Research: Generates new knowledge where there is no or limited research evidence available and which has the potential to be generalisable or transferable. More information can be found here.
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.
If you believe your project is clinical audit or service review (definitions below*) then contact the relevant departments.
Clinical Audit: email@example.com
Service Review: firstname.lastname@example.org
Measures existing practice against evidence-based clinical standards.
Service/practice development — 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. New developments should always be evaluated.
Service/practice evaluation- 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.
Project Classification Group
If you are unsure what definition your project fits within, the Trust's Project Classification Group can help. This group is made up of members from the Research and Innovation Department, Clinical Audit Department and the Quality Improvement Team who will review your project and decide collectively what definition the project meets and the next steps. If you wish to contact the Project Classification Group please complete this form and email it to email@example.com
A clinical trial is a research project that is assessing the safety and/or efficacy of an investigational medicinal product and/or a medical device. It is recommended to confirm early if your project is a clinical trial as there are certain Clinical Trials Regulations or Medical Devices Regulations, and different processes will need to be followed.
Clinical Research Studies
All other Clinical Research that is not governed by the Clinical Trials or Medical Devices regulations will be referred to as 'Clinical Research Studies'.
All Clinical Research within the NHS would need to have Health Research Authority approval.
Most Clinical Research would need Research Ethics Committee (REC) approval. To check if your project would need NHS REC review complete this toolkit.
The BHT R&I Department is able to assist with setting up your projects. You will need to follow the application procedure for:
Research Ethics Committee approval
Health Research Authority approval
NHS permission (Confirmation of Capacity of Capability)
* HQIP guide for clinical audit, research and service review (2011)