The Academy of Medical Sciences (AMS) has launched a second call for evidence in its review of the regulation and governance of medical research in the UK, specifically to consider the possibility of bringing all aspects of medical research under a single regulatory umbrella.
This idea was floated in the report on the future of ‘arm’s length bodies’ recently published under the new Conservative-Liberal coalition government by the Department of Health. The report fell into line with the government’s wider programme of seeking efficiencies and cost savings in the public sector through rationalisation and stripping out layers of bureaucracy.
A working group chaired by Sir Michael Rawlins, senior fellow of the AMS and chairman of the National Institute for Health and Clinical Excellence, is undertaking the medical research review first announced last March. The initial call for evidence closed on 1 June 2010.
Since then, the Department of Health (DoH) has published its Report on the arm’s-length bodies review (26 July), which referred to the AMS’ deliberations and noted that, as things stand, a number of different arm’s-length bodies in the UK have responsibility for different aspects of research regulation, including granting permissions.
There is a “strong argument” for rationalising this set-up and “creating greater strategic coherence around research by placing responsibility for these different aspects of medical research regulation within one arm’s-length body that would perform a stand-alone technical function as a research regulator”, the report suggested.
This would “streamline the process of gaining permission to undertake medical research, making it more attractive to universities and health institutions”, the report argued. “Moreover, there is potential for a single research regulator to have wider cross-government reach.”
In the light of the Academy of Medical Sciences review, “we will consider legislation
affecting medical research, and the bureaucracy that flows from it, and bring forward
plans for radical simplification”, the report stated.
The DoH further proposed that the future of the National Research Ethics Service, the umbrella body for ethics committees in the UK’s National Health Service, should be considered as part of the AMS review of research regulation, “with a view to moving this function into a single research regulatory body”.
The research regulatory activities of the Human Tissue Authority and Human Fertilisation and Embryology Authority are also within the scope of the AMS review, and “subject to the outcome of that review, there could be significant advantage in consolidating these functions” into a single regulatory body, the report suggested.
All of these points are offered for consideration in the second call for evidence to inform the AMS review. Respondents are invited to submit written evidence by 5pm on 31 August or, failing that, to “notify the Academy by 31 August of their intention to submit evidence and to highlight substantive issues that will form the basis of their submission”.
The final deadline for submissions is 5pm on 14 September 2010. The working group chaired by Sir Michael Rawlins aims to publish its final report and recommendations by the end of the year, subject to approval by the Academy’s Council.