Can an individual be enrolled in more than one clinical trial using exception from informed consent?
Can an individual be enrolled in more than one clinical trial using exception from informed consent?
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一个人可以使用知情同意例外的方式参加一项以上的临床试验吗？
DOI：
10.1111/acem.14799
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发表时间：
2024
期刊：
影响因子：
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通讯作者：
Donnino,MichaelW
中科院分区：
文献类型：
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作者：
Ross,CatherineE;Asad,Muhammad;Kleinman,MonicaE;Donnino,MichaelW
在美国，知情同意例外 (EFIC) 1 是招募患者参加无法获得知情同意的紧急介入试验的重要机制。最近，有人提出一个问题，即一名患者是否可以同时参加我们机构正在进行的两项 EFIC 试验。 第一项试验“败血症中平衡与正常生理盐水液体的 PRagMatic 儿科试验”(PRoMPT BOLUS；NCT03340805) 是一项开放标签试验，涉及因感染性休克而到急诊科 (ED) 就诊的儿童。受试者随机接受平衡/缓冲晶体或生理盐水进行初始复苏和维持液长达 48 小时。 2 第二项试验“儿科重症监护病房中的肾上腺素：剂量效应试验”（EPI Dose；NCT05327556）涉及儿科重症监护病房 (PICU) 中发生急性严重低血压并需要低剂量围停期推注肾上腺素的患者。 3 受试者随机接受 1 或 0.5 μg/kg 作为初始静脉注射肾上腺素剂量。初始剂量是盲的，但后续剂量可以是非盲的和/或滴定至效果。鉴于两项试验之间可能存在重大重叠，人们担心 EFIC 会导致患者/家属过度丧失自主权；然而，我们注意到应考虑共同注册的几个原因：
In the United States, exception from informed consent (EFIC) 1 serves as an important mechanism for enrolling patients in emergency interventional trials for which informed consent is not feasible. Recently, the question was raised as to whether a single patient could be enrolled in two EFIC trials concurrently in progress at our institution.The first trial,“PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis”(PRoMPT BOLUS; NCT03340805), is an open-label trial involving children who present to the emergency department (ED) with septic shock. Subjects are randomized to receive either balanced/buffered crystalloids or normal saline for initial resuscitation and maintenance fluids for up to 48 h. 2 The second trial,“Epinephrine in the Pediatric Intensive Care Unit: A Dose–Effect Trial”(EPI Dose; NCT05327556), involves patients in the pediatric intensive care unit (PICU) who develop acute profound hypotension and require low-dose periarrest bolus epinephrine. 3 Subjects are randomized to receive either 1 or 0.5 μg/kg as the initial intravenous epinephrine dose. The initial dosing is blinded, but subsequent doses may be unblinded and/or titrated to effect. Given the potential for significant overlap between the two trials, concerns for excessive loss of patient/family autonomy due to EFIC were raised; however, we note several reasons why coenrollment should be considered: