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Clinical trials involving prisoners: a bioethical perspective.

Since the Belmont report in 1979, protections for research participants in the USA have continued to advance and increase awareness among public and research communities about the importance of safeguards for special research-subject populations, particularly those with greater potential for exploitation [101]. Prisoners are one of those special populations due to their restrained liberties and potential for being abused. Unless additional safeguards are implemented and constantly monitored, prisoners will continue to be at risk of being coerced into participating as research subjects. However, with proper procedures and due diligence, prisoners’ choices about research participation can be informed, deliberate and voluntary. Prisoners should be afforded the opportunity to participate in biomedical and behavioral research, but only under conditions assuring adherence to accepted current and future bioethical principles. As with women who are pregnant, human fetuses, neonates, and children, indubitably, prisoners are a ‘vulnerable’ research population that needs protection from potential abuse. Inmates often find themselves in situations where they are unable to protect their own interests, such as feeling pressured by a correctional officer to complete a task or possibly face sanctions for noncompliance. But the potential for abuse should not equate to what has been perceived by some as a prohibition against research involving prisoners. Unquestionably, there have been major problems and concerns with the way some research has been conducted within prisons, but this does not mean that these problems cannot be addressed, thereby allowing researchers the opportunities to find significant and meaningful ways to improve inmate health and well-being through clinical trials. The benefits of research involving prisoners have been noteworthy and have positively impacted the prison population as well as society in general. For example, years of studies involving HIV-positive inmates have resulted in the successful implementation of testing and intervention strategies that have led to a 75% reduction in AIDS-related deaths, a decline that is similar to what has been seen in the community [1]. Building on these scientific achievements, the National Institute on Drug Abuse (MD, USA) is now focusing on implementing and evaluating a ‘seek, test, treat, and retain’ paradigm in criminal justice populations with several projects designed to help HIV-positive inmates maintain viral suppression after release from prison; a high-risk period when interruption of antiretroviral therapy is common and improved adherence strategies are sorely needed. Without the benefits of these research efforts, HIV-positive inmates would most likely not receive the testing and on-going treatment they need, and consequently, would continue to be infectious, posing a public health threat after release. Unfortunately, prisoner research has been disgraced by unscrupulous experiments in the past, such as the dermatological studies in Philadelphia’s Holmesburg Prison. These experiments included paying inmates large sums of money to participate in a “...with proper procedures and due diligence, prisoners’ choices about research participation can be informed, deliberate and voluntary.”