HRA Approval - What you need to know

Approval obtained

The HRA will issue HRA Approval in writing and individual sites will confirm, also in writing (email and/or signing the agreement), that they have the capacity and capability to deliver your research. HRA Approval is issued only when all other approvals are in place and the study meets the HRA criteria and standards. 

HRA Initial Assessment and Approval
You should receive an HRA Initial Assessment Letter not long after application (the timeframe will depend on whether there is more information that they need from you). Please note: This is not HRA Approval.

Ethics review - You will be notified by the HRA Ethics Service of the outcome of the REC review within 10 working days after the meeting if the outcome is not favourable, provisional or favourable with conditions.

If the outcome is favourable and HRA Approval is ready on the same working day these will be communicated together within 10 working days. If HRA Approval is not ready the favourable ethics opinion will be sent to you separately. Please note: This is not HRA Approval. More information on REC review is available.

When HRA assessment, REC review and any other approvals (e.g. section 251, or MHRA CTA) are complete you will receive an HRA letter with the outcome: ‘HRA Approval’ or ‘not approved’, and guidance on what to do next. If it’s approved this is the HRA Approval letter.

You can’t start the study in a particular location until that site has formally confirmed to the sponsor that all arrangements are in place. There are some study types (mainly staff questionnaire or interview studies) which do not need formal confirmation – if this is the case for your study this will be made clear in the HRA Initial Assessment and HRA Approval letters.

The timelines for HRA Approval for NHS sites in England is improving all the time. As of December 2017 the median time from the final REC favourable opinion to issuing HRA Approval is less than 5 days. Where the time is longer than this it is usually because another approval is outstanding (most commonly MHRA or CAG) or the HRA is waiting for a response to a query form a sponsor (or delegate).

Need more help? – More guidance on site set up is available on the relevant section of the HRA website.