New updates to UK amendment tool

The Health Research Authority and the devolved administrations have updated the UK amendment tool in line with existing guidance for changes to the Investigator Brochure (IB).

The latest version of the tool now indicates that substantial changes to the IB do not need to be submitted to an NHS Research Ethics Committee (REC) for review.

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.

Other 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.

You can get all the details on the changes made in the Change Record in the General Guidance tab on the tool.

All new amendments, from 6 December, should be submitted using the new version (1.6).

There is a two-week period where amendments will still be accepted using version 1.5, however amendments submitted on version 1.5 after 20 December 2021 will not be accepted.