The UK Policy Framework for Health and Social Care Research states that all research taking place within the NHS must have management approval from the 'host organisation'.
This means that any research that uses NHS patients, their data or tissue, 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.
If you would like to recruit our Trust staff and/or service users to 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 get your research study recruiting as quickly as possible.
If you are planning to write your own research study, we can offer local help, support and advice on all aspects related to the development of your study.
Contact our Research team in the first instance – early discussion is very useful and helps to minimise delays so please get in touch at the earliest stage of research development. Our contact details can be found on the right of this page.
Changes to the Health Research Authority (HRA) approval process
The Health Research Authority protects and promotes the interests of patients and the public in health and social care research. It works to make the UK a great place to do research where more people have the opportunity to participate in health and social care research and continue to feel safe when they do.
From April 2016, significant changes to the way that research in the NHS in England is approved and delivered have been introduced.
The new HRA approval process will change the way that the research department work – removing the need for separate local assessment, but also placing a greater emphasis on NHS Trusts to host and deliver research in a more flexible way.
What is HRA approval?
The new process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent Research Ethics Committee opinion provided through the UK research ethics service.
It replaces the need for local checks of legal compliance and related matters by each participating organisation in England, allowing them to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.
What difference will it make to health research?
The new system will simplify the approvals process for research, making it easier for research studies to be set up. The elimination of duplicate application routes means that the answers to research questions about how to improve patient care or about new treatments will be answered quicker. Patients will benefit from research funding being dedicated to the delivery of research rather than being wasted in navigating complex systems. By removing duplication of reviews of research by NHS support teams, the NHS will be freed up to focus on delivering research.
The Trust’s research department will continue to oversee all research. All research which takes place within the NHS – whether with patients and/or staff – should have received HRA approval and we will hold this information within the research department.
How will this impact on Trust staff?
If you are considering completing your own research and wish to recruit NHS patients and/or staff then you will need to apply for HRA approval – please speak to the research department for further information and advice.
When external research studies are received into the department, they will already be HRA approved (including ethics review). The research department will be required to check for 'capacity and capability', essentially a check on whether we have whatever is necessary to deliver that study within the Trust – the right clinical services, research support staff to complete data collection and/or the study intervention.
If you want to know more about the new HRA process, or are in any doubt about the validity of any research approach made to you, then please contact the research department for further advice.