University of Hawaii at Manoa, USA.
Am J Bioeth. 2010 Oct;10(10):5-8. doi: 10.1080/15265161.2010.519230.
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，一项广为宣传的豁免知情同意试验正在进行。该试验由 Northfield Laboratories, Inc.（伊利诺伊州埃文斯顿）赞助，旨在评估 PolyHeme®（一种携氧复苏液）的紧急使用，以防止因无法控制的出血而导致死亡。该方案允许在现场对失血性休克患者进行 PolyHeme®与生理盐水之间的随机分组，并且在到达急诊科后，仍无需征得同意，即可在 PolyHeme®与血液之间进行随机分组。管理豁免知情同意的联邦法规将其适用范围限制在无法获得已证实的满意治疗的情况下。血液是失血性休克的标准治疗方法，但在救护车上无法获得，而在医院可以获得。作者认为，研究的院内阶段不符合伦理和监管标准。
