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Skip to 0 minutes and 11 seconds In 1906, a cholera vaccine was tested on 24 inmates in a prison in Manila. No explanation was provided to the prisoners or consent sought for the trial. Tragically, the vaccine had been contaminated with bubonic plague organisms, and 13 of the 24 men died. Throughout World War II, the Nazis conducted medical experiments on prisoners, mostly Jewish, in concentration camps. These medical experiments routinely resulted in the deaths of the prisoners. After the war, the doctors involved in these experiments were brought to trial. Some of these doctors argued that there was no international law governing medical experimentation. In the 1950s, at Porton Down in England, soldiers took part in medical experiments in return for pay and three days’ leave.

Skip to 0 minutes and 56 seconds Many had no idea what was involved. On the 6th of May, 1953, Ronald Madison, a Royal Air Force engineer, was exposed to the nerve agent Sarin. He died 45 minutes later. In November, 2004, an inquest returned a verdict of unlawful killing. The Tuskegee syphilis experiment started in 1932 and continued for 40 years. The study recruited 399 black men with syphilis and 201 healthy black men as controls. Those with syphilis were never told of their diagnosis, and when penicillin was identified as an effective cure in the ’40s, it was withheld from these men. Some were told that they were receiving treatment, when they were only receiving placebo, so that the researchers could study the natural progression of the disease.

Skip to 1 minute and 46 seconds After World War II, a set of research ethics for human experimentation called the Nuremberg Code was created. These 10 principles cover the need for informed consent, avoiding unnecessary distress, patient safety, the right of subjects to withdraw from a study, and other principles aimed at ensuring the experiments are conducted rigorously and will lead to benefits for mankind. The Declaration of Helsinki further developed and amended the Nuremberg Code in 1964. In addition, we now have good clinical practise, an international quality standard which guides countries on the clinical trials regulations they need.

The importance of research ethics

In this brief slideshow, Dr Mark Kelson recounts some of the darker history of medical research to show why clinical trials must be regulated to ensure the ethical treatment of participants.

The US National Institutes of Health has some helpful information on the Guiding Principles for Ethical Research for people who are considering taking part in a research study.

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This video is from the free online course:

Making Sense of Health Evidence: The Informed Consumer

Cardiff University