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

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Book cover Clinical Research Involving Pregnant Women

Part of the book series: Research Ethics Forum ((REFF,volume 3))

Abstract

HIV/AIDS is among the most serious diseases confronting women who are pregnant. It is also one of the few areas of research involving humans where there is a long track record of research involving pregnant women. Yet the HIV/AIDS research community has struggled to expand the research agenda from research to prevent mother-to-child transmission of HIV to research encompassing issues pertaining to the pregnant woman’s own health. Research questions of interest include: which antiretrovirals are safest and most effective for pregnant women; how best to pursue preventive regimes for pregnant women who are not infected; or, how to treat HIV’s deadly co-infections, such as tuberculosis (TB), during pregnancy. 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.

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Notes

  1. 1.

    The scope and urgency of the pandemic have resulted in unusually high levels of public funding and robust public-private partnerships, including private pharmaceutical companies, with a notable emphasis on trials that have included research with pregnant women for the purposes of preventing mother-to-child transmission. In 2012, PEPFAR (the President’s Emergency Plan for AIDS Research) accounted for 73 % of all bilateral aid for HIV, 49 % of all international assistance, and 23 % of total HIV funding. Multilateral organisations, including the Global Fund to Fight AIDS, Tuberculosis and Malaria and the World Bank provided 28 % of international assistance for HIV, while the private sector, including the Bill and Melinda Gates Foundation, have contributed more than 5 % (AVERT 2014). Mirroring the public response, the pharmaceutical industry has invested significantly, reporting in 2014 that 44 medicines and vaccines are currently being developed with 94 active trials in the US alone and many more worldwide, including several trials that have included pregnant women (PhRMA 2014).

  2. 2.

    For instance, the World Health Organization (WHO) recommends the drug pyrazinamide (PZA) during pregnancy as first line therapy, but the US Centers for Disease Control (CDC) do not due to inadequate data on foetal effects (Gupta et al 2016).

  3. 3.

    Other studies have estimated even higher transmission rates. For example, in a cohort analysis of HIV-exposed births in New York City between 2002 and 2006, Birkhead et al. found that maternal acquisition of HIV during pregnancy was associated with a 15-fold increase (2010).

  4. 4.

    In the first year of the PHASES Project we held several group and individual discussions with HIV researchers and clinicians to get a sense of the priorities, barriers, and opportunities they saw around HIV research in pregnant women . Formal summary of these findings is in progress.

  5. 5.

    We observed this tendency previously in the National Children’s Study, the largest US study to investigate the effects of the environment on children’s health, from before birth to age 21. Of the 100,000 children to be studied, a cumulative 90 % were to be enrolled as foetuses, while their intended mothers were in the first trimester of pregnancy. In other words, tens of thousands of pregnant women would be studied, but primarily in terms of the effect their bodies and environments had on the health of their children (Lyerly et al. 2009).

  6. 6.

    Our discussions with HIV investigators – many of whom had considered, proposed, or conducted research with pregnant women – widely evoked these concerns.

  7. 7.

    Subpart B – Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research is part of DHHS regulations, and directly regulates DHHS/FWA funded research. That said, it has been highly influential as guidance governing other contexts, including any medications that seek FDA approval.

  8. 8.

    International Maternal Pediatric Adolescent AIDS Clinical Trials.

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Authors and Affiliations

  1. Kennedy Institute of Ethics, Georgetown University, Washington, DC, USA

    Margaret Olivia Little BPhil, PhD

  2. Center for Bioethics, Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

    Anne Drapkin Lyerly MD, MA

  3. University of Washington School of Law, Seattle, WA, USA

    Anna C. Mastroianni JD, MPH

  4. Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA

    Ruth R. Faden PhD, MPH

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  1. Margaret Olivia Little BPhil, PhD
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Correspondence to Margaret Olivia Little BPhil, PhD .

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  1. Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada

    Françoise Baylis

  2. University of Otago, Wellington, New Zealand

    Angela Ballantyne

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Little, M.O., Lyerly, A.D., Mastroianni, A.C., Faden, R.R. (2016). Ethics and Research with Pregnant Women: Lessons from HIV/AIDS. In: Baylis, F., Ballantyne, A. (eds) Clinical Research Involving Pregnant Women. Research Ethics Forum, vol 3. Springer, Cham. https://doi.org/10.1007/978-3-319-26512-4_13

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