Gary E. Marchant

Arbitrary and capricious : the precautionary principle in the European Union courts

The precautionary principle, stated most simply, says it is better to be safe than sorry in regulating health and environmental risks. Marchant (Arizona State U. College of Law) and Mossman (health physics, Arizona State U.) review ten years of application of the precautionary principle in the courts of the European Union, finding that it has been

What Does the History of Technology Regulation Teach Us About Nano Oversight

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.

A Framework Convention for Nanotechnology

With nanotechnology now a major funding priority for governments and industry around the world, devising the manner and timing of regulation presents a challenge. Too much regulation too soon could hinder development of beneficial technologies, while too little regulation too late may allow dangerous technologies to enter the market. Kenneth Abbott, Gary Marchant, and Douglas Sylvester argue that any solution to this regulatory dilemma must have four basic characteristics: the solution must be flexible, innovative, international, and official. In this Article, they advocate a framework convention on nanotechnology as a regulatory tool meeting these four requirements. The authors use a series of case studies to reveal framework convention best practices, and conclude with a summary of how a nanotechnology framework convention might be structured.

International Governance of Autonomous Military Robots

Unarmed aerial vehicles (i.e., drones) are already starting to transform the conduct of military engagements, and these systems are projected an increasingly prominent role in military forces in the future. A number of factors will push these systems toward increased autonomy, raising the possibility of the future development of lethal autonomous robotics (LARs). This article seeks to proactively address the ethical, policy, and legal aspects of ALRs. It first describes the technological status and incentives for LARs, and then reviews some ethical and policy concerns that autonomous systems present. The paper then describes three potential routes for proactive governance of LARs: (i) existing legal and policy regimes such as rules of engagement, laws of war, and international humanitarian law; (ii) arms control agreements; and (iii) “soft law” mechanisms such as codes of conduct and international consultative bodies.

A synthetic vitreous fiber (SVF) occupational exposure database: implementing the SVF Health and Safety Partnership Program.

The Health and Safety Partnership Program is a voluntary workplace safety program for workers involved in the manufacture, fabrication, installation, and removal of glass wool and mineral wool products. This article describes one element of this Partnership Program, the development of an occupational exposure database that characterizes exposures by fiber type, industry sector, product type, and job description. Approximately 6000 exposure samples are included in the database, most of which were collected over the past decade, making it the most extensive and recent exposure data set on record for glass wool and mineral wool. The development of this database, as well as the initial results for exposure measurements segmented by product type and/or job description, are described. The current database shows that most applications and uses of glass wool and mineral wool involve exposures below the voluntary 1 f/cc permissible exposure limit, although some specific product types and job descriptions involve average exposures approaching the 1 f/cc limit.

Physician liability: the next big thing for personalized medicine?

Liability is likely to be a major driver for the future direction and implementation of personalized medicine, spurring the adoption of genetic tests and other pharmacogenomic technologies, in some cases appropriately, and in other cases prematurely or as inefficient defensive medicine. While all entities in the personalized medicine chain will face liability risks, physicians will be at the greatest risk owing to their lack of defenses, limited experience in dealing with genetics and the growing disparities within the profession in implementing new medical technologies. The history of liability for genetic testing, primarily in the prenatal testing context, suggests that liability will often be both unpredictable and influential in changing medical practice. It is critical to anticipate and attempt to prevent such liability risks in a proactive manner so to minimize the disruptive impact that liability can cause.

Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field

Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine applications that includes drugs, biological products, and implantable medical devices incorporating nanoscale materials. These nanomedicine products can enable new or improved treatments and diagnostics for many diseases and disorders. Human subjects research (HSR) on nanomedicine interventions is already under way, with a number of products approved for use. Such research is subject to existing federal and institutional oversight rules and regulations, including Food and Drug Administration (FDA) rules on HSR for all FDA-regulated products and the Department of Health and Human Services (DHHS) Common Rule for HSR funded or conducted by NIH or any of the other signatory agencies. Both of these regimes require HSR protocols to obtain approval from an Institutional Review Board (IRB), based on assessment of the ethical appropriateness of research on human participants. However, some nanomedicine HSR may raise safety and ethics concerns that pose challenges to the existing system of oversight and that may merit consideration of additional oversight. The concerns that may warrant additional oversight include marked uncertainty about hazard and risk to human subjects and about occupational exposures of researchers and lab workers, exposures of bystanders such as family members, and environmental effects. Concerns posed by some nanomedicine HSR reflect the emergence of increasingly complex, active, and interactive products. These concerns also reflect the limits of an HSR oversight system developed over 30 years ago, with widely recognized problems and limitations. We are not arguing that the ethical issues raised by nanomedicine HSR are unique to that field and arise in no other domain of HSR for emerging science and technology. To the contrary, our recommendations regarding nanomedicine HSR offer an opportunity to examine the larger issue of the adequacy of the current HSR oversight system in the face of increasingly sophisticated science and technologies. This article presents the first published recommendations on how to comprehensively approach the challenges raised by nanomedicine research in human beings. While some nanomedicine HSR requires no extra oversight, we suggest an oversight approach that can identify research that may need extra oversight, that can structure that extra oversight in a targeted way, and that can evolve with greater knowledge about nanomedicine materials and interventions. We recommend the formation of two complementary bodies: (1) an interagency group comprised of governmental officials, and (2) a federal advisory committee comprised of outside experts and stakeholders who can offer advice in a public forum. Creation of both bodies ensures the administrative power to coordinate among agencies while also having a forum for all stakeholders. An interagency Humans Subjects Research in Nanomedicine (HSR/N) Working Group should be established to coordinate among federal agencies and offices addressing nanomedicine HSR oversight. We suggest that this HSR/N Working Group be housed within DHHS with member representatives from federal agencies and offices that are key to nanomedicine HSR. A Secretarys Advisory Committee on Nanomedicine (SAC/N) should additionally be established under the Federal Advisory Committee Act (FACA) to provide recommendations on sound approaches to nanomedicine human subjects research and a forum for public discussion. SAC/N may be created as a subcommittee of the Secretarys Advisory Committee on Human Research Protections (SACHRP) or as a separate body. HSR/N and SAC/N should initially serve (1) analytical, (2) advisory, and (3) information review functions. A fourth potential function, new federal protocol-by-protocol review (as was conducted in the past, for example, in the Recombinant DNA Advisory Committees (RACs) review of human gene transfer protocols), does not appear to be warranted at this time. For the purposes of nanomedicine HSR oversight and data collection, HSR/N and SAC/N in coordination with other nano-focused offices (including the Nanoscale Science, Engineering, and Technology Subcommittee (NSET) and National Nanotechnology Initiative (NNI)) should consider how best to establish an interim definition of nanomedicine, which may ultimately lead to a different approach, based on identifying key attributes of concern. Federal definitions of “nanotechnology” in general have varied, though NNIs definition focusing on functionalities engineered to emerge at dimensions of up to 100 nm has been most prominent. However, identifying “nanomedicine” products specifically for the purposes of HSR oversight raises somewhat different issues, calling for a more inclusive set of criteria in order to err on the side of capturing HSR concerns. It may be that any such definition should ultimately yield to a roster of relevant attributes of concern.1 Yet the creation of a roster of attributes of concern is difficult at present, given the state of scientific and toxicological knowledge. HSR/N and SAC/N may thus need to start with a size-based definition, in keeping with the traditional commitment of HSR review to anticipating and preventing harm to human subjects. Upon considering the recommendations of SAC/N, HSR/N should facilitate cross-agency coordination on a Points-to-Consider document to help guide institutions and researchers crafting and overseeing protocols for nanomedicine HSR. This Points-to-Consider document should articulate what information is needed to facilitate sound, science-based analysis of ethical and safety questions. It should also provide guidance for information-gathering by institutional review bodies such as IRBs, Data and Safety Monitoring Boards (DSMBs), and committees responsible for occupational and environmental review of research protocols. Our recommendations avoid the creation of additional regulation for nanomedicine HSR as a class. Instead we recommend establishing a means to convene and coordinate federal oversight authorities for the purposes of setting priorities, collecting information, and building infrastructure for effective oversight of nanomedicine HSR, relying on inputs from top experts in the field and key stakeholders as nanomedicine progresses to more complex, active, and interactive interventions. HSR/N and SAC/N will provide governmental and public forums to address nanomedicine HSR issues as the science and HSR challenges evolve. This flexible approach will reduce the burden on individual agencies and oversight bodies to independently develop their own analyses and data sets, by instead facilitating a coordinated process among relevant agencies, institutions, and centers. This will reduce duplication of effort, help avoid gaps in analysis and oversight, and will ensure a more science-based approach to HSR oversight, thus avoiding unnecessary impediments to innovation. This flexible and evolutionary approach to HSR oversight, including consideration of occupational, bystander, and environmental analysis, may provide a model for HSR oversight in other areas of emerging science and technology.

Ethical implications of epigenetics research

New advances in epigenetics research are being reported at an accelerating rate. Intriguing research findings, primarily from animal studies, show that epigenetic changes tend to occur at a much higher frequency than mutations in DNA sequence, that the susceptibility to epigenetic changes is greater at earlier stages of development, and that epigenetic changes are often reversible.. Importantly, a growing body of data from animal and human studies suggests that alterations in gene expression that are due to epigenetic processes, such as DNA methylation, can be inherited and affect future generations.

The Problems with Forbidding Science

Scientific research is subject to a number of regulations which impose incidental (time, place), rather than substantive (type of research), restrictions on scientific research and the knowledge created through such research. In recent years, however, the premise that scientific research and knowledge should be free from substantive regulation has increasingly been called into question. Some have suggested that the law should be used as a tool to substantively restrict research which is dual-use in nature or which raises moral objections. There are, however, some problems with using law to restrict or prohibit certain types of scientific research, including (i) the inherent imprecision of law for regulating complex and rapidly evolving scientific research; (ii) the difficulties of enforcing legal restrictions on an activity that is international in scope; (iii) the limited predictability of the consequences of restricting specific branches of scientific research; (iv) inertia in the legislative process; and (v) the susceptibility of legislators and regulators to inappropriate factors and influence. Rather than using law to restrict scientific research, it may be more appropriate and effective to use a combination of non-traditional legal tools including norms, codes of conduct, restrictions on publication, and scientist-developed voluntary standards to regulate problematic scientific research.

Legal pressures and incentives for personalized medicine

Legal liability has the potential to be a powerful driver pushing implementation of personalized medicine. Individuals injured by adverse drug effects are increasingly likely to bring lawsuits alleging that they have a polymorphism or biomarker conferring susceptibility to the drug that should have been identified and used to alter their drug treatment. Likely targets of such lawsuits include drug manufacturers, third party payors, physicians and pharmacists, of which physicians are most at risk of substantial liability.