An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent
An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent
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DOI：
10.1111/j.1553-2712.1999.tb00135.x
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发表时间：
1999-12-01
影响因子：
4.4
通讯作者：
Lewis, RJ
中科院分区：
文献类型：
--
作者：
Baren, JM;Anicetti, JP;Lewis, RJ
目标：1996年11月，食品和药物管理局（FDA）和卫生与人类服务部（DHHS）颁布了规则，允许在招收危重病人参加紧急治疗的临床研究时，对预期知情同意的要求有一个狭隘的例外。这些规则要求，在研究开始之前，适用的机构审查委员会（IRB）评估拟议的研究对研究所在社区成员的可接受性。具体来说，研究所必须进行社区咨询——在这个过程中，社区成员了解拟议的研究，并就其可接受性与调查人员或研究所代表交流他们的意见。FDA和DHHS的规则并没有定义进行社区咨询的具体可接受的方法。本研究的目的是证明执行这种社区咨询的一种拟议方法的可行性和效用。方法：要求在三家儿科急诊科就诊的儿童的父母参与一项关于知情同意的研究。征得同意后，指导员向家长描述苯妥英预防严重闭合性头部创伤儿童创伤后癫痫发作的前瞻性、随机、安慰剂对照试验。然后，所有的父母都被问及，如果他们的孩子遭受了这样的头部损伤，他们是否会同意让他们的孩子参加这项研究。家长们被进一步要求解释他们的回答的原因。结果：对227名儿童的家长进行了访谈（儿童平均+/- SD年龄8.0 +/- 4.8岁，男性占57%）。66%的家长（149/227）表示他们会同意孩子的参与。在149名同意的父母中，85%（126/149）认为对自己的孩子有潜在的好处，72%（107/149）认为对其他孩子有潜在的好处，60%（90/149）认为可以进一步提高医学知识。在78名不同意的父母（占总数的34%）中，54%（42/78）表示担心不良影响，39%（30/78）一般不希望他们的孩子成为研究对象，27%（21/78）认为他们需要与无法获得的家庭成员讨论参与，26%（20/78）表示除非他们处于实际情况，否则他们无法决定。研究发现，父母的种族和家庭收入会影响同意决定，而父母的性别、宗教、语言和教育水平与同意决定无关。结论：关于紧急研究方案的可接受性的社区咨询可以通过ED中的访谈技术获得。这种方法可以使研究人员获得目标社区的意见数据，以便IRE在审查建议放弃知情同意的紧急研究研究时进行考虑。
Objectives: In November 1996, the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) enacted rules allowing a narrow exception to the requirement for prospective informed consent when enrolling critically ill patients in clinical research studies of emergency treatments. These rules require that, prior to initiation of the study, the applicable institutional review board (IRB) assess the acceptability of the proposed research study to members of the community in which the research will be conducted. Specifically, the IRE must perform community consultation-a process during which community members learn about the proposed research and communicate their opinions regarding its acceptability to investigators or IRE representatives. The FDA and DHHS rules do not define specific acceptable methods for performing this community consultation. The objective of this study is to demonstrate the feasibility and utility of one proposed method for performing such community consultation. Methods: Parents of children being seen for minor traumatic injuries in three pediatric EDs were asked to participate in a study regarding informed consent. After consent, an instructor described to the parent a prospective, randomized, placebo-controlled trial of phenytoin for the prophylaxis of posttraumatic seizures in children with severe closed head trauma. All parents were then asked whether they would have consented for their own child's participation, if their child had suffered such head injury. The parents were further asked to explain the reason(s) for their responses. Results: Parents of 227 children (children's mean +/- SD age 8.0 +/- 4.8 years, 57% male) were interviewed. Sixty-six percent of parents (149/227) stated they would give consent for their child's participation. Of the 149 consenting parents, 85% (126/149) cited potential benefit to their child, 72% (107/149) cited potential benefit to other children, and 60% (90/149) cited furthering medical knowledge. Of the 78 nonconsenting parents (34% of total), 54% (42/78) cited fear of adverse effects, 39% (30/78) did not want their child to be a research subject in general, 27% (21/78) believed they needed to discuss participation with family members who were unavailable, and 26% (20/78) stated they were unable to decide unless they were in the actual situation. Parental ethnicity and household income were found to influence the consent decision, while the parent's gender, religion, language, and educational level were not associated with the consent decision. Conclusions: Community consultation regarding the acceptability of an emergency research protocol can be obtained via interview techniques in the ED. This methodology may allow investigators to obtain data on opinion from a targeted community for IRE consideration during the review of emergency research studies proposing a waiver of informed consent.