Ethical considerations of ensuring an informed and autonomous consent in research involving critically ill patients.

Despite several codes of research ethics, the issuance of comprehensive rules regarding informed consent by governmental agencies, and numerous writings on the subject of informed consent, many commentators still question the quality of the informed consent process in clinical research. A major concern is that investigators emphasize only the information-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 autonomous as well. This article aims to examine the issues involved with 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 respectful of autonomous decision making will also be discussed.