Consultation on a single research regulator
The Academy of Medical Sciences is leading a review in to the regulation and governance of UK medical research on behalf of the Government. Following the publication of the Department of Health’s report on arm’s-length bodies in July, the Academy has taken the decision to issue a second call for evidence to provide all interested parties with an opportunity to consider the proposals in the ALB report with direct relevance to the regulation of medical research.
The call for evidence includes:
- The merits of placing responsibility for different aspects of medical research regulation within a ‘single research regulator’.
- The future of the National Research Ethics Service and reorganisation of the research regulatory activities of the Human Tissue Authority and the Human Fertilisation and Embryology Authority
The AMS’s review will:
- Review the regulatory and governance environment for medical research in the UK, with a particular focus on clinical trials.
- Identify key problems and their causes, including unnecessary process steps, delays, barriers, costs, complexity, reporting requirements and data collection.
- Make recommendations with respect to the regulatory and governance framework that will: increase the speed of decision-making; reduce complexity; and eliminate unnecessary bureaucracy and costs.
The first deadline for responses is 31 August. Respondents unable to meet this deadline are asked 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 Tuesday 14 September.
The call for evidence from the AMS is available here.
