Informed consent of incapable (ICU) patients in Europe: existing laws and the EU Directive

Abstract

The new European legislation on good clinical practice in the conduct of clinical trials on drugs has raised serious concern that potentially lifesaving studies cannot be carried out in critically ill patients in Europe anymore after May 2004. The requirement of nominating a legal representative for obtaining informed consent before inclusion will deprive current and future patients of participation in research. The new legislation does not differentiate between patients who are incompetent because of a psychiatric illness or dementia and patients who are incapacitated owing to an emergency situation. All those patients may be enrolled in a clinical trial only after informed consent has been granted by a legal representative. Recent publications regarding the new European legislation manifest an outcry by intensive care specialists, emergency medicine specialists, traumatologists, and specialists of other related disciplines concerned about the proposed active withholding of potentially beneficial therapies for this very unfortunate group of patients. Many authors, although acknowledging the ethical principle of autonomy, express that in the field of emergency medicine not all criteria of autonomy may be met. The Declaration of Helsinki requires that even the best prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research. There is agreement among the authors that critically ill patients should not be deprived from the benefits of research. Many groundbreaking therapies will not be scientifically evaluated anymore, and thus beneficial treatments in fatal diseases will be prevented. The European legislation is asked to adapt the Directive to promote research in critically ill patients.