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PubMed1983

Reichsrundschreiben 1931: pre-Nuremberg German regulations concerning new therapy and human experimentation.

This is the first re-publication and first English translation of regulations concerning Human Experimentation which were binding law prior to and during the Third Reich, 1931 to 1945. The introduction briefly describes the duties of the Reichsgesundheitsamt, which formulated these regulations. It then outlines the basic concept of the Richtlinien for protecting subjects and patients on the one hand and for encouraging New Therapy and Human Experimentation on the other hand. Major issues, like personal responsibility of the physician or researcher, teaching of ethics of research and therapy, and research and therapy on vulnerable populations, are compared with the regulations in the Nuremberg Code and subsequent regulations influenced by the Nuremberg Code.

Codes of Ethics↗
PubMed1994

Historical background of clinical trials involving women and minorities.

The author provides a historical context for the difficult ethical and clinical issues associated with the inclusion of women and members of minority groups in clinical research. He cites as a point of departure the Nuremberg Code of the late 1940s, which declared the fundamental dignity of human beings involved as research subjects, a principle that was quickly endorsed worldwide. From the period following World War II through the 1970s, the prevailing attitude--not always practiced--toward research subjects in the United States was that they should be protected from exploitation. That attitude was reflected in the first broad federal policy on research subjects, created in 1966. During those years, research was widely regarded by the public as dangerous and of little value to individual participants; it is remarkable that so many men and women consented to participate in clinical studies at that time. Furthermore, during the 1970s, for reasons explained by the author, various events--the abortion debate, disclosures from the infamous Tuskegee syphilis study, Nixon's "war on cancer," new federal regulations in 1974 and 1975 (the latter providing additional protection for pregnant women in research), the broad interpretation of the FDA's 1977 policy excluding pregnant or potentially pregnant women from clinical trials, and the tendency of blacks and persons from other minority groups to shun participation in research--tended to deter participation of women and members of minority groups in clinical research.(ABSTRACT TRUNCATED AT 250 WORDS)

Beneficence↗
PubMed1994

Ethics and research in nursing.

Considering the importance of research in the development of nursing, we examine the ethical principles governing nurses' investigative activity, as well as the different codes regulating biomedical investigation with human beings, amongst which are the Nuremberg Code, the Declaration of Human Rights, and the Declaration of Helsinki. From the perspective of the central points of the article reference is made to different codes proposed by international nursing associations, as well as reviewing the Deontological Code of Spanish Nursing. The ethical principles a nurse has to bear in mind in research are analysed, with respect to patients, society and the profession. Finally, we refer to certain ethical aspects to be considered in the elaboration and development of a research project, as well as publication of the results.

Codes of Ethics↗
PubMedDate not supplied

[Informed consent in health legislation of Mexico].

This paper deals with informed consent in Mexican Health Legislation in the context of a contract regulated by the Mexican Civil Code, in which a patient capable of making a thoughtful decision agrees to a specific plan of medical management and has received sufficient information, in a clear and explicit manner so that he/she can make a decision and in consequence agrees, or does not agree, to a course of action and to its consequences, under the Nuremberg Code. In Mexico, informed consent has recently been incorporated into health care legislation, and is basically oriented toward the field of medical research, while in other medical procedures, a legal authorization, and not an informed consent form is required, as with surgical procedures such as definitive fertility control (e.g. vasectomy or fallopian tube ligation). We emphasize the necessity of the adding of informed consent to Mexican health legislation in general, substituting it for other terms to legalize medical action, such as authorization, permission, dispositioned compliance, acceptance or approval-all of which have an essentially different and limited connotation, and are not Patient's Rights legal protector mechanisms, from our point of view.

Informed Consent↗
PubMed1979

Problems with ethical aspects of psychotropic drug use.

1. Research is an important area within the purview of medical ethics. The Nuremberg Code and the Helsinki Declaration provide well established guidelines in this field. 2. Specific ethical issues still requiring clarification in psychopharmacological research are the informed consent, the benefit/risk ratio and the choice of placebo or standard. 3. Peer review committees, if well chosen for their objectivity, general competence and special expertise, are likely to be the best arbiters regarding such questions. 4. Legislation and other political interventions--unfortunately not always objective, competent or expert in the exercise of their powers--have recently developed into rampant paraethical problems that are plaguing medical treatment and research in many parts of the world and need to be dealt with urgently through internationally coordinated efforts. The WHO would appear to be the most appropriate agency for such action.

Ethics Committees, Clinical↗
PubMed1998

Fifty years after the Nuremberg Nazi Doctors' Trial: reviewing how the laws of the Third Reich applied to individuals with oral clefts.

The Nazi Doctors' Trial, held in the city of Nuremberg 50 years ago, is a landmark in the history of medicine and science. For the first time, the horrors inflicted by a group of German scientists on innocent victims became widely known. Most of the defendants received sentences that ranged from relatively short imprisonment to death. The Trial also provided elements to develop standards for permissible medical experimentation, known as the Nuremberg Code. The atrocities judged in the Nazi Doctors' Trial, however, were not isolated. They were part of an overall eugenic system that encouraged euthanasia, compulsory sterilization, and selective marriages based on "genetic health" and "racial hygiene." Individuals with oral clefts were considered subject to these laws and suffered their consequences. This paper describes the main features of the Trial, reviews the state of knowledge on oral clefts in the 1930s and 1940s, presents how the laws of the Third Reich impacted the lives of individuals with oral clefts, and speculates on the implications of past and present eugenic policies in the future of humankind.

Child↗
PubMed1989

Informed consent in the practice of acupuncture.

Early records reveal a parental, beneficent attitude, but an uncommunicative approach to the patient. The Nuremberg trials of 1946 demonstrated the need for ultimate responsibility of the physician, and for a well-informed, consenting patient in experimental procedures (Nuremberg Code of 1947). A later report, the Belmont Report (1975) emphasized the difference between therapeutic research and research unrelated to improving the patient's state of health. Acupuncture has the status of an experimental modality, and requires the informed consent discussion and signature on the form by the patient for each procedure.

Acupuncture Therapy↗
PubMed1998

Experimental studies: randomized clinical trials.

There are two major approaches to medical investigations: observational studies and experimental trials. The classical application of the experimental design to studies of human populations is the randomized clinical trial of the efficacy of a new drug or treatment. A further application of the experimental studies is to the testing of hypotheses about the etiology of a disease, already tested and corroborated from various forms of observational studies. Ethical considerations and requirements for consent of the experimental subjects are of primary concern in the clinical trials, and those concerns set the first and final limits for implementing a trial. General moral principles in research with human and animal beings, defined by the "Nuremberg Code," deal with strict criteria for approval, endorsement and evaluation of a clinical trial.

Animals↗
PubMed1996

[Research in psychiatry and legislative restrictions].

Over the last few weeks decades research in psychiatry has undergone a considerable efflorescence. Experimental projects in fields as different as neurobiology or psychopathology, neuro-anatomy or epidemiology, or even cognitive psychology are of course subject to precise conditions which may derive from ethical guidelines as well as different legal systems. These legislative contexts therefore represent a parallel set of restrictions in the path of research activities and may in some cases curb their development. Restrictions of an ethical or deontological type are direct heirs of necessity. They emerged on the eve of the second world war when it became apparent that precisely defined conditions in which research could be conducted in humans were required, and derived for the most part from the recommendations of the Nuremberg Code on the one hand, and the Helsinki declaration on the other. The last version of the Code of Medical Deontology applicable to medical practice in France, and published by decree in September 1995, devoted an article to the question of experimentation. Each country has its own specific legislation which, in France, was explicitly formulated with the publication of the Loi Huriet in December 1988. The European Union is currently attempting to produce a homologous version of the various legislative documents and recommendations should soon be forthcoming which will be applicable to all member countries of the Community. Another area of limitation is less clearly formulated and involves the technical and occasionally methodological framework within research projects take place. Technical demands are highly variable depending on the field of investigation and chiefly revolve around a dogged hunt for statistically significant results (statistical significance sometimes seems to dispense with the need to determine the real meaning of results!); in some cases they too may curb inventiveness. This last type restriction is particularly apparent in drug trials where imperatives of industrial development as viewed by the sponsor may not always coincide with the investigators' desire to mark therapeutic progress. The increasing rigidity of strategies for assessing new substances which has become obvious over the last few years may in the end risk penalizing the discovery of innovative treatments. Promoting a return to clinical practice in the setting of these research projects would indisputably provide some novel solutions. Although many of the restrictions which currently stand in the way of psychiatric research are, so to speak, natural limitations and difficult to debate, excessive formalism in some areas should be spoken out against. Much thought has been given to this subject, a trend which is likely to inject some dynamism into psychiatric research at the dawn of the third millennium just around the corner.

Data Interpretation, Statistical↗
PubMedDate not supplied

The suppressed legacy of Nuremberg.

The story of patient self-determination cannot be told without the Nuremberg trials. Patient autonomy was the first criterion enunciated by the Nuremberg judges and has served as a touchstone for human subject research and patient care ever since. Yet this ideal was in an important sense irrelevant at the moment it was originally proclaimed.

Decision Making↗
PubMed1997

The patient's rights in clinical research.

Standards in clinical research are laid down in the Nuremberg Code, the Declaration of Helsinki and EC directives on good clinical practice. Clinical research may relate to the causes of disease, improvement in diagnosis, improvement in treatment, and mechanisms of human biology. The patient has the right to informed consent, to withdrawal without prejudice and to confidentiality.

Confidentiality↗
PubMed1998

[Ethic aspects of conducting physiological-hygienic and psychological studies on human subjects as applied to the activities in extreme environments].

The paper deals with ethic concerns of biomedical research involving human subjects aimed at mitigating risks for and raising the effectiveness of humans in extreme environments. Cited are the main principles of the Nuremberg Code, Helsinki Declaration, Convention of the European Council on Bioethics and other international and national documents regulating ethic implementation of research with participation of human subjects. The 6-year experience of the Bioethics Commission convened at SRC RF--IBMP is summarised.

Environmental Exposure↗