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)

Fustel de Coulanges' thesis that ancient society was founded upon the cult of ancestral tombs has had, for a thoroughly self-contradictory argument, a remarkably successful career. Neither Fustel himself nor the many subsequent scholars who have quoted his views with approval faced clearly the difficulty of deriving a social structure dominated by corporate descent groups from the veneration of tombs placed in individually owned landed property. On the whole, historians have tended to play down Fustel's insistence on the relation between (...) ancestor-cult and property and to exaggerate the role of the corporate kin group. This tendency, which assimilates Fustel to Sir Henry Maine and other lawyers interested in the reconstruction of Indo-European institutions has in my view considerably impeded understanding of the role of kinship in early Greek society; it also obscures one of the most individual aspects of Fustel's work which, thanks to the researches of Philippe Ariès on the development of the modern tomb-cult in the nineteenth century, can now be placed in its historical context. (shrink)

Research ethics committees ‘ members’ perceptions of their role in regard to the science of research proposals are discussed. Our study, which involved the interviewing of 20 participants from amongst the UK’s independent ethics committees, revealed that the members consider that it is the role of the REC to examine and approve the scientific adequacy of the research – and this notwithstanding the fact that a more competent body will already have done this and even when that other body has (...) the legal responsibility for this function. The problematic nature of this situation, tantamount to double jeopardy, is considered: it can delay research and so add to costs whilst offering no countervailing benefits, or the double jeopardy may be just the cost society imposes, through its RECs, on researchers as the price for research on human subjects. (shrink)

Lobeck’s Aglaophamus (1829) has been read as beginning modern research on Orphism and the ‘ancient theology’. Replacing it in its historical context opens up new perspectives.

Although pharmaceutical practice tends to prefer to take DNA samples from whole blood, this could be both unnecessary and even unethical. The buccal swabbing method offers to provide an adequate and reliable sample less invasively and with the necessary minimal risk to the subject that virtually all ethical guidelines advocate.

Whilst research ethics committees exist to represent society's interests by placing appropriate checks on the economic power of ‘big pharma’, the political sphere is here seen to have generally acquiesced to economic interests and allowed industry to influence how it is regulated. RECs are accordingly urged to remain vigilant about the prospects of their being the subject of hidden influences.

This study appeared in full in the last issue of Research Ethics Review : 22). JM's research focuses on chronic pain and the evidence to support the effectiveness of current interventions. His current proposal has two dimensions in which mixed quantitative and qualitative methods will be used. One examines professionals' beliefs and the evidence on which they draw to support these. The other focusses on patients' experiences of the interventions and their views about what is most helpful in achieving pain (...) relief. JM is an experienced researcher. He has used a similar design in previous work. Before submitting his application he consulted with the key professionals and patient representatives in the pain team and elsewhere. Everyone has supported the study and senior colleagues are of the opinion that it is well designed and appropriate. JM attended the REC meeting and found it an uncomfortable experience. No one was introduced. Questioning was hostile and some of the questions raised seemed to suggest that the application had not been read very carefully, if at all. He has now received a letter stating that a favourable opinion cannot be issued. A completely different methodology is put forward as essential. The REC advises that ‘the study would be more successful if it were conducted in a different type of setting, eg out-patients, and based on a questionnaire alone’. JM is very angry about this. (shrink)

How the diversity of membership of research ethics committees is arrived at has, to date, largely been fairly arbitrary. However, a tool to help determine one's moral preference is now available and it is introduced here as, arguably, having the potential to assist with ensuring a more meaningful diversity amongst an ethics committee's membership. The tool is seen to be easily applied – but, it is argued, may be conceived on at least two false premises. Firstly, despite different theories of (...) ethics, none can be proved to give the ‘right’ answer other than in its own terms. Secondly, if there is an ethical hierarchy, as the model suggests, then ethical diversity must become redundant for the possibility of achieving ethical excellence. (shrink)

This study appeared in full in the last issue of Research Ethics Review : 26). SB, a 21-year-old healthy male, volunteered to take part in a phase I randomized, double-blind, placebo-controlled drug interaction study. The trial compound was a CNS-active drug currently under development for a range of CNS indications. The trial–which was not ‘first in class’ or ‘first in man’ –comprised two residential seven-day study periods with a washout period in between. Three days after the end of the first (...) study period the volunteer developed an acute, severe psychosis that warranted hospitalization. (shrink)

This study appeared in full in the last issue of Research Ethics Review : 159). There are three vacancies on the REC; one member has retired and left the area, a second has resigned because of pressures at work, and the third left because he was unable to attend the meetings. A fourth member will shortly be unavailable for several months because she is about to have her first baby. The day's agenda begins with a discussion about how to attract (...) new members. SG suggests that maybe members of the public should be invited to observe a meeting. DL feels that he can recommend two individuals who would be interested. (shrink)

In this article, I identify the peculiar challenges of current regulation in the UK to assess the safety of new medical devices. Not only is there a limited role for the regulatory authority in assessing their safety, but also no clinical investigation might be needed before many new devices can be marketed for use in populations across the European Union. As a lay member of a committee flagged to review research involving medical devices, I describe some of the difficulties we (...) face in this regard as well as recent developments designed to raise regulatory standards. (shrink)

The novel nature of certain investigational medicinal products may indicate that someone particularly knowledgeable about the risks involved should be the ‘first-in-man’ subject. Such self-experimentation has a noble and ethical heritage, and whilst its practice has declined of late it is perhaps timely to reconsider this situation.

Some anomalies in the legislation governing National Research Ethics Service research ethics committee member categories are discussed. It is suggested that not only may some members be in th...

Some anomalies in the legislation governing National Research Ethics Service Research Ethics Committee member categories are discussed. It is suggested that not only may some members be in the wrong category, but that the legislation identifies individuals who are simply ineligible for any form of REC membership.

The Strangeness of Gods combines studies of changes in modern interpretations of Greek religion with studies of changes in Athenian ritual. The combination is necessary in order to combat influential stereotypes: that Greek religion consisted of ritual without theological speculation, that ritual is inherently conservative. To re-examine the evidence for Greek rituals and their interpretation is also to re-examine our own preconceptions and prejudices. The argument presented by S. C. Humphreys tries to bring Greek texts closer to the `classic' texts (...) of other civilizations, and religion, as a form of speculative thought, closer to science. Her studies of Athenian rituals put this emphasis on changing interpretations into practice, showing that the Athenians thought about their rites as well as celebrating them. (shrink)

The Equality Act 2010 brings the concept of indirect discrimination to discrimination on the grounds of religion or belief. This has real potential to require a change in practice in certain types of clinical trials of which relevant ethics committees should be aware.

A selection of recent sociological literature dealing with bioethics, concentrating particularly on its interface with research ethics, is reviewed to reveal that the two disciplines of bioethics and sociology have tendencies to approach subject matters from opposed perspectives. These differences in approach have now been generally recognized, accepted and accommodated by proponents of both disciplines. A turning point in the relationship between the two disciplines may have been reached which augers greater mutual respect, appreciation and even learning.

Research Ethics, Ahead of Print. Due to an administrative error, this article was accidentally published twice Online First with different DOIs. Humphreys S. Research ethics committees: The ineligibles. Research Ethics. doi: 10.1177/1747016112466979 However, the correct and citable version of the article remains: Humphreys S.. Research ethics committees: The ineligibles. Research Ethics. 11, 142−150. doi: 10.1177/1747016113489944.

Due to an administrative error, this article was accidentally published twice Online First with different DOIs. Humphreys S. Research ethics committees: The ineligibles. Research Ethics. doi...