Dix Emily S, Esposito Domenic, Spinosa Frances, Olson Nancy, Chapman Stanley
Department of Preventive Medicine, University of Mississippi Medical Center, 2500 North State Street, Jackson, MI 39216-4505, USA.
J Investig Med. 2004 Mar;52(2):113-6. doi: 10.1136/jim-52-02-20.
This article describes how one Institutional Review Board (IRB) chose to implement the issue of waiver of consent for a research study involving brain trauma victims brought to an emergency department.
Presentations were conducted in the state of Mississippi among cultural and ethnic groups representative of Mississippi's demographic composition. Individuals from the neurotrauma research team, including neurosurgeons and nurse study coordinators, conducted all of the presentations. One IRB member served as an objective "community liaison" and attended all presentations. This individual administered evaluation forms to attendees that measured their levels of comprehension and acceptance for the use of waiver of consent in the brain trauma study.
All of the 137 attendees in 7 community consultation meetings gave their approval for the use of "waiver of consent." Continued community consultations are planned for the duration of the brain trauma study.
Based on our experience, we conclude that in collaborating with local IRBs, research teams can successfully develop strategies for obtaining "acceptable community consultations" as required by regulatory mandates. We suggest that standardized community consultation guidelines be developed for obtaining waivers of informed consent in emergency research. Such criteria should form the basis for local IRBs to obtain their respective community consultations.
本文描述了一个机构审查委员会(IRB)如何选择在一项涉及送往急诊科的脑外伤受害者的研究中实施同意书豁免问题。
在密西西比州向代表该州人口构成的文化和种族群体进行了介绍。神经创伤研究团队的成员,包括神经外科医生和护士研究协调员,进行了所有的介绍。一名IRB成员担任客观的“社区联络人”并参加了所有介绍。该人员向与会者发放评估表格,以衡量他们对在脑外伤研究中使用同意书豁免的理解程度和接受程度。
7次社区咨询会议的137名与会者全部批准使用“同意书豁免”。计划在脑外伤研究期间持续进行社区咨询。
基于我们的经验,我们得出结论,在与当地IRB合作时,研究团队可以成功制定策略,以获得监管要求的“可接受的社区咨询”。我们建议制定标准化的社区咨询指南,以便在紧急研究中获得知情同意书的豁免。此类标准应成为当地IRB进行各自社区咨询的基础。