Informed consent matters — so does protecting people from infectious diseases. This paper examines what the appropriate informed consent process for vaccines should look like and how the process is conceptualized by law and health authorities. Drawing on the extensive theoretical and empirical literature on informed consent and vaccination, this article sets out what an ideal informed consent process for vaccination would consist of, highlighting the need for autonomous decisions. To be autonomous, decisions need to be based on full, accessible information and reached without coercion. We suggest that the information provided must address the nature of the procedure — including benefits to the child, benefits to society, and risks. Parents should have their concerns and misconceptions addressed. The information needs to be accessible and include an opportunity to ask questions. Based on this ideal model we examined in detail the legal framework surrounding informed consent to vaccination and the process as conceptualized by health authorities in two countries, Israel and the United States, to assess whether they meet the requirements. These two countries are similar in some of their values, for example, the importance of individual autonomy, and face similar problems related to vaccine hesitancy. At the same time, there are meaningful differences in their vaccine policies and the current structures of their informed consent processes, allowing for a meaningful comparison. We found neither country met our ideal informed consent process, and suggested improvements both to the materials and to the processes used to obtain informed consent.

中文翻译：

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疫苗接种知情同意书：理论、法律和经验见解

知情同意很重要——保护人们免受传染病侵害也很重要。本文探讨了适当的疫苗知情同意程序应该是什么样的，以及法律和卫生当局如何对该程序进行概念化。本文借鉴关于知情同意和疫苗接种的大量理论和实证文献，阐述了理想的疫苗接种知情同意程序包括哪些内容，强调了自主决策的必要性。为了实现自主，决策需要基于完整的、可访问的信息，并且在没有强制的情况下达成。我们建议所提供的信息必须说明程序的性质——包括对儿童的益处、对社会的益处和风险。父母应该解决他们的担忧和误解。信息需要易于访问，并包括提问的机会。基于这一理想模型，我们详细检查了围绕疫苗接种知情同意的法律框架以及以色列和美国这两个国家的卫生当局概念化的流程，以评估它们是否符合要求。这两个国家在某些价值观上是相似的，例如个人自治的重要性，并且面临着与疫苗犹豫相关的类似问题。同时，他们的疫苗政策和他们的知情同意程序的当前结构存在有意义的差异，可以进行有意义的比较。我们发现这两个国家都没有达到我们理想的知情同意程序，并建议改进材料和用于获得知情同意的程序。