Applications are submitted.
Applications then undergo an initial check called ‘validation’.
Once validated, applicants receive a validation letter. They need to make sure that they keep their sites updated on progress throughout the approvals process.
After validation, applications then proceed to research ethics committee (REC) review and/or HRA and HCRW Approval.
Applications that require REC review will be reviewed at a REC meeting. Applicants will be invited to virtually attend the meeting.
The REC will issue their opinion following the meeting. This may be a final opinion, or they may request additional information and clarification before issuing a final opinion.
In parallel to the REC review, applications that require HRA and HCRW will undergo an initial assessment. Once this is completed, they will be provided with an initial assessment letter. Applicants should make sure that they keep sites updated on the progress of the approvals process.
HRA and HCRW assessment continues as other regulatory approvals are received.
Once the HRA and HCRW assessment has been completed, other regulatory approvals are received and a REC final opinion has been issued, then the final outcome of HRA and HCRW Approval can be provided.
Applicants should make sure that they keep sites updated on the progress throughout the approvals process.