Centre for Perinatal Neuroscience, Imperial College London, London, UK
Perinatal Trials Unit Foundation, Bengaluru, India.
BMJ Glob Health. 2021 May;6(5). doi: 10.1136/bmjgh-2021-005757.
Time-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in India, Sri Lanka and Bangladesh.
Term infants with neonatal encephalopathy, aged less than 6 hours, were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed A-V records of the consent process using a 5-point Likert scale on three parameters-empathy, information and autonomy. In addition, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 healthcare professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.
A total of 294 A-V records of the HELIX trial were analysed. Median (IQR) score for empathy, information and autonomy was 5 (0), 5 (1) and 5 (1), respectively. However, thematic analysis suggested that the consenting was a ceremonial process; and parental decision to participate was based on unreserved trust in the treating doctors, therapeutic misconception and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial nor the nature of the intervention. Professionals showed a strong bias towards cooling therapy and reported time constraints and explaining to multiple family members as key challenges.
Despite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context-appropriate strategies for informed trial participation.
在中低收入国家（LMICs）进行时间关键的新生儿试验引发了一些伦理问题。本研究采用定性主导的混合方法设计，探讨了在印度、斯里兰卡和孟加拉国进行的 Hypothermia for encephalopathy in low and middle-income countries（HELIX）试验中的知情同意过程。
胎龄≥37 周的新生儿脑病、发病年龄＜6 小时的新生儿，在获得父母知情同意后，随机分配至冷却治疗或常规护理组。所有情况下，均采用视听（A-V）记录知情同意过程。我们采用 5 点李克特量表，对 A-V 记录中的三个参数（同理心、信息和自主权）进行分析。此外，我们还采用探索性观察方法，记录父母与专业人员之间的相关讨论和同意过程中的其他方面。最后，我们对 20 名父母和 15 名医疗保健专业人员进行了深入访谈。我们对 A-V 记录的观察结果和访谈记录进行了主题分析。
共分析了 294 份 HELIX 试验的 A-V 记录。同理心、信息和自主权的中位数（IQR）评分分别为 5（0）、5（1）和 5（1）。然而，主题分析表明，同意过程是一种仪式性的过程；父母参与的决定是基于对治疗医生的无条件信任、治疗误解和免费获得昂贵治疗的机会。大多数父母不了解临床试验的概念，也不了解干预的性质。专业人员对冷却治疗存在强烈的偏见，并报告说时间限制和向多个家庭成员解释是主要挑战。
尽管有严格的研究治理和同意过程，但父母的决定受到情境能力不足和对医生代表他们做出正确决定的信任的强烈影响。需要进一步研究，以确定适合文化和背景的知情参与试验的策略。
