IRAS amendment tool updated to new version
6th December 2021
From Monday 6 December 2021, the amendment tool will indicate that substantial changes to the Investigator Brochure (IB) do not need to be submitted to a NHS Research Ethics Committee (REC) for review, aligning with existing guidance
The new version of the amendment tool will prompt the applicant to consider if any of the changes made to the IB need to be reflected in the participant facing documents. It will ask for justification where amended participant facing documents are not being submitted with the IB amendment. Any amended participant facing documents may be submitted with the IB (if ready) or as part of a subsequent amendment. In line with existing guidance, substantial amendments to participant facing documents to reflect IB changes will continue to require NHS REC review; the amendment tool will indicate this.
Changes have also been made to the amendment tool to make it easier to use, including:
- improved guidance in the Submission tab
- changes to the radio selection buttons to make it clearer to complete and view once converted to a pdf
- changes to help users avoid common mistakes
All details on the changes that have been made can be found in the Change Record in General Guidance tab on the tool. Please start to use the new version (1.6) for all new amendments from 6 December 2021. There is a 2-week wash out period prior where amendments will continue to be accepted using version 1.5. Amendments submitted on V1.5 after 20 December 2021 will not be accepted.