Essential Advice for Researchers
1. It is essential that the Gloucestershire Research and Development Support Unit (RDSU) Office is approached at the earliest stage if any research or service evaluation is planned in any department within GHNHSFT.
There are a number of statutory and governance requirements that need to be dealt with: importantly, if research is occurring in the NHS without the approval of the sponsoring organisation and/or the host trust there will be no indemnity cover. If the study is a trial involving a medicine (even a licensed one) this is illegal under UK and European law. You will be unable to publish the research in any journal without evidence of prior ethics approval and approvals can never be granted retrospectively and there are likely to be disciplinary consequences
2. The definition of what actually constitutes research is sometimes difficult to work out.
To avoid any confusion or misunderstanding potential researchers are urged to discuss this aspect with the research office prior to any research work starting (see below).
3. One of the commonest misconceptions is the difference between audit, service evaluation and research.
This is an important distinction because research always needs prior approvals, from an NHS Research Ethics Committee and the trust. Service evaluation needs approval from the RDSU office. Audit needs to be registered with the trust’s Audit office Liz Dawes (Clinical Audit Manager) phone number 08454 223131 e-mail address liz.dawes@glos.nhs.uk.
There is undoubtedly ‘overlap’ between what is classified as research, service evaluation and audit, generally though key discriminants are:
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a. Intent – the primary aim of research is to derive generalisable new knowledge, whereas the aim of audit and service evaluation is to measure standards of care. Research is to find out what you should be doing; audit is to find out if you are doing planned activity and assess whether it’s working.
b. Treatment or service – neither audit nor service evaluation uses an intervention without a firm basis of support in the clinical or health community.
c. Allocation – neither audit nor service evaluation allocate treatment or service by protocol. It is a joint decision by the patient and the clinician
d. Randomisation – if randomisation is used, it is research.
(National Research Ethics Service guidance 2009)
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4. The research office is a valuable source of advice about:
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a. How to develop your research idea, and deciding, is your proposed work research, service evaluation or audit.
b. Sources of funding: all research in GHNHSFT must have an identified funding source e.g. from a research grant or personally held funds .This is because all research has a finite cost, if only for use of the buildings/heating/infrastructure e.g. radiology etc. The RDSU can help identify research funds, assist in preparing grant applications, and even have some small ‘pump-priming’ funds available to help with otherwise un-funded research.
c. The type of research GHNHSFT supports. Current policy is to pursue research with is either already on the NIHR portfolio of research projects, or is likely to become eligible to join the portfolio: which will include projects funded by the larger research funding bodies, and some of the larger charities (available online - www.nihr.ac.uk). This is because portfolio research attracts additional payments to support local research infrastructure for each subject recruited.
d. Applying for ethical review
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To contact the Research and Development Support Unit office; phone GRH 5462/5463 or email one of the team:
julie.hapeshi@glos.nhs.uk
mark.walker@glos.nhs.uk or
thomas.llewellyn@glos.nhs.uk