ABSTRACT

Background Few people would disagree with the need to conduct acute clinical research to develop and improve methods of treating patients admitted to hospital with life-threatening and debilitating conditions. In these circumstances obtaining informed consent can be problematic. Patients may initially be unconscious, in shock or have some cognitive impairment, and if the study intervention has a short therapeutic window there is little time to locate a proxy for consent. It follows, therefore, that for research of this kind to proceed with patients who have impaired decisionmaking capacity, in some patients it must do so without their consent. This illustrates the key ethical dilemma of allowing acute research in which society as a whole will benefit, whilst maintaining respect for the individuals who contribute to that research[l]. Given the turn towards greater patient and public involvement in health care decisions [2] following the events of the 20th century relating to human subject research, research without consent clearly raises concerns about unethical practices [3-5] and the loss of individual autonomy[6] that is "respect for the patient's capacity of self-determination, and exercise of personal choice" [7]. The subject of considerable debate among researchers, medical ethicists and philosophers for a number of years, the overriding objection to waiving individual informed consent is that it erodes patient autonomy. However, some point out autonomy is not the sole applicable ethical principle and those involved in research have a duty - in respect to the principle of justice - to develop potentially beneficial therapies that are available to all populations[8,9]. Others have questioned the equity of excluding patients where individual or proxy consent is not possible and denying them the right to participate and to any potential benefits[10,11]. Opinion regarding informed consent ranges from the view that (in certain circumstances) the process is 'needlessly cruel'[12] and violates the principle of beneficence for some patients[13], to concerns that it should always be obtained[14,15] and permitting waiver of consent is a slippery slope toward unethical practices[16]. At the same time, emergency researchers are frustrated by a somewhat paradoxical situation where physicians are free to prescribe, without ethical approval, a medication for their own patients that has not been tested scientifically with that particular medical condition [17-20].