WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects

Adopted in Helsinki in 1964 by the World Medical Association WMA, the Ethical Principles were lastly amended in October 2013.

As a general principle, it is the duty of [the] physician[s] to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.

While the Principles acknowledge that medical studies ultimately include human subjects, they underline that medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.

 Relevant clauses:1

17. All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.

19. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection.

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.

26. In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. […] After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

28. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative.

 


  1. http://www.wma.net/en/30publications/10policies/b3/ []

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