Surrogate endpoints are a common application of biomarkers to estimate clinical benefit in clinical trials, despite questions about reliability. This article discusses ongoing opportunities for their validation, in the context of a regulatory environment in which they are increasingly championed.

The revised Common Rule adopts the reasonable person standard to guide research disclosure. Some members of the research community contend that the standard is confusing and ill-suited to the research oversight system. Yet the revised rule is not as radical as it might seem. During the 1970s, judges started using the standard to evaluate negligence claims brought by injured patients who said doctors had failed to obtain informed consent to the harmful procedures. In its influential Belmont Report, the National Commission recommended application of a “reasonable volunteer standard” to guide IRBs evaluating research disclosures. Evidence also suggests that IRBs often invoke the reasonable person standard in deliberations about consent forms. But past application of the standard has been informal and uneven. Robust application of the reasonable person standard will require researchers and IRBs to learn more about what ordinary people want and need to know about the studies they are invited to join. Input from people with personal experience as study participants could be particularly useful to this effort.

When Congress passed HIPAA, it did not intend to constrain public health's data sharing in the same way as clinical or payers. In fact, HIPAA recognizes data sharing with public health as a matter of national priority and shields this function from its reach. However, a health department may offer services that bring it within HIPAA's purview, such as running a Children's Health Insurance Program or a laboratory that bills electronically. When this is the case, HIPAA requires all information and departments be subject to HIPAA unless the public health authority chooses to hybridize. Health departments might re-assess their coverage and elect to become a hybrid entity, thereby restricting HIPAA to only where required and removing barriers to information sharing with communities.

This article discusses how advocacy can be taught to both law and public health students, as well as the role that public health law faculty can play in advocating for public health. Despite the central role that advocacy plans in translating public health research into law, policy advocacy skills are rarely explicitly taught in either law schools or schools of public health, leaving those engaged in public health practice unclear about whether and how to advocate for effective policies. The article explains how courses in public health law and health justice provide ideal opportunities to teach advocacy skills, and it discusses the work of the George Consortium, which seeks to engage public health law faculty in advocacy efforts.

This article examines how public health addresses alcohol use through marketing — place, product, promotion, and price. The article reviews current product trends and how restrictions on certain products designs may reduce youth consumption; how product availability may be restricted through zoning; and the current advertising landscape.

Public health emergencies, including infectious disease outbreaks and natural disasters, are issues faced by every community. To address these threats, it is critical for all jurisdictions to understand how law can be used to enhance public health preparedness, as well as improve coordination and collaboration across jurisdictions. As sovereign entities, Tribal governments have the authority to create their own laws and take the necessary steps to prepare for, respond to, and recover from disasters and emergencies. Legal preparedness is a key component of public health preparedness. This article first explains legal preparedness and Tribal sovereignty and then describes the relationship between Tribal Nations, the US government, and states. Specific Tribal concerns with respect to emergency preparedness and the importance of coordination and collaboration across jurisdictions for emergency preparedness are discussed. Examples of collaborative efforts between Tribal and other governments to enhance legal preparedness are described.

Bicycle helmets protect against head injury. Mandatory helmet laws likely increase their use. Although 21 states and Washington, DC have mandatory helmet laws for youth (variously defined) bicyclists, no U.S. state has a mandatory helmet law that applies to all ages; however, some localities have all-age helmet laws for bicyclists. This study abstracted local helmet laws applicable to all-ages to examine their elements.

Thirty-four states, the District of Columbia, and Puerto Rico have legalized medical cannabis. While no two state medical cannabis programs are alike, public health concerns related to advertising, packaging and labeling, pesticide use, scientific research, and the role of medical cannabis in the opioid crisis are emerging across the country. This article examines these issues, the policy approaches states are adopting to protect patients and the public, and an assessment of the underlying federal legal landscape.

This article explores innovative legal tools in built environment settings. Using tangible examples, the discussion will leverage the authors' expertise in the law, public health, and architecture to explore strategies in domestic and international settings to explain how healthy spaces make a direct public health impact on people's lives.

This article argues in general support of the sIRB rule, but also draws on recent empirical research to highlight several residual weaknesses in the US regulatory structure for research ethics review, and suggests ways in which these weaknesses might be addressed in future regulatory reforms to improve upon the sIRB rule.

Under the Common Rule, federally-supported activities involving human participants are presumptively required to undergo prospective ethics review if they are “designed to develop or contribute to generalizable knowledge.” However, the “generalizable knowledge” standard is inherently ambiguous; moreover, it is both over- and under-inclusive of the type of activities that warrant prospective ethical oversight. Rather than conditioning prospective ethics review on an ethically irrelevant criterion like the generalizable knowledge standard, this article proposes that prior ethics review should be required when some individuals are exposed to greater-than-minimal risks for the potential benefit of others, at least when the activity in question is conducted or supported by federal agencies. Under such an approach, the fact that an activity constitutes research would be neither necessary nor sufficient to trigger prospective ethical oversight.

The Flint water crisis demonstrates the importance of adequate legal preparedness in dealing with complicated legal arrangements and multiple statutory responsibilities. It also demonstrates the need for alternative accountability measures when public officials fail to protect the public's health and explores mechanisms for restoring community trust in governmental public health.

Broadband internet access is a super-determinant of health that plays an important role in healthcare and public health outcomes. Laws and policies shape implementation and use of broadband for healthcare and public health. Connecting broadband and telehealth laws with their health impacts, through legal epidemiological research, enables states to make evidence-based decisions to improve health outcomes for underserved populations.

The call for a public health approach to gun violence has largely ignored what role the nascent Second Amendment jurisprudence will play in hindering change. Given the state interest for infringing on Second Amendment rights is nearly always public safety, public health law doctrine provides an apt framework for analysis.