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Choosing a study type and getting permission

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. 

Choosing a study type 

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. The primary element which distinguishes one kind of study from another is not sample size, or obtaining consent, or what type of data you collect or from whom, or funding and so on, but the intent of the study. 

Do you have an idea for a service evaluation or research idea in the early stages? If you'd like to talk to a researcher in the NIHR Applied Research Collaboration North Thames Academy about developing your idea or collecting your data then sign up through the online support page for a one-to-one slot on Tuesday afternoons. 

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 

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. 

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 know 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 (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. 

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. 

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. 

Getting authorisation to start work

Once you know what kind of study you wish to undertake, there are different routes for obtaining permission to undertake the study in our Trust.  Keep in mind that even if a project falls outside the formal definition of 'R'esearch, it still requires appropriate approval before participants are recruited and/or data is collected. 

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 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. 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. 

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

To help us help you through the process as quickly (and painlessly) as possible, we have developed the follow advice on How to get permission from ELFT to conduct an evaluation?

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  

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 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 a 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 elft.gecse@nhs.net 

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. 

An additional note for students:

As a student, your main source of support in developing your proposal will be your academic supervisor. However, you should both familiarise yourself with the new (and more restrictive) criteria the NHS Health Research Authority applies to student research studies as well as those ELFT applies to all student projects.  If you have any queries about the eligibility criteria, please contact queries@hra.nhs.uk 

It is possible for students to learn about health and social care research without completing standalone Research projects. Looking at other ways to build skills and experience better reflects modern research and emphasises team science. View the video of the ‘Exploring good practice in Student Research’ event to hear from course leaders about how successful these alternative approaches have been (registration is required to view) or read the NHS HRA website for further information and ideas www.hra.nhs.uk/student-research.