The use of whole-genome sequencing in biomedical research is expected to produce dramatic advances in human health. The increasing use of this powerful, data-rich new technology in research, however, will inevitably give rise to incidental findings (IFs)-findings with individual health or reproductive significance that are beyond the aims of the particular research-and the related questions of whether and to what extent researchers have an ethical obligation to return IFs. Many have concluded that researchers have an ethical obligation to return some findings in some circumstances but have provided vague or context-dependent approaches to determining which IFs must be returned and when. As a result, researchers have started returning IFs inconsistently, giving rise to concerns about legal liability in circumstances in which notification could have potentially prevented injury. Although it is clear that ethical guidance should not be automatically codified as law and that crafting ethical obligations around legal duties can be inappropriate, the ethical debate should not proceed unaware of the potential legal ramifications of advancing and implementing an ethical obligation to return IFs. This Article assesses the legal claims that could be brought for a researcher's failure to return IFs. The potential for researchers to be held liable in tort is still uncertain and turns largely on a number of factors-including customary practice and guidance documents-that are still in flux. Unlike medical care, which has a well-defined duty into which evolving scientific knowledge about genetics and genomics can readily be incorporated, a researcher's duty to return IFs is less well defined, making it difficult to determine at the outset whether and when legal liability will attach. This Article advocates for a clearer, ethically sound standard of requiring that researchers disclose in the informed consent document which approach to offering IFs will be taken. This approach enables participants to know at the outset which findings, if any, will be returned, allows researchers to ascertain when their failure to appropriately return incidental findings will give rise to liability, and enables courts to make determinations that will produce more consistent legal guidance.

This article considers the scientific, legal, ethical, and social issues of the Brave New World of Biotechnology as they existed in 1976 and as they exist — interestingly — today. Central to these issues (e.g., in vitro fertilization, genetic planning) presented in historical context, is consideration of the extent to which freedom of scientific investigation should be allowed and even encouraged by the government. In order to shape normative standards of conduct from which ethical constructs can be developed and policy developed, scientific experimentation must be promoted and designed to safeguard the common good — this, by enhancing opportunities for more healthful living, strengthening the gene pool by combating disease, minimizing human suffering and containing health care expenditures. Indeed, this course of behaviour should be recognized as not only in the Nation’s best interests, but a valid and efficacious ethic to embrace. It is only by recognition of the freedom of scientific inquiry that a common language of scientific humanism can ever be fostered.

This Essay offers a normative theory of global health law. It builds on a theory of health and social justice I have long been developing and extends this theory in evaluating the role of international law in health. This theory takes human flourishing as the end goal of a global society and proposes that global health law be examined in terms of an ethical demand for health equity. This ethical demand will likely require legal instruments for realization, but it will also require individuals, states, and nonstate actors to internalize public ethical norms in support of global health goals. This Essay also argues that global health law should be examined in the contexts of international relations and global public policy and that law and policy should be linked at the global and domestic levels. Philosophical underpinnings of global health law cannot be studied separately from other global and domestic tools to reach global health equity. This Essay comprises three parts. Part I offers normative foundations for the future of global health law and presents a theory of global health equity. Part II analyzes the role of global health law in achieving health equity, examines the effectiveness and limits of international health law, and considers the conditions necessary for the effectiveness of global health law. Part III offers an analysis of global health law vis-a-vis domestic health law and policy. The Essay concludes by arguing that solutions to global health disparities and externalities require more than international treaties, conventions, and recommendations. They require domestic health policy, law, and institutional reforms establishing sustainable, government-sponsored health systems, including universal health insurance and public-health and health-care infrastructures. Thus, the success and future of global heath law depend as much on domestic health policy and law as they do on international health law itself.