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.
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 works with these 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. Use the menu on the left to access all the stages and the detailed information within them. 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.
The majority of information in the website is of relevance to Chief Investigators and sponsors with oversight of a whole study. If you are a Principal Investigator at a research site or part of a local research team recruiting participants then there are specific sections that are relevant to you. We recommend you focus on the following sections:
- Applying for approvals – NHS management permission
- The review process – NHS management permission
- Progress reports – NHS R&D
- Preparing for the end of the study