Summary

The Declaration of Helsinki (WMA, 2013) was drafted in 1964 and revised several times since then, the latest being in 2013. It is "addressed primarily to physicians" but the World Medical Association (WMA) "encourages others who are involved in medical research involving human subjects to adopt these principles."
Of most significance, the Declaration "binds the physician with the words, 'The health of my patient will be my first consideration,'" and cites the International Code of Medical Ethics in saying, "A physician shall act in the patient's best interest when providing medical care." It is thus "the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research" (Ibid).
The Declaration is consistent with, and expands upon, the principles expressed in the Nuremberg Code. It significantly adds a requirement for an ethics review committee that is "transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified" (Ibid). It also adds the requirement that "every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information" (Ibid). It also states "researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports" (Ibid).

Content

Force:yes