Feature Interview with Michael Rawlins

Regulating research

BMJ 2011; 342 doi: http://dx.doi.org/10.1136/bmj.c7461 (Published 11 January 2011) Cite this as: BMJ 2011;342:c7461
  1. Luisa Dillner, head of new product development
  1. 1BMJ, Tavistock Square, London, UK
  1. ldillner{at}bmj.com

Luisa Dillner talks to Michael Rawlins, the man behind the Academy of Medical Sciences’ review of medical research governance, about current hurdles in getting clinical trials started and what can be done to improve the process

One word leaps out of the document A new pathway for the regulation and governance of health research, the keenly awaited report on research governance from the Academy of Medical Sciences. “It’s ‘proportionate’,” says Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence and of the expert working group that wrote the report. “But I would say there is another word too: symmetry,” he adds. He is sitting in the refurbished offices of the academy in Portland Place, London, two days before Christmas while the report, in draft form, is being polished for release.

“These words are very important because the arrangements we have for regulation of trials are disproportionate and asymmetrical,” he adds. “They are disproportionate because the degree of risk is assumed to be constant, whereas in reality the degree of risk in trials varies hugely from ‘first in man’ studies to me giving you an aspirin and then asking you for a blood sample. They are asymmetrical because on the one hand it is quite appropriate for regulatory authorities or ethics committees to decline to approve inappropriate studies, but on the other hand to decline to approve an appropriate study carries the risk of losing the benefits that you could have got from doing the study. Some things are remarkably benign and some things are potentially very risky, but the whole system needs to be designed to take these things into account.”

The review was announced by the previous health secretary Andy Burnham in March 2010 and started in May. The academy was asked to review the …

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