The United Kingdom has developed a needlessly cumbersome bureaucracy that stifles, or drives overseas, medical research, and the country should create a new agency dedicated to streamlining the approval of biomedical studies, according to a report just issued by the U.K.'s Academy of Medical Sciences (AMS ).
The academy's review was commissioned last year in response to increasing concerns that the United Kingdom is losing its position as a preeminent place to do medical research. The country's worldwide share of clinical trials has been dropping amid complaints that obtaining necessary approvals and meeting all the regulations of a trial is too costly, time-consuming, and onerous. For example, the biomedical charity CancerResearchUK submitted evidence to AMS that after a trial receives funding, it now averages nearly 2 years before patients are even recruited.
"We have found unequivocal evidence that health research in this country is being jeopardised by a regulatory and governance framework that has become unnecessarily complex and burdensome. Further, we received no evidence that this increased regulatory and governance burden has led to enhanced safeguards for participants in research," concludes Michael Rawlins, the physician who chaired the AMS group that produced the review, in a statement.
AMS received more than 300 submissions of evidence from companies, research charities, and various U.K. government bodies that regulate medical research. "New regulatory bodies and checks have been introduced with good intentions, but the sum effect is a fragmented process characterised by multiple layers of bureaucracy, uncertainty in the interpretation of individual legislation and guidance, a lack of trust within the system, and duplication and overlap in responsibilities," Rawlins, who was the original chair of National Institute for Health and Clinical Excellence, and his colleagues concluded in the report:
The U.K.'s National Health Service has so-called trusts throughout the country that oversee medical services, and the conduct of research by NHS physicians, and the AMS report calls the need to get study approval in multiple trusts, each with its own local interpretations of clinical research regulations, the U.K.'s "single greatest barrier to health research." To address that and other problems, the AMS report calls for a new, independent Health Research Agency (HRA) that would bring together all the study-approval processes in the United Kingdom.
The new agency, which would also be charged with ethical oversight of clinical studies, could facilitate better use of patient data by researchers, the report says. "Access to patient data for research is currently hampered by a fragmented legal framework, inconsistency in interpretation of the regulations, variable guidance and a lack of clarity among investigators, regulators, patients and the public," it concludes.
The AMS review also examined the U.K.'s governance of human tissue research and suggested some loosening of oversight so that regulatory burden on work with a person's plasma, serum, feces, urine, and saliva is the same as required for studies on a person's hair and nails. There had been fears among some  that Rawlins's group would call for the U.K. to abandon giving human embryos "special status," a legal designation that brings with it additional regulatory oversight, but the AMS report made no recommendation on that matter.
It's uncertain how much influence the AMS report will have given recent changes in Britain's political situation. The review was requested by the Labour Party government just before the election last spring that saw the Conservative-Liberal Democrat coalition take power. As part of its austerity push and desire to reduce the size of government, the coalition is planning to eliminate some research regulatory bodies, such as the Human Fertilisation and Embryology Authority, so it may not embrace creating a new oversight body. Then again, if the proposed HRA would replace the duties of multiple agencies, and save money by doing so, it might earn a more favorable reception. David Willetts, the coalition government's science minister, issued a statement welcoming the AMS report's recommendation and noting: "As the government works to rebalance and grow the economy, it is vital that the UK continues to be an attractive environment to undertake clinical trials. This activity is a core part of the UK's strong life sciences industry, an important growth sector."
Below are additional statements publicly released in reaction to the AMS report:
Mark Walport, Director of the Wellcome Trust:
This report and its recommendations are both welcome and timely. The UK is a global leader in medical research, with benefits to health and the economy, but is prevented from maximising its potential because of unnecessarily complex and bureaucratic regulation. We must strike a better balance between protecting participants involved in research and not unduly or inappropriately obstructing the progress of research that will bring important health benefits. There should be symmetry in regulation - regulators should be held accountable for decisions to delay or prevent research as well as decisions to approve it.
Alison Murdoch, Head of the Newcastle Fertility Centre:
The proposed rationalisation of regulation of embryo research is welcomed as it should remove much of the duplication of the present system. A single organisation with oversight of embryo research and other medical research will provide a consistency of standards and ensure that bureaucracy is appropriate to the risks whilst not compromising the protection given by Parliament to the human embryo under the HFEAct. The 'special status' of the human embryo is protected by legislation and only the regulatory process is to be reorganised.
Chris Mason, Chair of Regenerative Medicine Bioprocessing, University College London (UCL):
This is an important first step for efficiently transitioning the world-class stem cell science in the UK into safe and effective advanced therapies for patients. Without urgent regulatory reform, the UK's position as a world leader in stem cell research will never be translated into routine therapies. The recommendations will undoubtedly benefit NHS patients as well as facilitate a major new UK healthcare sector.
James Lawford Davies, IVF Legal Expert, Lawford Davies Denoon, a life sciences law firm:
It has been suggested that these proposals will mean that 'the special status of the embryo will be lost', but this does not follow from the Report's recommendations. Research involving human embryos in the UK is governed by a licensing framework established by Parliament in 1990 and amended in 2008. It is not proposed that this be diluted or removed, only that the functions be transferred from one body to another. The streamlined regulatory process envisaged in the Report better reflects the multifaceted nature of some areas of research, such as stem cell research, where the current regulatory pathway is complex and can be duplicative.
Sarah Norcross, Director of the Progress Educational Trust:
Reviewing arm's-length bodies is a regular exercise for governments seeking to cut costs. In 2004, the UK government proposed to combine the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) into a single body, the Regulatory Authority for Fertility and Tissue (RAFT). In 2006 there was a similar proposal, except this time the new body was to be called the Regulatory Authority for Tissue and Embryology (RATE). These proposals were scrutinised and rejected, amid concerns about whether a single body covering such a wide and diverse area of practice could gain the respect of Parliament, professionals and the public. What has changed since then, to make the proposed new Health Research Agency viable? What makes the Academy of Medical Sciences think that this latest iteration of RAFT will float?
Allan Pacey, Senior Lecturer in Andrology, University of Sheffield:
In view of the explosion in research regulation and governance that we have witnessed over the past five years, I often wonder if Steptoe and Edwards were undertaking their research today whether IVF would ever have been invented in the UK? The bureaucratic complexities of undertaking even the most basic of research today are daunting. When I first started my research career 20 years ago, the procedures involved were much simpler than they are today. I still have the paperwork necessary to obtain the authorisation to carry out my first research project with human subjects. It was quite a complex project, but the file is barely a centimetre thick and correspondence with the ethics committee and a copy of the protocol amount only to 25 A4 pages. If my memory is correct, about 10 to 15 members of a local ethics committee considered the project and they gave their approval within a few weeks of it being submitted.
Fast-forward to 2008, and I set about gaining approval to carry out another, much simpler project where we were just planning to ask patients from two hospitals to fill out a questionnaire about their experiences of being a patient. Yet with the complexity of the ethics and research governance procedures now in place we had had to prepare documents that filled two A4 lever arch files. Moreover, it took almost 18 months to assemble and was reviewed by an estimated 200 people from three different ethics committees and two research governance departments as well as the funding body. Wherever the responsibility lies for regulating fertility research it must be simplified - the current system does not work for anyone - least of all the very patients who would benefit the most from the speedy pursuit of research.