| ABSTRACT: Advances in nanotechnology are laying the foundations for developing molecular manufacturing systems, bringing a dramatic revolution in the price, performance, and ubiquity of smart products along with advances in medicine, computation, environmental improvements, and space exploration. Regulatory and intellectual property legal regimes will need to accommodate the coming technology. However, U.S. policy toward researching and funding nanotechnology is following an inconsistent model. Changes must be made in this approach to avoid falling behind other nations in the development and implementation of nanotechnology.
The paper first analyzes how we are able, with some confidence, to project at least a part of what will be possible as a result of future developments. It then discusses the current understanding of molecular manufacturing itself and discusses at some length nanotechnology and policy and legal issues—raising more questions than answers—but opening some directions that are fertile for further investigation. The paper concludes with a discussion of current nanotechnology policy in the United States.
CITATION: K. Eric Drexler with Jason Wejnert, nanotechnology and Policy, 45 Jurimetrics J. 1–22 (2004).
ABSTRACT: Empirical investigation of public usage of the word "progress" in the United States of 1789 demonstrates that the word meant "dissemination." The original meaning of art. I, sec. 8, cl. 8, therefore, is that Congress has the right to grant only such temporally limited exclusive rights in writings and new technology as encourage the dissemination of knowledge and new technology to the population. This article explains the major differences between current United States positive intellectual property law and the logical dictates of this original constitutional meaning. Additionally, the article asserts that the original meaning of clause 8 supports modern calls for a public-empowering First Amendment doctrine, as suggested by scholars such as Jack M. Balkin.
CITATION: Malla Pollack, The Democratic Public Domain: Reconnecting the Modern First Amendment and the Original Progress Clause (a.k.a. Copyright and Patent Clause), 45 Jurimetrics J. 23–40 (2004).
ABSTRACT: This Note analyzes the admissibility of fingerprint expert testimony in light of Daubert. On the one hand, fingerprint expert testimony cannot easily survive an intellectually honest application of Daubert. On the other hand, courts have made it clear that they cannot bring themselves to exclude fingerprint expert testimony, notwithstanding the Daubert requirements. This Note suggests a policy of restricted admission as an alternative to the complete exclusion or unfettered admission of such evidence.
CITATION: Kristin Romandetti, Note, Recognizing and Responding to a Problem with the Admissibility of Fingerprint Evidence under Daubert, 45 Jurimetrics J. 41–58 (2004).
ABSTRACT: In United States v. American Library Ass’n, Inc., 539 U.S. 194 (2003), the Supreme Court held that Congress may condition the receipt of federal funds for Internet access under the E-rate and Library Services and Technology Act programs upon a library’s compliance with the Children’s Internet Protection Act’s requirement that pornography filters be installed on all computer terminals with Internet access. The Court reasoned that Internet access in libraries is not a public forum, and therefore such a content-based restriction is subject to a rational basis test rather than strict scrutiny. Under this test, Congress is afforded broad discretion to attach conditions to the receipt of federal aid. This Note explores the Court’s public forum analysis and ultimately concludes that the Court’s definition of a public forum is flawed and should be amended.
CITATION: Derrick Stomberg, Note, United States v. American Library Association, Inc.: The Internet as an Inherently Public Forum, 45 Jurimetrics J. 59–73 (2004).
ABSTRACT: In Kremen v. Cohen, 337 F.3d 1024 (9th Cir. 2003), the Ninth Circuit held that Internet domain names constitute intangible personal property subject to the tort of conversion. This Note concludes that the classification of domain names as intangible property is incorrect and suggests they are properly viewed as products of contracts for services.
CITATION: Jay Prendergast, Note, Kremen v. Cohen: The "Knotty" Saga of Sex.com, 45 Jurimetrics J. 75–91 (2004).
ABSTRACT: In Plant Genetic Systems v. DeKalb Genetics Corp., 315 F.3d 1335 (Fed. Cir. 2003), plaintiff held a patent covering genetically modified cells, seeds, and plants containing a gene that immunized the plants from nonselective herbicides. Plaintiff sued defendant for making and selling corn containing the gene. When the district court held in favor of defendant, plaintiff appealed, arguing that its invention was "pioneering" and deserving of broader protection. The Court of Appeals for the Federal Circuit affirmed, finding that plaintiff’s reliance on precedent concerning pioneer patents was misplaced because patentee had not met the statutory requirements for enablement. The applicability of the pioneer doctrine is fading as the fields of technological art are becoming more and more crowded. Courts will not apply it when statutory enablement requirements are not met.
CITATION: Karen Feng, Note, Plant Genetic Systems v. DeKalb: The Pioneer Doctrine Cannot Substitute for Defective Enablement, 45 Jurimetrics J. 93–102 (2004).
WINTER 2005
ABSTRACT: This paper identifies and compares current international guidelines in relation to ethical, legal, and social issues (ELSI) in genebank development and examines how they apply to seven proposed or newly established genebanks. More specifically, this article considers issues of sponsorship and benefit sharing, ethics committees, public engagement, consent, and data protection. In general, a consensus is emerging in the international guidelines that the human genome is the property of all humanity, that benefit sharing should include releasing relevant findings to the project participants, and that profit sharing may be appropriate. Similarly, there is agreement about the need for independent ethics committees, the requirement of voluntary informed consent, and the importance of protecting the privacy and confidentiality of patient information. However, the guidelines are less uniform with regard to consultation and education of the population, withdrawal of consent, data coding methods, and future use of data. New genebanks address these issues with a variety of policies and approaches. Because of the lack of global oversight and enforcement, it has been suggested that an international regulatory body be given the responsibility to oversee more standardized implementation of the guidelines.
CITATION: Melissa A. Austin, Julia Crouch, and Alyssa DiGiacomo, Applying International Guidelines on Ethical, Legal, and Social Issues to New International Genebanks, 45 Jurimetrics J. 115–134 (2005).
ABSTRACT: People who provide their tissue for genetic research have strong interests in controlling its future uses; traditionally such interests have been safeguarded by the doctrine of informed consent. Yet, researchers often have strong competing interests in conducting research on "stored" tissue, research that was unforeseen at the time the tissue was collected and to which consent thus could not meaningfully be given at that time. Various mechanisms have been proposed over the years to resolve the resulting tension. Most of these have been flawed in important respects. By far the best solution, advanced by Stanford Professor Henry Greely, would substitute rigorous ethical safeguards for the subject’s diminished consent. However, Greely’s accompanying recommendation—to change the regulatory law of informed consent to accommodate his ethically sound proposal—seems unlikely to be achieved. Surprisingly, it may also be unnecessary and of ambiguous overall benefit.
CITATION: Daniel S. Strouse, Informed Consent to Genetic Research on Banked Human Tissue, 45 Jurimetrics J. 135–152 (2005).
ABSTRACT: The traditional assumption in most genetic research is that the donors of genetic material used in research act altruistically and are entitled to no property rights or direct benefit-sharing in the fruits of the research. This traditional assumption is now being challenged from several different directions. Some international ethics guidelines, advocacy organizations for families suffering from genetic diseases, and special populations such as Indian tribes are all pushing for greater control, rights, and benefit-sharing for genetic donors. The failure to resolve the tensions between these new demands and the traditional assumption of genetic research has the potential to create a bottleneck in the supply of genetic samples vital to the advancement of genetic research. This Article traces the recent controversies and trends that are challenging the traditional assumption that DNA donors in genetic research have no property or other rights in their donated material and outlines some alternative approaches for resolving this problem.
CITATION: Gary E. Marchant, Property Rights and Benefit-Sharing for DNA Donors?, 45 Jurimetrics J. 153–178 (2005).
ABSTRACT: One of the first and most comprehensive banks of genetic information has long preceded the current interest in large collections of DNA: that of residual newborn dried blood spots (DBS) collected from nearly every infant born after 1965 in the United States. Because samples are collected all across the country and the samples remain quite stable over time, newborn dried blood spots are becoming more and more appealing as a potential resource. Currently, every state and the District of Columbia have laws establishing newborn screening programs. In this era of Genomics, a range of potential future uses of this vast collection of DNA may be possible. This Article will examine some of those uses and the considerations necessary before these previously collected samples can be used prospectively.
CITATION: Nanette Elster, Future Uses of Residual Newborn Blood Spots: Legal and Ethical Considerations, 45 Jurimetrics J. 179–189 (2005).
ABSTRACT: Genetics research has the potential to improve health care. American Indians (AIs) suffer from significant health disparities, including significantly higher incidence and prevalence of preventable diseases like diabetes, alcoholism, and their complications. Underfunding of health programs, including the Indian Health Service, and lower socioeconomic status among AIs contribute to these disparities. Improvements in disease prevention and treatment potentially offered by genetics research could help to reduce health disparities. However, a history of nonparticipation in the research process and a history of dishonest research practices have raised barriers to conducting research in AI communities. A paradigm for research that includes the community as a full research partner may be necessary to promote research in AI communities and to translate genetics research into reductions in health disparities.
CITATION: Donald Warne, Genetics Research in American Indian Communities: Sociocultural Considerations and Participatory Research, 45 Jurimetrics J. 191–203 (2005).
ABSTRACT: Genebanks are a revolutionary tool used to study and facilitate the development of therapies for human disease. However, human genebanks also raise several practical, ethical, legal, and social issues. This Article reviews these salient issues that invoke considerations of intellectual property, privacy, informed consent, community consent, and risk-benefit inequities that genebanks should consider when engaging in human genetic sampling and human subjects research.
CITATION: Michael D. Volk Jr., Christine Meis McAuliffe, and May Mowzoon, Genebank Management: A Review of Salient Ethical, Legal, and Social Issues, 45 Jurimetrics J. 205–223 (2005).
ABSTRACT: Genetic research generates databases and copyright liability could arise from unauthorized reproduction of those databases. Failure to consider copyright issues could result in unintended consequences for database owners. The fair use doctrine is not a complete bar to potential liability. Even though copyright protection for a database is "thin," owners should address the copyright issue by contract and may want to consider using an open source model for database ownership.
CITATION: Ray K. Harris and Susan Stone Rosenfield, Copyright Protection for Genetic Databases, 45 Jurimetrics J. 225–250 (2005).
ABSTRACT: The Privacy Standards, issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), have had a significant impact on how health-care providers may use and release patient information for research purposes. This Article discusses the Privacy Standards’ rules on use and disclosure of health information for research, with a special emphasis on how these federal rules affect the storage and use of genetic samples for research. This Article also discusses the following topics: (1) de-identification of genetic samples; (2) when sampling is human subject research; (3) when researchers may release a "limited data set" that is stripped of elements directly identifying research participants; (4) how to seek HIPAA-compliant authorization from the participant, the limitations on combining a HIPAA authorization form with the informed consent to participate in the study, and the limitation on obtaining authorization to use or disclose health information for future unspecified research projects; (5) when HIPAA authorization may be waived or altered by an Institutional Review Board or privacy board; (6) how health information may be used to identify and recruit research participants; and (7) how the Privacy Standards affect research started before the HIPAA compliance date. The Article concludes that, while the Department of Health and Human Services (HHS) has made an effort to clarify these confusing rules, changes to the regulations are required to remove inconsistencies with the HHS Common Rule and to remove regulatory barriers to genetic sampling and to creating other research repositories.
CITATION: Kristen B. Rosati, Human Genetic Sampling and the HIPAA Privacy Standards, 45 Jurimetrics J. 251–271 (2005).
SPRING 2005
ABSTRACT: Procreational autonomy is one’s ability to choose when to have a child. Because advances in human reproduction technology allow one to create embryos with donated sperm and egg and freeze them for future use, it is important to analyze the resulting legal implications. This Article proposes a complete disposition model in cases where the egg and sperm donors disagree about the embryo’s ultimate fate. While embryos should be accorded a level of respect as a potential life, referring to an embryo’s legal status as "chattel" is useful because it gives an embryo its deserved respect while bringing clarity to the law. This Article distills the policies alluded to in the scant case law dealing with the disposition of frozen embryos and argues that the right to avoid procreation is the stronger interest when attempting to resolve an embryo disposition dispute.
CITATION: Joseph Russell Falasco, Frozen Embryos and Gamete Providers’ Rights: A Suggested Model for Embryo Disposition, 45 Jurimetrics J. 273–300 (2005).
ABSTRACT: Radio Frequency Identification (RFID), like many other technologies, is a double-edged sword. On the one hand, this automatic identification technology would enable entirely unobstructed visibility into the supply chain and would dramatically reduce industry costs. On the other hand, RFID raises consumer privacy issues both in and outside retail surroundings. RFID not only permits extended capabilities of data collection, but also creates a new threat of tracking individuals.
Inherent drawbacks in Privacy Enhancing Technologies (PETs) developed to address these concerns make it impossible, at least at this stage of development, for the PETs to independently provide a satisfactory response to the privacy concerns. To achieve adequate privacy protection, industry behavior should not only be directed by technology, but also must be regulated by other means. This Article calls on users of RFID technology to embrace self-regulatory measures and argues that legislation or other governmental regulation may deny businesses and consumers of the benefits of technology and is therefore not yet warranted. As a self-regulatory measure, existing "fair information practices" (FIPs) offer a good starting point but cannot be adopted as-is for RFID technology. This Article attempts to assess what FIPs are to be adopted and how some of their existing principles should be adapted and tailored to the distinctive characteristics of RFID technology. The end result is a set of ten FIPs that could serve as the foundation of a strong privacy policy for the use of RFID tags.
CITATION: Gal Eschet, FIPs and PETs for RFID: Protecting Privacy in the Web of Radio Frequency Identification, 45 Jurimetrics J. 301–332 (2005).
SUMMER 2005
ABSTRACT: This article explores the connection between the Sarbanes-Oxley Act of 2002 and information security. Although the statute and implementing regulations do not address information security explicitly, the authors argue that compliance is incomplete without an adequate information-security regime in place. If necessary, laws should be amended to make documenting, assessing, and testing information security compulsory. The cost of compliance is likely to be less than losses investors will suffer if the security laws and rules remain silent regarding information security.
CITATION: Bruce H. Nearon, Jon Stanley, Steven W. Teppler, and Joseph Burton, Life After Sarbanes-Oxley: The Merger of Information Security and Accountability, 45 Jurimetrics J. 379–412 (2005).
ABSTRACT: Data collected from 1,295 employers on 15,293 law firm associates who graduated from law school between 2001 and 2003 were used to develop a "total quality score" for every ABA-accredited law school, both nationally and for nine geographic regions. Quantitative methods were then used to identify factors to help explain the variation in a law school’s national career placement success at elite law firms. The findings revealed that while a law school’s academic reputation is the single biggest predictor of placement, several other factors were also highly significant. Differences in grading system, class rank disclosure policies, and the number of first year courses required were responsible for significant variation. Numbers grading systems, such as those used at the University of Chicago, and honors/pass/fail grading systems, such as those used at Yale, both have a strong negative impact on placement when all else is held equal. This is likely because both systems impair the middle of the class’s job prospects relative to traditional letter grade systems. Law schools that do not disclose class rank to students or employers place better than schools that do disclose rank, when all else is held constant. It is unclear whether this is due to employer preferences or due to disparate psychological effects on students that impact their career placement strategies. Law schools that require a greater number of first year classes, however, can make up for deficiencies in these other areas.
CITATION: Anthony Ciolli, The Legal Employment Market: Determinants of Elite Firm Placement and How Law Schools Stack Up, 45 Jurimetrics J. 413–448 (2005).
ABSTRACT: The Third Circuit recently issued an opinion in United States v. Mitchell, 365 F.3d 215 (3d Cir. 2004), the first case to challenge to the admissibility of fingerprint evidence under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). Although the court rejected this challenge, it upheld the right of defendants to call "counter-experts" to testify about the limitations of fingerprint evidence. Unfortunately, the Third Circuit’s rationale for holding that fingerprint evidence meets the Daubert requirements suffers from fundamental misunderstandings of the nature of fingerprint evidence and fails to confront the lack of validation for forensic fingerprint identification.
CITATION: Simon A. Cole, Does "Yes" Really Mean Yes? The Attempt to Close Debate on the Admissibility of Fingerprint Testimony, 45 Jurimetrics J. 449–464 (2005).
ABSTRACT: In Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 593 (1993), the Supreme Court suggested that in evaluating the admissibility of scientific evidence, federal courts should consider "whether a theory or technique . . . can be (and has been) tested." Several commentators have thought that this suggestion represents an adoption of the philosophy of science of Karl Popper, and several courts have treated the abstract possibility of falsification as sufficient to satisfy this aspect of the screening of scientific evidence called for in Daubert. This essay challenges these views. It first explains the distinct meanings of "falsification" and "falsifiability." It then argues that while the Court did not embrace the views of any specific philosopher of science, inquiring into the existence of meaningful attempts at falsification is an appropriate and crucial consideration in admissibility determinations. Consequently, it concludes that courts that are substituting mere "falsifiability" for actual empirical testing are misconstruing and misapplying Daubert.
CITATION: D.H. Kaye, On "Falsification" and "Falsifiability": The First Daubert Factor and the Philosophy of Science, 45 Jurimetrics J. 473–481 (2005).
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