Law Commons^™

Direct To Consumer Or Direct To All: Home Dna Tests And Lack Of Privacy Regulations In The United States, Karen J. Kukla

IP Theory

Although the U.S. has some measures of privacy protection for genetic data, the lack of a comprehensive approach to protecting direct-to-consumer genetic testing results in privacy violations for both consumers and their relatives. This essay explores the critical need for the U.S. government to address these privacy violations and argues that the U.S. should approach the problem and strategize a solution similar to the European Union’s (EU) General Data Protection Regulation (GDPR). Part I identifies current United States law, both federal and state regulations that address DTC-GT and genetic privacy. Part II examines the lack of regulation surrounding current DTC-GT …

Privacy And Property: Constitutional Concerns Of Dna Dragnet Testing, E. Wyatt Jones

Honors Projects

DNA dragnets have attracted both public and scholarly criticisms that have yet to be resolved by the Courts. This review will introduce a modern understanding of DNA analysis, a complete introduction to past and present Fourth and Fourteenth Amendment jurisprudence, and existing suggestions concerning similar issues in legal scholarship. Considering these contexts, this review concludes that a focus on privacy and property at once, with a particular sensitivity to the inseverable relationship between the two interests, is Constitutionally consistent with precedent and the most workable means of answering the question at hand.

The Absence Or Misuse Of Statistics In Forensic Science As A Contributor To Wrongful Convictions: From Pattern Matching To Medical Opinions About Child Abuse, Keith A. Findley

Dickinson Law Review (2017-Present)

The new scrutiny that has been applied to the forensic sciences since the emergence of DNA profiling as the gold standard three decades ago has identified numerous concerns about the absence of a solid scientific footing for most disciplines. This article examines one of the lesser-considered problems that afflicts virtually all of the pattern-matching (or “individualization”) disciplines (largely apart from DNA), and even undermines the validity of other forensic disciplines like forensic pathology and medical determinations about child abuse, particularly Shaken Baby Syndrome/Abusive Head Trauma (SBS/AHT). That problem is the absence or misuse of statistics. This article begins by applying …

No Longer Innocent Until Proven Guilty: How Ohio Violates The Fourth Amendment Through Familial Dna Searches Of Felony Arrestees, Jordan Mason

Cleveland State Law Review

In 2013, the United States Supreme Court legalized DNA collection of all felony arrestees upon arrest through its decision in Maryland v. King. Since then, the State of Ohio has broadened the use of arrestee DNA by subjecting it to familial DNA searches. Ohio’s practice of conducting familial DNA searches of arrestee DNA violates the Fourth Amendment because arrestees have a reasonable expectation of privacy in the information that is extracted from a familial DNA search and it fails both the totality of the circumstances and the special needs tests. Further, these tests go against the intention of the …

People V. Buza: A Step In The Wrong Direction, Emily R. Pincin

Loyola of Los Angeles Law Review

No abstract provided.

The Nagoya Protocol And The Legal Structure Of Global Biogenomic Research, Sam F. Halabi, Michelle Rourke, Gian Luca Burci, Rebecca Katz

Faculty Publications

As life sciences technologies have advanced, so too has the potential for these international collaborations to lead to breakthrough medicines, enhance food security, and protect ecological systems. The linchpin of this progress is the development of high throughput genetic sequencing technologies. Researchers are now able to generate and compare large stretches of DNA - 1 million bases or more - from different sources quickly and inexpensively. Such comparisons can yield massive amounts of information about the role of inheritance in susceptibility to infection and illness as well as responses to environmental influences. In addition, the ability to sequence genomes more …

Is It Time For A Universal Genetic Forensic Database?, Christopher Slobogin, Ellen Wright Clayton, J. W. Hazel, B. A. Malin

Christopher Slobogin

The ethical objections to mandating forensic profiling of newborns and/or compelling every citizen or visitor to submit to a buccal swab or to spit in a cup when they have done nothing wrong are not trivial. But newborns are already subject to compulsory medical screening, and people coming from foreign countries to the United States already submit to fingerprinting. It is also worth noting that concerns about coercion or invasions of privacy did not give pause to legislatures (or, for that matter, even the European Court) when authorizing compelled DNA sampling from arrestees, who should not forfeit genetic privacy interests …

Is It Time For A Universal Genetic Forensic Database?, Christopher Slobogin, Ellen Wright Clayton, J. W. Hazel, B. A. Malin

Ellen Wright Clayton

The ethical objections to mandating forensic profiling of newborns and/or compelling every citizen or visitor to submit to a buccal swab or to spit in a cup when they have done nothing wrong are not trivial. But newborns are already subject to compulsory medical screening, and people coming from foreign countries to the United States already submit to fingerprinting. It is also worth noting that concerns about coercion or invasions of privacy did not give pause to legislatures (or, for that matter, even the European Court) when authorizing compelled DNA sampling from arrestees, who should not forfeit genetic privacy interests …

Is Dna Really A Natural Product? It's Time To Separate Fact From (Legal) Fiction: An Examination Of Dna Patentability As A Biological Algorithm In The Post-Myriad Era, Nicholas Ulen

Chicago-Kent Law Review

In 2013, the United States Supreme Court delivered its landmark decision in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., holding isolated DNA unpatentable, thereby invalidating the claims of thousands of DNA patents in the process. The opinion, delivered by Justice Thomas, reasoned that the act of separating DNA from the body did not sufficiently transform the molecule beyond what naturally exists. Yet the Court found that line to be crossed when it held certain artificially synthesized complementary DNA molecules coding for the exact same gene patentable. Unlike the Federal Circuit, the Court focused its analysis not on the …

The First Amendment Case For Public Access To Secret Algorithms Used In Criminal Trials, Vera Eidelman

Georgia State University Law Review

As this Article sets forth, once a computerized algorithm is used by the government, constitutional rights may attach. And, at the very least, those rights require that algorithms used by the government as evidence in criminal trials be made available—both to litigants and the public. Scholars have discussed how the government’s refusal to disclose such algorithms runs afoul of defendants’ constitutional rights, but few have considered the public’s interest in these algorithms—or the widespread impact that public disclosure and auditing could have on ensuring their quality.

This Article aims to add to that discussion by setting forth a theory of …

Deploying The Secret Police: The Use Of Algorithms In The Criminal Justice System, Jessica Gabel Cino

Georgia State University Law Review

Algorithms saturate our lives today; from curated song lists to recommending “friends” and news feeds, they factor into some of the most human aspects of decision-making, tapping into preferences based on an ever-growing amount of data. Regardless of whether the algorithm pertains to routing you around traffic jams or finding your next dinner, there is little regulation and even less transparency regarding just how these algorithms work. Paralleling this societal adoption, the criminal justice system now employs algorithms in some of the most important aspects of investigation and decision-making.

The lack of oversight is abundantly apparent in the criminal justice …

The Technologies Of Race: Big Data, Privacy And The New Racial Bioethics, Christian Sundquist

Articles

Advancements in genetic technology have resurrected long discarded conceptualizations of “race” as a biological reality. The rise of modern biological race thinking – as evidenced in health disparity research, personal genomics, DNA criminal forensics, and bio-databanking - not only is scientifically unsound but portends the future normalization of racial inequality. This Article articulates a constitutional theory of shared humanity, rooted in the substantive due process doctrine and Ninth Amendment, to counter the socio-legal acceptance of modern genetic racial differentiation. It argues that state actions that rely on biological racial distinctions undermine the essential personhood of individuals subjected to such taxonomies, …

Is It Time For A Universal Genetic Forensic Database?, J. W. Hazel, Ellen Wright Clayton, B. A. Malin, Christopher Slobogin

Vanderbilt Law School Faculty Publications

The ethical objections to mandating forensic profiling of newborns and/or compelling every citizen or visitor to submit to a buccal swab or to spit in a cup when they have done nothing wrong are not trivial. But newborns are already subject to compulsory medical screening, and people coming from foreign countries to the United States already submit to fingerprinting. It is also worth noting that concerns about coercion or invasions of privacy did not give pause to legislatures (or, for that matter, even the European Court) when authorizing compelled DNA sampling from arrestees, who should not forfeit genetic privacy interests …

The Unintended Consequences Of California Proposition 47: Reducing Law Enforcement’S Ability To Solve Serious, Violent Crimes, Shelby Kail

Pepperdine Law Review

For many years, DNA databases have helped solve countless serious, violent crimes by connecting low-level offenders to unsolved crimes. Because the passage of Proposition 47 reduced several low-level crimes to misdemeanors, which do not qualify for DNA sample collection, Proposition 47 has severely limited law enforcement’s ability to solve serious, violent crimes through California’s DNA database and reliable DNA evidence. This powerful law enforcement tool must be preserved to prevent additional crimes from being committed, to exonerate the innocent, and to provide victims with closure through conviction of their assailants or offenders. Proposition 47’s unintended consequences have led to devastating …

Biometric Cyberintelligence And The Posse Comitatus Act, Margaret Hu

Scholarly Articles

This Article addresses the rapid growth of what the military and the intelligence community refer to as “biometric-enabled intelligence.” This newly emerging intelligence tool is reliant upon biometric databases—for example, digitalized storage of scanned fingerprints and irises, digital photographs for facial recognition technology, and DNA. This Article introduces the term “biometric cyberintelligence” to more accurately describe the manner in which this new tool is dependent upon cybersurveillance and big data’s massintegrative systems.

This Article argues that the Posse Comitatus Act of 1878, designed to limit the deployment of federal military resources in the service of domestic policies, will be difficult …

The Privacy, Probability, And Political Pitfalls Of Universal Dna Collection, Meghan J. Ryan

SMU Science and Technology Law Review

Watson and Crick’s discovery of the structure of DNA (deoxyribonucleic acid) in 1953 launched a truth-finding mission not only in science but also in the law. Just thirty years later–after the science had evolved–DNA evidence was being introduced in criminal courts. Today, DNA evidence is heavily relied on in criminal and related cases. It is routinely introduced in murder and rape cases as evidence of guilt; DNA databases have grown as even arrestees have been required to surrender DNA samples; and this evidence has been used to exonerate hundreds of convicted individuals. DNA evidence is generally revered as the “gold …

Charting The Contours Of Copyright Regime Optimized For Engineered Genetic Code, Christopher M. Holman

Faculty Works

There is a growing disconnect between the traditional patent-centric approach to protecting biotechnological innovation and the emerging intellectual property imperatives of “synthetic biology,” a promising new manifestation of biotechnology that enables the design and construction of artificial biological pathways, organisms or devices, as well as the redesign of existing natural biological systems. As explained in previous articles, one way to deal with this disconnect would be to expand the scope of copyrightable subject matter to encompass engineered genetic sequences, much in the way that copyright was expanded in the 1970s and 1980s to include computer programs. The present article expands …

Useless Information: Genetic Patenting, The Usefulness Requirement, And The Effect On The “Big Freeze”, David T. Bennett

Journal of the National Association of Administrative Law Judiciary

This note considers the current state of affairs regarding patentability in the field of biotechnology, especially that of genes and DNA. Part II gives a brief background of patents in general, including the requirements that must be met for a patent to be granted, the way in which the patent process works, and the options available to a patent holder once a patent has been granted. Part III explores the history of biotechnology patents. Part IV takes a look at the relationship between patents and biotechnology, and sheds light on some of the common arguments both in favor of and …

Gina's Genotypes, David H. Kaye

David Kaye

In August 2009, the Board of Trustees of the University of Akron added to the university's employment policy the following proviso: "any applicant may be asked to submit fingerprints or DNA sample for purpose of a federal criminal background check." Although the federal government does not do background checks with DNA, the policy is significant because it highlights a largely unexplored feature of the Genetic Information Nondiscrimination Act of 2008 (GINA). GINA generally prohibits employers from asking for "genetic information." The faculty senate and outside commentators have declared that the Akron policy is "of doubtful legality" because it "appears to …

'False But Highly Persuasive:' How Wrong Were The Probability Estimates In Mcdaniel V. Brown?, David H. Kaye

David Kaye

In McDaniel v. Brown, the Supreme Court will review the use of DNA evidence in a 1994 trial for sexual assault and attempted murder. The Court granted certiorari to consider two procedural issues - the standard of federal postconviction review of a state jury verdict for sufficiency of the evidence, and the district court's decision to allow the prisoner to supplement the record of trials, appeals, and state postconviction proceedings with a geneticist's letter twelve years after the trial.

This essay clarifies the nature and extent of the errors in the presentation of the DNA evidence in Brown. It questions …

Can Dna Be Speech?, Jorge R. Roig

Jorge R Roig

Recombinant Dna And The Regulation Of Biotechnology: Reflections On The Asilomar Conference, Ten Years After, John E. Barkstrom

Akron Law Review

The year 1985 marks the tenth anniversary of the International Conference on Recombinant DNA Molecules held at the Asilomar Conference Center, Pacific Grove, California in late February, 1975. The entire field of genetic engineering technology or "gene splicing" is not much older than the Conference itself. Many articles and much discussion have been occasioned by the recombinant DNA debate, including legal symposia held by the Universities of Southern California and Toledo. This article looks back at the events which led to Asilomar, the debate which followed, and some of the legal and ethical problems involved in the debate.

Chimeras: Double The Dna-Double The Fun For Crime Scene Investigators, Prosecutors, And Defense Attorneys?, Catherine Arcabascio

Akron Law Review

This article first explores the mythological origins of the term “chimera.” It then explores the causes and scientific explanations of chimerism and the various conditions covered by the term chimera in the area of genetics. Although this article will discuss the various chimeric conditions that are thought to exist, its primary focus is on chimerism that is the result of the fusing of embryos in utero. Next, the article will discuss recent cases of chimerism – and of alleged chimerism – and how the genetic differences between chimeras and the general population came to light. It also will discuss the …

Dna Storage Banks: The Importance Of Preserving Dna Evidence To Allow For Transparency And The Preservation Of Justice, Cristina Martin

Chicago-Kent Law Review

What is the duty to preserve information in today’s society? In order for humanity to evolve, change and flourish in the future, society needs to preserve its information from the past. In the criminal justice field, preservation of evidence has special significance. DNA evidence in particular has become a helpful aid for innocent defendants who have been improperly imprisoned. Over the past twenty years, the number of exonerations of imprisoned criminal defendants has increased dramatically. With the advancement of technology, old, previously untestable or improperly tested DNA evidence will need to be retested. However, most states do not have proper …

Statistics In The Jury Box: How Jurors Respond To Mitochondrial Dna Match Probabilities, David H. Kaye, Valerie P. Hans, B. Michael Dann, Erin J. Farley, Stephanie Albertson

Valerie P. Hans

This article describes parts of an unusually realistic experiment on the comprehension of expert testimony on mitochondrial DNA (mtDNA) sequencing in a criminal trial for robbery. Specifically, we examine how jurors who responded to summonses for jury duty evaluated portions of videotaped testimony involving probabilities and statistics. Although some jurors showed susceptibility to classic fallacies in interpreting conditional probabilities, the jurors as a whole were not overwhelmed by a 99.98% exclusion probability that the prosecution presented. Cognitive errors favoring the defense were more prevalent than ones favoring the prosecution. These findings lend scant support to the legal argument that mtDNA …

Dna By The Entirety, Natalie Ram

All Faculty Scholarship

The law fails to accommodate the inconvenient fact that an individual’s identifiable genetic information is involuntarily and immutably shared with her close genetic relatives. Legal institutions have established that individuals have a cognizable interest in controlling genetic information that is identifying to them. The Supreme Court recognized in Maryland v. King that the Fourth Amendment is implicated when arrestees’ DNA is analyzed, and the Genetic Information Nondiscrimination Act protects individuals from genetic discrimination in the employment and health-insurance markets. But genetic information is not like other forms of private or personal information because it is shared — immutably and involuntarily …

Dalla Traccia Di Sangue All'identikit Facciale, Charles E. Maclean

Charles E. MacLean

Assessment of dilemmas inherent in using DNA phenotyping methods to generate a physical likeness of a crime suspect based only on DNA shed at the crime scene.

Science And The New Rehabilitation, Meghan J. Ryan

Faculty Journal Articles and Book Chapters

Rehabilitation’s making a comeback. Long thought to be an outdated approach to punishment, rehabilitation is reemerging in the wake of scientific advances. Not only have these advances in the fields of pharmacology, genetics, and neuroscience brought new rehabilitative possibilities, but the media’s communication of these advances to the general public have set the stage for rehabilitation’s reprise. The media constantly pummels the general public with reports of scientific breakthroughs like functional magnetic resonance imaging, prepping the public to be more accepting of deterministic viewpoints and to be more open to the possibility of transforming individuals. The rehabilitation that is emerging, …

Maintaining Competition In Copying: Narrowing The Scope Of Gene Patents, Oskar Liivak

Oskar Liivak

In supporting gene patents, the patent office, the courts and other supporters have assumed that gene discoveries are identical to traditional inventions and therefore the patent system should treat them as identical. In other words, they have assumed that the relatively broad claims that are used for traditional inventions are also appropriate for encouraging gene discovery. This article examines this assumption and finds that gene discoveries are critically different from traditional inventions and concludes that the patent system cannot treat them as identical.

As a doctrinal matter, this article applies the generally overlooked constitutional requirements of inventorship and originality and …

23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely

Other Publications

On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.