original commission, it is important to emphasize that it does not deviate from their core ethical principles.

Respect for persons requires that research subjects be treated as autonomous individuals. As discussed in Chapter 1, it is clear that prisoners are still an extremely vulnerable population, with severely restricted autonomy; thus, this issue requires special attention. Prisoners still need to be protected from the risk of coercion, undue inducement, and exploitation. The historical pattern of research abuses in prisons underscores the need to have an ethical framework that, first and foremost, is concerned with the welfare of prisoners. Similarly, justice still requires a careful consideration of the fair distribution of burdens and benefits. Prisoners, as a vulnerable population, are in jeopardy of receiving a disproportionate share of the risk associated with human subjects research. As stated by the National Bioethics Advisory Commission (NBAC), “In research involving human subjects, risk is a central organizing principle, a filter through which protocols must pass (NBAC, 1998). Like the original commission, our recommendations start with a baseline ethical concern for the protection of prisoners.

Respect for Persons

In this section, the committee expresses its support for a broadened view of the principle of respect for persons, to consider more than a narrow focus on informed consent issues, which are still vital but not the whole picture. It also suggests a shift from a categorical approach to research review to a risk-benefit approach.

An Expanded View of Respect for Persons

In accord with its emphasis on the principle of respect for persons, the original commission’s report focused on informed consent. Although informed consent is still an ethically important means of ensuring respect for the right of persons to engage in autonomous decision making, recent scholarship has questioned the myopia caused by such a narrow focus.

Kahn, Mastroianni, and Sugarman (1998) are the editors of a volume that captures a major research ethics reform agenda in its title: Beyond Consent: Seeking Justice in Research. One question the editors raise is whether research ethics has been too concerned with informed consent to the neglect of other matters. There seems to be agreement from a variety of perspectives that informed consent forms have consumed too much time and energy. Critics of the preoccupation with forms are not necessarily interested in shifting attention away from informed consent. Rather, they may emphasize that documentation should be but a part of an informed consent process that involves opportunities for questions and answers and



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