UK Researchers Demand Regulatory Relief

Regulatory burden of clinical research threatens to inhibit delivery of potential life-saving benefits
By Pat F. Bass, M.D.
HealthDay Reporter

FRIDAY, Oct. 17 (HealthDay News) -- High-quality clinical research is essential, but a poorly coordinated, inconsistent and illogical bureaucracy placed on investigators threatens continuation of clinical research in the United Kingdom, according to a report published online Oct. 16 in BMJ.

In their report, Paul M. Stewart, M.D., of the University of Birmingham in Birmingham, U.K., and colleagues provide their opinion on regulation and how clinical research is threatened.

Although lack of researchers and capacity were threats in the past, a research bureaucracy has allowed the United Kingdom to slip from one of the most attractive places to perform clinical trials to one of the least attractive. The authors provide anecdotal experiences from their research practice involving ethics review board submissions and legal issues that have become significant barriers to the conduction of clinical research. They recommend a single Web-based protocol submission system for the involved 'legal,' 'governmental' and 'funding' agencies. The authors also recommend improvements in both indemnity assurance and ethical board review so that both processes may become predictable and transparent.

"All major funders, including the National Institute of Health Research, Medical Research Council, Wellcome Trust and other charities, now place the highest priority on the translation of science into medicines. If their lofty ideals and generous funding are to be translated into productive research, the regulatory burden must be simplified and be seen to support clinical research rather than close it down," the authors conclude. "In a risk-benefit arena that is now heavily stacked towards perceived risk, the instigators of over-regulation must bear responsibility for the real and emerging risks of a failure to deliver the potential life-saving benefits of clinical research promptly."

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