Dear Sir,

Re. Lack of Indemnity for Research in Primary Care

We are writing to highlight a serious and important gap in the indemnity arrangements for research in primary care. All researchers are required to hold adequate indemnity as part of obtaining ethical approval for research. Most general practitioners and practice nurses are not direct employees of the NHS and are therefore outside the cover of the NHS litigation authority. Although most primary care trusts have issued honorary contracts to researchers, the NHS litigation authority has stated that these are not sufficient to provide indemnity. Projects where general practitioners or practice nurses are the grant-holders – i.e. most of the research taking place through Primary Care Research Networks - is therefore inadequately covered. Most researchers are unaware of their vulnerability.

Our research network has repeatedly asked the Department of Health for clarification and resolution of this matter but has not received a reply.

Research led by primary care is being compromised. Our practice was awarded a grant by the NHS R&D to carry out a randomised trial. After protracted discussions about indemnity and failure to establilsh cover, we are arranging to relinquish our status as the principal investigators and transfer this to our local academic unit. Another local practice will withdraw from research this year as a direct result of this problem.

This situation would be easily resolved by the NHS litigation authority to extend cover to NHS researchers in primary care. We ask them to do this.

Yours sincerely,

Chris Griffiths, General Practitioner
Meg McDonald, Practice Nurse

Competing interests: None declared

Dear Sir

The paper by Hearnshaw1 and your editorial comment2 are timely, coming as they do only a few weeks before the introduction of new governance arrangements for research ethics committees3. While those applying for review of conventional medical interventions may face time- consuming and arduous form-filling, they do at least usually have their proposals reviewed by experts in conventional scientific method. The same cannot be said for applications involving unfamiliar methodologies, such as qualitative research, or interventions using complementary or alternative treatments which are not currently accepted within the western medical system.

There is a least one ethics committee which refuses all qualitative proposals at first review (personal communication), and anecdotally there are many which regularly review CAM proposals without training or expertise in this area, and suggest unrealistic or inappropriate changes to study design.

Given the increasing number of unconventional submissions, and the new governance requirements for ethics committees to include expertise in these areas, we are currently preparing a project to investigate the current practices and attitudes of ethics committees in the United Kingdom.

Gay Walker,
Researcher,
Supportive Oncology Research Team, Lynda Jackson Macmillan Centre (LJMC), Mount Vernon Cancer Centre, Northwood, Middx, HA6 2RN

Dr Jane Maher,
Consultant Clinical Oncologist,
Medical Director, LJMC, Mount Vernon Cancer Centre, Northwood, Middx HA6 2RN

Dr George Lewith,
Senior Research Fellow, University of Southampton,
Visiting Professor, University of Westminster,
Complementary Medicine Research Unit, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST

Competing interests: None

1 Hearnshaw H. Comparison of requirement of research ethics committees in 11 European countries for non-invasive interventional study. BMJ 2004;328:140-1

2 Glasziou P, Chalmers I. Ethics review roulette: what can we learn? BMJ 2004;328:121-2

3 Governance arrangements for NHS Research Ethics Committees London: DoH 2001

Competing interests: None declared

Thankyou to Hearnshaw1 ,Glasziou and Chalmers2 for making points I would have made myself had my time not been taken with writing ethics applications. I am currently coordinating a qualitative investigation into the attitudes of Asian families to child and adolescent mental health problems and services. Because the research involves service users, non- patient members of the community, children and adults I have been required to make full submissions to three ethics committees – one University and two NHS. Despite the fact that the research had received very positive peer review from one of the top medical sociologists in the UK, each committee criticised the design or quality of the methodology and required fairly substantial clarifications and alterations to patient information. For example, one committee required that I lengthen the children’s information sheet to bring it into line with COREC guidelines, while another said it was “too wordy” and required me to shorten it. Meanwhile, our local Health Board is carrying out a similar focus group study without need for ethical approval because it is seen as “user involvement”, is not hypothesis driven and will not be published in the research literature.

While I can see the need for a Research Governance Framework, the current guidelines seem to have produced a climate of risk aversion without any weighing of possible benefits to patients. I my area, research by busy clinicians and by students on time-limited MSc programmes is all but grinding to a halt because the ethics barrier is seen as insurmountable. This is yet another example of clinical academia being strangled at its roots.

1. Hearnshaw, H. (2004) Comparison of requirements of research ethics committees in 11 European countries for a non-invasive interventional study. BMJ, 328, 140.

2. Glasziou, P., Chalmers, I., (2004) Ethics review roulette: what can we learn?

Competing interests: None declared