Independent review of medical research regulation report.
The Academy of Medical Sciences independent review of medical research regulation and governance reported in January 2011. Its recommendations covered:
- rationalising research regulation in a new arm’s-length body
- 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
The Government agrees with these headline recommendations and announced in the Plan for Growth in March 2011 its commitment to:
- set up a new Health Research Authority this year, initially as a Special Health Authority with the National Research Ethics Service as its core, to streamline regulation, create a unified approval process and promote proportionate standards for compliance and inspection within a consistent national system of research governance
- 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 Department of Health is now taking forward actions to deliver these commitments. Legislation to establish the Health Research Authority was laid before Parliament in September 2011. The NIHR Research Support Services were launched in May 2011.
Read the related news story.