Informed Consent to Vaccination: Theoretical, Legal, and Empirical Insights.

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.