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Declaration of Helsinki revision tightens up on tissue R&D consent

This article was originally published in Clinica

Executive Summary

The Declaration of Helsinki, which sets out ethical principles for medical research involving human subjects, has been revised, featuring new requirements on consent for research involving blood, tissues and DNA. New paragraphs also cover clinical trials, and specifically their need to be registered in a publicly accessible database. Also, the data used are subject to tighter consent rules. The revised Declaration also reaffirms the right of research subjects to share in any benefits that derive from the research, including access to interventions identified as beneficial. The revisions were adopted by the World Medical Association (WMA) during the just-concluded annual general assembly in Seoul, South Korea..

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