Abstract

In clinical research, informed consent is both a legal document and mechanism for respecting the dignity of participating subjects and protecting their rights and wellbeing. It should include information on the purpose of the research, its justification, and the risks and the benefits involved, so as to enable a subject to decide to participate voluntarily. Because it is the researcher’s duty to ensure protection of the life, health, dignity, integrity, right to self-determination, privacy and confidentiality of the subjects who take part in a study, the researcher must establish a permanent dialogue with them to assess the risks and safety inherent in their participation. This condition becomes a dynamic process that neither begins nor ends when informed consent is signed. It goes beyond legality and becomes a question of ethics and legitimacy.