It has become increasingly difficult for individuals to exercise meaningful control over the personal data they disclose to companies or to understand and track the ways in which that data is exchanged and used. These developments have led to an emerging consensus that existing privacy and data protection laws offer individuals insufficient protections against harms stemming from current data practices. However, an effective and ethically justified way forward remains elusive. To inform policy in this area, we propose the Ethical Data (...) Practices framework. The framework outlines six principles relevant to the collection and use of personal data—minimizing harm, fairly distributing benefits and burdens, respecting autonomy, transparency, accountability, and inclusion—and translates these principles into action-guiding practical imperatives for companies that process personal data. In addition to informing policy, the practical imperatives can be voluntarily adopted by companies to promote ethical data practices. (shrink)

Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.

Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.

This article argues that current data for the safety and efficacy of fecal microbiota transplants as a treatment for any indication, including recurrent Clostridioides difficile infection, is low-quality. It develops a governance proposal that encourages production of high-quality evidence by incentivizing well-designed RCTs of stool and stoolderived microbial products. The proposal would require that FDA change its current enforcement approach, but it would not require any change in statutes or regulations.

In the opening years of the 21st century, it became fashionable to describe the human genome as belonging to the common heritage of humanity. The United Nations, in its Universal Declaration on the Human Genome and Human Rights, now identifies the human genome as part of the common heritage, as does the international Human Genome Organization and the Council of Europe. The common heritage concept has played a prominent role in arguments against patenting the human genome or portions thereof. This (...) essay considers whether the common heritage designation will advance the political and legal goals of its proponents. (shrink)

This essay identifies two legal lineages underlying the common heritage concept, and applies each to the human genome. The essay notes some advantages and disadvantages of each approach, and argues that patenting of human genes would be allowable under either approach.

Information from forensic genetic tests of crime scene samples has been used to make claims about suspects' race and appearance. This article discusses and critiques the techniques used to make such claims, and raises policy concerns about them.

“DNAPrint Genomics, Inc. has applied the most recent advancements in human genomic technology for the deciphering of an individual's race. We are proud to introduce to the forensic community DNA WITNESS 2.0, a genetic test for the deduction of the heritable component of race, called Biogeographical Ancestry.”–Z. Gaskin“One definite and obvious consequence of the complexity of human demographic history is that races in any meaningful sense of the term do not exist in the human species.”–D. B. Goldstein and L. Chikhi.

The biosciences have become information sciences, in which knowledge is often produced in silica, by the manipulation and analysis of large datasets. Genomics has been at the forefront of the data explosion and is a model for bioscience as a large-scale endeavor. Large genome research datasets are frequently shared through research repositories. To protect the interests of people from whom the data were derived , human data are often shared through a controlled access mechanism, in which data repositories can, in (...) theory, place limitations on who uses the data and for what purpose. Controlled access is an innovative governance mechanism, but it may not protect data sources the way policy makers intended. Here, I describe one controlled access process in some detail, and provide insight into how and why researchers fail to comply with data use restrictions. (shrink)

Biomedical research is increasingly data intensive and computational, and “big data science” is migrating into the clinical arena. Unfortunately, ethicists, regulators, and policy‐makers have barely begun to explore the ethical, legal, and social issues raised by the variety of analytical and computational approaches in use and under development in biology and medicine. Most scholarship concerning big data bioscience has focused on privacy, a vitally important consideration but not the only one. Among the issues raised by new computational technologies are questions (...) about safety and safety assessment, justice, and how to obtain proper informed consent. These technologies also raise a myriad of regulatory issues that could influence the probability of translating new assays or computational tools to the clinical or public health spheres. (shrink)

The prelims comprise: Introduction Background on Patent Law: Fighting the Myths and Misconceptions The Ethics of Patenting Human Genes.