 What: we are checking whether older studies in IRAS are still active and need your help
Who: study sponsors
When: from 16 September 2024
What's changing
Over the next six weeks we’ll be getting in touch with sponsors to find out whether studies from before 2018 have been completed.
There are a large number of studies from this time for which we’ve received no amendments or information on completion. Contacting the sponsor for more information is one of the things that we’re doing to make sure that we have an accurate record of research reviewed and approved by the HRA.
We’re also working with the Medicine and Healthcare products Regulatory Agency (MHRA) and National Institute of Health and Care Research (NIHR) in case these organisations have information about older studies which we don’t. If we can update our records before contacting you, we will do.
What happens next
There is no need to do anything now, we are just letting you know that we will be in touch in the coming weeks.
Where there are more than 20 older studies with a single sponsor, we will send you one email with a list of all the studies that need to be checked. You will have a minimum of four weeks to reply but you can tell us if you need more time.
You may want to start thinking about the right person in your organisation to review older studies and to update us with the information that we need.
We’ll send you the
- IRAS ID (if we have this)
- Research Ethics Committee reference
- Chief Investigator’s name and
- Study title
for each of the studies we need an update for. We’ll also let you know if this was a student study, according to our records. If there is any other information that would help you to identify older studies, please let us know.
Why are we doing this?
We’re making some changes to the systems we use to review and approve research and want to make sure that we only move study data that’s still needed.
This will also help us to save money by only storing the data which we need to keep. This won’t affect the research summaries database, it just means we won’t needlessly move inactive study data in the new “active” system.
Get in touch
If you want to check anything or have any questions, please contact amendments@hra.nhs.uk
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