Legislation to establish the Health Research Authority (HRA), which will provide a new pathway for the regulation and governance of health research
Created initially as a Special Health Authority, the HRA will have the National Research Ethics Service at its core.
Establishment of the HRA forms part of the Government’s commitments as announced in the Plan for Growth in March 2011.
The aim is to streamline regulation, create a unified approval process, and promote proportionate standards for compliance and inspection within a consistent national system of research governance.
An independent review of medical research regulation and governance by the Academy of Medical Sciences, which reported in January 2011, recommended rationalising research regulation into a new arm’s length body.
Its recommendations also covered:
- facilitating NHS trusts’ timely approval of research studies
- improving the UK environment for clinical trials
- providing access to patient data that protects individuals’ interests
- embedding a culture that values research within the NHS
Today’s legislation takes forward the Department’s commitment to deliver on its plan, which also include committment to:
- launch a Research Support Services framework of good practice and standard procedures to facilitate consistent local research management and greatly improve performance, and publish outcomes against public benchmarks, including a 70-day benchmark to recruit first patients for trials
- reduce perceived gold-plating and increase the proportionality of the EU Clinical Trials Directive and its application
- build a consensus on using e-health record data to create a unique position for the UK in health research embed nationally the good practice identified by the National Institute for Health Research (NIHR), which showed the impact of trusts having a visible commitment from their chief executives to research within their organisation, rapid escalation and prompt management of extraordinary issues, and executive oversight of performance metrics
The NIHR Research Support Services were launched in May 2011.