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In this paper, the author argues that the requirement to conduct randomised clinical trials to inform policy in cases where one wants to identify a cheaper alternative to known effective but expensive interventions raises an important ethical issue. This situation will eventually arise whenever there are resource constraints, and a policy decision has been made not to fund an intervention on cost effectiveness grounds. It has been thought that this is an issue only in extremely resource poor settings. This paper gives an example from the United Kingdom illustrating that this is also a problem faced by richer countries. [ABSTRACT FROM AUTHOR]

Knowledge of the ethical and legal basis of medicine is as essential to clinical practice as an understanding of basic medical sciences. In the UK, the General Medical Council (GMC) requires that medical graduates behave according to ethical and legal principles and must know about and comply with the GMC's ethical guidance and standards. We suggest that these standards can only be achieved when the teaching and learning of medical ethics, law and professionalism are fundamental to, and thoroughly integrated both vertically and horizontally throughout, the curricula of all medical schools as a shared obligation of all teachers. The GMC also requires that each medical school provides adequate teaching time and resources to achieve the above. We reiterate that the adequate provision and coordination of teaching and learning of ethics and law requires at least one full-time senior academic in ethics and law with relevant professional and academic expertise. In this paper we set out an updated indicative core content of learning for medical ethics and law in UK medical schools and describe its origins and the consultative process by which it was achieved. [ABSTRACT FROM AUTHOR]

Background Journal editors are responsible for what they publish and therefore have a duty to correct the record if published work is found to be unreliable. One method for such correction is retraction of an article. Anecdotal evidence suggested a lack of consistency in journal policies and practices regarding retraction. In order to develop guidelines, we reviewed retractions in Medline to discover how and why articles were retracted. Methods We retrieved all available Medline retractions from 2005 to 2008 and a one-in-three random selection of those from 1988 to 2004. This yielded 312 retractions (from a total of 870). Details of the retraction including the reason for retraction were recorded by two investigators. Results Medline retractions have increased sharply since 1980 and currently represent 0.02% of included articles. Retractions were issued by authors (63%), editors (21%), journals (6%), publishers (2%) and institutions (1%). Reasons for retraction included honest error or non-replicable findings (40%), research misconduct (28%), redundant publication (17%) and unstated/unclear (5%). Some of the stated reasons might have been addressed by corrections. Conclusions Journals' retraction practices are not uniform. Some retractions fail to state the reason, and therefore fail to distinguish error from misconduct. We have used our findings to inform guidelines on retractions. [ABSTRACT FROM AUTHOR]

Local review of research by ethics committees in the UK has long been held to be an important right of the local research ethics committee and, even with the introduction of the European Clinical Trials Directive, the governance arrangements for research ethics committees continue to allow for local review of multicentre studies. There is no requirement for local review in either the European Union directive or in the guidelines on good clinical practice, and there is little evidence of it anywhere else in Europe. The idea that there can be "local", as opposed to "central" ethical issues in research is an interesting one, which raises important issues about the nature of research ethics and ethical review. The aim of this paper is to argue that there are no such things as local issues in research ethics, and suggest that those questions currently addressed as local issues properly belong within the research governance framework. [ABSTRACT FROM AUTHOR]

Aims: To describe individuals' perceptions of the activities that take place within the cancer genetics clinic, the relationships between these activities and how these relationships are sustained. Design: Qualitative interview study. Participants: Forty individuals involved in carrying out cancer genetics research in either a clinical (n = 28) or research-only (n = 12) capacity in the UK. Findings: Interviewees perceive research and clinical practice in the subspecialty of cancer genetics as interdependent. The boundary between research and clinical practice is described as vague or blurred, and this ambiguity is regarded as being sustained by a range of methodological, ethical and economic factors. The implications of these findings for the "therapeutic misconception" are explored. It is argued that while research participation is seen as having therapeutic benefit for individual patients, the interviewees are not labouring under any misconceptions about the relationship between research and clinical care. It is suggested that concepts such as the "therapeutic misconception" may have less relevance in highly technological specialities that are characterised by a developing evidence base. [ABSTRACT FROM AUTHOR]

Over recent years, considerable attention has been paid to the National Health Service (NHS) research governance and ethics approvals process in the UK. New regulations mean that approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) is now also needed for conducting all clinical trials. Practical experience of gaining MHRA and sponsorship approval has yet to be described and critically explored in the literature. Our experience, from start to finish, of applying for these four approvals for a multicentre randomised controlled trial of two licensed drugs for opiate detoxification in the prison setting is described here. In addition, the implications of the approvals process for research projects, particularly clinical trials, in terms of time and funding, and also indirect implications for NHS patients are discussed. Inconsistencies are discussed and suggestions that could improve and streamline the overall process are made. The current approvals process could now be hindering noncommercial clinical trials, leading to a loss of important evidence-based medical information. [ABSTRACT FROM AUTHOR]

The article talks about the implications of the Human Tissue Act of 2004 for close relatives in Great Britain. The Act allows for a direction to access a person's tissue so that genetic testing can be carried out for the benefit of a relative, without the consent of that person. According to the authors, this provision undermines many principles of clinical practice, such as that consent must be obtained before a genetic test is undertaken.