Biros M H, Lewis R J, Olson C M, Runge J W, Cummins R O, Fost N
Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN 55415, USA.
JAMA. 1995 Apr 26;273(16):1283-7. doi: 10.1001/jama.273.16.1283.
A coalition conference of acute resuscitation researchers was held to discuss the feasibility of applying current federal research regulations regarding informed consent to the emergency setting. This article presents consensus recommendations for regulatory changes for consent in emergency research.
Representatives from the Society for Academic Emergency Medicine and the American Heart Association identified several professional organizations as stakeholders in this issue, including research, clinical, bioethics, legal, and patient advocacy groups. The Office for Protection From Research Risks (OPRR), the Food And Drug Administration (FDA), and staff from specific legislative offices were also invited to observe. Forty-three participants attended, including representatives from 12 professional organizations, five medical institutions, and the FDA and OPRR. This was a closed meeting. Participants were self-funded or sponsored by their professional organizations.
Before the meeting, a draft of a position statement was developed by the conference organizers based on the current literature and discussions with experts in the field. This draft, copies of the current federal research regulations, and supporting articles were distributed before the conference.
Participants rotated through moderated discussion sessions to comment on subsections of the draft. Following discussion, a working draft was developed and distributed to each participant and represented organizational board for final review. All comments were considered in the final version of the document.
We believe there are circumstances when it is not feasible to obtain prospective or proxy consent for enrollment into an emergency research protocol. In these circumstances, patients are vulnerable, not only to research risks, but also to being denied potentially beneficial therapy when there is no known effective treatment for their life-threatening condition. We offer recommendations that should be met when the critical nature of the illness or injury or the need to apply an investigational therapy rapidly precludes prospective consent for participation in emergency research.
召开了一次急性复苏研究人员联盟会议，以讨论将现行联邦关于知情同意的研究法规应用于紧急情况的可行性。本文提出了紧急研究中同意相关监管变更的共识性建议。
学术急诊医学协会和美国心脏协会的代表确定了几个专业组织作为此问题的利益相关者，包括研究、临床、生物伦理、法律和患者权益倡导团体。还邀请了保护研究风险办公室（OPRR）、食品药品监督管理局（FDA）以及特定立法办公室的工作人员进行观察。43名参与者出席，包括来自12个专业组织、5家医疗机构以及FDA和OPRR的代表。这是一次闭门会议。参与者由自己或其专业组织资助。
会议前，会议组织者根据当前文献以及与该领域专家的讨论制定了一份立场声明草案。该草案、现行联邦研究法规副本以及支持性文章在会议前进行了分发。
参与者轮流参加主持的讨论会议，对草案的各小节发表评论。讨论之后，形成了一份工作草案并分发给每位参与者以及代表组织的委员会进行最终审核。文件的最终版本考虑了所有评论。
我们认为，在某些情况下，获得前瞻性或代理同意以纳入紧急研究方案是不可行的。在这些情况下，患者很脆弱，不仅面临研究风险，而且在其危及生命的状况尚无已知有效治疗方法时，还可能被拒绝接受可能有益的治疗。我们提出了一些建议，当疾病或损伤的危急性质或迅速应用研究性治疗的需求排除了参与紧急研究的前瞻性同意时，应满足这些建议。
