A new fast-track research ethics review pilot is opening in January. The pilot will test a rapid research ethics review for global clinical and phase I trials for any disease area.
The pilot – which will run between 4 January and 30 March 2021 - will test whether the Health Research Authority, on behalf of the UK, can establish a sustainable model for providing rapid research ethics review.
It builds on our work providing fast-track ethics review for COVID-19 research.
The pilot aims to provide a final opinion on applications within 15 calendar days, excluding the time for applicants to respond to any requests for further information after initial review. The analysis of the pilot will include a review of timelines with and without clock stops.
Juliet Tizzard, Director of Policy and Partnerships at the HRA, said:
Juliet Tizzard, Director of Policy and Partnerships at the HRA‘At the HRA we are always innovating and improving. We’ve shown that we can provide fast review for COVID-19 studies. We want to see if we can offer fast a research ethics review service for other clinical trials such as cancer research.
‘This pilot will give us information about the demand, feasibility and cost of delivering fast-track research ethics review. We will use the pilot to determine the level of demand for a fast-track service, and to determine the resources required as well as to discover if these faster turnaround times are sustainable.’
Eligibility criteria
Studies eligible for the pilot are global clinical trials or phase I trials (excluding trials which require review by the Gene Therapy Advisory Committee). More details about eligibility and how to apply are available on our website.
Research ethics review after COVID-19
The pilot is part of a wider programme to enhance our research ethics review service. We want to provide a review service which is more proportionate and efficient and continues to facilitate ethical research which is in the interests of research participants.
The programme will be run in partnership with fellow regulators and the organisations who review research in the devolved administrations.
We are currently holding workshops with commercial sponsors, academia, Research Ethics Committee members as well as public contributors and research participants to get their views on what future research regulation looks like. There will be more opportunity to get involved in 2021.