Trust and regulatory organisations: The role of local knowledge and facework in research ethics review

While trust is seen as central to most social relations, most writers, including sociologists of science, assume that modern trust relations – especially those in regulatory relationships – tend towards the impersonal. Drawing on ethnographic material from one kind of scientific oversight body – research ethics committees based in the UK NHS – this paper argues that interpersonal trust is crucial to regulatory decision-making and intimately bound up with the way in which these oversight bodies work, and that as such they build on, rather than challenge, the trust-based nature of the scientific community

Inducements for medical and health research: issues for the profession of nursing

Aims and objectives. Inducements, incentives, reimbursements and payment to subjects for participation in research projects raise many practical, professional and philosophical issues for nurses. Nurses are enjoined, either formally as research co-participants or informally as patients' professional carers, in any research which involves their patients. This role inescapably brings significant ethical obligations, which include those of bioethical audit. Background. A review of current international guidelines on reimbursement recommendations indicates that researchers select one of several paradigms which range from the 'commercial market model' of supply and demand to that of pure un-reimbursed altruism. In this latter, volunteers not only give their bodies and emotional commitment, but also sacrifice their time and convenience. Inducement is defined as the provision of resources or rewards which exceed the 'resource neutral' compensation for legitimate expense. If potential volunteers are truly free to make an informed choice to participate in research, no ethical compromise exists if inducements are offered; but by so doing both the research team and the volunteer patients have shifted the ethos of their research from caritas and altruism to one of a simple commercial relationship. Conclusions. Inducements are inappropriate when offered to those who are 'ethically captive' in the sense that autonomy of choice may be compromised. Relevance to clinical practice. In contemporary nursing practice, research involvement is both frequent and desirable. A perspective of current debate about inducements for volunteering, including legal and ethical issues, empowers nurses to protect the patients or clients in their care

The effect of the European Clinical Trials Directive on published drug research in anaesthesia

The clinical indications for anaesthetic drugs are developed through peer-reviewed publication of clinical trials. We performed a bibliometric analysis of all human research papers reported in nine general anaesthesia journals over 6 years (n = 6489), to determine any effects of the 2004 European Clinical Trials Directive on reported drug research in anaesthesia originating from Europe and the United Kingdom. We found 89% studies involved patients and 11% volunteers. Of 3234 (50%) drug studies, 96% were phase IV (post-marketing) trials. Worldwide, the number of research papers fell by 3.6% (p < 0.004) in the 3 years following introduction of the European Clinical Trials Directive (5% Europe, 18% United Kingdom), and drug research papers fell by 12% (p < 0.001; 15% Europe, 29% United Kingdom). The introduction of the Clinical Trials Directive has therefore coincided with a decline in European drug research, particularly that originating from the United Kingdom. We suggest a number of measures researchers could take in response, and we propose a simplification of the application process for phase IV clinical trials, emphasising patient risk assessmen