Exception from informed consent for emergency research: Consulting the trauma community
Exception from informed consent for emergency research: Consulting the trauma community
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DOI：
10.1097/ta.0b013e318278908a
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发表时间：
2013-01-01
影响因子：
3.4
通讯作者：
Reilly, Patrick
中科院分区：
文献类型：
--
作者：
Sims, Carrie A.;Isserman, Joshua A.;Reilly, Patrick
背景：研究不稳定创伤患者的复苏和管理对于改善护理和挽救生命是必要的。由于在紧急情况下不可能获得研究的知情同意，联邦药品管理局制定了知情同意例外（EFIC）政策，要求“社区咨询”作为保护患者自主权的一种手段。我们假设创伤性疾病代表了一个异质性人群，他们对EFIC的态度和参与紧急研究的意愿受到患者，家庭或地理社区成员的影响。在即将到来的审判中，创伤患者以及家庭和社区成员被要求使用5点Likert-类型比例尺。较高的总分反映了对EFIC（范围，4-20;中性= 12）和意愿（范围，21-105，中性= 63）的积极态度。通过Kruskal-Wallis和Mann-Whitney U检验评估人口统计学、教育和人际暴力的影响结果：309名受试者中，（创伤患者，n = 172;家庭，n = 73;社区，n = 64）对EFIC呈阳性（中位数，16;四分位距，[IQR]，14-18），并表现出较高的意愿得分（中位数，82; IQR，76-88.5）。EFIC和意愿不受年龄、性别、种族或教育程度的影响。人际暴力受害者及其家庭成员的EFIC评分低于其他机制的受害者（中位数[IQR]，16 [14-18] vs. 16 [13-16]; p = 0.04），但意愿相似。虽然EFIC评分在两组之间相似，但创伤患者的意愿明显低于家人（中位数[IQR]，74 [68-77] vs. 77 [70-85]; p = 0.03）或社区成员（中位数[IQR]，76 [70-84]; p = 0.01）。创伤患者，家庭和地理社区表示高度支持EFIC和愿意参加紧急研究，虽然支持的损伤机制和组状态的影响。紧急情况研究的协商工作应超越地理社区，包括创伤受害者及其家属。（J Trauma Acute Care Surg.2013;74：157-166.版权所有（C）2013由Lippincott威廉姆斯&威尔金斯）
BACKGROUND: Research investigating the resuscitation and management of unstable trauma patients is necessary to improve care and save lives. Because informed consent for research is impossible in emergencies, the Federal Drug Administration has established an Exception from Informed Consent (EFIC) Policy that mandates "community consultation'' as a means of protecting patient autonomy. We hypothesized that the traumacommunity represents a heterogeneous population whose attitudes regarding EFIC and willingness to participate in emergency research are influenced by status as a patient, family, or geographic community member.METHODS: In the context of an upcoming trial, trauma patients as well as family and community members were asked to rank statements regarding EFIC and willingness to participate in emergency research using a 5-point Likert-type scale. Higher total scores reflected a more positive attitude regarding EFIC (range, 4-20; neutral = 12) and willingness (range, 21-105, neutral = 63). The influence of demographics, education, and interpersonal violence were evaluated by Kruskal-Wallis and Mann-Whitney U-tests (p < 0.05).RESULTS: Overall, the 309 participants (trauma patients, n = 172; family, n = 73; community, n = 64) were positive about EFIC (median, 16; interquartile range, [IQR], 14-18) and demonstrated high willingness scores (median, 82; IQR, 76-88.5). EFIC and willingness were not influenced by age, sex, race, or education. Victims of interpersonal violence and their family members had lower EFIC scores than those with other mechanisms (median [IQR], 16 [14-18] vs. 16 [13-16]; p = 0.04) but similar willingness. Although EFIC scores were similar between groups, trauma patients had significantly lower willingness than family (median [IQR], 74 [68-77] vs. 77 [70-85]; p = 0.03) or community members (median [IQR], 76 [70-84]; p = 0.01).CONCLUSION: Trauma patients, families, and the geographic community expressed a high degree of support for EFIC and willingness to participate in emergency research, although support was influenced by injury mechanism and group status. Consultation efforts for emergency research should extend beyond the geographic community to include trauma victims and their families. (J Trauma Acute Care Surg. 2013;74: 157-166. Copyright (C) 2013 by Lippincott Williams & Wilkins)