Daryl Pullman

Historically the primary role of the Institutional Review Board (IRB) has been "to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research" (U.S. FDA, 1996). However, there is much to suggest that IRBs have been unable to fulfil this mandate, particularly in regard to the matter of informed consent. Part of the problem in this regard is that the competing interests of other stakeholders often undermine the IRB's capacity to serve the best interests of research subjects. This paper proposes an alternative view of the role of the IRB. It begins by treating the interests of other stakeholders as legitimate matters of concern for IRBs. Hence the process established to review and monitor human research should be treated as an exercise in social justice in which the interests of all legitimate stakeholders must be represented and considered. A variation of Rawls' (1971) heuristic "the veil of ignorance" is employed to explore the dynamic relationship between knowledge and interests that ensues when the role of the IRB is characterized in this manner. Inadequacies in the informed consent process are taken as illustrative of the inability of IRBs as they are presently construed to attend to the interests of research subjects. The major normative implication of the analysis offered here is that the role of the IRB must be expanded to include the granting of a provisional proxy consent on behalf of prospective research subjects. This provision is necessary, it is argued, if the interests of research subjects are to be fairly assessed by IRBs as a matter of social justice. It is necessary as well to ensure that an adequate standard of informed consent is attained. Somewhat paradoxically it is argued competing sets of interests the IRB must serve, rather than as the primary concern of the IRB.

This paper explores the problem of universalism and particularism in contemporary ethics, and its relationship to Christian bioethics in particular. An ethic of human dignity is outlined, which, it is argued, constrains moral discourse in the broad sense – thus meeting the demands of universalism – but which is at the same time amenable to a variety of particularist interpretations – thus acknowledging the current shift toward historicism, traditionalism, and culture. The particularist interpretations that are of central concern here are those provided by historic Christianity. The eventual goal is to indicate how a Christian conception of human dignity can have universal normative relevance both as a standard against which to assess competing particularist conceptions, and as a practical guide for everyday living. A Christian conception of dignity will in turn have significant implications when addressing contemporary issues in bioethics. These are ambitious goals, and a full explication of the ideas presented will not be possible in this context. Nevertheless, there is value in getting a bird's-eye view of the landscape before one goes about scaling the mountains and exploring the valleys. The present essay is intended as a general geography of the moral terrain in which an ethic of dignity in general, and a Christian perspective on dignity in particular, can provide normative guidance.