The Integrative Approach to Assessing and Managing Risk

Abstract

This chapter articulates the integrative approach to assessing and managing risk in research. This framework is grounded, not in role-related obligations, but in respect for the basic interests of persons. It models uncertainty as a property of a moderately idealized community of diverse experts, and it shows how studies that are designed to reduce conflict or uncertainty within such a community can reconcile the production of socially valuable information with respect for the status of research participants as free and equal. The merits of this approach relative to prominent alternatives, including component analysis, clinical equipoise, the non-exploitation view and the net risk view are elaborated at length. The merits off the integrative approach are demonstrated by showing how this framework allows trial that use response adaptive randomization to be designed in ways that respect a principle of equal concern and a series of related ethical requirements.