Module 5 Presentations
05/07/2024
Nuremberg Code 1947 (1)
The code was developed in response to the Nuremberg Trials of Nazi doctors
who performed unethical experimentation during World War II and was the
first major international document to provide guidelines on research ethics.
The Organisation for Professionals in Regulatory Affairs
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Nuremberg Code 1947 (2) Principles
1. Participation must be voluntary, and subjects should have the capacity to give consent. Further, subjects should be fully informed of the purposes, nature, and duration of the experiment. 2. The research should yield results that are useful to society and that cannot be obtained in any other way. 3. The research should have a sound footing in animal research and be based on the natural history of the problem under study. 4. Steps should be taken in the research to avoid unnecessary physical or psychological harm to the subjects. 5. Research should not be conducted if there is reason to believe that death or disability will occur in the subjects. 6. The risk involved in the research should be proportional to the benefits to be obtained. 7. Proper plans should be made and facilities provided to protect the subject from harm. 8. Research should be conducted by highly qualified scientists only. 9. The subject should have the freedom to withdraw at any time if he or she has reached the conclusion that continuing in the experiment is not possible. 10. The researcher must be prepared to discontinue the experiment if it becomes evident that continuing will be harmful to the subject.
The Organisation for Professionals in Regulatory Affairs
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