ETHICAL CONSIDERATIONS OF ENSURING AN INFORMED AND AUTONOMOUS CONSENTIN RESEARCH INVOLVING CRITICALLY ILL PATIENTS

Despite several codes of research ethics, the issuance of comprehensiv e rules regarding informed consent by governmental agencies, and numer ous writings on the subject of informed consent, many commentators sti ll question the quality of the informed consent process in clinical re search. A major concern is that investigators emphasize only the infor mation-giving aspect of ''informed'' consent, whereas moral philosophy stresses a more robust concept of informed consent that incorporates the additional requirements of subject competence and voluntariness of the consent, thus ensuring that a consent is not only informed, but a utonomous as well. This article aims to examine the issues involved wi th disclosure, competence, and voluntariness, especially those related to research involving critically ill patients. Suggestions concerning methods that can promote an informed consent process that is more res pectful of autonomous decision making will also be discussed.