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Results for “Helsinki Declaration”

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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↗
PubMed1996

[Is the placebo still ethically acceptable and scientifically useful in clinical drug experimentation?].

Here, the authors address the question whether the administration of placebo, in clinical trials of drugs to be registered or already registered, is ethically acceptable and/or scientifically useful. An important issue, particularly in view of the different opinions emerging in the international scientific community. Since many diseases are already treatable with established therapies and drugs, clinical trials should be performed mainly with placebo containing the appropriate active compound, in agreement with the Helsinki declaration. Active placebo should be employed when slightly modified compounds are tested and when trials are in phase 2/b, 3 or 4. The use of active placebo in these settings would be more correct from a scientific, ethical and economical point of view.

Clinical Trials as Topic↗
PubMed1997

Institutional review board approval and publication of human research results.

OBJECTIVE: To determine if journals' instructions for authors require that manuscripts being considered for publication indicate that studies involving human subjects had appropriate institutional review board (IRB) approval. DESIGN: A descriptive study of the ethical guidelines published in the Instructions for Authors sections of the 102 English-language biomedical research journals listed in the 1995 Abridged Index Medicus. INTERVENTION: Literature review. MAIN OUTCOME MEASURE: Policy regarding IRB approval of studies that involve human subjects. RESULTS: Of the 102 journals surveyed, 48 (47%) require IRB approval of studies involving human subjects as a prerequisite for publication, and 25 (24%) do not present or refer the author to any information related to human research ethics. Of the remaining journals, 15 (15%) referred authors to the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, 3 (3%) to the Declaration of Helsinki, and 10 (10%) simply indicated that informed consent should be obtained. There was only 1 medical specialty (anesthesiology) in which all the representative journals presented the same ethical requirement. In the 48 journals that clearly required IRB approval of studies, 37 (77%) documented IRB approval with a statement in the manuscript, 7 (15%) required a separate signed statement from the author, and 4 (8%) did not mention a method of documentation. CONCLUSIONS: The results of this study suggest that about half of the 102 English-language biomedical research journals listed in the 1995 Abridged Index Medicus do not publish guidelines indicating that IRB approval of studies involving human research subjects is a requirement for publication. The manner in which publication requirements related to ethical standards are presented in biomedical research journals is extremely variable.

Codes of Ethics↗
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↗
PubMed1997

Molecular mimicry as a therapeutic approach for an autoimmune disease: oral treatment of uveitis-patients with an MHC-peptide crossreactive with autoantigen--first results.

In the rat model of experimental autoimmune uveitis (EAU) we have demonstrated that a peptide from the sequence of human disease-associated MHC-class I antigens can induce uveitis upon immunization. Moreover, oral administration of this MHC-peptide tolerized Lewis rats to the disease induced with two different retinal autoantigens, retinal S-antigen (S-Ag) and IRBP. In uveitis patients T cells responding to S-Ag peptide also respond to the MHC-peptide, which shows crossreactivity with the major epitope from S-Ag due to some shared discontinuous amino acid homologies. The 14-mer peptide B27PD is derived from the sequence of all HLA-B antigens that are statistically associated with uveitis (including HLA-B27). Patients with long-lasting endogenous uveitis, suffering from side effects of conventional immuno-suppressive therapy or being therapy-refractive, were orally tolerized with peptide B27PD in this first open therapeutic trial. Patients received peptide three times a week over a 12 weeks period, while only low dose steroids were allowed as concomitant medication. The aims were (1) to investigate whether immunosuppressive therapy could be discontinued and steroids reduced while relapses of ocular inflammation reside and (2) to search for side effects. The Helsinki Declaration was strictly observed and the study design approved by the local ethical committee. The first patients orally tolerized with the HLA-peptide (two had stopped azathioprine immediately prior to onset of oral peptide treatment) could discontinue their steroids because of reduced intraocular inflammation. No side effects of therapy were observed. Oral tolerance induction with a peptide derived from the patients' own HLA-antigens and crossreactive with the organ-specific autoantigen seems to be a potent therapeutic approach.

Administration, Oral↗
PubMedDate not supplied

Requirements for pharmacokinetic evaluation of antibiotics in phase I studies.

Initial pharmacokinetic studies usually include healthy volunteers to minimize variation generated by diseases. Ethical aspects of initial studies are paramount. The guidelines of the Helsinki Declaration should be followed or even extended. Thorough toxicologic screening in animals is a prerequisite. The use of radioisotopes for pharmacokinetic studies should be limited. The basic design of studies includes cross-over administration of intravenous and oral doses of several sizes. Bioavailability, total area under the serum concentration curve, serum half-life, amount eliminated in urine as active drug, and metabolism are the most important data. The fate of the parent compound and of its possible metabolites in both healthy persons and ill individuals (including those with renal or hepatic dysfunction) should be monitored. Diet may have consequences with regard to recommended dosage schedules. When possible, tissue penetration of antibiotics should be assessed, preferably through the analysis of peripheral human lymph and of suction-blister and peritoneal fluids. Theoretical dosage schedules based on pharmacokinetic assessments in healthy persons should be tested in patients with infectious disease, particularly in those with reduced renal and/or hepatic function.

Administration, Oral↗
PubMed1997

Immunity and health after bereavement in relation to coping.

Coping was examined as an intervening variable between the stressor of bereavement and its effects on subjective health and immunity in thirty-nine recently bereaved Norwegian women. Coping was defined as: "positive response outcome expectancies". Data were collected approximately one month after the death of the husband, and twelve months thereafter. Data collected were: expected coping success (self-scoring), subjective health (UHI), anxiety and depression (GWB), and immunoglobulins (IgA, IgM, IgG) with components (C3, C4). Statistics were: frequencies, paired t-test, ANOVA, and MANOVA. Permissions and confidentiality were in accordance with the Helsinki-declaration. Coping was found to be related strongly to health and to health changes. Few relations were found between immunity and health. Coping, health, and anxiety and depression formed a triangle of interrelations. It was concluded that coping defined as "positive response outcome expectancies" may be a predictor of the adaptational outcome after a crisis.

Adaptation, Psychological↗
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↗
PubMed1996

Gastroenterology in the last decennia and initiatives in medical ethics: coincidence or linkage?

A quarter of a century ago ethics was an esoteric term, known to theologians and philosophers, but unknown as a discipline to the majority of doctors. Since then, however, ethics has become a substantial part of clinical medicine and health research. Ethics as an area of interest for Danish gastroenterologists appeared from several foci in the early days. One angle was an almost revival-like interest in research methodology and its ethical dimensions. Other angles were derived from Danish gastroenterologists' experiences transferred from other disciplines before the birth of Danish gastroenterology. From the time of these early incentives Danish gastroenterologists have constituted a platform for the implementation of the basic principles, lying behind medical ethics, now in collaboration with other parts of the medical profession. The topics are reflected in a number of publications and in the various practical diversions. An interest in information of patients appeared at an early stage. Publication ethics as a subdiscipline involved Danish gastroenterologists and has led to contributions within the framework of the International Group of Medical Journal Editors. Research ethics, a central topic throughout all years, has led to such important initiatives as the Second Helsinki Declaration and the establishment of a national control system for medical research in man. A further ramification of ethics is scientific dishonesty and good clinical practice. Here a recent initiative has led to the establishment of a national Committee on Scientific Dishonesty. Under the auspices of the OMGE (Organisation Mondiale de Gastroentérologie) Danish gastroenterologists have investigated transnational and transcultural differences in gastroenterologists' attitudes to information of patients and relatives and have unmasked considerable and important differences throughout the world. Medical ethics has, together with scientific methodology, to some extent reunited the sub-specialized fragments of the mother disciplines medicine and surgery and in this way has acted as partes pro toto.

Attitude of Health Personnel↗
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↗