For at least the past three decades, injuries have been recognized as an important public health problem in the United States. In 2001, there were approximately 157,000 deaths due to injuries in the US. There were also almost 30 million non-fatal injury incidents.

Injuries have been defined as: “…any unintentional or intentional damage to the body resulting from acute exposure to thermal, mechanical, electrical, or chemical energy or from the absence of such essentials as heat or oxygen”. Within public health, the field of injury prevention and control is dedicated to reducing the burden of injuries on the lives of people around the world.

Injury prevention seeks to reduce injuries by: 1) identifying risk factors, 2) designing interventions to address the risk factors, 3) implementing those interventions, 4) evaluating their effectiveness, and 5) replicating those that work. As with many other public health problems, interventions can target factors associated with the human or host, vehicle or vector, and the physical or social environment.

In recent years, a number of prominent scholars have touted the use of litigation as an effective tool for making public health policy. For example, Stephen Teret and Michael Jacobs have asserted that product liability claims against car makers have played a significant role in reducing automobile-related injuries, Peter Jacobson and Kenneth Warner have argued that litigation against cigarette manufacturers has advanced the cause of tobacco control, and Phil Cook and Jens Ludwig have suggested that lawsuits against the firearms industry can reduce gun violence. Critics have attacked this use of litigation as doing more harm than good to public health and as a misuse of the courts. This debate involves two distinct controversies: one over whether the public health benefits of litigation outweigh its costs and the other over the proper role of courts within our system of government.

Severe Acute Respiratory Syndrome (SARS) garnered a great deal of public attention because it was novel and its potential for spread was unknown. However, the SARS corona virus is significantly less virulent than pandemic influenza viral infections.

Interest in the ethics of research on human subjects, stimulated by atrocious human experimentation during WWII and the resultant Nuremberg Code, has been sustained by examples of unethical research in many countries and by proliferation of codes and guidelines. Such interest has intensified in recent years in association with expanding international collaborative research endeavors. The ongoing controversy in international research ethics takes place at two levels. At the practical level it is about the competing concerns of those predominantly interested in doing research to advance knowledge and those who, while supporting the need for research, are more acutely aware of the potential to exploit vulnerable participants, especially in developing countries. At the level of theory the controversy pits ethical universalism against moral relativism.

In her recent review of agreements and controversies in international research ethics, Ruth Macklin has concluded that, despite seeming agreement on several issues, many different viewpoints persist. In her view it is unlikely that these will be resolved easily.

Amongst Professor Dickens’ extensive writings on medical law and medical jurisprudence are a host of distinguished contributions on the subject of the proper legal and ethical limits on human experimentation. As early as 1975, Professor Dickens was examining the legal aspects of human experimentation. A few years later he was promoting the responsibility of researchers to recognize and protect human rights in medical experimentation. In the last two decades, Professor Dickens has penned a rich flow of scholarly contributions on the legal and ethical rights and duties in medical experimentation and the need to do better as a research community. His articles have considered a broad range of issues in medical experimentation including the imperative of voluntary consent, the ethical unacceptability of co-ercion or inducement of research participants, embryonic research, epidemiological research and the protection of vulnerable research participants, particularly children.

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.

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.“

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.

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.

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.

In his compelling novel Blindness, José Saramago tells us about victims stricken by a contagious form of blindness who were quarantined and came to see themselves as pigs, dogs, and “lame crabs.” Of course, they were all human beings - although unable to perceive themselves, or others, as members of the human community. The disciplines of bioethics, health law, and human rights are likewise all members of the broad human rights community, although at times none of them may be able to see the homologies, even when responding to a specific health challenge.

The boundaries between bioethics, health law, and human rights are permeable, and border crossings, including crossings by blind practitioners, are common. Two working hypotheses form the intellectual framework of this article: we can more effectively address the major health issues of our day if we harmonize all three disciplines; and American bioethics can be reborn as a global force by accepting its Nuremberg roots and actively engaging in a health and human rights agenda.

Modern bioethics, which is based on Western moral philosophy and Western biomedical perspectives, has evolved within a complex, highly individualistic culture that draws a sharp distinction between church and state and tolerates a multitude of values. This discipline defines its principles in secular and objective terms that often are bewildering to people of non-Western origin. Despite much discourse, principlism remains the fundamental framework of bioethics. Principlism is held in such high regard that many bioethicists equate autonomy with personhood, as if autonomy exists independently of specific beliefs and commitments.

In addition, we continue to minimize the substantial differences in the way people of different cultures perceive, experience, and explain illness, although our views of the potential cultural limitations of Western medicine have grown and expanded in recent years. At the heart of it we continue to be tied to a biomedical focus that largely neglects the context of the situation.

Protecting the privacy of individually-identifiable health data is a dominant health policy objective in the new millennium. Technological, economic, and health-related reasons substantiate the development of a national electronic health information infrastructure. Through this emerging infrastructure, billions of pieces of health data of varying sensitivities are exchanged annually to provide health care services and service transactions, conduct health research, and promote the public’s health. These multi-purpose, rapid exchanges of electronic health data, far removed from the typical disclosure of health information through the doctor/patient relationship of yesteryear, contribute to heightened individual concerns about identifiable health data. Responding to American fears and perceptions of actual and potential privacy abuses, policymakers have recently developed new, modern privacy protections through legislative and regulatory laws, as well as ethical and industry codes.

Modern health information privacy protections are reflected in federal regulations developed by the federal Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

The contributions of Professor Bernard Dickens to health law and bioethics span the era in which these fields have emerged as distinct domains of teaching, scholarship and professional and public conversation. Neither field exists in a vacuum. The concerns of bioethics, like the content of health law, are a product of social forces. The bureaucratization of medical care, the possibilities and uncertainties created by developments in medical technology, not to mention glaring health inequalities, have been destabilizing forces in medicine. Writing in 1974, American sociologist Renée Fox noted that medicine had reached “a stage of development characterized by diffuse ethical and existential self-consciousness.” This new medical introspection was evidenced by intense engagement with issues of biomedical regulation, and with the growth of professional codes and processes for resolving value-laden issues within clinical settings.

While sometimes described as a process or site for discussion and “engagement,” bioethics evolved rapidly into a domain of governance, with direct implications for clinical practice.

The international context of the last fifty years of modern bioethics have been significant in establishing health-care ethics or bioethics as a common parlance - an ideology of our times, achieving near universal acceptance, with little dissent. Most international health organizations have developed important declarations that have become the credo of their daily practice and long-term commitments. However, in the last decade in particular, bioethicists and other health-care practitioners and scholars have worried about the persistence of health-care inequities and the inadequate realization of bioethics, particularly in low-to-middle income countries. Global bioethics, now well into the new millennium, has entered a regulatory crisis: it needs to confront not just global bioethical commitments around major scientific revolutions such as genomics, but further, a regulatory crisis about the persisting national public law silences and health inequities, especially in low-to-middle income countries.

It is commonly said that patients (or their representatives) have no right to demand that treatment must be continued when medical carers believe it is “futile” to continue it. There are certainly many judicial statements to this effect, some of which are quoted in this paper. However, there are various ways that courts can intervene, even if they do not order directly that treatment must be provided or continued. First, patients or their representatives may argue the process of decision making was unfair or that they were unfairly discriminated against when treatment has been refused. To date, these arguments have met with limited success so far as enabling patients to have treatment provided or continued against medical advice. More recently, however, some patients have challenged the lawfulness of a proposed treatment regime by advancing human rights arguments, based in turn on a broader aspect of patients’ “best interests” than best medical interests.

The World Conference on Human Rights (the Vienna Conference) that was held in Vienna in 1993, marked an important beginning in the recognition of reproductive and sexual rights as human rights. Among other goals, the Vienna Conference sought to end gender discrimination in all its manifestations; gender-based violence, sexual harassment, and sexual exploitation. However, the turning point for the development of reproductive and sexual rights was the consensus that emanated from the International Conference on Population and Development held in Cairo in 1994 (the Cairo Conference), and the Fourth World Conference on Women in held in Beijing 1995 (the Beijing Conference) as evidenced by the programs for action that were adopted.

The Cairo Conference defined reproductive health as “a state of complete physical, mental and social well-being and not merely the absence of infirmity, in all matters relating to the reproductive system and to its functions and processes.”