Law Commons^™

The Reckoning: The Return Of Genomic Results To 1444 Participants Across The Emerge3 Network, Ellen W. Clayton, Kathleen A. Leppig, Et Al.

Vanderbilt Law School Faculty Publications

The goal of Electronic Medical Records and Genomics (eMERGE) Phase III Network was to return actionable sequence variants to 25,084 consenting participants from 10 different health care institutions across the United States. The purpose of this study was to evaluate system-based issues relating to the return of results (RoR) disclosure process for clinical grade research genomic tests to eMERGE3 participants.

Frontiers In Precision Medicine Iv: Artificial Intelligence, Assembling Large Cohorts, And The Population Data Revolution, Adam Bress, Rich Albrechtsen, Monika Baker, Jorge L. Contreras, Zachary Fica, Austin Gamblin, Chelsea Ratcliff, Bianca E. Rich, Matt A. Szaniawski, Alyssa Thorman, Chad Vansant-Webb, Willard Dere

Utah Law Faculty Scholarship

Large cohort studies and more recently electronic medical records (EMR) are being used to collect massive amounts of genetic information. Implementation of artificial intelligence has become increasingly necessary to interpret this data with the goal of augmenting patient care. While it is impossible to predict what the future holds, policy makers are challenged to create guiding principles and responsibly roll out these new technologies. On March 22, 2019, the University of Utah hosted its fourth annual Precision Medicine Symposium focusing on artificial intelligence, assembling large cohorts, and the population data revolution. The symposium brought together experts in medicine, science, law …

Addiction As Disease, Teneille R. Brown

Utah Law Faculty Scholarship

The opioid addiction epidemic is the most overwhelming public health crisis our country has faced. It is now creating a legal crisis, as the its poisonous fruits spill over into the criminal, tort, and family courts. The epidemic costs the U.S. economy about $500 billion every year, and the pressure is crippling our legal systems. This Article is an attempt to relieve some of that pressure, by advocating for a comprehensive public health campaign based upon a new model of addiction. Research shows that the prevalent “moral choice” model of addiction has facilitated stigma and discouraged treatment, by viewing affected …

Diagnostics Need Not Apply, Rebecca S. Eisenberg

Articles

Diagnostic testing helps caregivers and patients understand a patient's condition, predict future outcomes, select appropriate treatments, and determine whether treatment is working. Improvements in diagnostic testing are essential to bringing about the long-heralded promise of personalized medicine. Yet it seems increasingly clear that most important advances in this type of medical technology lie outside the boundaries of patent-eligible subject matter. The clarity of this conclusion has been obscured by ambiguity in the recent decisions of the Supreme Court concerning patent eligibility. Since its 2010 decision in Bilski v. Kappos, the Court has followed a discipline of limiting judicial exclusions from …

Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin

All Faculty Scholarship

Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists' ability to continue and expand research into the human genome to improve patients' access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court, which is considering a petition for certiorari in Ass'n for Molecular Pathology v. U.S. …

Manipulating Fate: Medical Innovations, Ethical Implications, Theatrical Illuminations, Karen H. Rothenberg, Lynn W. Bush

Faculty Scholarship

Transformative innovations in medicine and their ethical complexities create frequent confusion and misinterpretation that color the imagination. Placed in historical context, theatre provides a framework to reflect upon how the ethical, legal, and social implications of emerging technologies evolve over time and how attempts to control fate through medical science have shaped -- and been shaped by -- personal and professional relationships. The drama of these human interactions is powerful and has the potential to generate fear, create hope, transform identity, and inspire empathy -- a vivid source to observe the complex implications of translating research into clinical practice through …

Reexamining Models Of Disability And Applying Rationality, Morality, And Ethics To Support Disability Rights In Context Of Genetics, Gary C. Norman

Articles in Law Reviews & Journals

The author discusses genetic and assistive reproduction science and technology in light of their impact on people with disabilities. Specifically, he focuses on the prism of the models through which disability is recognized. If applied in a manner such that the best facets of both models of disability can bear forth, then the position of the author, a person with a vision disability, is that his colleagues in the disability civil rights movement should not reflexively excoriate genetic and assisted reproduction science and technology. However, safeguarding people with disabilities, who are a discrete and insular minority across the globe, against …

From Eugenics To The "New" Genetics: "The Play's The Thing", Karen H. Rothenberg

Faculty Scholarship

Genetics occupies a place in the public imagination with which few areas of science can compete. It is popularly understood to be the “science of life,” concerned with the essence of humanity: a subject that generates both awe and fear. These divergent emotions are encapsulated in the “promise versus peril” debate: the promise of an end to human disease is countered by the peril embodied in the discriminatory capacity of genetic essentialism. This debate has become ingrained in popular culture, and its dramatic potential has been effectively realized in theatre.

Plays have always been written and performed as expressions of …

Protecting Workers From Genetic Discrimination, Karen H. Rothenberg

Congressional Testimony

No abstract provided.

The Scarlet Gene: Behavioral Genetics, Criminal Law, And Racial And Ethnic Stigma, Karen H. Rothenberg, Alice Wang

Faculty Scholarship

Imagine that a scientist from the state university asks you and your family to participate in a study on a particular gene variant associated with alcoholism. The project focuses on your ethnic group, the Tracy Islanders, who have a higher incidence of alcoholism, as well as a higher incidence of the gene variant, than the general population. You will not be informed whether you have the gene variant, but your participation in the study might help scientists develop drugs to help individuals control their addiction to alcohol. You have a family history of alcoholism, and you are concerned that your …

When Should Judges Admit Or Compel Genetic Tests?, Diane E. Hoffmann, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.

Genetic Enhancement: Plan Now To Act Later, Maxwell J. Mehlman

Faculty Publications

No abstract provided.

Navigating Uncharted Waters: Intellectual Property Rights Surrounding Genomics Research & Development Information, Lawrence M. Sung

Faculty Scholarship

No abstract provided.

What Makes Genetic Discrimination Exceptional?, Deborah Hellman

Faculty Scholarship

No abstract provided.

Foreword: Phase Ii Of The Genetics Revolution: Sophisticated Issues For Home And Abroad, Frances H. Miller

Faculty Scholarship

The distinguished health law and policy scholars we invite to contribute to the American Journal of Law & Medicine's annual symposium issue are given carte blanche to write about any aspect of the designated topic that appeals to them. The authors in this year's genetics symposium, The Genetic Revolution: Conflicts, Challenges and Conundra, are already well known for their work in the field-in fact three of them have just co-authored the only casebook specifically dedicated to the law, policy and ethics of geneticsl-and we deliberately asked them for relatively short pieces on the theory that taken together their articles would …

Consent To The Use Of Stored Dna For Genetics Research: A Survey Of Attitudes In The Jewish Population, Marc D. Schwartz, Karen H. Rothenberg, Linda Joseph, Judith Benkendorf, Caryn Lerman

Faculty Scholarship

No abstract provided.

The Potential For Discrimination In Health Insurance Based On Predictive Genetic Tests, Karen H. Rothenberg

Congressional Testimony

No abstract provided.

Rules For Research On Human Genetic Variation: Lessons From Iceland, George J. Annas

Faculty Scholarship

Research on genetic variation aims to understand how genes function and requires the comparison of DNA samples from groups of individuals to identify variations that might have importance for health or disease. This work is easier if the samples are linked to accurate medical records and genealogic information. Iceland has medical records for all its citizens going back to World War I and detailed genealogic information going back even further. Because Iceland's small population (270,000) has long been isolated and homogeneous, it is thought by many to be an ideal place to search for disease-related genes. Journalists have cavalierly labeled …

Privacy In Genetics Research, Barbara Fuller, Mary Jo Ellis Kahn, P. A. Barr, L. Biesecker, E. Crowley, J. Garber, M. K. Mansoura, Patricia Murphy, J. Murray, J. Phillips, Karen H. Rothenberg, Mark Rothstein, J. Stopfer, Gary Swergold, B. Weber, Francis Collins, Kathy Hudson

Faculty Scholarship

No abstract provided.

The Misperception That Bioethics And The Law Lag Behind Advances In Biotechnology, David Orentlicher

Scholarly Works

No abstract provided.

Genetic Testing, Genetic Medicine, And Managed Care, Mark A. Rothstein, Sharona Hoffman

Faculty Publications

As modern human genetics moves from the research setting to the clinical setting, it will encounter the managed care system. Issues of cost, access, and quality of care will affect the availability and nature of genetic testing, genetic counseling, and genetic therapies. This articles explores such issues as professional education, coverage of genetic services, privacy and confidentiality, and liability. It concludes with a series of recommendations for the practice of genetic medicine in the age of managed care.

Cancer Genetic Susceptibility Testing: Ethical And Policy Implications For Future Research And Clinical Practice, Benjamin S. Wilfond, Karen H. Rothenberg, Elizabeth J. Thomson, Caryn Lerman

Faculty Scholarship

No abstract provided.

Genetic Information And The Workplace: Legislative Approaches And Policy Challenges, Karen H. Rothenberg, Barbara Fuller, Mark Rothstein, Troy Duster, Mary Jo Ellis Kahn, Rita Cunningham, Beth Fine, Kathy Hudson, Mary-Claire King, Patricia Murphy, Gary Swergold, Francis Collins

Faculty Scholarship

No abstract provided.

The Law Of Above Averages: Leveling The New Genetic Enhancement Playing Field, Maxwell J. Mehlman

Faculty Publications

In this article, I will explore some of the legal implications of this emerging technology-the technology of genetic enhancement. Specifically, I will discuss how the law might respond to two related consequences: an increase in social inequality, and the

The Human Genome Project And The Courts: Gene Therapy And Beyond, Maxwell J. Mehlman

Faculty Publications

No abstract provided.

How Will We Regulate Genetic Enhancement, Maxwell J. Mehlman

Faculty Publications

Genetic enhancement technologies present difficult and novel regulatory issues, including the problem of measuring and comparing risks and benefits and dealing with the impact of these technologies on social values. This Article describes and evaluates the potential approaches that may be taken to regulate these technologies. The author concludes that a variety of approaches will be necessary, involving self-regulation, government restrictions on access and use, licensing, and a national lottery.

Advances In Genetic Research And Technologies: Challenges For Public Policy, Karen H. Rothenberg

Congressional Testimony

No abstract provided.

Genetic Information And Health Insurance: State Legislative Approaches, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.