22 March 2019

Criminalizing medical research fraud: Towards an appropriate legal framework and policy response


Blog post by Gilberto Leung

When hunting for a topic for my Dissertation, I went from ‘research ethics’ to ‘research misconduct’ and eventually cases of medical research fraud that had been treated criminally in the US. Although there have also been calls for greater criminalization in the UK, little has been written about how the criminal law may actually be applied in this context. People were saying we should probably prosecute researchers such as Wakefield but no one seemed to know or wanted to know how to go about it. I thought I would examine the knowledge gap.

What I found was that the Fraud Act 2006 would work very well in dealing with MRF but it casts such a wide net that many ‘minor’ cases would also be caught. The main issue in front of me then was about determining the appropriate threshold for prosecution in something as complex as research fraud. I borrowed the concept of the CPS policy on assisted suicide and proposed a balance sheet approach. Together with some amateur work on actus reus and mens rea, I ended up with a (kind of) legal framework to complement the Fraud Act. In retrospect, it was a brave/mad move to dive into criminal law just like that but my supervisor (Professor Graeme Laurie) was extremely helpful and encouraging. Not sure if the government would listen to me but I am glad that the Dissertation got a prize and I shall always be grateful for the wonderful learning experience.

Please, access the article by following:


View other publications by Gilberto on the Mason Institute website.

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