Abstract
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.
I. INTRODUCTION
The individual right to autonomy and the doctrine of informed consent are well accepted principles in clinical practice. 1 Issues of individual autonomy also arise in the context of vaccination. The questions that arise in relation to every procedure — achieving meaningful informed consent — arise in this context as well. 2 Other aspects of the vaccination decision complicate the matter, however. Because of the nature of the infectious diseases that vaccines prevent, a parent's decision not to vaccinate a child affects not only that child, but other children as well. 3 Further, because the child cannot make the decision, the parent's autonomy may be in tension with the child's welfare. An informed consent process related to vaccines should combine an effort to protect each of these interests — parental autonomy, the child's welfare, and the public health — as best as possible. It is not an easy balance. It is, however, a vital one.
The public health aspect of vaccines imposes constraints absent in other contexts. When public health is at risk, the individual right to autonomy may be restricted through legal rules aimed to support vaccination rates. 4 Consequently, when public health considerations justify a restriction of individual autonomy, the degree of this restriction and the means by which this restriction is enacted are central questions in the ethical and legal literature. 5 When it comes to childhood vaccination, this conflict usually requires balancing parents' claims of autonomy over their children's medical treatments with the public interest in maintaining sufficiently high vaccination rates. 6
While there is a considerable body of academic writing on informed consent generally, and despite sharing the same theoretical framework, little attention has been paid in the literature to the issue of informed consent in the context of vaccination. 7 This article seeks to fill this gap by providing theoretical, legal, and empirical insights into the issue of informed consent to vaccination.
The article addresses the issue of informed consent to vaccination using the United States and Israel as case studies. The choice of these countries was based on their similarities as well as their differences. In terms of similarities, both countries are industrialized and democratic nations, whose political traditions include, to a degree, elements of liberal ideology. They both share a basic commitment to ideas of equality, freedom, individual autonomy, and human rights. 8 In addition, both are multi-cultural, multi-religious, and multi-lingual countries in which immigration plays a significant role in shaping the society. 9
The similarities between the countries stand out in the specific context of the doctrine of informed consent. Both legal systems adopted the doctrine of informed consent in the mid-20th century and based it on the individual right to autonomy. 10 In fact, the adoption and development of the Israeli doctrine of informed consent was strongly inspired by American law. 11 It is therefore not surprising that both legal systems share views regarding the scope of the duty of disclosure. 12
In the context of vaccination, the two countries often face the same problems and challenges. One common problem involves parental vaccination refusal and vaccination hesitancy. Since the 1990s, the United States has experienced an increase in the number of parents taking advantage of non-medical exemptions, which has resulted in a decline in childhood immunization rates. 13 Although not as prevalent as in the United States, parental vaccination refusal is becoming more common in Israel. 14 In recent years, health care providers have reported an increase in the number of parents who only vaccinate their children partially, or at ages that differ from the officially recommended protocols. 15 The reasons for vaccination refusal or hesitancy in Israel concord with those found in other countries, including the United States, such as religious beliefs, ethical and ideological considerations, concerns about vaccine safety, and doubts regarding vaccine effectiveness. 16 As the number of non-vaccinated children rises, both countries face the risk that the overall immunization rate will fall below the critical immunity threshold. 17
Unsurprisingly, both countries share another problem: the reoccurrence of diseases that were previously eliminated or brought under control. Although vaccination coverage in the United States and in Israel is generally high, both countries have experienced outbreaks of childhood infectious diseases, especially centered on pockets of vaccine refusers. For example, in 2014 and 2015, the Centers for Disease Control and Prevention (“CDC”) documented over 800 cases of measles in the United States. 18 In 2017, 120 people from 15 states and the District of Columbia were reported to have measles. 19 In 2019, the United States saw its largest measles outbreak since 1992, with 1,241 cases occurring between January 1 and September 5. 20 Israel has also experienced repeated outbreaks of measles. In 2003, 122 cases of measles were documented by the Israeli Ministry of Health (“IMH”). 21 Between 2007 and 2008, a severe outbreak of measles was documented with 1,467 cases of measles reported by the IMH, most of them in Jerusalem and its surrounding areas. 22 Since March 2018, Israel is experiencing another severe measles outbreak. 23 According to the IMH as of May 2019 the number of people with confirmed measles has reached approximately 4,250 people. 24 In both countries non-vaccination and under-vaccination have contributed to the increased rates of infection from measles. 25
Both countries also face the challenge of keeping vaccination rates sufficiently high in spite of the anti-vaccination movement. The anti-vaccination movement has played a key role in the history of vaccination in the United States and has long been recognized to pose a threat to public health. 26 While many factors undoubtedly influence parental vaccination decisions, one potential factor includes misinformation and conspiracy theories disseminated by the anti-vaccination movement. 27 With new forums available to communicate their messages to the public, such as the Internet and other media platforms, anti-vaccination activists continue to disseminate their arguments against vaccination. 28 Israel has similarly experienced the distribution of misinformation and conspiracy theories by anti-vaccination activists. One anti-vaccination association, “Hason,” is comprised of alternative health care providers, groups of parents, journalists, and other individuals who distribute inaccurate, unfounded, and misleading information regarding vaccination, both routinely and in response to vaccination initiatives. 29 These groups have been especially active during the 2009 A/H1N1 vaccination campaign, in response to the 2013 IPV vaccination campaign, and following a private initiative to create “vaccinated kindergartens” (privately owned kindergartens which would refuse to accept unvaccinated children unless they had medical contraindications). 30 In an effort to curb the influence of anti-vaccination messages on parents, policy makers in both countries face the question of what actions need to be taken to challenge them. These choices can have informed consent consequences.
Finally, the question of what public policies should be adopted in response to non-vaccination and under-vaccination (i.e., legal versus non-legal measures, voluntary versus compulsory strategies) challenges health authorities and stimulates a trenchant public discourse in both countries. 31
At the same time, the United States' and Israeli health care systems are different in several important respects. 32 Of importance in this paper is the fact that each country adopts different policies as to vaccination delivery, vaccination financing, 33 and vaccination requirements. 34
The existence of similar political, cultural, and legal characteristics, as well as related problems in the context of vaccination, provide enough common ground to justify a comparison between these two countries. The different vaccination policies in these countries provide a point of contrast, offering an opportunity to analyze issues of informed consent in vaccination in different legal environments.
By studying and comparing how these legal systems managed the issue of informed consent to vaccination, and how legal rules regarding informed consent to vaccination are being implemented in these countries, we will provide public health policymakers with a critical perspective on the process of informed consent to vaccination, as envisioned in law and implemented in practice. Based on this discussion, an understanding of the deficiencies and the required changes will emerge. Our aim is to provide a model of what an ideal informed consent process would look like, use case studies to examine what happens in practice, and suggest improvements to bring the cases closer to the ideal.
This paper proceeds in six parts. Part II sets the deontological and theological justifications for the doctrine of informed consent in the context of vaccination. Part III formulates a theoretical model of what an ideal informed consent process would look like. Its aim is to suggest guidelines for providing informed consent to vaccination and articulate a model against which policy makers would be able to critically evaluate existing norms and practices. Part IV presents the legal rules which regulate informed consent to vaccination in the United States and Israel. Part V explores how the legal rules regarding informed consent to vaccination are implemented by the health authorities in both countries. Part VI critically discusses the legal framework and the empirical findings, analyzing the justifications and the theoretical model. Part VII concludes the paper and identifies the research's general insights.
Before proceeding further, we identify two caveats. First, the focus of this paper is the process of informed consent to vaccination. Therefore, although the issue of parental autonomy will be mentioned, the general question of whether the State can or should restrict parents' autonomy to make medical decisions for their children in the context of vaccination will not be directly addressed. 35 However, because school mandates are an important part of the legal framework in the United States, the relationship between informed consent and school mandates is discussed. 36 Second, the issue of children's rights to participate in the decision-making process regarding their medical treatment and to be informed of such treatments exceeds the scope of this paper. Accordingly, the discussion will focus on parents as the party providing informed consent.
II. INFORMED CONSENT TO VACCINATION: DEONTOLOGICAL AND THEOLOGICAL JUSTIFICATIONS
The individual right to make an informed decision regarding medical treatment means that, subject to some exceptions and limitations, a competent individual (and a guardian in the case of a minor) has the right to make an intentional, free, and knowledge-based decision about his treatment by which others will be bound. 37
This right emerges from the moral principle that individuals have a right to make autonomous decisions. Its theoretical justification lies first and foremost in the intrinsic value of treating individuals as autonomous moral agents and allowing them to control diverse aspects of their lives. 38
In the health care setting, where a power imbalance between professionals and individuals is unavoidable, respecting the individual's right to make autonomous decisions is of special importance. It prevents professionals' authority from being exercised in a controlling fashion and gives the individual ultimate control over his body. 39 As with other medical procedures, the principle of autonomy applies to vaccination. In fact, because vaccination is a medical intervention that is not without risk and is performed on healthy people, patient (or guardian) informed consent for the procedure is of special importance. 40
There are two aspects that complicate the informed consent discussion in relation to childhood vaccination. First, consent comes from the parent, not the child. 41 This is true for all medical decisions made for children, but it is desirable to remember that parental autonomy is not absolute, and at times may be overridden in consideration of the child's best interest. 42 Second, the implications of parents' vaccination decisions exceed the health and wellbeing of their child. Most infant vaccinations provide both individual and community protection. 43 As history indicates, vaccinations have an important public health function. They prevent the spread of infectious diseases, reduce disease incidence and decrease mortality. 44 Achieving these goals requires a critical portion of the community be immune. Herd immunity hinders the transmission of disease by increasing the population's overall resistance and providing a protective ring around members of the community who do not have the required immunity. 45
It is therefore not surprising that calls to apply the doctrine of informed consent in the context of vaccination raise concerns as to its effect on public health. More specifically, it is feared that informing parents about vaccine risks, their prosocial nature, and the protection they provide to non-vaccinated children, will reduce parents' willingness to vaccinate their children and thus reduce vaccination rates. 46 Another concern is that fully applying the doctrine of informed consent to vaccination, which is a time-consuming process, would be impossible in clinical settings or might impede the provision of other services. 47 Time limitations have also been mentioned in the context of mass vaccination programs. Applying the doctrine of informed consent in these circumstances, so it was claimed, would undermine the goal of vaccinating as many people as possible, in as short a time as possible, and in a manner that causes minimal distress or disruption. 48 These concerns suggest that in the context of vaccination, the right to autonomy, and more specifically the right to be informed, may conflict with public health interests.
Facing a similar conflict in other contexts, public health advocates often claim that autonomy is not an absolute value and that it must give way at times to the greater good of public health. 49 Founded on the “harm principle” presented by John Stuart Mill in his work On Liberty, 50 and on the consequential theory of utilitarianism, 51 this approach supports the restriction of individuals' autonomy when such a restriction is needed for the protection of public health.
Applying this approach to the context of vaccination raises the question of whether providing parents information concerning vaccination negatively affects public health. In the discussion that follows we will try to answer this question.
Review of the empirical literature suggests that from the perspective of public health, providing parents with information about the risks and benefits of vaccination has both short-term and long-term advantages.
Social science research has shown that parents' vaccination decisions are made in a broad socio-cultural context. 52 They are driven by a complex configuration of issues, including perceptions about health and health services, personal experience, family lifestyle, personal, cultural and religious values, and a host of socio-demographic factors. 53
Among the most prominent factors influencing parental vaccination decisions are misinformation and uncertainty regarding vaccines' benefits and risks. 54 Concerns about vaccine safety is one of the most common factors reported by non-vaccinating parents. 55 Perceptions of low susceptibility to the disease, its severity, and vaccine efficacy were also associated with parental vaccination refusal. 56 More specifically, studies show that vaccine-hesitant parents are more likely to believe that vaccines are not safe, that children receive too many vaccines, that vaccines have serious side effects, and that vaccines may negatively impact the child's immune system. 57 These parents tend to question the effectiveness of vaccinations, prefer that their child acquire natural immunity, or believe that the human body can protect itself from the serious complications of vaccine-preventable diseases. 58 These misconceptions are often the result of inaccurate information and mistaken beliefs gathered or received by parents from family members, friends, the Internet, and mass media. 59 These sources of information often provide parents frightening and inaccurate “facts” (or, in today's parlance, “alternative facts”) concerning vaccination. 60 For example, stories link vaccines with autism, multiple sclerosis, sudden infant death syndrome, immune dysfunction, diabetes, and neurologic disorders, even though large-scale studies show that vaccines do not cause any of these issues. 61
Uncertainty, ambiguity, and contradictions in the information to which parents are exposed are all additional factors causing parents to refrain from vaccinating their children. 62 The growing number of informational sources are responsible for parental confusion and uncertainty about the risks and effectiveness of vaccines. 63 In the absence of a supportive reference point with which parents can interpret information and identify misleading information, parents might feel confused and uncertain as to the information to which they are exposed. 64 Facing such uncertainty, parents might react with fence-sitting and indecision. 65
These findings suggest that providing full, accurate and clear information to parents from an authoritative, trusted source, which can help with correcting misconceptions and reducing uncertainty, will positively influence parents' attitudes towards vaccination and induce more parents to vaccinate their children. 66
Empirical studies also support this conclusion. Several studies have identified the importance of providers' recommendations and pro-vaccine information in positively impacting parents' attitudes and decisions toward vaccination. 67 In addition, there is evidence that informing parents of the risks associated with the vaccine does not necessarily deter them from vaccinating their children. 68 Nevertheless, attention should also be given to the fact that there is mixed evidence on the effectiveness of educational interventions. 69 More specifically, several studies suggest that pro-vaccine messages do not always work as intended. It has been found that exposure to vaccination information does not significantly influence parents' vaccination intentions or behavior, and that specific types of information may be counterproductive (though those studies, by and large, were not looking at the provider/patient interaction). 70
We can cautiously say, then, that providing information to parents may have some short-term advantages, though this needs qualifying. A careful observation of the empirical literature suggests that several factors may influence the effectiveness of educational interventions. Thus, the effectiveness of pro-vaccination messages may vary depending on parental attitudes toward vaccines. 71 Unsurprisingly, parents whose attitudes are the least favorable toward vaccines were also the least responsive to pro-vaccination messages. 72 Tailored interventions were found to be more effective compared with untailored educational interventions. 73 Additionally, the framing of provaccination messages influences parents' vaccination intention. Thus, it was found that providing parents with information about the risks posed by failing to vaccinate is significantly more effective than providing them with corrective information aimed at dispelling myths about vaccines. 74 Studies also suggest that the provision of information alone is a relatively ineffective way and that the most effective interventions employed multiple strategies. 75 Communication style was also identified as an influential variable. Lower vaccine uptake was associated with parents' perceptions that conversations with providers were difficult, dismissive, and of inadequate depth and length. 76
This latter body of literature can explain the inconsistency in evidence as to the effectiveness of educational interventions. It suggests that content, framing, style, and recipient matter for effectiveness and that the effectiveness of educational interventions can be improved. 77 Most importantly, they indicate that solely communicating the same information to all parents is not expected to have a meaningful influence on parents' attitudes and vaccine uptake. 78 Thus, the content of information, its framing, and style of communication should be adaptive and responsive to parents' characteristics, concerns, and informational needs. 79 In addition, rather than using educational interventions as the only method to improve vaccination uptake, educational interventions should be integrated with other interventions (i.e., patient reminder/recalls and provider reminder, targeted promotion campaigns in the mass media, and economic incentives). 80 As the empirical literature suggests, such an approach is expected to have a meaningful positive influence on parents' vaccination decisions. 81
The advantages of providing parents with information about vaccination extend beyond short-term benefits. In the long run, providing parents full and accurate information can foster trust in health care providers and health care authorities. Trust is an important influential factor on parents' willingness to have their children vaccinated. 82 It has long been recognized that trust plays a key role in willingness to adhere to treatment recommendations. 83 Its importance stands out in the context of vaccination, considering that routine childhood vaccines are given to healthy children to prevent diseases that are becoming exceedingly rare. 84 According to several studies, vaccine uptake is significantly associated with parents' trust in health care providers and public health authorities. 85 More specifically, it was found that levels of trust in physicians and public health authorities were much higher among parents who vaccinated their children compared to non-vaccinators. 86 It is therefore not surprising that in 2014, the World Health Organization (“WHO”) Strategic Advisory Group of Experts (“SAGE”) Working Group on Vaccine Hesitancy identified confidence as one of three domains related to vaccine hesitancy. 87 The SAGE working group conceptualized confidence in terms of trust, including how much people trust the providers responsible for administering vaccines, and/or the entities involved in vaccine licensure and vaccination recommendations. 88
Building and maintaining trust in health care providers and health authorities is associated with multifaceted factors, including how people perceive the competence, objectivity, and fairness of health authorities. 89 Research shows that one of the key determinants of trust is sincerity. People need to feel that authorities and spokespeople are transparent, honest and open. 90 Hence, vital ingredients in building trust are sharing knowledge, ensuring mutual understanding, and creating a dialogue with parents. 91
On the other hand, the public perception that health authorities are hiding vital information, with the sole purpose of ensuring a positive vaccination uptake, sews mistrust. 92 It follows that health care providers and health authorities should avoid using tactics of information concealment or other information manipulations, even if in the short-run it is expected to maintain or increase vaccine uptake. In an age in which the Internet, blogs, and forums are used by individuals and organizations as sources of information and as tools for rapid information dissemination, concealment of information and other forms of informational manipulation are easily detectable. 93 Real life experience may also expose the fact that partial or inaccurate information was provided to the public. Revelations of this kind might cause parents to question the credibility of health authorities and health care providers. 94 Once trust is lost, it is difficult to reestablish. Risk communication becomes ineffective and parents become more skeptical and resistant to vaccinating their children. 95
Without underestimating the importance of providing full and accurate information to parents, the provision of information in and of itself is not enough to maintain trust. Several factors were found to increase trust, including using clear, understandable, non-technical language; providing consistent, evidence-based information; demonstrating an ability to listen to people's concerns by taking them seriously and responding to them; and ensuring that any areas of uncertainty are acknowledged and clarified. 96
It follows that informed consent plays an important part in fostering parents' trust in health authorities. By requiring that health care providers (1) inform parents about vaccines' risks and benefits, (2) share with them uncertainties, (3) honestly answer their questions, and (4) seriously address their concerns, the legal doctrine of informed consent can also promote trust between the public and health authorities. 97
III. INFORMED CONSENT TO VACCINATION: THE THEORETICAL MODEL
A. General
In order to suggest appropriate guidance for providing informed consent to vaccination and to critically evaluate existing norms and practices, we need to formulate a theoretical model of what an ideal informed consent process would look like.
The theoretical model proposed in the following sections is based on three pillars. The first pillar is based on Faden and Beauchamp's work on autonomous decisions as presented in their book A History and Theory of Informed Consent which provides one of the most extensive and influential definitions of autonomous decisions in the field of bioethics. 98 According to Faden and Beauchamp, for a decision to be autonomous, four conditions should be fulfilled: (1) the individual should have the relevant abilities to make the decision—that is, he must have the specific competence required for making the decision; (2) the individual needs to act intentionally when making the decision; (3) the decision must not be the result of external controlling influences (for a decision to be autonomous the individual must act out of his free will); and (4) the individual must have a substantial understanding of the relevant and material facts that accurately describe the nature of the decision and its possible outcomes. 99
As the empirical literature previously presented suggests, articulating a theoretical model mainly requires consideration of the third and fourth conditions. While issues of competence and intention may arise as well, they do not reflect the core problems that arise in the context of informed consent to vaccination. Therefore, for the present discussion we will assume that the parents whose consent is needed are competent and that the act of giving consent is an intentional one. 100
The second pillar on which the theoretical model is built is empirical literature, specifically empirical findings identifying barriers to a successful process of informed consent in the context of vaccination and providing methods to overcome them.
The third pillar consists of the special characteristics of vaccination. As already noted, vaccines have two unique characteristics. First, they are preventive medical interventions performed on healthy individuals. Second, their effects extend beyond the well-being of the vaccinated child, as they can impact the well-being of others.
Given vaccines' preventive nature and their importance in promoting public health, a theoretical model of informed consent to vaccination should be articulated with the goal of both protecting parents' right to make autonomous decisions for their children (as their guardians) and the interest of public health. As previously revealed, such a goal is achievable. 101 Protecting parents' right to decision-making autonomy is not necessarily inconsistent with public health interests, as promoting the former could simultaneously promote the latter. Moreover, considering the two interests when articulating a theoretical model communicates the idea that while both are important, neither of these values is absolute, and at times each should be limited for the protection of the other.
B. The Condition of Understanding
1. What is Understanding?
Faden and Beauchamp claimed that for the condition of understating to be fulfilled, the individual should have a substantial understanding of the relevant and material facts that accurately describe the nature of the decision and its possible outcomes. 102 They define understanding as an individual's accurate interpretation of the facts. 103 Such an interpretation usually takes place in the context of interpersonal communication and can therefore be described as justified beliefs or assumptions about phrases spoken by others. 104 According to this approach, understanding is the existence of a correspondence between the interpretation the individual gives to the sentence and what the speaker intended to say. To the extent that such a correspondence does not exist, the recipient of the information does not correctly interpret what was said to him and therefore does not understand the information that was given to him. It follows that if there is a fundamental discrepancy between the facts that correctly describe the nature of the decision and its consequences and the interpretation made by the individual of the information given to him, it cannot be said that he substantially understood the nature of the decision and its implications. 105
To fulfill the condition of understanding, the physician should take reasonable measures to ensure that parents will have an opportunity to accurately interpret the facts provided to them and avoid actions that may imperil such understanding. The following components of this section describe the conduct that is required of physicians in this regard.
2. Acts That Do Not Comply With the Condition of Understanding
Faden and Beauchamp's approach leads, first and foremost, to the conclusion that providing parents with false or inaccurate information or withholding critical information from them is counterproductive to the condition of understanding because it results in a discrepancy between the interpretation made by the parents and the facts that correctly describe the nature of the decision and its consequences. Therefore, providing false or inaccurate information or withholding information should be avoided, as it prevents parents from making an autonomous decision. Other forms of informational manipulation, such as framing or formatting effects, which result in misconceptions as to the vaccine's purpose, risks, and benefits, should also be avoided.
Misleading parents to induce them to vaccinate their children not only imperils their ability to make an autonomous decision; it also undermines parents' trust in health care providers and healthauthorities. 106
On the other hand, types of presentations which are not expected to result in parents' misinterpretation of the facts regarding the suggested vaccine are permissible. 107
3. The Information That Should be Provided to Parents
Another conclusion that emerges from Faden and Beauchamp's definition is that parents should be provided with relevant, material, and accurate information regarding the nature of the procedure, including its purpose and its expected benefits, as well as its possible risks and side effects. 108
One of the major problems is determining what information is relevant and material and thus should be provided to parents. We believe that answering this question requires consideration of four issues: (1) the nature of the procedure — a preventive procedure administered to healthy children, which is beneficial to the vaccinated child, other individuals and the society as a whole; (2) the scientific facts that correctly describe the nature and the outcomes of a vaccination decision, including benefits and risks; (3) parents' common concerns and misconceptions; and (4) parents' special informational needs as they become apparent from their questions, statements, religious beliefs, values, lifestyles, medical circumstances, health histories, and medical knowledge. 109
This four-stage model has several advantages. First, it increases the probability that parents will understand the nature and the outcome of a decision whether to vaccinate a child, and thus improve their ability to make autonomous decisions. Second, it is expected to increase parents' willingness to vaccinate their children. As the previous part indicates, addressing parents' concerns, misconceptions and special informational needs is positively associated with parents' attitudes towards vaccination. 110 Third, it enables policymakers and health care providers to consider both parental right to autonomy and the interest of public health when articulating the scope of the duty of disclosure.
Applying this model suggests that the information provided to parents should include the following types of information: 111 the disease against which the vaccine is administered; how contagious the disease is; how the disease spreads (i.e., air/saliva/nasal secretions or blood); the implications of being infected with the disease (i.e., how many days it usually lasts, the physical discomfort it is expected to cause to the infected individual, and the incidence of death or serious injury associated with the disease); alternative methods of preventing the disease, if any, and their effectiveness compared to vaccination (i.e., keeping good hygiene); the method of administrating the vaccine (i.e., an injection or orally); the pain or discomfort the child is expected to experience during the administration of the vaccine; side effects of the vaccine (i.e., redness and swelling at the place of injection, fever, rash, and diarrhea); the vaccine's effectiveness in preventing infection; risks of a serious adverse reaction from the vaccine (for the general population and for at special risk groups); particular classes of individuals whom the vaccine is not recommended for; and alternative vaccine formulas, their risks and benefits. 112
Considering that trust is an important influential factor on parents' willingness to have their children vaccinated, transparency as to what is not known about a vaccine is just as important as current knowledge of it. 113 It follows that parents should also be informed as to uncertainties, even if in the short run such a revelation will result in some parents' refusal to vaccinate their children. 114
The need to maintain public trust in health authorities, as well as the fact that vaccines are preventive medical procedures administered to healthy children, is also important in considering which of the risks associated with the vaccine should be disclosed to parents. We believe that parents should be informed of rare risks of serious morbidity or death, even if the disclosure of such risks would not have been required in the case of curative treatments. When it comes to vaccination—a medical procedure administered to healthy children—rare risks should be considered as material information, which a reasonable parent would attach importance, even though the probability of materializing is negligible. 115 However, parents should also be informed of the low probability that these risks will materialize.
The that parents should be informed of rare risks and the probability of their occurrence (which is generally very low) is in line with parental right to autonomy because it enables parents to fully appreciate the consequences of a vaccination decision. Moreover, being fully transparent and honest about the risks involved in vaccination, even the rare ones, might promote parents' trust in health care authorities. Finally, including such risks in the information provided to parents might not necessarily result in parental refusal or hesitancy, as long as the low probability of their occurrence is clearly and openly communicated. This suggests that informing parents of the rare risks involved in vaccination can also be justified through the interest of public health.
The information provided to parents should include not only the risks and benefits applicable to the vaccinated child. It should extend to the social nature of vaccination and its benefits to the community. 116 More specifically the information should include: the protection it provides to members of the community who are not immune; its importance in preventing outbreaks of infectious diseases, and, as a result, reducing the rates of morbidity and mortality in the community; its contribution to the saving of healthcare costs savings and other social costs; and its significance to the society's economic development. 117
Although such information goes beyond issues directly related to the vaccination of the child, it addresses the implications of the decision to vaccinate. Parents that lack such information cannot be said to fully understand the nature of the decision and its consequences. When the social nature of vaccination is downplayed, parents are expected to assume that vaccination benefits only their children and that their children's benefit is the only consideration addressed by health authorities when recommending a vaccine. They may also wrongly conceive of vaccination decisions as private decisions with no implications for others. 118 Obviously, this is incorrect, and a decision made based on such an interpretation is not an autonomous one as it lacks full understanding. Thus, the principle of autonomy justifies providing such information.
The approach asserting that parents should be informed about the social benefits of vaccines also finds support in the interest of public health. Although current empirical studies do not provide conclusive evidence for the influence of such information on parents' vaccination decisions, there are grounds to infer that such information might positively affect parents' vaccination decisions and that its influence can be improved. 119 More specifically, there is evidence suggesting that prosocial motives play a role in vaccination decisions and that individuals are sensitive to the positive impact their vaccination could have on the health of others. 120 Studies on parents' vaccination decisions indicate that parents may be willing to vaccinate their children for the benefit of other individuals. 121 There is also some evidence that underscoring vaccines' benefits to society, as well as to the vaccinated child, may result in higher intentions to vaccinate. 122 Furthermore, as Wendy Parmet has pointed out, identifying vaccination as a social act instead of as a private act might decrease parents' resentment towards mandatory vaccination policies and thus increase vaccine uptake. In Parmet's words, “if … the government explains to the parent why the decision is not private, and how it affects other people, especially sick and vulnerable children in the child's community, perhaps the parent will have a different attitude.” 123
In the long run, presenting vaccination as an act aimed to benefit the vaccinated child and no more, while concealing its true social nature, may erode public trust and strengthen parents' resistance to vaccination. In an age in which the Internet, blogs, and forums are used by individuals and organizations as additional sources of information, the fact that protecting others is a prominent aim of vaccination is likely to be revealed to parents. Once parents become aware that this fact was concealed from them, the credibility of information and authorities may be lost. 124
Finally, vaccination is a prosocial act aimed to preserve public health, and parents should consider not only the benefit to their child, but the benefits to others as well. Parents cannot be expected to consider the social benefits of vaccination if they are unaware of them. It follows that informing parents about the social benefits of vaccination is an important part of achieving full informed consent in this area, in addition to its potential contributions to public health.
Another type of information which requires consideration is the personal protection provided to unvaccinated children through herd immunity. Herd immunity occurs when sufficient numbers of individuals in the community are immune from the disease to provide protection to members of the community who do not have immunity. 125 While herd immunity provides real benefits, there is also a risk that parents will rely on the protection provided to their children through it and avoid vaccinating them. 126 This proposition finds support in empirical studies which have found that when the information provided to parents emphasizes the personal benefit that indirect protection provides to individuals through herd immunity, individuals' inclination to abstain from vaccination increases. 127 These findings suggest that while you cannot hide the benefits to the child from herd immunity, they should be presented as part of a more comprehensive picture that emphasizes that vaccination is a social act, conditional on everyone contributing their share. More specifically, parents should be informed that the protection provided to unvaccinated children through herd immunity is contingent: it depends on the preservation of high vaccination rates. As more parents choose not to vaccinate their children, vaccination rates may fall below the required threshold, and the protection of herd immunity decreases. 128 Parents should also be reminded that they may not be aware in real time of the fact that vaccination rates have fallen below the required threshold. 129 Furthermore, they should be informed that herd immunity will not protect the child if the child is personally exposed—for example, by travelling to an endemic country or exposure to an infected individual. 130 In other words, parents need to know that herd immunity reduces the risk for unvaccinated children, but that an unvaccinated child is still at a higher risk of being infected if exposed. 131 Such an explanation not only decreases the risk that parents will choose to rely on herd immunity, it also describes more accurately the purpose and the importance of vaccination. 132
4. Content, Style, and Methods of Providing Information to Parents
Providing parents with information as to the nature and implications of vaccination is a necessary but not sufficient condition to ensure understanding. Another condition should be fulfilled: information should be provided to parents in a way that enables them to correctly interpret it. 133 Providing information to parents will not in and of itself increase parents' understanding. If the information is provided in a manner that is difficult to understand, the effect of the information on their behavior is lost, irrespective of how much information was provided. 134 Accordingly, several guidelines should be applied when articulating information and choosing methods for its communication.
First, information should be provided to parents in a language they know and through which they can communicate at a satisfactory level. Therefore, whether presented orally or in writing, information provided to non-English or non-Hebrew speakers should be translated.
Second, considering that inadequate health literacy skills have been found to be an important determinant of individuals' capacity to provide fully informed consent to medical treatments, 135 special attention should be given to parents with low health literacy skills. 136
Third, when provided in writing, information should be presented in a readable manner. 137 Several criteria have been proposed through which the readability of documents can be assessed and improved. 138 These guidelines relate to the content, structure, and writing style of the document. 139
A useful example for such guidelines can be found in a toolkit written by the Centers for Medicare and Medicaid Services (“CMS”). 140 Among the guidelines included in the tool kit, the following are relevant to the issue of readability:
Guidelines as to content: use the title and other prominent text to make clear to readers what the information is about; repeat new concepts and summarize the most important points; and incorporate definitions and explanations of new phrases into the text. 141
Guidelines as to structure: limit the information to an amount that is reasonable for the intended readers; 142 group the information into meaningful “chunks” of reasonable size; organize the information in an order that will make sense to the intended readers; use headings, subheadings, and other devices to signal what is coming next; and use tools to make important information easy to find (i.e., page numbers, table of contents, and index). 143
Guidelines as to style of writing: keep your sentences simple and relatively short; be direct, specific, and concrete as to the implications of the information and what the reader should do; create cohesion by making strong, logical connections among your sentences and paragraphs (i.e., repeat key words); choose words that are familiar and culturally appropriate for the intended readers; and use technical terms and acronyms only when readers need to know them, otherwise, use simpler words whenever you can considering the reading skills of your intended audience. 144
In addition to these guidelines, readability and comprehension of informed consent forms can be improved through readability formulas. 145 Although useful, these formulas should be carefully applied. Readability formulas predict the difficulty of words and sentences, usually based on word length, syllable count, and sentence length correlated with school grade level. 146 By focusing narrowly on individual words, sentences, and the length of the document, these formulas ignore every other factor that contributes to the ease of reading and comprehension. 147 Moreover, these formulas assume that longer text is necessarily more difficult to read. Thus, they ignore the fact that aiding the reader with comprehension sometimes requires adding explanations to unfamiliar concepts or situations. In these cases, the length of the document may in fact contribute to its readability. 148 It is therefore recommended to use scores from readability formulas with discretion and not as the single indicator of readability of the document. 149
Forth, the method of providing information — written, oral, visual, auditory, interactive — should be adapted to the characteristics and informational needs of parents. For example, in the case of parents who cannot read, providing information orally, visually, or using audio devices is appropriate. 150
In addition, attention should be given to empirical literature indicating that there is no evidence of the superiority of one method of providing information over other methods for improving comprehension. 151 Literature also suggests that the use of a combination of different methods to provide information appears to be more effective than using a single method. 152
It follows that while written materials have an important role in providing information to parents, they should not be used as the exclusive method for the provision of information. Written materials should be used as a supplement to other methods. They should be provided to parents prior to the encounter with the health provider, accessible during the encounter, and provided to them for personal deliberation when the encounter is finished. It would also assist parents in communicating their concerns to the health provider during the encounter and enable them to discuss the information with their network and reflect on it after the encounter. 153
Fifth, the style of communication should enable parents to ask questions about vaccination, be candid about their concerns and fears, and converse comfortably with the health provider about their doubts. For this purpose, physicians should establish an open, interactive, non-judgmental and non-adversarial dialogue. Moreover, parents should not feel rushed, intimidated, or concerned about what the health care provider thinks about their knowledge and attitudes towards vaccination. 154
Empirical studies suggest that adopting such a communication style not only improves parental ability to make informed decisions, it also positively influences their vaccination intentions. 155 Conversely, poor communication can contribute to rejecting vaccinations. 156
Establishing such a dialogue might be time consuming, and thus may be hard to accomplish in the reality of busy clinical environments. 157 Nevertheless, providing parents information before the encounter, making additional sources of information available at the clinic, and improving health provider communication skills may help make consultations more time efficient.
5. Who Should Provide the Information and When?
Informed consent is most effective when parents discuss the vaccine with a health care provider who is both well-informed about the vaccine and skilled at communicating information. 158 That does not mean that health care providers should be the only source for information. Parents reported that they want vaccination information to be available to them outside of the context of vaccination appointments, including from health workers, parents' groups, online forums, and other sources. 159 Moreover, making several sources of information available to parents increases the probability that they will understand the substance of the information. It may also shorten the time needed for the provision of information, which is an advantage given the limited time available to health care providers. 160
Nevertheless, the importance of health care providers in the informed consent process should be acknowledged. 161 A survey conducted in the United States in 2007 found that doctors and other health care providers were the most trusted source of health information. 162 Another study revealed that information or reassurance from a health care provider was the main factor in changing parents' vaccination decisions. 163 There are multiple other studies supporting the claim that a physician's recommendation of any vaccine significantly impacts the receipt of a particular vaccine. 164 It follows that placing the task of providing information with health care providers is not only justified through the principle of autonomy, it is also consistent with the interest of public health.
Having said that, attention should also be given to special characteristics of specific communities. For example, parents who are members of a close-knit group (e.g., religious group) would form their own community with group-specific values and biases. Members of such communities often distrust state authorities and as a result, the information provided by their representatives. 165 In these cases, the use of an in-group representative as a mediator might be preferable. 166
C. The Condition of Free Will
Faden and Beauchamp claim that autonomous decisions are decisions that are not controlled by others in a way that deprives the chooser of self-direction. 167 According to their approach, the condition of free will is associated with two basic notions: (1) external influences or interventions, and (2) the ability to resist them. 168 Only when the chooser cannot resist the external influence or intervention of another is his decision no longer autonomous. 169 Faden and Beauchamp continued and differentiated between three types of interventions: (1) persuasion, which is never controlling; (2) coercion, which is always controlling; and (3) manipulations, whose natures depend on the question of whether they prevented the chooser from exercising free will. 170
When applied to vaccination encounters, Faden and Beauchamp's approach suggests that reasonable efforts to persuade parents to vaccinate their children are consistent with the principle of autonomy. 171 Such efforts may include the provision of accurate and balanced information, presenting the vaccination recommendations of medical organizations, describing the social implications of non-vaccination, and mentioning clinician support of vaccinations.
Telling real-life stories in order to exemplify the results of non-vaccination is also an acceptable persuasion technique, so long as the information is presented to parents in a balanced manner. On the other hand, using intimidation techniques, such as presenting shocking images and horrifying facts about the fate of those who were not vaccinated is not recommended, since such manipulations may prevent parents from acting out of free will. Similarly, although parents should be informed about the private and social benefits of vaccination, blaming hesitant or abstaining parents for being “bad parents,” accusing them of being free-riders or behaving in a nonconformist manner, claiming that they are irresponsible, describing them as a possible source for epidemic outbreaks, and accusing them of endangering the health of others, are all inadvisable. Each of these techniques may be controlling to the point that parents will not be able to exercise free will.
Finally, threatening parents with severe consequences for non-vaccination, such as social condemnation, deprivation of medical treatment, or legal sanctions, should also be avoided. 172 Each of these techniques carries a substantial risk that parents will feel deprived of alternative courses of action and thus, coerced into vaccinating their child.
Health care providers should also be aware of empirical findings suggesting that controlling interventions not only endanger parents' abilities to exercise free will, but are also inconsistent with public health interests. Judgmental and adversarial discourse, pressure to vaccinate, and overbearing vaccination advocacy were found to deter parents from vaccination. 173 Consistent with these findings are parents' reported wishes that health care providers conduct open, respectful discussions with them regarding vaccination in a caring, sensitive, and non-judgmental manner by providing clear answers to their questions and a supportive environment for decision-making. 174 It follows that avoiding controlling communication techniques not only increases the probability of a successful informed consent process, it is also consistent with the interests of public health.
D. A Right to be Informed or a Duty to be informed ?
As we have seen, for a parent's vaccination decision to be autonomous, the parent should have a substantial understanding of the nature of the decision and its possible outcomes. 175 Considering that such understanding is not possible in the absence of relevant and accurate information, parents have a right to be informed about the proposed vaccine. However, should parents have an obligation to be informed about the implications of a decision not to vaccinate their child? More broadly, should parents have an obligation to be educated about the nature, benefits, and risks of vaccination, regardless of whether or not they decide to vaccinate?
We believe that the answer to this question is yes. Unless children are vaccinated without the permission of their parents, vaccination requires parental cooperation. It requires that they approach a relevant health care provider. Such cooperation is required even in countries where a decision not to vaccinate a child carries legal sanctions. So long as parents are willing to bear the burden of these sanctions, and in the absence of a legal duty to approach health care services, parents may simply refrain from any direct discussion about vaccination with health care providers.
As Part III indicates, vaccination hesitancy and refusal are often associated with misconceptions, mistaken beliefs, and uncertainty about vaccines. 176 When this is the case, parents cannot be considered to substantially understand the implications of a decision not to vaccinate their child and their decision cannot be considered to be autonomous. Thus, from the perspective of understanding, obligating parents to seek education about vaccination is consistent with the principle of autonomy.
When observed from the perspective of free will, requiring parents to be educated about vaccination is problematic. Parents who are not interested in being educated about vaccination or discussing their conceptions, beliefs, and attitudes towards the topic will be forced to do so, thus infringing upon their right to autonomy.
Nevertheless, we believe that the law should not only protect parents' right to give informed consent for vaccination, but it should also strive to ensure that a refusal to vaccinate a child will be an equally informed decision. Several considerations support this approach. A decision not to vaccinate a child risks, first and foremost, the health of the unvaccinated child. 177 Under these circumstances, limiting parental autonomy by requiring parents to be informed of the vaccine's benefits and risks is a proportionate measure for the protection of the child's health. Second, vaccines are not regular medical procedures. They are procedures whose implications extend beyond that of the vaccinated child and his parents to influence society as a whole. Because the decision to vaccinate is both a private and public health decision, intervening in parents' decision-making processes is justified (assuming that such interventions positively influence their vaccination decisions). 178 Third, requiring parents to be educated about vaccination does not deprive them of the option to refuse vaccination after receiving the information to the extent that the law allows such a refusal. Fourth, like the decision not to vaccinate a child, a refusal to become educated about vaccination will most probably end in legal sanctions, 179 though it is reasonable to assume that parents will not be physically coerced to attend education appointments or otherwise be educated. 180 Therefore, parents who are willing to accept the sanctions will still have the option of avoiding educational interventions. It follows that although requiring parents to receive education about vaccination interferes with their right to autonomy, this interference is limited in scope and is reasonable.
IV. THE LEGAL FRAMEWORK: A COMPARISON
A. Israeli Law
1. Informed Consent to Vaccination
The right to autonomy and the doctrine of informed consent are well established in Israeli law. It is anchored in Israeli law through court rulings which have acknowledged it since the 1990s, 181 the Patient's Rights Act, 182 and legislation which applies to specific treatments. 183
Subject to several exceptions, a patient has a right to autonomy. 184 Derived from this right is the physician's duty to obtain the patient's free consent to treatment (or his guardian's consent in the case of a minor) and to provide him with information regarding the proposed treatment so he can make an intelligent decision. 185
Contrary to the United States, Israeli legislation does not specifically address the issue of informed consent to childhood vaccination. That is, it does not specifically instruct what information should be delivered to parents before the administration of a vaccine, who should deliver the information, how the information should be provided, or how parents' consent should be accepted and documented. 186
In the absence of specific legislation, questions regarding informed consent for childhood vaccinations are left to the interpretation of the IMH and the courts. 187 Both the IMH and the courts should base their interpretation on patients' rights legislation, public health legislation, court decisions addressing the doctrine of informed consent, and general constitutional principles.
Three statutes are relevant to a discussion regarding informed consent to childhood vaccination: the Public Health ordinance of 1940, 188 the Patient's Rights Act of 1996, 189 and the Basic Law: Human Dignity and Liberty. 190 The Public Health Ordinance specifically regulates the issue of vaccinations, but it does not explicitly address the issue of informed consent. 191 Nevertheless, it is interpreted to authorize the IMH Director General to instruct what information should be provided to parents and how it should be provided. 192 According to the ordinance, the Director General is authorized to use all necessary measures to protect the public from infection by an infectious disease and to prevent its spreading. 193 These sweeping clauses can be interpreted as authorizing the Director General to instruct what information should be provided to the public, if such an instruction is necessary to protect the public from an infectious disease. 194
Like the Public Health Ordinance, the Patient's Rights Act does not explicitly address the issue of informed consent with respect to vaccination. Article 13(a) of the Act generally establishes the obligation to receive a patient's informed consent prior to any medical treatment. 195 Article 13(b) describes which information should be provided to the patient. 196 Neither of these provisions specifically address vaccinations. 197 Nevertheless, Article 2 of the Act defines “medical treatment” as including “preventive treatment,” thus clarifying that the law's provisions do not apply to therapeutic treatments alone. 198 Moreover, Article 1 declares that the purpose of the Patient's Rights Act is to protect the rights of an individual who seeks or receives medical treatment, thus extending its scope beyond individuals who need medical treatment due to a current illness. 199 In addition, the law is not limited in application; its provisions apply to every health care provider and every health care setting. 200 It follows that the provisions of the Patient's Rights Act regarding informed consent are applicable to vaccinations, notwithstanding the fact that vaccination is not a routine medical treatment, but a public intervention directed at protecting and improving public health. 201
Finally, and of special importance, is the Basic Law: Human Dignity and Liberty. 202 According to rulings by the Israeli Supreme Court, the right to autonomy, and therefore the parental right to autonomy, is considered a constitutional right that is embedded in the law. 203 It is also well accepted that the right of autonomy is of special importance in the context of medical treatment given the possible implications for an individual's quality and length of life. 204 Although recognized as a constitutional right, parental autonomy may be restricted by law provided that such a restriction is required for a worthy purpose and does not exceed what is required (the “proportionality test”). 205 Important to this discussion is the ruling of the Israeli Supreme Court, which held that protecting the health of children through vaccination and protecting public health by increasing vaccination rates both constitute worthy purposes. 206
It follows that according to Israeli law, parents' right to make informed decisions for their children applies to routine childhood vaccinations. However, this right may be restricted if required for the protection of the health of the vaccinated child or the public health, and if the restriction does not exceed what is required to accomplish these goals. 207
Once applied to childhood vaccines, the rules of the doctrine of informed consent as adopted in the Act and through court rulings regulate the acceptance of parental consent to vaccination. 208 According to these rules, vaccination should not be provided to a child unless his guardian consents to it. 209 The guardian's consent can be given in writing, orally, or implicitly via conduct. 210
For the guardian's consent to be valid it should be based on relevant information. 211 Hence, the parent has a right to receive information regarding the vaccine prior to its administration. The parent himself is not obligated to be educated about the risks and benefits of the vaccine, however, and he has the right to refuse the vaccine even if his refusal is not informed. 212 It follows that according to Israeli law, the attendance of unvaccinated children in school is not conditioned on the presentation of a certification verifying that the parent was educated about the risks and benefits of vaccination versus non-vaccination. 213
The obligation to provide information to the guardian rests on the health care provider. 214 There is no obligation to provide the guardian with the information in writing. 215 However, the information should be provided to the guardian as soon as possible and in a way that enables maximum understanding of the information so he will be able to decide using his free will. 216
This rule, as interpreted by the courts, imposes a number of duties on health care providers before vaccine administration. First, providers must explain the full meaning of the information regarding the proposed vaccine to the parent, in a language he is comfortable with, using clear terms, and according to his ability to understand. 217 The health care provider must make sure her explanations have been properly understood by the patient. 218 Second, health care providers must discuss the information with the parent. 219 This means that only providing a parent a form which includes the necessary information is insufficient to fulfill this duty. 220 Third, providers must enable the parent to make a free choice. 221 Keeping this duty in mind, a health care provider should not communicate information to parents and ask for their consent only a few minutes before administering the vaccine. 222 Moreover, health care providers should not exploit their status, power of persuasion, and information gaps between them and the parent. 223
Of special importance is the scope of information that should be provided to parents. According to Article 13(b) ofthe Patient's Rights Act, a guardian should be provided with medical information that he reasonably needs in order to make a vaccination decision. 224 Article 2 of the Act defines “medical information” as information which directly relates to the physical or mental condition of the patient or to the medical treatment. 225 Article 13(b) asserts that “medical information” includes the patient's medical condition, the nature of the proposed treatment, its goal and expected benefits, the probability of success, the risks involved in the proposed treatment, its side effects, expected pain and discomfort, the risks of alternative medical treatments compared with the risks of no treatment, and the fact that the treatment is experimental if that is the case. 226
Article 13(b) specifically notes that this list is not exhaustive. 227 The duty of disclosure may apply to types of information which are not explicitly mentioned in Article13(b), so long as its disclosure is required according to the general criteria for disclosure. The same rule applies to information expanding the term “medical information” as defined in Article 2 of the Act. 228
Article 13(b) was interpreted by Israeli courts as applying a “reasonable patient” standard. 229 According to this test, the duty of disclosure applies to information that a patient has a reasonable expectation to receive. 230 In deciding the issue of disclosure, a court's consideration is not limited to the patient's right to autonomy and his need for information. 231 Rather, professional attitudes about the information should also be provided to patients, in addition to budget limitations. 232
Several conclusions can be derived from these rules. To begin with, prior to administering a vaccine, a child's guardian should be informed about the following: (1) that the child is not sick and that the vaccine's purpose is preventive and not curative; (2) the diseases for which the vaccine provides immunity; (3) the method used to administer the vaccine (i.e., a shot or orally); (4) the expected benefits to the child (i.e., its importance and effectiveness in preventing an infection and the probability for a vaccine failure); (5) the risks, side effects, and discomfort involved in the vaccine for which a parent has a reasonable expectation to receive notice;(6) the expected risk of infection to unvaccinated children;(7) scientifically accepted alternative methods to prevent an infection (e.g. keeping good hygiene) and their probable success in preventing the infection; 233 and (8) the experimental nature of the vaccine, if applicable.
Notably, the scope of the duty of disclosure is not limited to information related to the risks and benefits to the vaccinated child. The wording of the Act, as well as the “reasonable patient” test adopted in case law, make the duty of disclosure applicable to other types of information. 234 For example, the duty can apply to information concerning the benefits of vaccination for others or data refuting unreliable claims presented by anti-vaccination movements. Both types of information can be considered information that will enable a parent to make an autonomous decision, and parents have a reasonable expectation to receive such information.
Finally, in deciding the scope of the duty of disclosure as it pertains to vaccination, consideration is not limited to parental rights to autonomy. According to Israeli law, consideration should also be given to professional attitudes and norms concerning the appropriate scope of disclosure. 235 This may include professional attitudes with respect to the appropriate balance between parents' right to autonomy and public health interests. Thus, when providing certain types of information could endanger public health, professional attitudes might support the conclusion that it should not be provided to parents, even if it is information that a parent requires in order to make an autonomous decision.
There is a belief that the scope of the duty of disclosure might be restricted in the case of vaccination. This perspective finds support by the ruling of the Israeli Supreme Court decision on the matter of CA 470/87 Altori v. Israel. 236 In this case, a child who received a vaccine against tetanus, diphtheria, and pertussis was diagnosed with brain damage several years after the administration of the vaccine. 237 She claimed that her condition resulted from the vaccine. 238 Among other arguments, the plaintiff ascribed negligence to the State, claiming that the State did not provide her parents with any warnings about the vaccine's risks. 239 The claim was rejected along with the argument that the State owed a duty to inform the parents of the vaccine's risks, and that the duty was breached. 240 The court explained that a decision to vaccinate a child is not a private decision that concerns the delivery of a treatment to a specific patient for a defined disease. 241 Rather, the decision to vaccinate a child is a decision that concerns mass vaccinations of healthy children, with the goal of protecting them from the risks of a severe childhood disease. 242 In such cases, parents are not competent to make this decision. 243 Therefore, they should not be provided with this information, which may cause panic and force them to make a decision to which they are not competent to make. 244
2. Vaccination Requirements
Unlike the law in the United States, Israeli law does not require children to be vaccinated against certain communicable diseases to attend school. 245 Additionally, the Israeli legislature has not adopted legal sanctions or initiatives designed to increase parents' willingness to vaccinate their children in other states. 246 Thus, according to Israeli law, parents' choice not to vaccinate their child carries no legal implications for the parent or the child. 247 Accordingly, unless the Director General of the Ministry of Health specifically decides otherwise, 248 there are no vaccination requirements that would significantly affect parents' right to make autonomous decisions for medical treatment of their children. 249
3. Causes of Action
The Vaccine Injuries Insurance Law (1989) and the Polio Injuries Compensation Law (2007) adopt a no-fault compensation system for vaccine injuries. 250 According to the Vaccine Injuries Insurance Law, an injured individual is entitled to compensation if a committee of experts finds that there is a causal connection between the vaccine and the injury. 251 The Polio Injuries Compensation Law states that an Israeli resident who contracts poliomyelitis in Israel is entitled to compensation if a qualified physician or medical committee determines that he suffers from a disability due to that illness. 252 According to both laws, the entitlement to compensation is not conditioned on proof of negligence on the part of the state, the manufacturer of the vaccine, or the vaccine provider. 253 Even though the laws establish specific arrangements for the compensation of vaccine victims, both allow the injured individual to choose whether to receive a no-fault compensation or to file a negligence claim. 254
If the injured person chooses to file a negligence claim, he may base his claim on the doctrine of informed consent, in addition to any other possible argument of negligence. 255 He also carries the burden of proving a breach of the duty of disclosure and the existence of a causal connection between the breach and his physical injury. For this purpose, the claimant should prove a causal connection between the breach and the decision to accept medical treatment (“decision causation”) and between the medical treatment and the plaintiff's physical injury (“injury causation”). 256 If the plaintiff meets this burden, he is entitled to compensation for the physical injury he suffered as a result of the vaccine. However, even if the plaintiff fails to prove that the breach of duty of disclosure resulted in physical injury to his body, he may still be entitled to compensation for infringement of his right to autonomy. Since 1996, Israeli law recognizes infringement upon the right to autonomy as compensable damage that entitles the plaintiff to compensation, regardless of whether he suffered physical injury as a result of such infringement. 257 The compensation for infringement on the right to autonomy is substantial and may range from $5,000 to $100,000. 258
B. Law in the United States
The present legal framework for vaccine informed consent in the United States has three parts. First, general informed consent requirements apply to this context with one important change: a federally required Vaccine Information Statement (“VIS”) is the center of vaccine informed consent for parents. 259 Second, state educational requirements attached to school immunization requirements matter for informed refusal. 260 Third, liability protections limit the availability of judicial review in this area and can have important implications. 261
As background, the National Childhood Vaccine Injury Act of 1986 (“NCVIA”) dramatically changed the legal framework governing informed consent related to vaccines. 262 The Act requires the Secretary of Health and Human Services to create materials describing the risks and benefits of the vaccine and requires providers to give them to patients before administering a vaccine. 263 The Act also limits the ability of a person to sue in civil court for harms from vaccines by only allowing any suits after a claimant has gone through a special administrative program created by the Act called the National Vaccine Injury Compensation Program. 264 The Act also reinstates the learned intermediary doctrine that limits manufacturer liability for not providing direct warnings to patients. 265 The changes in the legal framework were so profound that a detailed description of the former framework is likely unhelpful. We therefore only include descriptions of the former framework to the extent that it helps explain the present framework.
1. Informed Consent to Vaccination
Consent to medical treatment, derived from the importance of bodily autonomy, is a longstanding and well-established requirement in the United States. 266 In the context of minors, parents usually must give informed consent on behalf of their children. 267
Case law generally does not treat informed consent to vaccination differently than informed consent for other areas. There is, however, a statutory difference. The most important part of the current informed consent framework is the VIS, mandated by §§300aa-26 of the NCVIA. The Act requires the Secretary of the Department of Health and Human Services to create “information materials for distribution by health care providers to the legal representatives of any child or to any other individual receiving a vaccine set forth in the Vaccine Injury Table.” 268 The process of creating these materials is analogous to the requirements set in the Administrative Procedures Act for notice and comment rulemaking. 269 The Secretary publishes notice of the materials and provides sixty days for public comment. 270 The Secretary also consults with “the Advisory Commission on Childhood Vaccines, appropriate health care providers and parent organizations, the CDC, and the Food and Drug Administration.” 271 The final version is published in the federal register and is available online. 272 The non-profit organization Immunization Action Coalition has translations of the VIS into multiple languages available on its website, 273 and the CDC, which has the most current versions available to the public, provides links to those translations. 274 The NCVIA requires that healthcare providers give the person being vaccinated, or their legal representative, a copy of the materials, usually the–VIS, before the vaccine is administered. 275 The materials have to include, by law:
a concise description of the benefits of the vaccine,
a concise description of the risks associated with the vaccine,
a statement of the availability of the National Vaccine Injury Compensation Program, and
such other relevant information as may be determined by the Secretary. 276
Note that the law is silent on whether the listed benefits are for the child or also for society. Most states use the VIS. Alaska, 277 California, 278 Hawaii, 279 Oregon, 280 Massachusetts 281 and New York, 282 for example, link to the VIS when discussing informed consent requirements. Michigan, on the other hand, links to its own state-produced VIS, which replicates the federal VIS except that it adds information about the state immunization registry, Michigan Care Improvement Registry. 283 Some states, like Kansas and Louisiana, require a signature on receipt of the VIS. 284 Several states require written acknowledgement of the receipt of VIS and consent when vaccines are administered by pharmacists, particularly in instances when pharmacists provide vaccines without authorization by a medical practitioner. 285 In short, the VIS is the main state focus for informed consent. In addition, some states ask providers to have refusing parents sign a form. 286
Important questions not answered by the Act or by jurisprudence (see below) are whether, and to what extent, an oral discussion of the VIS is required by law, and how far in advance parents need to receive the VIS.
A final part of the informed consent framework is the question of informed refusal. A 1980 California case embodies the doctrine. 287 In Truman v. Thomas, children of a woman who died from cervical cancer sued her doctor for failing to explain the material risks of refusing a pap smear – a refusal directly linked to her death. 288 The Supreme Court of California found that informed consent cannot be meaningfully exercised without the patient having been given material information for the decision, which includes information about the consequences of refusal. 289 This doctrine applies to vaccine refusal. 290
2. Vaccination Requirements
An important part of the normative framework in the United States is the interaction between school immunization requirements and informed consent. At present, all fifty states and the District of Columbia require that children receive certain vaccines before going to school, though the specific vaccines required vary by state. 291 While all states and the District of Columbia provide medical exemptions from these requirements, non-medical exemptions vary. 292 For example, four states — - California, Mississippi, New York and West Virginia — do not provide non-medical exemptions. 293 Maine will join these states in September 2021. 294 On the other hand, some states, like Colorado and Minnesota, provide relatively easily attainable exemptions that allow anyone with any opposition to vaccines to exempt their child. 295 Other states are in between, allowing exemptions under some conditions but not others. For example, New York requires a showing of a sincere religious opposition to vaccines. 296 Notably, Washington, Oregon, and Michigan add educational requirements for parents seeking exemptions. 297
Two issues deserve discussion. First, school immunization requirements clearly protect public health by reducing outbreaks, 298 but by limiting parental freedom, do these requirements affect informed consent? Second, how do educational requirements attached to exemptions from school immunization requirements interact with informed consent?
School immunization requirements clearly make the choice to not vaccinate a harder, less comfortable one. In fact, in one case addressing vaccine injury, the Supreme Court of Nevada, in obiter dicta, suggested that immunization requirements removed choice. 299 In Allison v. Merck, a mother sued claiming the measles, mumps and rubella vaccine (“MMR”) caused her son permanent disability. 300 Because the injuries in question preceded the NCVIA, the mother could choose whether to go through the no-fault program or to state court, and she chose state court. 301 The main claims in the case are beyond the focus of this paper, but in its conclusion, the court added the following statement:
It is one thing to proffer a medicine to a prospective user, saying: “You have a pernicious disease. We have a medicine that has serious side effects, even, possibly, blindness and deafness. You make the choice.” It is quite another thing to say: “You must have your son vaccinated or he cannot go to school. Your son might get a rash or, on ‘one out of a million’ odds, might get a ‘brain inflammation.’” In the first case, the user's knowing acceptance of the risks frees the purveyor of liability. In the second case, the traditional public policy behind strict product liability comes into play. Ms. Allison did not and could not have bargained for this misfortune. She had no real choice. 302
While this is dicta, the court was suggesting that school immunization requirements remove choice which undermined informed consent. For a number of reasons, we think the court overstates the case. First, most states have exemptions to mandates, and if Ms. Allison had an exemption available, her claim that she had no choice is unconvincing. Second, many medical choices have external consequences. For example, drivers with epilepsy will often need a doctor's recommendation before they can get a license. 303 If those drivers do not want to follow a doctor's guidance in managing their epilepsy — including in taking seizure-controlling medication — these drivers may be denied a license; the drivers are free to do what they want, but if they want a driver's license, they need to follow the doctor's guidance. 304 In another case, the New Jersey Superior Court, citing extensive precedent, confirmed a statute allowing the City of Newark to confine an individual who refused treatment for tuberculosis. 305 There are similarities and differences between these situations and ours, of course. A person with active tuberculosis is a much more immediate threat than the unvaccinated child before exposure to disease. 306 In both cases, however, there is a risk of transmitting a potentially fatal disease. 307 Arguably, direct confinement is also a more severe consequence than limits on sending a child to school, especially when other educational opportunities are available. Not driving can be a much more severe sanction, as it can, in some areas in the United States, make it impossible to reach shopping, work places, or hospitals. 308 Yet, because of the risk to others, driving is conditioned on certain medical treatments. 309 In other words, restrictions based on medical decisions that create public health risks are not new — and they do not directly undermine the right to consent. Courts in the United States have, though rarely, ordered that children be vaccinated over parental opposition. 310 These actions involve direct coercion. Denial of school attendance under a mandate is a serious consequence, 311 but it is less coercive than jailing parents or force-vaccinating. Whether it does negate consent — especially if the state allows options like home schooling — is debatable.
Another way school immunization requirements are relevant to the discussion is that several states have adopted an educational requirement as part of their process for obtaining exemptions. 312 Between 2011 and 2013, several states passed laws that required parents to complete educational requirements before their children could be exempt from school immunization requirements. 313 While Washington, California and Oregon all have passed such laws, 314 the specific educational requirements in these Western states vary. In Washington and California parents are required to obtain the signature of a medical provider confirming that the practitioner provided parents with information about the risks and benefits of vaccines. 315 Oregon's law is a little more flexible and offers parents the opportunity to watch an online educational module as an alternative to a signature from the provider. 316 Other areas of the country have also adopted such rules. In 2015, Michigan passed a rule that required parents who seek a non-medical exemption to attend an educational session at their local health department. 317 In Illinois, parents using exemptions must have a provider signature confirming that they recieved education on the benefits of immunization and the health risks, to both the student and the community, of the communicable diseases. 318 In Vermont, parents filing exemptions must submit a form stating that the parent reviewed evidence-based educational material provided by the Department regarding immunizations. 319 In Arizona, parents filing exemptions have to submit a signed statement to the school administrator confirming that they received information about immunizations provided by the Department of Health Services and understand the risks and benefits of immunizations and the potential risks of non-immunization. 320 While less extensive than some other states, Utah still requires that the exemption form include the department's position about the benefits of immunization. 321
All these requirements draw on two main intellectual roots. The one more commonly emphasized is a convenience rationale: a view that many exemptions are exemptions of convenience, and that increasing the difficulty to obtain exemptions would reduce exemptions. 322 A solid body of work shows that states where exemptions are easy to obtain also have higher rates of exemptions. 323 The other reason for these tools, and the one that fits our recommendations, is informed refusal. As mentioned, informed refusal is part of informed consent law in the United States, and these requirements fit that framework. 324 Prof. Ross Silverman was the first, to our knowledge, to connect the legal informed refusal requirement with school mandates. 325 Prof. Silverman suggested:
[A]ny applicant wishing to apply for an exemption should be required to undergo an “informed refusal” process. Prior to receiving an exemption, applicants would meet with a health professional (e.g. public health officer, school nurse, or primary care provider) to discuss the relative risks and benefits of immunization and exemption. This interaction would need to be memorialized on a standardized form. 326
In a footnote he connected it more explicitly to Truman v. Thomas 327 and added:
In Truman, “informed refusal” described an affirmative duty on the part of physicians as part of their adherence to the standard of care. My intent is to use the phrase more broadly to describe an affirmative duty on the part of the guardian of the child seeking exemption to hold an exemption-specific conversation with a health care provider, and then to present evidence of such a conversation to exemption-granting authorities …, the greater burden proposed in the case of childhood exemption “informed refusal” is upon the person seeking exemption rather than the provider. 328
Aside from their effect on public health, the informed refusal requirements attached to exemptions can support informed consent by putting in place an informed refusal process. These requirements give doctors an opportunity to provide nonvaccinating parents with data on the risks of their choice. This is not a perfect solution. For one, parents who do not vaccinate their children may seek out sympathetic doctors who do not properly inform. Even so, informed refusal requirements create an opportunity for discussion that may not exist without them.
3. Causes of Action
In addition to addressing the VIS, the NCVIA also changed the framework for judicial review in two important ways. First, the Act required that claims related to a “vaccine-related injury or death” be brought before an administrative no-fault program before it can be brought in state court. 329 As a result, since the passage of the Act, there has been no real jurisprudence on informed consent related to vaccines because the program only requires showing causation and damages and does not require showing fault, which prevents discussion of informed consent questions in the cases. 330 Moreover, while there are no further legal barriers for petitioners suing their physicians in state court after going through the program, we were unable to find any informed consent cases of that variety, which supports the conclusion that most people do not go to state court after going through the program. 331
C. Comparative Observations
There are both similarities and differences between the legal frameworks in the United States and Israel. Following the order of discussion, a glaring difference is that Israel has neither routine school immunization requirements nor routine informed refusal requirements, while all states in the United States have some requirements (though some have easily attainable exemptions). 332 The differences are just as noticeable in the framework for informed consent: while both countries apply the general legal regime for informed consent to the vaccination context, the United States has a special, standardized form required by law for every vaccination, standardizing at least part of the consent process across states and across all childhood vaccines. Israeli law, on the other hand, does not require the use of a specific informed consent form for childhood vaccination. Nevertheless, the difference here might be less significant in practice. As the next part explains, Israel has its own set of forms, but it is a narrower and the content and standardization of it are different. Finally, while both countries have a no-fault system available for compensating claims of vaccine injury, the United States system is mandatory – claimants have to go through the vaccines court to be compensated – while in Israel, claimants have a choice to go through the regular path of claiming malpractice and violation of informed consent. This difference means that informed consent cases in the area are almost non-existent in the United States, while they exist – though rarely – in Israel.
V. INFORMED CONSENT TO VACCINATION IN PRACTICE: THE AMERICAN AND ISRAELI EXPERIENCE
This section uses several sources to examine more closely how informed consent works in practice. This article does not provide a detailed empirical study of what, when, and how information is presented to parents. Instead, it draws on official documents to construct how health authorities and professional organizations think informed consent to vaccination should look in practice. In addition, this section also examines the resources actually used to provide informed consent. It does draw on a few qualitative sources to add depth, but it is not a systematic empirical study of informed consent.
A. Israel
The practice of informed consent to routine childhood vaccination in Israel is based on guidelines articulated by the IMH. 333 Issues that are not addressed by these guidelines are left to the discretion of the medical institution or the health provider administering the vaccine. 334
The guidelines regulate informed consent to vaccination in the three settings where routine childhood vaccinations are administered: (1) neonatal units in hospitals, (2) Mother and Child Health Centers (“MCHCs”), and (3) schools. 335
Soon after birth and while hospitalized in the neonatal unit, newborns receive the hepatitis B vaccination. 336 According to an IMH circulate published in 1997, health care providers in the neonatal and maternity units should inform parents of the medical procedures provided to newborns during hospitalization. 337 The information may be provided to parents orally, in writing, or through pamphlets. 338 The circulate instructs health care providers to accept parents' consent to the expected procedures and to inform them that they have the right to refuse those procedures. 339 The consent may be given orally or in writing. The circulate states explicitly that the duty to obtain parental informed consent applies to vaccination. 340 A circulate published two years later 341 describes the information that should be provided to parents using a uniform information form. The circulate clarifies that the information form does not exempt the health provider from the duty to provide parents the information orally, the duty to obtain their consent orally or in writing, or the duty to inform them of their right to refuse treatment. 342 The form informs parents that routine medical treatments are administered in the neonatal unit, including the first dose of hepatitis B vaccination. It also states that according to the recommendation of the IMH, all newborns in Israel should be vaccinated against hepatitis B soon after birth or when the child reaches a certain weight. 343 Finally, the form specifically declares that parents have the right to refuse any of the medical treatments described in the form and invites parents to present questions to the medical staff. 344
Several conclusions emerge from this description. First, parental consent to the administration of the hepatitis B vaccine may be given orally or in writing. Thus, the medical institution decides how parental consent would be obtained. Second, while the first circulate determines that the information may be provided to parents orally, in writing, or through pamphlets, the second circulate clarifies that an information form does not replace oral explanation (suggesting that an oral discussion is necessary even if written materials are provided). Hence, the IMH guidelines are inconsistent on this issue. Third, while the second circulate includes a uniform information form, it does not obligate health care providers to use this form or to provide parents the information in writing. 345 Accordingly, the question of whether to provide the information in writing and what information should be provided to parents is left to the discretion of the medical institution and the health provider. Fourth, the information provided to parents regarding the vaccine is part of a general form aimed to inform parents of the medical treatments administered to newborns. 346 Fifth, the vaccine information included in the form is partial and inadequate. The few facts mentioned in the form include: the disease against which the vaccine is administered (infectious hepatitis B), that the vaccine is administered to all children in Israel, that the vaccine is administered according to the recommendation of the IMH, the timing of vaccination, and medical instructions for vaccination. 347 Other material facts regarding the vaccine are not mentioned. These include the implications of being infected with the disease, the vaccine's side effects and risks, and the vaccine's importance, effectiveness and benefits. 348 However, as noted above, parents wishing to present questions about the vaccine are invited to consult with the medical staff. 349 Sixth, parents' right to refuse the administration of the vaccine receives special attention in the IMH guidelines. The guidelines acknowledge and seek to protect the parents' right to autonomy by emphasizing that parents should be informed of their right to refuse. 350
MCHCs are another setting where children are vaccinated. 351 According to the IMH recommendations, between the time of release from the hospital and the start of elementary school, children should receive the following vaccines: DTaP-Hib-IPV, MMRV, PCV, hepatitis B, hepatitis A, and the rotavirus vaccine. 352 Two documents regulate the administration of vaccination in MCHCs: the Vaccines Guide 353 and the Guide to Vaccines Injection. 354 The two guides regulate the medical aspects of vaccination in a comprehensive and detailed manner. In addition, the Guide to Vaccines Injection includes specific guidelines regarding informed consent to vaccination. 355 As part of the preparation process for vaccination, health care providers are instructed to inform parents about the immunization schedule, the specific vaccine, the way the vaccine is administered and the potential side effects of the vaccine. 356 Another part of the Guide to Vaccines Injection that addresses reducing anxiety during vaccination also mentions the importance of informing parents about the vaccine benefits and answering their questions. 357
Several conclusions emerge from this review. First, the issue of informed consent to vaccination receives little attention compared to the medical aspects of vaccination that are comprehensively discussed in the guides. Second, although the Guide to Vaccines Injection instructs providers to provide parents information about the vaccine, it does not instruct them to ask for their consent before administering the vaccine. Third, the guidelines themselves are very general and vague on the issue of informed consent. They instruct providers to inform parents of the “specific vaccine” without specifying the information that should be provided when informing the parents (e.g. only its name or its components as well?). 358 Furthermore, while the Guide to Vaccine Injection asks providers to inform parents of “side effects of the vaccine,” it does not provide any specific instructions on what side effects to tell the parents (e.g. only material side effects or all side effects?). 359 Fourth, the information providers are instructed to provide to parents is partial and insufficient. Accordingly, the Guide to Vaccine Injection does not require providers to inform parents of the nature of the disease the vaccine targets, the contagiousness of the disease, how the disease spreads, the implications of infection, alternative methods to prevent the disease and their effectiveness compared to vaccination, effectiveness and safety of the vaccine, and the social benefits of vaccination. 360 Fifth, although the Guide to Vaccine Injection highlights the importance of informing parents about the vaccine's benefits and answering their questions, it also makes it clear that the purpose of these measures is to reduce parents' and children's anxiety about vaccination. 361 Thus, it ignores the fact that these measures have an additional purpose — to enable parents to make an autonomous decision. Finally, the Guide describes the information that should be provided to parents. It does not address other relevant issues like ways of obtaining parental consent and providing them information, the obligation to provide the information in an understandable form, and the obligation to refrain from actions that may prevent parents from making a free and voluntary decision.
Information regarding the vaccines administered to children in MCHCs is also provided to parents through a pamphlet drafted by the IMH. 362 The pamphlet addresses all routine childhood vaccines, including those administered in MCHCs. 363 It starts with a general declaration as to the importance of vaccination and states as follows:
Vaccination means protection. The most effective and safe way to protect children from contagious diseases is to administer a vaccine. Vaccines are considered the most important breakthrough in preventive medicine. Vaccines prevent the infection of dangerous diseases that can cause great suffering, severe disability and even death…The percentage of children receiving routine immunizations in Israel is one of the highest in the world, although vaccination is not required by law. 364
The pamphlet also refers parents to the treating staff and to the IMH's website for further information. 365 In addition, the general part of the pamphlet explains the way vaccines work, the importance of vaccinating a child on time, the advantages of combining several vaccines in one shot, and whether vaccination can be administered to a sick child. 366 Of special importance is the reference to vaccination's side effects. On this issue, the general part of the pamphlet declares as follows:
Vaccination, like any medication, can cause symptoms, such as fever, general bad feeling, redness and swelling where the injection was given. These symptoms are usually mild and go away in a short time, usually within a day or two…Very rarely (once in a million doses), an immediate anaphylactic allergic reaction may occur… The risks of the diseases against which a child is being vaccinated are far more severe than the risks involved in vaccinations. The Ministry of Health cares for the welfare and health of our children and seeks to protect them from serious and dangerous diseases with minimum side effects after vaccination. 367
In addition to general information about vaccination, the pamphlet provides specific information about each vaccine and the disease against which it is administered. 368 This includes the age range for the vaccination, the method of administration, and possible side effects. 369 The pamphlet differentiates between common, rare, and very rare side effects. 370 Additionally, it includes the name of each disease against which the vaccine is administered, a description of its nature and risks (morbidity, disability, and mortality), and populations especially susceptible to the disease (e.g. babies and the elderly). 371 The pamphlet also has information on the communicability of the diseases associated with the influenza trivalent inactivated vaccine (TIV) and vaccines against rotavirus and HPV. 372 It also mentions the ways the diseases associated with the vaccines for hepatitis B, hepatitis A, PCV, rotavirus, and HPV spread. 373 Finally, the pamphlet has information about the effectiveness of the vaccines for hepatitis A and HPV to prevent infection. 374
Several conclusions emerge from this description. First, the information provided to parents regarding the specific vaccines is incomplete. For example, information about the contagiousness of the disease against which the vaccination is administered is not presented for the following vaccines: MMRV, hepatitis B, hepatitis A, PCV, and DTaP-Hib-IPV. 375 The absence of such information is particularly surprising in the context of the MMRV considering that measles is a very contagious disease. Another glaring omission in the pamphlet is the absence of information for all but two vaccines regarding their effectiveness in preventing infection. 376 Second, even though the general part of the pamphlet provides parents with information regarding vaccination, it does not differentiate between vaccines. For example, the general part of the pamphlet presents vaccination as the most effective way to prevent infection, but it does not provide parents with any specific information regarding the effectiveness of each vaccine. 377 In fact, it does not even inform parents that different vaccines have various degrees of effectiveness, a well-known fact. 378 Third, although the pamphlet includes a general declaration regarding the importance of childhood vaccination, it does not explicitly address the social benefits of vaccinating a child. The pamphlet uses the slogan: “Parents protect their children. Vaccines protect children,” which explicitly presents vaccination as an act with only individual benefits. 379 Fourth, parents are not informed that more detailed information can be found at the IMH website even though the pamphlet only presents partial information. 380 Fifth, because the pamphlet informs parents that childhood vaccination is not obligated by law, 381 it also impliedly informs them of their right to refuse to vaccinate their children. The pamphlet, however, does not inform parents explicitly that they can refuse to vaccinate their children.
The third setting where routine childhood vaccines are provided to children is school. 382 According to the IMH guidelines, children attending school should be vaccinated through on-site health providers with the following vaccines: MMRV, DTaPHib-IPV, flu vaccine, and HPV. 383 Guidelines published by the IMH in 2018 specify the methods for accepting parents' consent to vaccination and for providing them information. 384 The guidelines provide four alternative methods for accepting parental consent to vaccination: (1) acceptance of records of immunizations from the parent following a message sent by the school nurse regarding the expected vaccination; (2) parental consent to vaccination by telephone; (3) return of the signed vaccination information form, which includes no objection to the administration of the vaccine, by the parents; and (4) parents' signature on a Parental Declaration Regarding the Health of a Child and Consent to the Provision of Student Health Services, detailing the vaccinations provided at the school. 385 It follows that parental consent to vaccination may be given orally, in writing, or through conduct, and refusal can be provided either orally or in writing.
The guidelines have determined four cumulative methods for providing information to parents about on-site vaccines: (1) publication by the IMH in the general press at the beginning of the school year in several languages; 386 (2) an information pamphlet detailing the immunization program at school; (3) an information form, which is provided to parents before the administration of every vaccine, that includes information regarding the vaccine and the health conditions that require notification; and (4) a Parental Declaration Regarding the Health of their Child. 387 Notably, according to the above IMH guidelines, information regarding the vaccines provided to children in school should be provided to parents in writing.
An important conclusion that emerges from this review is that parents may consent or refuse to the administration of a vaccine without having a conversation with a health provider regarding the information provided to them in writing or the implications of their decision.
As its name reveals, the Parental Declaration Regarding the Health of a Child requires parents to provide a declaration about the health of their child, provides them with information regarding the medical treatments to be provided to their child, and asks parents to consent to the vaccine's administration. 388 More specifically, the declaration asks parents to confirm that they are aware that their child will be vaccinated with the vaccines detailed in the form, according to the immunization program determined by the IMH. 389 Parents are also asked to confirm their consent to the administration of the vaccines or inform the school nurse in writing of their objections. 390 Parents should sign and deliver the declaration to the school at the beginning of each year. 391
When this method is used, a parent consents to vaccination for her child through a general form, which lists several vaccines and other medical procedures. 392 Moreover, upon signature of this form, a parent will be considered to have consented to the administration of all vaccines, unless she informs the school nurse, in writing, that she objects to the provision of the vaccine. 393 At the same time, the form explicitly informs parents that they can refuse to vaccinate their child. 394
In addition to this form, every year parents receive a pamphlet informing them of the health services to be provided to children at school. 395 The pamphlet includes information on: the health provider administering the vaccines (school nurse), the vaccines to be administered, the fact that the vaccine is administered according to the routine immunization program in Israel, a general declaration regarding the importance of vaccination (“the most effective and safe method to protect your child from dangerous infectious diseases is vaccination”), ways of providing consent to vaccination, and the need to inform the school health provider of any reservation the parents might have as to the administration of any of the medical procedures mentioned in the pamphlet. 396 Parents are also advised to present whatever question they have to the school nurse. 397
Notably, the pamphlet presents vaccination as a private act that carries individual benefits to the child being vaccinated. 398 The social benefits of vaccination are not mentioned in the pamphlet. 399
Finally, and most importantly, the school provides information sheets prior to the administration of every vaccine (MMRV, Infl.TIV, Tdap, Tdap-IPV, and HPV). 400 According to a circulate published by the IMH, parents should receive the information pamphlet two weeks before the administration of the vaccine. 401 Although a specific information sheet exists for each vaccine, all information sheets include the name of the disease, the name of the vaccine against the disease, the fact that the vaccine is administered according to the routine immunization program in Israel, the purpose of the vaccine (“to prevent the child from being infected with the disease which might result in severe or deadly complications”), the method of administration, possible side effects of the vaccine (common vs. extremely rare), and the fact that most side effects are mild and go away in a short time. 402 All informational sheets also state that parents must provide the school nurse medical information that is important for making a medical decision regarding vaccination (e.g. if on the day the vaccine is administered the child has an acute fever disease, if the child had a severe reaction to a previous dose of the vaccine, and whether the child has had an anaphylactic reaction to any drugs, food, vaccination or latex). 403
The only sheet that provides information about the current dose given to a child and the number of doses required to achieve immunity is the HPV information sheet. 404 Additionally, all sheets have some general information about the effectiveness of the vaccine, but none of them present specific data about it. 405 Moreover, three out of five information sheets only indirectly address the issue of vaccine effectiveness. Those three, the Tdap, Tdap-IPV, and MMRV sheets, merely state “vaccination against these diseases prevents the diseases.” The influenza TIV information sheet (“the vaccine decreases the risk of being infected with the disease … ”) and the HPV information sheet (“the vaccine is effective and safe”) include direct references to the vaccines' effectiveness. 406 Finally, three out of five information sheets address the issue of the vaccine's safety. The HPV information sheet states, “The vaccine is safe and effective.” 407 Both Tdap and Tdap-IPV information sheet state that “[t]he administration of the vaccine against these diseases is much safer than being infected with one of them”. 408 The two other information sheets (the MMRV and the influenza TIV information sheets) do not address this issue. 409
As with the other information materials provided to parents before vaccination, these sheets are also partial and inadequate. Once again, the sheets do not reference the contagiousness or transmission methods of the diseases. Moreover, they do not provide information on whether an infection may be prevented through other methods (i.e., keeping good hygiene) and the effectiveness of such methods. Additionally, the information sheets only provide the consequences of being infected with the disease in general terms. Furthermore, no information sheet provides specific information about the possible complications of infection or the disease's mortality rates. The information provided in the sheets about the vaccines' effectiveness and safety is also woefully incomplete and general. All sheets provide, at most, laconic declarations about these issues, and none provide detailed information about the effectiveness and safety of the vaccine. 410
The information sheets do not invite parents to visit the IMH website for more detailed information even though the sheets include only partial and general information regarding vaccination. 411 This is surprising since the IMH website provides extensive and detailed information regarding vaccination through diverse sources of information (written materials, shorts educational videos, and presentations). 412 Moreover, the sheets do not invite parents to consult with the school nurse or other health care providers about the information provided to them. 413
Finally, the pamphlets and information sheets are, generally, reasonably readable. They use titles and other upfront text to make the subject matter of the information clear to readers. They are short and contain a limited amount of information that is grouped into meaningful and reasonably sized “chunks,” of which some are only one sentence. Furthermore, overall information is organized in a way that makes sense to the intended readers with headings and subheadings used to signal what is next and sentences being simple and relatively short. Finally, the pamphlets and sheets rarely use technical terms, in most cases, only used when readers need to know them. 414 Even so, these documents contain two characteristics that decrease their readability. First, the information is often presented in a general and vague way, which makes it hard for the reader to acquire a substantial understanding of the implications of a decision to vaccinate or refuse to vaccinate a child. Second, the documents do not incorporate definitions and explanations of technical or unfamiliar terms. 415
B. United States
The vaccine schedule in the United States includes recommendations that children be vaccinated against diphtheria, haemophilus influenzae B, hepatitis A, hepatitis B, influenza, measles, mumps, pertussis, pneumococcus, polio, rotavirus, rubella, tetanus, and varicella before the age of two. 416 During their teen years, the recommendation is that children receive vaccines against meningococcal disease and human papilloma virus (HPV), and a booster for tetanus, diphtheria and pertussis. 417
1. Guidance and Recommendations by Professional Organizations
The American Academy of Pediatrics (“AAP”) is a good starting point for examining professional organizations' guidance about vaccine informed consent because childhood vaccines and pediatricians play a major role in the vaccine informed consent discussion. The AAP has an important role in vaccine regulation in the United States. It is one of the organizations that makes recommendations about vaccine schedules. 418 It has a website for parents to receive vaccine information, 419 and it often clearly expresses strong support for immunization. 420
On the topic of informed consent, the AAP has a document on best practices. 421 The document opens with the National Vaccine Advisory Committee 422 standard 7, which addresses informing parents. 423 The National Vaccine Advisory Committee, created in 1987, “ recommends ways to achieve optimal prevention of human infectious diseases through vaccine development, and provides direction to prevent adverse reactions to vaccines.” 424 The standard opens with the general principle that “[p]arents/guardians and patients [be] educated about the benefits and risks of vaccination in a culturally appropriate manner and in an easy-to-understand language.” 425 It then addresses the way education will take place:
Health care professionals should allow sufficient time with parents/guardians and adolescent patients to discuss the benefits of vaccines, the diseases that they prevent, any known risks from vaccines, the immunization schedule and the need to receive vaccines at the recommended ages, and the importance of bringing the patient's hand-held vaccination record to each health care visit…
For all commonly used childhood vaccines, all health care professionals are required by federal law to give a [VIS] to vaccine recipients or their parents/guardians at each visit … If necessary, health care professionals should supplement the VIS with oral explanations or other written materials that are culturally and linguistically appropriate. Health care professionals should review written materials with patients and their parents/guardians and address questions and concerns. 426
The document continues with its self-described “best practices for pediatric offices” which it encourages providers to adopt. 427 The AAP document recommends giving the VIS early, having written materials to address common concerns, helping parents find reliable online information, allowing time for the discussion, documenting, and having refusing parents sign an informed refusal form acknowledging the risks of not vaccinating. 428 It ends with a list of additional resources. 429
The CDC addresses the VIS — though not informed consent generally — on several different webpages. 430 Among other guidance, the CDC instructs providers to supplement the VIS with “visual presentations or oral explanations as appropriate.” 431 For translations, providers are referred to the Immunization Action Coalition (“IAC”) website. 432
The IAC's site was created in 1994. IAC is a non-profit organization that “works to increase immunization rates and prevent disease by creating and distributing educational materials for healthcare professionals and the public that enhance the delivery of safe and effective immunization services.” 433 It has partnered with the CDC on multiple projects. 434 Most relevantly, the CDC directs people seeking translations of VISs to the IAC sites. 435 In addition, the IAC offers its own guidance on VISs. In a document titled “You Must Give Your Patients Vaccine Information Statements (VISs) — It's Federal Law!” the IAC describes VISs and explains to providers that VISs are required in public and private settings, before a vaccine is given, and for each dose. 436 The resource reminds providers to document giving the VIS. 437
2. Looking at the Vaccine Information Statement
The VIS has such an important role in the United States' informed consent process for vaccines, so it is worth going in detail into their content and quality. This section addresses two issues: content and readability of VISs.
A good place to start is the multiple vaccines VIS, since it can be used instead of individual ones and covers vaccines common in infant routine visits. 438 The VIS covers the diphtheria, tetanus and pertussis vaccine (DTaP), the vaccine against haemophilus influenzae B (hib) disease, hepatitis B, polio, and thirteen strains of the pneumococcus bacteria (PCV13). 439 The VIS opens with a section called, “Why get vaccinated?” that states that preventable diseases have not gone away. It continues with a bold-font statement that reads “[w]hen fewer babies get vaccinated, more babies get sick.” 440 After that, the VIS describes the seven diseases covered by the five vaccines. Each section describes the disease's signs and symptoms and says something about the risks of the disease. The risks description starts with the same language – “[name of disease] can lead to” followed by a list of possible complications, and then adds a fact about the risks of the disease. 441 For example, the VIS states that “[t]etanus kills about 1 person out of every 10 who get it,” and that “[m]ost pertussis deaths are in babies younger than three months of age.” 442
The list of diseases is followed by a statement about how people can get infected, and a table correlating the vaccines given with the diseases they prevent. 443 The VIS then sets out who should not be vaccinated. 444
The VIS also sets out situations in which people need to consult with the doctor before vaccinating. These include situations where specific problems followed the administration of a past DTaP vaccine, such as non-stop crying for three or more hours, or allergic reactions. 445
The next section discusses the risk of a reaction. The section opens with a general summary, highlighting that most vaccines' side effects are mild, and serious injuries are rare but possible. 446
The VIS then elaborates on the problems for the few vaccines associated with moderate or serious reactions. Only DTaP and pneumococcal vaccines have such reactions. 447 It ends with the following passage:
After any vaccine:
Any medication can cause a severe allergic reaction. Such reactions from a vaccine are very rare, estimated at about [one] in a million doses, and would happen within a few minutes to a few hours after the vaccination.
As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.
The safety of vaccines is always being monitored. For more information, visit CDC's Vaccine Safety website. 448
The next sections give parents instructions on what to do, what to look for, and where to go if their child experiences a serious reaction and explains that either the doctor or the parent should report the reaction to the Vaccines Adverse Reporting System. 449 It also provides information about the National Vaccine Injury Compensation Program, the no-fault program that handles claims of vaccine injury in the United States. 450 The VIS ends with suggestions of sources for more information including the patient's provider, the CDC, state or local health departments. 451
The multi-vaccine VIS covers reasonably clearly the risks of the vaccines, the diseases in question, and at least some information about each. It could always provide more detail, but the amount of detail should be balanced against the ease of reading. Here, the balance struck is reasonable. Additionally, the VIS references the general benefits of vaccination, which suggests that it is referring to social benefits as well as the personal ones. Another sentence clarifying this, however, would be helpful. 452 Generally, the multiple vaccine VIS is an accessible and comprehensive document.
It would be unnecessarily cumbersome to address all the VISs, but we would like to provide an analysis of several. For this paper, we chose the DTaP, MMR and HPV vaccines. DTaP is an infant vaccine given multiple times during a baby's first year with more moderate side effects than most other infant vaccines. 453 Additionally, the VIS for the vaccine is from 2007, allowing a comparison of an older VIS to more recent ones. 454 The MMR VIS provides a contrast, since the VIS for MMR was updated in 2018. 455 The HPV vaccine is a teen vaccine, and a relatively new one, so can offer a counterpoint to infant vaccines. 456
All three VISs open with a “Why Get Vaccinated” section that describes the diseases the vaccine prevents and their risks. The HPV and MMR VISs – the newer ones – follow these descriptions with a description of how the diseases are transmitted. 457 The DTaP VIS, on other hand, explains that the vaccine protects against these three diseases, and adds that “[m]any more children would get these diseases if we stopped vaccinating.” 458
All three VISs follow with information about the age recommended for the vaccine and the dosage, though the titles differ. 459 The MMR VIS mentions the existence of MMRV as an option. 460 One thing the MMRV VIS does that the MMR VIS does not is mention that the risk of febrile seizures is higher with MMRV than with MMR. 461 This means that people who are not considering MMRV will not be aware of this. On the other hand, since MMRV has a higher risk, maybe that is the correct place for the caution. All three VISs follow the section with a list of people who should not be vaccinated. 462 DTaP also mentions the existence of another vaccine – Tdap – for adults and adolescents. 463
The next section in all three VISs examines risks. Here, the VIS differ in format and substance. First, the HPV VIS combines mild and moderate problems, while both DTaP and MMR separate out mild and moderate events (the MMR VIS uses the term “minor” instead of “mild”). 464 All VISs mention local reactions, like soreness or redness, as mild (or minor) events. 465 Second, the HPV VIS does not have a severe events section. Instead, it has the following language:
Problems that could happen after any injected vaccine:
People sometimes faint after a medical procedure, including vaccination. Sitting or lying down for about 15 minutes can help prevent fainting and injuries caused by a fall. Tell your doctor if you feel dizzy, or have vision changes or ringing in the ears.
Some people get severe pain in the shoulder and have difficulty moving the arm where a shot was given. This happens very rarely.
Any medication can cause a severe allergic reaction. Such reactions from a vaccine are very rare, estimated at about 1 in a million doses, and would happen within a few minutes to a few hours after the vaccination.
As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.
The safety of vaccines is always being monitored. For more information, visit the vaccine safety site. 466
The lack of a detailed severe events section reflects data from around the world, summarized by a World Health Organization review as follows:
Since licensure in 2006, over 270 million doses of HPV vaccines have been distributed. … The risk of anaphylaxis has been characterized as approximately 1.7 cases per million doses, and syncope was established as a common anxiety or stress-related reaction to the injection. No other adverse reactions have been identified and GACVS considers HPV vaccines to be extremely safe. 467
The statement may, however, cause concern among those who are familiar with the online materials that make claims that the vaccine is unsafe. This concern needs to be addressed through the VIS or oral conversation. Both the DTaP and MMR VISs have sections for severe events that clearly state they are rare. 468
The subsequent section in all three VISs addresses what to do if there is a serious reaction. 469 The final sections are also similar to each other and that of the multi-vaccines VIS, and they all provide information about Vaccine Adverse Event Reporting System, the National Vaccine Injury Compensation Program, and additional sources. 470
Generally, the VIS for each of these vaccines is very comprehensive. It details the risks and benefits of vaccines, and explains what to do if there is a problem. It could, however, use some additions such as the social risks of not vaccinating, the modes of administration, and any vaccination alternatives for preventing the disease (or the lack of alternatives, in the more common cases).
The readability of the VIS for multiple vaccines and the VIS for DTaP is around a tenth-grade level.471,472 This appears problematic, since the average adult in the United States reads at an eighth-grade level, and the recommended reading level for informed consent forms is sixth grade. 473
However, as discussed, readability formulas have real limits, which may be even more applicable to the VIS. 474 VISs have to name the diseases, and disease names are long — leading to higher scores on readability formulas that count long words. The VISs repeat the disease multiple times and correctly reading the name is not likely to be crucial to understand the form. Looking at other elements of readability, VISs are short, less than two pages. In addition, they have very few paragraphs, and those paragraphs are only a few sentences each. Most of the VISs consist of short bullet points. VISs have clear headlines describing the content of each section. VISs do include the names of the diseases, but there are very few technical words beyond that. They read as if much effort was put into making them accessible and they appear reasonably readable.
In terms of language, while the CDC does not itself provide translations of the VIS, the Immunization Action Coalition created translations of the VISs to which the CDC directs the providers and the public. 475 The multi-vaccine VIS is available on the IAC site in Arabic, Armenian, Burmese, traditional and simplified Chinese, Farsi, French, Hmong, Korean, Russian, Somali, Spanish, Tagalog, Turkish, and Vietnamese (but not in Hebrew). 476 The DTaP VIS is available in Arabic, Armenian, Bengali, Burmese, Cambodian, simplified and traditional Chinese, Farsi, French, Haitian Creole, Hmong, Japanese, Karen, Khmer (Cambodian), Korean, Nepali, Oromo, Polish, Portuguese, Russian, Somali, Spanish, Tagalog, Thai, Tigrinya, Turkish, Vietnamese and Yiddish. 477 Additionally, the other VISs are each translated into over ten languages. 478 While there does not appear to be an audio version of the VIS, the CDC instructs providers that patients with readability problems may need the VIS read aloud or explained orally. 479 Whether that is, in fact, done is a different question, and one on which we do not have data.
There are some reasons to be concerned that not all pediatricians in all practices comply with the federal requirement to provide a VIS before vaccinating. A study from 2001 suggests that at that time close to thirty percent of family physicians and over thirty percent of pediatricians did not give a VIS to patients. 480 This study is relatively old and cannot be assumed to reflect current practices. However, the more recent AAP guidance document also stated that “[o]nly 8 out of 10 pediatricians report being very or somewhat familiar with the federal requirement to distribute a VIS with each dose of vaccine.” 481
Indeed, if a healthcare practitioner does not provide a VIS before vaccination, she has violated federal law, and, given states' practice to rely heavily on the VIS, is a more general problem. 482
There is also no clear indication of an oral discussion about vaccines in most practices, as a routine matter. However, there are multiple efforts and studies looking at training physicians to discuss issues with concerned parents, so discussions are clearly happening — at least when concerns arise. 483
VI. ASSESSING INFORMED CONSENT
This section pulls the previous sections together by comparing informed consent in the United States and Israel by using the provided theoretical model. To remind readers, the starting point of our discussion is the importance of both parental autonomy and public health, in the context of vaccines. Both countries, as demonstrated in Part V, value autonomy and make provisions for informed consent in the legal framework both generally and in the vaccine context. Both countries also protect the public health.
Using the three pillars we set out — the need for autonomous decisions under the Faden and Beauchamp model, the empirical literature on informed consent and vaccines, and two special characteristics of vaccines, the fact that they are given to healthy children and have a role in public health — we created, in Part III, a model for appropriate informed consent in the vaccination context. Our model provided insights for the content and format for informed consent.
Without repeating all or most of the points made above, this section will remind readers of some of the salient ones to provide context for the assessment provided below. Among other things, we pointed out that, while the public health nature of vaccines may be in tension with autonomy, there are powerful reasons, even from a public health perspective, to provide parents with accurate, comprehensive, and accessible information on vaccines. Such a policy is expected to promote trust that would encourage parents to cooperate with providers' recommendations to vaccinate. We pointed out, however, justifications and legal backing exist to limit autonomy by requiring parents to be informed about vaccines even if they are not interested or unwilling to receive such information. In terms of content, we suggested that parents should be provided information under four headings. Parents should be informed about the nature of the procedure, including not only that it is provided to healthy children and the form of administration, but also that the process offers direct protection to the child as well as indirect protection from the existence of herd immunity. We also claimed that parents should be informed about the social benefits of vaccination. We further suggested that parents should receive information about the benefits and risks of vaccination, and that common concerns and misconceptions should be addressed as needed. Finally, parents' special information needs should be addressed.
In terms of format, we pointed out that accessibility matters — parents need information to be in an accessible language, readable, and if they cannot read, provided in another manner. We highlighted the importance of providing an opportunity to ask questions and matching the form of delivery to the person. We also suggested written materials may not be enough by themselves. Given our insights, it is important to discuss whether either country conforms to this model, and that we make suggestions as to what needs to be improved. One important caveat to remember is that we have not conducted an independent empirical study of how informed consent to vaccination works in practice. There may be problems or strengths that our analysis misses. However, even an examination of the materials available suggests important insights.
A. Informed Consent Process
The process for providing informed consent is where both countries need substantial improvement. Our discussion of the theory suggests that an appropriate informed consent process would involve, at a minimum, making the needed information available in an accessible format (we discuss the format in part B of this section), providing an opportunity for the parents to absorb the information, and providing an opportunity to raise questions and concerns and have them addressed.
We examine the countries from the point of view of parents with basic literacy skills, with an acknowledgement that for parents without those skills, the process will need to be modified. We presume that the general informed consent process provided will be geared to basic literacy, as most structured processes are aimed at adults in bureaucratic states. Parents who lack the adequate level of literacy, however, should still give informed consent. For those adults, providers need to present informed consent in alternative ways.
For literate adults, we conclude that an adequate informed process would involve providing adequate written materials ahead of time, allowing a week or more for parents to consider the materials and think of questions. A provider would then repeat at least some of the salient points orally — for example, “today we will vaccinate against …, protecting your child against Y disease and helping protect others. The common side effects of these vaccines are mild; serious harms are very rare. The materials we gave you go provide more details.” Finally, an opportunity to raise and address questions and concerns would be provided.
Neither country follows this process adequately, in our view. In Israel, the materials provided to Israeli parents are incomplete, and the guides to the most common site of infant vaccination, Tipat Halav clinics, give very short shrift to informed consent. 484 Providers will need instruction to give an appropriate informed consent process that will meet the description above. Right now, there is no indication that this is done in Tipat Halav. Moreover, there are indications that it is not done in the school clinic process where parents are provided with written materials, but do not have an opportunity to discuss the information, to express their concerns, and to present questions. In both contexts, the process needs to be meaningful. Parents should be provided with information and a real opportunity to discuss issues they are interested to learn more about. It needs to be restructured to fit the description above.
We appreciate the challenges of providing individualized informed consent in a mass clinic context. However, not providing parental informed consent not only violates existing Israeli laws and legal framework, but it also increases the risk that parents will look to online materials and receive incorrect information that may deter them from vaccinating.
One way to handle a mass clinic context is to provide parents with improved information sheets about the vaccines in advance, and then organize an opportunity for questions with a qualified health provider using one of the channels Israeli parents already use to discuss information. For example, a WhatsApp discussion hour, an in-person session, or both could provide parents with answers to their questions. Another solution is to have school nurses follow up with parents who signal that they have concerns, providing them an opportunity to present questions. While these are not perfect alternatives to a one-on-one discussion with a provider, they do suggest that there are ways to structure the process to meet the heart of a meaningful informed consent process, without excessively burdening the effort and making it impractical.
In the United States, while, as discussed below, the federal VIS is reasonable as an informed consent document (though we suggest slight modifications), several sources suggest the VIS is not always provided before vaccinating. 485 This is a violation of federal law, which goes against the clear message from professional associations. Unless an in-depth alternative is provided, this violation undermines informed consent because the information that was not given cannot be examined. One problem is that there is no penalty attached to the requirement to provide a VIS. 486 This is a place where legislative change is appropriate.
Doctors should give the VIS, and if they do not, it is appropriate to sanction them. One possible sanction is to remove liability protections and allow doctors who fail to provide a VIS to be sued in tort law for not providing informed consent. The United States could draw on Israeli law for this and add a monetary sanction for the violation of autonomy involved, without a need to show actual damages. Alternatively, there could be a fine for doctors who fail to provide the VIS.
Ideally, doctors would do more than provide the VIS during the visit in which vaccines are given. This practice does not allow parents time to examine it. Medical practices with electronic medical systems in place can have parents receive the VISs a week or so before hand — as some now send in questionnaires — and require that parents sign that they have read them. Parents may or may not read the VISs in depth, but they are more likely to do so with the materials provided beforehand. Next, a provider should, as mentioned above, present the most basic information again (and make another VIS available for perusal) and allow time for possible questions or concerns. We have no indication at all that this is actually done.
Both countries could also benefit from a broader informed consent process that covers those who refuse to vaccinate. As pointed out in Part IV, in the discussion of the United States, informed refusal is also an acknowledged legal claim in the United States. 487 While requiring refusers to receive information is a limit on autonomy, it is justified because, as we discussed it protects the interests of the child and the community. 488
B. Content of Available Written Materials
Since written materials are a large part of the informed consent process for people with basic literacy, it is extremely important that these materials include the relevant information and are accessible. An assessment of the materials provided in Israel suggests several deficiencies. For starters, the materials are not consistent in what they cover and do not cover. To give one example, the IMH pamphlet provides information about the contagiousness of the disease for some diseases, but not for others including, for example, for the very contagious measles. 489 Information about vaccine effectiveness is provided for some vaccines and not others, both in the pamphlet and in the vaccine information sheets parents receive in relation to school vaccines. 490 Information about how a disease is spread exists for only a few of the diseases in the pamphlets. 491
The materials are also characterized by gaps in coverage and content. For example, vaccine effectiveness, again, is missing for many of the vaccines, both in the specific handouts given with school vaccines and in the IMH pamphlet. 492 The information sheets provided for specific vaccines given in the school context lack detailed information about the risks of the diseases. 493 In both cases, parents are not referred to the IMH's more detailed materials, which can provide additional information on important issues. 494 A reference to the IMH's website would help – though the website itself is not user friendly. A better situation would be making the site more accessible and then adding a reference.
The materials also do not address the social benefits of vaccines. In fact, they appear to emphasize the individual benefits, suggesting these are the sole benefits of vaccination. 495
Finally, the materials instructing professionals – The Vaccines Guide and the Guide to Vaccines Injection – give very little emphasis to informed consent and appear to strongly downplay the need for patient autonomy. 496 This is in tension with the Israeli legal framework that does give an important place to patient rights and autonomy.
Ideally, the Israeli materials given to patients would be changed in several ways. The information sheets given to parents in relation to school immunization, and the IMH pamphlet given in the context of immunizing infants, could be changed for consistency and completeness of the materials. A template covering the same issues for each vaccine would prevent gaps and allow for ease of reading. The materials should also be changed to include the social benefits of vaccination.
The materials directed at professionals should also be changed, with the informed consent sections enhanced, a section on the importance of patient autonomy included, and suggestions for an improved informed consent process included. Materials should also be made available in other languages.
The Vaccine Information Statements in the United States are, by and large, high quality informed consent materials. They are accessible, clear, and mostly follow a uniform format. They have most of the information necessary to make an informed decision, though they do make tradeoffs between completeness and accessibility, and they are available in multiple languages through the IAC. While the IAC is not a governmental agency, informed consent does not have to — and is usually not — done by the government directly, and as long as translations are available, we do not see a flaw in making them available through a private body.
In terms of content, most of the important elements of informed consent are in the document. Some information not strictly necessary for informed consent is included as well, such as information on how to file a vaccine injury claim. The document also offers reference to easily navigable sources for more information. However, the VIS should present the social benefits of vaccines more clearly, adding a sentence to all VISs about herd immunity and protecting the vulnerable.
In short, the main issues in the United States informed consent framework are around the process, as discussed above, not the content. The content can be somewhat improved, but the process is where most work is needed.
C. CONCLUSION
Balancing important values can be hard. In this case, we have powerful reasons to value both autonomy and preventing diseases that can harm and kill. This article made a case for an informed consent process that protects autonomy while not sacrificing public health. Providing complete, authoritative, and accurate information on vaccines is important for autonomy and for maintaining trust. Having a robust informed consent process that allows parents to process the information provided and have their concerns addressed also helps. An informed refusal process would also help protect children and the community.
Footnotes
1
See Marcela G. Del Carmen & Steven Joffe, Informed Consent for Medical Treatment and Research: A Review, 10 O
2
See Juana I. Acosta, Vaccines, Informed Consent, Effective Remedy and Integral Reparation: An International Human Rights Perspective, 64 V
3
See Roy M. Anderson & Robert M. May, Vaccination and Herd Immunity to Infectious Diseases, 318 N
4
See Wendy E. Parmet, Informed Consent and Public Health: Are They Compatible When It Comes to Vaccines?, 8 J. H
5
See, e.g., Lotte Asveld, Mass Vaccination Programs and the Value of Respect for Autonomy, 22 B
6
See, e.g., Lindsey Heinz, “Please, Don't Shot My Daughter!” Is There Legal Support for State-Compelled HPV Vaccination Laws? Why Ethical, Moral, and Religious Opposition to These Laws May Be Jumping the Gun, 56 K
7
See Annakarina De La Torre-Fennell, Chapter 821: Mandated Vaccinations Bring Informed Consent, 44 M
8
See B
9
See C
10
Zeev Weil, Informed Consent to Medical Treatment - The Israeli Experience, 17 M
11
Weil, supra note 10, at 259.
12
Nili Karako-Eyal, The Law as a Mechanism for Social Change – The Case of the Doctrine of Informed Consent, in D
13
See Saad B. Omer et al., Vaccination Policies and Rates of Exemption From Immunization, 2005-2011, 367 New Eng. J. Med. 1170, 1171 (2012); Figure Depicting Coverage with Individual Vaccines from the Inception of NIS, 1994-2012, C
].
14
Noa Aharony & Romina Goldman, E-health Literacy and the Vaccination Dilemma: An Israeli Perspective, 22 I
15
Baruch Velan, Vaccine Hesitancy as Self-Determination: An Israeli Perspective, 5 I
16
Anat Gesser-Edelsburg et al., Why Do Parents Who Usually Vaccinate Their Children Hesitate or Refuse? General Good vs. Individual Risk, 19 J. R
17
See Steve P. Calandrillo, Vanishing Vaccinations: Why Are So Many Americans Opting Out of Vaccinating Their Children?, 37 U. M
18
Measles Cases and Outbreaks, C].
19
Id.
20
Id.
21
Emilia Anis et. al., Measles in a Highly Vaccinated Society: The 2007-08 Outbreak in Israel, 59 J. I
22
Id. at 254.
23
Measles, I].
24
Id.
25
Paul A. Gastanaduy, et. al., Measles, in M] (explaining that Israel is currently experiencing a dramatic increase in measles cases, and that a third of the infected individuals are residents of one settlement, Itamar, where a substantial portion of residents oppose vaccinations).
26
Azhar Hussain et al., The Anti-Vaccination Movement: A Regression in Modern Medicine, 10 C]; Marian Ołpiński, Anti-Vaccination Movement and Parental Refusals of Immunization of Children in USA, 87 P
27
Daniel Jolley & Karen M. Douglas, The Effects of Anti-Vaccine Conspiracy Theories on Vaccination Intentions, 9 PL
28
Eve Dubé et al., Vaccine Hesitancy, Vaccine Refusal and the Anti-Vaccine Movement: Influence, Impact and Implications, 14 E
30
See Itái Gal, Anti-Vaccination Signs Against the “Vaccinated Kindergarden” in Ramat Hasharon, Y]; Nili Karako-Eyal, The Right for Autonomy, the Duty of Disclosure and Public Health Considerations – The 2013 Polio Crisis in Israel as a Case Study, 36 P
31
Anat Gesser-Edelsburg et al., Voluntary or Mandatory? The Valence Framing Effect of Attitudes Regarding HPV Vaccination, 20 J. H
32
In Israel, the 1995 National Health Insurance (NHI) Law guarantees universal health insurance coverage to all citizens and permanent residents. In the United States, citizens receive healthcare through a complex public-private marketplace. For an extensive and elaborated description of the differences between the countries, see B].
33
See Vaccination Programs, C]; see also Philip J. Smith et al., Underinsurance and Pediatric Immunization Delivery in the United States, 124 P
34
For differences in vaccination delivery and requirements, compare Vaccination Programs, C
35
For a paper discussing this issue, see Dorit Rubinstein Reiss, Rights of the Unvaccinated Child, 73 S
36
For the relationship between informed consent and school mandates in the United States, see infra text accompanying footnotes 291–331.
37
S
38
M
39
M
40
For the approach that the principle of informed consent applies to vaccination, see Meena Rajput & Luv Sharma, Informed Consent in Vaccination in India: Medicolegal Aspects, 7 H]; Woolley, supra note 7 at 1314. Contrary to the approach that there should be only a minimal requirement of informed consent in the context of vaccination, see Grant Gillett & Simon Walker, Bioethical Issues: Immunisation and Minimally Informed Consent, 20 J. L. & M
41
Ann McNary, Consent to Treatment of Minors, 11 I
42
See Jared P. Cole & Kathleen Swendiman, Cong. Research Serv., RS21414, Mandatory Vaccinations: Precedent and Current Laws 4–5, 7 (2014).
43
Dewesh Kumar et al., Vaccine Hesitancy: Understanding Better to Address Better, 5 I
44
See L
45
Kochuba, supra note 7, at 765; see also N]. There may be various reasons why some children have not been or cannot be vaccinated. Some children cannot receive the vaccine for medical reasons. Other children have not reached the age at which vaccination would be recommended. There are children who were not vaccinated because they lack access to health services or their parents have refused the vaccine. Other children may not have the required immunity although vaccinated. For example, children who did not complete the recommended childhood immunization schedule and individuals who did not develop protective responses to vaccines (vaccine failure). These individuals depend on herd immunity for protection from the disease. Id.
46
See generally Terry C. Davis et al., Childhood Vaccine Risk/Benefit Communication in Private Practice Office Settings: A National Survey, 107 P
47
Davis, supra note 46, at 1, 5.
48
Gillett & Walker, supra note 40.
49
G
50
J
51
Jeremy Bentham, The Collected Works of Jeremy Bentham: An Introduction to the Principles of Morals and Legislation 11-14 (J.H. Burns & H.L.A. Hurt eds., Oxford Univ. Press 1996).
52
Eve Dubé et al., Vaccine Hesitancy: An Overview, 9 H
53
Id.; see also Matthew Browne et al., Going Against the Herd: Psychological and Cultural Factors Underlying the ‘Vaccination Confidence Gap’, 10 PL].
54
Whyte et al., supra note 53, at 211-212.
55
Daniel A. Salmon et al., Factors Associated with Refusal of Childhood Vaccines Among Parents of School-aged Children: A Case-Control Study, 159 A
56
Id.; see also Jean Adams et al., Effectiveness and Acceptability of Parental Financial Incentives and Quasi-Mandatory Schemes for Increasing Uptake of Vaccinations in Preschool Children, 19 H
57
Harmsen et al., supra note 53, at 1188; Allison M. Kennedy et al., Vaccine Beliefs of Parents Who Oppose Compulsory Vaccination, 120 P
58
Paul Corben & Julie Leask, To Close the Childhood Immunization Gap We Need a Richer Understanding of Parents' Decision-Making, 12 H
59
See Am. Acad. of Pediatrics, Policy Statement: Increasing Immunization Coverage, 125 P
60
Dan Ferber, Fighting back against ‘alternative facts': Experts share their secrets, S].
61
Steve P. Calandrillo, Vanishing Vaccinations: Why Are So Many Americans Opting Out of Vaccinating Their Children?, 37 U. M
62
See Gesser-Edelsburg et al., General Good vs. Individual Risk, supra note 16, at 406 (discussing generally the informational uncertainty and ambiguity associated with a decreased willingness to adopt preventive measures, such as vaccinations).
63
Am. Acad. of Pediatrics, supra note 59; Greenberg et al., supra note 53, at 2-3.
64
See Astrid Austvoll-Dahlgren & Solvi Helseth, What Informs Parents' Decision-Making about Childhood Vaccinations?, 66 J. A
65
See Carolina Betsch et al., Using Behavioral Insights to Increase Vaccination Policy Effectiveness, 2 P
66
For a similar claim, see Kumar et al., supra note 43, at 4; Zachary Horne et al., Countering Antivaccination Attitudes, 112 P
67
C]; see also De La Torre-Fennell, supra note 7, at 724; Horne et al., supra note 66, at 10321; Caitlin Jarrett et al., Strategies for Addressing Vaccine Hesitancy – A Systematic Review, 33 V
68
Schumacher, supra note 7, at 118 and text accompanying note 128; Severyn, supra note 7, at 271.
69
C
70
Corben & Leask, supra note 58, at 3171; Brendan Nyhan et al., Effective Messages in Vaccine Promotion: A Randomized Trial, 133 P
71
Nyhan et al., supra note 70, at e835.
72
Id.
73
Williams, supra note 53, at 2585, 2588. Tailored interventions are people-centered interventions, built on the approach that the intended beneficiaries should be listened to and the wide range of factors influencing vaccination uptake should be acknowledged and considered in the programing of a vaccination communication strategy. These include not only individual motivation, attitudes and beliefs, but to a high degree social, community and cultural factors as well as legislative, institutional and structural factors. A non-tailored intervention is a “one-size fits all” approach to immunization communication strategy. See Eve Dubé et al., The WHO Tailoring Immunization Programs (TIP) Approach: Review of Implementation to Date, 36 V
74
Horne et al., supra note 66, at 10324. However, it should also be noted that other studies found mixed effects of loss framed messages and fear appeals on vaccination and other preventive health behaviors. Nyhan et al., supra note 70, at e840.
75
Jarrett et al., supra note 67; Williams, supra note 53, 2589.
76
Corben & Leask, supra note 58, at 3172.
77
For a similar claim, see Kumar et al., supra note 43, at 6.
78
For a similar claim, see Corben & Leask, supra note 58, at 3171-72.
79
For a similar claim, see Hardt et al., supra note 53, at 213.
80
Dubé et al., supra note 69, at 4191, 4201. For a review of the different interventions used to address vaccine hesitancy, see id. at 4193-99.
81
Id. at 4199.
82
W]. See also Parmet, supra note 4, at 97-98; Williams, supra note 53, 2585.
83
Glen J. Nowaka & Michael A. Cacciatore, Parents' Confidence in Recommended Childhood Vaccinations: Extending the Assessment, Expanding the Context, 13 H
84
E]; see also Ozawa et al., supra note 83, at 136.
85
Ames et al., supra note 59, at 20; Kumar et al., supra note 43, at 2; Hardt et al., supra note 53, at 206; Petrelli et al., supra note 66, at 90-91; Williams, supra note 53, 2585.
86
Greenberg et al., supra note 44, at 9-10; Williams, supra note 53, 2585.
87
W] [hereinafter W
88
Id.; see also Nowaka & Cacciatore, supra note 83, at 687.
89
Ozawa et al., supra note 83, at 136; see also W
90
W
91
E
92
Id.
93
Id.
94
For a similar claim, see Thomas May, Public Communication, Risk Perception, and the Viability of Preventive Vaccination Against Communicable Diseases, 19 B].
95
W
96
E
97
For similar claims, see Karin Hardt et al., supra note 53, at 213; Parmet, supra note 1, at 97-98.
98
See generally F
99
F
100
For the definition of an intentional act, see F
101
See supra notes 66-81 and accompanying text.
102
F
103
Id.
104
Id.
105
Id. at 255. Faden and Beauchamp acknowledge that complete understanding is not possible. Therefore, to allow decisions to be autonomous, they were satisfied with a substantive understanding of the information. Id. at 238–49, 289.
106
For a discussion regarding public trust in health authorities, see supra text accompanying notes 13-15.
107
An example for informational formatting that is not expected to result in misconceptions, would be the provision of accurate information to parents about the proposed vaccine without mentioning the myths associated with it.
108
See Tom L. Beauchamp, Informed Consent: Its History, Meaning, and Present Challenges, 20 C
109
For the claim that in deciding what information should be provided to parents', the personal characteristics of the parents should be considered, see Hardt et al., supra note 53, at 213.
110
See also W
111
As is apparent from the model proposed above, this list is not exclusive. The content of information provided to parents should be adapted according to their special informational needs. See generally E].
112
See Woolley, supra note 7, at 1307, for the claim that parents should be informed of alternative vaccines. The writer rightly claims that the duty to disclose such information to parents is limited to cases in which the risks and benefits of the alternative vaccine are significantly different from those of the vaccine being considered. Id.
113
See supra text accompanying notes 67-81.
114
See also Parmet, supra note 1, at 100; Woolley, supra note 7, at 1311.
115
This approach differs from the one applied to curative medical treatments, both in the U.S and Israel, according to which patients should not be informed of rare and far-reaching risks. Underlying this approach is the fear that providing patients such information will cause them unnecessary anxiety and flood them with more information than they can reasonably process, endangering their ability to make informed decisions. We believe that these arguments don't apply to vaccination. First, the number of risks, common or rare, involved in vaccination is small. Hence, the fear that parents will be flooded with information is less relevant. Second, providing accurate and clear information about the rarity of the risks involved in vaccination is likely to reduce parent's anxiety. Third, the negative effects involved in providing such information to parents are a reasonable cost considering the possible costs involved in concealing such information from parents: lost of trust in health authorities.
116
See Parmet, supra note 1, at 107.
117
W
118
Parmet, supra note 1, at 109-110.
119
See Kristin S. Hendrix et al., Vaccine Message Framing and Parents' Intent to Immunize Their Infants For MMR, 134 P
120
Meng Li et al., Stimulating Influenza Vaccination via Prosocial Motives, 11 PL
121
Id.
122
See Rachel Casiday, Risk and Trust in Vaccine Decision Making, 13 D
123
See Parmet, supra note 1, at 109-11.
124
See Karako-Eyal, The Right for Autonomy, supra note 30, at 953.
125
N
126
Once herd immunity occurs, the additional benefit to the child from being vaccinated is very small because even if not vaccinated, he would likely be protected from the disease through herd immunity. See N
127
Cornelia Betsch et al., Inviting Free-Riders or Appealing to Prosocial Behavior? Game-Theoretical Reflections on Communicating Herd Immunity in Vaccine Advocacy, 32 H
128
See, e.g., N
129
Id. at 62-63.
130
Id.
131
Several outbreaks in the United States were the result of an unvaccinated child traveling abroad and returning infected with measles. See, e.g., Amy A. Parker et al., Implications of a 2005 Measles Outbreak in Indiana for Sustained Elimination of Measles in the United States, 355 N
132
See Woolley, supra note 7, at 1310.
133
See John Coggon and José Miola, Autonomy, Liberty, and Medical Decision-Making, 70 C
134
Victor Ali, Consent Forms as Part of the Informed Consent Process: Moving Away from “Medical Miranda”, 54 H
135
Beatrice Perrenoud et al., The Effectiveness of Health Literacy Interventions on the Informed Consent Process of Health Care Users: A Systematic Review Protocol, 13 JBI D
136
Yael Schenker et al., Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: A Systematic Review, 31 M
137
Readability is a quality that reflects how easy texts are to read for a particular individual. Miraida Morales & Sarah Barriage, R].
138
Id.
139
Id.
140
Jeanne McGee, McGee & Evers Consulting, Inc., Part 3: Summary List of the “Toolkit Guidelines for Writing and Design,” in T].
141
CMS Toolkit Part 3, supra note 140, at 7-8.
142
Attempts at improving readability of informed consent forms often focus on decreasing the length of the forms. Although some studies suggest that decreasing consent form length may improve understanding, not all studies found improvement. See Leanne Stunkel et al., Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form, 32(4) IRB 1, 4-5 (2010); Wittenberg & Dickler, supra note 140, at 15-16. Moreover, some even found that that shortening sentences and using words with fewer syllables to improve readability often ends up causing more confusion and misunderstanding. See Ali, supra note 134, at 1587-88. It follows that less concern should be given to the length of the consent than its ability to be read and understood. The drafters of informed consent forms should therefore strive to balance between the need not to overload parents with excessive information and the need to provide them information in a clear manner, which at times requires the provision of more explanation. For more on this approach, see CMS Toolkit Part 3, supra note 140, at 8.
143
CMS Toolkit Part 3, supra note 140, at 8-9.
144
Id. at 9-10.
145
There are several dozen readability formulas, including the Fry formula, SMOG, and Flesch tests (Flesch-Kincaid and Flesch Reading Ease). See Jeanne McGee, PhD, McGee & Evers Consulting, Inc., Part 7: Using Readability Formulas: A Cautionary Note, in T] [hereinafter CMS Toolkit Part 7], at 1.
146
CMS Toolkit Part 3, supra note 140, at 10. Because the average adult in the United States reads at an 8th grade level, the National Institutes of Health (NIH) and the American Medical Association (AMA) recommend the readability of patient materials be at or below 6th grade reading level. Adam E. M. Eltorai et al., Readability of Invasive Procedure Consent Forms, 8 C
147
See CMS Toolkit Part 7, supra note 145, at 5; Morales & Barriage, supra note 137.
148
See Morales & Barriage, supra note 137.
149
See CMS Toolkit Part 7, supra note 145, at 15-16.
150
Ali, supra note 134, at 1588.
151
Mark Pennington, Should We Teach Reading Comprehension Strategies?, L].
152
See Dubé, supra note 69, at 4201; Nancy Kass et al., A Pilot Study of Simple Interventions to Improve Informed Consent in Clinical Research: Feasibility, Approach, and Results, 12 C
153
Similar approaches were presented in the general context of informed consent. See Ali, supra note 134, at 1578.
154
For similar approaches, see Petrelli et al., supra note 66, at 92-93; see also P. Kinnersley et al., Interventions to Promote Informed Consent for Patients Undergoing Surgical and Other Invasive Healthcare Procedures, C].
155
Ames et al., supra note 59, at 18-19.
156
See Julie Leask, et al., supra note 53, at 154; see also Corben & Leask, supra note 58, at 3172.
157
Corben & Leask, supra note 58, at 3170-73.
158
For a similar claim, see Kinnersley et al., supra note 154, at 125-26.
159
Ames et al., supra note 59, at 15.
160
Such strategies may include Internet-based platform with vaccine information and interactive social media. See generally Matthew F. Daley et al., Addressing Parents' Vaccine Concerns: A Randomized Trial of a Social Media Intervention, 55 A
161
Corben & Leask, supra note 58, at 3172.
162
See E
163
See Dubé, supra note 69, at 4201.
164
Williams, supra note 53, at 2593.
165
See, e.g., Julia Belluz, Religion and vaccine refusal are linked. We have to talk about it., V].
166
This suggestion is supported by previous and current experience. See Wilhelmina LM Ruijs et al., The Role of Religious Leaders in Promoting of Vaccination Within a Minority Group: A Qualitative Study, BMC P
167
F
168
Id. at 257-258.
169
Id. at 258.
170
Id. at 258-59.
171
As the text indicates, persuasion efforts should be reasonable for the condition of free will to be fulfilled. Unyielding persuasive efforts could result in putting too much pressure onto parents, which they can't resist. Id. at 261-62.
172
While these techniques should be avoided, parents should be informed in an objective manner of the legal implications of not vaccinating their child, i.e. school entry vaccination requirements, depravation of child support payments. A separate question is who should provide them this information. Considering the importance of an open and non-judgmental communication between health providers and parents, we believe that the task of providing such information to parents should not be imposed on health providers.
173
Ames et al., supra note 59, at 19.
174
Id. at 15, 27.
175
F
176
Dubé et al., supra note 52, at 1765, 1768.
177
Id. at 1769.
178
As we have claimed in the previous part, this assumption finds support in empirical findings. See also Weithorn & Reiss, supra note 31, at 1612-13.
179
Id., at 1613-14.
180
Id. at 1612, 1615.
181
CA 2781/93 Ali Da'aka v. Carmel Hosp., 53(4) PD 526, 572-73 (Aug. 28, 1999) (Isr.).
182
Patient's Rights Act, 5756-1996, SH No. 1591 art. 13, 13 (d), 15 (Isr.).
183
See, e.g., The Use of Hypnosis Law, 5744-1984, SH No. 1538 (Isr.).
184
Patient's Rights Act, 5756-1996, SH No. 1591 (Isr.).
185
Id.
186
This is in contrast to U.S. law. See National Vaccine Childhood Injury Act, 42 U.S.C. §§ 300aa to 300aa-34 (1986).
187
See Shelly Kamin-Friedman, Would It Be Legally Justified to Impose Vaccination in Israel? Examining the Issue in Light of the 2013 Detection of Polio in Israeli Sewage, I
188
Public Health Ordinance, 1940, I.R. 1065 (Isr.).
189
Patient's Rights Act, 5756-1996, SH No. 1591 (Isr.).
190
Basic Law: Human Dignity and Liberty Public Health Ordinance, 5752-1992, SH No. 1391 (Isr.).
191
Public Health Ordinance, 1940, I.R. 1065 (Isr.).
192
Id.
193
Id.
194
Id.
195
Patient's Rights Act, 5756-1996, SH No. 1591 (Isr.).
196
Id.
197
Id.
198
Id.
199
Id.
200
Id.
201
For characteristics of these public health interventions and a comparison to “regular” medical treatments, see James F. Childress et al., Public Health Ethics: Mapping the Terrain, 30 J.L. M
202
Basic Law: Human Dignity and Liberty, 5752-1992, SH No. 1391 (Isr.).
203
See HCJ (Jerusalem) 7245/10 Adalah v. Ministry of Welfare & Soc. Affs. (June 4, 2013) (Isr.); CA 2781/93 Ali Da'aka v. Carmel Hosp., Haifa 53(4) PD 570–71 (Aug. 29, 1999) (Isr.); HCJ 4330/93 Ganem v. Israeli Bar Ass'n 50(4) PD 221, 231 (Oct. 13, 1996) (Isr.).
204
See Ali Da'aka v. Carmel Hosp. 53(4) PD 570–72 (Aug. 29, 1999) (Isr.); HCJ (Jerusalem) 7245/10 Adalah v. Ministry of Welfare & Soc. Affs. (June 4, 2013) (Isr.).
205
Basic Law: Human Dignity and Liberty, 5752-1992, SH No. 1391 (Isr.).
206
See HCJ (Jerusalem) 7245/10 Adalah v. Ministry of Welfare & Soc. Affs. (June 4, 2013) (Isr.).
207
See Kamin-Friedman, supra note 187 at 6 (citing Basic Law: Human Dignity and Liberty, 5752-1992, SH No. 1391 (Isr.)).
208
HJC (Jerusalem) 5304/15 Israeli Med. Ass'n v. Isr. Knesset (Sept. 11, 2016) (Isr.).
209
See Patient's Rights Act, 5756-1996, SH No. 1591, art. 13 (Isr.); Legal Capacity and Guardianship Law 1962, 120-1962, SH No. 380, art. 4 (Isr.)
210
Id. Although the law recognizes the existence of exceptions to the consent requirement, none is relevant to the case of routine childhood vaccination.
211
Id.; see also CA (Jerusalem) 1303/09 Kadosh v. Bikur Holim Hosp. (Mar. 5, 2012), Nevo Legal Database (by subscription, in Hebrew) (Isr.).
212
Indeed, the health provider is obligated to inform the patient of the risks of not vaccinating a child. See Patient's Rights Act, 5756-1996, SH No. 1591 art. 13(b)(4) (Isr.). However, a parent is not obligated to participate in such an encounter. (Note that Hebrew is a gendered language, and the default is use of the masculine gender, which is understood to cover both genders. That custom was followed here to produce a consistent translation. The requirements are the same whether the acting parent is the mother or the father.)
213
Id.
214
Id.
215
Id.
216
See Patient's Rights Act, 5756-1996, SH No. 1591; CA (Jerusalem) 1303/09 Kadosh v. Bikur Holim Hosp. (Mar. 5, 2012), Nevo Legal Database (by subscription, in Hebrew) (Isr.).
217
See CA (Jerusalem) 1355/11 Hadasa Med. Ctr. v. Mehuhedet Health Fund (Feb. 9, 2015), Nevo Legal Database (by subscription, in Hebrew) (Isr.).
218
Id.
219
See CA (Jerusalem) 1997/10 Tsoref v. Rozenbaum (Feb. 13, 2012), Nevo Legal Database (by subscription, in Hebrew) (Isr.).
220
Id.
221
See CA (Jerusalem) 4380/13 Rikman v. Clalit Health Fund (Jan. 13, 2015), Nevo Legal Database (by subscription, in Hebrew) (Isr.).
222
See id.
223
See CA (Jerusalem) 1997/10 Tsoref v. Rozenbaum (Feb. 13, 2012), Nevo Legal Database (by subscription, in Hebrew) (Isr.).
224
See Patient's Rights Act, 5756-1996, SH No. 1591 art. 13 (b).
225
See Patient's Rights Act, 5756-1996, SH No. 1591 art. 2.
226
See Patient's Rights Act, 5756-1996, SH No. 1591 art. 13 (b).
227
Id.
228
As the discussion above indicates the enactment of the Act did not abolish the doctrine of informed consent as articulated in courts' rulings. Therefore, when making a decision as to the scope of duty of disclosure consideration should also be given to courts' ruling. Contrary to the Act the courts did not define the duty of disclosure as limited to information that directly relates to the physical or mental condition of the patient or to the medical treatment. Instead, they focused on the general criteria through which the scope of the duty of disclosure is determined. See, for example: CA (Jerusalem) 1303/09 Kadosh v. Bikur Holim Hosp. ¶ 3 (Rivlin, J.) (Mar. 5, 2012), Nevo Legal Database (by subscription, in Hebrew) (Isr.). It follows, that the definition of the term “medical treatment” adopted by the Act, does not prevent the applying of the duty of disclosure to other types of information.
229
See CA 2781/93 Ali Da'aka v. Carmel Hosp., Haifa 53(4) PD 570–71 (Aug. 29, 1999) (Isr.).
230
Id.
231
Id.
232
See CA 4960/04 Sidi v. Clalit Health Fund (Jan. 13, 2015) (Isr.); CA (Jerusalem) 1303/09 Kadosh v. Bikur Holim Hosp. (Mar. 5, 2012) (Isr.).
233
The physician's duty to inform the patient about alternative treatments is limited to treatments accepted by respectable medical bodies. See CA (Jerusalem) 6936/09 Yehuda v. Clalit Health Fund (Mar. 5, 2012), ¶¶ 15-16 (Rivlin, J.), Nevo Legal Database (by subscription, in Hebrew) (Isr.).
234
See Patient's Rights Act, 5756-1996, SH No. 1591; see also Kamin-Friedman, supra note 187 at 6 (discussing duty to disclose information about vaccines in Israeli case law).
235
See CA 1303/09 Kadosh v. Bikur Holim Hosp. (Mar. 5, 2012), ¶¶ 26-27 (Rivlin, J.), Nevo Legal Database (by subscription, in Hebrew) (Isr.).
236
CA 470/87 Altori v. Israel 47(4) PD 146 (Aug. 24, 1993) (Isr.).
237
Id.
238
Id.
239
Id.
240
Id.
241
Id.
242
Id.
243
Id.
244
The same line of reasoning was applied in Haliba v. Ministry of Health, decided by the District Court following Altori v. Israel. DC 1018/00 (Beer Sheve) Haliba v. Ministry of Health (Nov. 16, 2005) (Isr.).
245
In addition to existing in the U.S., school entry vaccination requirements exist in some Australian states or territories (e.g., New South Wales, Victoria, Tasmania and Australian Capital Territory). See N]. Measures to enforce mandatory vaccination that are more stringent have been adopted in other countries. For example, Slovenia adopted a mandatory program for nine designated diseases, and a failure to comply results in a fine. See Walkinshaw, supra, at E1167–68.
246
Other countries share Israel's non-mandatory vaccination policy. In a study of vaccination programs and policies in the EU, Iceland, and Norway, 15 of the 29 total countries (including the U.K.) were not found to mandate any vaccines. See M. Haverkate et al., Mandatory and Recommended Vaccination in the EU, Iceland and Norway: Results of the VENICE 2010 Survey on the Ways of Implementing National Vaccination Programs, 17 E
247
Over the years, there have been calls for a mandatory vaccination policy. These assertions were followed by several initiatives to impose a legal obligation on parents to vaccinate their children. See Adopting School Entry Vaccination Requirements, H] (transferred to the Committee for preparation to second and third reading). Among other things the bill obligates a refusing parent to sign a refusal declaration and to be informed about vaccines. It also authorizes the MHI to close an educational institute in a case of an outbreak or to forbid the entrance of non-vaccinated children to the institute.
248
For the authority of the Ministry of Health Director General to take measures for the protection of the public from an infectious disease, see infra note 249.
249
The Public Health Ordinance, 1940, authorizes the Ministry of Health Director General to declare a mandatory vaccination in circumstances where there is a risk to the public owing to an infectious disease. Nevertheless, this authority was invoked rarely and was never invoked for routine child vaccinations. See Michal Alberstein & Nadav Davidovich, Therapeutic Jurisprudence and Public Health: Israeli Perspectives, 26 B].
250
Vaccine Injuries Insurance Law, 5750-1989, art. 4(A) (Isr.); Polio Victims Compensation Law, 5767-2007, art. 2 (Isr.).
251
See Vaccine Injuries Insurance Law, 5750-1989, art. 4(A) (Isr.).
252
Polio Victims Compensation Law, 5767-2007, art. 2 (Isr.).
253
See Vaccine Injuries Insurance Law, 5750-1989, art. 2 (c) (Isr.); Polio Victims Compensation Law, 5767-2007, art. 2 (Isr.).
254
See Vaccine Injuries Insurance Law, 5750-1989, art. 7 (Isr.); Polio Victims Compensation Law, 57-67-2007, art. 10(a) (Isr.).
255
CA 2781/93 Ali Da'aka v. Carmel Hosp. 53(4) PD 526 (Aug. 8, 1999) (Isr.).
256
See CA 1303/09 Kadosh v. Bikur Holim Hosp. (Mar. 5, 2012), ¶¶ 26-27 (Rivlin, J.), Nevo Legal Database (by subscription, in Hebrew) (Isr.); CA 2781/93 Ali Da'aka v. Carmel Hosp. 53(4) PD 526, 564 (Aug. 8, 1999) (Isr.).
257
CA 1303/09 Kadosh v. Bikur Holim Hosp. (Mar. 5, 2012), ¶ 33 (Rivlin, J.); CA 2781/93 Ali Da'aka v. Carmel Hosp. (Aug. 8, 1999) (Isr.).
258
CA 1303/09 Kadosh v. Bikur Holim Hosp. (Mar. 5, 2012), ¶ 48 (Rivlin, J.).
259
National Childhood Vaccine Injury Act of 1986, 42 U.S.C. § 300aa-26 (2012).
260
See Truman v. Thomas, 611 P.2d 902 (1980).
261
National Childhood Vaccine Injury Act of 1986, 42 U.S.C. § 300aa-11(a)(2) (2012).
262
42 U.S.C. §§ 300aa-1 to 300aa-34.
263
42 U.S.C. § 300aa-26.
264
42 U.S.C. § 300aa-11(a)(2).
265
42 U.S.C. § 300aa-22 (c).
266
Jaime Staples King & Benjamin W. Moulton, Rethinking Informed Consent: The Case for Shared Medical Decision-Making, 32 A
267
Lawrence Schlam & Joseph P. Wood, Informed Consent to the Medical Treatment of Minors: Law and Practice, 10 H
268
42 U.S.C. § 300aa-26 (a).
269
Administrative Procedure Act, 5 U.S.C. §553 (2018). Though not necessarily the complications added to the process by judicial review and other sources. But see Jeffrey S. Lubbers, The Transformation of the U.S. Rulemaking Process - For Better or Worse, 34 O
270
42 U.S.C. §§ 300aa-26 (b)(1).
271
42 U.S.C. § 300aa-26(b)(2); see also Advisory Commission on Childhood Vaccines (ACCV), H].
272
Vaccine Information Statements (VISs), C].
273
See, e.g., MMR (Measles, Mumps, and Rubella) VIS, I].
274
Vaccine Information Statements (VISs), supra note 272.
275
42 U.S.C. § 300aa-26(d)(2).
276
42 U.S.C. § 300aa-26(c).
277
Vaccine Information for Parents, Patients, and Health Care Providers, A] (last visited Jan. 19, 2019).
278
Laws and Regulations, Immunization Branch, C].
279
Vaccine Information Statements, Disease Outbreak Control Div., H].
280
Vaccine Information Statements, O] (last visited Jan. 19, 2019).
281
Vaccine Administration and Clinical Guidance, M] (last visited Jan. 19, 2019).
282
Vaccine Information Statements, N.Y. S].
283
Important Vaccine Information Statement (VIS) Facts, M].
284
See Talking to Vaccine Hesitant Parents, L].
285
See, e.g., Requirements to Administer Influenza Vaccination, M] (requiring pharmacists who administer influenza vaccinations to obtain signed consent from patients).
286
Examples include Indiana and Tennessee. See, e.g., Refusal to Vaccinate Form, I] (last visited Jan. 19, 2019).
287
Truman v. Thomas, 611 P.2d 902, 904 (1980).
288
Id. at 288-289.
289
Id. at 292-293.
290
In a recent article hosted by the American Academy of Pediatrics, a doctor reminded other doctors that failure to get (or document) informed refusal for not vaccinating can lead to liability. James P. Scibilia, Document ‘Informed Refusal' Just as You Would Informed Consent, AAP N]. We therefore assume the situation is hypothetical; nonetheless, the article still reflects the state of the law as set by Truman v. Thomas.
291
Dorit Rubinstein Reiss & Lois A. Weithorn, Responding to the Childhood Vaccination Crisis: Legal Frameworks and Tools in the Context of Parental Vaccine Refusal, 63 B
292
Id. at 915-18.
293
U].
294
Evan Simko-Bernardski, Maine Bars Residents from Opting Out of Immunizations for Religious or Philosophical Reasons, CNN (May 27, 2019), https://www.cnn.com/2019/05/27/health/maine-immunization-exemption-repealed-trnd/index.html [].
295
See C
296
Reiss and Weithorn, supra note 291, at 917.
297
See infra, text accompanying notes 312-21. For a detailed discussion of such requirements, see Karako-Eyal, supra note 295, at 355-359 (2019).
298
See Varun K. Phadke et al., Association Between Vaccine Refusal and Vaccine-Preventable Diseases in the United States: A Review of Measles and Pertussis, 315 J.
299
Allison v. Merck & Co., 878 P.2d 948, 961 (Nev. 1994).
300
Id. at 948.
301
42 U.S.C. §300aa-11 (2012).
302
Allison, 878 P.2d at 961.
303
Driving and Transportation, E].
304
305
City of Newark v. J.S., 652 A.2d 265, 268 (1993). Similar laws exist in a number of states. See Oscar A. Cabrera, et al., Express Tuberculosis Control Laws in Selected U.S. Jurisdictions, C].
306
See Tuberculosis, W] (“People with active TB can infect 10-15 other people through close contact over the course of a year.”).
307
Vaccine-Preventable Adult Diseases, C] (“Vaccine-preventable diseases cause long-term illness, hospitalization, and even death.”).
308
See, e.g., How Far Americans Live from the Closest Hospital Differs by Community Type, P] (“Rural Americans live an average of 10.5 miles from the nearest hospital, compared with 5.6 miles for people in suburban areas and 4.4 for those in urban areas …”).
309
See, e.g., Epilepsy and Driving, E] (discussing restrictions on people with epilepsy for getting a driver's license).
310
Dorit Rubinstein Reiss, Rights of the Unvaccinated Child, in 73 S
311
Reiss and Weithorn, supra note 291, at 961-962.
312
Karako-Eyal, supra note 295, at 355-359
313
Id. at 355-56.
314
Denise F. Lillvis et al., Power and Persuasion in the Vaccine Debates: An Analysis of Political Efforts and Outcomes in the United States, 1998-2012, 92 M
315
W
316
O
317
Denise Lillvis, Managing Dissonance and Dissent: Bureaucratic Professionalism and Political Risk in Policy Implementation, 41 L. & P
318
Karako-Eyal, supra note 295, at 357-58.
319
Id. at 356.
320
Id. at 358.
321
Id. at 359.
322
See Y. Tony Yang & Ross D. Silverman, Legislative Prescriptions for Controlling Nonmedical Vaccine Exemptions, 313 JAMA 247 (2015).
323
See, e.g., Nina R. Blank et al., Exempting Schoolchildren from Immunizations: States with Few Barriers Had Highest Rates of Nonmedical Exemptions, 32 H
324
See Truman v. Thomas, 611 P.2d 902 (1980).
325
See Ross D. Silverman, No More Kidding Around: Restructuring Non-Medical Childhood Immunization Exemptions to Ensure Public Health Protection, 12 A
326
Id.
327
See Truman, 611 P.2d at 904.
328
Silverman, supra note 325, at 294.
329
42 U.S.C. § 300aa-11(a)(2)(A) (2012). On the program, see Nora Freeman Engstrom, A Dose of Reality for Specialized Courts: Lessons from the VICP, 163 U. P
330
See Engstrom, supra note 329, at 1672, 1696.
331
See id. at 1673. Westlaw, Lexis, and Google searches turned up no cases of parties who went to civil courts using a theory of informed consent after rejecting VICP settlement.
332
Karako-Eyal, supra note 30, at 934-35.
333
See supra Section IV.A; I] [hereinafter V
334
Unfortunately, we could not find an empirical study exploring the practice of informed consent to vaccination in Israel. EBSCO and ProQuest searches, as well as google searches, using a variety of terms turned up no such studies. Appeal to researchers in this field yielded no results as well.
335
See Vaccines for Babies and Children, I
336
Id.
337
Circulate 57/97: Providing Information to Women Giving Birth During Hospitalization, I].
338
Id.
339
Id.
340
Id.
341
Circulate 17/99: Providing Information to a Women Giving Birth During Hospitalization, I].
342
Id.
343
Id.
344
Id.
345
Id.
346
Id.
347
Id.
348
For comparison, see the information presented in the WHO website regarding infectious Hepatitis B. See Hepatitis B, W].
349
Circulate 17/99, supra note 341.
350
See G
351
See Tipat Halav – Family Health Centers, S].
352
See V
353
V
354
G
355
Id.
356
Id.
357
Id.
358
Id.
359
Id.
360
Id.
361
Id.
362
I] [hereinafter C
363
Id.
364
Id.
365
Id.
366
Id.
367
Id.
368
Id.
369
Id.
370
Id.
371
Id.
372
Id.
373
Id.
374
Id.
375
Id.
376
Id.
377
Id.
378
Efficacy and Effectiveness, T].
379
C
380
Vaccines for Babies and Children, I
381
C
382
Vaccines for Babies and Children, I
383
Id.
384
See I].
385
Id.
386
The phrase “the general press” is the exact phrase used in the guidelines. Id. Although the guidelines don't clarify what this phrase means, it likely means “commonly read, major newspapers.”
387
Id.
388
Circulate 0083: Parental Declaration Regarding the Health of a Child and Consent to the Provision of Student Health Services, I].
389
Id.
390
Id.
391
See Circulate 0083, supra note 388.
392
Id.
393
Id.
394
Id.
395
I].
396
Id.
397
Id. The form is also available in Arabic on the Natali Healthcare Solutions website. See S].
398
Id.
399
Id.
400
D] [hereinafter HPV I
401
Circulate 12/2015: Students' Health Services (2015), I].
402
See, e.g., HPV I
403
Id.
404
Id.
405
See, e.g., T
406
See information sheets for TIV, MMRV, Tdap, Tdap-IPV, and HPV, supra note 400.
407
HPV I
408
T
409
I
410
See, e.g., I
411
Id.
412
See, e.g., Vaccines of Children and Babies, I]. Most of the information regarding vaccination found in the IMH website is also presented in Arabic and English.
413
See, e.g., I
414
Id.
415
For example, the MMRV information sheet uses the phrase: “Long term immunity,” without providing explanation to this phrase. MMRV I
416
U.S. Dep't of Health and Human Services, 2019 Recommended Vaccinations for Infants and Children, C].
417
U.S. Dep't of Health and Human Services, Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, C].
418
See, e.g., id.
419
Healthy Children, Immunizations, A].
420
Fernando Stein & Karen Remley, American Academy of Pediatrics Emphasizes Safety and Importance of Vaccines, A].
421
Id. See also Childhood Immunization Support Program, AAP Immunization Resources Best Practices, A].
422
See National Vaccine Program Office, National Vaccine Advisory Committee (NVAC), U.S. D].
423
Childhood Immunization Support Program, AAP Immunization Resources Best Practices, supra note 421.
424
National Vaccine Advisory Committee, D].
425
Childhood Immunization Support Program, Best Practices, supra note 421.
426
Id. The standard ends with a recommendation that professional encourage patient and parents to report adverse events and additional sources to obtain information that we omitted for brevity.
427
Id.
428
Id.
429
Id.
430
All webpages link to the CDC's VIS home page. See Vaccine Information Statements, supra note 272.
431
Instructions for Using VISs, C].
432
Id.
433
The Immunization Action Coalition, I].
434
Id.
435
Instructions for Using VISs, supra note 431. The IAC website has translations of VISs into are large number of languages. See Vaccine Information Statements, I].
436
You Must Provide Patients with Vaccine Information Statements, I].
437
Id. The IAC also has a supplemental document on VISs. Documenting Vaccination, I].
438
Your Child's First Vaccines, C].
439
Id.
440
Id. Emphasis in the original.
441
Id.
442
Id.
443
Id.
444
Id. Emphasis in the original.
445
Id.
446
Id.
447
Id.
448
Id. Emphasis in the original.
449
450
Id. The National Vaccine Injury Compensation Program's website is at https://www.hrsa.gov/vaccine-compensation [].
451
Id.
452
Id.
453
See C].
454
It is dated May 17, 2007. Nat'l Ctr. for Immunization and Respiratory Diseases, Vaccine Information Statements for Currently Available Vaccines, C].
455
It is dated February 12, 2018. Id.
456
The current version is dated December 2, 2016. Id.
457
Nat'l Ctr. for Immunization and Respiratory Diseases, DTaP (Diptheria, Tetanus, Pertussis) VIS, C] [hereinafter HPV VIS].
458
DTaP VIS, supra note 457.
459
See supra note 457.
460
MMR VIS, supra note 457.
461
Nat'l Ctr. for Immunization and Respiratory Diseases, MMRV (Measles, Mumps, Rubella & Varicella) VIS, C].
462
See supra note 457.
463
DTaP VIS, supra note 457 (“DTaP is not licensed for adolescents, adults, or children 7 years of age and older. But older people still need protection. A vaccine called Tdap is similar to DTaP. A single dose of Tdap is recommended for people 11 through 64 years of age. Another vaccine, called Td, protects against tetanus and diphtheria, but not pertussis. It is recommended every 10 years. There are separate Vaccine Information Statements for these vaccines.”).
464
See supra note 457.
465
See supra note 457.
466
HPV VIS, supra note 457.
467
Global Advisory Committee on Vaccine Safety, Safety Update of HPV Vaccines, W].
468
DTaP VIS, supra note 457; MMR VIS, supra note 457.
469
See supra note 457.
470
See supra note 457.
471
The formula followed these guidelines: How to Use the SMOG Readability Formula on Health Literacy Materials, R].
472
DTaP VIS, supra note 457.
473
Adam E. M. Eltorai et al., Readability of Invasive Procedure Consent Forms, 8 C
474
See supra notes 145–149 and accompanying text.
475
Vaccine Information Statements, supra note 272.
476
Your Child's First Vaccines, supra note 438.
477
DTaP (diphtheria, tetanus, pertussis) VIS: Up-to-date translations, I].
478
The CDC released an interim VIS for the HPV vaccine on October 30, 2019, and an interim VIS for the MMR vaccine on July 15, 2019, so the translations currently available through the Immunization Action Coalition are slightly out of date. “CDC states that it is acceptable to use out-of-date VIS translations since there have not been significant content changes in the interim version compared with the previous VIS.” HPV (Human Papillomavirus) VIS: Out-of-date translations, I].
479
Nat'l Ctr. for Immunization and Respiratory Diseases, Facts About VISs, C] [hereinafter Facts About VISs].
480
Terry C. Davis et al., supra note 46.
481
Childhood Immunization Support Program, supra note 425; see also Facts About VISs, supra note 479.
482
National Vaccine Childhood Injury Act, 42 U.S.C. § 300aa-26 (2012).
483
Terry C. Davis et al., supra note 46.
484
State of Isr., Ministry of Health, Childhood Vaccines, supra note 362.
485
Terry C. Davis et al., supra note 46.
486
42 U.S.C. § 300aa-26 (2012).
487
See supra notes 287–290 and accompanying text.
488
See supra notes 49–50 and accompanying text.
489
C
490
Id.; MMRV I
491
C
492
MMRV I
493
C
494
Id.
495
See, e.g., MMRV I
496
G