Concern about the ethics of clinical drug trials research on patients and healthy volunteers has been the subject of significant ethical analysis and policy development—protocols are reviewed by Research Ethics Committees and subjects are protected by informed consent procedures. More recently attention has begun to be focused on DNA banking for clinical and pharmacogenetics research. It is, however, surprising how little attention has been paid to the commercial nature of such research, or the unique issues that present when subjects are (...) asked to consent to the storage of biological samples. Our contention is that in the context of pharmacogenetic add-on studies to clinical drug trials, the doctrine of informed consent fails to cover the broader range of social and ethical issues. Applying a sociological perspective, we foreground issues of patient/subject participation or ‘work’, the ambiguity of research subject altruism, and the divided loyalties facing many physicians conducting clinical research. By demonstrating the complexity of patient and physician involvement in clinical drug trials, we argue for more comprehensive ethical review and oversight that moves beyond reliance on informed consent to incorporate understandings of the social, political and cultural elements that underpin the diversity of ethical issues arising in the research context. (shrink)

The first objective of this article is to demonstrate that ethics committee members can learn a great deal from a forensic analysis of two classic psychology studies: Zimbardo’s Stanford Prison Study and Milgram’s Obedience Study. Rather than using hindsight to retrospectively eradicate the harm in these studies, the article uses a prospective minimization of harm technique. Milgram attempted to be ethical by trying to protect his subjects through debriefing and a follow-up survey. He could have done more, however, by carrying (...) out what ethics committees routinely insist on today for those researching sensitive topics. The establishment of counselling supports to identify harm to participants would have minimized additional harm. Were these in place, or in Zimbardo’s case had the Stanford Ethics Committee properly identified Zimbardo’s conflict of interest – he was both a principal investigator and the prison warden – how much harm could have been minimized? The second aim is to examine how some qualitative authors routinely demonize these classic studies. It might appear that there are too few cases of unethical qualitative research to justify such an examination; however, this article identifies a number of recent examples of ethically dubious qualitative research. This would suggest that qualitative research should examine its own ethics before poaching from psychology. (shrink)

This paper describes the establishment of and the issues experienced by the Research Ethics Committee (REC) of a Business School within a University in Ireland. It identifies the issue of voluntarily given informed consent as a key challenge for RECs operating in a Business School context. The paper argues that whilst the typology of ethical issues in business research are similar to the wider social sciences, the fact that much research is carried out in the workplace adds to the complexity (...) of the REC deliberations. The use of deception in the design of research studies, pestering the local community and the potential for harm to the researcher are also discussed briefly in the context of business research. The experiences of the authors’, two of whom have served as respective chairpersons of the business school REC since its inception in addition to being members of the university level REC, inform the discussion. (shrink)

Recognizing that students are fundamentally engaged in a process of learning and self-development, ethical review of sub-doctoral student research should be proportionate to that objective. A student's tutor has the pedagogical role and an ethics committee should not interfere with that relationship other than to seek to avoid harms unforeseen by either the student or tutor. Underpowered or other statistically or methodologically flawed sub-doctoral research should not however, in general, be regarded as ethically concerning. With the proviso that no subject (...) is harmed the student can be allowed to learn such lessons as their mistakes may afford them. (shrink)

The history of the National Health Service research ethics system in the UK and some of the key drivers for its change into the present system are described. It is suggested that the key drivers were the unnecessary delay of research, the complexity of the array of processes and contradictions between research ethics committee (REC) decisions. It is then argued that the primary drivers for this change are and will be replicated by the systems of research ethics review being put (...) in place at UK universities in response to the Economic and Social Research Council research ethics framework. It is argued that this is particularly problematic for multi-centre review and for researchers who switch institutions. Finally, some potential solutions to this problem and their feasibility are discussed. (shrink)

This paper is, in part, a response to the model of university-based human subjects ethics review described by Bryn Williams-Jones and Soren Holm in Research Ethics Review [1] and the current ethical review process at the University of Ulster [2]. In this paper the two predominant systems of ethical review within UK universities are described. It is argued that each of these systems has significant deficiencies. Having suggested why these two models are less than ideal, a “third way’ of ethical (...) review is proposed that encapsulates the strengths of these two models while avoiding the weaknesses. (shrink)