Department of Neurology, University of Pennsylvania, 3400Spruce St., Philadelphia, PA 19104, USA.
Ann Emerg Med. 2011 Apr;57(4):346-354.e6. doi: 10.1016/j.annemergmed.2010.07.009. Epub 2010 Sep 27.
We improve our understanding of the community consultation process for acute neurologic emergency trials conducted under the federal regulations for Exception From Informed Consent (EFIC) for emergency research.
We performed a qualitative study using focus groups to collect data from patients with a previous stroke or brain injury and their families and from young men at risk for traumatic brain injury. Discussions were transcribed, coded, and analyzed for major themes and subthemes.
Five focus groups, involving 40 participants, were convened. Major themes included the awareness and understanding of key clinical trial concepts, including prominent concerns about placebo and therapeutic misconception; inability to obtain informed consent and acceptable surrogate decision-making; EFIC in emergency research and whether existing regulations are acceptable; specific trial design problems, including comparison to standard of care versus 2 competing active therapies; and community consultation and representation.
In this study sample, EFIC trials were deemed appropriate and acceptable for acute neurologic emergency research. Education, along with open discussion about basic clinical research concepts, disease- and trial-specific information, and potential surrogate decision-making, was essential to determine the acceptability of an EFIC trial. Approval by institutional review boards was highly regarded as a means of human protection and effective community consultation for such trials. A data repository of information gained from similar qualitative research may help investigators and regulators who wish to plan, conduct, review, and provide oversight for acute neurologic emergency trials under EFIC regulations.
我们通过联邦法规下的紧急研究豁免知情同意（EFIC）来提高对急性神经急症试验社区咨询过程的理解，这些法规适用于紧急情况。
我们采用焦点小组的定性研究方法，从有既往中风或脑损伤的患者及其家属，以及有外伤性脑损伤风险的年轻男性中收集数据。对讨论内容进行转录、编码和分析，以提取主要主题和次要主题。
共召集了五组焦点小组，涉及 40 名参与者。主要主题包括对关键临床试验概念的认识和理解，包括对安慰剂和治疗误解的明显关注；无法获得知情同意和可接受的替代决策；紧急研究中的 EFIC，以及现有的法规是否可以接受；特定的试验设计问题，包括与标准护理的比较与 2 种竞争的积极治疗方法；社区咨询和代表性。
在本研究样本中，EFIC 试验被认为适用于急性神经急症研究，并且是可以接受的。教育，以及对基本临床研究概念、疾病和试验特定信息以及潜在替代决策的公开讨论，对于确定 EFIC 试验的可接受性至关重要。机构审查委员会的批准被视为保护人类和有效进行此类试验社区咨询的一种手段。从类似的定性研究中获得的信息数据库可能有助于计划、进行、审查和监督 EFIC 法规下的急性神经急症试验的研究人员和监管者。
