Declaration of Helsinki

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First passed in 1964, as an evolution of the Nuremberg Code, the world consensus position on ethical principles in biomedical research involving human subjects is the Declaration of Helsinki. Developed by the World Medical Association establishes overall policies, including the requirements for informed consent.[1]

The declaration was last revised in 2000, but, if for no other reason than advancing medical technology, it is constantly being reviewed. In 2000, the "most contentious issues included:[2]

What has easily been the most contentious issue is the standard of treatment that should be assured to human participants involved in research projects. The WMA has affirmed its position that at the conclusion of any research study, every patient entered into a research project should be assured of the best proven prophylactic, diagnostic and therapeutic methods identified by that study". "The WMA has also been very concerned about the possible exploitation of so-called "poor" nations for research by companies from so-called "rich" countries. New guidelines in the Declaration will now call on researchers to make sure that there is a reasonable possibility that the local participants in a study, including their fellow countrymen, would be able to benefit from the results (whether positive or negative) of such studies". — Dr. Delon Human, Secretary-General, World Medical Association

References

  1. World Medical Association (adopted 1964, with amendments through 59th WMA General Assembly, Seoul, October 2008), Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
  2. World Medical Association (9 October 2000), Press release: WMA Revises The Declaration Of Helsinki