Step 6
Maintaining your approvals – amendments
When conducting your project, it's crucial to follow the proper procedures for any amendments to your protocol or supporting documents. Here are the key steps and considerations:
1. Submitting amendments
- Summary of changes: For all amendments, prepare a detailed summary that outlines the proposed changes to the protocol or supporting documents.
- Updated documents: Ensure that all updated documents have new version numbers clearly marked.
- Submit to Ethics Committee: Any amendments must be submitted to the ethics committee that approved your original application for review and approval.
2. Approval requirements
- Non-clinical research: You cannot implement any amendments without receiving approval from the SHLS ethics committee.
- NHS clinical research: For clinical research amendments, you need to use the IRAS system to make your submissions. This will also require the authorisation of Sharron Dolan, ADR, who is the designated sponsor representative for SHLS.
3. Clinical research amendments via IRAS
- For guidance on submitting through the IRAS system, consult the relevant guidelines at myresearchproject.org.
- Ensure you follow the specific submission and authorisation processes laid out in the IRAS guidelines.
By adhering to these guidelines, you will ensure that your research remains compliant with ethics standards and institutional requirements.