Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research

TitleAdditional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research
Publication TypeLegal Ruling
Year of Publication2007
Corporate AuthorsCouncil of Europe
Rule NumberCETS No.195
PublisherCouncil of Europe
AbstractThis Protocol is intended to build on the principles embodied in the Convention, with a view to protecting human rights and dignity in the specific field of biomedical research. Its purpose is to define and safeguard fundamental rights in biomedical research, in particular of those participating in research. The Protocol is to cover the full range of biomedical research activities involving interventions on human beings. The fundamental principle for research involving human beings, as in the Convention itself, is the free, informed, express, specific, and documented consent of the person(s) participating. The Protocol addresses issues such as risks and benefits of research, consent, protection of persons not able to consent to research, scientific quality, independent examination of research by an ethics committee, confidentiality and the right to information, undue influence, safety and duty of care.
URLhttp://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/195