allows time for reflection before a decision is made, and that more attention should be paid to ameliorating basic power and knowledge differentials, which may undermine information sharing, understanding, and voluntariness. One proposal for reform advises simply raising the consciousness of investigators and ancillary personnel. Another suggests the use of external measures such as third-party monitoring to guard against deficiencies. This could be accomplished by the integration of third-party research subject advocates in the informed consent process, especially for studies that are considered unusually sensitive or risky or that involve subjects with impaired autonomy (see prison research subject advocate [PRSA] discussion in Chapter 6).

A more fundamental question is whether too much weight has been placed on informed consent in the framework of research ethics and research regulation. As noted previously, the National Research Act charge to the commission focused on informed consent issues, so the centrality of consent issues in the report is neither surprising nor necessarily indicative of a judgment on the part of the commissioners that the most compelling issues in research with prisoners are those of consent.

An alternate perspective, discussed by Emanuel et al. (2000), focuses on directing attention to risks and to risk-benefit analysis. According to this view, only health-related benefits derived from the research can be counted as benefits to individual subjects, meaning that extraneous benefits, such as payments or medical services unrelated to the research, are excluded in this analysis. Further, although the process of weighing risks against benefits is inherently subjective, the analysis should be based on data permitting identification of the types of potential harms and benefits, their probability of occurrence, and their long-term consequences. For example, a placebo-controlled trial of new antiemetic therapy for patients undergoing chemotherapy could be rejected because the investigators failed to give adequate weight to the discomfort associated with nausea and vomiting and failed to take steps to minimize this potential harm by using available antiemetic agents in the control group (Emanuel et al., 2000).

These questions about an undue focus on informed consent influence our recommendations. More attention needs to be paid to risks and risk-benefit analysis rather than the formalities of an informed consent document. The ethical risks associated with research involving prisoners cannot be solved by focusing only on the informed consent document.

The Role of Protectionism

A risk-benefit paradigm is necessarily more flexible than the current categorical approach. Although some might view this flexibility as opening

The National Academies of Sciences, Engineering, and Medicine
500 Fifth St. N.W. | Washington, D.C. 20001

Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement