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How to protect incompetent clinical research subjects involved in critical care or emergency settings

This paper is available in a repository.
This paper is available in a repository.

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Preprint: policy unknown
Question mark in circle
Postprint: policy unknown
Question mark in circle
Published version: policy unknown

Abstract

Clinical research is an essential component of medical activity, even in intensive care. Adequate information and consent are universally considered necessary for the protection of research subjects. Yet, in emergency situations, the majority of critical patients are unable to consent and a legally acceptable representative is often unavailable. The situation is even more complex in Italy, as the relevant legislation fails to specify how investigators should manage research in the emergency or critical care setting when it involves incompetent patients who do not have an appointed legal representative. While special measures for the protection of incompetent subjects during emergency research are necessary, not allowing such research at all practically condemns critically ill patients to receive non-evidence based treatments without the prospect of improvement. The recently issued Regulation EU n. 536/2014 will probably help clarify the situation. Indeed, it specifically addresses the issue of "research in emergency situations" and introduces detailed rules aimed at protecting patients while allowing research. In this article, we argue that informed consent is unfeasible during emergency research on incompetent subjects and that substituted judgment by proxies carries major flaws in most cases. Strict criteria in evaluating the risk-benefit ratio of proposed intervention and a careful evaluation of the trial by a local or national Research Ethics Committee are perhaps the most workable solution.