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.

Historically, judicial enforcement of constitutional rights to health care has played a fairly limited role in enabling access to health care, a trend particularly prevalent in North America, and reflected in many other regions. This trend is due in part to judicial resistance to recognizing socioeconomic rights like health as appropriately legal, or as appropriately enforceable in light of the doctrine of separation of powers. This resistance is evident in judicial deference to social and economic policy, a reluctance to view socioeconomic claims as invoking “fundamental values” that courts consider themselves authorized to protect: and a real reluctance to recognize and enforce “positive” obligations pertaining to social welfare. As a result, health has often fallen largely into the political rather than legal sphere, and domestic courts have been relatively reluctant to review health policies from a human rights perspective, given the belief that doing so would exceed the appropriate democratic function of the judiciary.

The quality of end-of-life care in this country is often poor. There is abundant literature indicating that dying individuals do not receive adequate pain medication or palliative care, are tethered to machines and tubes in a way that challenges their dignity and autonomy, and are not helped to deal with the emotional grief and psychological angst that may accompany the dying process. While this is true for individuals in many settings, it seems to be especially true for individuals in nursing homes. This is somewhat puzzling given that (1) considerable resources have been devoted to bringing public attention to this problem, (2) we have the knowledge and expertise to provide such care, and (3) we have a government-financed benefit that covers this type of care - the Medicare hospice benefit (MHB).

While utilization of hospice care has increased during the last decade, there is considerable evidence that hospice care remains underutilized particularly in the long term care setting.

Biobanks are repositories of human biological materials collected for biomedical research. There are over 300 million stored specimens in the United States, and the number grows by 20 million per year. In the post-genome world of high throughput gene sequencing and computational biology, biobanks hold the promise of facilitating large-scale research studies. New organizational and operational models of research repositories also raise complex issues of big science, big business, and big ethical concerns.

In 2004, the journal Health Matrix published a very interesting symposium volume titled “The Field of Health Law: Its Past and Future. As the title implies, the various commentators took both a retrospective and a prospective look at past trends and future prospects in health law. Some, including Clark Havighurst, Skip Rosoff and Walter Wadlington, wrote thoughtful essays on the development of health law over time and the implications of those trends. Others, including Rob Schwartz, Jim Blumstein, Rand Rosenblatt, and Mark Hall and Carl Schneider, wrote equally thoughtful essays that reflected on the past but focused more on future directions and prospects. And one, Kep Wing, wrote a semi-dyspeptic essay debunking the entire field of health law.

Taken together, these essays present a comprehensive view of how health law has developed so far and where its future might lie. Four themes emerge from the collected writings. First, there is considerable agreement on how and why health law has developed, but little agreement on where it is headed.

In this era of globalization, as the health problems of poor countries and rich countries become increasingly intertwined, medical research is being conducted at the international level. For example, a research study may be sponsored by a developed country and conducted in a resource-poor country to address health problems faced by both nations. The globalization of medical research is, in effect, quickly outpacing the development of internationally accepted ethical guidelines for the conduct of research. For many medical researchers working in resource-poor countries, ethical decision-making is like sailing in the days before modern navigation; one is never quite sure where one is, or in what direction one is headed. Our aim in this article is to fix a few navigational points on an ethical compass to guide biomedical researchers from developed countries working in resource-poor countries.

Just as one of the principles underlying the Hippocratic Oath is “First, do no harm,” a principle underlying medical research ethics may be “First, do not exploit.”

The normative approach to defining an ethic of a field, which focuses on one disciplinary field, requires modification in the consideration of a biodefense ethic to include not one discipline, but many. The consideration of an ethic in biodefense must capture issues in a multidisciplinary scope, including the ethical studies in the disciplines of medicine, sciences, technology, law, international relations, public health, environment, and war, each having their unique framework of ethical constructs.

An ethic of bioterrorism and biodefense raises issues which can be examined utilizing multidisciplinary ethical considerations. The disciplines of medicine, sciences, technology, law, international relations, public health, environment, and war each have a framework of ethical principles which are essential in the scope of ethics which are incident to bioterrorism and biodefense; the absence of any one of which would create a void in our understanding of the complexity of this subject.

In the past twenty years, advances in forensic DNA technology have revolutionized the American criminal justice system. The use of forensic DNA testing in America began in 1987, and its demonstrated scientific accuracy quickly led jurisdictions to accept expert testimony regarding DNA matches between suspects and crime scene evidence. Wielding the power to exonerate the innocent and apprehend the guilty, the use of DNA identification technology has become an indispensable resource for prosecutors and law enforcement officials, as well as for defense lawyers representing persons falsely accused or wrongfully convicted of crimes they did not commit. As states began to compile DNA profiles from convicted offenders, the need for a repository for these profiles resulted in the DNA database.

Originally, DNA databases included only “those classes of offenders with a high recidivism rate, such as sex offenders and violent felons.” Recognizing the crime-solving potential of this technology, state legislatures soon began to expand the scope of DNA database statutes to include broader classes of offenders.

What are the Differences between Public Health Practice and Research? This perplexing question constantly arises in the planning and performance of public health activities involving the acquisition and use of identifiable health information. Public health agencies collect and analyze significant identifiable health data from health care providers, insurers, other agencies, or individuals to perform an array of public health activities. These activities include surveillance (e.g., reporting requirements, disease registries, sentinel networks), epidemiological investigations (e.g., to investigate disease outbreaks), and evaluation and monitoring (e.g., public health program development and analysis, oversight functions). Few debate that these essential public health activities, often specifically authorized by law, are classifiable as public health practice.

Other public health activities in which identifiable health data are acquired or used, however, can resemble, include, or constitute human subjects research. “Human subjects research” is legally defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” that involves living human subjects (or their identifiable, private data).

Medical quarantines often threaten the civil rights of the persons whom they confine. This might happen in two ways. First, quarantines might inflict harsh conditions on their occupants; and, second, quarantines might be imposed in an arbitrary or indeed discriminatory manner. These concerns, moreover, are anything but fantastic. Infectious diseases, particularly in epidemic forms, commonly trigger retributive and discriminatory instincts, so that actual quarantines often impose inhumane, stigmatizing, or even penal treatment upon persons who are confined based on caprice or even prejudice.

But quarantines that impose no gratuitous hardships and that are applied pursuant to orderly and non-discriminatory procedures are theoretically possible and also practically available. And such well-run quarantines, especially when they are employed to combat epidemic diseases, cannot plausibly be said to violate the civil rights of the quarantined. Even the staunchest civil libertarian must accept that one person's liberty may be restricted when this is necessary for preventing harm to another.

In the research ethics literature, there is strong disagreement about the ethical acceptability of placebo-controlled trials, particularly when a tested therapy aims to alleviate a condition for which standard treatment exists. Recently, this disagreement has given rise to debate over the moral appropriateness of the principle of clinical equipoise for medical research. Underlying these debates are two fundamentally different visions of the moral obligations that investigators owe their subjects.

Some commentators and ethics documents claim that physicians, whether acting as care givers or researchers, have the same duty of beneficence towards their patients and subjects: namely, that they must provide optimal medical care. In discussing placebo surgery in research on refractory Parkinson's disease, Peter Clark succinctly states this view: “The researcher has an ethical responsibility to act in the best interest of subjects.”

Over the past decade or so, no issue in medical ethics or bioethics law has raised more concerns about federal intervention in the practice of medicine, about judicial attempts to craft health policy, or about the wisdom of public mandates directing specific health care initiatives than the issue of physician-assisted suicide. State voter referenda, lower and federal court cases (including two U.S. Supreme Court decisions), proposed legislation in both houses of Congress, and orders and determinations from agencies within the executive branch of two administrations are representative of the kinds of actions taken in the last ten years implicating medical care at the end of life. Whether the intent was to codify into law physician-assisted suicide, to deny a constitutional right of assisted suicide, or to make “easier” physicians' efforts to alleviate intractable suffering at the risk of hastening death, or to prohibit physician aid in dying altogether, the impact on the patient-doctor relationship and on our understanding of what constitutes dignified and humane care at the end of life is undeniable.

Some authors argue that the ethics of medical care and the ethics of research differ, and that it is a mistake to conflate the two. They propose “that medical research and medical treatment are two distinct forms of activities, governed by different ethical principles.” This raises the question of whether physicians who are also clinical investigators may separate their role as physician from that of researcher when they are involved in clinical trials, thereby avoiding the obligations required in the physician-patient relationship. Miller and Brody suggest that medical training is to blame for what they believe is the physicians’ tendency to confound the obligations of research and practice. “Physician-investigators, after all, went to medical school” they explain. They believe that considering research with patients outside the ethical framework of the physician-patient relationship may be “difficult and threatening” to physicians who have “psychological needs” to consider the ethical obligations flowing from their relationship with their patients.

An increasingly long line of high-profile scientific misconduct cases raises the question of whether regulatory policy ought to incorporate more rigorous sanctions for investigators and their institutions. Broad and Wade graphically describe these cases through the early 1980s. They continue to recent times with the cases of Evan Dreyer, Kimon Angelides and Robert Liburdy, Justin Radolf, and others. In addition, recent Congressional investigation into conflict of interest concerns surrounding consulting by National Institutes of Health scientists has raised further questions about ethical standards. The record of continuing scandal suggests that current policy may not be optimal for controlling scientific misconduct. Would an alternative policy better minimize its incidence and associated costs?

What should we expect of public policy governing misconduct by American scientists? Surely the public has a right to presume that its tax money is being spent wisely and that any economic rewards from taxpayer funded research are used prudently and in the public interest.

The problem of harmful, unnecessary and neglected pain has been studied extensively in many health care settings over the past decade. Research has documented the incidence of untreated pain, and scholars and advocates have given the problem several names: “public health crisis,” “oligoanalgesia, and “moral failing,” among them. Articles have identified a litany of now familiar “obstacles” or “barriers” to effective pain relief. Each of these individual obstacles or barriers has been the subject of targeted remedial action in at least some context.

The checklist approach to improving care for patients in pain, however, is likely to have only limited effect. What really appears to be operating is a complex ecosystem that supports ambivalence, denial, and even suspicion of the circumstance of patients in pain and efforts to treat them. Pain relief in emergency medicine, a relatively new setting for the study of challenges to treating pain, provides a revealing context for viewing discrete obstacles to effective pain management in medicine as part of an integrated environment into which patients with pain enter for treatment.

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.

The legalization of physician-assisted suicide (PAS) remains a hotly debated issue throughout the United States, and continues to capture the attention of government officials at both the state and federal levels. While the practice is currently legal in Oregon, some federal lawmakers and officials from the U.S. Department of Justice have attempted to outlaw that state's practice through legislation (e.g., the Pain Relief Promotion Act of 1999), or through a strained interpretation of the federal Controlled Substances Act. And while several citizen groups throughout the United States have attempted but failed to legalize PAS through popular initiative, several state lawmakers have succeeded in specifically outlawing the practice. Yet even though physician-assisted suicide (PAS) remains unlawful in every state except Oregon, there is ample evidence that American physicians throughout the United States have participated in PAS by providing their terminally ill patients with lethal prescriptions.

One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he owes his medical patients, or whether they differ in any fundamental way.

Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior.

For nearly twenty-five years, federal regulation of privacy issues in research involving human subjects was the primary province of the federal rule for Protection of Human Subjects (Common Rule). As of April 14, 2003, the compliance date for the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA), however, the Common Rule and the Privacy Rule jointly regulate research privacy. Although, in theory, the Privacy Rule is intended to complement the Common Rule, there are several areas in which the rules diverge. In some instances the inconsistencies result in gaps in privacy protection; in other instances the inconsistencies result in added burdens on researchers without additional privacy protections. In all instances, the lack of harmonization of these rules has created confusion, frustration, and misunderstanding by researchers, research subjects, and institutional review boards (IRBs). In this article, I review the major provisions of the Privacy Rule for research, explain the areas in which the Privacy Rule and Common Rule differ, and conclude that the two rules should be revised to promote consistency and maximize privacy protections while minimizing the burdens on research.