title: Intensive care unit research ethics and trials on unconscious patients.
abstract: There are widely acknowledged ethical issues in enrolling unconscious patients in research trials, particularly in intensive care unit (ICU) settings. An analysis of those issues shows that, by and large, patients are better served in units where research is actively taking place for several reasons: i) they do not fall prey to therapeutic prejudices without clear evidential support, ii) they get a chance of accessing new and potentially beneficial treatments, iii) a climate of careful monitoring of patients and their clinical progress is necessary for good clinical research and affects the care of all patients and iv) even those not in the treatment arm of a trial of a new intervention must receive best current standard care (according to international evidence-based treatment guidelines). Given that we have discovered a number of 'best practice' regimens of care that do not optimise outcomes in ICU settings, it is of great benefit to all patients (including those participating in research) that we are constantly updating and evaluating what we do. Therefore, the practice of ICU-based clinical research on patients, many of whom cannot give prospective informed consent, ticks all the ethical boxes and ought to be encouraged in our health system. It is very important that the evaluation of protocols for ICU research should not overlook obvious (albeit probabilistic) benefits to patients and the acceptability of responsible clinicians entering patients into well-designed trials, even though the ICU setting does not and cannot conform to typical informed consent procedures and requirements.
authors.affiliation: Dunedin Hospital and Otago Bioethics Centre, University of Otago, Dunedin, New Zealand.
authors.forename: G R
authors.initials: GR
authors.lastname: Gillett
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000379:methods; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods; D003422:Critical Care / Q000941:ethics / Q000379:methods; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D007362:Intensive Care Units / Q000941:ethics*; D014474:Unconsciousness
keywords: clinical research; consent; ethics; incompetent patients