History

At the turn of the 20th century, attention has focused again on research ethics committees. A series of enquiries, including those in Liverpool and North Staffordshire, have highlighted the system whereby research is regulated.4 This is not new. There have been waves of interest worldwide over the past fifty years in medical research and its regulation, and cases of malpractice have been revealed.

There was widespread horror at Nazi doctors' experiments, which were revealed in the post-war Nuremberg trials in 1947.5 This led to the Nuremberg Code, which set out principles for the conducting of experiments on humans and which focused on the need for informed consent and a favourable risk:benefit ratio. These principles were later subsumed into the Declaration of Helsinki, 1964,6 the original version of which related to physicians conducting research on patients and the need for an independent review. It also drew a distinction between therapeutic research for the benefit of treating individual patients, and non-therapeutic research designed to benefit the population at large and where benefit to the individual patient is unlikely.

In 1962 in the USA, it was discovered7 that many women taking thalidomide during pregnancy had not been told that it was an experimental drug. Unethical clinical research studies were revealed by the American anaesthetist, Henry Beecher, in 1966, and subsequently by the London physician, Maurice Pappworth. In 1972 the Tuskegee Syphilis

The same cancer specialists were also found to have forged and invented data in 47 scientific articles. A breast cancer researcher at the University of Witwatersrand was accused of, and later admitted at an international conference, to misrepresenting results of a clinical trial.24

A further GP in the UK was found guilty of falsifying patient consents.25 Handwriting experts found that the consent forms of a large proportion of patients entered into two trials, by the second GP referred to above, had not been signed by the patients themselves.21

Not following protocol as approved

A former professor in respiratory medicine in London was struck off the medical register for trying to persuade a junior colleague to break a blinded trial code, a protocol violation, by using bullying and threatening behaviour.26

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