Cut ‘burdensome’ red tape stifling medical research, report urges

Health research in the UK is being “stifled” by excessive regulation, a report by the Academy of Medical Sciences has concluded.

January 11, 2011

The report, written by a working group chaired by Sir Michael Rawlins, emeritus professor of clinical pharmacology at Newcastle University, recommends urgent changes to the system to lighten the regulatory burden on researchers without impacting on patient safety.

Sir Michael said the panel had 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” and that prevents patients from participating in studies.

The report, A New Pathway for the Regulation and Governance of Health Research, lists a number of specific problems, such as inappropriate constraints on access to patient data, a lack of proportionality in the regulation of clinical trials, and delays and duplication in obtaining research permissions from NHS trusts.

It says the problems are discouraging academics and companies from carrying out studies in the UK, contributing to a recent decline in its global share of clinical research activity.

The report contains a number of recommendations, including the creation of a new independent Health Research Agency that would carry out all NHS research governance checks and ethical approvals.

The report recommendations have been widely endorsed by the research community. Sir John Savill, chief executive of the Medical Research Council, described them as “a pragmatic way forward”, while Harpal Kumar, chief executive of Cancer Research UK, said a single health research agency could reduce approval times by 80 per cent.

Andrew Lansley, the health secretary, said the government would “consider carefully how to implement [the report’s] recommendations”.

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