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Back Issues and Articles

Table of Contents
Table of Contents
ASLME - [PDF] (Free Download)
Table of Contents
Introductions
Introduction
Mark A. Rothstein, Bartha Maria Knoppers - [PDF]

Introduction
Symposium Articles
Biobanking: International Norms
Bartha Maria Knoppers - [PDF]

Genetic research is moving from the study of heredity, to risk factors in common diseases to that of normal genetic variation. A similar pattern is emerging in biobanking. From use for diagnosis and treatment or, for pathology and research, banked tissue samples are now seen as valuable for the study of whole populations. Discrepancies exist however, between the socio-ethical and legal frameworks governing biobanks at the international, regional and national levels. Indeed, unless some harmonization is promoted, the proposed benefits may never be achieved.
Informed Consent and Biobanks
Ellen Wright Clayton - [PDF]

Informed consent can serve many purposes - disclosing risk, honoring the individual, and addressing lack of trust. Consent documents in many instances have become enormously complex, due in part to intricate, conflicting, and changing regulatory schemes, which are described herein, and institutional fear of penalties. The future role of informed consent actually turns on many other factors, including the protection actually provided to information and materials, the public's trust in research, the role of oversight bodies, some of which may need to be created, the resolution of intellectual property issues, and most important, what we will choose to do about disclosing individual research findings.
Harnessing the Benefits of Biobanks
Lori B. Andrews - [PDF]

The emerging biobank economy raises profound ethical and legal questions that need to be addressed in institutional policies and legal regulations regarding informed consent, control of genetic information, and limits to commercialization.
Cyberbanks and Other Virtual Research Repositories
Mary Anderlik Majumder - [PDF]

The processes by which collections of biological specimens are assembled, translated into information, combined with more information, and distributed are taking research repositories into the virtual realm. Many ethical and regulatory concerns are relevant to all repositories regardless of their nature, but virtual repositories have some distinctive features that bear on matters such as informed consent, confidentiality, and security. In the area of consent, information technology specialists are developing web-based architectures for repositories that allow annotation of specimens and data to capture constraints imposed by donors and that facilitate continuing communication with donors, suggesting a possible solution to the problem of blanket consent. And, while electronic datasets make certain breaches of confidentiality and security easier or more momentous, researchers are creating strategies that seek the optimal balance between considerations of research utility and protection against risk. However, concerns remain about monitoring and enforcement of standards, as well as broader social issues.
Accountability in Population Biobanking: Comparative Approaches
Mylene Deschenes, Clementine Sallee - [PDF]

The recent rise of large-scale population-based biobanks poses unique challenges in terms of governance structures, key components of the success of such endeavors. This article proposes a review and comparative analysis of the surveillance and accountability mechanisms adopted by selected population research projects, and proposes avenues for consideration.
Technology Transfer in Bio Banking:Credits, Debits,and Population Health Futures
Michael J. Malinowski - [PDF]

The effort to make medical sense out of the map of the human genome has raised demands for access to human samples and medical information to an all-time high. This demand is giving rise to ambitious bio-banking initiatives. This article proposes that creative technology transfer in bio-banking raises an opportunity to accomplish a range of desirable objectives, such as the involvement of groups largely excluded from participation in the genomics revolution.
Should Liability Play a Role in Social Control of Biobanks?
Larry I. Palmer - [PDF]

Biobanking is a powerful metaphor for conceptualizing the role of law in the distribution and control of data used in genomic research. As in commercial banking, commentators and courts tend to think of contract and property rules for resolving disputes. Rather than think of blood, DNA, cell lines, etc., solely in terms of their materiality, assets subject to control, this article proposes to think of these specimens (whether derived from humans, animals, or plants) as data with the potential to become useful knowledge. With this recasting of the problem of biobanking, the larger ethical question courts and scholars will have to face is the role of liability doctrine in balancing the interests of individuals and researchers in the creation and distribution of new professional knowledge.
Genetic Information,Privacy and Insolvency
Edward J. Janger - [PDF]

Current law provides very little protection to tissue donors when a biobank becomes insolvent or files for bankruptcy. The author suggests that a property regime which focuses on unauthorized use, rather than unauthorized transfer of samples might ameliorate the risk faced by donors.
Expanding the Ethical Analys is of Biobanks
Mark A. Rothstein - [PDF]

Biobanks differ from traditional forms of research and raise substantial ethical and policy concerns. Traditional issues, such as informed consent and privacy, are more complicated with biobanks. New regulatory systems, liability rules, and commercial arrangements all require a careful ethical analysis.
Independent Articles
Is Obtaining an Arrestee's DNA a Valid Special Needs Search Under the Fourth Amendment? What Should (and Will) the Supreme Court Do?
Tracey Maclin - [PDF]

A small number of states have enacted laws that authorize the taking and analysis of DNA from certain categories of arrestees. This article addresses the constitutionality, under the Fourth Amendment, of taking DNA samples from persons subject to arrest.
An Enhanced Approach to Distinguishing Public Health Practice and Human Subjects Research
James G. Hodge, Jr. - [PDF]

This article discusses the conceptual, legal, and practical distinctions between public health practice and human subjects research, proposing a two-stage process to better classify activities that involve the collection of individually identifiable health information as public health practice or research. Public health authorities, institutional review boards, and others must determine whether public health activities are classified as research or public health practice to comply with the federal Common Rule governing human subjects research, the HIPAA Privacy Rule, and other federal, state, and local laws. Existing guidance, however, is inconsistent and fragmented, resulting in misclassifications, delays or barriers in conducting needed public health activities, or insufficient protections for participants in human subjects research. The proposed criteria are based upon an examination of existing laws, scholarship, and applied methods for making distinctions. The first analytical stage applies foundational principles of public health practice and research to help classify activities in simple cases. For more difficult cases, the second analytical stage applies enhanced criteria including: general legal authority, specific intent, responsibility, participant benefits, experimentation, and subject selection.
Evaluating the Dissent in State of Oregon v. Ashcroft: Implications for the Patient-Physician Relationship and the Democratic Process
Bryan Hilliard - [PDF]

On May 26, 2004, a three judge panel of the Ninth Circuit Court of Appeals held unlawful and unenforceable Attorney General John Ashcroft's determination that physician prescription of opioid analgesics to assist in suicide was not a "legitimate medical purpose" under the Controlled Substances Act. This article analyzes select arguments and observations from the dissent in Oregon v. Ashcroft and argues that the dissent misunderstands the nature of the patient-doctor relationship, trivializes the ethical and legal significance of role obligations in medicine, and minimizes the importance of the democratic process in formulating public policy on end of life
Columns
Currents in Contemporary Ethics
Mark A. Rothstein - [PDF]

Currents in Contemporary Ethics
The Ethical Health Lawyer
Leslie Griffin - [PDF]

The Ethical Health Lawyer
Reviews in Medical Ethics
Vanessa S. Perlman - [PDF]

Reviews in Medical Ethics
Recent Developments in Health Law
Ellen Moskowitz, Elaine Ewing, Benjamin Falit, and Christopher Robertson - [PDF]

Recent Developments in Health Law