January 10, 2011

expert reaction to the AMS report on the regulation of health research

A report published by the Academy of Medical Sciences called for improvements in the regulation and governance of health research in the UK.

Professor Alison Murdoch, Head of the Newcastle Fertility Centre, said:

“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.”

Professor Chris Mason, Chair of Regenerative Medicine Bioprocessing, University College London, said:

“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, said:

“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, said:

“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?”

Dr Allan Pacey, Senior Lecturer in Andrology, University of Sheffield, said:

“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.”