Ethical considerations for research involving pregnant women with HIV and their children.

Pregnant and postpartum women with HIV (PPWH) and their children have historically been excluded from certain research in the name of protection. This may, however, inadvertently exacerbate health disparities. While calls for their inclusion have increased, additional practical guidance to achieve this goal is needed. Within this editorial, we provide practical recommendations for enabling PPWH and their children to participate ethically in research by identifying and addressing issues that potentially put them at risk. We ground this discussion in a framework that considers the various vulnerabilities that may exist when involving this population in research. These considerations were further informed by person-centered empirical data collected in Kenya, as well as reviews of the literature. Five key domains of consideration include: prioritizing confidentially, support for appropriate agency in decision-making, broad considerations related to respect for persons, community engagement, and appropriate oversight. We hope that the resulting guidance will inform future research practices, with implications for advancing ethical and inclusive research involving PPWH and their children.