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At least 19 recordsLinked to original sources
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↗
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↗
PubMed1990

[Informed consent. Historical background and current problems].

At present, informed consent is essential before patients can participate in clinical trials. The fact that a doctor asks the patient for informed consent is an expression of respect for the patient's right to make decisions about his own body. The request is made in recognition of the fact that optimal treatment can only be ensured by means of clinically controlled trials. The need for regulation of research arose at the beginning of the present century when pharmacological development accelerated. The Nürenberg Declaration was elaborated after the second world war and, subsequently, the Helsinki Declarations I and II. In these, directives are established for clinical research and for the rights of participants. A number of conditions make it difficult to fulfill these intentions. It may be difficult to ensure that the patient has adequate basic knowledge. The patient may feel that he is in a state of dependence on the doctor which influences his possibility to choose freely. Confidence between doctor and patient may be undermined if the patient is requested to participate in randomization for choice of treatment. Doctors know too little about how valid information can be ensured.

Ethics, Medical↗
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↗
PubMed1990

[The doctrine of free and informed consent: its ethical and legal foundations and its applications in research and practice of psychiatry].

This article briefly examines the ethical and legal foundations for the doctrine of informed consent in medical research and practice. The doctrine is based upon the importance of respecting the individual's autonomy and his right to self-determination. The article also reviews the development of the doctrine of informed consent based on its recent application. The authors cite the Nuremburg Code and the Helsinki Declarations and particularly the media denunication of several scandals in the United States during the late 1960s, when Henri Beecher's name figured prominently. The effects of informed consent in psychiatry are examined specifically, as well as the consequences for psychiatric research, on subjects who are able to give their consent, as well as those who are unable to do so. As for its effects on clinical practice, the paper discusses the right of the hospitalized patient to refuse treatment, and informed consent and the risks for patients treated with neuroleptics of developing tardive dyskinesia. The authors conclude that in psychotherapy the concept of informed consent cannot be taken for granted.

Antipsychotic Agents↗
PubMed1992

[The effect of oxygen administration on serum concentration of potassium during exercise].

Recently, there have been many reports on the role of serum concentration of potassium as a potential limiting factor during exercise. K+ is known to induce muscle fatigue and to increase ventilation by direct stimulation of peripheral chemoreceptors. These two K(+)-mediated effects are considered to be the factors that limit exercise capacity. This effect seems to be exacerbated in hypoxemic states. The occurrence of hypoxemia in chronic pulmonary disease patients during exercise is believed to cause the excessive efflux of potassium to the extracellular space from skeletal muscles. The present study evaluated the relationship between the changes in arterial concentration of K+ and hypoxemia during exercise in 37 chronic pulmonary patients and 9 healthy controls. The study was carried out after obtaining formal and written consent of the patients in accordance with the stipulations of the Helsinki Declaration. Patients were divided into two groups according to PaO2 level at maximum exercise capacity; group I: PaO2 less than 55 torr, group II: PaO2 greater than or equal to 55 torr. The arterial concentration of K+ in group I patients tended to be higher than that in group II and controls. In group II, K+ concentration was significantly elevated (p less than 0.05) compared to controls. In group II, PaO2 values were inversely correlated with K+ (r = 0.3026; p less than 0.025), whereas in controls and group II they were unrelated. These results suggest that the augmented serum level of potassium in patients with chronic pulmonary disease is an important limiting factor during exercise.

Aged↗
PubMed1990

[Verbal information in clinical trials at an oncology department].

Prior to participation in clinical trials, patients must give their consent on the basis of information from the doctor. The content of the information is defined in the Helsinki Declaration. Information given in an oncological department was investigated and the patients were interviewed about the information obtained. The problems associated with the informative interviews with the patients were that these were frequently unstructured, that the patients were more concerned with their illness and treatment and that doctors had done too little to ensure that the patients had understood the information. It was most difficult for the doctors to provide thorough information about side-effects and disadvantages. Patients had greatest difficulty in understanding the principle of randomization. The patients' main reason for participation in the trial was the hope for therapeutic benefit. In departments where clinical research is undertaken, constant attention is required for how information on clinical trials is best given.

Aged↗
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↗
PubMed1990

[Quality assurance in clinical studies: a necessity].

Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP) are the constituents of a new concept for quality assurance in pharmaceutical research. They are to establish standards for preclinical and experimental research in animals (GLP), for the manufacturing of drugs (GMP), and for trials on medical products in human beings (GCP), respectively. Each of the 3 entities is characterized by the same principles of control; these involve written instruction describing the general operations to be performed, the so called Standard Operating Procedures (SOP), and Quality Assurance Units being responsible for surveying the operations in accordance with the SOP, and ensuring that the generated data will satisfy the requirements for quality. As far as clinical trials are concerned, the SOP is represented by the study protocol and a Monitor provides for the surveying of the trial. GCP is further characterized by ethical principles, which aim primarily at protecting personal integrity and welfare of the trial subjects. The Declaration of Helsinki is the accepted basis for clinical trial ethics. Following the Declaration of Helsinki during the planning, conducting, surveying and evaluating of clinical trials provides for a degree of seriousness being the real hallmark of Good Clinical Practice.

Animals↗