Opening a study at our site
When planning a study, one of the first questions you need to ask is “is my study research”? This Health Research Authority defining research table and toolkit will help you to identify whether your study is research as defined by the UK Policy Framework for Health and Social Care Research. If your study is not research, it may be service evaluation, quality improvement or clinical audit. Depending on the type of study, you may need to have different approvals in place before the study can commence.
The UK Policy Framework for Health and Social Care Research governs research into healthcare. This document states that, in addition to other necessary approvals, all research taking place within the NHS must have management approval from the 'host organisation'.
This means that any research involving NHS patients, their information or tissue (e.g. blood), NHS staff, premises or resources, (that is, the pharmacy or laboratories), must have obtained the approval of the relevant NHS Trust before the study can commence.
Research at our Trust complies with national guidelines and best practice, including obtaining necessary approvals as well as following the relevant Trust policies. You can find out more information about the necessary regulatory approvals on the Health Research Authority webpage.
Our clinical research service consists of a variety of experienced professionals including Doctors, Nurses, Allied Health Professionals, Midwives and Clinical Research Practitioners. Research involving those experiencing a wide range of mental health difficulties is a large proportion of our research portfolio but we also have experience in research involving older people, those with learning difficulties, research into COVID-19, commercial research and much more. You can find out more information about some of the projects we have ongoing here: Get Involved
If you have identified your study as not being research using the HRA definition and toolkits listed above, then you do not need to seek HRA or REC approval. However, depending on the nature of your study, there may be other approvals or agreements necessary.
Clinical Audit – In line with the Trust policy, all clinical audits need to be registered with the Clinical Audit Department. Registering clinical audits provides implied patient consent, meaning their records can be interrogated for clinical audit purposes. The starting point for any audit, be it baseline or re-audit, is the completion of a project plan that should be accompanied by a proforma (data collection tool). The team can provide advice and guidance as well as assist with literature searches to find standards to audit current practice against. Clinical Audit overlaps with Quality Improvement techniques, and following the production of a report, presentation or poster, a driver diagram will need to be produced followed by PDSA (Plan, Do, Study, Act) cycles to apply continuous quality improvement.
Service Evaluation or Quality Improvement –There may be data sharing agreements and/or CAG approval necessary depending on the nature of your project. If you are looking to access patient identifiable data without consent (and you are outside of the patient’s direct and current care team), you will need to apply for CAG approval. For advice and guidance around data sharing please contact the Records Management Team.
If you are at all unsure as to whether your project is research or something else, and therefore what approvals you may need to have in place before your study commences, then please contact us and we will be happy to advise.
If you are a Commercial or non-commercial Sponsor and would like to involve our Trust staff and/or service users as participants in your current research study, you will need our team’s approval before you can proceed. We aim to be proportionate and pragmatic in our local reviews - we want to enable you to get your research study recruiting as quickly as possible.
Please contact us using the details below in which we would be happy to discuss further.
If you are wanting to open a study at our site, then please contact our research team in the first instance to discuss your ideas and plans to date. Early discussion is very useful and not only helps to minimise delays in study set up, but can also increase the quality and success of delivery. So please get in touch at the earliest stage of project development.
In addition to facilitating clinical research, the department can offer advice and guidance on all aspects of research and evaluation - from study design and approval processes, through to data analysis and publication.
Telephone: 01332 623579