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参与2005年美国急诊医学学会复苏研究伦理行为共识会议的招募与沟通流程:方法、挑战及经验教训

Recruitment and communication process for participation in the 2005 AEM Consensus Conference on the Ethical Conduct of Resuscitation Research: methodology, challenges, lessons learned.

作者信息

Baren Jill M, Nathanson Pam G

机构信息

Department of Emergency Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.

出版信息

Acad Emerg Med. 2005 Nov;12(11):1027-30. doi: 10.1197/j.aem.2005.06.014.

DOI:10.1197/j.aem.2005.06.014
PMID:16264069
Abstract

The 2005 Academic Emergency Medicine Consensus Conference, "Ethical Conduct of Resuscitation Research," was designed with the goal of developing consensus on important issues for human subjects and researchers surrounding the 1996 federal regulations jointly published by the Department of Health and Human Services and the Food and Drug Administration and known as the Final Rule. These regulations, which guide the conduct of research using the emergency exception from informed consent or waiver of informed consent, have been the subject of much debate in the resuscitation research community. Therefore, the editorial board of Academic Emergency Medicine chose this topic as the subject of their annual consensus conference. This report outlines the methods by which individuals and organizations were recruited to participate, how the conference was advertised, and the way in which participants and nonparticipants were encouraged to communicate before and after the conference. The limitations and potential biases of these methods and activities are also presented.

摘要

2005年学术急诊医学共识会议“复苏研究的道德行为”旨在就与人类受试者及研究人员相关的重要问题达成共识,这些问题围绕着美国卫生与公众服务部和食品药品监督管理局于1996年联合发布的联邦法规(即《最终规则》)。这些法规指导着利用紧急情况下无需知情同意或放弃知情同意的例外情况进行的研究行为,一直是复苏研究界诸多争论的主题。因此,《学术急诊医学》编辑委员会选择该主题作为其年度共识会议的议题。本报告概述了招募个人和组织参与的方法、会议的宣传方式,以及鼓励参会者和未参会者在会议前后进行交流的方式。同时也介绍了这些方法和活动的局限性及潜在偏差。

相似文献

1
Recruitment and communication process for participation in the 2005 AEM Consensus Conference on the Ethical Conduct of Resuscitation Research: methodology, challenges, lessons learned.参与2005年美国急诊医学学会复苏研究伦理行为共识会议的招募与沟通流程:方法、挑战及经验教训
Acad Emerg Med. 2005 Nov;12(11):1027-30. doi: 10.1197/j.aem.2005.06.014.
2
Using the exception from informed consent regulations in research.在研究中使用知情同意法规的例外情况。
Acad Emerg Med. 2005 Nov;12(11):1031-9. doi: 10.1197/j.aem.2005.06.021.
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Communicating with subjects: special challenges for resuscitation research.与受试者沟通:复苏研究面临的特殊挑战。
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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
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Resuscitation research involving vulnerable populations: are additional protections needed for emergency exception from informed consent?涉及弱势群体的复苏研究:紧急情况下豁免知情同意是否需要额外保护?
Acad Emerg Med. 2005 Nov;12(11):1071-7. doi: 10.1197/j.aem.2005.06.020.
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Researchers' understanding of the federal guidelines for waiver of and exception from informed consent.研究人员对联邦关于知情同意书豁免与例外的指导方针的理解。
Acad Emerg Med. 2005 Nov;12(11):1045-9. doi: 10.1197/j.aem.2005.06.013.
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The International Liaison Committee on Resuscitation (ILCOR) consensus on science with treatment recommendations for pediatric and neonatal patients: pediatric basic and advanced life support.国际复苏联合委员会(ILCOR)关于儿科和新生儿患者的科学共识及治疗建议:儿科基础与高级生命支持
Pediatrics. 2006 May;117(5):e955-77. doi: 10.1542/peds.2006-0206. Epub 2006 Apr 17.
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Executive summary: the 2005 AEM Consensus Conference on Ethical Conduct of Resuscitation Research.执行摘要:2005年美国急诊医学学会复苏研究伦理行为共识会议
Acad Emerg Med. 2005 Nov;12(11):1017-8. doi: 10.1197/j.aem.2005.06.016.
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Confronting the Ethical Conduct of Resuscitation Research: a consensus opinion.直面复苏研究的伦理行为:共识意见
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Research conditions that qualify for emergency exception from informed consent.符合知情同意紧急例外情况的研究条件。
Acad Emerg Med. 2005 Nov;12(11):1040-4. doi: 10.1197/j.aem.2005.06.022.

引用本文的文献

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Exceptions to the rule of informed consent for research with an intervention.针对有干预措施的研究的知情同意规则的例外情况。
BMC Med Ethics. 2016 Feb 6;17:9. doi: 10.1186/s12910-016-0092-6.
2
Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting.以患者为中心开展具有挑战性的研究:一项为儿科急诊护理环境中的随机对照试验提供信息的定性研究。
BMJ Open. 2014 May 15;4(5):e005045. doi: 10.1136/bmjopen-2014-005045.
3
How experience makes a difference: practitioners' views on the use of deferred consent in paediatric and neonatal emergency care trials.
经验如何产生差异:从业者对在儿科和新生儿急救护理试验中使用延期同意的看法。
BMC Med Ethics. 2013 Nov 6;14:45. doi: 10.1186/1472-6939-14-45.
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Use of deferred consent for severely ill children in a multi-centre phase III trial.多中心 III 期临床试验中对重病儿童使用延期同意。
Trials. 2011 Mar 31;12:90. doi: 10.1186/1745-6215-12-90.