Is Emergency Research Without Initial Consent Justified?

Abstract

Emergency research poses a fundamental ethical dilemma: prohibit valuable research because informed consent is not possible or enroll individuals in clinical trials without informed consent. Although emergency research without initial consent is allowable in the United States, its regulatory status remains uncertain internationally. More important, no ethical justification for emergency research without consent has been widely accepted. Whether emergency research without initial consent can be justified depends on whether the values that are secured by informed consent-respect for autonomy and protection of well-being-can be secured by other means. Analysis suggests that these values can be secured by the satisfaction of 5 conditions: (1) responsiveness (the experimental intervention must be responsive to an urgent medical need of the patients), (2) comparable risk-benefit ratio (the risk-benefit ratio of the experimental intervention is favorable, and at least as favorable as that of available alternatives and the control, if any), (3) no conflicting preferences (there is no compelling reason to think that participation in the research conflicts with enrolled patients' values or interests), (4) minimal net risks (nonbeneficial procedures included in the study cumulatively pose no greater than minimal risk), and (5) prompt consent (consent for ongoing and additional emergency research interventions is obtained as soon as possible). Together, these conditions constitute an ethical substitute for informed consent in emergency research-forming the consent substitute model.

ICU research: the impact of invasiveness on informed consent

“…This is in contradiction with some current rules that would allow a waiving of consent for observational studies [29]. The suggested requirement for dual consent in which one person should be the family or ICU doctor might be a solution regarding the exceptional and specific circumstances of emergencies [30,31]. Our results were also consistent with literature in which between 50 and 86 % of respondents accepted deferred consent [22,32,33].…”

Exploring ethical conflicts in emergency trauma research: The COMBAT (Control of Major Bleeding after Trauma) study experience

“…Despite heavy regulation surrounding ER-EIC, there is little guidance on how to conduct the CC/PD and no set goals to evaluate its effectiveness. The current report builds on the previous publication to expand the discussion of the ethical challenges while implementing the CC/PD and to provide an example of the CC/PD implementation and the application of the consent substitute model 10 for ER-EIC using the Control of Major Bleeding after Trauma (COMBAT) study as a model.…”

“…The consent substitute model (CSM) consists of five conditions which are essentially restatements of 21 CFR 50.24 stipulations with more emphasis on honoring patients’ values. 10 First, the experimental intervention must treat an urgent medical need in characteristically incapacitated patients. Second, the risk-benefit ratio of the experimental interventions must be comparable to standard emergency care of the patients’ medical needs.…”

Uninformed refusals: objections to enrolment in clinical trials conducted under an Exception from Informed Consent for emergency research

“…If these conditions apply, there are unlikely to be strong reasons why most patients would object to enrolment. In a comprehensive analysis of the ethical justification for EFIC, Largent et al argue more explicitly that an important condition is that ‘there is no compelling reason to think that participation in research conflicts with enrolled patients’ values or interests.’12 This condition, we believe, offers instructive guidance regarding how objections should be approached. The additional protections in the EFIC regulations help to ensure that approvable trials are ones to which most patients are unlikely to object.…”