You will need to apply for Health Research Authority (HRA)/Health and Care Research Wales approval, which needs to be in place before you can start your research study.
HRA/Health and Care Research Wales approval is a combined process for applying for approvals for all project-based NHS and social care research taking place in England or Wales.
You will need to ensure you are conducting research to required standards and are compliant with relevant legislation. Further information can be found on our set up a research study page. Information on planning your study is also available in the research planning section on the HRA website.
Submitting your application
All applications are made using the UK’s online integrated research application system (IRAS).
You will be asked questions that will help identify whether you need ethical or Medicines and Healthcare Products Regulatory Agency (MHRA) approval for your study, and you will be directed to the appropriate forms within the IRAS system.
For information on how to prepare and submit an application for HRA/Health and Care Research Wales approval please refer to the IRAS website.
Further information on HRA/Health and Care Research Wales approval can be found on the HRA website.
Studies involving Northern Ireland and Scotland
For new studies that are led from Northern Ireland or Scotland but have English and/or Welsh NHS sites, the lead nation will share information with the HRA and Health and Care Research Wales to enable the issue of HRA/Health and Care Research Wales approval for English and Welsh sites.
For new Welsh-led studies that have NHS sites in Northern Ireland and/or Scotland, the approvals service will share information with participating nations. The relevant R&D coordinating function will provide advice on the setting up of sites in their nation.