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Research approval and regulation

Before a research study can start in the NHS and Health and Social Care (HSC); it must be approved by the relevant bodies and health regulatory organisations.


HRA Approval brings together the assessment of governance and legal compliance for all project based research involving the NHS and Health and Social Care (HSC) that is being led from England.

Research Ethics Committees (REC) are independent groups of people who review certain types of research to assess whether studies are ethical. Not all health research will require approval from a NHS REC this decision tool will help you to determine if your study requires ethical approval.

The Confidentiality Advisory Group (CAG) provides advice on specific projects that will be using confidential medical information.

NHS and HSC locations including NHS hospitals, doctors/GP surgeries, dentists, care homes or residential care services with patients and service users. Some health research testing new medicines involves healthy volunteers and takes place in universities or in commercial research centres. In health and social care research, these are called the research sites.

There will be someone responsible for the overall research study called a chief investigator (CI), this may be a doctor, dentist, nurse, social worker or a university researcher. The principal investigator is the person responsible for the conduct and day to day running of a study at each research site and will lead a team to carry out the research.

There will also be a sponsor for the study, this is usually the chief investigators employer. The sponsor takes on responsibility for initiation, management and financing (or arranging the financing) of the research.

To gain the relevant approvals, researchers must use the Integrated Research Application System (IRAS) to complete a single application that is submitted to all the relevant approval bodies for your type of research. The application and all supporting documentation is then reviewed and the researcher is notified of the outcome.


If you have any questions, please contact us.

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