that their data “challenge current notions that de facto exclusion of pregnant women from research is justified.”

“The data also point toward both the feasibility and responsibility of reforming current practices and policies so that they fairly benefit pregnant women — both those who choose to participate in research and those who stand to benefit form the knowledge it generates.”

The authors are Anne Drapkin Lyerly, MD, MA, associate professor of social medicine, Department of Social Medicine, and associate director, Center for Bioethics, at the University of North Carolina at Chapel Hill; Emily E. Namey, MA, senior research associate for behavioral and social sciences at FHI 360, in Research Triangle Park, N.C.; Beverly Gray, MD, is assistant professor of obstetrics and gynecology at Duke University; Geeta Swamy, MD, is associate professor of obstetrics and gynecology at Duke University; and Ruth R. Faden, PhD, MPH, is Philip Franklin Wagley Professor of Biomedical Ethics and director of Johns Hopkins Berman Institute of Bioethics.

Contact:Michael Turton, Communications Associate
turtonm@thehastingscenter.org
845 424 4040 ext. 242