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Article Comparison - Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine

Article 16
Protection of persons undergoing research

Research on a person may only be undertaken if all the following conditions are met:

i) there is no alternative of comparable effectiveness to research on humans,

ii) the risks which may be incurred by that person are not disproportionate to the potential benefits of the research,

iii) the research project has been approved by the competent body after independent examination of its scientific merit, including assessment of the importance of the aim of the research, and multidisciplinary review of its ethical acceptability,

iv) the persons undergoing research have been informed of their rights and the safeguards prescribed by law for their protection,

v) the necessary consent as provided for under Article 5 has been given expressly, specifically and is documented. Such consent may be freely withdrawn at any time.