Much activity continues around the Academy's successful report 'A new pathway for the regulation and governance of health research'. Many of the recommendations from the report, which outline steps to streamline the regulatory approval of health research, were accepted by the Government as part of the 2011 Budget. Through engaging Government officials, Parliamentarians and European policymakers, work is now focused on the implementation of our recommendations and ensuring the momentum and support generated by our Review is maintained.

The creation of the Health Research Regulatory Agency (HRRA)
The Academy's recommendation was that a new regulator be established to remove complexity and oversee a new regulatory and governance pathway for health research. The creation of the new body has received strong support from across the research community and by all political parties:

"The Academy of Medical Sciences made a proposal to create a health research agency that was not just supported by the medical and research professions, but by all the political aspects of all the parties in both Houses of Parliament. It is rare for that to occur...".(Lord Willis of Knaresborough)

"I am immensely supportive of the splendid report produced by a committee chaired by Sir Michael Rawlins for the Academy of Medical Sciences on the future regulation of research." (Lord Walton of Detchant)

In line with our proposals, there has been a firm commitment from Government that the HRRA will be established as a Special Health Authority in 2011, with additional regulatory functions then transferred through primary legislation. Discussions around the most appropriate legislative vehicle to fully establish the new body are ongoing and staff and the working group chair, Sir Michael Rawlins FMedSci, recently spoke at the AGM of the All Party Parliamentary Group on Medical Research to inform discussion on this issue.

Influencing revisions to the European Clinical Trials Directive
The Academy responses to the recent European Commission consultation on proposals to revise the Directive included: an individual submission; leading on a response from the Federation of European Academies of Medicine (FEAM); and contributing to a joint statement by UK non–commercial research organisations (including Wellcome Trust, Medical Research Council, Cancer Research UK, British Heart Foundation and the Association of Medical Research Charities).

Given the influence of submissions from pan–European bodies, the Academy's strong relationship with FEAM has been crucial and Dr Rob Frost, Policy Manager, recently represented both the Academy and FEAM at a Brussels meeting of the European Forum for Good Clinical Practice on 'How to achieve successful new trial legislation'.

In addition to amending the Directive, we have also called for the MHRA to adopt a more proportionate approach within the scope of the current Directive and their pilot of a notification scheme for 'low–risk' trials is a welcome and important first step in this area.

We look forward to keeping Fellows updated on future progress on all aspects of the report in future newsletters.