From last Monday, those wishing to carry out drug research in the UK have been required to register their trials in a publicly-accessible database as a condition of receiving ethics committee approval. Failure to register within six weeks of recruiting the first patient will be treated as a serious breach of best practice and be dealt with accordingly.
This is just part of the UK HRA’s drive to greater transparency in research – which saw it sign up to the AllTrials campaign on full publication of clinical-trial data.
If you consider this alongside the HEFCE’s (Higher Education Funding Council for England) planned Research Integrity Concordat, it is easy to leap to the conclusion that UK research is a very murky business indeed.
The ICH GCP rules were published back in 1996 – has the world become a more dishonest place in the last seven years? Is the guidance still fit for purpose?
In truth, GCP rules and the inspection regimes that back them up are principally geared to detecting unintentional breaches of best practice. Deliberate research fraud is generally harder to detect. Those prepared knowingly to commit such fraud are also usually willing and able to cover their tracks.
Transparency, whilst still controversial in some quarters, is undeniably a strong tool in the fight against fraud. When you add to it HEFCE’s intention to refuse funding for any English Universities who refuse to sign its Integrity Concordat, you send a very strong message not only to those who may wish to abuse the system but those with doubts over the integrity of research in general.
Do you think enough is being done to tackle research fraud? Do you believe these actions are out of proportion?
I’d love to know what you think!
Blog Author: Dr. G.C. Practice
