HRA (Health Research Authority) Approval
If your study involves the NHS in England, you should use HRA Approval. HRA Approval is the process for the NHS in England that brings together the assessment of governance and legal compliance with the independent REC opinion provided through the UK research ethics service.
- HRA Approval will be used wherever the project involves NHS organisations in England.
- Where a project also involves NHS/HSC organisation(s) elsewhere in the UK (i.e. other than in England) the study will be supported through existing UK-wide compatibility systems, by which each country accepts the centralised assurances, as far as they apply, from national coordinating functions without unnecessary duplication.
If you are unsure whether you require NHS REC approval, the HRA have created a decision tool that will advise you as to whether or not you will need to complete an application using the IRAS (Integrated Research Application System). The HRA provides detailed guidance on the process and how to apply, which you should read carefully before submitting an application. The guidance also contains a link through to IRAS and a bite-size eLearning module.
Please note that once you have received approval from the HRA, you are still required to submit an application via the online ethics system. Please include all documents submitted including the approval letter/notification.
NHS REC review
The Research Ethics Committees (RECs) review research applications and give an opinion about whether the research is ethical. For most applicants to the HRA, the REC review forms part of the overall HRA Approval process. For some projects that do not require HRA Approval REC review may still be required.
Researchers must ensure they have in place a suitable procedure for reporting adverse events and where necessary adhering to specific issues of relevance to that work only. This could involve:
- Developing a Form for reporting adverse events.
- Ensuring that there is a system by which all collaborators are made aware of any patient or participant experiencing adverse reaction to the clinical trials and that the funder and the patient’s doctor are immediately made aware of this or in the case of work involving collection of sensitive personal data if this has been inadvertently leaked eg to the press, that procedures are in place to bring this to the attention of relevant authority. Participants must be made aware at the start of the work that if there is an adverse event then the procedure to deal with adverse events will be implemented, eg in the case of the patient this could involve making their doctor aware of the event.
- Making the participant in the research aware of the procedures to follow if they need to contact the lead applicant within a reasonable timescale in the case of an adverse event.
If you are a PhD student, your confirmation form will need to be signed off by your Supervisor.
If you are an Academic, your confirmation form will need to be signed off by your Departmental Director of Research.
Please return the completed declaration form to the ethics mailbox
If you require a research passport, if you are a student please contact the doctoral school, if you are an academic please contact HR.
Covid 19 guidance
Guidance on COVID-19 related to Research Ethics Committee and NHS arrangements
Guidance which relates to health and social care research projects conducted by undergraduate and master’s students