not have the expertise to directly measure health-care quality in correctional settings. Certain indirect measures, however, may help with this determination. For example, has the specific correctional system’s health-care services been found to be unconstitutional by a court? Is it under a consent decree, settlement agreement, or a similar process relevant to the adequacy of the health-care services? Such situations create a presumption that the system was inadequate at that time. Research in a correctional facility that involves subject matter addressed under a court order/settlement/consent decree should be presumptively disapproved. (The concern is primarily biomedical research, but behavioral research could be implicated under the standards proposed here if the underlying mental health support is seriously lacking in the institution and if the proposed research project has mental health as an integral component of the behavioral research.)

To allow biomedical research under such circumstances, the IRB must apply the risk-benefit analysis the committee proposes in a heightened form and find that the research proposed is permissible only after reviewing the specific components of the research and its interaction with the specific components of the system presumed to be deficient. This risk-benefit application should address the theoretical aspects of the proposed research, as well as its administration and monitoring, including the informed consent. The IRB must assure itself that no prisoner is choosing to be a research subject in order to bypass the presumptively deficient system.

Other factors, which would be useful though not definitive, include:

  • Is the system accredited by a third party, such as National Commission on Correctional Health Care (NCCHC), American Correctional Association (ACA), or Joint Commission on Accreditation of Healthcare Organizations (JCAHO)?

  • Have any recent internal or external assessments been made of the health-care system?

  • Do relevant quality improvement studies exist?

  • Do other relevant assessments exist?

Recommendation 5.3 Ensure adequate standards of care. Human research participant protection programs,6 together with the prison administration and prison health-care professionals, are responsible for


The term human research participant protection program (HRPPP) is used throughout this report to mean the network of entities with direct responsibility for the safety of those enrolled in the studies carried out under its purview. The HRPPP most often includes the research organization, the study sponsor, investigator, IRB, and, when relevant, the data safety monitoring board (IOM, 2003). In the contexts described in this report, prison research subject advocates would be an important part of this network as well.

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