Biomedical Research Involving Prisoners: Ethical Values and Legal Regulation

Until the early 1970\u27s, approximately 90% of all pharmaceutical research was conducted on prisoners, who were also subjected to biochemical research, including studies involving dioxin and chemical warfare agents. By the mid-1970\u27s, biomedical research in prisons sharply declined as knowledge of the exploitation of prisoners began to emerge and the National Commission for the protection of Human Subjects of Biomedical Research was formed. Federal regulations to protect human subjects of research were established in 1974. Special protections for prisoners were added in 1978, severely limiting research involving prisoners. However, the US correctional system has undergone major changes since the adoption of the federal regulations, making it appropriate to reexamine the ethical framework for research involving prisoners. While the history of prisoner exploitation cautions against allowing research, modern science might be able to improve understanding of the intractable problems faced by prisoners. Finding a balance between encouraging beneficial research and safeguarding prisoners is challenging and politically controversial. This commentary presents a series of proposals, based on the recommendations of Institute of Medicine Committee on Ethical Considerations for Research Involving Prisoners. If adopted, the following proposals would provide such a system of safeguards while allowing responsible research. 1) Expand the Definition of Prisoner to include non-custodial prisoners, comprehensively covering all individuals whose autonomy and liberty are restricted by the justice system. 2) Ensure Universal, Consistent Ethical Protection of prisoners by regulating all research on prisoners uniformly, irrespective of the source of funding, supporting agency, or type of correctional facility. 3) Create a National Database of Prisoner Research to permit greater accountability, provide a scientific methodology for assessing the success of research projects, and facilitate the implementation of beneficial research findings to prisoner populations. 4) Shift from a Category-Based to a Risk-Benefit Approach to Research Review to ensure that research with prisoners should be conducted only if it offers a distinctly favorable benefit-to-risk ratio, not because prisoners are a convenient source of research participants or have no access to therapeutic treatment. 5) Update the Ethical Framework to Include Collaborative Responsibility meaning that, to the extent possible, stakeholders (e.g., prisoners, correctional officers, medical staff) should participate in the design, planning, and implementation of research. 6) Enhance Systematic Oversight of Research by strengthening safeguards, making them consistent, and applying them in relation to the levels of risk and restriction of liberty experienced by prisoner-subjects