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PubMed2002

The revised Declaration of Helsinki--is justice served?

The World Medical Association revised the Declaration of Helsinki in October 2000. The Declaration is intended to provide a universal set of principles, which direct the ethical conduct of clinical medical research involving human subjects throughout the world. Previous research ethics codes emphasized the principles of informed consent and beneficence toward research subjects. The revised Helsinki Declaration places a premium not only upon these values but also the principle of distributive justice. The new Declaration demands that scientists see to it that the risks and benefits of scientific inquiry are distributed fairly to those that participate in research and to the communities from where participants are drawn. The authors of the Declaration have sought to establish justice by minimizing the use of placebo controls, insisting that populations from where research subjects are drawn stand to benefit from the research, and by requiring that therapeutic agents be made available to all trial participants long after a trial is completed. This paper argues that the aim of seeking a morejust distribution of the risks and benefits of research may actually be undermined by the tools that the Declaration employs to enforce justice.

Clinical Trials as Topic↗
PubMed1978

Patients, doctors and experimentation: doubts about the Declaration of Helsinki.

The World Medical Association's Declaration of Helsinki offers guidelines to doctors engaged in biomedical research with human subjects. The fundamental distinction of the Declaration is between clinical research combined with professional care and non-clinical scientific research. If hospital patients are the experimental subjects, then the former research must be carried out by the patient's own doctor, whereas the latter research must not be; it must be carried out by other doctors. The relevance of the distinction between the patient's own doctor and other doctors is challenged and an alternative conception of the patient-doctor relationship is drawn, together with an alternative justification, based on the work of Hans Jonas, of the use of patients in research. Finally, the political nature of the patient-doctor relationship is mentioned, and it is claimed that the alternative conception of this relationship developed in the paper is more in line with the ethical principles of the Hippocratic tradition.

Ethics, Medical↗
PubMed2002

Placebo-controlled trials and the Declaration of Helsinki.

A revised version of the Declaration of Helsinki, issued in October, 2000, remains a vital expression of medical ethics, and deserves unanimous support. A strict interpretation of the declaration seems to rule out clinical trials that use a placebo control group whenever licensed therapeutic methods already exist, preferring active controls. Although the efficacy of some new medicines can be satisfactorily established without the use of a placebo, for others the judicious use of placebo remains essential to establish their effectiveness.

Clinical Trials as Topic↗
PubMed2004

The revision of the Declaration of Helsinki: past, present and future.

The World Medical Association's Declaration of Helsinki was first adopted in 1964. In its 40-year lifetime the Declaration has been revised five times and has risen to a position of prominence as a guiding statement of ethical principles for doctors involved in medical research. The most recent revision, however, has resulted in considerable controversy, particularly in the area of the ethical requirements surrounding placebo-controlled trials and the question of responsibilities to research participants at the end of a study. This review considers the past versions of the Declaration of Helsinki and asks the question: How exactly has the text of the Declaration changed throughout its lifetime? Regarding the present form of the Declaration of Helsinki we ask: What are the major changes in the most recent revision and what are the controversies surrounding them? Finally, building on the detailed review of the past and present versions of the Declaration of Helsinki, we give consideration to some of the possible future trajectories for the Declaration in the light of its history and standing in the world of the ethics of medical research.

Ethics, Medical↗
PubMed2002

[Declaration of Helsinki: its vicissitudes during the last five years].

The Declaration of Helsinki is one of the major ethical guidelines for conducting clinical research. Along its existence it has been modified on diverse occasions, the latest one in October 2000. The objective of this article is to carry out a revision of the discussions that were taken up at this latest modification and the debates raised since its promulgation which still continue, fundamentally in relation to the use of placebo in pharmacological clinical investigation. This includes a revision of the most outstanding articles and of the opinions of the participants in the discussions that have been published in the last five years. The scientists' arguments in favor or against the use of placebo are pointed out. We consider that it is difficult to find simple answers to the questions raised by the use of placebo in clinical trials both in developed countries and in countries under development and that the Declaration of Helsinki continues to constitute a guide of ethical ideal which all those involved in clinical research should try to take into consideration.

Clinical Trials as Topic↗
PubMed2004

The standard of care debate: the Declaration of Helsinki versus the international consensus opinion.

The World Medical Association's revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors show that there is also consensus regarding the broad conditions under which this is acceptable.

Clinical Trials as Topic↗
PubMedDate not supplied

[Changes in the Declaration of Helsinki: economic fundamentalism, ethical imperialism and social control].

This study is a critical reflection on attempts to alter the Declaration of Helsinki, a key document of the democratic theses achieved in the latter half of the 20th century and thus a legacy for humanity because of its ethical guidelines for research involving human beings. Therefore, there must be worldwide social control over such a document, and any change in it demands ample debate with international participation to avoid any reversal in its humanitarian thrust. The study analyzes current aspects of research with human subjects in so-called "outlying" or "developing" countries. It also brings a social and political focus to the matter, highlighting that the economic fundamentalism exercised by wealthy countries inevitably leads to an ethical imperialism, exposing communities of poor countries to even greater vulnerability, discrimination, and social exclusion.

Ethics, Medical↗
PubMed2000

Legal prerequisites for clinical trials under the revised Declaration of Helsinki and the European Convention on Human Rights and Biomedicine.

Biomedical research is a perennially controversial subject. While the provisions of the Revised Declaration of Helsinki enjoy world-wide acceptance, they are increasingly placed in question--not least by the Council of Europe's Bioethics Convention, which allows non-therapeutic research in restricted cases on those incapable of giving informed consent. Taking as its starting-point the fundamental conflict between the general interest in research and the individual interests of the patients concerned, this article analyses the conditions under which medical experimentation on human beings is permissible. The article recognises the model of risk/benefit analysis and the doctrine of informed consent as equally valid core principles which do not conflict with restricted, non-therapeutic research, whether on patients who lack the capacity to consent or in placebo-controlled trials.

Clinical Trials as Topic↗
PubMed2001

Ethical research issues: going beyond the Declaration of Helsinki.

La Vaque and Rossiter made a strong, supported argument that it is unethical to use a "no treatment" control group in a research study if a known, effective treatment is available. Their argument is based on the supposition that the Declaration of Helsinki is the ethical world standard for research with humans. Their argument appears to be straightforward, but is not simple to apply. The issues are very complex, include issues not discussed in their argument, and can lead to a different conclusion as pointed out in this paper. The World Medical Association developed the Declaration of Helsinki as one of their official policies. The Declaration of Helsinki, however, is not accepted as the world ethical standard, as demonstrated by its lack of adoption by many professional associations or even by the United States Federal Government. Perhaps it is not mentioned because its ethical provisions are aspirational rather than mandatory as implied by La Vaque and Rossiter. Researchers and clinicians should also be aware of other ethical issues not directly discussed in the La Vaque and Rossiter paper. The Belmont Report is the basis for the ethical protection of human research subjects for at least 17 federal agencies and does not mention the Declaration of Helsinki. The Belmont Report mentions several ethical principles that form the basis for informed consent, risk/benefit assessment, confidentiality of data, subject selection, Institutional Review Boards, and other protections needed when doing research with human subjects. At least 2 of these core principles have direct implications to the discussion related to the use of placebo controls. The ethical principle of fidelity is also important in guiding research activities with human subjects. Researchers should be familiar with the La Vaque and Rossiter argument, the Belmont Report, and the federal policies developed to implement the provisions of that report, for example, Regulation 45 CFR 46.

Ethics↗
PubMed2003

The Declaration of Helsinki and clinical trials: a focus on placebo-controlled trials in schizophrenia.

OBJECTIVE: The authors' goal was to consider ethical approaches to placebo-controlled clinical trials in the light of the evolving Declaration of Helsinki, with special attention to applications to research on schizophrenia. METHOD: They review the Helsinki position on placebos, including the 2002 Clarification, exploring the potential negative effects of banning placebos in studies involving conditions for which at least partially effective treatments exist. The Clarification is examined as an approach to this issue that, in contrast to earlier formulations, better acknowledges the complexity of clinical research and the need for protocol-specific determinations. Placebo controls in schizophrenia studies are used to illustrate issues relevant to all clinical research on therapeutic interventions. RESULTS: The Helsinki Clarification provides a basis for operationalizing criteria for review of placebo use in clinical trials. Six criteria are proposed for judging the ethical acceptability of placebo controls, including the likelihood that the intervention being tested will have clinically significant advantages over existing treatments, the presence of compelling reasons for placebo use, subject selection that minimizes the possibility of serious adverse consequences, and a risk-versus-benefit analysis that favors the advantages from placebo use over the risks to subjects. CONCLUSIONS: The Helsinki Clarification constitutes an important advance in international approaches to placebo use, requiring protocol-by-protocol judgments on complex issues of clinical research ethics. When operationalized, it provides review boards with a useful methodology for reaching determinations on the appropriateness of placebo controls in particular studies.

Controlled Clinical Trials as Topic↗
PubMed2006

The declaration of Helsinki 2000: ethical principles and the dignity of difference.

The first detailed regulations about nontherapeutic research were promulgated by the Prussian Government in 1900. In 1947, the Nuremberg Code was decreed. Since then, the Declaration of Helsinki (DOH) was adopted in 1964 and has been revised five times. The object of this article is to evaluate the 2000 Revision of the DOH and discuss three problems of concern. These problems are: (1) If, unlike its predecessors, the DOH (2000) has recast itself as a minimum set of international standards 'binding' on physicians worldwide, from where does it derive its authority? (2) The wording of the DOH is incongruent with the underlying ethical principles. (3) The projection of the DOH into the realms of social justice raises the issue of human dignity. Finally, the feasibility or desirability of a theory of justice privileging human dignity as one of its guiding principles and the future of the DOH are examined.

Helsinki Declaration↗
PubMed1999

[Emphasizing of ethical criteria for medical scientific reporting and the Declaration of Helsinki].

The 'Bill on Medical Scientific Research with Humans' is about to be introduced in the Netherlands. Clinicians who have scientific interests when carrying out diagnostic and therapeutic procedures and who are not solely motivated by the well-being of their patients are subject to a potential conflict of interests. The Declaration of Helsinki, of which a Dutch integral version is presented, deals with the pertinent ethical guidelines. The 'Uniform requirements for manuscripts submitted to biomedical journals' (so-called Vancouver rules) stipulate that research should be in accordance with the Helsinki statements. Journal editors may ask authors to produce the written approval of their research by an ethical committee. With respect to the disclosure of patient data in scientific articles, which in principle requires informed consent of the patients concerned, it is the policy of this journal to anonymize the data when the paper is edited in such a way that people other than the patients themselves are unlikely to recognize the patients. If this is not possible explicit written consent of the patients is required.

Confidentiality↗