ABSTRACT

There have been considerable refinements in our understanding of the ethical analysis of risk in the last twenty-five years. Three distinct views on the ethical analysis of risks and potential benefits in research can be found in the National Commission's opus: analysis of entire protocols; analysis of protocols with particular components; and analysis of components. The ethical analysis of the various "components" in a research study presents a number of advantages: and colleagues were the first to formalize a "component" approach to the ethical analysis of research risk. This chapter discusses the moral analysis of potential benefits and risks presented by therapeutic procedures; the moral analysis of potential benefits and risks presented by non-therapeutic procedures; and the role of the concept of minimal risk in the protection of vulnerable research subjects. More work is required to determine how the ethical analysis of risk for communities in research ought to proceed.