title: Ethical considerations in consenting critically ill patients for bedside clinical care and research.
abstract: Care of critically ill patients, as in any other field, demands the exercise of ethical principles related to respect of patient's autonomy, beneficence, nonmaleficence, and distributive justice. Professional duty and the common law require doctors to obtain consent before giving treatment or for requesting participation in clinical research. A procedure or research study must be adequately explained, and the patient must have the capacity to consent. If a patient does not have decision-making capacity, treatment must be given using alternative forms of consent or using principles of implied consent in emergency or life-threatening situations. In the case of clinical research, informed consent must always be sought. Exemptions to this rule are morally justified in circumstances related to research in life-threatening conditions or life-saving interventions in which the investigator departs from sound principles of equipoise. This usually implies the imposition of safeguards such as consultation with the community in which the study were to take place, oversight in patient screening and recruitment process by institutional review boards, special study designs, retrospective and prospective consent processes, and independent safety monitoring.
authors.affiliation: Divisions of Critical Care and Neurotrauma, Department of Neurology and Neurosurgery, Thomas Jefferson University, Philadelphia, PA, USA fred.rincon@jefferson.edu.
authors.forename: Fred
authors.initials: F
authors.lastname: Rincon
authors.affiliation: Department of Neurology and Neurosurgery, The Mischer Neuroscience Institute, Memorial Hermann of Texas Medical Center, Houston, TX, USA.
authors.forename: Kiwon
authors.initials: K
authors.lastname: Lee
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D003422:Critical Care / Q000941:ethics*; D016638:Critical Illness / Q000523:psychology*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D016743:Mental Competency; D020458:Third-Party Consent / Q000941:ethics
keywords: decisional capacity; informed consent; surrogate