Informed consent is the right to make an “intentional, free, and knowledge-based decision about” medical treatment (Reiss and Karako-Eyal, Am J Law Med 45:357–363, 2019.). This idea is grounded in the moral principle that individuals have a right to make autonomous decisions and to control certain aspects of their lives, including decisions about their bodies. Informed consent is especially important in healthcare settings, including when it comes to vaccination. However, because vaccination is a preventative public health measure intended to reduce the spread of disease, the decision to vaccinate affects not only the individual, but others in a community, creating a discrepancy between personal autonomy to make vaccination decisions and the health of the community. This creates a question: how do we balance an individual’s interest in informed consent and the public health interest in broad vaccine coverage? What happens when the state sees a need to mandate vaccines—how does that interact with informed consent?
This chapter explores the role of informed consent in vaccination, and then discusses how the concept interacts with vaccine mandates. We begin with a discussion on its background. Then, we lay out a theoretical model for informed consent, and what is needed for meaningful informed consent to vaccinate. Next, we discuss the United States (U.S.) legal framework for informed consent. Following this, we examine practical considerations for implementing the theoretical model for informed consent in the U.S. We conclude that although mandates may affect an individual’s ability to voluntarily consent to vaccination, vaccine mandates should still incorporate the principles behind informed consent. Furthermore, they should require the sharing of adequate information about the benefits and risks of the vaccine. Therefore, this tension between informed consent and vaccine mandates is not as problematic as it might initially seem.
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