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Out of the horrors of World War II came the Nuremberg Code, the prototype for human research protection.
We can trace today’s research ethics principles directly to the inhumane experimentation on prisoners in the Nazi death camps during World War II. In 1947, during the Nuremberg War Crime Trials that followed the end of that war, the Nuremberg Code was drafted as a set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners. The code includes such principles as informed consent and absence of coercion, properly formulated scientific experimentation, and beneficence toward experiment subjects.
This code, along with the Helsinki Declaration of 1964 (revised in 1975) and the Belmont Report of 1979, among others, became the prototype of many later codes intended to assure that research involving human subjects would be carried out in an ethical manner. From these evolved the ethics principles of the National Institutes of Health Office of Human Subject Research now governing such research.
For more on ethical issues and clinical trial lawsuits, check out the upcoming July issue of Applied Clinical Trials to read John F. Kouten's feature article: A Ten Step Trial Crisis Plan.
Source: The National Institutes of Health, Office of Human Subjects Research, Regulations & Ethical Guidelines (bioethics.od.nih.gov/IRB.html).