P45.03
Background: Pregnant women need safe and effective HIV prevention methods. In many countries, pregnant women are at high risk of HIV acquisition; countries with high rates of HIV incidence and generalized epidemics are also largely countries with high fertility rates. Also, social and structural barriers to women's autonomous decision-making may hinder pregnant women from protecting themselves.
While the HIV prevention field is moving rapidly, testing prevention interventions in trials with pregnant women remains daunting. Ethical and regulatory barriers are significant, and community, provider, and individual women's perspectives are complex.
The consequences of failing to conduct research with pregnant women are serious. Absent robust data, pregnant women must either eventually use these products without knowing if they are safe and effective, or avoid the products and continue to be exposed to high risks of HIV acquisition.
Methods: Significant barriers and opportunities must be identified. Human research regulations place stringent restrictions on research with pregnant women. Although the heaviest burden of HIV lies in sub-Saharan African countries, each with its own research regulations, US regulations have a significant impact. The US is a major funder of biomedical HIV prevention research, and any study funded by the US government must adhere to US regulations. Researchers may have difficulty meeting criteria for approval under this rule.
Results: To overcome these challenges, a more robust ethical approach to research with pregnant women is needed. This paper explores the key ethical parameters that must be considered in finding an appropriate balance for inclusion of pregnant women in research, and discusses how this might fit under current regulatory standards.
Conclusions: Research with pregnant must advance to extend the benefits of HIV prevention to this key population. A new and more appropriate ethical framework will help accomplish this goal.
