A Proposed Consent Process in Studies that Use an Exception to Informed Consent

Abstract

Abstract. Federal regulations allow an exception to informed consent when it is not feasible to obtain informed consent in certain emergency research circumstances. A multicenter, randomized, singleblinded, normal saline procedure-controlled efficacy trial of diaspirin cross-linked hemoglobin (DCLHb) in acute traumatic hemorrhagic shock was conducted. The study intended to include 850 of the most severely injured trauma patients with hemorrhage and persistent hypoperfusion as demonstrated by vital signs suggestive of vascular collapse or a base deficit that signified prolonged hypoperfusion. It was anticipated that some patients would be unable to provide informed consent, and that identification and availability of some patients' legally authorized representatives (LARs) would be unlikely within the therapeutic window of the intervention. Each participating institution therefore developed a process to implement exception to informed consent. Each hospital's proposed process was reviewed by the institutional review board, the sponsor, the FDA, and the study's data monitoring committee chair. The goal was the development of local implementation processes by which the best interests of patients and their families could be fulfilled using prospective informed consent, the exception to informed consent, and consent to continue in emergency research, as appropriate for each individual patient. This paper describes the proposed implementation method developed for Cook County Hospital. It includes several important features, 1) prospective informed consent by the patient, when feasible; 2) the ability of the patient to decline participation, even when deemed incompetent to provide prospective informed consent; 3) prospective consent by the family/LAR, when feasible; 4) the use of a scripted abbreviated consent by the patient family/ LAR in life-threatening situations when it is possible only to briefly discuss the research being conducted; 5) independent approval for the use of the consent exception by a second physician immediately prior to patient enrollment; 6) the repeated use of consent to continue (both for the family/LAR and by the patient) when an exception to consent has been utilized; and 7) ongoing review of the informed consent process on a case-by-case basis by the institution's scientific review committee. The authors believe this proposed informed consent process maximizes the communication between investigators, patients and their proxies, and the institution's scientific review committee. Multiple mechanisms exist that allow for consent to be provided or declined, both prior to and after enrollment in the research protocol. The ongoing immediate review of the process allows for process enhancements to be made as needed.

Variation of community consultation and public disclosure for a pediatric multi-centered “Exception from Informed Consent” trial

“…14 Previous EFIC studies of adult subjects outline suggestions for community consultation and public disclosure. 12,13,21–35 It is interesting to note that adult survivors who were enrolled into EFIC trials, the medical community, and members of the general community are generally willing to take part in emergency medical research, even if they were unable to give consent. 13,21–25,35 People were more concerned, however, with the risks and benefits of the research rather than the absence of informed consent.…”

“…13,22,23,25 Some recommend that the amount of required community consultation or public disclosure activities should be based on the incremental risks of a study. 10,34,35 Although most EFIC studies have the potential to enroll anyone from the entire community, some studies are more likely to enroll patients with a particular risk factor and thus may be targeted.…”

Attitudes of Emergency Department Patients and Visitors Regarding Emergency Exception from Informed Consent in Resuscitation Research, Community Consultation, and Public Notification

“…We, therefore, thought is was important to study public opinion now that the regulations have been used in several studies. 16,20,[23][24][25][26] We asked five questions about willingness to participate in research without consent. These questions varied the circumstances to include research that involved both minimal risk and higher risk.…”

A qualitative study of institutional review board members’ experience reviewing research proposals using emergency exception from informed consent

“…20 21 On the other hand, several studies on adults have already successfully been carried out under the emergency exception to informed consent regulations. [22][23][24][25][26][27][28] Although the current rules are used more and more often to perform resuscitation research, protection of human subjects still remains the responsibility of every researcher and a primary purpose of the IRB. The experiences and beliefs of IRB members is one of the ways to increase understanding of the effectiveness of these rules.…”