and epidemiological categories, that carry very low risks for the prisoner subjects but no personal benefit for the subjects. Instead, the potential benefits may be for prisoners as a class (e.g., studies to identify factors that predict recidivism or that seek to understand the effects of prior trauma on antisocial behavior). Applying a risk-benefit analysis may determine that, because the risks are very low and important knowledge or benefits may accrue for prisoners as a class, the research is ethically acceptable. The same may hold true for epidemiological studies that require analysis of biomedical samples, such as tissue, blood, or urine, but are not designed to assess outcomes of an intervention.

For all studies under consideration, the greater the risk and the more restrictive the correctional setting, the stronger the design and monitoring safeguards need to be.

Update the Ethical Framework to Include Collaborative Responsibility

In the Belmont Report (NCPHSBBR, 1979), the national commission identified respect for persons, justice, and beneficence as the fundamental ethical principles that should guide the conduct and regulation of research with prisoners. These three principles should continue to anchor discussions of research with prisoners. However, ideas about ethical research have evolved over the past three decades, leading the committee to suggest that collaborative responsibility be added as a derivative of the principle of justice to give attention to the needs and responsibilities of all parties who will be involved with or affected by a research endeavor.

Recommendation: Use a collaborative research approach. Under an ethic of collaborative responsibility, investigators should find ways to obtain input from prisoners and other stakeholders on the design and conduct of any research protocol involving prisoners. (Recommendation 5.2)

Collaborative responsibility is intended to convey the idea that, to the extent feasible, all aspects of research (design, planning, and implementation) should include the active participation of relevant institutional stakeholders (prisoners, correctional officers, medical staff, administrators). A focus on collaboration would help cope with the reality that each institution has its own unique conditions and may facilitate openness of the research environment. The responsibility for collaboration lies with investigators, who need to make the effort to engage prison administration and prisoners themselves for their input, and with the other components of the HRPPP, which must determine that the effort was made.

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