Discussion on the regulation of biomedical research

1 April 2009

Regulation of biomedical research is important in ensuring progress in research whilst minimising potential harms. However, this is often a complex process involving a number of stakeholders and the formulation of appropriate regulations that are understood by all those involved. In spring last year, the MRC and Wellcome Trust held a workshop which bought together representatives from academia (including scientists and lawyers), government, UK and overseas regulators and industry to discuss biomedical regulation, the problems associated with it and how these could be resolved. The proceedings of this workshop have now been published in a report (see press release).

The workshop was informed by a literature review of regulation and its aim was “to consider ways in which the regulation of research involving human participants might be simplified, while retaining the confidence of the public” (MRC/Wellcome Trust workshop: Regulation and biomedical research) The report summarises perspectives different stakeholders have of regulation as well as providing UK and international examples of regulatory processes. In addition, views from other sectors such as the Food Standards Agency and the Office of Rail Regulation were also given in order to identify aspects which could be adopted for biomedical regulation.

The report concluded that although biomedical regulation is necessary in order to protect consumers, research participants and researchers, in the UK the current process is overly complex. A number of recommendations were made in order to improve the process, such as asking governments to involve stakeholders earlier as well as improving communications between regulators. In addition, the workshop highlighted difficulties non-lawyers had in understanding legislation and suggested Bills and Acts should be formulated in such a way as to be comprehensible by everyone. However, the report recognises that regulation of biomedical research is an inherently complex process due to the competing objectives of facilitating research whilst safe-guarding public interests. They recognise that in the short-term the regulatory environment in the UK cannot be changed radically but that there may be scope for change in the way rules are applied.

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