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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 541 records · Page 30Linked to original sources
PubMed2005

[Therapy research in times of patient preference].

The Declaration of Helsinki bears the consequence that in the future reference-controlled clinical trials will increasingly replace placebo-controlled trials. This has enormous implications on research in complementary and alternative medicine: strong preferences for or against the compared therapies will prevent patients to consent to randomisation. In these circumstances a number of alternative designs have been proposed, based on the combination of preference and randomisation, but some of them suffer from severe methodological problems. Others are internally valid but unfeasible in practice and difficult to interpret. Thus, in case of strong patient preferences, we suggest to conduct non-randomised trials but to give special interest to advanced statistical methods (e.g. structural equation models) which must replace simple two-group comparisons.

Controlled Clinical Trials as Topic↗
PubMed2005

[Take-over of the risk-benefit by the clinical study subject and its regulation].

There should be two levels of the risk-benefit consideration related to all the clinical trials. At the individual trial subject's level, whose rights should be protected against the interest of the society. At the level of the community, the main interest is to improve the therapeutical procedures, to provide more efficacious health care for the present and future patients. The summary intends to shed light, whether the guidelines has been shifted from the absolute defend of the individual subject's interest towards the considerations of the interest of the society since the Nürnberg-Code or not.

Clinical Trials as Topic↗
PubMed1997

Clinical studies in the intensive care unit: ethical and legal aspects.

This article draws on international experience to explore the ethical and legal aspects of performing clinical studies on patients in intensive care units. It discusses aspects of consent relevant to clinical studies in this medical environment, it considers the involvement of ethical committees, and the role and appropriate level of intensive cover.

Brain Death↗
PubMedDate not supplied

Limitation of medical research in German law.

In Germany, pharmaceutical trials and the testing of medical devices is regulated by statute. Any other kind of medical experimentation is handled according to the Declaration of Helsinki. Medical experimentation has to be reviewed by an ethics committee before the start and there has to be an elaborate research protocol, which provides for the protection of the experimental subject. In case of an accident, there is compulsory accident insurance as far as pharmaceutical trials and the testing of medical devices are concerned. The third party accident insurance just covers material loss, there is no provision paying and suffering. The sum paid by the insurance company is set off against damages for negligence. There is no strict liability for medical experimentation, but the German courts are expected to set very high standards for medical care in experimentation. The data protection and medical confidentiality have been lessened because of the European law that requires the experimental subject to give his consent to the inspection of the data or the file and if he takes part in the experimentation, that his data and some of his cells might be with the pharmaceutical company forever. In general, the German law seems to be adequate to the protection of experimental subjects.

Biomedical Research↗