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At least 19 recordsLinked to original sources
PubMed2004

Placebo and the Helsinki Declaration--what to do?

The Helsinki Declaration is the 'gold standard'--a directive, not a law, on how to conduct controlled studies in humans in conformity with ethical principles. In spite of many discussions about their unsuitability some articles have remained unchanged in the most recent (sixth) revision of the Declaration. The demand to use "the best treatment" excludes use of placebo in the control group and presents an obstacle to the scientific evaluation of a number of drugs and treatments in general. The use of placebo is justified whenever its use does not cause irreversible damage or considerable suffering to the well informed patient. It must be, is, and will be used in the controlled clinical trials of treatments of a great number of diseases especially those which have a tendency to spontaneous improvement, even healing, or have a pronounced psychological component.

Beneficence↗
PubMed1989

[The Helsinki Declaration--a misleading Norwegian translation?].

The Declaration of Helsinki (1964, revised 1983) is an important tool for the committees on research ethics in Norway and other countries. The author is appointed member of the Committee on Research Ethics in health region II. He questions the adequacy of the official Norwegian translation of the Declaration of Helsinki and shows how it presents the norms of the document as rules rather than guidelines. This is unfortunate for how the committees' understand their own deliberations and also for what others expect of the committees. The translation should therefore be revised.

Ethics, Medical↗
PubMedDate not supplied

[The Helsinki Declaration: relativism and vulnerability].

The Helsinki Declaration is a crucial ethical landmark for clinical research involving human beings. Since the Declaration was issued, a series of revisions and modifications have been introduced into the original text, but they have not altered its humanist approach or its international force for regulating clinical research. A proposal for an extensive revision of the Declaration's underlying ethical principles has been debated for the past four years. If the proposal is approved, international clinical research involving human beings will be modified, further increasing the vulnerability of certain social groups. This article discusses the historical process involved in passing the Helsinki Declaration and the most recent debate on the new draft. The article analyzes the new text's social implications for underdeveloped countries, arguing for a political approach to the vulnerability concept.

Bioethics↗
PubMed2000

The Helsinki Declaration: why all the fuss?

Since 1964, the Declaration of Helsinki has been accepted internationally as the cornerstone for research ethics. As such it has been incorporated into a number of guidance documents for research undertaken on human subjects. In 1999, the American Medical Association put forward a proposal for wide-ranging revision of the document, which would significantly weaken the rights of research subjects and lower the standards for research on human subjects. This article discusses the probable effects of the most significant proposals for change and argues against them. It also urges nurses, especially those involved in research, to become involved in the international consultation currently being undertaken by the World Medical Association.

Ethics, Nursing↗
PubMedDate not supplied

[Helsinki Declaration VI: a necessary revision, but sufficient?].

With the fifth amendment of the Declaration of Helsinki (Edinburg, 2000), the World Medical Association took a fundamental step forward in the history of the document, after years of internal and external debate. The Declaration was firstly adopted in 1964 as a clear intent to show that the medical profession could manage the ethical control of medical research with human beings. However, several disgraced episodes, like the Tuskegee Syphilis study, showed the insufficiency of such a system. An external control in the form of legal regulation was then proposed. Paradoxically, the importance of the Declaration did not decrease because many national regulations included it as a reference, actually providing it a legal status. But, though formally important, the Declaration hardly had an impact on real-world terms, because it assumed an old-fashion logic of clinical research failing to incorporate the modern methodological developments. The amendment could not be put off longer. In the present paper, I analyse the main shortcomings of the Declaration before the 2000 amendment and to what extent the fifth revision has corrected them.

Helsinki Declaration↗
PubMed2000

The shrinking of human rights: the controversial revision of the Helsinki Declaration.

The right of access to health care for HIV patients in developing countries has been weakened by the 1999 revision of the Helsinki Declaration. There is a dichotomy between discussions of human rights and liberal international public health policy. Utilitarian ethics, devoid of a sound notion of universal justice, encourage discrimination against economically vulnerable patients in developing countries. Greater coherence is needed between ethical principles and practical issues, particularly with regard to scientific research.

AIDS Vaccines↗