RE: Modi110 Nov 2021 21:06
Balerno
Ethics in the UK are done through the Health Research Authority (HRA) via the Integrated Research Application system (IRAS). Applications for clinical trials use IRAS to send the application to both the MHRA (who deal with the technicalities of the trial and scientific data) before it goes to a HRA ethics committee for ethical approval.
An ethics committee aims to give an opinion within sixty days of receipt of an application, though this depends whether there are any queries or issues raised.
A submission to the HRA can Either go to a nominated ethics committee in which case it will be heard at the next available meeting slot or it can go to any ethics committee - this is usually quicker but some people prefer to use their local one for convenience.
Once an ethical opinion is given, if this is conditional, then the research has to go away, do the edits to the documentation, before resubmitting it to the REC for sign off. Usually for minor issues raised at ethics these can be done between meetings, if issues raised are major then the applicant may be asked to resubmit to the ethics committee before a verdict can be given.