HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

Other Issues:	Contents: Winter 2009, Volume 37, Issue 4   [Index by author]  Symposium Articles   I. CASE STUDIES OF OVERSIGHT SYSTEMS   II. COMPARING ACROSS CASE STUDIES   III. CROSS-CUTTING IDEAS Independent Articles Columns
Find articles in this issue containing these words: [Search ALL Issues]

Symposium Articles

I. CASE STUDIES OF OVERSIGHT SYSTEMS

Evaluating Oversight Systems for Emerging Technologies: A Case Study of Genetically Engineered Organisms Jennifer Kuzma, Pouya Najmaie, and Joel Larson J Law Med Ethics 2009 37: 546–586. [PDF] [References]   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. Through an interdisciplinary policy analysis approach, blending legal, ethical, risk analysis, and policy sciences viewpoints, criteria were used to identify strengths and weaknesses of GEOs oversight and explore correlations among its attributes and outcomes. From the three sources of data, hypotheses and broader conclusions for oversight were developed. Our analysis suggests several lessons for oversight of emerging technologies: the importance of reducing complexity and uncertainty in oversight for minimizing financial burdens on small product developers; consolidating multi-agency jurisdictions to avoid gaps and redundancies in safety reviews; consumer benefits for advancing acceptance of GEO products; rigorous and independent pre- and post-market assessment for environmental safety; early public input and transparency for ensuring public confidence; and the positive role of public input in system development, informed consent, capacity, compliance, incentives, and data requirements and stringency in promoting health and environmental safety outcomes, as well as the equitable distribution of health impacts. Our integrated approach is instructive for more comprehensive analyses of oversight systems, developing hypotheses for how features of oversight systems affect outcomes, and formulating policy options for oversight of future technological products, especially nanotechnology products.

Commentary: Emerging Technologies Oversight: Research, Regulation, and Commercialization Robbin Johnson J Law Med Ethics 2009 37: 587–593. [PDF] [References]   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. In commenting on that analysis, this paper suggests that looking at "oversight" in three phases -- research and development, regulatory review, and market acceptance -- can help to determine when certain of these attributes should take precedence over others and how to structure remedies when an error occurs. The result is an approach that is precautionary with respect to research and development, prudent and open to public input in the regulatory review stage, and purposefully persuasive once market acceptability is at stake, with remedies that are risk-containing in the first phase, risk-managing in the second, and risk-assuaging in the third. Combining the key attributes with the idea of three phases can help attune oversight to society's needs.

Commentary: Is It Possible to Determine the Extent to Which Informational Asymmetries and Prejudice Bias Responses? Terrance Hurley J Law Med Ethics 2009 37: 594–597. [PDF] [References]   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." It offers suggestions regarding how supplemental information might be used to gain additional insights into the authors' results and how future research could further enhance our understanding of the attributes and outcomes of regulatory oversight for 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, and Efrosini Kokkoli J Law Med Ethics 2009 37: 598–624. [PDF] [References]   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. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight.

Commentary: Public Outreach by the FDA: Evaluating Oversight of Human Drugs and Medical Devices Mark S. Frankel J Law Med Ethics 2009 37: 625–628. [PDF] [References]   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. Low public confidence in the FDA, the general lack of knowledge about nanotechnology among ordinary Americans, and the way in which the "average" citizen obtains and evaluates knowledge about a public policy issue all pose serious challenges to any public outreach by the FDA. It will be necessary for the FDA to be attentive to not only its own public messages, but also to who is listening and how those messages are being perceived.

Commentary: Evaluating Oversight of Human Drugs and Medical Devices Susan Bartlett Foote J Law Med Ethics 2009 37: 629–632. [PDF] [References]   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 and Gurumurthy Ramachandran J Law Med Ethics 2009 37: 633–650. [PDF] [References]   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. The oversight system had inadequate resources in terms of finances, expertise, and personnel, and insufficient incentive for compliance. The system showed a lack of flexibility in novel situations. There were minimal requirements on companies for data on health and safety of their products. These factors have a strong influence on public confidence and health and safety. The oversight system also scored low on attributes such as public input, transparency, empirical basis, conflict of interest, and informed consent. The experts in our sample tend to believe that the current oversight system for chemicals in the workplace is neither adequate nor effective. It is very likely that the performance of the OSHA oversight system for nanomaterials will be equally inadequate.

Commentary: Oversight of Engineered Nanomaterials in the Workplace Andrew D. Maynard J Law Med Ethics 2009 37: 651–658. [PDF] [References]   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. Here, 12 characteristics of the U.S. occupational safety regulatory framework identified by Choi and Ramachandran are considered in the context of emerging nanotechnologies. The assessment suggests that, as the number of new materials entering the workplace continues to increase, OSHA will need to develop flexible approaches to identifying and reducing potential risks. Relying on conventional approaches in the face of unconventional challenges will increase the probability of otherwise avoidable heath impacts. If the potential for engineered nanomaterials to cause harm is to be understood and managed, the agency will need to look at new approaches to generating, sharing, and using information.

Gene Therapy Oversight: Lessons for Nanobiotechnology Susan M. Wolf, Rishi Gupta, and Peter Kohlhepp J Law Med Ethics 2009 37: 659–684. [PDF] [References]   Oversight of human gene transfer research ("gene therapy") presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution (by the Institutional Review Board and, for some research, the Institutional Biosafety Committee) and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research oversees human gene transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of nanobiotechnology.

Commentary: Who's Afraid of the RAC? Lessons from the Oversight of Controversial Science Jeffrey P. Kahn J Law Med Ethics 2009 37: 685–687. [PDF] [References]   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.

II. COMPARING ACROSS CASE STUDIES

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, and Gurumurthy Ramachandran J Law Med Ethics 2009 37: 688–705. [PDF] [References]   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). All can learn from assessment of the successes and failures of past oversight efforts aimed at emerging technologies. This article reports on work funded by the National Science Foundation (NSF) aimed at learning the lessons of past oversight efforts. The article offers insights that emerge from comparing five oversight case studies that examine oversight of genetically engineered organisms (GEOs) in the food supply, pharmaceuticals, medical devices, chemicals in the workplace, and gene therapy. Using quantitative and qualitative analysis, the authors present a new way of evaluating oversight.

III. CROSS-CUTTING IDEAS

Governance of Nanotechnology and Nanomaterials: Principles, Regulation, and Renegotiating the Social Contract George A. Kimbrell J Law Med Ethics 2009 37: 706–723. [PDF] [References]   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. To do that will require mandatory regulation, grounded in precaution, that takes into account the uniqueness of nanomaterials. Moreover, this policy dialogue is not taking place in a vacuum. In applying the lessons of the past, nanotechnology provides a window to renegotiate our public's social contract on chemicals, health, the environment, and risks. Emerging technologies illuminate structural weaknesses, providing a crucial chance to ameliorate lingering regulatory inadequacies and provide much needed updates of existing laws.

What Does the History of Technology Regulation Teach Us about Nano Oversight? Gary E. Marchant, Douglas J. Sylvester, and Kenneth W. Abbott J Law Med Ethics 2009 37: 724–731. [PDF] [References]   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, and Michael J. Banker J Law Med Ethics 2009 37: 732–748. [PDF] [References]   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. However, traditional ERA has come under considerable criticism for its many shortcomings and current governance institutions have demonstrated limitations in transparency, public input, and capacity. Problem Formulation and Options Assessment (PFOA) is a methodology founded on three key concepts in risk assessment (science-based consideration, deliberation, and multi-criteria analysis) and three in governance (participation, transparency, and accountability). Developed through a series of international workshops, the PFOA process emphasizes engagement with stakeholders in iterative stages, from identification of the problem(s) through comparison of multiple technology solutions that could be used in the future with their relative benefits, harms, and risk. It provides "upstream public engagement" in a deliberation informed by science that identifies values for improved decision making.

Science, Ethics, and the "Problems" of Governing Nanotechnologies Linda F. Hogle J Law Med Ethics 2009 37: 749–758. [PDF] [References]   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. What comes to count as a technical or social "problem" says much about the sociotechnical and political-historical networks in which technologies exist. This symposium's case studies provide insight into procedural successes and failures in the regulation of novel products, and ethical or social analyses that have attended to implications of novel, disruptive technologies. Yet what may be needed is a more fundamental consideration of forms of governance that may not just handle individual products or product types more effectively, but may also be flexible enough to respond to radically new technological systems. Nanotechnology presents an opportunity to think in transdisciplinary terms about both scientific and social concerns, rethink "knowns" about risk and how best to ameliorate or manage it, and consider how to incorporate ethical, social, and legal analyses in the conceptualization, planning, and execution of innovations.

Risk Communication for Nanobiotechnology: To Whom, About What, and Why? Susanna Hornig Priest J Law Med Ethics 2009 37: 759–769. [PDF] [References]   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. In recent decades, broad public input with respect to new technologies has also been sought "upstream" of hard policy decisions in the hope of ultimately gaining legitimacy for those decisions -- and perhaps increasing their quality. When communication fails, oversight may also be seen as failing -- rightly or wrongly. As part of a larger project organized by the University of Minnesota, this paper presents six models of public risk communication and uses those models to analyze the communication challenges facing nanotechnology and nanobiotechnology. Reviewing the communication dynamics associated with the historical cases of technology regulation with which this symposium issue is concerned (genetically engineered organisms [GEOs] in the food supply, pharmaceuticals and medical devices, chemicals in the workplace, and gene transfer research or "gene therapy") helps shed light on the communications challenges facing nanobiotechnology.

Using Expert Elicitation to Prioritize Resource Allocation for Risk Identification for Nanosilver Emma Fauss, Michael E. Gorman, and Nathan Swami J Law Med Ethics 2009 37: 770–780. [PDF] [References]   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 Instrumental and Contextual Approaches: Nanotechnology and Sustainable Development Nina Liao J Law Med Ethics 2009 37: 781–789. [PDF] [References]   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. There are two views on how emerging technologies such as nanotechnology can influence and affect developing countries. Instrumentalists believe that the international community can transfer nanotechnology from one context to another and use it to assist the poor. Contextualists warn that nanotechnology can increase inequality in underdeveloped regions. Because of inadequacies in both positions, the international community must adopt a mixed strategy. This article argues that this mixed strategy should target the bottom of the pyramid, develop native capability, implement emergency protocols in projects, create accountability, and engage the public. Managed well, this strategy can propel developing countries toward sustainable development.

INTRODUCTION: Comparative Health Law and Policy: What, If Anything, Can We Learn from Other Countries? Diane Hoffmann J Law Med Ethics 2009 37: 790–791. [PDF] [References]

Why Patients Sue Doctors: The Japanese Experience Eric A. Feldman J Law Med Ethics 2009 37: 792–799. [PDF] [References]   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 J Law Med Ethics 2009 37: 800–806. [PDF] [References]   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 J Law Med Ethics 2009 37: 807–818. [PDF] [References]   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. The United States, Mexico, and Canada all provide public health insurance programs either to the entire population as in Canada or to vulnerable groups as in the United States. In none of these countries have private, for-profit providers and insurers been able to provide universal and affordable health coverage and care in a truly free market. Private insurers and for-profit providers should not profit from the care of the healthy and wealthy in ways that compromise the public programs that serve the poor and seriously ill. Nor should they be allowed to use NAFTA processes to compromise public programs. Policy makers must consider implications of NAFTA and move toward assuring access to affordable health care for all people on the North American continent.

Independent Articles

Columns

To see an article, click its [Full Text] or [PDF] link.