UK | New HRA Pilot to Approve Programmes of Research

RWR CONTEXT

The Health Research Authority (HRA) is piloting an innovative approach to Non-CTIMP protocols that include sub-studies (I.e., master protocols or umbrella protocols).

Under the terms of the pilot project, sub-studies will not need to undergo (full?) ethics committee approvals.

This is a timely, pragmatic and risk-proportionate approach to the increasing number of non-interventional studies that include subsidies. 

27 MARCH 2024 – The Health Research Authority (HRA) is launching a pilot to see whether it is possible to streamline the approval process for sub-studies within a programme of research [Link] [1].

The pilot, which launches on 1 April 2024, will involve Research Ethics Committees reviewing the overall study application for ethics approval.

If it gets ethics approval, any sub studies connected to the main study won’t need to go through the same process. The pilot will evaluate the feasibility of approving sub-studies in this way.

The hope is that this will provide a more proportionate process to providing ethics approval to studies that are part of the same programme of research, and help save researchers time which means they can start their studies quicker.

The types of programme which would be suitable for the pilot are where the individual sub-studies are connected and collectively aim to meet a defined aim.

Some of the sub-studies may be submitted with the programme application but will not be a requirement.

The pilot excludes Clinical Trials of Medicinal Products (CTIMP), research which involves the administration of radioactive substances and research involving adults with incapacity taking place in Scotland.

References

1. Health Research Authority – New Pilot to Approve Programmes of Research

Link: https://www.hra.nhs.uk/about-us/news-updates/new-pilot-approve-programmes-research/