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 f easible to obtain informed consent in certain emergency research circumstan ces. A multicenter, randomized, single-blinded, normal saline procedure-con trolled efficacy trial of diaspirin cross-linked hemoglobin (DCLHb) in acut e traumatic hemorrhagic shock was conducted. The study-intended to include 850 of the most severely injured trauma patients with hemorrhage and persis tent hypoperfusion as demonstrated by vital signs suggestive of vascular co llapse or a base deficit that signified prolonged hypoperfusion. It was ant icipated that some patients would be unable to provide informed consent, an d 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 proc ess to implement exception to informed consent. Each hospital's proposed pr ocess was reviewed by the institutional review board, the sponsor, the FDA, and the study's data monitoring committee chair. The goal was the developm ent of local implementation processes by which the best interests of patien ts and their families could be fulfilled using prospective informed consent , the exception to informed consent, and consent to continue in emergency r esearch, as appropriate for each individual patient. This paper describes t he proposed: implementation method developed for Cook County Hospital. It i ncludes several important features, 1) prospective informed consent by the patient, when feasible; 2) the ability of the patient to decline participat ion, even when deemed incompetent to provide prospective informed consent; 3) prospective consent by the family/LAR, when feasible; 4) the use of a sc ripted abbreviated consent by the patient family/ LAR in life-threatening s ituations when it is possible only to briefly discuss the research being co nducted; 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) whe n an exception to consent has been utilized; and 7) ongoing review of the i nformed consent process on a case-by-case basis by the institution's scient ific review committee. The authors believe this proposed informed consent p rocess maximizes the communication between investigators, patients and thei r proxies, and the institution's scientific review committee. Multiple mech anisms exist that allow for consent to be provided: or declined, both prior to and after enrollment in the research protocol. The ongoing immediate re view of the process allows for process enhancements to be made as needed.