A proposed consent process in studies that use an exception to informed consent.

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, single-blinded, 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.