RE: Is this ethical?16 Jul 2020 14:30
If they applied to the MHRA for ethical approval then yes. But as with any clinical trial, you've got to have the thing fully costed, with a clinical trials unit to back you, all the necessary paperwork in place (consent, patient information leaflets, protocols etc). Then you have to go through each individual NHS R&D department to get them to sign off on the trial, allocate staffing time etc to it.
The number of processes and things that have to be in place prior to a clinical trial opening are tremendous. A standard clinical trial probably takes upwards of a year to be designed, approved and signed off and that's multiple people working on it full-time. It's not as simple as just asking people to sign a piece of paperwork.
As somebody who has sat on MHRA ethics committees, and submits to them regularly, the time it takes to get a trial started (even a very basic trial) is colossal. Generally for our ethics for a non-CTIMP trial, in 20 hospitals across the UK takes routinely 6-12 months to get everything signed off. For a CTIMP trial this could be longer and for CTIMP challenge trial it wouldnt surprise me if timelines are stretched even further. Though I would add the caveat that currently ethics committees are prioritising all C-19 trials, hence it may take less time to go through than we would appreciate normally.