Kipnis Ken, King Nancy M P, Nelson Robert M
University of Hawaii, Manoa, USA.
Am J Bioeth. 2006 May-Jun;6(3):18-21. doi: 10.1080/15265160600685580.
At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme and saline in the field and, still without consent, randomized between PolyHeme and blood after arrival at an emergency department. The Federal regulations that govern the waiver of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood-the standard treatment for hemorrhagic shock-is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards.
在撰写本文时，一项广泛宣传的免知情同意试验正在进行。该试验由诺斯菲尔德实验室公司（伊利诺伊州埃文斯顿）赞助，旨在评估聚血（PolyHeme）的紧急使用情况，聚血是一种携氧复苏液，可能预防因失控性出血导致的死亡。该方案允许出血性休克患者在现场被随机分配接受聚血或生理盐水治疗，并且在未经同意的情况下，到达急诊科后再被随机分配接受聚血或血液治疗。管理免知情同意的联邦法规将其适用范围限制在没有经过验证的、令人满意的治疗方法的情况下。出血性休克的标准治疗方法——血液，在救护车上没有，但在医院里有。作者认为该研究的住院阶段不符合伦理和监管标准。
