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Friday, October 1, 2010

Ethics in Clinical Research- Important Dates

1803 - Thomas Percival - first code of medical ethics to include requirements concerning research
1833 - William Beaumont - ethical code specifically focussed on human experimentation
1865 - Claude Bernard, a French physiologist published ‘Introduction to the Study of Clinical Medicine’: “It is our duty and right to perform and experiment on man when it can save his life, cure him or gain him some personal benefit. The principal of medical and surgical morality, therefore, consists of never performing on man an experiment which might be harmful to him to any extent, even though the result might be highly advantageous to science, that is, to the health of others.”
1900 - Research regulations in Prussia introduced following vaccination trials performed without consent on poor and vulnerable people (abandoned children, prostitutes).
1920’s Some of the earliest and clearest pronouncements on the importance of consent in medical research are to be found in early 20th Century in Germany.
1931 - Directive from the Home Secretary of the German Reich forbids “innovative therapy” unless the “subject or his legal representative has unambiguously consented to the procedure in the light of relevant information provided in advance”
1947 - The Nuremberg Code was published following experiments in Second World War on risoners-of-War.
1964 - World Medical Associations Declaration of Helsinki revised in 1975, 1983, 1989, 1996 and 2000 replaces the Nuremberg Code.
1993, 2002 CIOMS International Ethical Guidelines for Biomedical Research Involving Human
Subjects.
1996 - ICH Tripartite Guideline on Good Clinical Practice (1996) in Clinical Trials.
1997 - European Bioethics Convention on human rights and biomedicine in Oviedo in Spain in 1997
2001 - EU Directive 2001/20/EC

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