Some Research Projects in Health and Social Care will need to go through HRA permissions (DoH Governance) process to obtain approvals. This is applied for via the IRAS online system
When applying for HRA Approval you will need to check all the supporting documents, this will avoid unnecessary delays to your application. Lack of date and version number is one of the main reasons that applications cannot be validated. See here for guidance.
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
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
A useful toolkit to see if HRA approval is need can be found here
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