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 fourth 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 explores the role of ethics committees in reviewing proposed conditions for recruiting human subjects and in checking the intended procedures for gaining consent. In so doing the paper will reiterate the conditions which are traditionally thought to make (...) consent valid, identify a number of limitations to meeting these conditions, and show when consent, however broadly construed or indeterminately focused, may be unnecessary. (shrink)

Research subjects do not always conform to research requirements. When their personal interests conflict with the demands of participation, some subjects surreptitiously break the rules. These subjects are subversive — they undermine the research endeavor. In rejecting the restrictions research imposes, subversive subjects diminish the value of research results. From one vantage point, subversive subjects engage in unethical behavior. They create risks to themselves and others; they also disregard ethical responsibilities to adhere to research agreements and tell the truth. At (...) the same time, subversive subjects expose ethical problems in the design and conduct of clinical trials. Features of the research environment create fertile ground for subject subversion. Intensified policing and guidance are two common strategies for reducing subject subversion, but collaborative reforms are more consistent with the partnership model of clinical research. (shrink)

Scientific reports about clinical research appear objective and straightforward. They describe a study's findings, methods, subject population, number of subjects, and contribution to existing knowledge. The overall picture is pristine: the research team establishes the requirements of study participation and subjects conform to these requirements. Readers are left with the impression that everything was done correctly, by the book.In other places, however, one finds a different and messier picture of clinical research. In this picture, research subjects deviate from the prescribed (...) plan. One author contrasted the “tidy graphics” and “crisp prose” of the New England Journal of Medicine's HIV/AIDS trial publications with reports that subjects shared medications and broke other trial rules. Awareness of this behavior, he wrote, could lead insiders to “conclude that knowledge was resting on something rather less solid than bedrock.”. (shrink)

The purpose of this study is to examine the importance that real patients attach to their right to withdraw from an on-going feasibility randomised trial (RCT) evaluating types and timings of breast reconstruction (two parallel trials) following mastectomy for breast cancer. Our results show that, while some respondents appreciated that exercising the right to withdraw would defeat the scientific objective of the trial, some patients with a surgical preference consented only given the knowledge they could withdraw if they were not (...) allocated to their preferred treatment. (shrink)