Informed consent is a basic ethical and legal requirement for human subjects research. The U.S. federal regulations governing research on human subjects stipulate general requirements for informed consent. Investigators are required to disclose to prospective subjects material information about the purpose, procedures, and likely consequences of the study, among other things. However, investigators sometimes employ deception for methodological reasons. In order to keep subjects’ responses unbiased, investigators deceive subjects about such things as the fact that they are taking part in research, the purpose of the research, the research interventions or interactions, or the likely consequences of those interventions or interactions. When investigators deceive subjects about such aspects of a study, the study fails to meet these general requirements for informed consent.

In order for the Food and Drug Administration (FDA) to receive the trust and deference it needs to accomplish its mission, it must be seen as relatively impervious to political manipulation. For most of the FDA’s history, it has been seen as an institution driven by scientific expertise, not by political maneuvering. However, the FDA was increasingly criticized during the Bush administration for politicizing decisions such as rejecting an application to grant the “morning after pill,” known as Plan B, over-the-counter (OTC) status for women of all ages. After an atypical approval process, the FDA approved OTC Plan B use only for women over the age of 18. Because some groups perceive the morning after pill as a form of abortion, the politically appointed leadership of the FDA was suspected of dramatically departing from normal FDA procedures in order to ensure that the application would not be approved.

Societal evaluation of new technologies, specifically nanotechnology and genetically engineered organisms (GEOs), challenges current practices of governance and science. When a governing body is confronted by a technology whose use has potential environmental risks, some form of risk analysis is typically conducted to help decision makers consider the range of possible benefits and harms posed by the technology. Environmental risk assessment (ERA) is a critical component in the governance of nanotechnology and genetically engineered organisms because the uncertainties and complexities surrounding these technologies pose such risk potential. However, GEOs are unique technologies, and there is widespread, international recognition (e.g., the Cartagena Protocol on Biosafety of Living Modified Organisms) that many traditional forms of ERA are not well-suited for evaluating them. Nanotechnology products are also likely to need different models of risk assessment, as there is very little information on their fate, transport, and impacts in the environment.

That cacophony you hear is coming from the growing number of commentators addressing ethical, social, and policy issues raised by nanotechnology. Like many novel technologies that disturb the status quo, nanotechnologies raise questions about the adequacy of oversight systems; the extent to which the technologies push legal, moral, and political boundaries; and ultimately, the implications for human health and well-being. Because nanoscale techniques and products challenge our ways of thinking about biology, physics, and chemistry, nanotechnology forces us to reconsider accepted wisdom on toxicity, mutagenicity, contamination, biocompatibility, and other interactions among humans, the environment, and technologies. The sheer scale and reach of nanotechnologies demands institutions, collaborations, and conventions that can cross-link knowledge across organizations, disciplines, and locales. If ever there was an occasion to rethink the limits of disciplinary-specific knowledge, norms about regulatory processes, and societal implications of new technologies, nanotechnologies provide the opportunity.

In March 2009, the Supreme Court held in Wyeth v. Levine that federal drug labeling laws do not pre-empt state tort claims against drug manufacturers. The decision surprised many Court watchers, coming on the heels of a 2008 decision, Riegel v. Medtronic, in which the Court found that the Food, Drug, and Cosmetic Act (FDCA) does pre-empt state-law claims for injuries caused by medical devices that received premarket approval from the Food and Drug Administration. Wyeth dealt an immediate and surprising blow to the pharmaceutical industry’s principal strategy for avoiding tort lawsuits, but failed to clarify the Court’s overall pre-emption jurisprudence.

A recent Organisation for Economic Co-Operation and Development (OECD) survey demonstrated that an internationalization of genetic laboratory services currently emerged from the rarity of certain genetic abnormalities and from the small of laboratories performing specialized testing. When DNA samples cross national boundaries for genetic testing services to be performed in another country, the heterogeneity of national legal frameworks raises important questions regarding quality of genetic services available internationally.

Some aspects of the genetic laboratories’ services are abundantly discussed by the literature, among which most prominent are quality control standards and patients rights. Firstly, a 2003 study identified key distinctions between the different legal frameworks for genetic services. While some countries impose exhaustive regulatory requirements, others favor guidelines for good practices. Moreover, proficiency assessment, clinical validity, retention of laboratory records and test reports are not dealt with uniformly.

As of July 1, 2008, females aged 11-26 years seeking status as permanent residents in the United States must produce documentation that they have received the human papillomavirus (HPV) vaccine before the U.S. Citizenship and Immigration Services will approve their status adjustment. Immigration rights activists and public health officials have objected to this new requirement on the grounds that it is unnecessary and imposes unreasonable barriers to lawful immigration due to its expense. The Supreme Court has generally upheld mandatory vaccination requirements for citizens and non-citizens and has tolerated federal immigration regulations that would be unconstitutional if applied to citizens. However, the HPV vaccination requirement may be arbitrary, unnecessary, and discriminatory as applied to green card applicants who pose no greater threat to public health than citizens who are not subject to the same requirements. Furthermore, the requirement may also impose unreasonable restraints on aliens individual liberties as well as real barriers to immigration.

It has been 40 years since the seminal papers on pharmacy’s status as a profession sparked debate about the pharmacist’s role in health care, yet the questions they raised are just as poignant today as they were then. The issue of pharmacy’s status as a profession and its role in health care has again been brought into question, albeit in a roundabout manner, through discussions over the pharmacist’s right to refrain from dispensing emergency contraception. The key to understanding the contemporary pharmacist’s role as part of the health care team, as well as the pharmacist’s alleged right to refrain from dispensing emergency contraception, is to examine a situation that almost every contemporary pharmacist experiences.

Regulatory oversight and public communication are intimately intertwined. Oversight failures, both actual and perceived, quickly galvanize attention from both the media and the public, as has occasionally happened in all of the historical cases with which this symposium is concerned — gene therapy, workplace chemicals, drugs and devices, and genetically modified organisms (GMOs), especially those used as (or in) foods. Some developments, such as GMOs, seem to have more cultural significance or “cultural resonance” than others and are especially likely to garner public attention. Developments in nanotechnology, on the other hand, do not seem to have captured as much popular attention. However, the accelerating convergence between nanotechnology as material science and biotechnology, health, and medicine could easily change this situation.

Understanding of the human genome and its functional significance has increased exponentially since the completion of the Human Genome Project (HGP) in 2003. The HGP fueled the discovery of more than 1,800 disease genes and paved the way for researchers to identify and test for genes suspected of causing inherited diseases. Currently, there are more than 1000 genetic tests for human diseases and conditions on the market. These tests can play an integral role in the delivery of health care by providing information that could potentially form the basis for profound life decisions, such as whether to undergo a prophylactic mastectomy, whether to terminate a pregnancy, or whether to take a particular drug or medication dose.

Many of today’s uses of nanotechnology and nanomaterials can comfortably fall under the current regulatory system with minor adjustments. However, the Woodrow Wilson Center’s Project on Emerging Nanotechnologies has pointed out that the U.S. regulatory system is not prepared to deal with successive generations of nanotechnology and emergent technologies. Nanotechnology presents a challenge. The current regulatory standards and methods are no longer sufficient to help ensure the public’s safety. It is an area of high uncertainty in which environment, health, and safety information is scarce; there is no single index such as concentration to measure toxicity; standards do not yet exist; the ready environmental transport of nanomaterials can increase the chance of exposure; real-time monitoring is not available; and nanomaterials might have systemlevel human and environmental risks. Thus, there is a need for a new and improved oversight system. Within this system there is a need for quickly assessing risks of emergent technologies so that informed policy decisions can be made.

With the publication of the Carnegie Foundation’s 2007 report on legal education, law schools are focused again on curriculum reform. The Carnegie report highlighted a number of important issues, one of which is the need to improve the teaching of lawyering skills. This article takes up one subset of the skills package of lawyers – transactional law skills – and suggests that health law courses provide an excellent forum for exploring and teaching such skills.

With their reliance on the case method, law schools historically have done little to introduce students to transactional thinking, practice, or skills. Yet today, transactional work is a significant component of most attorneys’ practices. A common misperception is that transactional law only means “doing deals” while at a large law firm.

Hailed as the “foundation of the next industrial revolution,” nanotechnology is reshaping the landscape of technological innovation and creating hope around the world. Some believe that nanotechnology can address the critical needs of developing countries, but others are less optimistic. At one end of the spectrum, scientists predict that, among other accomplishments, nanotechnology can alleviate poverty, provide safe drinking water, and cure diseases. At the other end, skeptics warn that nanotechnology can further widen the gap between the rich and the poor, contributing to an already imbalanced global landscape. What can nanotechnology bring to the 21st century? How and in what ways should it intersect with law, public policy, and the plight of the developing world?

This article argues that the international community can harness nanotechnology to create sustainable development, particularly in the field of water remediation and treatment, but it must learn from its past missteps and adopt a strategy that combines two competing theories: instrumentalism and contextualism. Instrumentalism is the concept that technology is superb and stakeholders can easily transfer it from one application to another. In contrast, contextualism places technology in a socioeconomic context and conditions technological success on the stakeholders’ ability to meet local needs.

In January 2009, the California Court of Appeal for the Fifth District held that an individual suffering from paranoid schizophrenia could be forcefed and medicated despite his refusal of consent. The patient was a prison inmate, who engaged in a hunger strike to protest imagined abuses by prison guards. The court, reconciling conflicting provisions of California law, upheld the appointment of a conservator to make treatment decisions because the patient could not participate in those decisions “by means of a rational thought process.” However, in tying mental capacity to the plausibility of a protestor’s claims, the court risks placing political dissent at the mercy of judicial discretion.