Requesting a waiver from meeting any of the research transparency requirements in the new legislation will be possible.
If a waiver is given, the sponsor will never be required to fulfil the research transparency requirements for the trial.
This differs to a deferral which only postpones the date in which the sponsor needs to meet the transparency requirements.
A request for a waiver should only be made in exceptional circumstances, for example, for reasons of national security or national defence.
Waivers will not be given on the basis of a sponsor’s commercial confidential interests. In these cases, the sponsor should instead request a deferral.
If a sponsor is planning a trial and wants to request a waiver, they should contact deferrals@hra.nhs.uk.
The request must describe why a waiver is requested and provide information on the trial.
Any information in the waiver request that would identify a trial, or any individuals or organisations involved in it, will be kept confidential.
After receiving a request, we’ll consider the information provided, respond to discuss the request further and inform the sponsor of the decision.