HRA Approval and Permission
Some Research Projects in Health and Social Care will need to go through HRA permissions (DoH Governance) process to obtain approvals. This is applied form via the IRAS online system
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The UK Local Information Pack is the group of documents that is provided to NHS / HSC organisations to set up research studies. The majority, but not all, of the components will have been submitted as part of the IRAS Form submission
More information here.
During the HRA permissions process the research project will be assessed based around the following criteria:
- IRAS application completed correctly and documents in order
- Risk to participants i.e. Participant information / consent documents / consent process
- Protocol assessment
- Allocation of responsibilities
- Insurance / indemnity arrangements assessed
- Financial arrangements assessed
- Compliance with the Data Protection Act and data security issues assessed
- Compliance with any applicable laws or regulations ie HTA , MCA Radiation Regulations