Initial Steps in Ascent to Assent for Pediatric Critical Care Research.
Initial Steps in Ascent to Assent for Pediatric Critical Care Research.
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获得儿科重症监护研究同意的初步步骤。
DOI：
10.1097/pcc.0000000000003144
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发表时间：
2023
期刊：
影响因子：
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通讯作者：
Zimmerman,JerryJ
中科院分区：
文献类型：
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作者：
Zimmerman,JerryJ
将儿童纳入研究被认为是一种基于若干伦理原则的道德要求，包括为所有人群提供高质量医疗保健的分配公正(1)，提供循证护理的有益（《儿童最佳药物法案》的目标），以及避免有害治疗的非恶意（仅基于合理性的治疗蔓延或成人经验，但缺乏关于利弊的高质量数据）(3)。公平要求将儿童纳入研究，儿童应根据其发展能力参与是否参加研究的决定(4)。“同意”是指在无法获得完全同意的情况下同意参与研究的概念(5)。虽然同意的概念很容易被证明是合理的，但它在儿科重症护理研究中的应用仍然具有挑战性。在此背景下，在本期的《儿科重症医学》杂志上，O 'Hearn等人(6)代表加拿大重症监护试验组报告了一项匿名横断面调查研究的结果，该研究涉及加拿大14家三级护理儿科医院，目的是澄清同意在儿科重症监护研究中的作用。凭借在调查研究方面的丰富经验，调查人员描述了193名受访者提供的同意观点，包括研究伦理委员会主席、研究协调员、重症监护护士和专注于儿科重症监护的研究人员（主要是PICU主治医生）。总体而言，至少有50%的受访者表示，征求参与重症监护研究的儿童的同意是“重要/非常重要”的。任何参与招募危重儿童/家庭参与临床研究的人都可以确定持续休克、气管插管、镇静、化学麻痹、残余麻醉、基线发育障碍、谵妄、未解决的疼痛和焦虑、感染隔离和父母内疚所带来的独特挑战。令人难以置信的是，35%的受访者表示，在PICU登记时没有任何障碍。此外，18%的受访者表示，在儿童PICU入院的前24-48小时内，“总是或几乎总是”可以获得同意。对于一个致力于在同意的概念上达成共识的临床试验小组来说，这些回答听起来像是令人沮丧的。
Including children in research is recognized as a moral imperative based on several ethical principles including distributive justice for high-quality healthcare availability to all populations (1), beneficence in providing evidence-based care (the goal of the Best Pharmaceuticals for Children Act [2]), and nonmaleficence in avoiding harmful therapies (therapy creep based on plausibility alone or adult experience but lack of quality data regarding benefit/harm)(3). Equity mandates the inclusion of children in research, and children should be involved in the decision to take part in research as appropriate for their developmental capacity (4). Assent is the notion of providing agreement to participate in research when full consent is not possible (5). Although the concept of assent is readily justifiable, its application in pediatric critical care research remains challenging.Within this context, in this issue of Pediatric Critical Care Medicine, O’Hearn et al (6), on behalf of the Canadian Critical Care Trials Group, report the results of an anonymous cross-sectional survey study involving 14 tertiary care pediatric hospitals in Canada with a goal of clarifying the role of assent in pediatric critical care research. With significant experience in survey research, the investigators describe perspectives of assent provided by 193 respondents including research ethics board chairs, research coordinators, critical care nurses, and researchers (mostly PICU attending physicians) focusing on pediatric critical care. Overall for all scenarios presented, at least 50% of respondents indicated that it was “important/very important” to seek assent from children involved with critical care research. Anyone who has been involved in recruiting critically ill children/families into clinical research studies can ascertain the unique challenges imposed by ongoing shock, tracheal intubation, sedation, chemical paralysis, residual anesthesia, baseline developmental disability, delirium, unresolved pain and anxiety, infection isolation, and parental guilt. Incredulously, 35% of survey respondents reported no barriers to assent at the time of enrollment that are unique to the PICU. Additionally, 18% of respondents indicated it was “always or almost always” possible to obtain assent during the first 24–48 hours of a child’s PICU admission. These read like disheartening responses for a dedicated clinical trials group endeavoring to develop some consensus around the concept of assent.