Emergency research studies are high-stakes studies that are usually performed on the sickest patients, where many patients or guardians have no opportunity to provide full informed consent prior to participation. Many emergency studies self-select healthier patients who can be informed ahead of time about the study process. Unfortunately, results from such participants may not be informative for the future care of sicker patients. This inevitably creates waste and perpetuates uninformed care and continued harm to future patients. The waiver or deferred consent process is an alternative model that may be used to enroll sick patients who are unable to give prospective consent to participate in a study. However, this process generates vastly different stakeholder views which have the potential to create irreversible impediments to research and knowledge. In studies involving newborn infants, consent must be sought from a parent or guardian, and this adds another layer of complexity to already fraught situations if the infant is very sick. In this manuscript, we discuss reasons why consent waiver or deferred consent processes are vital for some types of neonatal research, especially those occurring at and around the time of birth. We provide a framework for conducting neonatal emergency research under consent waiver that will ensure the patient's best interests without compromising ethical, beneficial, and informative knowledge acquisition to improve the future care of sick newborn infants.

中文翻译：

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对采用放弃或延迟同意方法进行新生儿紧急研究的基本原理的叙述性回顾。

紧急研究是高风险的研究，通常针对病情最严重的患者进行，许多患者或监护人在参与之前没有机会提供充分的知情同意。许多紧急研究会自行选择更健康的患者，他们可以提前获知研究过程。不幸的是，这些参与者的结果可能无法为病情较重的患者的未来护理提供信息。这不可避免地会造成浪费，并使不知情的护理长期存在，并对未来的患者造成持续伤害。放弃或延迟同意程序是一种替代模式，可用于招募无法给予前瞻性同意参与研究的患者。然而，这一过程产生了截然不同的利益相关者观点，有可能对研究和知识造成不可逆转的障碍。在涉及新生儿的研究中，必须征得父母或监护人的同意，如果婴儿病得很重，这会为本已令人担忧的情况增加另一层复杂性。在这篇手稿中，我们讨论了为什么放弃同意或延迟同意程序对于某些类型的新生儿研究至关重要，尤其是在出生时及其前后发生的研究。我们提供了一个在放弃同意的情况下进行新生儿紧急研究的框架，该框架将确保患者的最大利益，同时又不损害道德、有益和信息性知识的获取，以改善患病新生儿的未来护理。