Baren Jill M, Nathanson Pam G
Department of Emergency Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
Acad Emerg Med. 2005 Nov;12(11):1027-30. doi: 10.1197/j.aem.2005.06.014.
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.
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。