Is my project research?

Early in the study planning process, you need to first assess if the project being developed is research, service evaluation or audit. The Health Research Authority (HRA) decision tool can help you decide if your study is research.

Please see below a summary about these project categories. You can find a more exhaustive description in this link:

Research

Research projects attempt to derive generalisable or transferable new knowledge to answer questions with scientifically sound methods. This includes studies that aim to generate hypotheses as well as those that aim to test them, in addition to simply descriptive studies.

Please note that our Research Management Team will only review and assess those projects classified as Research by the HRA decision tool.

These projects include: clinical trials, basic science, studies administering questionnaires, qualitative studies, research tissue banks and databases etc.

Clinical research studies

The National Institute for Health Research (NIHR) Clinical Trials Guide provides an excellent information resource about Clinical Research.

If your project is Clinical Research, then it is important to consider whether it will be classified as a Clinical Trial of an Investigational Medicinal Product (CTIMP) or a Medical Device Trial, as different processes and regulations will be applied.

The Medicines and Healthcare products Regulatory Agency (MHRA) have produced an algorithm to help you decide whether your study is a CTIMP or not. Please see: Is it a Clinical Trial of a Medicinal Product?

For further support please contact ClinTrialHelpline@mhra.gsi.gov.uk

Research Database

A research database is a structured collection of individual-level personal information, which is stored for potential research purposes beyond the life of a specific research project with defined endpoints. Research purposes in this context refers to analysis of data to answer research questions in multiple projects.

HRA Approval is not required for the establishment of research databases. Organisations responsible for the management of research databases anywhere in the UK may apply on a voluntary basis for ethical review of their arrangements for collection, storage, use and distribution of data, including arrangements for release of non-identifiable data for analysis by external researchers.

Where the activities of a research database would include accessing or otherwise processing the identifiable data of patients or services users in England and Wales outside the normal care team without consent, a favourable ethical opinion from a Research Ethics Committee (REC)  is required by law, and an application to the Confidentiality Advisory Group under Section 251 of the NHS Act 2006 should be made to set aside the common law duty of confidentiality owed by care professionals to their patients or clients.

Service evaluation and clinical audit

Service evaluation

A Service Evaluation is designed and conducted solely to define or judge current care. 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 bench-marking.

Service development

A Service Development is a special category that introduces a change in service delivery or practice for which there is evidence derived from research or from other health/social care settings that have already introduced and evaluated the change.

Clinical audit

A Clinical Audit is a way to find out if healthcare 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.

The aim is to allow quality improvement to take place where it will be most helpful and will 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.