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Approvals and amendments

The Health Research Authority provides the following approvals and opinions for research studies. 'What approvals and decisions do I need' in this section will help you understand what services you require and how to navigate and manage your application.

  • HRA Approval brings together the HRA's assessment of governance and legal compliance with the independent ethical opinion by a Research Ethics Committee (REC). HRA Approval is for all project based research involving the NHS and Health and Social Care (HSC) that is being led from England;
  • certain types of research may only need to apply for REC review. For example, studies taking place outside of the NHS where there is a legal or policy requirement for ethical review under GAfREC and Research Tissue Banks and Research Databases applying for review by a Research Ethics Committee on a voluntary basis

  • our Confidentiality Advisory Group makes recommendations on projects that require identifiable patient information where it is not always practical to obtain consent. 

  • if your study involves ionising radiation or is a CTIMP you may be eligible to apply for one of our Technical Assurances - Radiation or Pharmacy - which have been designed to facilitate regulatory applications and site set-up.

Before you begin your application and submit your project for approval there are a number of planning and preparation activities you need to complete. Visit the 'planning and improving research' section to ensure your application is 'right first time'.

To support you with writing and submitting your application for HRA Approval, we have created a series of top tips, which can be found within the IRAS help section.