Health Records Authority approval
HRA Approval applies only to the NHS in England and brings together the assessment of governance and legal compliance undertaken by dedicated HRA members of staff with the independent ethical opinion by a Research Ethics Committee (REC) so that researchers only need to submit one application. It applies where the NHS organisation has a duty of care to participants either as patients/service users or staff/volunteers.
What approvals do I need?
Visit the HRA website for more details on what approvals you will require and how to gain permissions.
This diagram on the HRA website, shows the steps that need to be taken to get HRA Approval.
It is important that the R&D office is notified as early as possible before any submissions are made. This avoids delays when regulatory approvals have been issued, therefore R&D can issue approval in conjunction with HRA Approval. Contact the R&D office via email should you need any advice or support with submission to HRA.
Regulations and guidelines
The Research Governance Framework outlines principles of good governance that apply to all research within the remit of the Secretary of State for Health. Research governance is one of the core standards for health care organisations. It applies to the full range of research types, contexts and methods.
The research governance framework is designed to:
- Safeguard the participants of the research
- Protect researchers by providing a clear framework
- Promote good practice and minimize risk
- Enhance the ethical and scientific quality of research
- Monitor practice and performance
The framework is available to download; https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/
For more information, please contact the R&D office