Publications from the PHASES grant team

As part of our work to develop ethics guidance for the responsible and ethical inclusion of pregnant women in the HIV research agenda, we publish papers and author book chapters describing our intermediary findings and processes.

 
 

Advancing HIV Research with pregnant women: navigating challenges and opportunities

CB Krubiner, et al. 2016. AIDS.

"Concerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. We conducted a series of group and one-on-one consultations with 62 HIV investigators and clinicians to elicit their views and experiences conducting HIV research involving pregnant women. Challenges to conducting research on pregnancy and HIV included ethical concerns, legal concerns, financial and professional disincentives, and analytical and logistical complexities. Advancing such research will require clearer guidance regarding ethical and legal uncertainties; incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs."
 

Ethics and Research with Pregnant Women: Lessons from HIV/AIDS

MO Little, et al. 2017. Clinical Research Involving Pregnant Women (eds. Baylis and Ballantyne).

"In this chapter, we describe two key lessons about research in pregnancy from the context of HIV/AIDS: first, why addressing the health needs of pregnant women, not just the needs of their offspring, is so critical; and second, why doing so is immediately possible, even as we work to resolve certain ethical and regulatory debates, particularly about when it is appropriate to impose foetal risk without the prospect of foetal benefit. In particular, the HIV/AIDS context shows how treatment or prevention of maternal disease often entails not just risk – but the prospect of benefit – to the foetus; and creative trial designs can advance no-benefit studies without imposing foetal risk in the first place. For all the challenges that research with pregnant women entails, the HIV/AIDS context reveals that it is possible to conduct a wide range of important research during pregnancy that is both ethically responsible and consonant with US regulations."
 

Research with Pregnant Women: New Insights on Legal Decision-Making

AC Mastroianni et al. 2017. Hastings Center Report.

"U.S. researchers and scholars often point to two legal factors as significant obstacles to the inclusion of pregnant women in clinical research: the Department of Health and Human Services’ regulatory limitations specific to pregnant women's research participation and the fear of liability for potential harm to children born following a pregnant woman's research participation. This article offers a more nuanced view of the potential legal complexities that can impede research with pregnant women than has previously been reflected in the literature. It reveals new insights into the role of legal professionals throughout the research pathway, from product conception to market, and it highlights a variety of legal factors influencing decision-making that may slow or halt research involving pregnant women.