Applications submitted through the fast-track service require advanced reservation to a REC meeting slot
The sponsor will contact a Research Ethics Committee (REC) that accepts fast-track ethics review submissions and, if a meeting slot is available, ask the REC to reserve a slot at the meeting for their application.
The sponsor will then submit the application. A validation check will be carried out to make sure the submission is valid.
If there are any issues that prevent it being valid, the sponsor will be asked to address these 7 calendar days before the selected meeting. If this is not possible, the sponsor will need to resubmit the application to another REC, making sure the validation issues are addressed.
After the full REC meeting, the REC will give the outcome of the initial review within 7 calendar days. This will either be a favourable opinion, a favourable opinion with conditions or, if it's not possible to issue these, they will send a request for further information.
If the REC sends a request for further information, the sponsor will have up to 60 calendar days to provide a response. The sponsor can respond at any point within this timeframe.
After a response to a request for further information is received, the REC will review the response and give the final outcome, which will either be a favourable opinion or an unfavourable opinion. This will be done within a maximum of 10 calendar days of the Medicines and Healthcare products Regulatory Agency (MHRA) or REC receiving the response, however RECs will aim to complete this within 7 calendar days.