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Contents - JLME - 2009 Volume 37: 4
Table of Contents
  1. Table Of Contents
Letter From The Editor
  1. Letter From The Editor
Symposium Articles
  1. Introduction: The Challenge of Developing Oversight Approaches to Nanobiotechnology
  2. Evaluating Oversight Systems for Emerging Technologies: A Case Study of Genetically Engineered Organisms
  3. Commentary: Emerging Technologies Oversight: Research, Regulation, and Commercialization
  4. Commentary: Is It Possible to Determine the Extent to Which Informational Asymmetries and Prejudice Bias Responses?
  5. Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology
  6. Commentary: Public Outreach by the FDA: Evaluating Oversight of Human Drugs and Medical Devices
  7. Commentary: Evaluating Oversight of Human Drugs and Medical Devices
  8. Review of the OSHA Framework for Oversight of Occupational Environments
  9. Commentary: Oversight of Engineered Nanomaterials in the Workplace
  10. Gene Therapy Oversight: Lessons for Nanobiotechnology
  11. Commentary: Who's Afraid of the RAC? Lessons from the Oversight of Controversial Science
  12. Developing U.S. Oversight Strategies for Nanobiotechnology: Learning from Past Oversight Experiences
  13. Governance of Nanotechnology and Nanomaterials: Principles, Regulation, and Renegotiating the Social Contract
  14. What Does the History of Technology Regulation Teach Us about Nano Oversight?
  15. Problem Formulation and Option Assessment (PFOA) Linking Governance and Environmental Risk Assessment for Technologies: A Methodology for Problem Analysis of Nanotechnologies and Genetically Engineered Organisms
  16. Science, Ethics, and the "Problems" of Governing Nanotechnologies
  17. Risk Communication for Nanobiotechnology: To Whom, About What, and Why?
  18. Using Expert Elicitation to Prioritize Resource Allocation for Risk Identification for Nanosilver
  19. Combining Instructional and Contextual Approaches: Nanotechnology and Sustainable Development
  20. Introduction: Comparative Health Law and Policy: What, If Anything, Can We Learn from Other Countries?
  21. Why Patients Sue Doctors: The Japanese Experience
  22. Between Public Opinion and Public Policy: Human Embryonic Stem-Cell Research and Path-Dependency
  23. Realization of the International Human Right to Health in an Economically Integrated North America
Independent Articles
  1. Tobacco Industry Use of Corporate Social Responsibility Tactics as a Sword and a Shield on Secondhand Smoke Issues
  2. Ethical and Legal Analyses of Policy Prohibiting Tobacco Smoking in Enclosed Public Spaces
  3. Opioid Contracts and Random Drug Testing for People with Chronic Pain - Think Twice
Columns
  1. Currents in Contemporary Ethics
  2. Teaching Health Law
  3. Reviews in Health Law
Table of Contents
Table Of Contents
Letter From the Editor
Letter From The Editor
ASLME - [PDF]

Exactly three years ago, in our winter 2006 issue, the Journal of Law, Medicine & Ethics published a symposium on nanotechnology, exploring ethical, legal, and social issues surrounding this exciting scientific development. The fact that we have chosen to revisit the topic a mere 36 months later only hints at the importance, and the importance of the questions surrounding, nanotechnology in our everyday lives.
Symposium Articles
Introduction: The Challenge of Developing Oversight Approaches to Nanobiotechnology
Jordan Paradise, Susan M. Wolf, Jennifer Kuzma, Gurumurthy Ramachandran, Efrosini Kokkoli - [PDF]

Nanotechnology is being hailed by many as the "next industrial revolution." A convergence of scientific fields including chemistry, biology, physics, optics, and mechanics, nanoscale science and technology operates at the scale of 1-100 nanometers where structures, devices, and systems have novel functions and properties because of their size.
Evaluating Oversight Systems for Emerging Technologies: A Case Study of Genetically Engineered Organisms
Jennifer Kuzma, Pouya Najmaie, Joel Larson - [PDF]

The U.S. oversight system for genetically engineered organisms (GEOs) was evaluated to develop hypotheses and derive lessons for oversight of other emerging technologies, such as nanotechnology. Evaluation was based upon quantitative expert elicitation, semi-standardized interviews, and historical literature analysis.
Commentary: Emerging Technologies Oversight: Research, Regulation, and Commercialization
Robbin Johnson - [PDF]

This paper reviews the paper by Kuzma, Najmaie, and Larson that looks at what can be learned from the experience with genetically engineered organisms for oversight of emerging technologies more generally. That paper identifies key attributes of a good oversight system: promoting innovation, ensuring safety, identifying benefits, assessing costs, and doing so all while building public confidence.
Commentary: Is It Possible to Determine the Extent to Which Informational Asymmetries and Prejudice Bias Responses?
Terrance Hurley - [PDF]

This commentary provides a brief overview of the methods and results presented by Jennifer Kuzma, Pouya Najmaie, and Joel Larson in "Evaluating Oversight Systems for Emerging Technologies: A Case Study of Genetically Engineered Organisms."
Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology
Jordan Paradise, Alison W. Tisdale, Ralph F. Hall, Efrosini Kokkoli - [PDF]

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach.
Commentary: Public Outreach by the FDA: Evaluating Oversight of Human Drugs and Medical Devices
Mark S. Frankel - [PDF]

As nanotechnology emerges as an important public policy issue, the FDA's relationship with society is about to be tested. Most would agree that fostering public input will be critical to developing effective public policy for nanotechnology. Yet, it will not be easy.
Commentary: Evaluating Oversight of Human Drugs and Medical Devices
Susan Bartlett Foote - [PDF]

This article seeks to provide insights into appropriate FDA oversight of nanotechnology. This commentary identifies limitations in the methodology employed and concludes that the analysis would be stronger with a more in-depth institutional dimension based on administrative law and political science research.
Review of the OSHA Framework for Oversight of Occupational Environments
Jae-Young Choi, Gurumurthy Ramachandran - [PDF]

The OSHA system for oversight of chemicals in the workplace was evaluated to derive lessons for oversight of nanotechnology. Criteria relating to the development, attributes, evolution, and outcomes of the system were used for evaluation that was based upon quantitative expert elicitation and historical literature analysis.
Commentary: Oversight of Engineered Nanomaterials in the Workplace
Andrew D. Maynard - [PDF]

Research and business investment in emerging nanotechnologies is leading to a diverse range of new substances and products. As workers are faced with handling new materials, often with novel properties, the robustness of current workplace health and safety regulatory frameworks is being brought into question.
Gene Therapy Oversight: Lessons for Nanobiotechnology
Susan M. Wolf, Rishi Gupta, Peter Kohlhepp - [PDF]

Oversight of human gene transfer research ("gene therapy") presents an important model with potential application to oversight of nanobiology research on human participants.
Commentary: Who's Afraid of the RAC? Lessons from the Oversight of Controversial Science
Jeffrey P. Kahn - [PDF]

This commentary asks what we can learn from our oversight of controversial science and how can we do better in the future? After briefly examining the history of gene transfer research oversight, some observations are offered for the oversight of nanobiotechnology and other emerging areas of science.
Developing U.S. Oversight Strategies for Nanobiotechnology: Learning from Past Oversight Experiences
Jordan Paradise, Susan M. Wolf, Jennifer Kuzma, Aliya Kuzhabekova, Alison W. Tisdale, Efrosini Kokkoli, Gurumurthy Ramachandran - [PDF]

The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Department of Agriculture (USDA), Occupational Safety and Health Administration (OSHA), and National Institutes of Health (NIH).
Governance of Nanotechnology and Nanomaterials: Principles, Regulation, and Renegotiating the Social Contract
George A. Kimbrell - [PDF]

Good governance for nanotechnology and nanomaterials is predicated on principles of general good governance. This paper discusses on what lessons we can learn from the oversight of past emerging technologies in formulating these principles. Nanotechnology provides us a valuable opportunity to apply these lessons and a duty to avoid repeating past mistakes.
What Does the History of Technology Regulation Teach Us about Nano Oversight?
Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott - [PDF]

As policy makers struggle to develop regulatory oversight models for nanotechnologies, there are important lessons that can be drawn from previous attempts to govern other emerging technologies. Five such lessons are the following: (1) public confidence and trust in a technology and its regulatory oversight is probably the most important factor for the commercial success of a technology; (2) regulation should avoid discriminating against particular technologies unless there is a scientifically based rationale for the disparate treatment; (3) regulatory systems need to be flexible and adaptive to rapidly changing technologies; (4) ethical and social concerns of the public about emerging technologies need to be expressly acknowledged and addressed in regulatory oversight; and (5) international harmonization of regulation may be beneficial in a rapidly globalizing world.
Problem Formulation and Option Assessment (PFOA) Linking Governance and Environmental Risk Assessment for Technologies: A Methodology for Problem Analysis of Nanotechnologies and Genetically Engineered Organisms
Kristen C. Nelson, David A. Andow, Michael J. Banker - [PDF]

Societal evaluation of new technologies, specifically nanotechnology and genetically engineered organisms (GEOs), challenges current practices of governance and science. Employing environmental risk assessment (ERA) for governance and oversight assumes we have a reasonable ability to understand consequences and predict adverse effects.
Science, Ethics, and the "Problems" of Governing Nanotechnologies
Linda F. Hogle - [PDF]

Commentators continue to weigh in on whether there are ethical, social, and policy issues unique to nanotechnology, whether new regulatory schemes should be devised, and if so, how. Many of these commentaries fail to take into account the historical and political environment for nanotechnologies. That context affects regulatory and oversight systems as much as any new metrics to measure the effects of nanoscale materials, or organizational changes put in place to facilitate data analysis.
Risk Communication for Nanobiotechnology: To Whom, About What, and Why?
Susanna Hornig Priest - [PDF]

Regulatory oversight and public communication are intimately intertwined. Oversight failures quickly galvanize media and public attention. In addition, regulations sometimes require that risks and uncertainties be included in communication efforts aimed at non-experts outside of the regulatory and policy communities - whether in obtaining informed consent for novel medical treatments; by including risk information on drug labels, in drug advertisements, or on chemicals used in the workplace; in providing nutritional information on food packages; or by opening environmental impact assessments to public comment.
Using Expert Elicitation to Prioritize Resource Allocation for Risk Identification for Nanosilver
Emma Fauss, Michael E. Gorman, Nathan Swami - [PDF]

This article introduces a method to identify risks through expert elicitation, using silver nanotechnology as a case study. Unique features of the method include supplying experts with a list of silver nanotechnology products, and conducting the elicitation in an extended interview format that captures the experts' reasoning. The end result is a series of graphical representations of expert thinking from which high-risk scenarios and knowledge gaps can be reliably inferred. This methodology, combined with other approaches to expert elicitation, can help identify knowledge and oversight gaps, and can be used as part of an adaptive management strategy.
Combining Instructional and Contextual Approaches: Nanotechnology and Sustainable Development
Nina Liao - [PDF]

Billions of people live in poverty, with no access to safe drinking water or solutions for other critical health and medical needs. Nanotechnology is poised to create workable solutions for large-scale public health needs in developing countries, including improving water quality and providing life-saving pharmaceuticals.
Introduction: Comparative Health Law and Policy: What, If Anything, Can We Learn from Other Countries?
Diane Hoffmann - [PDF]

The field of comparative law and policy, while not new, has grown in significance as the trend toward globalization has accelerated and technological advances have made it easier for people to travel, communicate, and do business internationally. Globalization has also removed barriers between national borders facilitating the flow of goods, services, capital, and labor between countries.
Why Patients Sue Doctors: The Japanese Experience
Eric A. Feldman - [PDF]

Scholars in the U.S. have shown relatively little interest in the management of legal conflict over health care in other nations. This article examines the Japanese health care system, particularly litigation over medical malpractice, and asks what (if anything) American scholars and policy makers can learn from the Japanese experience.
Between Public Opinion and Public Policy: Human Embryonic Stem-Cell Research and Path-Dependency
Stephen R. Latham - [PDF]

In bioethics as in other areas of health policy, historical institutional factors can shape policy independently of interests or public opinion. This article finds policy divergence among countries with similar national moral views of stem cell research, and explains that divergence as the product of path-dependency.
Realization of the International Human Right to Health in an Economically Integrated North America
Eleanor D. Kinney - [PDF]

With the North American Free Trade Agreement (NAFTA), the health care sectors of the United States, Canada, and Mexico are becoming more economically integrated. NAFTA poses major challenges to the realization of the international human right. These include: (1) Cross Border Trade in Medical Products, (2) Cross Border Trade in Medical Services, and the attendant investment protections, (3) Portability and Comparability of Health Insurance Coverage, and (4) Protection of Public Health Insurance Programs.
Independent Articles
Tobacco Industry Use of Corporate Social Responsibility Tactics as a Sword and a Shield on Secondhand Smoke Issues
Lissy C. Friedman - [PDF]

The tobacco industry has used corporate social responsibility tactics to improve its corporate image with the public, press, and regulators who increasingly have grown to view it as a merchant of death. There is, however, an intractable problem that corporate social responsibility efforts can mask but not resolve: the tobacco industry's products are lethal when used as directed, and no amount of corporate social responsibility activity can reconcile that fundamental contradiction with ethical corporate citizenship.
Ethical and Legal Analyses of Policy Prohibiting Tobacco Smoking in Enclosed Public Spaces
Taiwo A. Oriola - [PDF]

A spate of legislations prohibiting cigarette smoking in enclosed public spaces, mainly on grounds of public health protection, recently swept across cities around the world. This is in tandem with a raft of increasingly restrictive national laws that emerged on the back of the ratification of the WHO Framework for Tobacco Control by more than one 168 countries in 2005.
Opioid Contracts and Random Drug Testing for People with Chronic Pain - Think Twice
Mark Collen - [PDF]

The use of opioid contracts, which often require patients to submit to random drug screens, have become widespread amongst physicians using opioids to treat chronic pain. The main purpose of the contract is to improve care through better adherence to opioid therapy but there is little evidence as to its efficacy.
Columns
Currents in Contemporary Ethics
Heather Harrell - [PDF]

The recent increase in the number of diseases for which newborns are screened has led to renewed discussion about the risks, benefits, ethics, and advocacy involved in newborn screening.
Teaching Health Law
Lawrence E. Singer, Megan Bess - [PDF]

While law schools are well recognized and respected as institutions of intellectual debate and scholarship, they nonetheless have been criticized for failing to prepare graduates for the actual practice of law. Health law is not immune from this criticism, particularly because as the health law field has grown law schools may find it difficult to fully expose students to the full depth and breadth of this area of law.
Reviews in Health Law
Christine Nero Coughlin - [PDF]

Health Law and Bioethics, edited by Professors Sandra Johnson, Joan Krause, Richard Saver, and Robin Fretwell Wilson, is a creative textbook that details the story behind the story of many landmark legal cases in this dynamic area of law. This text is an essential addition to health law and bioethics scholarship, which, until now, has lacked socially relevant background materials for many health law and bioethics issues.