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The Health Research Authority provides approvals and opinions for research studies. This section will help you understand what services you require and how to navigate and manage your application.

One of the first steps in deciding which approvals you need for your project is to determine whether it is classed as research, and therefore whether it should be managed as such. The responsibility for determining whether a project is classed as research lies with the managing organisation. For studies that are determined to be research, the managing organisation would then accept the role of sponsor.

HRA Approval is for all project-based research that involves NHS organisations in England where the NHS organisation has a duty of care to participants, either as patients/service users or NHS staff/volunteers. References to participants include people whose data or tissue is involved in a research project.

Research Ethics Committees (RECs) review research applications and give an opinion about whether the research is ethical. They look at areas such as the proposed participant involvement and are entirely independent of research sponsors (that is, the organisations which are responsible for the management and conduct of the research), funders and investigators. This enables them to put participants at the centre of their review.

This section focuses on the steps you need to follow in order to apply to a Research Ethics Committee.

Unless your applications is being processed under the Proportionate Review Service, you should attend the REC meeting if possible. Please check directly with the REC manager if you can only dial in to the meeting by phone.

HRA Approval currently applies to project-based research taking place in NHS organisations and independent contractor primary care services. HRA Approval does not yet cover non-NHS organisations commissioned to provide NHS services. Non-NHS Site Specific Information (SSI) forms should continue to be sent to the Research Ethics Committee for these sites.