Choosing a study type and getting permission

Research

Research (with a capitol ‘R’) 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 which can be generalised, or transferred more widely.

• Will your study generate evidence to support, refute or develop a hypothesis?
• Will the results be generalizable (will they apply) beyond the population upon with the study was based?
• Does your study involve randomisation and/or adding to or changing clinical practice?

If you answer yes to any of these: it’s a Research study.

Evaluation

Whereas an Evaluation is defined as study in which research procedures are used in a systematic way to judge the quality or worth of a service or intervention, providing evidence that can be used to improve it. An 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.  

• Does your study provide practical information to help decide whether a specific service should be continued or not?
• Does your study aim to make judgements about the value of the current service/care being assessed?

Sounds like an evaluation; to help you plan your project, please see this five-step guide to the evaluation cycle. 

Audits

Clinical Audits are 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 shows care providers and patients where their service is doing well, and where there could be improvements.

• Does your study aim to explore whether healthcare is provided in accordance to the approved policies and standards?  Does it measure care provided against a pre-determined standard?
• Does your study aim to find out where improvement can be made in a particular healthcare service?

Sounds like you are planning an Audit.

Quality Improvement

Quality Improvement (QI) is all about problem-solving. It 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 the frequency of violence in 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.

• Is your project intended to bring about an immediate improvement in healthcare provision?
• Does it involve a design that is iterative and flexible (rather than a pre-determined protocol)?
• Does your project utilise the expertise of people closest to the issue – staff and service users – to identify potential solutions and test them?

This sounds like a QI project. Visit the QI website at https://qi.elft.nhs.uk/ or reach out to ELFT’s QI department at elft.qi@nhs.net for further support. 

Case Study

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.

• Does your study involve an in-depth analysis and description of one patient or group of similar patients in a natural real-life scenario in order to promote a detailed understanding of their circumstances?
• Is your project focused on describing clinical care and experiences of clinicians regarding a particular case, service development or policy?

Sounds like a Case Study. 

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.

• Is your study aiming to summarise and critically evaluate previous research on a specific topic?
• Does it involve surveying academic papers, books, and other sources relevant to the particular area of study?

Sounds like you are conducting a literature review. 

Research

All research taking place in the NHS must both be assessed by the Health Research Authority (HRA) and receive confirmation from the R&D Office at each proposed NHS site before work  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. Applications should be submitted through our research support services partner, Noclor.

The HRA has produced a very helpful toolkit to help you answer questions such as ‘Is my study research?’ ‘Is my research being carried out in the NHS and needs NHS approval?’ and ‘Do I need an NHS REC Review?’ Although originally designed for students, it is quite helpful for all researchers when deciding what approvals are needed.

Evaluation

Investigators wishing to conduct an evaluation at ELFT should apply by completing a template Proposal for a Service Evaluation and submitting it for assessment by the Trust’s Governance and Ethics Committee for Studies and Evaluations (GECSE).

NEW! To help us help you through the process as quickly (and painlessly) as possible, we have developed a dedicated GECSE webpage providing advice, the template proposal and good practice examples. 

Contact the GECSE: elft.gecse@nhs.net

Audits

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 elft.qa@nhs.net. 

Quality Improvement

We encourage all staff to be involved in improving the way their team works, through quality improvement (QI). All QA 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. 

Case Study

The ELFT Case Study governance form should be completed and submitted to the Trust’s Governance and Ethics Committee for Studies and Evaluations (GECSE) for any case study, report, or series intended for public dissemination. For the purposes of ELFT’s governance review, the remit is limited to case studies related to the clinical care of patients.

NEW! Find the Case Study governance form on our dedicated GECSE webpage. 

Literature Review

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 above.