tections to provide systematic oversight of research involving prisoners that is within its purview. (Recommendation 6.5)
Four necessary functions are currently lacking in whole or in part in oversight of research involving prisoners:
Maintain a national registry of all prisoner research that is conducted.
Make determinations if a study requires federal-level review.
Enforce compliance with the regulations, investigate reports of possible problems, intervene to curtail abuses, and impose sanctions for non-compliance.
Serve as a national resource for HRPPPs to promote a uniform understanding and consistent application of the regulations.
OHRP is designed to perform three of the four functions above, but does not currently have the funding or personnel to adequately carry out the tasks. OHRP needs to be revitalized and refocused to carry out the three functions already within its purview. In addition, it should be charged with the task of creating and maintaining a national registry of research involving prisoners. This recommendation, however, covers only research supported by DHHS and two other federal agencies. The majority of research involving prisoners is being conducted in the absence of any obligation to provide safeguards or oversight. To remedy that inadequacy and ensure that these protections apply to all research involving prisoners, the enhanced OHRP model must be replicated for all agencies and privately funded research.
Recommendation: Establish systematic oversight of all research involving prisoners. Congress should establish a national system of oversight that is applied uniformly to all research involving prisoners. (Recommendation 6.6)
To expand prisoner protections beyond the narrow jurisdiction of DHHS, Congress should establish a national system of oversight that is applied uniformly to all research involving prisoners, performing all of the functions listed in the recommendation before last. The vast majority of research involving prisoners does not fall within OHRP 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 research involving prisoners. These functions could be performed by the revitalized and properly funded OHRP if OHRP’s jurisdiction were extended to the entire range of research involving prisoners regardless of funding source (i.e., federal or nonfederal, public or