The Ethical Concerns of Seeking Consent from Critically Ill, Mechanically Ventilated Patients for Research - A Matter of Possessing Capacity or Surrogate Insight.

Conducting clinical research on subjects admitted to intensive care units is challenging as they frequently lack the capacity to provide informed consent due to multiple factors including ICU acquired delirium, coma, the need for sedation, or underlying critical illness. However, the presence of one or more of these characteristics does not automatically designate a potential subject as lacking capacity to provide their own informed consent. We review the ethical issues involved in obtaining informed consent for medical research from mechanically ventilated, critically ill patients, in addition to the concerns that may arise when a legally authorized representative is asked to provide informed consent on behalf of these patients.