Aims: The aims of the study were to explore expert opinion on the distinction between “research” and “audit”, and to determine the need for review by a National Health Service (NHS) Research Ethics Committee (REC). Background: Under current guidelines only “research” projects within the NHS require REC approval. Concerns have been expressed over difficulties in distinguishing between research and other types of project, and no existing guidelines appear to have been validated. The implications of this confusion include unnecessary REC applications, (...) and crucially, the potential for ethically unsound projects to escape review. Methods: A three-stage Delphi method was chosen to explore expert opinion and develop consensus. Stage 1 comprised ten semi-structured interviews gathering opinion on distinguishing between types of project and how to determine need for ethical review. Stages 2 and 3 were questionnaires, asking 24 “experts” to rate levels of ethical concern and types of project for a series of questions. Anonymised responses from stage 2 were fed back in stage 3. The final responses were analysed for consensus. Results: Of 46 questions, consensus was achieved for 14 (30.4%) for level of ethical concern and for 15 (32.6%) for type of project. Conclusions: Several ideas proved discriminatory for classifying the type of project and assessing level of ethical concern, and they can be used to develop an algorithm to determine need for ethical review. There was little relationship between assessment of the level of ethical concern and classification of the project. There was inconsistency in defining and classifying studies as something other than “research” or “audit”. (shrink)

Progress in transplantation outcomes depends on continuing research into both donor and recipient factors that may enhance graft and patient survival. A system of licencing for transplantation research, introduced by the Human Tissue Act 2004, which separates it from the transplantation process (then exempt from licencing), has damaged this vital activity by a combination of inflexible interpretation of the 2004 Act and fear of criminal liability on the part of researchers. Now, following the European Union (EU) Directive (2010) on standards (...) of quality and safety of human organs intended for transplantation, new UK Regulations have been drafted, which are intended to implement it. These Regulations impose a compulsory licencing system, similar to that for research, on the whole transplantation process. This goes beyond what is required by the Directive and may even have an inhibitory effect similar to that already seen in research. Initial draft Regulations went further, imposing criminal sanctions for breaches. However, following a public consultation process, the Department of Health (DH) has recently stated that, as a result of the overwhelming view of respondents that the proposed licencing system was unnecessary, all sanctions under the final Regulations are now decriminalised, with the sole exception of operating without a licence. While this does not eliminate the negative effect of licencing, it does suggest an awareness of the DH that excessive regulation unnecessarily harms the transplantation process. An opportunity thus arises for the Human Tissue Authority (the regulatory body for both the new licences and research licences under the 2004 Act) to end the current illogical and harmful separation of transplantation and transplantation research by ensuring that all centres licenced for organ donation, retrieval and transplantation are also fully licenced for related research. (shrink)

If the editor had done a proper job, his introductory rhetoric would have been superfluous. Indeed in the second fit of hubris immediately consequent upon the heady act of initiating CRITICAL INQUIRY, its coeditors agreed that the success of our venture must be measured by the precise degree to which this issue was self-defining. Our goals would be fully explained by our accomplishment. Our commitment to reasoned inquiry into significant creations of the human spirit would be transformed from proclamation to (...) actuality—revealed as less, and therefore more, than pompous aspiration—by a collection of essays, individually excellent, which, when viewed together, would represent the full range of interests and values implicit in our commitment. (shrink)

The publication in this issue of Leonard B. Meyer’s superbly detailed analysis of the Trio of Mozart’s G Minor Symphony became the occasion of us to reexamine and restate some of the general aims of Critical Inquiry. From its inception Critical Inquiry was based on the assumption that we can indeed understand each other, at least to the point where critical exchange becomes meaningful and fruitful. It is this belief, for example, that has led us to eschew the more fiery (...) debates and to concentrate instead on articles in which distinguished critics of all the arts attempt to explore the issues that divide them—the correspondence between Gombrich and Bell, for example, Booth’s attempt to represent his understanding of Abrams followed by Abrams’ representation of how he understands his own work, or, similarly, the exchange between Angus Fletcher and Northrop Frye. Even in our more heated Critical Response section, we have tended to reject those arguments that reflect primarily the egos of the disputants in favor of discourse that reveals the actual issues that separate them. We have been fully conscious that such a focus eliminates some of the excitement of fiery battle, and we are aware as well that we have not always succeeded in our attempt. (shrink)

For example, in the traditional "who done it" , the basic pleasure is in the creation and solution of the riddle itself - somewhat akin to the pleasure of solving a difficult crossword puzzle. In such works the riddle itself must be sufficiently ingenious to surprise us but never so labyrinthine as to destroy the illusion that we may beat the professional to the solution. In no case may necessary clues be withheld for, failing to solve the riddle ourselves, we (...) must at the very least see how we should have been able to solve it with the same information as the professional; given an unreliable narrator, we will feel deceived rather than pleasantly surprised. It is clear that in such instances the value judgments, as opposed to the riddle, should be as unoriginal and conventional as possible. The agents or agent whose initial act caused the riddle might best perform an act of murder for obvious gain or because he wants to replace a current wife with a beautiful mistress. Complexity of thought and judgment must never reach the point where it distracts our attention from the pleasure of the riddle itself; ethical values must merely be minimally consonant with our desire to see the riddle solved in terms that prevent moral indignation. The detective in turn may be given minimal idiosyncrasies that define him as a character, but again since, in this kind of work, the alteration of circumstances of who commits the crime is merely pro forma—usually he is merely caught and his future in prison or the electric chair is unstressed—the traits possessed by the detective are almost solely restricted to those that allow him to solve the riddle that we should have been able to solve ourselves. It is this kind of work that is frequently advertised by plaintive requests "please don't reveal the ending." We rarely read such works a second time. We are completely remote from the pursuit of Lew Archer. (shrink)