Ensuring the Ethical Inclusion of Pregnant Women in HIV Research

Many OB/GYNs frequently must make treatment recommendations for pregnant patients – including patients living with or at risk for HIV – based on insufficient evidence about how well medications will work for them. This is an unfortunate reality, due to longstanding concerns about the ethics of conducting research with pregnant women. Anne Drapkin Lyerly, Greenwall Faculty Scholar Class of 2007, Professor of Social Medicine and board-certified OB/GYN, is working to change this.  She is aiming to improve patient care by ensuring that ethical research informs treatment options for prevention and treatment of disease in pregnancy.  

Many pregnant women around the world have HIV or are at risk of contracting HIV: In 2017, an estimated 1.1-1.7 million pregnant women worldwide were living with HIV. However, large gaps exist in understanding the impact of new HIV medications on pregnant women and their fetuses. Research on the safety and efficacy of new HIV medications for pregnant women often happens years after drugs are initially approved. This is, in part, because researchers often perceive pregnant women as “vulnerable,” and exclude them from studies to avoid any potential harm to them or their fetuses. Dr. Lyerly and others argue, however, that when pregnant women are excluded from participating in research, they are also excluded from its benefits, which include recommendations for treatment, access to critical medications, and clinical decisions based on evidence rather than anecdote.  

Several U.S. and international organizations have called for increased research to fill these information gaps. Responding to this call, the PHASES Working Group, funded by the National Institute of Allergy and Infectious Diseases and led by Dr. Lyerly, along with bioethicists Maggie Little and Ruth Faden, has developed specific actionable recommendations to help researchers and other stakeholders design and conduct ethical research on HIV medications for pregnant women. The 26-member interdisciplinary and international Working Group issued its Guidance, Ending the evidence gap for pregnant women around HIV & co-infections: a call to action, in July as part of a seven-year effort. 

The PHASES Guidance aims to help researchers meet the ethical imperative to conduct responsible research with pregnant women – both by ensuring protection from research-related harms and underscoring opportunities for the ethical inclusion of pregnant women and their interests in the HIV and coinfection research agenda. The Guidance is broadly applicable: it includes recommendations to help organizations make their culture more conducive to research with pregnant women as well as specific recommendations on how to balance the research risk that pregnant women face and their need for evidence-based treatment.  For example, the Guidance suggests that organizations with power to impact research priorities explicitly reaffirm a commitment to studying the impacts of HIV & co-infection treatment and prevention on pregnant women; it also recommends that researchers address legacy evidence gaps by prioritizing research on the maternal impacts of drugs already deemed safe for fetuses, and on the maternal impacts of drugs which are known to be particularly effective for the general population.  

The International Community of Women Living with HIV and the International Community of Women Living with HIV in Eastern Africa have already endorsed the PHASES Guidance. Dr. Lyerly and the Working Group anticipate that, with wide implementation, the Guidance will help reduce the information gap surrounding HIV and coinfection medication for pregnant women and ultimately improve their care as well as outcomes for the children they bear.  

The full PHASES Guidance and an executive summary can be found here. Dr. Lyerly’s related work includes: 

• Anne Drapkin Lyerly, Dolutegravir: advancing ethical research in pregnancy, The Lancet, Nov 2019.  
• Kristen Sullivan et al,. Women’s views about a paternal consent requirement for biomedical research in pregnancy, Journal of Empirical Research in Human Research Ethics, Oct 2018. 
• Margaret Olivia Little et al., Ethics and research with pregnant women: Lessons from HIV/AIDS, in Clinical Research Involving Pregnant Women, Springer, 2016.  
• Carleigh Krubiner et al., Advancing HIV research with pregnant women: Navigating challenges and opportunities, AIDS, Sept 2016. 
• Anne Drapkin Lyerly et al., The second wave: Toward responsible inclusion of pregnant women in research, IJFAB, Oct 2008.