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PubMed1999

The protection of the person in medical research in Germany.

Because of its history Germany has many rules concerning the protection of persons in medical research. In fact Germany was the first state to issue a directive regulating medical experimentation with human beings in the year 1900. The ten principles of Nuremberg originated out of the medical case. Germany adheres to the Revised Declaration of Helsinki of the World Medical Association and will probably sign the European convention on biomedicine. The pharmaceutical act contains elaborate provisions for the protection of the patient or proband, e.g. informed consent, risk-benefit ratio, no experimentation on prisoners, approval of a local ethics committee. Moreover in pharmaceutical trials there has to be third party accident insurance for the experimental subject. There is no strict liability for medical experimentation, but the standard of care is high. In general the German law seems to be adequate for the protection of experimental subjects.

Confidentiality↗
PubMed1999

Informed consent for psychiatric research: the case of medication-free research.

Informed consent for research in psychiatry raises a number of ethical and legal issues. To illustrate some of the ethical problems involved, in particular issues of patient competence and proxy consent, as well as the motives of patients to become research participants, as an example the case of so-called medication-free research in schizophrenia is discussed. It is argued that an assessment of the competence of potential research subjects to consent to participation, based on explicit criteria, is necessary. In case of substituted consent it is shown that proxy decision makers may fail to protect the interests of incompetent patients in research. Finally, researchers ought to be aware that research subjects may be motivated to participate in research because they may mistakenly believe that the research project is designed to benefit them directly.

Antipsychotic Agents↗
PubMed2000

[UNESCO's bioethical norms to avoid eugenic practices].

The author, member of the UNESCO Bioethics Committee, participated in the preparation of the Universal Declaration about Human Genome and Human Rights, in 1997. The aim of this work is to analyze the initial articles of such Declaration, defining the bioethical principles that defend human dignity, freedom and rights, against the madness of the present biotechnological revolution. The development of genetics for the benefit of mankind will be guaranteed if these principles are honored. Genetic discrimination, reductionism and determinism, are identified by the author as perversions that, if used by biotechnologists, can lead to the rebirth of eugenism and racism, that were condemned by the Code of Nuremberg, in 1947. Investigators must assume their responsibility, respecting the principles of human dignity, the real freedom of research and solidarity among people. This attitude will avoid the use of genetics for purposes other than the welfare of mankind.

Bioethics↗
PubMedDate not supplied

Clinical trials and physicians as double agents.

Inherent in the dual role of physician-researcher is a conflict of interest arising out of the competing objectives of research and medical practice. Most commentary and policy recommendations on this conflict of interest have focused on the problems that arise in negotiations for informed consent. These are not, however, the only problems presented by this conflict; they are not necessarily even the most important. In order to deal with these problems, several commentators have suggested various procedural safeguards to protect the interests of the patient-subject--for example, separating the roles of physician and researcher, or introducing third parties into the relationship in order to assist in the initial or continuing negotiations for informed consent. In my view, the necessity for special procedural protections of patient-subject interests should be a discretionary judgment of the Institutional Review Board (IRB). In determining the need for special procedural protections for any research protocol, the IRB should consider three factors. To the extent that any one of these or a combination of two or more seems to present a problem, the IRB should consider it increasingly important to recommend special procedural protections: 1. There are serious impairments of the prospective subjects' capacities to consent. 2. The risk of physical or psychological injury presented by procedures done in the interests of research exceeds the threshold of "a minor increment above minimal risk." 3. The protocol is designed to introduce, test, evaluate, or compare therapeutic, diagnostic, or prophylactic maneuvers.

Advisory Committees↗
PubMedDate not supplied

[Codes of ethics for nursing research].

This article is a review of codes of ethics for research on human subjects with emphasis on the Code of Nuremberg and the Declaration of Helsinki which constitute the guidelines for health science researchers. The need for function of ethical committees is discussed and a framework of ethics in nursing research is pointing out since the subject of nursing research is mainly the human being healthy or sick.

Ethics, Nursing↗
PubMed1994

[Ethical principles in human scientific research].

Hippocrates was the first physician to use the scientific method to find rational and not religious or mythic causes, for the etiology of diseases. Hippocrates and Aristoteles did not dare to dissect the human body. Afterwards however, many scientists such as Herophilus, Erasitastrus, Vesalus and Fallopio, performed experiments in human beings using vivisection. According to that age's ideas, there was no cruelty in performing vivisection in criminals, since useful knowledge for the progress of medicine and relief of diseases was obtained. Only during the nineteenth century and with Claude Bernard (1865), the ethical principles of systematic scientific research in humans were defined. These principles were violated by nazi physicians during Hitler's dictatorship in Germany (1933-1945). As a response to these horrors, the Ethical Codes of Nuremberg (1947) and Geneva (1948), that reestablished all the strength of Hippocratic principles, were dictated. The Nuremberg rules enact that a research subject must give a voluntary consent, that the experiment must by necessary and exempt of death risk, that the research must be qualified and that the experiment must be discontinued if there is a risk for the subject. The Geneva statement is a modernized hippocratic oath that protects patient's life above all. These classical rules, in force at the present time, are the essential guides that must be applied by physicians and researchers.

Animals↗
PubMed1995

Research ethics--a brief historical review to 1965.

Most discussions on modern research ethics--particularly the formation of research ethics committees (institutional review boards)--focus on the revelations of the dreadful practices in the Nazi concentration camps at the Nuremberg trial after the second world war, with the subsequent production of the Nuremberg and Helsinki Codes. In fact, however, these trials were not pivotal: there was a long history of such concerns, going back at least to the 1830s, when William Beaumont introduced a contract with his patient Alexis St Martin, as well as the later part of the century when the celebrated leprosy worker Hansen was prosecuted in Bergen for having experimented on a patient without her consent, losing his post as a result. Probably, had it not been for the entry of the USA into the First World War, public indignation at the growing number of reports of unethical experimentation in public hospitals would have resulted in regulations, while official codes were introduced in Prussia at the turn of the century and in Berlin again in 1931. Nevertheless, the impetus for modern developments came principally from the furore aroused by the proselytising of two physicians: Henry Beecher, an anesthesiologist at Harvard, and Maurice Pappworth in London, whose respective books Experimentation in Man and Human Guinea Pigs, documented case histories of egregiously less than ethical research practices that went largely unquestioned by other clinical research workers. Here I shall discuss the reactions to and influence of some of these episodes, as well as more recent developments.

Ethics, Medical↗
PubMed1996

Nuremberg lamentation: for the forgotten victims of medical science.

Fifty years after the Nuremberg medical trial there remain many unanswered questions about the role of the German medical profession during the Third Reich. Other than the question of human experimentation, important ethical challenges arising from medicine in Nazi Germany which have continuing relevance were not addressed at Nuremberg. The underlying moral question is that of the exercise of professional power and its impact on vulnerable people seeking medical care. Sensitisation to the obligations of professional power may be achieved by an annual commemoration and lament to the memory of the victims of medical abuse which would serve as a recurring reminder of the physician's vulnerability and fallibility.

Codes of Ethics↗