What is Research?

Any research activity that takes place within the NHS is subject to the Department of Health's Framework for Research Governance in Health and Social Care (RGF) which sets standards for the research process and formalises the responsibilities of all those involved.  The framework “sets out the responsibilities and standards that apply to work managed within the formal research context…and systems for assuring the quality of innovative work in non-research contexts.”

It is clear that, although the NHS has a responsibility for assuring the quality of all work undertaken within the service, not all innovative work should be defined and managed as research.  In response to the increasing amount of evaluation, practice development, audit and other investigations, the Trust has set up an internal Ethics Sub-Committee which acts as an advisory group for the Trust Board and Clinical Directors. The Ethics Sub-Committee provides scrutiny and overview of all non-research projects in the Trust, which fall outside standard clinical care and involve service users and/or carers in order to ensure that such projects fulfil ethical criteria.

Any non-research project requires approval by the relevant Clinical Director before participants are recruited and/or data is collected. The Clinical Director’s decision will be informed by the advice of the Trust's Ethics Sub-Committee. Applications to conduct non-research work are made to the relevant Clinical Director and the Trust Ethics Sub-Committee simultaneously through the use of the Ethics Approval Form.  

For those people who wish to conduct a Research Project, the East London NHS Foundation Trust has agreed to integrate its research management and governance (RM&G) activities with those of one of the Trust’s Higher Education Institution partners, the Barts and the London School of Medicine and Dentistry, part of Queen Mary University of London.

The difference between clinical audit and other non-research activity and research is not always clear and there will be some grey areas where it is not easy to distinguish research from other forms of innovative work.  So how do you determine whether a proposed study is ‘research’ or not?

Research

According to the RGF, “research can be defined as the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods.”  Research generates evidence to refute or support or develop a hypothesis. Research aims to find out what happens if we add or change (manipulate) clinical or service practice in some way, or aims to find out in a systematic way the views/ opinions/ experiences/ understandings of stakeholders. The results of research or the theories derived from the research should be generalisable or transferable beyond the population upon which the research was based.

What is not research?

  • Case Studies / Reports
  • Clinical Audit – is directly related to improving services against a standard that has already been set
  • Clinical Investigations – where the purpose of requesting the test is to obtain a diagnosis or to determine the appropriate care for a particular patient (or relatives, in the case of genetic disease), the request for the test should not be regarded as research.
  • Consensus methods, techniques and workshops – are a communication process used to inform decision-making where evidence is lacking or contradictory.
  • Routine Data Management and Analysis – Data collected in the course of normal administrative functions of the NHS may be analysed to provide management information to monitor current provision or to plan future developments of the service.
  • Literature Review – is considered to be a scholarly exercise which does not entail gathering original data
  • Service Evaluation – provides practical information to help decide whether a development or service should be continued or not.

Telling the difference

The difference between clinical audit and other non-research activity and research is not always clearand there will be some grey areas where it is not easy to distinguish research from other forms of innovative work.

For example, a piece of work is not exempt from the requirements of the Research Governance Framework merely by the fact that it is being undertaken in fulfilment of an educational degree; many theses are of genuine research value.  Nor is the level of degree indicative of whether a piece of work is ‘research’ or not; the thesis requirements of a PhD may be fulfilled by a literature review, service evaluation or other piece of investigative work not defined as ‘research’.

If there is any uncertainty either on the part of the study team, the first port of call is the Trust Research Office (ResearchOffice@eastlondon.nhs.uk) which can advise you as to whether or not a given piece of work should be treated as research.  Alternatively, an A4 summary (one side only) outlining the proposal should be submitted via email to the Chair of a Research Ethics Committee or to the National Research Ethics Service Queries Line (queries@nres.npsa.nhs.uk).

All projects determined to be research must receive authorisation from the Trust Research Directorate before work, including the recruitment of participants, may begin.