The Subject–Researcher Relationship: In Defense of Contracting Around Default Rules

Abstract

In this short article in the top-ranked bioethics journal, which is part of a broader project of rethinking the way we govern human subjects research, I consider a proposal to improve the quantity, quality and speed of research by requiring subjects to contractually agree not to withdraw from research, at least without good reason. That proposal would require altering the current regulations governing human subjects research, which provide subjects with an inalienable right to withdraw from the research at any time, for any reason, without penalty or loss of benefit to which they would otherwise be entitled.

I argue that the gains sought by this particular proposal would likely be swamped by the costs of enforcing such contracts and by the chilling effect they would have on subject recruitment. But I agree that we should explore the role of contract in rethinking the way we govern human subjects research. Doing that in any significant way, however, requires an understanding of the subject-researcher relationship that is not fiduciary. In this article, I defend the claim that this relationship is in fact not fiduciary, cannot coherently be made fiduciary, and ought not to be fiduciary. I then defend the role of contract not only in the efficient conduct of research, but also, and more importantly, in serving the interests and welfare of research subjects.

Keywords: Human subjects research, right to withdraw, alienability of rights, contract law