Governance arrangements for research ethics committees is a policy document of the UK Health Departments. It describes what is expected from the research ethics committees that review research proposals relating to areas of the UK Health Departments’ responsibility. It also explains when review by these committees is required.
The policy confirms that the following projects are exempt from NHS ethics review:
GAfRECs (Governance arrangements for research ethics committee)
The below five categories are exempt from NHS Ethics however, R&D Approval must be granted before the project commences.
- Research involving staff - This is solely for Research involving staff due to the nature of their role.
- Research involving previously collected, non-identifiable tissue samples - This is using samples that have been collected as part of standard clinical care and the patient has consented for excess blood that wasn’t tested to be used for the purpose of research. Applications for this at UHCW need to be made to Arden Tissue bank.
- Research involving acellular material - Research limited to use of human biological material not consisting of or including cells (e.g. plasma, serum, DNA)
- Research involving previously collected, non-identifiable information - This include data that is collected as part of standard clinical care and is anonymised for this project
- Research involving premises and facilities. – This is to solely use the facilities for a project that you are running elsewhere.
All the above do not require NHS REC review however, they do require R&D acknowledgement. Any multi-centre project will require HRA approval.
For all GAfREC applications, we will require the following information to begin the process of approval:
- All documents relating to the project.
- GAfREC Application Form
- If required for your project:
- Data Template
- Questionnaires
- Focus Group Material
- Consent Forms
- Participant Information Sheet
- Invitation Letters/Email
- If not on placement at UHCW, you will need to complete a research passport and then a LOA (Letter of Access) to collect data. If seeing participants, an honorary contract will be needed.
- Confirmation of UHCW supervisor (an email is sufficient).
- If the project is going towards academic qualification, University Ethical approval will need to have been granted and sent to UHCW for the project to be approved.
- Approval from the clinical lead within the UHCW speciality confirming they are happy for the project to take place.