Challenges in the conduct of emergency research in children: A workshop report
Challenges in the conduct of emergency research in children: A workshop report
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DOI：
10.1080/15265160600939284
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发表时间：
2006-11-01
影响因子：
13.4
通讯作者：
Nelson, Robert M.
中科院分区：
文献类型：
--
作者：
Nelson, Robert M.
A workshop on “Emergency Research in Children: Ethical, Regulatory, and Clinical Challenges” was sponsored by the National Institute of Child Health and Human Development, National Institutes of Health, and held on January 12 to 13, 2006, in Bethesda, MD. The purpose of the workshop was to identify issues and concerns with the conduct of research involving children under the emergency exception from informed consent (EFIC) allowed under United States Food and Drug Adiminstration (FDA) and Department of Health and Human Services (DHHS) regulations. Invited participants included investigators, ethicists, and local institutional review board (IRB) members. The workshop was not designed to achieve nor reach consensus among the workshop participants, nor was it intended to provide advice to any branch of the federal government. Federal officials were present at the meeting as observers and provided information on policies or regulations as needed. This report was prepared from the minutes of the meeting; however, it represents only the views of this author.The meeting was arranged as a focused discussion around five general topics: 1) subject eligibility; 2) study design; 3) consent; 4) communication; and 5) implementation. Following an introductory “Review of the Ethical and Regulatory History of the Current EFIC Regulation,” each topic (and related questions) was afforded up to 2 hours of group discussion. Each topic included one or more questions to stimulate discussion. The following sections are arranged according to the five general topics, starting with the initial question (s), a summary of the discussion, and one or two concluding remarks by this author.
