The United Kingdom has developed an unnecessarily heavy bureaucracy that stifles, or readers overseas, medical research, and the country should create a new agency dedicated to streamlining the approval of biomedical studies, according to a report just published by the British Academy of medical sciences (AMS).
The review of the academy was commissioned last year in response to growing concerns that the UK is losing its position as a preeminent place to do medical research. share in the world's countries clinical trials has declined amid complaints that the necessary approvals and meet all regulations of a trial is too costly, tedious and expensive. For example, biomedical charity CancerResearchUK presented evidence to AMS that after a trial receives funding, the now averages nearly 2 years before patients are not even enrolled.
"We found compelling evidence that health research in this country is threatened by a regulatory framework and governance has become unnecessarily complex and cumbersome. In addition, we have received no evidence that this increase regulation and the burden of governance led to increased guarantees of the research participants, "says Michael Rawlins, the doctor who chaired the AMS group that produced the review, in a statement.
AMS received over 300 submissions of evidence of companies, research organizations and various government agencies UK governing medical research. "the new regulators and controls have been implemented with good intentions, but effect of the sum is a fragmented process characterized by multiple layers of bureaucracy, uncertainty in the interpretation of laws and individual counseling, a lack of confidence in the system, and duplication and overlap in responsibilities "Rawlins, who was the original chair of the National Institute for health and clinical excellence, and colleagues concluded in the report:
National health Service in the UK has supposedly trusts throughout the country who oversee medical services, and the conduct of research by doctors of the NHS, and the AMS report urges the need to obtain the approval of the study in several trusts, each with its own local interpretations regulation of clinical research, "the greatest obstacle in the UK for research in health." To address this and other problems, the AMS report calls for a new independent agency for health research (HRA) that would bring together all the approval processes study in the UK.
The new agency, which would also be responsible for ethical oversight of clinical trials could facilitate better use of patient data by researchers, the report said. "Access to patient data for research is currently hampered by a fragmented legal framework, the inconsistency in the interpretation of regulations, variable orientations and a lack of clarity between researchers, regulators, patients and the public ", he concludes.
The AMS review also examined the governance of UK research on human tissue and suggested some easing of monitoring so that the regulatory burden on working with the plasma of a person , serum, stool, urine and saliva is the same as that required for studies on hair and nails of a person. There had been fears among some that the Rawlins group called for the UK to abandon giving human embryos "special status", a legal designation that brings with it additional regulatory oversight, but the AMS report makes no recommendations on this subject .
It is unclear what influence the AMS report has given the recent changes in the political situation in Britain. The review was requested by the government of the Labour Party just before the last spring election that saw the Conservative-Liberal Democrat coalition took power. As part of its push austerity and the desire to reduce the size of government, the coalition plans to eliminate some regulatory bodies of research, such as the Human Fertilisation and Embryology Authority, so it can not embrace the creation of a new oversight body. Again, if the HRA would replace the functions of several agencies, and save money by doing so he could earn more favorably. David Willetts, science minister in the coalition government, issued a statement welcoming the recommendation of AMS report, noting:. "As the government works to balance and develop the economy, it is essential that the UK continues be an attractive environment for undertaking clinical trials This activity is an essential part of the strong life sciences industry in the UK, an important growth area. "
The following additional statements issued in response 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 world leader in medical research, with benefits for health and the economy, but is prevented from maximizing its potential because of the unnecessarily complicated and bureaucratic regulations. We must find a better balance between the protection of participants involved in the research and not unduly or unreasonably impede the progress of the research that will bring significant health benefits. There should be a symmetry in regulation - regulators should be responsible for decisions to delay or prevent the research and decisions to approve it.
Alison Murdoch, head of the Newcastle Fertility Center
The regulation of embryo research rationalization project is welcomed as it should withdraw much of the duplication of the current system. A single organization with oversight of research on the embryo and other medical research will provide a consistency of standards and ensure that the bureaucracy is appropriate to the risk, while not compromising the protection afforded by Parliament to the embryo human under the HFEAct. The "special status" of the human embryo is protected by law and the regulatory process must be reorganized.
Chris Mason, chair of regenerative medicine bioprocessing, University College London (UCL):
This is an important first step in ensuring the effective transition of science stem cells World class UK in advanced safe and effective therapeutics to patients. Without reform of the emergency regulation, the position of the UK as a world leader in research on stem cells will never be translated into routine therapies. The recommendations will undoubtedly be beneficial for NHS patients and to facilitate a major new health sector in the UK.
James Lawford Davies, IVF Legal Expert, Lawford Davies Denoon, a law firm in the life sciences:
It has been suggested that these proposals mean that "the special status of the embryo will be lost," but this does not follow from the report recommendations. Research on human embryos in the UK is governed by the licensing framework established by Parliament in 190 and amended in 08. It does not propose that this be diluted or deleted, only that the functions are transferred from one body to another. The streamlined regulatory process envisaged in the report to better reflect the multifaceted nature of some areas of research, such as research on stem cells, where the current regulation is complex and may be redundant.
Sarah Norcross, director of the Progress Educational Trust:
The review of independent bodies is regular exercise for governments looking to cut costs. In 04, the British government has proposed combining the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) in a single body, the Regulatory Authority for Fertility and Tissue (RAFT). In 06, there was a similar proposal, except this time the new body would be called the tissue Regulatory Authority and Embryology (RATE). These proposals were considered and rejected, amid concerns about whether a single body covering a vast and diverse field of practice could earn the respect of Parliament, professionals and the public. What has changed since then, for the new sustainable health research proposed agency? What makes the Academy of Medical Sciences think this latest iteration of RAFT float?
Allan Pacey, Senior Lecturer in Andrology, University of Sheffield
Given the explosion of regulation and governance research we have witnessed over the past five years, I often wonder if Steptoe and Edwards began their research today when IVF would never have been invented in the UK? Bureaucratic complexities of the same company the most basic research of today are daunting. When I started my research career there 20 years ago, the procedures involved were much simpler than they are today. I still have the necessary documents to get permission to make my first research project involving human subjects. It was quite a complex project, but the file is barely a centimeter thick and correspondence with the ethics committee and a copy of the protocol amount of 25 A4 pages. If I remember correctly, about 10 to 15 members of a local ethics committee discussed the draft and they gave their approval within weeks of filing.
Fast forward to 08, and I began to get approval to proceed with another, a much simpler project where we were just planning to ask patients to two hospitals to complete a questionnaire on their experience of being a patient. Yet the complexity of ethics and governance procedures of research in place, we had to prepare documents that filled two A4 lever arch files. In addition, it took nearly 18 months to assemble and has been reviewed by about 0 people from three different committees of ethics and governance of two research departments as well as the funding agency. Wherever responsibility is to regulate research on fertility, there should be simplified - the current system does not work for everyone - all within the same patients who would benefit most from the rapid pursuit of research.
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