There are a number of different kinds of projects involving data collection, research, audit, service evaluation, Quality Improvement (QI) initiatives, case notes studies, student thesis, etcetera. All of them require formal authorisation from the Trust before participants can be approached or data collected.
The first step is to determine what kind of project you propose to undertake, as different types of projects are subject to different regulations and routes to obtain the appropriate authorization. Please refer to the Guidance for projects involving data collection which helps you to distinguish between research, audit, service evaluation and public health surveillance and how to apply for authorization for each; you can also refer to the HRA Decision tool.
Need help choosing the best study design?
ELFT runs quarterly clinics and offers 1:1 sessions with experienced investigators to help our staff choose the best study design for their idea. Contact firstname.lastname@example.org to book a slot.
Is Your Project Defined as Research?
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. It may also require only observation, without any intervention, and may be prospective or retrospective. It may be qualitative or quantitative in approach. The results of research or the theories derived from the research should be generalizable or transferable beyond the population upon which the research was based.
Be precise about applying this category to a student’s ‘service-related research’ thesis where often the small scale of the work makes it ungeneralizable and therefore more appropriately categorised as a service evaluation.
Any research activity that takes place within the NHS is subject to the UK Policy Framework for Health and Social Care Research which sets standards for the research process and formalises the responsibilities of all those involved. The governance approval process protects both participants and researchers. All our research activity needs to be covered by our insurance and that requires lots of information.
For projects meeting the definition of research, you then need to determine whether your study requires NHS REC approval. Once again, the Health Research Authority (HRA) has developed a Do I need NHS REC approval? on-line tool to assist you.
You must also bear in mind that all research taking place in the NHS must both be assessed by the HRA and receive confirmation from the R&D Office at each proposed NHS site that they have the capacity and capability to support the project before work, including the recruitment of participants, may begin. This applies to all research conducted in the NHS, including work undertaken by students, and there is currently no 'fast track' process for either HRA or Trust approval. There are, however, certain conditions ELFT applies to all student research projects.
As of March 2014, ELFT became a NOCLOR partner. The team at NOCLOR can support research submissions. They will review your draft and identify any areas which need to be amended. There is a guide to the Research Life Cycle which will assist you in all aspects of your project; mandatory training is also provided. All applications to conduct a research project should be submitted through the noclor office and not to the research office at ELFT.
Applications to the HRA are prepared with the support of your research sponsor; if you wish ELFT to sponsor your project you must contact noclor to arrange this. Only the Trust R&D Office is authorised to sign IRAS forms on behalf of the sponsor.
For more information, see our page on HRA Approval.
What if it's a different kind of study?
Where your project falls outside the definition of research, it still requires appropriate approval before participants are recruited and/or data is collected.
Clinical Audit is directly related to improving services against a standard that has already been set. Audits are essentially about comparing what should be happening with what has actually happened. It is a way to find out if care is being provided in line with standards and lets care providers and patients know where their service is doing well, and where there could be improvements.
All audits undertaken at ELFT are aligned to Trust and directorate assurance priorities, and coordinated by the Trust’s Quality assurance team. We do not encourage or support individuals to undertake isolated audits, as our audit programme is linked to change planning processes in each directorate which are tracked and monitored. For any queries about audit, please contact email@example.com
2. Quality Improvement (QI)
Quality Improvement (QI) goes beyond traditional management, target setting and policy making. QI methodology is best applied when tackling complex adaptive problems – where the problem isn’t completely understood and where the answer isn’t known – for example, how to reduce frequency of violence on inpatient mental health wards. QI utilises the subject matter expertise of people closest to the issue – staff and service users – to identify potential solutions and test them.
We encourage all staff to be involved in improving the way their team works, through quality improvement. All QI work at ELFT takes place in teams, so we do not support individuals to undertake QI work on their own. There is a process for formal authorisation of QI projects within each directorate – every project is approved by the directorate’s QI forum and has a named project sponsor who is accountable for the work. To find out more about which projects are going on in your directorate/team, and who to contact for support, please visit https://qi.elft.nhs.uk
3. Service Evaluation / Development
A Service Evaluation provides practical information to help decide whether a development or service should be continued or not. Evaluation also involves making judgements about the value of what is being evaluated. Service evaluations must be submitted to the Trust’s Governance and Ethics Committee for Studies and Evaluations (GECSE). For these projects, investigators should complete a template Proposal for a Service Evaluation / Development and submit it to firstname.lastname@example.org copying in the Clinical Director of the service in which the data will be collected.
4. Literature Review
A Literature Review is a summary of previous research on a topic. The literature review surveys scholarly articles, books, and other sources relevant to a particular area of research or interest. Within the review the author provides a description, summary and critical evaluation of each source, i.e. the strengths and weaknesses. The literature review may also identify gaps or controversies in the literature and topics needing further research.
As a literature review does not contain any data from ELFT sources, it does not require any governance approval from the Trust. If it is linked to a case study, please follow guidance below.
5. Case Study/Review
A Case Study is an in-depth analysis and systematic description of one patient or group of similar patients to promote a detailed understanding of their circumstances. The illustrative 'grand round', 'case report' and 'case series' have a long tradition in clinical practice and research. Presenting detailed critiques, typically of one or more patients, aims to provide insights into aspects of the clinical case and, in doing so, illustrate broader lessons that may be learnt.
Case reports are usually anonymised and there are rarely ethical issues to be considered as long as consent is obtained. However, some journals may require evidence of approval prior to publication. Best practice in writing up a case study is described in a 2011 editorial by Lowman & Kilburg in Consulting Psychology Journal: Practice and Research.
Case Studies which conform to the Trust’s standards (detailed in the Case Study Governance template) do not normally require assessment. However, where the author (or student supervisor) has question about the appropriateness of a proposal and specifically if an exception to Trust standard is being sought, the Case Study Governance template should be completed and submitted to the Trust’s Governance and Ethics Committee for Studies and Evaluations (GECSE) at email@example.com