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Encyclopedia > Declaration of Helsinki

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 World Medical Association (WMA), an international organization of physicians, was formally established on 17 September 1947, pursuant to deliberations and decisions taken in the First General Assembly of WMA held in Paris, France. ... Human experimentation involves medical experiments performed on human beings. ... 1964 (MCMLXIV) was a leap year starting on Wednesday (the link is to a full 1964 calendar). ...

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 examples and perspective in this article or section may not represent a worldwide view. ... Informed consent is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of an action. ...

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. An institutional review board/independent ethics committee (IRB/IEC) is an appropriately constituted group that has been formally designated to review and monitor biomedical and behavioral research involving human subjects. ...


  • 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

See also

This article is about the Declaration of Geneva pertaining to the medical profession. ... The Belmont Report is a report created by the former dee dee dee (which was renamed to Health and Human Services) entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research and is an important historical document in the field of medical ethics. ... The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical... Informed consent is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of an action. ... Medical ethics is the discipline of evaluating the merits, risks, and social concerns of activities in the field of medicine. ... In medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a research study. ...

External links

  • Declaration of Helsinki at the World Medical Association home page

  Results from FactBites:
Bioline International Official Site (site up-dated regularly) (1560 words)
The Declaration of Helsinki was adopted in June 1964 in Finland.
The Declaration of Helsinki stresses that the design and performance of the study should be clearly formulated in an experimental protocol.
Also, a clarification of the Declaration of Helsinki issued in October 2001 states that a placebo control may be ethically acceptable when there is a scientifically sound methodological reason or the study involves a minor condition with no additional risk of serious harm.
  More results at FactBites »



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