Online Module: The Holocaust and Fundamental Rights

Doc. 8: The declaration of Helsinki

About

The Declaration of Helsinki is a set of ethical principles regarding human experimentation, developed by the World Medical Association (WMA). It was originally adopted in June 1964 and has been revised several times, most recently in October 2013. The Declaration of Helsinki is not a legally-binding instrument under international law, but morally binding on physicians and other health care professionals.

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The Declaration of Helsinki more specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation' used in the Nuremberg Code.

Preamble

1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.
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General Principles

3. The Declaration of Geneva of the WMA binds the physician with the words,
“The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient's best interest when providing medical care.”
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7. Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.

8. While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.
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10. Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.
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25. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.

The entire document is provided in the Download section.

 

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