Is my project research?

Early in the study planning process, you first need to decide if the project being developed is research, a service evaluation or an audit. This will determine which approvals you need for your project.

Research is designed and conducted to generate new knowledge. This includes studies that aim to generate hypotheses as well as those that aim to test them, in addition to simply descriptive studies. These projects include clinical trials, basic science, studies administering questionnaires, qualitative studies, research tissue banks and databases etc.

All clinical research requires a sponsoring organisation, R&D approval and other regulatory approvals.

Service Evaluations are designed to answer the question “what standard does this service achieve?” It evaluates the effectiveness or efficiency of an existing or new service/practice that is evidence-based, with the intention of generating information to inform local decision-making. This type of activity is sometimes referred to as a clinical effectiveness study, baseline audit, activity analysis, organisational audit and benchmarking.

Audits (or Quality Improvement) are designed to find out whether the quality of a service meets a defined standard and are processed by the Clinical Audit and Improvement Department. The aim is to allow quality improvement to take place where it will be most helpful and will inform best care and improve outcomes for patients. Clinical audits can look at care nationwide (national clinical audits) and local clinical audits can also be performed locally in trusts, hospitals, or GP practices anywhere healthcare is provided.

The National Research Ethics Service (NRES) has published guidance to help you decide the category of your project.

In addition, the Health Research Authority (HRA) have provided this decision tool. So long as the information you enter is correct, the outcome of the decision tool can be taken as authoritative, and you do not need to seek further confirmation. You are advised to keep a copy of this decision for the duration of your project.

Where a project will not be managed as research there is no need to apply for HRA Approval or to an NHS REC. However, you should contact the NNUH clinical audit/governance, information governance or research and development (R&D) office to discuss what other local review arrangements or sources of advice may apply.  For example, there may be standard guidelines on the conduct of clinical audit, or arrangement around access to patient data. You can get in touch with the NNUH clinical audit team using this email address: clinicalauditandimprovement@nnuh.nhs.uk

For both research and non-research, if your project will involve the use of patient data outside the direct care team without consent you may still need support from the Confidentiality Advisory Group (CAG).