High incarceration rates among black men enrolled in clinical studies may compromise ability to identify disparities.

In 1978 the federal government restricted research on prison and jail inmates in medical studies, the result of decades of unethical research in correctional institutions. We evaluated the impact this policy has had on studies of health outcomes in minority populations, particularly studies involving black men, who are disproportionately incarcerated. Specifically, we explored the effect of incarceration on follow-up rates of fourteen prospective clinical studies funded by the National Heart, Lung, and Blood Institute. We estimated that during the past three decades high rates of incarceration of black men may have accounted for up to 65 percent of the loss to follow-up among black men in these studies. The impact of incarceration was far less among white men, black women, and white women. These estimates suggest that the ability of those studies to examine racial disparities in health outcomes, as well as to understand the experience of this group, could be compromised. We believe that community-recruited subjects who are incarcerated should be allowed to continue participating in observational clinical research that poses minimal risk to participants.