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.
As noted earlier, the committee recommends that the current Subpart D framework, with modifications for application with prisoner-subjects, be utilized to define permissible research. The modifications necessary for such research to be approvable include (1) a risk-benefit analysis to ascertain whether participation carries potential benefits that outweigh risks, and (2) the utilization of special design and monitoring safeguards,7 which would vary as a function of the type of research, the risks it poses, and the nature of the research setting. The greater the restrictions upon liberty in a particular correctional setting, the greater the need for safeguards and protections of prisoner-subjects.
The guidance and examples in this section are intended to be illustrative of the ethical framework presented in Chapter 5. Specifically, it demonstrates the importance and application of the risk-benefit approach with appropriate safeguards and monitoring based on the level of risk and the restrictions of the correctional setting. The framework respects the principle of justice and provides adequate protection and potential benefit for prisoners involved in research.
As stated in Chapter 5, a risk-benefit analysis would normally prohibit the following types of biomedical research involving prisoners because potential risks outweigh potential benefits:
phase 1 and phase 2 studies of experimental treatments, as defined by the FDA, because of insufficient evidence of prospect of direct benefit at this early stage of testing (Example 7 provides a rare, specific circumstance in which phase 1 and phase 2 studies might be permissible, and in which case, federal-level review and high-level safeguards and monitoring would be required);