What do I need to do?

Last updated on 16 Dec 2020

The public involvement responsibilities of the research team are defined in the UK Policy Framework for Health and Social Care Research.

Chief Investigators are responsible for making sure that a research project makes effective use of patient, service user and public involvement where appropriate.

Sponsors have overall responsibility for ensuring the research proposals and protocols make appropriate use of patient, service user and public involvement.

Funders are responsible for involving patients, service users and the public where appropriate in funding decisions.

Involving patients in research

Involving patients and the public in your research is not a legal requirement for research regulated by the Health Research Authority in Great Britain. However, we strongly advise it as minimum good practice because it is likely to improve your research and to address some of the Research Ethics Committee’s key considerations. For studies led from Northern Ireland, the Health and Social Care (Reform) Act (Northern Ireland) 2009 does place a statutory duty to involve and consult service users and carers in the planning and provision of care, or changes to the way care is provided. The HSC R&D website has further information and support. 

Best practice in public involvement

The UK Policy Framework for Health and Social Care statement of principles serves as a benchmark for good practice that the management and conduct of all health and social care research in the UK are expected to meet. Principle Four: Patient, Service User and Public involvement in the UK Policy Framework states that, ‘patients, service users and the public are involved in the design, management, conduct and dissemination of research.’ 

The HRA expects applicants to involve enough of the right people in the right ways to benefit their research and to describe how it's helped. We’ve identified four principles for best practice in public involvement to explain this in more detail. 

I am planning to work with patients and the public

Please read through our four principles for best practice in public involvement carefully. We strongly advise researchers to involve patients and the public as early as possible in the research planning process, and to make use of the resources available to help you. 

We expect applicants for Research Ethics Committee (REC) review to involve relevant people well in the design, conduct and dissemination of their studies. Research Ethics Committees consider whether applicants for ethical approval have involved patients, service users, or the public in the design, management, and undertaking of the research. Meaningful involvement with patients, service users, and the public is an important factor in the Confidentiality Advisory Group’s (CAG) review of whether a proposed unconsented activity is in the public interest. 

I am not planning to work with patients and the public 

Public involvement can benefit every type of research that the HRA regulates; choosing the right type of involvement will depend on the research itself. Have a look at our resources page for examples.

Choosing not to work with relevant patients or other members of the public could mean missing the opportunity to address ethical issues at the outset of a research project. 

If you are not planning to involve patients or the public in your research, you will need to justify this clearly when you apply for Research Ethics Committee review.

If you would like to discuss involving relevant people in current or future research projects, contact our Public Involvement Team at public.involvement@hra.nhs.uk

Do I need HRA ethical approval before I work with patients and the public? 

No. You do not need to submit an application to a Research Ethics Committee in order to involve the public in the planning or the design stage of research, even if the people involved are NHS patients.

Please note: Public Involvement does not refer to research participants taking part in a study. To find out which reviews your project needs, please use our tool

You should describe how you plan to involve people in the management, conduct, analysis, or dissemination of your study in your application for Research Ethics Committee review, because doing so is likely to address ethical considerations which are of interest to the Research Ethics Committee. See best practice in public involvement principle 4.

I have questions about involving patients and the public in my research

The resources page on the left links to practical guidance and training opportunities about public involvement. If you would like to discuss how to involve people in your project with our Public Involvement Team, please email public.involvement@hra.nhs.uk

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