The growing practice of returning individual results to research participants has revealed a variety of interpretations of the multiple and sometimes conflicting duties that researchers may owe to participants. One particularly difficult question is the nature and extent of a researcher’s duty to facilitate a participant’s follow-up clinical care by placing research results in the participant’s medical record. The question is especially difficult in the context of genomic research. Some recent genomic research studies — enrolling patients as participants — boldly address the question with protocols dictating that researchers place research results directly into study participants’ existing medical records, without participant consent. Such privileging of researcher judgment over participant choice may be motivated by a desire to discharge a duty that researchers perceive themselves as owing to participants. However, the underlying ethical, professional, legal, and regulatory duties that would compel or justify this action have not been fully explored.

The question of legalizing physician-assisted suicide (PAS) has become a serious public debate. Growing interest in assisted suicide reflects a public increasingly fearful of the process of dying, particularly the prospect of dying a painful, protracted, or undignified death. PAS has been proposed as a compassionate response to unrelievable suffering, designed to give terminally or incurably ill individuals direct control over the timing, manner, and circumstances of their death. Although the American Medical Association remains firmly opposed to legalizing PAS, many physicians have begun to express support for the practice, and some have acknowledged that they have helped patients commit suicide despite the existing legal ban.

As support for PAS grows, it becomes increasingly likely that the practice will be legalized in at least some states in the not-too-distant future. In 1994, Oregon voters approved a referendum legalizing PAS for competent, terminally ill patients; a federal court injunction preventing the referendum from going into effect is currently on appeal, and it is widely expected that the injunction will be lifted.

In 1982, the President's Commission produced its report on human gene therapy. One of that report's recommendations was to expand the Recombinant DNA Advisory Committee (RAC) to the National Institutes of Health to include a subcommittee on human gene therapy. In 1984, the Human Gene Therapy Subcommittee was established, and in 1989 it produced a document—“Points to Consider for Protocols for the Transfer of Recombinant DNA into Human Subjects”—that stated the RAC's position on what sorts of protocols it would approve.

In assessing the impact of the President's Commission report, Alexander Capron wrote,

SARS and monkeypox have given the public health community a unique opportunity to examine the use of quarantine measures. Until recently, the word “quarantine”was not used in polite conversation, and evoked unsavory images. The recent SARS epidemic illustrated the important role of quarantine and isolation as a public health response to communicable disease.

As public health officials in Toronto began to take control of the SARS epidemic, a second wave of the disease (SARS II) emerged. In the first SARS epidemic, approximately 8,200 individuals were isolated. There were approximately 82 probable cases, 66 suspect cases, and 24 deaths. On May 22, 2003, SARS II emerged. In total, approximately 13,000 people were quarantined. SARS II saw the onset of difficult questions being asked about the control and spread of SARS.

The province of Ontario establishes the public health policies and legislative framework for the entire province.

Several methods have been reported for extracting sperm from a man after he dies or enters a persistent vegetative state (PVS). Although such sperm retrieval could be performed for nonprocreative purposes, such as research, in this paper I focus on cases involving procreative intent. Since 1980, more than ninety cases have occurred in which family members requested sperm retrieval from patients who died or were irreversibly unconscious, with the intent that a wife, girlfriend, or other woman would be inseminated. Recently, the first report of pregnancy and birth following postmortem sperm retrieval appeared in the media.

In these cases, death or PVS typically is caused by anoxic injuries, trauma, or rapidly progressing infections.

Access to human biospecimens is widely regarded as essential to the progress of medical research, and in particular, to the success of “personalized medicine.” Understanding the influence of genetic variation on human health and disease requires that researchers conduct genetic and other studies on thousands of human specimens. Over the past decade, human “biobanks” — vast collections of human biospecimens — have proliferated both in the United States and internationally. These biobanks are subject to a heterogeneous mix of standards that govern the collection and use of biospecimens.

Bioethics has no theory of process. We have labored to develop a widely shared set of substantive values, but have been slow to spell out exactly what processes our values command. Nor have we examined process itself, to gauge the impact of different procedures and debate what we should value in process itself.

The little work that has been done on process focuses almost exclusively on what action should be taken in one-to-one encounters. Thus, much has been said on the obligation of the physician to speak with the patient, share information, and seek consent. Indeed, it would have been difficult to advocate respect for patient autonomy at all, without at least requiring this minimal and individualistic sort of procedure. But the requirement of certain behaviors in individual encounters has not been set in any broader vision of institutional process.

In 1989 the Oregon Legislature voted not to wait any longer for national leaders to serve up a solution to the problem of the millions of Americans (450,000 in Oregon) who are uninsured for health care. Under the leadership of Senator John Kitzhaber, President of the Oregon Senate, the lawmakers put together a package of bills designed to bring every Oregonian the security of third party financing for needed health care. The Oregon Plan's key innovation is the idea that, from a societal perspective, some health services can be declared more important than others. From that central idea came the thought that the whole range of health services could be arrayed to reflect social priorities relevant to Medicaid budgeting and the design of new health insurance programs for “the uninsured.”

Institutional ethics committees (IECs) now exist at many health care facilities and are in the planning stages at others. Due in part to the recent origins of IECs and the continuing debate over their optimal composition, role, and status in health care institutions, legislatures and courts have yet to recognize or clarify their legal status. Neither reported cases nor statutes clearly explain whether the proceedings and records of IECs must be disclosed to prosecuting attorneys or to parties to civil lawsuits, whether such information can be introduced as evidence in a trial, or whether persons serving on IECs or those providing information to IECs may be held civilly or criminally liable for actions by the committees.

This article sets forth some basic principles relating to the composition and functions of IECs, then examines the questions of confidentiality of IEC proceedings and immunity for persons serving on or providing information to the committees. Several reasons against and in favor of confidentiality and immunity are stated.

Studies in several developing countries for treatmen to prevent HIV-transmission from mother to child generated considerable controversy in 1997. Critics of the studies argued that basic principles of research ethics were violated. According to the critics, researchers subjected women in developing countries to studies that would have been unethical in the United States (and other developed countries) and that the researchers were therefore engaged in unethical exploitation ofcitizens of the developing countries in which the studies were conducted.

While the critics agreed that unethical exploitation had occurred, they differed on the exact nature of the exploitation. Some observers condemned the researchers for employing a double standard — because the researchers were applying a standard of care that would have been unacceptable in their own country. In the view of these critics, researchers should have been comparing the experimental treatment to established therapy rather than to placebo, as would have been required in the United States or other developed countries.

Although Canada has not yet enacted any biobanking-specific privacy law, guidance and oversight are provided via various federal and provincial health and privacy-related laws as well as via ethics and policy documents. The primary policy document governing health research, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, provides the framework for the strong role of Research Ethics Boards in Canada, and limits research funding from Canada's three main federal funding agencies to those who agree to adhere to its policies. The broad consent model is gaining traction in Canada, although lack of legal and constitutional precedence for the broad consent or opt-out options makes this an evolving issue. In general, data is required to be coded; more specific security measures are outlined in guidelines that may be implemented by local policy. International sharing is allowed, and Canada meets the European Union's standards for receipt of data and samples.

This paper is one of the four interrelated action agenda papers resulting from the National Summit on Public Health Legal Preparedness (Summit) convened in June 2007 by the Centers for Disease Control and Prevention (CDC) and multi-disciplinary partners. Each of the action agenda papers deals with one of the four core elements of public health legal preparedness: laws and legal authorities; competency in using those laws; coordination of law-based public health actions; and information. Options presented in this paper are for consideration by policy makers and practitioners — in all jurisdictions and all relevant sectors and disciplines — with responsibilities for all-hazards emergency preparedness.

Advancing and protecting the public's health depends upon the coordination of actions by many, diverse partners. For effective public health preparedness, there must be effective coordination of legal tools and law-based strategies across local, state, tribal, and federal jurisdictions, and also across sectors such as public health, health care, emergency management, education, law enforcement, community design, and academia.

We say that celebrated accidents shape public perception of safety and risk in health care. Take the so-called celebrated story of the three Colorado nurses who, by administering bezathine penicillin intravenously, caused the death of a neonate. The nurses were charged with criminal negligence, with one pleading guilty to a reduced charge and another fighting the charge and eventually being exonerated. “Celebrated” accidents (i.e., celebrated in the media and, accordingly, popular imagination, amplified momentarily by the media as it may get ferried along from courtroom to courtroom) seem to follow a predictable script and cast participants in recognizable roles. They present heroes (e.g., a care provider who tried to save the patient despite the odds and errors of others), survivors, and victims. And, of course, they put villains, or anti-heroes, center stage – the chief protagonists of a fatal plot.

First-in-human (FIH) research has several characteristics that require special attention with respect to ethics and human subjects protections. At least some nanomedical technologies may also have characteristics that merit special attention in clinical research, as other papers in this symposium show. This paper considers how to address these characteristics in the consent form and process for FIH nanomedicine research, focusing principally on experimental nanotherapeutic interventions but also considering nanodiagnostic interventions.

It is essential, as a starting point, to recognize that the consent form and process are by no means the primary protectors of human subjects (although they are sometimes so regarded). Instead, consideration of the form and content of informed consent becomes relevant only after a clinical trial has been reviewed and deemed scientifically and ethically acceptable.

Two convergent types of challenges to informed consent are posed by nanomedicine FIH research. First, some issues appear generally applicable to FIH research, but have specific nanomedicine implications.

Over-enthusiastic newborn screening has often caused substantial harm and has been imposed on the public without adequate information on benefits and risks and without parental consent. This problem will become worse when genomic screening is implemented. For the past 40 years, there has been broad agreement about the criteria for ethically responsible screening, but the criteria have been systematically ignored by policy makers and practitioners. Claims of high benefit and low risk are common, but they require precise definition and documentation, which has often not occurred, undermining claims that involuntary testing is justified. Even when the benefits and risks are well established, it does not automatically follow that involuntary testing is justified, a position supported by the widespread tolerance for parental refusal of immunizations and newborn screening.

Public health emergencies have occurred throughout history, encompassing such events as plagues and famines arising from natural causes, disease pandemics interrelated with wars (such as the influenza pandemic of 1918-1919), and industrial accidents such as the 1986 Chernobyl disaster, among others. Law and legal tools have played an important role in addressing such emergencies. Three prime U.S. examples are Congressional authorization of quarantine as early as 1796, legally mandated smallpox vaccination upheld in a landmark 1905 U.S. Supreme Court ruling, and the President's 2003 executive order adding SARS to the federal government's list of “quarantinable communicable diseases.”

The public health emergencies of the present — both actual and potential — pose equally serious threats but do so in the context of greatly magnified expectations that stem directly from the attacks of September 11, 2001, and the immediately following anthrax attacks.