Informed Consent - as a Protective Tool of the Right to Autonomy and Dignity of Human Subjects Participating in Biomedical Research, in the Context of the International Law of Human Rights

Abstract

Informed consent is an instrument aimed at protecting the right to autonomy and dignity of human subjects participating in biomedical research. In this article, a series of forms of consent are presented, which together with informed consent, ensure the observance of these rights in accordance with the international law of human rights: delegated consent, broad consent and consent assent (in the case of minors). A series of normative acts issued by the United Nations, aplicable at a global level, or as part of the normative system of the Council of Europe and of the European Union, aplicable at an European level, are analyzed, as well as their reflection in the normative acts enforced, at a national level, in Romania.