METHOD

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.

RESULTS

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.

DISCUSSION

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.