Debate over the proper use of racial and ethnic categories in biomedical research has raged in recent years. With the Human Genome Project showing that human beings are overwhelmingly alike genetically, exhibiting more genetic variation within supposed “races” than between them, many have come to doubt the scientific utility of such categories. Yet federal authorities use Directive 15 from the Office of Management and Budget (OMB) to mandate the continued use of such categories in research. Moreover, researchers studying health disparities argue that data collection using racial and ethnic categories is necessary to determine whether conditions and care vary by race and ethnicity. Epidemiologists also defend the use of racial and ethnic categories to understand contributors to disease such as the stress of experiencing racial prejudice and reduced access to care because of bias.

Perhaps it has always been so, but certainly in the post-Enlightenment era there are inevitable linkages between the fields of law, medicine, and science. Each of these realms of activity is embedded in the social milieu of the era, with practitioners emerging from families, communities, regions, and nations bearing deep unexamined assumptions about what is natural and normal. Equally important, these fields’ theoretical accounts of natural behavior will tend to dovetail and fit each other's – most especially as they pertain to the grand social issues of the period.

For the last century and a half, a conversation with a cross-section of lawyers, scientists, and physicians at any given historical juncture would produce a remarkable pattern, consistently repeated: There would be strong enthusiasm for the idea that the “current state of knowledge and practice” is both objective and transcends the current social milieu.

There are deep divides over the use of racial and ethnic categories in biomedical research and its application in both medical and non-medical contexts. On one side of a roughly described dividing line are practitioners who need to use every piece of information at their disposal to solve pressing, realworld problems in real time, such as making clinical diagnoses or identifying perpetrators of crime. On the other side are scientists and policy makers committed to meeting a scientific and social need for accuracy and thus trying to avoid miscategorization.

As Jay Cohn describes in this issue, medical practitioners in particular have used racial and ethnic categories to “enhance diagnostic and therapeutic precision.” He argues for retaining this practice. The plea, motivated by genuine concern for patients, is to avoid “throwing the baby out with the bathwater.” However, Cohn and others mischaracterize the nature of the debate. The argument is not about whether differences among populations exist, or even whether differences among “races” exist.

Race and ethnicity are closely related, contentious concepts that have been abused and misinterpreted through history, but have a vast potential for good, at least in the health sciences. This article is not intending to elaborate on the conceptual foundations of race and ethnicity; I have addressed that elsewhere and summarized my stance in the glossary reprinted below in the Appendix. The terminology used here follows the glossary. Assuming that the conceptual foundations of my stance are reasonable, the questions addressed here focus on public health and its primary health science, epidemiology, in a European context. The questions are simple ones:

1. 1. In epidemiology and public health what are we trying to achieve when we use the concepts of race and ethnicity?

2. 2. What would we lose by rejecting these concepts?

3. 3. If we do not reject them, how do we put the concepts into operation to help achieve our goals?

4. 4. What practical actions can result from the application of these concepts in order to improve the health and well-being of populations?

Most discussions of the use of race and ethnicity in biomedical research and clinical care focus on broad national and transnational populations. Looking at the problem from the perspective of large populations, however, misses the rest of a continuum that runs from the global human population to local communities. If race and ethnicity are fundamental categories for biomedical analyses, they should be informative at all points along that continuum, much as the definition of a gene remains unchanged whether analyzed in the context of an individual, a group, or the total human population. By examining the utility of racial and ethnic categories at a local community level, we can better evaluate whether those categories are indeed fundamental units for analysis. Alternatively, these categories may be analytic proxies useful primarily for approximating aggregate biological and social features of large populations at national and transnational levels of analysis.

The issue of how race and genetics should interrelate goes to the heart of an unfinished discussion about race and racism in both the United States and around the world. The category of race is still powerful and dangerous, especially in scientific work. Addressing this issue is all the more important given the fact that race is still frequently essentialized and treated as biologically real. This tendency continues even as social and natural scientists such as Troy Duster and Charles Mills largely agree that race is a social construction. Mills sees this racial construction as deeply rooted in the legal and constitutional orders of American society. Race is a modern category invented by white male scientists in the “era of modernity” and instantiated globally in the consciousness, social practices, and institutional interstices of Western European cultures, among countless others worldwide. Indeed, the pseudoscience of the period was highly informed by tales of difference brought back by explorers.

Race and ethnicity are commonly reported variables in biomedical research, but how they were initially determined is often not described and the rationale for analyzing them is often not provided. JAMA improved the reporting of these factors by implementing a policy and procedure for doing so. However, still lacking are careful consideration of what is actually being measured when race/ethnicity is described, consistent terminology, hypothesis-driven justification for analyzing race/ethnicity, and a consistent and generalizable measurement of socioeconomic status. Furthermore, some studies continue to use race/ethnicity as a proxy for genetics. Research into appropriate measures of race/ethnicity and socioeconomic factors, as well as education of researchers regarding issues of race/ethnicity, is necessary to clarify the meaning of race/ethnicity in the biomedical literature.

The scientific validity of racial categories has been the subject of debate among population geneticists, evolutionary biologists, and physical anthropologists for several decades. After World War II, the rejection of eugenics, which had supported sterilization laws and other destructive programs in the United States, generated a compelling critique of the biological basis of race. The classification of human beings into distinct biological “races” is a relatively recent invention propped up by deeply flawed evidence and historically providing the foundation of racist ideology and inequities of power. Social scientists’ conclusion that race is socially constructed was confirmed by genomic studies of human variation, including the Human Genome Project, showing high levels of genetic similarity within the human species. Some scholars came to believe that the science of human genetic diversity would replace race as the preeminent means of grouping people for scientific purposes.

We have previously addressed the use of race in health care generally. Subsequent developments have made the issue even more pointed. Given the recent Food and Drug Administration (FDA) approval of BiDil as a result of a clinical trial limited to participants identifying themselves as African-American, this Symposium could not be more timely as an effort to further advance the dialogue on the issue of race in medical research. While this dialogue has informed our own analysis, we believe our distinctive contribution concerns the extent to which the law does and should constrain such use of race. Even in legal academic circles – somewhat notorious for considering problems of little practical significance – the issue has been given little thought. This piece, therefore, attempts to analyze extant legal regimes against the backdrop of medical and scientific developments.

The practice of using race or ethnic origin as a distinguishing feature of populations or individuals seeking health care is a universal and well-accepted custom in medicine. Although the origin of this practice may, in part, reflect past prejudicial attitudes, its use today can certainly be defended as a useful means of improving diagnostic and therapeutic efforts. Indeed, the tradition of dividing populations by some racial distinction in clinical research has nearly always revealed differences in mechanisms of disease and disease frequency that can enhance diagnostic and therapeutic precision.

At the conference occasioning this symposium, Professors Duster and Rotimi provided persuasive evidence that so-called race is not an accurate way to distinguish populations and that identification by race has led to serious prejudice. Professor Cho pleaded that race should never be used to characterize population differences.

Taking notice of race is both risky and inevitable, in medicine no less than in other endeavors. The literature on race as a classifying tool in clinical research poses this core dilemma: On the one hand, race can be a useful stand-in for unstudied genetic and environmental factors that yield differences in disease expression and therapeutic response. On the other hand, racial distinctions have social meanings that are often pejorative or worse, especially when these distinctions are cast as culturally or biologically fixed. Our country's troubled past in this regard and the persistence of race-related disadvantage should keep us on notice about this hazard. Yet paying attention to race in order to ameliorate past wrongs sometimes supports the quest for social justice, as Dorothy Roberts points out in this issue. And at times, as Jay Cohn and Raj Bhopal note, attention to race can make a therapeutic difference, to the point of saving lives.

In 1982, cinemas around the world screened Sophie's Choice, a film starring Meryl Streep and Kevin Kline, adapted from the book by William Styron. The film opens with Stingo, a young journalist from the South, who arrives in New York in 1947 and rents a room in Brooklyn. Stingo is drawn into a relationship with Sophie and Nathan, the couple who live upstairs. Sophie is a Polish concentration camp survivor; Nathan is the man who saved her when she arrived in America. Nathan is charismatic, schizophrenic, and violent.

In one of the film's flashbacks, a German soldier imposes a terrible choice on Sophie, a young mother who arrives at Auschwitz with other prisoners from Krakow. Sophie is ordered to choose which of her two children will be sent to the ovens, and which will live.

Although knowledge of torture and physical and psychological abuse was widespread at both the Guantanamo Bay detention facility and Abu Ghraib prison in Iraq, and known to medical personnel, there was no official report before the January 2004 Army investigation of military health personnel reporting abuse, degradation, or signs of torture. Mounting information from many sources, including Pentagon documents, the International Committee of the Red Cross (ICRC), Amnesty International, Human Rights Watch, etc., indicate that medical personnel failed to maintain medical records, conduct routine medical examinations, provide proper care of disabled and injured detainees, accurately report illnesses and injuries, and falsified medical records and death certificates. Medical personnel and medical information was also used to design and implement psychologically and physically coercive interrogations. The United States military medical system failed to protect detainee's human rights, violated the basic principles of medical ethics and ignored the basic tenets of medical professionalism.

Investigator and institutional financial conflicts of interest have raised concerns about both the integrity of clinical research and protecting the rights and welfare of research participants. In response, professional groups and governmental bodies have issued guidance for managing conflicts of interest to minimize their potential untoward effects. Although a variety of approaches have been offered, a common protection is to disclose financial interests in research to potential research participants as part of the recruitment and informed consent process. This approach reinforces a basic norm of candor, ideally allowing potential research participants to evaluate whether financial interests should affect their decision to participate in research. Disclosure to potential research participants is viewed as an alternative to having regulators or research institutions limit or prohibit all financial interests in research, assuming that not all such interests are unacceptable.

Concerns about the influence of financial interests on research have increased, along with research dollars from pharmaceutical and other for-profit companies. Researchers’ financial ties to industry sponsors of research have also increased. Financial interests in biomedical research could influence research design, conduct, or reporting, and could compromise data integrity, participant safety, or both. Investigators’ financial ties with for-profit companies may influence reported scientific results, and may have compromised research participant safety.

Disclosure is one commonly accepted method of managing financial relationships in order to minimize possible threats to scientific objectivity, the safety of research participants, or public trust in the integrity of clinical research. Disclosure is presumed useful to the extent that “it gives those who would be affected, or who are otherwise in a good position to assess the risks, information they need to make their own decision.”

In the past few years, medical practices surrounding the decision to resuscitate marginally viable newborns have received a fair amount of attention. Baroness Warnock, of the UK Nuffield Council on Bioethics, has recently suggested that Britain follow the recommended practice in Holland of setting a gestational age limit below which marginally viable newborns should not be routinely resuscitated, despite reported statistical probabilities of raw survival approaching twenty percent. In the US, a highly publicized case from Texas came to a controversial legal conclusion, permitting physicians to disregard parental preference for palliative care and unilaterally initiate resuscitation when faced with the birth of an extremely premature baby.

Nearly 2.5 million Americans currently reside in nursing homes and assisted living facilities in the United States, accounting for approximately five percent of persons sixty-five and older. The aging of the “Baby Boomer” generation is expected to lead to an exponential growth in the need for some form of long-term care (LTC) for this segment of the population within the next twenty-five years. In light of these sobering demographic shifts, there is an urgency to address the profound concerns that exist about the quality-of-care (QoC) and quality-of-life (QoL) of this frailest segment of our population.

The flu has an interesting history with respect to health care rationing in the United States. Consider that just about two years ago, the American public faced a shortage of influenza vaccine. Dire predictions were made about how many people might perish, and rationing protocols were created. However, many of the rationing protocols were ignored. Luckily, that flu season did not result in the horrible fatalities that were predicted. For these reasons, problems of health care rationing around issues of the flu were postponed, rather than resolved.

Over the last year, the public has focused its anxious attention on the possible avian influenza pandemic. Last week I noticed that at least once each day I heard mention in some discussion or another of the threat of this disease becoming easily transmissible from human to human.

What happens when being a good doctor requires being a bad citizen? What should a doctor do when living up to the requirements of a professional code of ethics or staying true to deeply held personal values requires breaking the law? What should a health care professional do when the appropriate conduct in a particular case is inconsistent with a more generalized principle that has been incorporated into law? Further, what is the role of the ethical health lawyer who advises a health care provider facing such a dilemma?

As health care lawyers advising individuals and institutions, is it our job to advise our clients of all the options available to them, and all the potential legal consequences, or is our role simply to keep our clients acting within the law? Are we information providers, policy counselors, risk managers, or some combination of these?