Biomedical regulation workshop shapes long-term goals

24 February 2009

Biomedical regulation experts convened at a joint Medical Research Council (MRC) and Wellcome Trust workshop in May 2008. A report of the meeting identifies a long-term goal - to analyse the wide range of issues associated with regulation and ultimately achieve an optimum regulatory environment to support biomedical research.

Regulation needs a multifaceted and considered approach, concluded participants of a workshop. Jointly sponsored by the MRC and the Wellcome Trust and held in London in May 2008, the workshop brought together representatives from academia (including biomedical researchers and lawyers), industry, Government, regulators, and overseas representatives. The participants aimed to consider how research involving human participants may be simplified, using comparative experiences from other areas of regulation.

The outcome of the event was clear agreement that regulation of biomedical research is necessary - protecting the public against the risks of untested medicines and other technologies, providing appropriate checks on commercial motives and scientists' interests, and protecting participants in research and the researchers themselves.

It is also generally recognised that regulation is complex, with difficult balances between public benefit and participants, patient and consumer risk, and competing demands of stakeholders. Because of these complexities, all those involved in legislation and regulation need to work together to ensure that regulation neither inhibits important research nor fails to protect those concerned.

Full report and summary of the workshop.

Comments on the reports would be welcome and should be sent to: corporate@headoffice.mrc.ac.uk