The Health Research Authority (HRA) was established in December 2011 to protect and promote the interests of patients and the public in health research, and to streamline the regulation of research. The HRA are in the process of rolling out a new system for approving research in the NHS in England, called HRA Approval.
What is HRA Approval?
HRA Approval is an authoritative approval for research studies in the NHS in England, including independent contractors, such as General Practices. It comprises a review by a Research Ethics Committee (where applicable) and an assessment of regulatory compliance and related matters. HRA Approval provides assurance that a study has fulfilled all regulatory requirements. There will no longer be a separate local NHS assurance process.
What does this mean for GP Practices?
General Practices should feel confident about participating in a study that has HRA Approval.
Whilst practices will continue to have the final decision on whether to undertake a study based on their capacity and capability, close working will still be required with local primary care R&D offices, who will continue to provide support in a number of ways. Practices are able to start a study when the HRA Approval letter is granted AND local arrangements to set up the study are in place. You should liaise with the primary care R&D office supporting your area.
Sponsors will continue to communicate with the site through both the study delivery team and the research management team supporting that site.
When will HRA Approval be rolled out?
HRA Approval will be implemented in stages during 2015. New studies running only in a primary care setting will be eligible for HRA Approval from 10 August 2015. The ambition is for HRA Approval to be fully implemented by the end of December 2015.
How can I find out more about HRA Approval?
For more information, please see the HRA website: www.hra.nhs.uk. If you have any questions about HRA Approval, please speak to your local R&D office in the first instance. Local R&D office contacts can be found on the R&D Forum website. You can also contact hra.approvalprogramme@nhs.net.