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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 in Helsinki, Finland, and has since undergone eight revisions, most recently in the year 2000. The Declaration expands upon the principles first stated in the Nuremberg Code and applies these ideas specifically to clinical research.
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. These regulations came into effect in 1981 and are encapsulated in the 1991 revision to the US Department of Health and Human Services title 45 CFR 46 subparts A, B, C and D. Subpart A ("The Common Rule") is the baseline standard of ethics by which any government-funded research in the US is held, and nearly all academic institutions hold their researchers to these statements of rights regardless of funding.
In October 2000, the Declaration was revised to reflect the controversy caused by placebo-controlled trials funded by the United States Center for Disease Control in Africa on the effect of Zidovudene to prevent perinatal transmission of HIV in the developing world. This revision held that developed-world standards of care should apply to any treatment or research thereof conducted on any human subjects. Opponents to this revision argued that when no standards of care exist in a given country, then placebo-controlled trials are appropriate. Others adopted a utilitarian argument, holding that the principle of distributive justice should apply, given that many will benefit from this research even though a few are being left behind when treatment is available.
- 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
- Brennan, TA. "Proposed Revisions to the Declaration of Helsinki — Will They Weaken the Ethical Principles Underlying Human Research?" N Engl J Med. 1999 Dec 9;341(24):1852-3.
- Merson MH. "Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World." N Engl J Med. 1997 Sep 18;337(12):853-6.
- Nuremberg Code
- Belmont Report
- Declaration of Geneva
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- Informed consent
- Medical ethics
- Clinical trial
- Federal Regulations for the Protection of Subjects from Research Risks
- Declaration of Helsinki at the World Medical Association home page
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