Abstract PR004

Abstract

Background & Objectives: Critically ill patients in the Intensive Care Unit (ICU) often lose their capacity for legal consent during part or all of their stay there, posing serious difficulties for enrolment in research into therapies which may improve their outcome. Although the insistence of strict consent requirements originates from the need to protect these vulnerable patients from possible exploitation, the unintended result might well be that of an impoverished evidence base from which to direct therapy. Can alternative approaches to consent balance the need for protection from exploitation with sufficient leeway to allow participation in therapeutic research which can expand the evidence base for Intensive Care medicine? Materials & Methods: Alternative approaches were identified from published studies in the Intensive Care field, proposals for advanced or proxy decision making for the mentally incapacitated and traditional bedside approaches. They are assessed with regard to autonomy, beneficence and non-maleficence of the four principles approach. Additional consideration is given to cultural context, conflict of interest of stakeholders, etc. Results: Traditionally the family is often involved on an everyday clinical basis. However, that completely disregards the autonomy of the patient, and the possibility of conflict of interest also exists. Often this approach is not formalized and considerable variation may occur. However, in countries and regions with a strong Confucian background (such as Japan and Korea), this approach is culturally acceptable and appropriate. Advanced medical directives and living wills appointing proxy decision makers are common approaches to the problem of decision-making for the mentally incapacitated patient, but are usually applied to therapeutic interventions rather than therapeutic research. There is acknowledgement of patient autonomy, but the possibility of conflict of interests always exists where a proxy is involved. The 2006 report of the Hong Kong Law Reform Commission noted that England and Scotland had made proposals regarding the regulation of medical research in mentally incapacitated persons, but it was also obvious that this was not common amongst the other jurisdictions reviewed. Delayed consent was used in the Australian SAFE study on the use of albumin in Intensive Care. Element of presumed consent somewhat disregards autonomy of the patient. Presumed consent would expose patient to risks before chance to refuse was presented. Conclusion: The approaches evaluated present few definitive advantages as they stand at present. In areas with a large Confucian influence, approaching the family might be a culturally appropriate way forward. Advance medical directives and living wills with proxy decisions makers can offer a way forward if further development on its application to therapeutic medical research in further undertaken. Disclosure of Interest: None declared