Declaration of Helsinki

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For the political accords, see Helsinki Accords.

The Declaration of Helsinki, developed by the World Medical Association, is a set of ethical principles for the medical community regarding human experimentation. It was originally adopted in June 1964 and has since been amended multiple times.

The Declaration considers the conduct of clinical research and makes an important distinction between therapeutic and nontherapeutic research. However, this distinction was eliminated in later versions of the Declaration. 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 subject 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 important in the history of research ethics as the first significant effort of the medical community to regulate itself. In principle, this document set the stage for the implementation of the Institutional Review Board /independent ethics committee (IRB/IEC) process (Shamoo & Irving, 1993) in USA and ethics committee, ethical review board or Human Research Ethics Committees (HREC) in some other countries.

[edit] References

U.S. National Institutes of Health - "Declaration of Helsinki", Human Participant Protections Education for Research Teams
Shamoo, Adil E. and Irving, Dianne N. "Accountability in Research." 1993 in press - Public Responsibility in Medicine and Research, Boston, Oct. 21 - 22, 1993