A response to 'Consent for observational studies in critical care: time to open Pandora's box', Reade MC, Young JD, Anaesthesia 2003; 58: 1-3.

Abstract

We read with interest the recent editorial discussing the problem of informed consent for critically ill patients (Reade & Young, Anaesthesia 2003; 58: 1–3). We applaud the authors' efforts to bring this problem into the open for discussion, but would draw attention to the issue of removal of the need for consent for the critically ill. Reade and Young describe the differences between Europe, the United States and the United Kingdom, pointing out that while valid in the first two, consent by proxy has no standing in law in the UK. This is the overwhelming mechanism by which subjects' rights are protected during clinical trials in our ICU. At our institution, any prospective research study (in patients or volunteers) requires written informed consent, from either the subject or their next of kin. Any retrospective study (including chart reviews) requires either written informed consent or a waiver from the Institutional Review Board (IRB). Further, the IRB will only grant a waiver if the research cannot otherwise feasibly be carried out. Laboratory research on human blood or tissues always requires an IRB approved protocol, and may also require written consent if the specimen has not yet been obtained. Prospective sample banking for later study also requires written informed consent. The authors give the impression that the majority of research samples in critically ill patients in the US are obtained without consent (solution 4, p. 3, col. 1) after surveillance committee review. This is not the case. In fact, there have been several well-publicised cases in the United States involving perceived breaches in informed consent; these were summarised and reported in a networked documentary television programme. We would like to re-assure Drs Reade and Young that informed consent is very much required here, but would agree with them that the availability of the instrument of consent by proxy certainly makes it easier to recruit subjects into critical care research.