In the first five of these articles I have questioned the justice, and effectiveness, of total dependence in clinical research on willing volunteers. I have explored ways that might better and more equitably spread the burden of participating in clinical research as subjects of it. Here I consider this question: if consent is the barrier, must we regard consent as indispensable?

In a series of articles, I set out my belief that investigators and subjects of research should work together in a partnership based in shared aims. Such a relationship – quite different from what is usual today – would impose duties on both partners. In earlier papers I explored the origin and nature of the duties that would fall on patients; here I examine their limits.

This series of articles argues for a different relationship between investigators and subjects of clinical research based on partnership in shared aims and recognition, by each, of their duties within this partnership. This second essay describes how those duties arise and explores the basis on which, and by and to whom, they are owed. The conclusion that patients have duties in research raises a number of moral issues which, ultimately, question the concept of consent. Discussion of these will be continued (...) in future articles. (shrink)