Am. J. Respir. Crit. Care Med., Vol 154, No. 3, 09 1996, 582-586.
Ethical considerations of ensuring an informed and autonomous consent in research involving critically ill patients
HJ Silverman
Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.
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.