• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

在紧急研究中实施社区协商以豁免知情同意:一个机构审查委员会的经验

Implementation of community consultation for waiver of informed consent in emergency research: one Institutional Review Board's experience.

作者信息

Dix Emily S, Esposito Domenic, Spinosa Frances, Olson Nancy, Chapman Stanley

机构信息

Department of Preventive Medicine, University of Mississippi Medical Center, 2500 North State Street, Jackson, MI 39216-4505, USA.

出版信息

J Investig Med. 2004 Mar;52(2):113-6. doi: 10.1136/jim-52-02-20.

DOI:10.1136/jim-52-02-20
PMID:15068227
Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

摘要

背景

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。

方法

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。

结果

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。

结论

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。

相似文献

1
Implementation of community consultation for waiver of informed consent in emergency research: one Institutional Review Board's experience.在紧急研究中实施社区协商以豁免知情同意:一个机构审查委员会的经验
J Investig Med. 2004 Mar;52(2):113-6. doi: 10.1136/jim-52-02-20.
2
Waiver of informed consent for emergency research and community disclosures and consultations.紧急研究的知情同意书豁免以及社区披露与咨询
J Investig Med. 2004 Mar;52(2):109-12. doi: 10.1136/jim-52-02-19.
3
Exception from informed consent: viewpoint of institutional review boards--balancing risks to subjects, community consultation, and future directions.知情同意的例外情况:机构审查委员会的观点——平衡对受试者的风险、社区咨询及未来方向
Acad Emerg Med. 2005 Nov;12(11):1050-5. doi: 10.1197/j.aem.2005.06.015.
4
Emergency research: using exception from informed consent, evaluation of community consultations.紧急研究:使用知情同意豁免,评估社区咨询。
Acad Emerg Med. 2013 Jan;20(1):98-103. doi: 10.1111/acem.12039.
5
Toward ethical best practices in community consultation for research conducted with waiver of informed consent.在获得知情同意豁免的研究中,实现社区咨询的道德最佳实践。
Crit Care Med. 2008 Mar;36(3):993-4. doi: 10.1097/CCM.0B013E318164E9AC.
6
Community meetings for emergency research community consultation.用于紧急研究社区咨询的社区会议。
Crit Care Med. 2008 Mar;36(3):731-6. doi: 10.1097/01.CCM.OB013E318161FB82.
7
A qualitative study of institutional review board members' experience reviewing research proposals using emergency exception from informed consent.一项关于机构审查委员会成员使用知情同意紧急例外情况审查研究提案的经验的定性研究。
J Med Ethics. 2007 May;33(5):289-93. doi: 10.1136/jme.2005.014878.
8
Waiver of consent in noninterventional, observational emergency research: the PROMMTT experience.非干预性、观察性急诊研究中同意的豁免:PROMMTT 经验。
J Trauma Acute Care Surg. 2013 Jul;75(1 Suppl 1):S3-8. doi: 10.1097/TA.0b013e31828fa3a0.
9
Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience.利用知情同意的紧急例外情况进行研究:公众可及除颤(PAD)试验经验。
Resuscitation. 2004 Apr;61(1):29-36. doi: 10.1016/j.resuscitation.2003.11.016.
10
Ethical and regulatory challenges associated with the exception from informed consent requirements for emergency research: from experimental design to institutional review board approval.与紧急研究知情同意要求豁免相关的伦理和监管挑战:从实验设计到机构审查委员会批准。
Arch Surg. 2006 Oct;141(10):1019-23; discussion 1024. doi: 10.1001/archsurg.141.10.1019.

引用本文的文献

1
Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent.满足特殊需求:在紧急情况下使用免除知情同意的例外情况下进行研究的社区咨询和公开披露。
Acad Emerg Med. 2021 Oct;28(10):1183-1194. doi: 10.1111/acem.14264. Epub 2021 May 26.
2
Repurposing current therapeutics for treating COVID-19: A vital role of prescription records data mining.重新利用现有疗法治疗 COVID-19:挖掘处方记录数据的重要作用。
Drug Dev Res. 2020 Nov;81(7):777-781. doi: 10.1002/ddr.21689. Epub 2020 May 18.
3
A community consultation survey to evaluate support for and success of the IMMEDIATE trial.
社区咨询调查,评估 IMMEDIATE 试验的支持度和成功率。
Clin Trials. 2014 Apr;11(2):178-86. doi: 10.1177/1740774514526476.
4
Perceived challenges to obtaining informed consent for a time-sensitive emergency department study of pediatric status epilepticus: results of two focus groups.在一项针对小儿癫痫持续状态的急诊科时效性研究中,获取知情同意书所面临的感知挑战:两个焦点小组的结果
Acad Emerg Med. 2009 Aug;16(8):763-70. doi: 10.1111/j.1553-2712.2009.00455.x.
5
The random dialing survey as a tool for community consultation for research involving the emergency medicine exception from informed consent.随机拨号调查作为一种用于涉及急诊医学知情同意豁免研究的社区咨询工具。
Ann Emerg Med. 2009 Mar;53(3):341-50, 350.e1-2. doi: 10.1016/j.annemergmed.2008.07.021. Epub 2008 Sep 27.
6
A qualitative study of institutional review board members' experience reviewing research proposals using emergency exception from informed consent.一项关于机构审查委员会成员使用知情同意紧急例外情况审查研究提案的经验的定性研究。
J Med Ethics. 2007 May;33(5):289-93. doi: 10.1136/jme.2005.014878.
7
Ethical principles--emergency medicine.伦理原则——急诊医学
Emerg Med Clin North Am. 2006 Aug;24(3):513-45. doi: 10.1016/j.emc.2006.05.007.
8
Ethical goals of community consultation in research.研究中社区咨询的伦理目标。
Am J Public Health. 2005 Jul;95(7):1123-7. doi: 10.2105/AJPH.2004.058933. Epub 2005 Jun 16.