Is ethical approval necessary for manikin studies?

Our department has published a number of studies involving the use of manikins [1,2]. Manikin studies may be necessary as difficult intubation is uncommon and clinical investigation fraught with ethical problems. In South-east Wales, Research Ethics Committees (RECs) take the view that formal ethical approval is not necessary when testing either operator skills or apparatus under investigation in manikin studies. With the introduction of the European Clinical Trials Directive, researchers have a legal responsibility to undertake research in the correct ethical manner. The new National Research Ethics Application Form[3], gives no guidance about manikin studies. An extensive literature search has revealed nothing on the ethics of manikin studies. However, editorials have highlighted the difficulties arising when there is a difference in opinion ethically between editorial teams and RECs [4,5]. While not advocating ‘mob rule’, one way to increase our understanding of an ethical ambiguity is to elicit the opinion of the majority and to this end a questionnaire was circulated to ascertain anaesthetists' opinions. Four hundred and twelve numbered questionnaires were sent to a random selection of consultants on the Association of Anaesthetists of Great Britain and Ireland database. The questionnaire asked whether they or trainee staff might feel obliged to participate; whether if a manikin study was being performed they or trainees might feel exposed to criticism if they participated; and whether they felt that publication should be possible without REC approval. As some RECs may feel ethical approval unnecessary, the final question asked whether an editorial team should respect this decision or make their own on publication. Two hundred and thirty-two questionnaires were returned (56%), many with additional comments added. As many respondents had strong and very diverse opinions on the matter, no further attempt was made to contact respondents. The respondents had spent a mean of 20 years in anaesthesia and 59% worked in a district general hospital. Ninety-two per cent felt ethical approval should not be necessary in manikin studies when equipment is being assessed; 77% said that ethical approval should not be necessary if skills were being assessed. During skills assessment, 32% felt that they might feel obliged to participate if asked to take part and 68% felt trainee staff might feel obliged to participate. When asked if they might be potentially exposed to criticism of their skills, 58% said they might and 70% felt trainees might. If ethical approval had not been gained, 86% of respondents felt that publication should still be possible. If the local REC did not consider ethical approval necessary, 92% said that an editorial team should respect this view. Comments were made by 41% of respondents, including: Ethical approval is necessary as professionals, like patients, need protection. Ethical approval is unnecessary as approval is designed to protect patients, though sensitive handling is required. Positive criticism is fine as a manikin study is surely a teaching/learning tool and participation is voluntary. A journal is a journal and not a judge. I cannot believe that this is even an issue. The results show that a majority of respondents felt ethical approval was unnecessary when testing equipment or skills in manikin studies. Although we have standards such as the Research Governance Framework [6], no direction is given on this particular subject. Guidance produced by the General Medical Council states ‘Research must be conducted in an ethical manner and one that accords with best practice’[7]. Although there is no specific guidance on manikin studies, general advice is offered stating that protection of autonomy and interests of participants should be put first and that researchers should ensure that no coercion is used on dependent participants. An overwhelming number of respondents felt editorial teams should respect the decision of RECs who have considered ethical approval unnecessary. Journals do play a role in supporting ethical research practice by not publishing manuscripts when they feel there should have been REC approval. All the main English language journals state this in their instructions to authors [8], although there is no mention of manikin studies in the four highest impact anaesthetic journals. The word ‘ethics’ has been defined as ‘a moral principle or set of moral values held by an individual or group’[9]. Perhaps, as a professional body, anaesthetists should consider the issues relating to manikin studies and from this a moral principle formed. At present the Central Office for Research Ethics Committees (COREC) states that ‘ethical advice from appropriate NHS REC is required for any research proposal involving NHS staff recruited as a research participant by virtue of their professional role’[10]. Although this suggests that ethical approval should be necessary when carrying out a manikin study, Professor Stacey, Director of COREC, states that this is not his interpretation. We contacted Professor Stacey and asked him to respond to our main questions ‘Is ethical approval necessary when assessing user skills on a manikin?’ and ‘Is ethical approval necessary when assessing equipment when using a manikin?’. His answer was that REC approval is required (broadly speaking) for research on human beings undertaken in the NHS. Assessing user skills is not research and does not require REC approval and that testing equipment on non-human manikins does not fulfil the above criterion. Finally, a comment from one respondent highlighted that ethical approval is neither necessary nor sufficient to ensure that people treat each other in a humane way. Whether ethical approval is necessary or not, colleagues should still treat each other humanely. Indeed, is this not the most important thing? I thank Mrs Cann and her colleagues for their thoughtful comments on a difficult ethical ‘grey area’ and for going to the trouble of eliciting views from other interested parties. I admit to be disappointed, but not surprised, by the large proportion of respondents who feel that journal editors should abide by whatever local research ethics committees (RECs) decide is acceptable; unfortunately, while editors remain responsible for whatever they publish, and while RECs continue to differ markedly in the standards that they apply, this is simply not going to happen. More contentious, perhaps, is the inconsistency between the content of COREC's website and the view apparently expressed by Professor Stacey as to whether REC approval is needed for manikin-based studies. Professor Stacey and I have communicated in some detail about this, and he agrees with me that his views can be represented as follows: There is a difference between studies designed primarily to assess the performance of the participants and those which utilise the skills of the participants to test or compare items of equipment. REC approval is needed for the former. REC approval may not be needed for the latter, as long as the following conditions apply: Individuals do not feel coerced to take part; There is no attempt made to analyse the results by grade, gender or any other characteristic of the participants; The individual data, if retained by the researchers or their department, are anonymised and not made available to anyone outside the department. I note the results of Cann's survey, that 68% of respondents believe that trainee staff would feel obliged to participate in a skill-assessment study if asked. It is not clear whether the figure would be similar for a study designed to compare pieces of equipment but, if it were, then it seems that, in Professor Stacey's view, REC approval should be sought for such a study. Certainly, it would be unusual for researchers not to analyse results of a study by grade of anaesthetist, number of years of training, etc., and this would also trigger the need for ethics review. Finally, I wholeheartedly agree that humane treatment of participants in studies is important, but it is far from sufficient. The use of the term ‘humane’ carries a strong flavour of a relationship where one party is subordinate to the other, but relies on the good nature of the first to ensure his or her protection. Research ethics is all about equalising the relationship as much as possible, in a way that makes such reliance – which sadly is occasionally misplaced – unnecessary. D. Bogod Editor-in-ChiefAAGBI, London, UK