According to the Academy of Medical Sciences, a new body to regulate all health research in the UK should be established. The authorities suggest that the current regulatory system was dysfunctional and thus hampering medical advances and they blame red tape for the decline in the UK’s share of clinical research. The report suggests creating a Health Research Agency that would make approving projects quicker and cheaper. According to Health Secretary for England, Andrew Lansley, the government would consider how the recommendations could be implemented.
At present the figures showing the number of clinical trials in UK are dismal. Global figures show that in 2000, 6% percent of patients taking part in trials were from the UK. Six years later that figure had more than halved. Professor Sir Michael Rawlins, lead author of the report said, “The current system of regulation is making it increasingly difficult to initiate health research… We have found unequivocal evidence that health research in this country is being jeopardized by a regulatory framework that has become unnecessarily complex and burdensome.” Professor Peter Johnson, who is from Cancer Research UK, a co-author of the report added, “It takes an average of 621 days between awarding a research grant and the first patient taking part in the trial…We’ve built a Rolls Royce and are driving it down a cart track.” Allison Jeynes-Ellis, medical and innovation director at The Association of the British Pharmaceutical Industry, also said, “The timely endorsement of this report is vital if the UK is to be seen as a serious player in clinical research in an increasingly competitive arena.” Harpal Kumar, chief executive of Cancer Research UK, said patients were missing out on trials of new drugs that might help them. “The process for getting clinical and health research up and running in the UK is unacceptably slow,” he said.
The proposed HRA when developed would function as a “one-stop shop” to give ethical approval and also speed up the process. This would effectively incorporate the work of the National Research Ethics Services and a host of specialist approval bodies such as the Gene Therapy Advisory Committee as well as the need for individual NHS trusts to give their own approval. It would also include a National Research Governance Service which would perform checks on behalf of NHS Trusts in England. The agency would work with the devolved nations to develop an integrated approvals system for the whole of the UK.
According to Mr. Lansley, “National regulation and local governance of health research are too complex and scattered across too many different bodies…The government welcomes the report and will consider carefully how to implement its recommendations.”
Rawlins review also speaks on the controversy that the new agency could take over the responsibilities the Human Fertilisation and Embryology Authority (HFEA) and Human Tissue Authority (HTA) currently have for applications to carry out experiments on human embryos and body parts. Experts like Professor Lisa Jardine, chair of the HFEA and Professor Alison Murdoch, head of the Newcastle Fertility Centre have expressed concerns whether a single general body can take care of the ‘nitty gritties’ of the ethics of embryonic research.
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