Research ethics and consent in the intensive care unit.
OBJECTIVE
The subject of research ethics and informed consent in the ICU has recently received unprecedented attention during the past year, the reasons for which are reviewed herein.


RESULTS
The controversy over research design and informed consent issues in studies conducted by the Acute Respiratory Distress Syndrome Network in the United States have been responsible for much of the attention on research ethics. So has the draft directive to create a harmonization of the provisions governing clinical trials within the European Union. These and other factors have prompted renewed interest in the proper design of clinical trials, the difficulty of obtaining informed consent for research from critically ill patients and their surrogates, conflicts of interest on the part of investigators and their institutions, the need for improving institutional protections for human subjects, and the desirability of clarifying the investigator-subject relationship.


CONCLUSIONS
Clinical trials should compare new therapies with "standard" ones if a standard of care exists. Surrogate consent is required for research involving most critically ill subjects, and state laws in the United States and national statutes in Europe should reflect this requirement. Conflicts of interest should be identified at both the individual and the institutional levels. Institutional review boards should focus on ethical issues after conflicts of interest are evaluated. Making the investigator-subject relationship transparent should help protect subjects.
Luce
John M
JM
Medical and Surgical Intensive Care Units, San Francisco General Hospital, University of California, San Francisco, California 94110, USA. john.luce@sfdph.org
D016265:Conflict of Interest; D003422:Critical Care / Q000941:ethics*; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D007362:Intensive Care Units / Q000941:ethics*; D012107:Research Design / Q000592:standards; D035844:Researcher-Subject Relations / Q000941:ethics; D012128:Respiratory Distress Syndrome / Q000628:therapy; D014481:United States; D037041:United States Government Agencies