Background and methods: Psychiatric research can occasionally present particular ethical dilemmas, but it is not clear what kind of problems local research ethics committees (LRECs) actually experience in this field. We aimed to assess the type of problems that committees encounter with psychiatric research, using a postal survey of 211 LRECs.
Results: One hundred and seven (51%) of those written to replied within the time limit. Twenty eight (26%) experienced few problems with psychiatric applications. Twenty six (24%) emphasised the value of a psychiatric expert on the committee. The most common issues raised were informed consent (n=64, 60%) and confidentiality (n=17, 16%). The use of placebos (and washout periods) (n=18, 17%), the validity of psychiatric questionnaires (n=16, 15%) and overuse of psychiatric “jargon” (n=14, 13%) in psychiatric applications also raised concern.
Conclusions: Our results suggest that LRECs have specific concerns regarding methodology, consent, and confidentiality in psychiatric research, and that they find psychiatric input invaluable.
- ethics committees
- mental disorders
- cross-sectional studies
- research support
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The 211 United Kingdom local research ethics committees (LRECs) have a central role in the ethical conduct of research. Their efficiency and consistency have, however, caused discontent among researchers (both in and outside psychiatry). Studies have reported wide ranging opinions, decisions, conduct, and membership among LRECs, and have suggested that this diversity results in great difficulty for researchers submitting research proposals for ethical review.1 ,2 There has been less focus on the problems experienced by LRECs themselves, and as academics in psychiatry we were particularly interested to explore what ethical concerns LRECs have in connection with mental health.
Psychiatric research is often believed to pose more difficult and numerous ethical dilemmas. Caution is often advised when patients with mental health problems are invited to participate in research.3 Psychiatric patients are seen as particularly vulnerable by virtue of their illnesses. The process of gaining informed consent is frequently emphasised as a potential source of difficulty. Contemporary examples of potential ethical problems in psychiatric research include the recruitment to trials of new agents for Alzheimer's disease. How do we ethically involve participants who may not have capacity to give informed consent? Alternatively, if a patient with schizophrenia is detained under the Mental Health Act, how can we be sure that she does not feel unduly pressurised to participate in research hosted by the institution in which she is detained?
The Royal College of Psychiatrists recently reviewed ethical guidelines relating to psychiatric research with human participants. Fully revised guidelines have now been published.4 During the review, we surveyed UK LRECs regarding their experiences of psychiatric research.
An open questionnaire was sent to all chairs of the 211 UK LRECs . The letter asked two questions: firstly, what problems the LREC experienced with psychiatric research, and secondly, what type of guidelines they would find useful in this field.
Replies were scrutinised for common themes by both authors. We listed all problems and conditions reported, and calculated frequencies for items mentioned more than once.
One hundred and seven of the 211 (51%) LRECs responded and 34 LREC chairs (32%) explicitly indicated that they had discussed the issues with their committee. Twenty eight responses (26%) “rarely experienced problems with psychiatric applications”, either due to small numbers of such applications, absence of ethical dilemmas within such applications, or presence of psychiatric experts to assist the committee. For those who did detail ethical difficulties, these could be divided into three main categories. These categories and respondents' views about future ethical guidelines, are detailed in the table. Several (n=26; 24%) valued a psychiatric expert on the committee. One reply suggested that such expertise should be mandatory for committees reviewing psychiatric applications.
The response rate was somewhat disappointing, but consistent with many postal surveys. The results are striking in that any common themes were generated only through spontaneous responses. Since we are not sure that all LREC chairs consulted their committees, there is the risk that results only really reflect the views of a minority of LRECs.
The main concerns clearly relate to informed consent. More than half the respondents cited this as a potential difficulty. In addition, certain specific groups of patients were singled out as requiring specific attention, including those with cognitive impairment, children, and those with learning disability. Acute psychiatric patients and those with schizophrenia were occasionally mentioned, perhaps less frequently than might have been expected. The greater emphasis on the process of informed consent, rather than specific groups as such is interesting. We have argued that there is a move towards focusing on the process of gaining consent in psychiatric patients, rather than labelling certain diagnostic categories as unable to consent.5 Although it may sometimes be more difficult to gain the understanding necessary for informed consent in conditions such as schizophrenia or learning disability, improving the consent process can increase the numbers of people with these conditions who are able to consent to participating in research. The conditions themselves are not necessarily barriers to research participation.
Many LRECs value specialist psychiatric advice, which could be coopted when necessary. This person might also help with two further problems that were identified: psychiatric jargon in applications, and the validity of psychiatric instruments. The methodological concerns, such as use of placebos and confidentiality, were in many ways a reflection of contemporary ethical issues debated in the literature, for instance as a result of the revision of the Declaration of Helsinki and the UK Data Protection Act.
Finally, it is important to recognise the limitations of our somewhat quantitative approach to essentially qualitative research. Whilst few LRECs reported specific problems with psychiatric research, the low response rate might conceal a number of problems undetected by our survey. Our results only show the number of ethical issues that are recognised by LRECs, rather than the true prevalence of such problems in proposals submitted to LRECs. Although many of the common ethical concerns of psychiatric research were mentioned by our respondents, it is essential that our results do not provide any false reassurances about the need for careful scrutiny of all research proposals, whether psychiatric in nature or not.
The authors are solely responsible for the content of this manuscript. We are grateful to the chairs of the LRECs who responded to the survey. We are also grateful to the members of the Royal College of Psychiatrists Working Party on ethical guidelines on psychiatric research involving human participants and, in particular, to the chair of the committee Professor Sir Michael Rutter.
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↵* K W M (Bill) Fulford is Honorary Consultant Psychiatrist, Department of Psychiatry, University of Oxford, Oxford, UK
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