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Results for “Helsinki Declaration”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 253 records · Page 14Linked to original sources
PubMed1994

The morality of clinical research--a case study.

The paper is a record of a debate which took place between a group of clinicians and the author concerning a clinical trial of a drug supposed to postpone the time when HIV-patients develop AIDS. A problem with the trial was that on available (inconclusive) evidence it appeared that one patient out of 500 was killed by the drug. The question raised was whether, in view of this evidence, it was morally defensible to go on with the trial. The discussion came to involve general topics such as the appropriate role of the ideal of autonomy as well as more particular topics of quantitative and qualitative risk assessments. The main thrust of the argument is that different conceptions of rationality may provide rationales of conflicting clinical decisions. Philosophy matters to medicine.

Acquired Immunodeficiency Syndrome↗
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↗
PubMed1991

Informed consent: study of quality of information given to participants in a clinical trial.

OBJECTIVE: To determine whether the participants in a clinical trial had perceived adequate information about the trial according to the guidelines of the Declaration of Helsinki. DESIGN: About 18 months after the end of a gynaecological clinical trial the participants received a questionnaire by post, which focused on the quality of the information given to them before entering the trial. Neither researchers nor participants were aware in advance that the trial would become the subject of this follow up investigation. SETTING: Eight different centres in Sweden. SUBJECTS: 43 women out of the 53 who completed the trial (mean (range) age 23 (16 to 35) years) returned the questionnaire. MAIN OUTCOME MEASURES: Adequacy of the information (based on requirements of the Declaration of Helsinki) to enable the following: understanding of the aims of the study; awareness of what participation meant; and awareness of the possibility of withdrawing from participation at any time. Motives for agreeing to participate, and a subjective evaluation of the given information were also recorded. RESULTS: All but one of the participants had been aware that they were taking part in a research project. Five women stated that they had not been aware that a second laparoscopy was performed only for research reasons. Seven women reported that they had not been aware of the meaning of participating in the project and 17 that they had had no information about the possibility of withdrawing from the study whenever they wanted. In the subjective rating 22 women considered the information given as good or very good. There was a systematic variation in the quality of the given information among the eight centres. CONCLUSION: Although all but one of the participants had been aware that they were taking part in a clinical trial, the quality of the information understood and recalled by participants varied, and in many cases clearly did not meet the guidelines of the Declaration of Helsinki. Variations among centres in participants' perception of information suggest that deficiencies in perception may be caused by informers rather than the participants.

Clinical Trials as Topic↗
PubMed1990

Between scientific application and therapy: the ethical consideration.

The development of bioscience and biotechnology during the last thirty years exerted a tremendous influence on medicine. New techniques have risen and new kinds of treatment have been and still are introduced. The theories concerning the pathogenesis and the causes of disease change, while new therapeutical drug become constantly available on the market. The way in which new technologies and drugs are introduced contains more and more an experimental phase in which animals and human beings are used to test the outcomes of research. As a rule, these experiments are performed in accordance with the Declaration of Helsinki (WMA, Helsinki 1964, Tokyo, 1975). The guidelines of this Declaration are concerned with the ethical aspects of those experiments which involve human subjects. Although the guidelines are intended to have a global import, it still remains a matter of fact that some of them are a matter of debate in several regions of the world. They seem to have a cultural background (e.g. respect for the individual) and bioscientists sometimes argue that fort this reason they have to be considered as non-scientific restrictions. On the basis of a general philosophical and ethical consideration, it will be argued in this paper that ethical guidelines belong to the heart of biomedicine and biology itself. It is the common interest of researchers, clinicians, patients and scientists to consider the ethical implications of research outcomes before it can be stated that any worthwhile knowledge is obtained. The implementation of monoclonal-antibodies in clinical practice can be seen as a sample of this argument.

Animals↗