If your study is led from England and involves the NHS in England, you should now use HRA Approval.
In this section, we provide guidance for applicants and the research community for the full research pathway, from initial study idea to publication and dissemination of results at the end of a study.
Information for Principal Investigators who are leading projects at individual sites is at the bottom of this page.
The regulation of health research provides participants with assurance that the research that they take part in is of high quality, safe and ethical. It also ensures that the results of research can be relied on and used as evidence to inform future decisions about healthcare and treatment.
The UK has a range of bodies which have roles in regulating different aspects of health research in humans. The Health Research Authority provides Research Ethics Committees and the Confidentiality Advisory Group, which review applications to undertake certain types of research. We also work with other bodies to coordinate the overall system for regulation and governance of research.
Regulatory bodies have legal responsibilities to approve, licence or inspect particular research activities. In addition, research sites have responsibilities to manage research they host. This website will help you determine what regulatory oversight is relevant to your research and how to work with research sites.
This section is organised by the key stages in the research pathway:
- Before you apply for approval
- Applying for approvals
- The review process
- During your research project
- End of study and beyond
- Further guidance for the research community
In addition to providing guidance, these sections will also signpost you to further sources of information, including other relevant organisations and to providers of local support and advice. The links below take you to useful sources of help.