College of Health Sciences, Department of Obstetrics and Gynecology, Makerere University, P.O. Box 7072, Kampala, Uganda.
Philos Ethics Humanit Med. 2020 Aug 26;15(1):6. doi: 10.1186/s13010-020-00090-7.
Randomized controlled trials (RCTs) are central to generating knowledge about effectiveness of interventions as well as risk, protective and prognostic factors related to diseases in emergency newborn care. Whether prospective participants understand the purpose of research, and what they perceive as the influence of the context on their understanding of the informed consent process for RCTs in emergency obstetric and newborn care are not well documented.
Conceptual review.
Research is necessary to identify how the illnesses may be prevented, to explore the causes, and to investigate what medications could be used to manage such illness. Voluntary informed consent requires that prospective participants understand the disclose information about the research, and use this to make autonomous informed decision about participation, in line with their preferences and values. Yet the emergency context affects how information may be disclosed to prospective research participants, how much participants may comprehend, and how participants may express their voluntary decision to participate, all of which pose a threat to the validity of the informed consent. I challenge the claim that the 'understanding' of research is always necessary for ethical informed consent for research during emergency care. I argue for reconceptualization of the value of understanding, through recognition of other values that may be equally important. I then present a reflective perspective that frames moral reflection about autonomy, beneficence and justice in research in emergency research.
While participant 'understanding' of research is important, it is neither necessary nor sufficient for a valid informed consent, and may compete with other values with which it needs to be considered.
随机对照试验（RCTs）是产生关于干预措施的有效性以及与紧急新生儿护理中疾病相关的风险、保护和预后因素的知识的核心。前瞻性参与者是否理解研究的目的，以及他们如何看待背景对他们理解紧急产科和新生儿护理中 RCT 知情同意过程的影响，这方面的记录并不完善。
概念综述。
有必要开展研究来确定如何预防这些疾病，探索其病因，并研究哪些药物可用于治疗此类疾病。自愿知情同意要求前瞻性参与者理解研究披露的信息，并根据自己的偏好和价值观，利用这些信息对参与研究做出自主知情决定。然而，紧急情况会影响向前瞻性研究参与者披露信息的方式、参与者可能理解的程度以及参与者表达自愿参与研究决定的方式，所有这些都对知情同意的有效性构成威胁。我对在紧急情况下进行研究的伦理知情同意中，研究“理解”总是必要的这一说法提出质疑。我主张通过承认其他可能同样重要的价值观来重新构想理解的价值。然后，我提出了一个反思的观点，即在紧急研究中，将自主、有利和公正的道德反思纳入研究框架。
虽然参与者对研究的“理解”很重要，但它既不是有效知情同意的必要条件，也不是充分条件，而且可能与其他需要考虑的价值观相竞争。
