Medical practice should evolve alongside medical ethics. As our understanding of the ethical implications of physician-patient interactions becomes more nuanced, physicians should integrate those lessons into practice. As early as the 1930s, epidemiological studies began to identify that the rates of medical procedures varied significantly along geographic and socioeconomic lines. Dr. J. Alison Glover recognized that tonsillectomy rates in school children in certain school districts in England and Wales were in some cases eight times the rates of children in other districts, with the only significant predictive factors being the current chief medical officer in the area and the socioeconomic well-being of the child's parents. Unfortunately, Dr. Glover's work revealed that the increase in tonsillectomies did not improve the health of adolescent patients and appeared to be performed “as a routine prophylactic ritual for no particular reason and with no particular result.”

As we look to the future in a world with porous borders and boundaries transgressed by technologies, an inevitable question is:Can there be a single, global bioethics? Intimately intertwined with this question is a second one: How might a global bioethics account for profound - and constantly transforming - sources of cultural difference? Can a uniform, global bioethics be relevant cross-culturally? These are not simple questions, rather, a multi-dimensional answer is required. It is important to distinguish between two meanings of bioethics: the academic discipline of bioethics as opposed to bioethics as a set of (increasingly globalized) practices governing clinical care and scientific research. There is growing evidence to support the notion of a shared global understanding of bioethics as a field of inquiry focused on the moral dimensions of science and biomedicine.

A physician-investigator conducting brain imaging research to study the pathophysiology of depression detects a suspicious finding in a healthy volunteer that suggests a possible brain tumor. Must the investigator disclose this finding to the research subject? Further, is there a duty to ensure that brain scans performed to answer research questions are evaluated clinically to identify potential health problems? If so, what in the nature of the investigator-subject relationship gives rise to such an obligation?

Investigators and Institutional Review Boards (IRBs) commonly struggle with the question of how to address incidental findings — that is, “a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study.” A working group convened by the National Institutes of Health has recommended that brain imaging research studies should establish protocols for handling incidental findings. However, there is little ethical guidance available to steer such efforts, and practices appear to vary widely. Although several articles have catalogued the ethical dilemmas surrounding incidental findings, with the exception of seminal work by Henry Richardson and Leah Belsky on the more general topic of researchers’ obligations to provide ancillary clinical care to research subjects, systematic ethical analysis of the incidental findings problem is lacking.

For decades, worries about undue inducement have Pervaded clinical research, and are especially common when research is accompanied by payment or conducted in developing countries. Few ethical judgments carry as much moral opprobrium or are thought to undermine the ethical soundness of a clinical trial as thoroughly as undue inducement. Indeed, the admonition to prevent undue inducement is one of the few explicit instructions in the Common Rules requirements for informed consent.

Despite their long history and pervasiveness, charges of undue inducement in clinical research are almost always mistaken. Indeed, I will advance an even more radical claim: Aresearch trial that otherwise fulfills the fundamental ethical requirements for human subjects research inherently cannot create the possibility of undue inducement because substantial risk of serious harm isprecluded. Charges of undue inducement tend to express displaced and mislabeled ethical concerns about other aspects of human subjects research. Consequently, claims of undue inducement should rarely be made, and when they are advanced should be treated with skepticism, placing a heavy burden of proofon those advancing such charges.

Since the Quinlan decision in 1976, courts and legislatures have made substantial progress in defining rules to govern nontreatment of dying and debilitated patients. For example, the right of the competent patient to refuse necessary care is now widely established, and the legality of withdrawing respirators and even nutrition and hydration from permanently unconscious patients is increasingly recognized.

More difficult questions arise, however, when the patient is neither competent nor permanently unconscious, but instead is in a conscious, severely demented and debilitated state, with experiences that appear quite limited. Thousands of patients in this condition are cared for in private homes, hospitals, and nursing homes, the victims of stroke, senility, Alzheimer's disease, and other illnesses. Even though they usually require only low-tech, minimally supportive care, such patients can impose great stress on their families and high financial costs on the health care system.

Criminal law is one of the regulatory tools being used in the United States to influence risk behavior by people who have HIV/AIDS. Several different types of laws have been or could be used in this way These include:

• HIV-specific exposure and transmission laws — i.e., laws that explicitly mention and exclusively apply to conduct by people with HIV;

• public health statutes prohibiting conduct that would expose others to communicable diseases and/or sexually transmitted diseases (STDs); and

• general criminal laws governing attempted murder and assault.

Technology has outpaced the capacity of researchers performing research on human participants to interpret all data generated and handle those data responsibly. This poses a critical challenge to existing rules governing human subjects research. The technologies used in research to generate images, scans, and data can now produce so much information that there is significant potential for incidental findings (IFs), findings generated in the course of research but beyond the aims of the study. Neuroimaging scans may visualize the entire brain and even the entire head; computed tomography (CT) colonography research may visualize the entire torso, from the base of the lungs to the pubis; genetics studies may reveal “extra” and sometimes unwanted information about the family, such as misattributed paternity and undisclosed adoption; and genomic microarray research increasingly involves whole-genome analysis (WGA) revealing an individual’s complete genotype, with enormous potential for uncovering unexpected information about an individual’s genetics and risks of developing future conditions.

Public health ethics in the future will be distinguished from public health ethics in the past by this new subfield being labeled as such, acknowledged, and called upon for service. Ethical dilemmas have been present throughout the history of public health. The question of whether to force Henning Jacobson to be immunized in 1905 in accordance with the 1902 Massachusetts smallpox vaccination law was one of ethics as well as law. How Thomas Parran, Surgeon General in 1936, chose to respond to a raging syphilis epidemic in the United States in the early part of the 2W century raised considerable moral debate in determining the appropriate public health response for a government? More recently, questions have arisen concerning the appropriate reach of government in controlling HIV banning smoking, or promoting healthy lifestyles. Debates over government infringement, morality, and justice recur throughout the history of public health.

While the socio-ethical and legal issues surrounding clinical genetics have long been the subject of international interest, the thorny questions of genetic research and biobanking are more recent. Add to this the fact that national guidelines and laws usually precede international policymaking, and the delay in international approaches is understandable. In that regard, the United Nations Educational, Scientific and Cultural Organization’s 1997 Universal Declaration on the Human Genome and Human Rights is unique in its prospective guidance on genetic research. Also, it is in the very nature of international normative instruments to be general, except on specific issues considered to be in the interest of humanity, such as research into human reproductive cloning or access to AIDS drugs.

Concussion is a form of traumatic brain injury that has been defined as a “trauma-induced alteration in mental status that may or may not involve loss of consciousness.” Terms such as getting a “ding” or getting your “bell rung” are sometimes used as colloquialisms for concussion, but inappropriately downplay the seriousness of the injury. It is estimated that between 1.6 and 3.8 million concussions occur annually in the United States as a result of participation in sports or recreational activities. To date, there are no objective, biological markers for concussion; rather, the current diagnosis of concussion is dependent upon symptom reporting by the athlete. In the acute phase, concussions can result in a broad spectrum of symptoms that can be transient or last for days, weeks, or even months. Symptom prolongation is generally referred to as post-concussion syndrome.

The use of statistics in medical research has been compared to a religion: it has its high priests (statisticians), supplicants (journal editors and researchers), and orthodoxy (for example, p <.05 is significant). Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of placebo controls. The ethical and scientific controversies associated with placebo-controlled trials, never far below the surface, have once again seized public attention. Clearly, concern about these issues within the professional community runs deep and wide, as evidenced by the volume of response generated by Kenneth Rothman and Karin Michels's recent Critique. Criticisms of the use of placebo controls in clinical research are scattered through the literatureo; our objective is to present the case against placebos in a compendious form that takes account of scientific and statistical as well as normative issues.

Patient advocacy organizations (PAOs) provide patient- and caregiver-oriented education, advocacy, and support services. PAOs are formally organized nonprofit groups that (a) concern themselves with medical conditions or potential medical conditions and (b) have a mission and take actions that seek to help people affected by those medical conditions or to help their families. Examples of PAOs include the American Cancer Society, the National Alliance on Mental Illness, and the American Heart Association. These organizations advocate for, and provide services to, millions of people with physical and mental conditions — such as cancer, mental illness, diabetes, and cardiovascular disease — via their outreach, meetings, counseling, websites, and published materials. A PAO usually seeks to raise public awareness of a disease’s symptoms, risk factors, and treatment options and promotes research to cure or to prevent that disease.

The concept of brain death was recently described as being “at once well settled and persistently unresolved.” Every day, in the United States and around the world, physicians diagnose patients as brain dead, and then proceed to transplant organs from these patients into others in need. Yet as well settled as this practice has become, brain death continues to be the focus of controversy, with two journals in bioethics dedicating major sections to the topic within the last two years.

By way of background, the Uniform Determination of Death Act states that “[a]n individual who has sustained either: (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead. A determination of death must be made in accordance with accepted medical standards.” In other words, death can be defined by either cardiorespiratory or neurological criteria, with “brain death” representing the loss of all brain function. This standard, or closely related variants, has become the accepted approach throughout the United States and in many parts of the world.

The debate about how to manage individual research results and incidental findings in genetic and genomic research has focused primarily on what information, if any, to offer back to research participants. However, increasing controversy surrounds the question of whether researchers have any responsibility to offer a participant’s results (defined here to include both individual research results and incidental findings) to the participant’s relatives, including after the participant’s death. This question arises in multiple contexts, including when researchers discover a result with potentially important health implications for genetic relatives, when a participant’s relatives ask a researcher whether any research results about the participant have implications for their own health or reproductive planning, when a participant’s relative asks whether any of the participant’s results have implications for a child’s health, and when the participant is deceased and the participant’s relatives seek information about the participant’s genetic results in order to address their own health or reproductive concerns.

This paper presents first an account of informed consent as it is envisioned and ethically grounded in the Western world. Next there is a discussion of why the Western model is unsuitable in much of the remainder of the world where the concept of “person” differs substantially from that of Western societies. This is followed by some comments on the current controversy on whether ethical standards should be regarded as universally applicable or, rather, whether some degree of ethical and cultural relativism is to be regarded as legitimate. After providing preliminary responses to some questions posed by the Conference Programme Committee, the paper concludes with a proposal for a procedural approach to the resolution of problems with informed consent.

The accelerating adoption of electronic health record (EHR) systems will have profound impacts on clinical care. It will also have far-reaching implications for public health research and surveillance, which in turn could lead to changes in public policy, statutes, and regulations. The public health benefits of EHR use can be significant. However, researchers and analysts who rely on EHR data must proceed with caution and understand the potential limitations of EHRs.

Much has been written about the risk of EHR privacy breaches. This paper focuses on a different set of concerns, those relating to data quality. Unlike clinical trial data, EHR data is not recorded primarily to meet the needs of researchers. Because of clinicians’ workloads, poor user-interface design, and other factors, EHR data is surprisingly likely to be erroneous, miscoded, fragmented, and incomplete. Although EHRs eliminate the problem of cryptic handwriting, other kinds of errors are more common with EHRs than with paper records.

Defining “community” from a research perspective is difficult. Communities consist of environmental, social, and geographic components. In addition, race, ethnicity, socio-economic status (SES), and group memberships often play roles in community identity. Barry Wellman and Scot Wortley urge that to truly understand and influence a community, and most certainly to conduct research within communities, one must take into account the varied nature of relationships and networks and how they may work together synergistically to meet the needs of community members. Using the Social Ecological Model, with its delineation of multiple spheres of influence (individual-interpersonal-organizational-community-public policy), community-based research has attempted to reach this understanding. Although dramatic shifts have not yet been realized, many studies suggest improved health behaviors and healthy environments, which indicate a promising future for community intervention work. The discussion that follows reviews the theory and rationale for community-based interventions, the socialecological approach to understanding and studying obesity, and the progress and promise of community interventions.

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.