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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 325 records · Page 18Linked to original sources
PubMed2003

John Williams.

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Bioethics↗
PubMedDate not supplied

Rotavirus vaccines.

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Clinical Trials as Topic↗
PubMed1978

Is it ethical to conduct volunteer studies within the pharmaceutical industry?

There is a case for appropriately selected drug studies within the pharmaceutical industry in which employee volunteers are used. Provided the organisation and conduct of such studies are approached in an ethical manner, with attention to safe-guarding the volunteer and recognising the limitations, this work can be done expeditiously, cheaply, and safely. Some details are given of the arrangements made for volunteer studies within a company.

Adolescent↗
PubMed2001

Human in vivo studies of non-pharmaceutical products.

Two principal types of human in vivo studies with non-pharmaceuticals can be distinguished: (1) human metabolism studies are used for identification of target metabolites which can subsequently be used in biological monitoring studies. Furthermore, they allow extrapolation from excretion of metabolite(s) to exposure to the parent compound on the basis of an understanding of human pharmacokinetics. (2) Pharmacodynamic or effect studies are restricted to the study of acute and inherently reversible changes and are most likely to improve risk assessment in the following areas: neurobehavioural effects (e.g. alcohol, organic solvents), alterations in biochemical markers (e.g. cholinesterase inhibition following organophosphate exposure) and topical effects (e.g. skin irritancy). Ethical considerations are of prime importance and, as a minimum, any human study must comply with the principles of the Declaration of Helsinki. The protocol should include scientifically sound objectives, a justification of subject numbers, a formal risk-benefit analysis and provisions for appropriate ethical review. The welfare of the individual participating in the study must be paramount. Informed consent has to be obtained and subjects must be free to withdraw from the study at any time. Compensation should be given for the inconvenience of participating in the study, but never for undergoing risk. Provided these conditions are met, human volunteer studies can be a powerful tool in risk assessment and risk management of exposure to non-pharmaceutical products.

Ethics↗
PubMed1998

[Legislative and ethical aspects of drug experimental in children and adolescents].

Experimentation of drugs in children meets with ethical and legal difficulties. After studying historical development of drug trials regulation, the different ways to define the modalities of clinical trials (law, technical aspect, deontology, ethics) are described. The importance of the informed consent and its particularities when children are concerned are emphasized. Finally, it appears ethical and necessary to practice drug trials in children in order to obtain safe and efficient drugs and prescriptions in pediatrics.

Adolescent↗
PubMed2002

Regulatory issues for clinical trials at EORTC: the way forward. European Organisation for Research and Treatment of Cancer.

Since the Declaration of Helsinki, the performance of clinical trials is subject to ethical and gradually also legal requirements. As the EORTC is performing clinical trials in more then 30 countries, it gained expertise in the field of Regulatory Affairs of all those countries. This paper intends to address the general approach with regard to European Regulatory Affairs. Furthermore, it is focusing on the role of the EORTC at the level of the competent regulatory authorities. As recently things are moving and changing on a European level, it describes the perception of the current and future European regulatory framework, and last, but not least, it is explained in what respect the achievements of the EORTC could be of benefit to society when defining their cancer treatment policies.

Antineoplastic Agents↗