Declaration of Helsinki

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The Declaration of Helsinki is the world consensus position on ethical principles in biomedical research involving human subjects and was first passed in 1964, evolving from the Nuremberg Code.[1] As developed by the World Medical Association it establishes overall policies, including the requirements for informed consent.[2]

In 2000, the "most contentious issues included:[3]

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

Policy on placebo controls

The use of placebos in randomized controlled trials remains controversial. Current policy is defined by Article 32: "The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances:

  • The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or
  • Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option."

References

  1. The Nuremberg Code
  2. 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
  3. World Medical Association (9 October 2000), Press release: WMA Revises The Declaration Of Helsinki