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.

Back injuries have a bad reputation. The workman looks upon them with apprehension, the insurance company with doubt, the medical examiner with suspicion, the lawyer with uncertainty. The medical examiner is faced with the difficulty of estimating the true value of the subjective symptoms in the comparative absence of physical signs. His suspicion is born of the frequent disparity between these two.

This prophetic statement made almost 100 years ago highlights an ongoing problem - how people who are incapacitated by painful conditions such as chronic low back pain can be evaluated consistently and equitably for purposes of disability compensation. We confronted this vexing problem when we participated in writing the chapter devoted to impairment associated with pain (Chapter 18) of the American Medical Association s Guides to the Evaluation of Permanent Impairment, 5th edition AMA Guides 5th Our purposes in this essay are to clarify several important conceptual issues associated with the assessment of pain among disability applicants, and to articulate reasons why pain should be considered in impairment and disability ratings.

Xenotransplantation is defined as “any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.” Xenotransplantation has been viewed by desperate patients and their surgeons as a solution to the problem of the paucity of human organs available for transplantation. Foes of xenotransplantation argue that the use of animal organs degrades the human race and should be avoided.

In this paper, we briefly review the cultural context of xenotransplantation and explore the infectious disease risk of xenotransplantation. The United States Code of Federal Regulations requires life-long surveillance of a xenotransplantation recipient due to the largely unknown risk of novel infectious disease transmitted across species, known as xenogeneic infectious disease. We argue that despite being in the interest of protecting the public health, the imposition of lifelong surveillance requirements on xenotransplant recipients effectively abrogates the right to withdraw from a clinical trial after the transplantation has taken place. Moreover, we argue that a waiver of the right to withdraw should be made explicit in the interest of full disclosure, out of respect for the research subject’s right of self-determination.

Although scientific and commercial excitement about genomic biobanks has subsided since the biotech bust in 2000, they continue to fascinate life scientists, bioethicists, and politicians alike. Indeed, these assemblages of personal health information, human DNA, and heterogeneous capital have become and remain important events in the ethics and politics of the life sciences. For starters, they continue to reveal and produce the central scientific, technological, and economic paradigms so ascendant in biology today: genome, infotech, and market. Biobanks also illustrate what might be called the new distributive politics of biomedical research. Within those politics, the commodification of persons – or at the very least, of their informational representations – has challenged the ontological, ethical, and political underpinnings of the social contract between researchers and their human research subjects. In brief, biobanks are unsettling relations between genes, tissue, medical records, and persons (both individual and collective). But it is also clear that these relations are increasingly being restructured by new rights of control, access, exclusion, and use known as “property,” both material and intellectual.

Important medical advances over the last several decades have vastly improved the technical capacity to control human pain. Millions of patients suffering from cancer, HIV/AIDS, and other conditions have been able to find relief from incapacitating chronic and acute pain. However, despite these developments, pain remains severely under treated worldwide, particularly in developing countries. The tragic consequence is that for millions of people around the globe, excruciating pain is an inescapable reality of life.

Although the importance of including vulnerable populations in medical research is widely accepted, identifying how to achieve such inclusion remains a challenge. Ensuring that the language of informed consent is comprehensible to this group is no less of a challenge. Although a variety of interventions show promise for increasing the comprehensibility of informed consent and increasing a climate of exchange, consensus is lacking on which interventions should be used in which situations and current regulations provide little guidance. We argue that the notion of individual autonomy — a foundational principle of informed consent — may be too narrow for some vulnerable populations by virtue of its failure to acknowledge their unique histories and current circumstances. It has a different meaning for members of structured groups like American Indians than for unstructured groups, such as African Americans, whose complicated histories foster group identity. Ensuring broad participation in research and selecting appropriate methods for obtaining informed consent — namely, methods aligned with the source of vulnerability and level of risk — require new ways of thinking that might produce guidelines for matching informed consent models and processes with subpopulations.

Criminalization is a form of social marginalization that is little appreciated as a determinant of poor health. Criminalization can be understood in at least two ways — in the narrow sense as the imposition of criminal penalties for a certain behavior, and more broadly as the conferral of a criminalized status on all individuals in the population, whether proven guilty of a specific offense or not. Both criminal penalties and criminalized status threaten the mental and physical health of these populations in many ways. Incarceration, abandonment by families and communities, social disdain, physical abuse, discrimination, and relentless fear undermine their ability to enjoy their right to the highest attainable standard of health goods and services. Understanding the social determinants of health in these populations and formulating programs to address them have rarely been high priorities in national or international policy.

For more than two decades, significant controversies have been brewing over the efficacy and safety of Selective Serotonin Reuptake Inhibitors (or SSRIs) and other treatments for depression, and also over the expansion of their use for the treatment of a variety of other conditions. These controversies culminated, in June 2004, with alawsuit intended by Eliot Spitzer, Attorney General of the State of New York. The lawsuit accused pharmaceutical giant GlaxoSmith-Kline of “repeated and persistent fraud by misrepresentation, concealing and otherwise failing to disclose to physicians information in its control concerning the safety and effectiveness of its antidepressant medication paroxetine” (better known as “Paxil”) in treating children and adolescents suffering from depression.

Recent studies have exposed the startling inadequacy of health care providers knowledge about and practice of effective pain management. For example, in one study, it was reported that 79 percent of a random sample of 454 medical-surgical inpatients experienced pain during hospitalization, and that 58 percent of patients with pain considered the pain horrible or excruciating. In another study, 67 percent of 2,415 randomly selected hospitalized patients had pain during the twenty-four hours prior to being interviewed, and 50 percent reported pain at the time of the interview. In a study of seriously ill hospitalized patients reported in 1996, half of the patients complained of pain, and one-sixth reported that they experienced extremely severe pain at least half the time. According to one literature review, 75 percent of cancer patients have reported suffering pain, and one study estimates that 25 percent of cancer patients die with severe unrelieved pain. Chronic nonmalignant pain has been described as an extremely prevalent problem, and over two-thirds of nursing home residents experience serious pain.

In April 1999, Dr. Curt Freed of the University of Colorado in Denver and Dr. Stanley Fahn of Columbia Presbyterian Center in New York presented the results of a four-year, $5.7 million government-financed study using tissue from aborted fetuses to treat Parkinson’s disease at a conference of the American Academy of Neurology. The results of the first government-financed, placebo-controlled clinical study using fetal tissue showed that the symptoms of some Parkinson’s patients had been relieved. This research study involved forty subjects, nineteen women and twenty-one men; all suffered from Parkinson’s disease for an average of 13.5 years. In the study, each subject underwent neurosurgery: “four tiny burr holes, drilled through the wrinkle lines above the eyebrows into the skull, to clear a pathway to the brain. But only half received injections of fetal cells into the putamen, the region of the brain that controls movement; the other half received nothing. One year later, three members of the placebo group said their symptoms had improved.” In two-thirds of the transplant recipients, the fetal tissue took hold and seemed to establish a new network to produce the missing neurochemical dopamine.

Spurred by a confluence of factors, most notably the decreasing cost of high-throughput technologies and advances in information technologies, a number of population research initiatives have emerged in recent years. These include large-scale, internationally collaborative genomic projects (Table 1) and biobanks (Table 2), the latter of which can be defined as an organized collection of human biological material and associated data stored for one or more research purposes. Biobanks are a key emerging research infrastructure, and those established as prospective research resources comprising biospecimens and data from many participants are viewed as particularly promising drivers of biomedical progress. Such biobanks, particularly those publicly funded and set up to promote the public interest, have expanded across the globe in recent years.

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.

Ever since the 1960s, when medical science became capable of prolonging the dying process beyond bounds that many patients would find acceptable, people have sought “death with dignity,” or “a natural death,” or “a good death.” Once debilitation from a fatal affliction has reached a personally intolerable point, dying patients have sought to control the manner and timing of death via diverse techniques. Some sought the disconnection of life-sustaining medical interventions, such as respirators and dialysis machines. Beyond freedom from unwelcome interventions, some patients intent on avoiding suffering sought access to pain relief medication—even in dosages posing some risk (perhaps even a certainty) of hastening death. Other dying patients sought access to deep sedation, even knowing that they would never emerge from the resultant unconsciousness. Still other patients voluntarily refused to eat or drink or to accept artificial nutrition and hydration.

Over the past decade, there has been an extensive debate about whether researchers have an obligation to disclose genetic research findings, including primary and secondary findings. There appears to be an emerging (but disputed) view that researchers have some obligation to disclose some genetic findings to some research participants. The contours of this obligation, however, remain unclear.

As this paper will explore, much of this confusion is definitional or conceptual in nature. The extent of a researcher's obligation to return secondary and other research findings is often limited by reference to terms and concepts like “incidental,” “analytic validity,” “clinical validity,” “clinical relevance,” “clinical utility,” “clinical significance,” “actionability,” and “desirability.” These terms are used in different ways by different writers to describe obligations in different sorts of cases.

In Canada (as elsewhere) there is a growing demand for human eggs for reproductive purposes and currently demand exceeds supply. This is not surprising, as egg production and retrieval is onerous. It requires considerable time, effort, and energy and carries with it significant physical and psychological risks. In very general terms, one cycle of egg production and retrieval involves an estimated total of 56 hours for interviews, counseling, and medical procedures (i.e., screening, hormonal stimulation, and egg retrieval). The screening carries risks of unanticipated findings with severe consequences for insurability (which can be catastrophic). The daily hormone injections can be painful and uncomfortable, causing cramping, abdominal pain, nausea, vomiting, bloating, mood changes, and irritability.

Even many women who view reproductive capabilities not as a detriment but as an important source of joy in their lives recognize that women's reproductive capabilities have long been used to oppress them. The ability to reproduce has been an important factor in women's loss of control over their own lives, contributing to their being controlled by chance, by government, and by other people—husbands, boyfriends, parents. In the past, to the extent that reproduction has not been left to chance, the woman herself has often not been the decision-maker. Husbands have often coerced women into producing and raising offspring when they did not want to, and societal attitudes have had the same effect of encouraging marriage, then motherhood. Historically, state governments have participated in coercing childbirth as well, some by prohibiting or restricting birth control and all states by prohibiting abortion.