The Declaration of Helsinki is a set of ethical principles regarding human experimentation Clarifications of Articles 29, 30 (–); Sixth revision (); Seventh revision (). 3 Future; 4 Timeline (WMA meetings); 5 See. Helsingforsdeklarationen som en sam- ling etiska principer i syfte att vägleda läkare och andra som medverkar i medi- cinsk forskning som omfattar männi- skor. Från Helsingforsdeklarationen och Biomedicinkonventionen till den svenska Genom en ändring i lagen ändras etikprövningslagens definition av.

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Facing the 21st Century. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the he,singforsdeklarationen for research subjects set forth in this Declaration.

Perspectives on the fifth revision of the Declaration of Helsinki. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research.

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

Helsingfforsdeklarationen has continually grown and faced more frequent revisions. The terms of reference included only a limited revision compared to No amendment to the protocol may be made without consideration and approval by the committee.

Medical progress is based on research that ultimately must include studies involving human subjects.

It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects.

After consultation, which included expressions of concern, [68] a final rule was issued on April 28, replacing the Declaration of Helsinki with Good Clinical Practice effective October The opposing view, as expressed by Levine [19] and by Temple and Ellenberg [43] is referred to as ‘placebo orthodoxy’, insisting that placebo controls are more scientifically efficient and are justifiable helsingforsdeklarationrn the risk of harm is low.

Declaration of Helsinki – Wikipedia

Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.


Article 30 introduced another new concept, that after the conclusion of the study patients ‘should be assured of access to the best proven’ intervention arising from the study, a justice issue.

Selection of pregnant or nursing breastfeeding women as research subjects”. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.

The Declaration was originally adopted in June in HelsinkiFinlandand has since undergone seven revisions the most recent at the General Assembly in October and two clarifications, growing considerably in length from 11 paragraphs in to 37 in the version.

For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. Retrieved from ” https: These included the claims that the continuing trials in developing countries were unethical, and pointing out a fundamental discrepancy in decisions to change the study design in Thailand but not Africa.

It clearly stated that “concern for helsingfofsdeklarationen interests of the subject must always prevail over the interests of science and society. The second revision included seeking the consent of minors where possible. Despite these changes, as Macklin predicted, consensus was no closer and the Declaration was considered by some to be out of touch with contemporary thinking, [57] and even the question of the future of the Declaration became a matter for conjecture. Now doctors were asked to obtain consent ‘if at all possible’ and research was helsnigforsdeklarationen without consent where a proxy consent, such as a legal guardian, was available Article II.

New England Journal of Medicine. Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use helaingforsdeklarationen placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not 208 subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.


Empirical and methodological myths”. Helsingforsdeklarationen is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association WMA. This revision implies that in choosing a hflsingforsdeklarationen design, developed-world standards of care should apply to any research conducted on human subjects, including those in developing countries.

Forskning som involverar människan

When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study. Article 19 first introduces the concept of social justice, and extends the scope from individuals to the community as a whole by stating that ‘research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research’.

Indian Journal of Dermatology, Venereology and Leprology. The Declaration developed the ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Genevaa statement of 2008 ethical duties. Extreme care must be taken to avoid abuse of this option.

The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. Following the fourth revision in pressure began to build almost immediately for a more fundamental approach to revising the declaration.

This consisted of a call for submissions, completed in August Helsingforsdeklaratioonen idea of ethical imperialism was brought into high attention with HIV testing, as it was strongly debated from because of its centrality to the issue of regimens to prevent helsingforsdemlarationen vertical transmission.