facilities regarding their approaches to protecting the rights, health, and dignity of prisoners participating in human subjects research, individuals who are among the most vulnerable human subjects of research.

Establishing uniformity within the research protections systems specific to prisoners would enable a second, important step to be realized. Currently, there is no central repository of information about the amount and type of research with prisoners as subjects. For the same reasons that registries of clinical research on drugs and biologics exist and have garnered strong support (DeAngelis et al., 2004; IOM, 2006), a national database would bring clarity to the currently murky landscape of research involving prisoners.

Recommendation: Maintain a public database of all research involving prisoners. The Department of Health and Human Services, in cooperation with the Department of Justice, should systematically and comprehensively document all human subjects research with prisoners. (Recommendation 2.1)

The establishment of a publicly available, national registry of research involving prisoners should include data such as who is conducting research with what support, with what kind of research on what populations, and the nature and extent of ethical oversight provided. A national registry would shed light on the totality of research taking place on prisoners and the quality of ethical oversight provided for each protocol. To enable consideration of questions of justice, it could be used to examine the magnitude and volume of prisoners in different types of research to determine the allocation of benefits and burdens of research among prisoners. A registry would also enhance the application of research findings to prisoner populations.

Recommendation: Ensure transparency and accountability in the research enterprise. Human research participant protections programs and prison administrations conducting human subject research should be open, transparent, and accountable. (Recommendation 6.7)

A sound, ethical protection program involves an open, transparent research process. It requires that the mechanisms used to protect participants from undue harm and to respect their rights and welfare must be apparent to everyone involved. This transparency requires open communication and interaction with the local community, research participants, investigators, and other stakeholders in the research enterprise. Accountability entails maintaining fidelity to the methodology stipulated in the protocol as well as accountability to ensure the quality and performance of the protection program itself.



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