Research on human genetic variation can present collective risks to all members of a socially identifiable group. Research that associates race or ethnicity with a genetic disposition to disease, for example, presents risks of group discrimination and stigmatization. To better protect against these risks, some have proposed supplemental community-based reviews of research on genetic differences between populations. The assumption behind these appeals is that involving members of study populations in the review process can help to identify and minimize collective risks that otherwise could go unnoticed. In contrast to this position, critics have argued that supplemental community-based reviews are unnecessary, impractical, and morally problematic. This paper is our attempt to advance this debate by distinguishing the various goals of community review and the forms that it can take.

While primary malignant brain tumors account for only two percent of all adult cancers, these neoplasms cause a disproportionate amount of cancer-related disabilities and death. The five-year survival rates for brain tumors are the third lowest among all types of cancer. Malignant gliomas (glioblastoma and anaplastic astrocytoma) comprise the most common types of primary central nervous system (CNS) tumors and have a combined incidence of five to eight cases per 100,000 people. The median survival rate of conservatively treated patients with malignant gliomas is 14 weeks; with surgical resection alone, 20 weeks; with surgery and radiation, 36 weeks; and with the addition of newer biochemotherapies such as temozolomide and bevacizumab, upward of 14-18 months.

The profound cost of caring for terminally ill patients with primary malignant brain tumors raises ethical considerations for the American public; the stewardship of health care dollars for the population at large maintains a juxtaposed tension against a dynamic, necessary balance of hope, care, rehabilitation and research efforts for affected patients and their advocates.

In March 2003, the world discovered, again, that I humanity's battle with infectious diseases continues. The twenty-first century began with infectious diseases, especially HIV/AIDS, being discussed as threats to human rights, economic development, and national security. Bioterrorism in the United States in October 2001 increased concerns about pathogenic microbes. The global outbreak of severe acute respiratory syndrome (SARS) in the spring of 2003 kept the global infectious disease challenge at the forefront of world news for weeks. At its May 2003 annual meeting, the World Health organization (WHO) asserted that SARS is “the first severe infectious disease to emerge in the twenty-first century” and “poses a serious threat to global health security, the livelihood of populations, the functioning of health systems, and the stability and growth of economies.”

Physicians frequently are asked to assess whether a patient has the capacity to make informed decisions about his or her medical care. Such assessments may be difficult and controversial. There are few explicit legal standards for judging competency to make medical decisions. Furthermore, clinical practices for evaluating decision-making capacity are problematic. The following case illustrates some of these problems.

Mrs. C., a 74 year old widow with congestive heart failure, angina pectoris, and mild dementia, has been admitted to the hospital for shortness of breath and chest pain. In the past three years she has suffered two heart attacks. During the past two months, her symptoms have worsened despite several medications, including maximally tolerated doses of diltiazem, furosemide and enalapril. She now develops shortness of breath and chest pain when walking one block. Because there are no other medical treatments for her condition, her physician recommends angioplasty or bypass surgery in order to ameliorate her symptoms.

Biomedical research has always relied on access to human biological materials and clinical information, resources that when combined form biobanks. In the past, it appears that investigators sometimes used these resources with relatively little oversight, and without the consent of the individuals from whom these materials and information were obtained. Several developments in the last ten to fifteen years have converged to place greater emphasis on the role of individual consent in the creation and use of biobanks. The most important by far is the power of information technology, which has transformed our lives in almost every domain. In the research setting, it is now easy to abstract information from electronic medical records. Computers make it possible to analyze enormous datasets and have contributed in essential ways to the dramatic increases in our understanding of genomics and other areas of biomedical science.

There is much we do not know about nanotechnology. Despite its tremendous promise, nanotechnology today is mostly forecast and fervent hope. Predictions that spending on nanotechnology will increase from current levels of $13 billion to more than $1 trillion by 2015 are no more than that – simply predictions. Hopes that nanotechnology will be an essential part of solving the globe's energy, food, and water problems should be tempered by recalling a century of revolutionary technologies that failed to live up to their early promise such as nuclear energy, supersonic airplanes, or gene therapy. Many other questions continue to nip at nanotechnology's heels, not the least of which are debates about what is and is not technically feasible. Despite these uncertainties, we can have complete confidence in one aspect of nanotechnology's future – it will be subject to a host of regulations.

Zoning laws determine what types of land uses and densities can occur on each property lot in a municipality, and therefore also govern the range of potential environmental and health impacts resulting from the land use. Zoning regulations are the most ubiquitous of the land use laws in the United States, as well as in many other countries. As such, they have far-reaching effects on the location of noxious uses, and any concomitant environmental or human health impacts.

Zoning has enormous implications, in general, for shaping our environment, and because changes to zoning are made through a political process, it has possibilities for abuse. One zoning expert stated:

Over the past decade, the number of clinical trials registered with the Food and Drug Administration (FDA) has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board (IRB) review, data monitoring, and informed consent forms. However, the protection of human subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research.

In the past ten years, there has been growing interest in and concern about protecting the privacy of personal medical information. Insofar as medical records increasingly are stored electronically, and electronic information can be shared easily and widely, there have been legislative efforts as well as scholarly analyses calling for greater privacy protections to ensure that patients can feel safe disclosing personal information to their health-care providers. At the same time, the volume of biomedical research conducted in this country continues to grow. The budget of the National Institutes of Health, for example, was $20,298 million in 2001, having more than doubled from a budget of $9,218 million 10 years before. This growing body of research includes increased efforts to use stored medical records as a source of data for health services, epidemiologic, and clinical studies.

Translational science is a 21st century mission. Government officials and industry leaders are making huge investments in an attempt to transform more basic science discoveries into therapeutic applications. Scientists and policymakers express great excitement about the medical advances that could come with the current bench-to-bedside campaign.

A key step in translational science is the move from animal and other preclinical studies to initial human testing. Researchers ability to predict human effects is limited, and first-in-human (FIH) tests present significant uncertainty. Participants in this form of research face risks and can experience serious, even lethal, harm. Well-known incidents involving Jolee Mohr and Jesse Gelsinger, as well as subjects in the 2006 study of the investigational agent TGN1412, show the dangers that can arise in early human research.

The bench-to-bedside campaign will need many volunteers to participate in early human testing. Investigators and regulators must not allow the policy enthusiasm for translational science to overshadow the commitment to protect human subjects. Participants in exploratory research are diverse and as a group lack characteristics usually associated with vulnerable populations, such as impaired decisional ability or economic or educational disadvantage.

As is evident from the other articles in this special issue, end-of-life treatment has engendered a vigorous dialogue in the United States over the past few decades because decision making at the end of life raises broad and difficult ethical issues that touch on health professionals, patients, and their families. This concern is exacerbated by the high cost related to the end of life in the U.S. Moreover, in light of demographic patterns, progressively scarce health care resources, and an expanding array of life-saving technologies, decisions at the end of life are becoming problematic matters of public and, thus, scholarly concern in most countries. Issues at the end of life are central not only to bioethics but also raise important ancillary policy dimensions.

This paper explores the convergence of two recent and growing streams of bioethical work and concern. Each has originated independently, but each arises from the fact that the Common Rule that has shaped medical research ethics, as institutionalized in the United States and also abroad, is largely silent about what needs to be done in response to researchers’ positive obligations. One stream concerns what to do about the sometimes vast range of findings that may arise incidentally to performing research procedures. The other asks whether medical researchers owe their study participants any “ancillary care” — that is, medical care that their study participants need but that goes beyond what is required to do the science safely.

Not all intellectual property rights grant the right to exclude that is indicative of “property rules,” as that term was used by Guido Calabresi and A. Douglas Melamed in their seminal article. Some intellectual property rights are “liability rules,” in which the right holder has an entitlement to compensation for use of the protected invention, not a right to preclude the use. Although patent laws normally grant a right to exclude others from use of the protected invention as a default, most countries’ laws allow the government to convert the patent property rule into a liability rule through a compulsory license. It has been noted, for example, that by the end of the 1950s, the U.S. had issued compulsory licenses covering 40 to 50 thousand patents, including substantial portions of the patent portfolios of AT&T, General Electric, IBM, and Xerox. The U.S. Supreme Court recently expressed a willingness to accept liability rules over injunctions in some patent infringement cases.

Our society currently faces many complex and perplexing issues related to biotechnology, including the need to define the outer boundaries of genetic research on human beings and the need to protect individual and group rights to human tissue and the knowledge gained from the study of that tissue. Scientists have increasingly become interested in studying so-called “population isolates” to discover the nature and location of genes that are unique to particular groups. Indigenous peoples are often targeted by scientists because “the relative isolation of the communities ensures minimal gene flow.” Such studies raise a number of issues related to privacy rights, property rights, informed consent, and group rights versus individual rights. These issues recently came to light in a case brought by the Havasupai Tribe and its members over the use of blood samples, handprints, and genealogy information initially taken by researchers at Arizona State University (ASU) for a diabetes project. These materials were then allegedly used by researchers at ASU and other institutions for a multitude of unauthorized purposes, including research into the frequency of mental health disorders and the origin of human populations. Consequently, the affected members sued for damages under several legal theories. However, underlying all of these claims was the allegation that this unauthorized use of genetic resources and data not only injured the individuals who gave samples, but also caused a collective harm to the Havasupai Tribe and the cultural and spiritual beliefs of its members.

Physicians, scholars, and policymakers continue to be concerned about conflicts of interests among health care providers. At least two main types of objections to conflicts of interest exist. Conflicts of interests may be intrinsically troublesome if they violate providers’ fiduciary duties to their patients or they contribute to loss of trust in health care professionals and the health care system. Conflicts of interest may also be problematic in practice if they bias the decisions made by providers, adversely impacting patient outcomes or wastefully increasing health care costs. This latter objection may be observed in differences in the prescriptions written, procedures performed, or costs billed by health care professionals who have conflicting interests, when compared to those that do not have such financial relationships.

This paper addresses two interconnected concepts — health disparities and social justice — as they pertain to screening, diagnosis of disease, and health care access among minority elders in the American society. Health disparities are defined as differences in treatment provided to members of different racial or ethnic groups that are not justified by the underlying health conditions or treatment preferences of patients. Disparities currently exist in many aspects of American health care. For example, when compared to whites, the infant mortality rate is higher for African Americans; health insurance coverage is lower for Latinos and African Americans; and ethnic minorities experience poorer care and survival rates for HIV, even after controlling for other confounding factors including income, insurance, health status, and severity of disease. Among older Americans, health status varies by race, income, and gender. Older minority Americans have consistently been shown to have worse health than whites of the same age group across measures of disease, disability, and self-assessed health. When compared to whites, elderly Latinos have higher rates of diabetes and disabilities, and older African Americans have more chronic conditions.

This article argues that the misalignment of private profit-maximizing objectives with public health needs causes institutional corruption in the pharmaceutical sector and systematically leads firms to act contrary to public heath. The article analyzes how financial incentives generate a business model promoting harmful practices and explores several means of realigning financial incentives in order to foster therapeutic innovation and promote the rational use of medicines.

Current methods of forensic DNA profiling (known also as DNA fingerprinting and DNA typing), based on Polymerase Chain Reaction (PCR) amplifications of a varying number of Short Tandem Repeat (STR) loci found at different locations on the human genome, are regularly described as constituting the “gold standard for identification” in contemporary society. At a time when criminal justice systems in Europe and North America increasingly seek to utilise the epistemic authority of a variety of sciences in support of the apprehension and prosecution of suspects and offenders, genetic science and recombinant DNA technology are often singled out for particular approbation. Indeed, the development and application of DNA profiling has been widely described as the “greatest breakthrough in forensic science since fingerprinting.”

Prior to the implementation of PCR based extraction and amplification methods in the 1990's, the initial uses of DNA fingerprinting (based on Multiple and Single Locus Probes) were largely confined to reactive forensic casework.

Discussion of the ethics of forgoing medically provided nutrition and hydration tends to focus on adults rather than infants and children. Many appellate court decisions address the legal propriety of forgoing medically provided nutritional support of adults, but only a few have ruled on pediatric cases that pose the same issue.

The cessation of nutritional support is implemented most commonly for patients in a permanent vegetative state (often referred to as persistent vegetative state (hereinafter “PVS”)). An estimated 4,000 to 10,000 American children are in the permanent vegetative state, compared to 10,000 to 25,000 adults. Yet the dearth of literature, case reports, and court decisions suggests that physicians and families of pediatric patients stop medically provided nutrition or seek court orders much less frequently.