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. Author manuscript; available in PMC: 2017 Jan 17.
Published in final edited form as: J Health Care Law Policy. 2016;19(1):99–117.

DO ETHICS DEMAND EVALUATION OF PUBLIC HEALTH LAWS? SHIFTING SCIENTIFIC SANDS AND THE CASE OF YOUTH SPORTS-RELATED TRAUMATIC BRAIN INJURY LAWS

Kerri McGowan Lowrey *, Stephanie R Morain **, Christine M Baugh ***
PMCID: PMC5241084  NIHMSID: NIHMS833594  PMID: 28104996

I. Introduction

Ideally, public health laws would be developed on a robust base of scientific, epidemiologic, and medical data and enacted independent of the various political forces at play. In reality, of course, this “gold standard” is often unattainable. The success of public health legislation in the United States depends on a combination of empirical data, anecdotal evidence, political will, political palatability, media involvement, and the myriad number of issues simultaneously vying for policymakers’ attention.1 For example, in the months and years following September 11, 2001, legislative attention focused suddenly and squarely on homeland security; chronic disease prevention and other kinds of public health measures understandably took a back seat.2 A cursory scan of state public health and environmental laws reveals that lawmaking often requires compromise with political factors at play.3 This may explain why jambalaya, a traditional Louisiana rice dish, when prepared in the “traditional manner” for public consumption, is exempt from any conflicting state sanitation laws4 or why a frog that dies during a frog-jumping contest in California cannot be eaten.5 Furthermore, academic evidence often is poorly tailored to serve the process by which laws are made, and anecdotal evidence often seems to have more power to “move” legislators than does aggregate empirical data.6 This complex combination of factors driving the development and passage of public health laws means that they are often the result of compromise; public health is one among many important (and sometimes competing) national values, including, for example, civil liberties, autonomy, and privacy.7 When laws infringe upon one of these other values because lawmakers deem public health to take precedence—or when public health laws serve to create in the public a perception of safety or protection—do principles of ethics demand that the law be effective? Others have described the importance of acknowledging ethics in public health policy and the position of policy analysis as “lying squarely (if uncomfortably) between science and ethics.”8 We seek to take this conversation further, using youth sports-related traumatic brain injury (“TBI”) laws as a case study to argue that policy evaluation—the attempt to ensure that public health laws are effective, or at least not harmful—and action based upon resulting knowledge are ethical imperatives, particularly in the face of evidentiary uncertainty.9

II. The Phenomenon of Youth Sports-Related TBI Policymaking

Concussion from sport is a clear public health problem10 and the population at risk is large. A survey conducted by the National Federation of State High School Associations estimates that participation in high school sports exceeded 7.7 million in the 2012 to 2013 school year, increasing for the twenty-fourth consecutive year.11 Further, an estimated 60 million U.S. children play youth sports each year—although this number is probably low given limitations on available survey data.12 An estimated 173,285 youth and adolescent brain injuries are treated in emergency departments in the United States annually.13 Rates of concussion diagnosis are increasing,14 particularly in states that were early adopters of youth concussion legislation.15 This is likely due to increased awareness and better tracking, rather than to a true increase in the incidence or prevalence of the injury.16

Despite increasing diagnosis, it is estimated that more than 50 percent of concussions still go undiagnosed and unreported in some athlete populations.17 Underdiagnosis may be particularly problematic in young athletes in two ways. First, youth athletes may have a less robust understanding of concussions, their consequences, and the importance of symptom reporting; thus, they may be less likely to communicate their symptoms to a parent or coach. Further, medical professionals are not always present at youth-level sports events or practices, making reporting more logistically challenging.18 On top of this, young athletes face elevated health risks associated with sports-related brain trauma. For example, compared to adults who sustain a concussion, acute concussion symptoms tend to last longer and be more severe in youth.19 In addition to delayed recovery, youth athletes are at an elevated risk of sustaining a concussive injury.20 Furthermore, youth athletes who have experienced at least one previous concussion, particularly one sustained recently, are more likely to experience prolonged symptoms if they sustain a subsequent brain injury.21 A second concussion experienced in close temporal proximity to the first may also put a youth athlete at risk of second impact syndrome,22 which can result in major neurological consequences and even death.23 Even without catastrophic, acute consequences, the risks of repeated brain injury in youth are not well understood, but there is the possibility that such injuries could alter neurodevelopment.24 Because a variety of brain functions are not fully formed in youth (e.g., executive functions), the full extent of deficits from injury may not be initially realized. Given the nature and extent of possible health consequences of brain trauma in youth in particular, ensuring timely removal from play and medical evaluation are important secondary prevention mechanisms targeted by recent concussion legislation.25 However, even without a diagnosed brain injury, exposure to repeated head impacts through sports has been associated with measurable cognitive impairment,26 indicating that impacts that do not result in concussive injury may nevertheless have detrimental health effects.27

In 2009, states began to pass legislation designed to educate student athletes, their parents, and (in many cases) coaches about TBI and the risks associated with returning to physical activity before the brain has healed sufficiently.28 Washington was the first state to pass a so-called “return-to-play” law in 2009. Washington’s “Lystedt Law” was named for a thirteen-year-old middle school football player who suffered a TBI during a game and was allowed to return to the game fifteen minutes later, ultimately suffering a debilitating brain injury.29 Over the next five years, other states followed suit, using Washington’s law as a prototype.30 By the summer of 2015, youth sports concussion legislation had been passed in all fifty states and the District of Columbia.31 This rapid, nationwide adoption of public health policy was almost unprecedented and likely occurred as a result of the nonpartisan support of concussion legislation, the low perceived cost of the initiatives, and the sympathetic population targeted by the laws.32 In addition, nationwide passage of youth sports-related TBI legislation rode atop a wave of increased media attention on TBI related to professional sports, including the tragic suicides of Dave Duerson, Derek Boogaard, and Junior Seau, which may have worked to garner popular support for legislative initiatives that would “prevent” such tragedies.33

One implication (and criticism) of this rapid adoption is that the laws themselves were rather similar. Legislatures relied largely on Washington’s Lystedt Law as a model, without policy experimentation to tailor to existing state infrastructures and processes or empirical evidence on effectiveness.34 As such, most youth sports-related concussion laws included three key elements: education for parents and student athletes, immediate removal from play after suspected concussion, and medical clearance before return to play.35 In May 2010, National Football League Commissioner Roger Goodell wrote a letter to the governors of the forty-four states that had not yet enacted return-to-play legislation, urging them to adopt a law with these three elements.36 Another criticism of initial return-to-play laws is that they were almost completely aimed at secondary prevention (e.g., early detection of sports-related TBI) and tertiary prevention (e.g., rehabilitation and management of sports-related TBI).37 Only Massachusetts included legislative attempts at primary prevention, directed toward precluding the occurrence of youth sports-related TBI in the first place.38 From the outset, the Massachusetts law prohibited coaches, athletic trainers, and others from encouraging or allowing a student athlete to use sports equipment as a weapon or to engage in sports techniques that are unreasonably dangerous, such as helmet-to-helmet hits.39 Given what was known, championing the three key provisions of the Lystedt Law and focusing on secondary and tertiary prevention were appropriate, if not inclusive of all potentially important preventive factors (e.g., mandatory training for coaches). But what about now? Science is ever-evolving, and with it our understanding of brain injury, prevention, and protective factors are constantly changing.

To date, twenty-two states have made substantive changes to their laws since original enactment, eight states more than once.40 These amendments generally fall into three types: (1) expanding coverage of the law (e.g., to include younger grades or recreational sports leagues),41 (2) tightening or clarifying existing requirements,42 and (3) efforts to prevent concussions from occurring in the first place (primary prevention) and improved early detection (secondary prevention).43 Since original passage, seven states have expanded coverage of their laws to include, for example, recreational youth sports (Arkansas),44 charter and private schools (California),45 and sports organizations using public school property (Indiana and Virginia).46 New Jersey amended its law in 2011 to expressly include cheerleading.47 Nineteen states passed legislation to change specific requirements since the original passage of the law—amendments that may have come about in response to experience with implementation of the original law or new developments in knowledge.48 For example, in 2012 Alaska added athletic trainers to its list of providers qualified to make return-to-play (“RTP”) decisions and clarified that “return to play” as defined in the statute includes return to practice as well as to competition.49 States with large rural populations, such as Alaska, faced implementation challenges due to availability of medical providers trained in the recognition and management of concussions,50 so such amendments may have been proposed to increase the number of providers qualified by law to make return-to-play decisions.51

Several states implemented stronger education and informed consent provisions for parents as well as training requirements for coaches and officials.52 Two states passed new provisions requiring concussion data collection,53 perhaps realizing that controlling any public health problem and assessing the effectiveness of interventions requires adequate surveillance.54 Other states incorporated provisions that require the establishment of academic adjustment protocols for student athletes that have sustained concussions, or “return to learn” provisions.55 Perhaps states acted in response to a flurry of recent research on the need for cognitive rest and accommodations for concussed student athletes returning to the classroom.56

From a public health perspective, states’ recent emphasis on primary prevention and improvement of early TBI detection is encouraging. As noted, only Massachusetts included primary prevention measures, such as mandated limits on contact in practices and scrimmages or safer rules of play, into its original concussion law.57 Since original adoption, however, more states have amended their laws to add primary prevention strategies such as limits on minutes of contact during practices and scrimmages, training for coaches on strategies for reducing risk of concussion, and equipment requirements.58 In an effort to improve early detection of TBI, New Jersey’s amended law requires a physical examination and concussion history prior to athletic activity to identify students at greater risk.59

As described above, amendments enacted since initial passage of the concussion legislation may have occurred for a variety of reasons. Since passage of the first concussion law in 2009, there has been a rapid proliferation of scientific research in the area of concussion.60 In particular, a growing body of literature indicates that concussions are widely underreported and underdiagnosed.61 Additionally, some research has suggested that repetitive “minor” brain injuries, including subconcussive blows, can lead to functional,62 structural,63 biochemical,64 and potentially chronic neurodegenerative changes65 with significant health consequences. This developing scientific evidence may have motivated legislators to incorporate the primary prevention strategies as described above. Further, experience upon implementation may have led to the amendments’ clarification of language (e.g., that returning to play includes practice) or stipulation that only parents need to sign and return a single concussion information sheet per year per organization or school.66

III. Scientific Evidence and Public Health Lawmaking

The discipline of public health law has been defined as “[t]he study of the legal powers and duties of the state … to ensure the conditions for people to be healthy … and of the limitations on the power of the state to constrain for the common good the autonomy, privacy, liberty, proprietary, and other legally protected interests of individuals” for protection or promotion of community health.67 Lawrence Gostin argues that public health law concerns government authority to prevent injury and disease and to promote the public’s health, as well as appropriate constraints on state action to protect individual freedoms.68 In short, government has widespread authority to act in the public’s interest, but must do so within the constraints of law and the Constitution.69

Public health laws are passed upon a certain set of scientific assumptions that guide decision-making on whether the benefit to the common good outweighs any resulting limitations on individual liberties or other values. When evidence emerges that challenges those assumptions, that legal intervention must be revisited and revised.70 Likewise, when surveillance demonstrates an unacceptable, unintended consequence, the law must be retooled to mitigate such unfavorable consequences. For example, a recent study of Graduated Drivers Licensing (“GDL”) laws, which now exist in all fifty states and the District of Columbia, found a significant reduction in fatal crashes for sixteen-year-old drivers in states with stronger GDL laws; however, the study also revealed an increase in fatal crashes for eighteen-year-olds in those same states, suggesting that strong GDL laws may have induced young drivers to wait until age eighteen to obtain licensure to avoid GDL requirements.71 Policymakers and injury prevention professionals must now grapple with this new problem, possibly by revising the laws or through targeted education. Without evaluation research, however, unintended consequences of the law would remain unknown.

There is precedent for acting in the face of scientific uncertainty, and there is often good justification for doing so. The Precautionary Principle states that “[w]hen an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.”72 When potential harm is great, legislating with less substantial scientific evidence of “effectiveness” is probably appropriate.73 Even if a policy intervention infringes upon individual or organizational liberties, ethics may actually require that policymakers make an educated guess, based on incomplete evidence, about what is causing a certain harm and craft an educated attempt to alleviate that risk.74

Researchers are still studying the precise pathophysiology of concussion and its sequelae.75 However, by 2009, when the first sports-related concussion law was passed in Washington, researchers could agree that there was something about repeated concussion that elevated risk for at least some young athletes, and that a reasonable approach to addressing this risk was to ensure that concussed athletes did not suffer a subsequent concussion before the brain had adequately healed from the first.76 While some implementation challenges existed,77 the laws posed minimal burdens for individuals and organizations. Furthermore, they were often consistent with existing state policies and procedures, as many state-level athletic associations and school departments had already begun implementing some sort of concussion protocol for students.78 Thus, the laws merely codified what was already happening. By 2014, all states and the District of Columbia had passed similar laws.79

IV. Discussion of Ethical Considerations

Ethical principles dictate that public health laws should be evidence-based.80 In the ideal case, extensive and high-quality data exist to demonstrate a clear causal link between a legal intervention and the desired health outcome. For example, decades of epidemiological and medical research have established a clear causal link between tobacco smoke and a premature death for smokers and bystanders alike.81 Economic studies have demonstrated that tobacco excise taxes reduce tobacco consumption, particularly among younger populations, curbing both current and future tobacco use, and correspondingly reducing tobacco-related morbidity and mortality.82 The extensive evidence provides a compelling case for the use of public health authority. However, a commitment to evidence-based policymaking does not necessarily require policymakers to refrain entirely from action until such robust evidence exists.83 It would be unrealistic—and deleterious to the public’s health—to demand that public health laws be delayed until they can be supported by robust scientific evidence from systematic reviews.84 In some cases, the urgency of the public health problem at issue demands that policymakers devise solutions in the face of uncertain or mixed evidence.85

In evaluating the level of evidence necessary to justify implementation, policymakers must consider both the significance of the public health problem and the extent of the burdens imposed by proposed legislative action.86 Both considerations lend support to the initial passage of youth sports TBI laws. First, the prevalence of sports-related concussions represents a clear public health problem.87 The age of the target population adds additional justification, given the vulnerable status of minors and the corresponding societal interest in safeguarding their health and welfare, as well as the downstream implications of concussions and other brain injuries for long-term cognitive development.88 Second, the burdens imposed by the laws are arguably minimal. As the laws focus on educational and secondary prevention strategies, rather than imposing specific tests or invasive procedures for individuals or changes to the sports themselves, such as limiting the type or frequency of contact, they present a relatively light infringement upon individual liberty.89 In addition, while there are some financial costs associated with development and implementation of educational materials, these costs seem reasonable given the magnitude of the public health problem.90

In light of these considerations, the initial passage of youth sports TBI laws seems consistent with an ethical commitment to evidence-based policymaking. However, acting in the face of uncertainty creates an additional duty for public health policymakers to monitor and evaluate both the health condition targeted by the policy and the specific effects of policy, and tailor the law accordingly.91 Even where scientific evidence is sound, the policy may not “work” as intended due to any number of features in the implementation environment.92

In general, policymakers have the duty to ensure that public health laws are consistent with available evidence and effective in achieving their aims. One way of explaining the origin of this duty is that in creating public health laws, policymakers are generally infringing on individuals’ liberties. Certain infringements are justified if the public health issues involved are important; the public health benefit of laws banning smoking in restaurants or requiring drivers and their passengers to wear seatbelts are deemed to outweigh the individual liberty interests at stake.93 However, the right of policymakers to constrain personal liberty for the sake of public health relies upon being sufficiently certain that the public health aims are achieved. In this way, policymakers and the public health community that advocated for the intervention bear a duty to ensure that the policy effectively advances the public health ends that justified it.

In addition to the clear normative value for evaluating effectiveness, such evaluation may also yield political benefits. Providing evidence of the effectiveness of public health legal interventions may help overcome ideological opposition to the expanding use of government authority. Conversely, acknowledging areas in which public health authority has misfired may also help to stem concern for an ever-expanding regulatory state.94

Evaluating effectiveness is thus a critical step in public health policymaking. Furthermore, as the effectiveness of an intervention may shift as underlying conditions change, the duty to monitor effectiveness should be viewed not as a one-time commitment, but rather an ongoing process. For example, effective interventions to promote screening for TBI “may become less effective as baseline screening rates improve.”95 Similarly, the effectiveness of concussion education programs may decline as baseline levels of concussion awareness increase among coaches, players, and the broader population. In other circumstances, the feasibility of policy implementation may change.96 For example, changes in the geographic distribution of medical providers may affect the availability of qualified providers to evaluate concussed student-athletes, which in turn will shape the ability of schools to comply with RTP requirements.

Policy evaluation becomes more important where the science is uncertain or where the law (as with youth sports-related TBI laws) creates a presumption of safety. Many facets of youth sports-related TBI laws are untested. For example, youth and parent concussion education are required by many of the existing youth TBI laws.97 However, approaches to implementing this education vary widely and remain largely unevaluated. Furthermore, several aspects of existing approaches call into question the plausibility of efficacy.98 For example, in some states the information sheets themselves must be signed and returned, precluding the opportunity for later reference if the athlete or parent is concerned about a possible concussion.99 Additionally, many approaches are relatively passive, such as the small-print information sheets or pass-through screens on youth sports registration websites.100 Although these approaches may comply with the education requirement of state law, the effectiveness is unknown and to-date largely untested.101

The rapid pace of concussion research is likely to yield further insights that will show where current concussion laws are likely to yield health gains—but also where they are likely to fall short.102 For example, ongoing research into the pathophysiology of concussion sequelae will hopefully shed light upon whether and when an athlete can safely return to play, which should be incorporated into future educational and RTP requirements.103 Other research into subconcussive hits may further support arguments for the reduction of repeated head impacts, which should then shape decision-making regarding reduction of contact practices and perhaps even rule changes.104 Investigations examining the differential effects of brain trauma across phases of neurodevelopment could yield important information about when it may be more or less risky to begin participation in contact football.105 The dialogue between evolving science and concussion policy could allow for important reductions in the risks of participation in contact sports while facilitating the important benefits of physical activity.

Finally, policy evaluation should be also undertaken with an eye towards assessing the unintended consequences of TBI laws. For example, as one of us has argued elsewhere, the problem of TBI in youth sports may be a double-edged sword for public health.106 That is, interventions that aim to reduce concussion incidence may have the unintended consequence of reducing overall youth participation in sports in general, potentially exacerbating challenges of childhood obesity and physical inactivity, which themselves can lead to serious health consequences.107 TBI laws may also have deleterious implications for equity, as schools serving primarily minority and low-socioeconomic students, as well as schools in rural settings, may face the greatest implementation challenges.108 Indeed, research on the early implementation of TBI laws identified concerns related to access to qualified medical providers to assess concussed athletes, particularly in rural and medically underserved areas.109 It is concerning that additional requirements aimed at protecting youth, such as baseline assessments or requiring attendance of an athletic trainer or medical professional at games or other events,110 might prove too expensive or otherwise infeasible for low-resourced schools. This could lead to closures of sports programs and exacerbation of underlying disparities in access to sports and other activities for poor and minority youth.111 Alternatively, if these measures are implemented in situations where appropriate resources are not available, they may provide a false sense of security. For example, if baseline testing is implemented in a way that is ineffective (e.g., without sufficient medical oversight), parents may feel that return to play decisions are being made on sounder medical evidence than is, in fact, the case. Further policy evaluation will prove critical in ensuring that policies are not only effective, but also equitable.

V. Supporting Evidence-Based Policymaking

Our proposition that policymakers have an ethical duty to evaluate public health laws and use that evidence to modify them as necessary suggests several key features needed to fulfill this commitment. First, fulfilling a commitment to evaluation implies that public health policymaking should be viewed as a recursive process, one in which scientific evidence is constantly evaluated to identify the effects of implementation of existing policies, and evidence is fed back into the policymaking process to shape decisions about existing and future policies.112 Policy surveillance is thus integral for ethical public health policymaking—generating longitudinal data about the laws’ provisions and implementation to be used in policy evaluation research, and facilitating understanding about when a public health law meets its health objective, and the mechanism by which it does so.113 Continued development of longitudinal, coded legal datasets, such as the National Cancer Institute’s Classification of Laws Associated with School Students (“C.L.A.S.S.”),114 and resources for the systematic creation of such datasets, such as Public Health Law Research (“PHLR”) LawAtlas,115 will be critical to building capacity for ongoing sound research on the effectiveness of legal and legislative interventions.

Second, it suggests the importance of involving stakeholders in policymaking. Research suggests that when key stakeholders—including the targeted populations affected by legislation and those responsible for implementation—were involved in policymaking directed at youth TBI from the outset, there were fewer barriers to implementing TBI laws.116 Involving stakeholders in policymaking can provide important insights for what works “on the ground,” and can suggest strategies for overcoming early obstacles.

Finally, just as lawmakers have the duty to evaluate the effectiveness of their concussion legislation, sports leagues have the duty to evaluate the effectiveness of their rule changes aimed at reducing concussive impacts. In recent years, many sports leagues have made rule changes in response to the increased awareness of the health impacts of concussion.117 These rule changes are positive steps by the leagues in reaction to a growing public health concern. However, in creating an appearance of increased safety through this rule-making, sports leagues have assumed the duty of ensuring that the rules put in place actually achieve the intended goal.118 Without ensuring effectiveness, these rule changes may inappropriately influence parents’ decisions to enroll their children in contact sports or adult athletes’ decisions about continuing to participate in sports without actually altering the true associated risks.

VI. Conclusion

We argue that evaluating public health laws and retooling them in light of shifting evidence are potential ethical mandates, and suggest such obligations are deserving of further study and discussion. If public health is “an inescapably moral enterprise,”119 then ethics must play an important role in public health law development, enactment, implementation, and evaluation. Legal interventions in public health ideally would rest on robust, valid, and replicable evidence of “effectiveness,” evidence that the law will bring about a desired health outcome or prevent an undesired one. This is not always possible or desirable; there are valid reasons to take action before the evidence base is solid, particularly when vulnerable populations are involved (e.g., children). Youth sports-related TBI laws represent a timely case study: public health laws that were enacted to protect children despite an uncertain evidence base as to the nature of the problem and the most effective way to address it.120 As evidence from the medical field and from implementation emerge, states have begun to amend their laws in response— even those that had been in effect for less than a year. A law that restricts freedom or creates a perception of enhanced safety or protection and does not “work” is, we argue, an unethical one, because it either unnecessarily restricts autonomy or creates a false perception of safety. Should evidence of ineffectiveness or unintended consequences of the laws rise to the surface, we argue that ethics requires the law be changed to ensure that young athletes truly are protected by the legal intervention. As Carol Petrini argues, “an ethically sound health policy is likely to be a practical, effective health policy.”121

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  • 84.See id. (stating that if policymakers waited to act until there were no scientific disagreements, a “substantial and preventable burden” would be imposed on policy)
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