HRA Approval - What you need to know

During the study (Amendments and reports)

Once your study has HRA Approval you will need to keep the HRA updated on progress and any changes to your study. The following text summarises the HRA guidance on ‘During your research project’.

Amendments
For general information and guidance on amendments please see the amendments section of IRAS Help, which defines substantial and non-substantial amendments. Some may need ethical review. The process for submitting amendments to Ethics and the lead nation is also provided in IRAS Help. Please follow these instructions.

The HRA currently have a large number of amendments to process, so if possible please group changes to your study for the HRA to review in a single amendment submission. However if your amendment includes a new site or changes of PI please submit these separately as they can be dealt with more quickly than other types of amendment.

Where the lead NHS R&D office is based in England:

  • For substantial amendments to studies that have undergone REC review where the REC is in England you email the appropriate notification form (available in IRAS) and any supporting documentation to the REC.
  • For substantial amendments to studies that have undergone REC review where the REC is in Scotland, Wales or Northern Ireland you email the appropriate notification form (available in IRAS) and any supporting documentation to the REC and copy to hra.amendments@nhs.net.

Amendments should include any documents that have been modified and show both the previous and new wording.

The substantial amendment form is on IRAS, once you have HRA approval the ‘Amendment’ tab will appear at the bottom left of the ‘Navigation’ page. At this stage it needs to be created and emailed, you can’t submit it electronically yet.

Adding a new site to a study is not a substantial amendment, unless it is a CTIMP and the site wasn’t listed on the original application.

  • For all non-substantial amendments where the lead NHS R&D office is in England submit the template amendment form and any supporting documentation by email to hra.amendments@nhs.net.
  • For substantial amendments where the lead NHS/HSC R&D office is based in Scotland, Wales or Northern Ireland you email the appropriate notification form (available in IRAS) and any supporting documentation to the REC and copy email to the lead nation.
  • For all non-substantial amendments where the lead NHS R&D office is in Scotland, Wales and Northern Ireland NHS/HSC R&D should be notified on the template amendment form to the lead nation.

Include the IRAS ID for your project in the subject line of the email along with the text “Notification of Amendment” and ensure that your email includes your contact details (email and phone number).

All lead nations will review amendments in line with the UK process for effective management of amendments and will provide information about the arrangements for handling the amendment with participating sites.

Other review bodies may also need to be notified. Please see the IRAS help for information on which review bodies need to approve or be notified of which types of amendments.

Progress reports
Studies in receipt of HRA Approval must make regular progress reports to the HRA, and may need to make safety reports, in line with normal requirements. These requirements apply to all studies with HRA Approval.