Regulatory agencies vary widely in their classification of FMT, with significant impact on patient access. This article conducts a global survey of national regulations and collates existing FMT classification statuses, ultimately suggesting that the human cell and tissue product designation best fits FMT's characteristics and that definitional objectives to that classification may be overcome.

International guidelines regarding ethics, and in particular the ethics of clinical research, are problematic on two broad levels. First, by asserting their universality, “international” guidelines obscure real and legitimate crosscultural differences in ethical expectations. International guidelines seek to make homogeneous something which is not necessarily so. Second, existing guidelines are ambiguous about their objectives and purposes. On the one hand, guidelines are structured as a set of goals, largely aspirational in language and content. But on the other hand, such guidelines also suggest a normative function, providing a set of standards by which to judge and, if appropriate, sanction investigators’ conduct.

These criticisms are not intended to argue that international guidelines are useless. Nor are they intended to question the good faith under which such guidelines are developed. Rather, we wish to suggest that the role of present international guidelines is somewhat more limited than is ordinarily appreciated.

The patient in a persistent vegetative state (hereafter, the PVS patient) has played a central role in recent American bioethical discussions and in recent litigation involving bioethical issues. From Quinlan’ to Cruzan and Wanglie, some of the most important cases involving ethical issues at the end of life have involved PVS patients. Major American medical groups such as the AMA and the American Academy of Neurology have adopted important policy statements on the care of such patients, statements that have been followed by at least one European group.

I have always found this activity a bit of a mystery. There is, after all, a relatively clear consensus about decision-making at the end of life, a consensus embodied in such documents as a report from the President's Commission and a report from the Hastings Center.

Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons (MIC). We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.

The United States, like other countries facing rising health care costs, is pursuing a commitment to interoperable electronic health records. Electronic records, it is thought, have the potential to reduce the risks of error, improve care coordination, monitor care quality, enable patients to participate more fully in care management, and provide the data needed for research and surveillance. Interoperable electronic health records on a national scale — the ideal of a national health information network (or NHIN) — seem likely to magnify these advantages. Thus, the recent economic stimulus package contains considerable funding for the development of “health information technology architecture that will support the nationwide electronic exchange and use of health information in a secure, private, and accurate manner.”

If we want to understand the allure of pharmaceuticals, we need to look beyond both medical efficacy and profit motives. The success (or failure) of a drug depends not only on these, but also on how it mobilizes prior conceptions of identity. The extent to which a drug is taken — or talked about — is related to commodity properties that exceed the physiological and the economic. In implicit contrast to the discussions of BiDil elsewhere in this collection, I explore how the links between race and pharmaceuticals can be both unstable and generative even when the drug in question is old and generic. By attending closely to an encounter around generic thiazide outside of a medical or marketing context, I show that although pharmaceuticals can seem to rely on scientific data and marketing for their power, they are, in fact, also subject to claims on many more registers that cannot quite subsume or refute each other.

Advances in science and technology frequently raise new ethical, legal, and social issues, and developments in neuroscience and neuroimaging technology are no exception. Within the field of neuroethics, leading scientists, ethicists, and humanists are exploring the implications of efforts to image, study, treat, and enhance the human brain.

This article focuses on one aspect of neuroethics: the confidentiality and privacy implications of advances in functional magnetic resonance imaging (“fMRI”). Following a brief orientation to fMRI and an overview of some of its current and proposed uses, this article highlights key confidentiality and privacy issues raised by fMRI in the contexts of health care, research, employment, insurance, criminal justice, litigation, and cognitive privacy.

In a recent discussion about how scientific knowledge might potentially change our understanding of the nature and extent of human genetic, cultural, or biological variation, the sociologist David Skinner identified two competing visions of the future: one that was decidedly dystopian, which conjured up a “re-racialized” future, and an opposing utopian future in which the potential for racialized thinking might be finally overcome. We can situate the ongoing debates about the congestive heart failure drug BiDil, approved by the Food and Drug Administration (FDA) for use only by African Americans, in relation to these differing future prospects.

When the FDA announced its approval of BiDil in June 2005, it located the drug, and perhaps the future of pharmaceutical development, within a particular vision of the future, heralding BiDil as “representing a step toward the promise of personalized medicine.” The discourse of “personalized medicine” can be characterized as part of a utopian future, one in which clinicians will be able to make increasingly individualized decisions based on each patient’s genetic makeup so that the drugs they take will be those that work best for them.

In this article I want to ask what we should do, either collectively or individually, if we could identify by genetic and family profding the 12% of the male population likely to commit almost half the violent crime in our society. What if we could identify some individuals in that 12% not only at birth, but in utero, or before implantation? I will explain the source of these figures later; for now, I will use them only to provide a concrete example of the kind of predictive claims we can expect to be made with some frequency, and some scientific credibility, over the next generation. I will adopt an outlook that one commentator has called “pragmatic optimism,” but which could also be called technological optimism - the belief that a science or technology will achieve many or most of its advertised goals. My optimism will be directed towards human behavioral genetics, the source of predictions like the one I just offered; I will assume that this controversial discipline will achieve a substantial pan of its scientific ambition to identlfy genetic differences among individuals that help predict and possibly explain future behavior, psychological health, and cognitive skill. This optimism is very limited -it concerns the scientific success of behavioral genetics, not the social value of that success.

Pain is the single most common reason patients seek care in the emergency department. Given the prevalence of pain as a presenting complaint, one might expect emergency physicians to assign its treatment a high priority; however, pain is often seemingly invisible to the emergency physician. Multiple research studies have documented that the undertreatment of pain, or oligoanalgesia, is a frequent occurrence. Pain that is not acknowledged and managed appropriately causes dissatisfaction with medical care, hostility toward the physician, unscheduled returns to the emergency department, delayed return to full function, and potentially, an increased risk of litigation. Failure to recognize and treat pain may result in anxiety, depression, sleep disturbances, increased oxygen demands with the potential for end organ ischemia, and decreased movement with an increased risk of venous thrombosis.

In August 2000, Arthur Matas and his colleagues de scribed a protocol in which their institution began to accept as potential donors, individuals who came to the University of Minnesota hospital offering to donate a kidney to any patient on the waiting list. Matas and his colleagues refer to these donors as nondirected donors by which is meant that the donors are altruistic and that they give their organs to an unspecified pool of recipients with whom they have no emotional relationship. This paper represents an ethical and policy critique of the nondirected donation protocol that was implemented at the University of Minnesota in August 1999. Specifically, I address the ethical questions: Whether altruistic living solid organ donations by strangers (nondirected donations) should be permitted? And if so, What are appropriate ethical guidelines for such donations?

The United Nations Convention on the Rights of Persons with Disabilities (CRPD) aims at empowering people with disabilities by granting them a number of civil and political, but also economic, social, and cultural rights. This is a groundbreaking agreement for all persons with disabilities, especially because it is the first human rights agreement for disabled people, and it is legally binding. For those states who signed it, it also brings various governmental obligations. Implementing the CRPD will clearly be politically challenging and also very expensive for all states, but even more so for poor ones.

This article advances, for the first time, a framework for situating public health law interventions as occurring in a predictable four-stage process. Whether the intervention is related to mandatory seat-belt laws, HIV prevention through needle-exchanges, or distracted-driving laws, these public health law interventions have generally been characterized by the following four stages. First, a series of publicized incidents, observances, or outcomes generate significant media attention, and are framed as public health harms. Then, a few select states evaluate such harms and proactively seek testimony or evidence designed to support a law-based intervention. After this initial public engagement, states enact legal frameworks designed to minimize or reduce the harm, often in the absence of full information about the scope of harm or potential effectiveness of the intervention. In contrast, scholars have proposed that at these early stages, lawmaking should be evidence-based and “developed through a continuous process that uses the best available quantitative and qualitative evidence.”5 Our experience evaluating youth sports traumatic brain injury (TBI) lawmaking suggests that, like other public health issues with sudden and intense media (and, therefore, constituent) attention, an evidence-based approach was lacking during these early stages.

Despite philosopher George Santayana's famous injunction that those who do not remember the past are condemned to repeat it, history holds no simple truths. Nevertheless, there are a number of significant historical questions relating to the AIDS epidemic. What does the history of medicine and public health have to tell us about contemporary approaches to the very difficult dilemmas raised by AIDS? Is AIDS something totally new, or are there instances in the past that are usefully comparable? Are there some lessons in the way science and society has responded to epidemic disease in the past that could inform our understanding of and response to the current health crisis?

There are obviously no simple answers to such questions. History is not a fable with the moral spelled out at the end. Even if we could agree on a particular construction of past events, it would not necessarily lead to consensus on what is to be done. And yet, history provides us with one means of approaching the present. In this regard, the history of responses to particular diseases can inform and deepen our understanding of the AIDS crisis and the medical, social, and public health interventions available.

Consent forms given to potential subjects in research protocols typically contain a sentence like this: “You have a right to withdraw from this study at any time without penalty.” If you have ever served on an institutional review board (IRB) or a research ethics committee, you have no doubt read such a sentence often. Moreover, codes of ethics governing medical research endorse such a right. For example, paragraph 24 of the Declaration of Helsinki says, “The subject should be informed of the right… to withdraw consent to participate at any time without reprisal.” Similarly, section C of the Belmont Report says that subjects must be informed that they have the right “to withdraw at any time from the research.” And in section 46.116 of the Common Rule (issued by the United States Department of Health and Human Services), it says that one of the elements of informed consent must include a statement that “the subject may discontinue participation at any time without penalty or loss of benefit to which the subject is otherwise entitled.”

Tort claims have been studied for various reasons. Several studies have found that most tort claims are not related to negligent adverse events and most negligent adverse events do not result in tort claims. Several studies have examined the disposition of tort claims to understand the likelihood of payment once a claim has been made. Still others have proposed that tort-claims trend analysis may help administrators target their quality-improvement efforts and identify problems with quality that would not otherwise be captured.

In this article, we conduct a tort-claims analysis to explore areas for quality improvement, specifically for patient safety, in the Veterans Health Administration (VHA). Patient safety is an increasingly highlighted aspect of health-care delivery. Failure to assure patient safety can result in bad clinical outcomes, additional costs of care, and a negative organizational image. Filing a tort claim is one way for an individual to express concern about an organization. For our analysis, we draw from resolved tort claims in the Veterans Health Administration from fiscal years 1989 to 2000.

This paper organizes the question of gun controls as violence policy under two quite different headings. The first issue to be discussed is the relationship between gun use and the death rate from violent crime. The second question is whether and how firearms control strategies might reduce the death rate from violence. When we review the evidence on the relationship between guns and violence, it seems clear that gun use, usually handgun use, increases the death rate from violence by a factor of three to five. Nobody in mainstream social science or criminology argues against such weapon effects these days, although some are more skeptical of the magnitude estimated than others (one example is Lance Stell; please see his essay in this issue). Thus the problem is both genuine and important.

As early as the 1960s and 1970s, astute commentators began to call into question the degree of influence that the pharmaceutical industry was exercising over all aspects of medical research, education, and practice in the U.S. More recently, a spate of books and articles demonstrates that the issue has only become more serious in the last decade or two.

My focus in this paper will be on the industry’s influence on medical education. The influence that the industry exerts on undergraduate and graduate medical education (that is, the training of medical students and residents) often occurs through the system of pharmaceutical sales representatives, who also “detail” drugs to practitioners; or through the influence that the industry exerts over medical research. I will therefore devote my attention here primarily to the system of continuing medical education (CME) by which practitioners receive information about medical advances. The pharmaceutical industry currently supports about one-half of the costs of CME in the U.S., so it seems appropriate to question the degree of industry influence over the content of CME.

Clinical research employing the randomized clinical trial has, traditionally, been understood to pose an ethical dilemma. On the one hand, each patient ought to get the treatment that best meets her needs, as judged by the patient in consultation with her doctor. On the other hand, the method most helpful to advancing our understanding about what treatments are indeed best able to meet patient needs is the randomized trial, which necessitates that each patient's care is decided not by physician judgment or patient choice but instead by random assignment. The tension can be described as a conflict between the interests of individual patients who are sick today, and the interests of the group of people who will become sick in the future and would benefit from advances in medical understanding. How one ought to balance these important and often competing interests is an important ethical question that resists easy resolution.

Post-industrial societies confront common problems in pharmaceutical industry-physician relations. In order to promote sales, drug firms create financial relationships that influence physicians' prescriptions and sometimes even reward physicians for prescribing drugs. Three main types exist: (1) kickbacks, (2) gifts, and (3) financial support for professional activities. The prevalence of these practices has evolved over time in response to changes in professional codes, law, and markets. There are certainly differences among these types of ties, but all of them can compromise physicians' independent judgment and rational prescribing.

Drug firms have paid kickbacks for prescribing drugs, purchasing drugs, switching brands prescribed, adding a drug to a hospital formulary, enrolling patients in post-marketing clinical trials, and writing practice guidelines that encourage the use of certain drugs.