I propose in this essay to briefly describe some of the main current stakeholders who issue guidance on the ethics of human subjects research. This will be preceded by a very brief historical introduction.

Prior to World War II, as far as I have been able to ascertain, there were no international efforts to regulate human experimentation. National activities were few and far between. One exception was a Directive on Human Experimentation issued in December 1900 by the then Prussian Minister of Religious, Educational and Medical Mairs. This was followed by a Circular on innovative therapy and scientific experimentation promulgated by the then Reich Minister of the Interior in February 1931. Just over five years later, in April 1936, the Bureau of the Medico-Scientific Council of the People’s Commissariat for Health of the Russian Socialist Federated Soviet Republic (RSFSR), the main constituent Republic of the then Union of Soviet Socialist Republics, issued an Advisory Resolution on the procedures for testing new medicinal substances and methods which may present a hazard for the health and life of patients.

Violence is an extremely prevalent problem in the United States and throughout the world, and it is a major contributing factor to increased mortality and mortalityty. These facts are well documented in the recent Report on violence and Health published by the World Health Organization. This report, which is likely to become a landmark document in the public health community, defines violence broadly as: The intentional use of physical force or power, threatened or actual, against oneself, another person, or against a group or community, that either results in or has a high likelihood of resulting in injury, death, psychological harm, maldevelopment or deprivation. This World Health Organization definition encompasses three types of violence: 1) suicide and selfharm, 2) collective violence, and 3) interpersonal violence.

Interpersonal violence is defined asviolence inflicted by an individual or small group of individuals and includes youth violence, violence between intimate partners, other forms of family violence such as abuse of children and the elderly, rape and sexual assault by strangers, and violence in institutional settings such as schools, workplaces, nursing homes and prisons.

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.

Even Americans who have only a vague knowledge of health policy know that the U.S. is different. We do not have “socialized medicine,” like our European or Canadian neighbors. We believe that health care is not rationed here, and that, unlike citizens of other nations, we do not have to wait in long queues when we need medical care. We believe that U.S. health care is the best in the world.

At the same time, the U.S. spends more on health care - both per capita and as percentage of gross domestic product (GDP) - than other nations do. One in six non-elderly Americans has no health insurance, and voluminous studies show that lack of health insurance has a dramatic effect on both access to care and on health status. Furthermore, on many of the most important indicators of population health, such as infant mortality and life expectancy, the U.S. scores worse than do other nations.

A medical profession which did not seek improved means to conquer disease would be condemned for dereliction of its duty, Members of the public will not accept the current state of the medical arts as finite but feel justified in expecting the development of more effective therapies for illness, and the promotion of improved means of preventive care.

With this assertion, the distinguished academic, Bernard Dickens, places research firmly in the domain of the public interest. Foster agrees, saying that, “[t]o improve medical care as much as we can, if not to perfect it, means that we have to accept the need for research.” Giesen adds a further emphasis to the search for medical advancements, saying that “freedom of research and scientific inquiry is, in itself, an important aspect of open societies.“

As indicated in the title, the focus of this essay is on where we should go from here and not the how, which is addressed by other authors in this issue. I am assuming that there is probably a general consensus as to where we should be heading with health care reform, but there may well be some strong differences as to how this can or should be attained.

In the summer of 1966, a year after the enactment of “Medicare,” I listened to Harry Becker, then the Executive Director of the New York Academy of Medicine, discuss the significance of the new health legislation and further changes that were likely in the near future. His analysis was that, after numerous attempts over many years, the United States was finally on the verge of implementing universal health insurance for all Americans. The next step would be health insurance for children, “Kiddicare.”

Over the last two decades in the United States, public health practitioners, policy makers, and researchers have charted new tenitory by increasingly using public health strategies to understand and prevent youth violence, which has been considered a criminal justice problem. The utilization of public health approaches has generated several contributions to the understanding and prevention of violence, including new and expanded knowledge in surveillance, delineation of risk factors, and prop design, including implementation and evaluation strategies.

While public health activities generally complement those of criminal justice, confrontations, challenges and turf issues within this cross-disciplinary enterprise remain inevitable. Continued progress is dependent upon expanded efforts and greater collaboration within both disciplines.

Over the last decade, more U.S. taxpayers money has been spent trying to anticipate and address the bioethical issues raised by advances in human genetics than any other set of issues in the field. Does this make sense? Not everyone in bioethics thinks so. Some think there are more important topics, like issues of health care justice, that will be neglected if the field continues to follow the money to dwell on the moral challenges of a relatively small community of research scientists. Others decry genetic exceptionalism as inappropriately singling out this scientific enterprise for criticism and regulation, when the same issues are faced even more acutely in other parts of the biomedical world. Human genetics is not accelerating as fast as pharmacology, for example, or as easy to abuse as virology, or as philosophically challenging as neurology.

Health reform proposals tend to be rich with details and dimensions. The primary goal of health reform is typically to extend health coverage to people who lack it. Yet even the most similar of plans differ in terms of exactly who is targeted for assistance, the means by which assistance is delivered, and the type of health coverage promoted. Moreover, the Byzantine nature of the existing U.S. health system means that any reform plan can appear complex. The plan that aims for a new, simple health system will require radical changes to achieve it, while the plan that strives to be the least disruptive will have extensive rules that target assistance while maintaining the existing sources of coverage. Indeed, some have argued that the complexity inherent in meaningful reform is an impediment to reform itself.

When the South Carolina Supreme Court upheld the conviction and twelve-year sentence of Regina McKnight, it affirmed that state 's commitment to bring the full force of the law to the punishment of pregnant women who use drugs. Prosecutors linked the delivery of Ms.McKnight 's stillborn baby to her use of cocaine, and argued successfully for a finding of homicide by child abuse. The McKnight judgment follows the South Carolina Supreme Court decision in the case of Cornelia Whitner. Whitner was sentenced to prison for illegal drug use during pregnancy on the grounds that the viable fetus is a child under the state s criminal child endangerment statute.

On the basis of constitutional concerns such as due process and privacy, worries that criminal prosecutions may thwart public policy goals such as keeping families together and promoting the health of women and children, and findings that legislatures did not intend to include the fetus in the scope of drug laws or child abuse and neglect laws, criminal prosecution has been resisted in most jurisdictions.

If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken.

Background

In the past two decades, the involvement of non-academic sponsors of biomedical research, particularly clinical trial research, has increased exponentially. The value of such sponsored research is difficult to ascertain. However, it is estimated that, between 1980 and 2003, overall research and development expenditures by US pharmaceutical companies increased from $2 billion to $33 billion and that, in 2001, clinical trial research expenditures in Canada totaled $800 million to $1 billion.

The source of funding for biomedical research has shifted significantly from predominantly government and private foundations to industry. By 2002,70% of funding for clinical trials came from industry. These factors have affected the conduct of research, particularly clinical trial research, in a variety of ways.

Bioethics is clearly a field in transition, if not confusion. Bioethics began as a scholarly, reflective, academic enterprise. Increasingly, however, some in bioethics are not as interested in producing scholarship as they are in practicing bioethics by providing services to institutions and clients.

Bioethics also began as an interdisciplinary line of inquiry, with its major contributors all trained in some established discipline. We were and for the most part still are a field composed of theologians, philosophers, lawyers, physicians, nurses, and social scientists who work in bioethics. Today, however, some young people actually aspire to be bioethicists. Increasingly, they have the option of being trained directly in bioethics, without any other disciplinary background.

We are not the first field to find itself engaged in these kinds of transitions. In this short piece, I consider very briefly how two fields--health psychology and epidemiology- have approached similar branch points.

Human reproductive cloning has become the most palpable example of the globalization of science. Throughout the world, events and conjectures in the media, such as the birth and death in the United Kingdom of the cloned sheep Dolly and projects to clone human beings by Korean scientists, by members of the Canadian-based Raelian cult, and by the Italian physician Antinori in an undisclosed country, have galvanized the political will of individual countries to ban human reproductive cloning.

Yet, international attempts to harmonize policies in the area of biomedical ethics and human research, such as the 1997 Council of Europe’s Convention on Human Rights and Biomedicine, and most recently, the United Nations’ efforts to adopt an international convention against human reproductive cloning, have been insufficient to trigger a substantial global policy design process on issues relating to these new technologies.

Health care reform is an important issue in the 2004 presidential elections and is receiving serious attention from the Democratic and Republican candidates. Changes in the economy that fuelled increased productivity and depressed job growth have also shifted more of the costs of medical care and insurance onto employees. The rising costs of insurance premiums and health care are far outpacing the general inflation rate and workers’ wages. Meanwhile, state governments reacted to widening budget deficits from 2001 to 2003 by reducing Medicaid eligibility and benefits. These changes in employer-based health insurance and government policy have contributed to the largest rise in the share of Americans without health insurance in a decade. In 2002, the uninsured numbered 43.6 million and, according to the Congressional Budget Office, 57 to 59 million non-elderly people are uninsured at some point over the course of a year.

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.

The relationship between sociology and bioethics has been an uneasy one. It has been described as contentious and adversarial, and at least some of the sociologists who have ventured into the territory of medical ethics report back on unfriendly natives. This bioethical ill will toward sociology is not without cause. Sociologists have been quite critical of what they call (with not-so-subtle pejorative overtones) the bioethical project.

Two decades ago - when bioethics was just getting up on its organizational feet - Renée Fox and Judith Swazey leveled the charge of cultural myopia against bioethics, noting that this myopia generally manifests itself in the form of systematic inattention to the social and cultural sources and implications of its own thought. They go on to say ifbioethics is an indicator of the general state of American ideas, values, and beliefs, of our collective self knowledge, and our understanding of other societies and cultures - then there is every reason to be worried about who we are, what we have become, and where we are going