The UK Policy Framework for Health and Social Care Research sets out the principles of good practice for research carried out in the NHS and social care across the UK (or Health and Social Care (HSC) in Northern Ireland).
If you are a student, then the Health Research Authority (HRA)’s student research toolkit provides guidance on what you can and can’t do in terms of research in the NHS.
If you don’t have a clinical role within the NHS yourself, then it may help you to find a local care practitioner to collaborate with you on your research.
If your research will involve NHS premises, patients or staff then you should contact the NHS as early as possible for advice. You can get advice from your local NHS research and development office or where appropriate one of the following:
- in England the National Institute for Health and Care Research’s Clinical Research Network
- Health and Care Research Wales
- Northern Ireland’s Clinical Research Network
- NHS Research Scotland.
Your local NHS research and development office or one of the national research support services can discuss the feasibility of running your research, such as:
- availability of your patient population
- availability of any support services for your research for example, local availability of pharmacy, laboratory and radiology services.
They can also help you identify any costs associated with running your research in the NHS. If you are applying for funding, MRC provides guidance on NHS costs.
Sponsorship and approvals
All research involving the NHS or HSC in Northern Ireland needs to have a sponsor. You can learn more about sponsorship in your local research office.
In addition to sponsorship, there are a number of approvals which may be needed before your research can begin. For research involving the NHS you will need ethical approval from an NHS research ethics committee and NHS or HSC research and development permission as a minimum. You may need more. Exactly what approvals you will need, and other regulatory requirements that you will need to meet, depends on your research and what it will involve.
We provide further guidance on:
- using data about people in research
- using human samples in research
- developing healthcare products like medical devices, diagnostics, software, artificial intelligence, clinical trials and advanced therapies.
Please visit developing healthcare products if you are developing an app or other technology with a medical purpose, it may be classed as a medical device.
NHS and HSC research and development permissions
If your research involves premises, patients or staff in the NHS (or Health and Social Care (HSC) in Northern Ireland) then you will need appropriate NHS and or HSC research and development permissions. The review process is managed slightly differently across the UK, for example, if your lead NHS site is in England or Wales you should apply for HRA Approval (Health and Care Research Wales (HCRW Approval) in Wales), if led from Scotland NHS research and development permission and if led from Northern Ireland HSC research and development permission.
Cross-border research is coordinated across the four nations. So, if your project is led from Scotland or Northern Ireland and involves NHS sites in England or Wales, you do not need to apply separately for HRA or HCRW Approval. You need only apply for NHS or HSC research and development permission in the lead nation, and once approved HRA and HCRW approval will be issued for the English or Welsh sites.
The UK Local Information Pack is the UK wide mechanism for setting up your research in NHS or HSC organisations.
You do not need to complete the UK Local Information Pack for a single centre study with an NHS or HSC Sponsor if that single site is an NHS or HSC organisation and it is also the sponsor of your study.
If that’s not the case, then each NHS or HSC organisation needs to agree to take part in your research. They need to receive the UK Local Information Pack to do this and confirm they have the capacity and capability to take part in your research. Responsibility for sharing the UK local information pack lies with the sponsor, but this can be delegated. You can find more details on sharing the UK Local Information pack on IRAS.
If your research involves the NHS, you will find further guidance on the NHS and HSC research and development approval process on the Integrated Research Application System (IRAS) help pages.
Applying for approvals using IRAS
The Integrated Research Application System allows you to apply for a number of research approvals.
For clinical trials, the combined review service brings together review for both the clinical trial authorisation and research ethics committee opinion, from a new part of IRAS.
The IRAS online guide helps explain how to use IRAS. It is designed to help those applying for approvals, as well as those who review and or sign off projects. If you are new to IRAS then you may find the new users information helpful.
If your research will involve people as participants then you should consider how you can be transparent at all stages of the research process. You need to ask questions like:
- where will you register your study once it has been approved so everyone can see it is happening?
- how will your research participants find out about the results of your research?
- will the research results be written in a way that they can easily understand?
You can learn more in the HRA’s policy on Research Transparency.