Ethics and NHS research

A selection of letters in response to 'Entangled in an ethical maze'.

I am writing in support of Professors Della Sala and Cubelli (‘Entangled in an ethical maze’, December 2016), who have addressed an issue that is of increasing concern to many researchers and clinicians. Taking a lead from their analysis of how important basic research is being hampered by the decisions of ethics committees, I would contend that the situation is even more problematic in many fields of applied clinical research, with difficulties with NHS ethics being one of the primary reasons why much of the mandatory doctoral-level research currently undertaken by trainee clinical psychologists in the UK at a cost of over £7m per annum is conducted with non-clinical populations, often other trainee clinical psychologists.

In my own area of intellectual and developmental disorders (IDD) we have seen the unforeseen consequences of the lack of relevant expertise on NHS ethics committees, on which clinical psychologists can only sit as ‘lay members’ irrespective of their research knowledge or experience, combining with prevailing legislation and policies on capacity to consent and safeguarding of ‘vulnerable’ adults. The result is a situation where is it nigh on impossible to engage and recruit adults with IDD to take part in research without invoking time-consuming, expensive and highly intrusive safeguarding procedures in order to speak to them or to their carers and supporters. The irony is that we know very little about the psychological and emotional needs and wellbeing of people with IDD, who are in turn protected and safeguarded from the very research that might significantly improve their quality of life and that of their carers. It is perhaps worth reflecting on the fact that the recent maltreatment and abuse of people with IDD, such as was perpetrated at the infamous Winterbourne View, occurred in settings well beyond the remit of any ethics committee, whilst research into the effects of such abuse and trauma is regarded as something of concern that people with IDD must be protected from, even if such research only involves talking to their carers with their permission.

As per Professors Della Sala and Cubelli, I am not arguing for the freedom for researchers to do as they please, but for ethics committees to see both basic and applied research in the broader context and to work as enablers of high-quality, ethical psychological research. A first step would be for the UK NHS Health Research Authority to look again at its remit of public protection and to acknowledge that high-quality research is ultimately in the interests of the general public, service users and patients, especially those who are currently marginalised, ignored and all too frequently abused.

Dr Dougal Julian Hare
Reader in Clinical Psychology,
Cardiff University

Perhaps surprisingly, I agree with much of what Sergio Della Sala and Roberto Cubelli say in their recent opinion piece (‘Entangled in an ethical maze’). We need ethics in research; different research needs call for specific ethical consideration; and all research should benefit from the advice of an ethics committee. This is why NHS Research Ethics Committees (RECs) exist: to provide these services and ensure that decisions are made in a consistent and proportional way. The Health Research Authority is responsible for RECs in England but works closely with the devolved administrations to ensure a UK-wide approach to ethics service provision.

I also agree that applications should only receive an unfavourable opinion in exceptional circumstances. What the authors’ series of anecdotes don’t show is that only 6 per cent of applications receive an unfavourable opinion at first review by an REC, with many resubmitting and going on to receive a favourable opinion. Or that 80 per cent of users feel that the REC review added value to their application.

Our training programmes that committee members undertake include quantitative and qualitative research methodologies. We also have RECs flagged for qualitative research whose members have expertise and experience in research using this methodology.

Of around 6000 applications UK-wide each year, only 16 per cent are clinical trials of medicinal products. Committees’ experience of reviewing other studies – including those in psychology research – is therefore significant. But only 19 of the 87 RECs in the UK have a psychologist as a member, so we’d welcome applications from more.

We would always like to improve on what we do, and if psychologists feel they experience difficulties with review of their research then we want to hear about it.

Patients and the public deserve to have the widest possible access to the fruits of our world-class researchers. And everyone – both patients and researchers – deserve to know that it’s being done in the safest and most beneficial way.

Joan Kirkbride
Director of Operations
Health Research Authority

I read with interest the article by Sergio della Sala and Roberto Cubelli ‘Entangled in an ethical maze’ (December 2016 issue). The concerns raised by the authors, regarding the obtaining of ethical approval for neuropsychological research projects, parallel those expressed by many prospective researchers in the field of neuropsychology. The UK has, in the past, enjoyed a pre-eminent position globally in neuropsychological research, but there are worries that this is being jeopardised. The perceived barriers are making it increasingly difficult for talented academic researchers to engage in clinical research.  This is worrying, particularly at a time when psychological and behavioural health is receiving greater attention nationally. 

Ethical approval for neuropsychological research studies has been a topic of discussion within the British Neuropsychological Society for some time. We now need to engage in constructive dialogue with Ethics Committees. It is crucial that we safeguard the rights, safety, dignity and well-being of research participants and, for that, we value the advice that Ethics committees can offer. At the same time, we need to communicate to Ethics committees the very unique character of neuropsychological research and offer practical solutions to the issues raised by della Sala and Cubelli.

Julie Snowden  
President British Neuropsychological Society 

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