Consent in emergency clinical research

Abstract

The need for medical research involving critically ill patients with severe neurosurgical conditions is self-evident. Clinical trials in emergency and critical care settings frequently involve patients with acute catastrophic cerebral conditions causing loss of decision-making capacity and facing very short time frames. Examples of such conditions are severe traumatic brain injury, subarachnoid hemorrhage, and spontaneous intracerebral hemorrhage. All clinical trials are subject to the ethical and juridical principles of good clinical practice and international and national guidelines and regulations. The most important ethical principle underlying clinical trials is the respect for autonomy. Furthermore, protection against discomfort, harm, risk, and exploitation and the prospect of potential benefit are essential. In this chapter the ethical dimensions of consent for clinical trials in severely incapacitated individuals are discussed with focus on different models of surrogate or proxy consent. This chapter has some overlap with Chaps. 5 and 16.