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.
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.
Catherine Blewett, Senior Development Manager, HRAWe know that institutions can feel frustrated at having to individually apply for ethics review each time they want to run a new study within a programme of research.
We think that this approach will benefit ethics review by cutting back bureaucracy for programmes which have already received a favourable ethics opinion, leading to quicker set-up times for sub-studies.
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.
Get in touch
The HRA is calling on any institutions who think they have a programme which might be suitable to take part in the pilot to get in touch by emailing pilot.testing@hra.nhs.uk with ‘APR pilot’ in the subject heading.