The inability to consent in critical care research: emergency or impairment of cognitive function?

Excerpt

Obtaining consent for participation in a research trial from people who cannot consent has always been the nightmare of clinician–researchers working in intensive care units (ICUs) – not to mention the lawmakers. In this issue of Intensive Care Medicine, Dr Sheila Harvey and colleagues have addressed this topic from a UK perspective [1]. From data collected during the PAC-man study they published earlier [2], they demonstrate how frequently this actually happens: out of the 498 patients they included, only 13 (2.6%) were able to consent! Their study was designed in such a way that they could further assess the process of surrogate consent. Indeed, their conclusions are important: assent granted by relatives was obtained in 81% of 485 incompetent patients. Relatives could not be identified in only 18 patients. These figures are even better than those (8%) provided in 34 French ICUs by Elie Azoulay et al. [3]. When survivors were asked later to re-consent, 93% of them (175) accepted, with only six refusals. This is good news, which certainly will consolidate the views and arguments of those who plead for the feasibility and legitimacy of proxy consent/assent in the realm of human research. Another fascinating piece of information in this paper is the way the consent process, as implemented in the UK, is dissected and controlled step by step: the chain of possibilities starts from the patient's consent, when possible, which, as showed in the study is rare; if not, relatives', when available; if not, inclusion of the patient in the trial; then, relatives' assent, when/if they show up; if patient regains ultimately mental competency, his consent is requested; if he dies or never regains consciousness, authorization to use the data is required from a central national ethics board (MREC). …