Informed Consent in Research Involving Human Subjects

Abstract

Informed consent (IC) in research is a key element in ensuring the ethical character of any research involving human subjects, either bio-medical or psychosocial. IC involves three elements: validity, communication of information, and deliberation. Obtaining IC is a dynamic process of ethical reflection in order to facilitate the expression of autonomy of the subject involved in research. The process of obtaining the IC must be accompanied by the administrative procedure for completing a consent form signed by both the participant and the researcher. If the participant cannot sign—either because he is a minor or because of the medical condition—a delegated consent signed by the legal representatives of the subject is required.