required to submit to OHRP oversight. According to the committee’s review of current research involving prisoners (see Chapter 2), only 11 percent of all of the studies reviewed were funded by the DHHS, indicating that the vast majority of research involving prisoners does not fall within the OHRP’s overview jurisdiction. Therefore, to ensure the ethical conduct of all research involving prisoners, the enhanced OHRP oversight model must be replicated for all research involving prisoners, regardless of funding source, so that research supported by any federal agency, all nonfederal agencies, and the private sector is subjected to the same systematic oversight.

Recommendation 6.6 Establish systematic oversight of all research involving prisoners. To expand prisoner protections beyond the narrow jurisdiction of the Department of Health and Human Services, Congress should establish a national system of oversight that is applied uniformly to all research involving prisoners, performing all of the functions listed in Recommendation 6.5. The vast majority of research involving prisoners does not fall within the Office for Human Research Protections’ overview jurisdiction. Strengthening the safeguards provided for all prisoners involved in research, regardless of funding source, will facilitate safe and ethical research across the full range of prisoner-involved research.

These functions could be performed by the revitalized and properly funded OHRP if its jurisdiction were extended to the entire range of research involving prisoners regardless of funding source—federal or nonfederal, public or private. An alternative is to compose a national entity to perform the necessary oversight functions. Placing the functions within the OHRP may be more feasible and less disruptive, but it must be done with serious attention to the extra support needed within the OHRP to undertake those tasks fully and much more broadly than its current limits to Common Rule agencies. The committee is calling for substantial improvements to the existing system of oversight; if a new entity is necessary to make it happen, then it should be created.

Finally, for reasons similar to those underlying the committee’s recommendation for establishing systematic oversight, the research process needs to be characterized by transparency and accountability.

Recommendation 6.7 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.

A sound, ethical protection program involves an open, transparent



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