Ethics regulation and the Nobel Prize
Anyone who seeks to defend the current level of bureaucracy
surrounding research ethics might consider last year’s Nobel Prize for
Medicine, and ask whether that work could be done today.
Marshall and Warren took 100 gastric biopsies from the diagnostic
archives, stained sections to highlight bacteria, and correlated the
results with the presence of inflammation. This led to the discovery of
H. pylori as the cause of gastritis and peptic ulceration.
This crucial first step was an extremely speculative project, done by
busy clinicians, driven only by curiosity. Would Marshall and Warren have
bothered to struggle through the mandatory regulatory quagmire, if they
were doing the work today?
REC approval would now be a legal requirement (Human Tissue Act
2004). But this research was unfunded, had no peer review and was done
without consent. How disreputable! Would it now be approved?
This project involved only archival endoscopic biopsies. The results
have saved thousands of lives (by avoiding perforation, haemorrhage and
surgical complications) and improved the health of even more, probably
millions. The work posed absolutely no risk to any patient. Yet we would
now impose the full weight of NHS R&D and COREC oversight on this project.
Massive benefit; zero risk. On the balance of risk and benefit, a
regulatory system which inhibits this sort of work is surely profoundly
unethical. It damages future patients and benefits no-one.
The author is involved in non-commercial research using tissue samples
Competing interests: No competing interests