Historical perspectives and their significant impact on the development of ethical standards governing research using human participants


Declaration of Helsinki (1964): Concern for the interest of the participant must prevail



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Declaration of Helsinki (1964): Concern for the interest of the participant must prevail

The Declaration of Helsinki (http://www.wma.net/e/policy/b3.htm) was developed by the World Medical Association for use by the medical community following dissemination of the Nuremberg Code. The Declaration considers the conduct of clinical research and makes an important distinction between therapeutic and nontherapeutic research, which was later removed. Like the Nuremberg Code, the Declaration made informed consent a central requirement for ethical research while allowing for surrogate consent when the research participant is incompetent, physically or mentally incapable of giving consent, or a minor. The Declaration also states that research with these groups should be conducted only when the research is necessary to promote the health of the population represented and when this research cannot be performed on legally competent persons. It further states that when the participant is legally incompetent but able to give assent to decisions about participation in research, assent must be obtained in addition to the consent of the legally authorized representative. The Declaration is the first significant effort of the medical community to regulate itself.





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