In “Assessing the Remedy: The Case for Contracts in Clinical Trials,” Sarah Edwards (2011) proposes that research participants acquire contractual obligations to investigators, thus opening the doo...

This is the third in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper examines the role of ethics committees in balancing the social value of the research it reviews against the risks it imposes on those who take part. The ethics committee's role in assessing the social value of research goes (...) well beyond checking its scientific validity and this assessment may affect the risks ethics committees are prepared to ask of subjects not only for their own potential personal interests but importantly and inevitably in the name of science. However, their function is importantly restricted by the wider regulatory and governance environment in which they work. (shrink)

Most ethics committees which review research protocols insist that potential research participants reserve unconditional or absolute ‘right’ of withdrawal at any time and without giving any reason. In this paper, I examine what consent means for research participation and a sense of commitment in relation to this right to withdraw. I suggest that, once consent has been given (and here I am excluding incompetent minors and adults), participants should not necessarily have unconditional or absolute rights to withdraw.This does not imply (...) that that there should be a complete absence of rights, or, indeed, an abandonment of the right to withdraw. The point of this paper is to show that the supposed unconditional or absolute nature of these rights may be self‐defeating and so fail to respect the autonomy of participants. In addition, and on a more positive note, I suggest that, attaching certain conditions on the right to withdraw, may better respect the autonomy of these participants by underlining the idea that autonomy is more than mere whim or indifference to the fate of others. On the contrary, research staff are currently unable to ‘push’ participants, who may merely have logistical difficulties unrelated to the research itself, but who really want to stay the course, for fear of coercing them. Furthermore, researchers now try to ‘screen out’ people they think may be unreliable to protect the science of the study and so groups at risk of dropping out may be unfairly denied access to research treatments. I conclude that on‐going negotiation between the relevant parties could be on balance the only truly acceptable way forward but concede certain important limitations to take into account. (shrink)

Current orthodoxy in research ethics assumes that subjects of clinical trials reserve rights to withdraw at any time and without giving any reason. This view sees the right to withdraw as a simple extension of the right to refuse to participate all together. In this paper, however, I suggest that subjects should assume some responsibilities for the internal validity of the trial at consent and that these responsibilities should be captured by contract. This would allow the researcher to impose a (...) penalty on the subject if he were to withdraw without good reason and on a whim. This proposal still leaves open the possibility of withdrawing without penalty when it is in the subject's best interests to do so. Giving researchers recourse to legal remedy may now be necessary to protect the science, as existing methods used to increase retention are inadequate for one reason or another. (shrink)