Financial relationships and business transactions between physicians and the health care industry are common. These relationships take a variety of forms, including payments to physicians in exchange for consulting services, reimbursement of physician travel expenses when attending medical device and pharmaceutical educational conferences, physician ownership in life science company stocks, and the provision of free drug samples. Such practices are not intrinsic to medical practice, but as the Institute of Medicine described in its 2009 report, these relationships have the potential to produce positive collaborations that improve patient care and public health, and most physicians view it as “ethically proper to accept items ranging from drug samples to a lucrative consultantship.”

However, financial relationships between physicians and pharmaceutical, medical device and biotechnology companies can also create negative influences on physician judgment that compromise patient care and jeopardize the public’s trust.

In this issue of the Journal of Law, Medicine & Ethics Peter Clark provides a comprehensive and sound ethical analysis of clinical trials examining the treatment of advanced Parkinson's disease with fetal tissue transplantation. These studies raise profound questions about how clinical trials of surgical interventions ought to be conducted. At stake is not only the ethical basis of such trials, but differing views as to the proper role of science in medicine and its limitations.

Experience with the broader debate on the ethical permissibility of placebo controls has taught us that the choice of control treatment is an aspect of trial design in which ethical and scientific issues overlap. Accordingly, I will highlight, and perhaps expand upon, three issues raised by Clark: What scientific questions ought clinical trials of surgical interventions ask? How should the ethical analysis of risk for such trials be conceived? And, are surgical patients a vulnerable population?

The general perception of how innovative assisted reproductive technologies (ART) are introduced is through a carefully controlled series of experiments in an animal model, such as the mouse. Only after the technique has been proven can one consider confirmatory studies on mammals closely related to humans, such as rhesus monkeys or other nonhuman primates. With this background of a peer-reviewed body of well-established published data, there is sufficient foundation and rationale to propose a clinical investigation to a responsible human subjects institutional review board (IRB). IRBs weigh the benefits and risks of the new methods to human subjects, and then consider the appropriate informed consent procedures for the particular case. Only after a large number of clinical studies are performed at multiple sites and are peer reviewed can the efficacy and safety of the innovative approach be clearly evaluated. At that time, the potential therapy can be responsibly offered to suitable beneficiaries.

In July of 2005, Indianapolis witnessed streaming headlines in the local newspaper attempting to distill the confusion surrounding the adoption of two premature infants by an adoptive parent. Thirteen articles and opinion pieces introduced the public to a murky legal and ethical transaction. Stating his overwhelming desire to have children, a New Jersey schoolteacher hired the services of a local attorney. The attorney procured a South Carolina woman for a compensated gestational surrogacy contract. Under the contract, the surrogate and the attorney would meet in Indiana to complete the execution of the contract and transfer parental rights via adoption after the birth of the twins.

A decade ago, conventional wisdom in the medical establishment was that physicians treating chronic pain with opioid analgesics were at a substantial risk of being sanctioned for overprescribing by state medical regulatory boards. Dozens of articles written since have alluded to this risk as an obstacle to effective pain re1ief. In the early 1990s, a number of high profile cases in which physicians were disciplined by regulatory boards for overprescribing to patients with chronic pain were reported in the press. Although the board actions in many of these cases were eventually overturned by state judiciaries, the publicity heightened practitioners’. sensitivity to the regulatory risks associated with prescribing opioids.

A review of the available data on state medical board actions nationwide for the period from 1990 to 1996 reveals that the perception of regulatory risk far exceeds the reality. Indeed, relatively few (less than 5 percent) of the disciplinary actions taken for overprescribing by state medical boards in any given year directly concern the treatment of chronic pain—malignant or nonmalignant—in patients.

U.S. Department of Health and Human Services (HHS) federal regulations pertaining to the protection of human subjects at Title 45 of the Code of Federal Regulations, Part 46, Subpart A (“the Common Rule”), refer to the need for special precautions when persons characterized as vulnerable are used as human research subjects. Under the Common Rule, persons considered “vulnerablae” are those who are likely to be susceptible to coercive or undue influence; the term “vulnerable” includes “children, prisoners, pregnant women, mentally disabled persons,” or those who are “economically or educationally disadvantaged.” The need for special precautions with some of these vulnerable persons in the context of research has long been addressed by both mandatory additional protections found in Subparts B through D of 45 C.F.R. pt. 46 (that are not, coincidentally, part of the Common Rule) and additional detailed guidance documents provided by HHS or its components to investigators and their respective institutions.

The right not to know is a contested matter. This can be because the inversion of the normal framing of entitlement to information about one's own health is thought to be illogical and inconsistent with self-authorship and/or because the very idea of claiming a right not to know information is an inappropriate appeal to the discourse of rights that places impossible responsibilities on others. Notwithstanding, there has been a sustained increase in this kind of appeal in recent years fueled in large part by the rise and rise of the importance of personal autonomy in health care ethics, and by domestic and international health law. The right not to know has been acknowledged in at least two important international legal instruments. For example, the UNESCO Universal Declaration on the Human Genome and Human Rights (1997), Article 5c provides: “The right of every individual to decide whether or not to be informed of the results of genetic examination and the resulting consequences should be respected.”

Interest in the ethics of research on human subjects, stimulated by atrocious human experimentation during WWII and the resultant Nuremberg Code, has been sustained by examples of unethical research in many countries and by proliferation of codes and guidelines. Such interest has intensified in recent years in association with expanding international collaborative research endeavors. The ongoing controversy in international research ethics takes place at two levels. At the practical level it is about the competing concerns of those predominantly interested in doing research to advance knowledge and those who, while supporting the need for research, are more acutely aware of the potential to exploit vulnerable participants, especially in developing countries. At the level of theory the controversy pits ethical universalism against moral relativism.

In her recent review of agreements and controversies in international research ethics, Ruth Macklin has concluded that, despite seeming agreement on several issues, many different viewpoints persist. In her view it is unlikely that these will be resolved easily.

The World Health Organization (WHO) has in the last decade identified mental health as a priority for global health promotion and international development, to be targeted through promulgation of evidence-based medical practices, health systems reform, and respect for human rights. Yet these overlapping strategies are marked by tensions as the historical primacy of expert-led initiatives is increasingly subject to challenge by new social movements — in particular, disabled persons’ organizations (DPOs). These tensions come into focus upon situating the WHO’s contributions to the analysis of global mental health in light of the negotiation and early stages of implementation of the Convention on the Rights of Persons with Disabilities (CRPD), particularly as it applies to persons with mental disabilities.

It is common for physicians who prescribe opioids for chronic pain to have their patients sign an opioid contract (OC) in order to receive opioid therapy. A vast majority of these contracts contain a stipulation requiring patients to submit to random drug testing (RDT) which screens for both licit and illicit drugs. Physicians who prescribe opioids may be concerned about prosecution and disciplinary actions; medication abuse and misuse; and addiction. Steven Passik et al. write, “…physicians still fear the risk of abuse or addiction as well as the potential legal consequences of their prescribing.”

Issues surrounding OC/RDT need a closer look with a focus on enforceability and efficacy of the opioid contract; accuracy and complications of drug screens and their interpretation; and the importance of trust between patient and physician. In addition, it is vital to dispel fears with facts regarding prosecutions, nonmedical use of prescription opioids, and addiction.

The importance of legal epidemiology in public health law research has undoubtedly grown over the last five years. Scholars and practitioners together have developed guidance on best practices for the field, including: placing emphasis on transdisciplinary collaborations; creating valid, reliable, and repeatable research; and publishing timely products for use in decision-making and change. Despite the energy and expertise researchers have brought to this important work, they name significant challenges in marshalling the diverse skill sets, quality controls, and funding to implement legal epidemiology activities. The Centers for Disease Control and Prevention (CDC) has worked to develop cross-cutting research and translation on issues of national priority in legal epidemiology, and has explored ways to overcome some of these challenges. As such, this article describes a case study of the use of law to characterize states' prior authorization policies regarding medication used to treat attention-deficit/hyperactivity disorder (ADHD), a central component of a broader effort to improve behavior therapy options for young children with ADHD. This article highlights the types of legal epidemiology work we have undertaken, the application of this work to an emerging public health problem, and the lessons learned in creating impactful research for the field.

The legal status of the human body is hotly contested, yet the law of the body remains in a state of confusion and chaos. Sometimes the body is treated as an object of property, sometimes it is dealt with under the rubric of contract, and sometimes it is not conceived as property at all, but rather as the subject of privacy rights. Which body of law should become the law of the body? This question is even more pressing in the context of current biomedical research, which permits commodification and commercialization of the body by everyone except the person who provides the “raw materials.” The lack of property protection for tangible parts of the human body is in stark contrast to the extensive protection granted to intellectual property in the body in the form of patents upon human genes and cell lines. Moreover, even courts that reject ownership claims on the part of those who supply body parts appear willing to grant property rights to scientists, universities, and others who use those body parts to conduct research and create products.

Newborn screening has evolved to include an increasingly complex spectrum of diseases, raising concerns that screening should be optional and require parental consent. Early detection of disorders like PKU and MCAD is essential to prevent serious disability and death in affected children. These are examples of high benefit-risk ratio disorders because of the irrefutable health benefits of early detection, coupled with the low risks of treatment. The dire consequences of not diagnosing an infant with a treatable disorder because of parental refusal to screen are wholly unacceptable. Thus, we believe that newborn screening for disorders with high benefit-risk ratios should continue to be mandatory.

As genetic and genomic research has progressed since the sequencing of the human genome, scientists have continued to struggle to understand the role of genetic and socio-cultural factors in racial and ethnic health disparities. Recognition that race and ethnicity correlate imperfectly with differences in allele frequency, environmental exposures, and significant health outcomes has made framing the relationship between genetic variation, race, ethnicity, and disease one of the most heated debates of the genome era. Because racial and ethnic identities reflect a complicated mix of social and genetic factors, critics have argued that use of racial and ethnic categories as analytical variables in biomedical research lacks rigor, leads to potentially dangerous stereotyping in medical practice, and sends harmful messages of innate racial difference to the broader public.

Concerns over the current lack of diversity in human genetic and genomic studies have developed in parallel to discussions of the appropriate use of racial and ethnic categories during the research process.

Antibiotic development and usage, and antibiotic resistance in particular, are today considered global concerns, simultaneously mandating local and global perspectives and actions. Yet such global considerations have not always been part of antibiotic policy formation, and those who attempt to formulate a globally coordinated response to antibiotic resistance will need to confront a history of heterogeneous, often uncoordinated, and at times conflicting reform efforts, whose legacies remain apparent today. Historical analysis permits us to highlight such entrenched trends and processes, helping to frame contemporary efforts to improve access, conservation and innovation.

Surrogacy and abortion represent two facets of procreative liberty, the right to reproduce and the right to avoid reproducing. Research on stigma associated with abortion and surrogacy illuminates how these very different experiences carry similar stigmatic harm. Why do certain decisions about reproduction engender social support, other decisions social disapproval? Restrictions on surrogacy and abortion derive from a common legal paradigm — state regulation on the pregnant body — that is rooted in traditional gender roles. Not all laws restricting abortion and surrogacy evince gender stereotyping. Abortion and surrogacy pose complex moral and social dilemmas. But research of stigma associated with abortion and surrogacy suggests that gender stereotypes play a role in the creation of stigma.

Researchers, scientists, and physicians in Uganda have become increasingly aware of the need to develop a systematic approach to reviewing bio-medical research conducted in their country. Much of this awareness and their concern stems from Uganda's high seroprevalence of human immunodeficiency virus (HIV) and the consequent large influx of research monies and HIV researchers from developed countries, including the United States and Great Britain.

We report on the proceedings of a five-day symposium on bioethical principles governing clinical trials, which convened in Jinja, Uganda in September 1994. The thirteen male and female workshop participants included representatives from the Uganda Ministry of Health, Makerere University, the Uganda AIDS Commission, Uganda's National Council of Science and Technology, and the National Chemotherapeutic Laboratory. These representatives included ethicists, physicians, researchers, and pharmacists, all of whom have conducted research themselves. Initial workshop sessions focused on the history of human experimentation and the development of protections for human participants in medical research, both in the United States and internationally.