Minorities as Research Subjects

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MINORITIES AS RESEARCH SUBJECTS

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In 1984 Margaret Heckler, secretary of the U.S. Department of Health and Human Services (HHS), established the Task Force on Black and Minority Health to investigate the health status and health needs of minority groups in the nation. A year later, that panel presented its report, noting the lack of data about many aspects of minority health and the need for greater inclusion of minorities (defined as blacks, Hispanics, Asian/Pacific Islanders, and Native Americans) in medical research projects (U.S. Department of Health and Human Services, 1985). In response, the National Institutes of Health (NIH), the largest financial supporter of medical research in the United States, began to urge that grant applicants include African-Americans and other minorities as research subjects in their projects. Applicants not incorporating minorities in proposed studies were expected to provide "a clear rationale for their exclusion" (U.S. Department of Health and Human Services, 1988, p. 3). The NIH Revitalization Act of 1993 turned those suggestions into requirements that minorities (categorized as American Indian or Alaskan Native, Asian or Pacific Islander, Black-Not of Hispanic Origin, and Hispanic) must be included in all NIH-supported biomedical and behavioral clinical research projects involving human subjects, except where clear and compelling rationale and justification existed for their exclusion from such studies (U.S. Department of Health and Human Services, 2000, 2002).

The HHS task force's rationale for promoting datagathering and research studies on minorities was both practical and humanitarian: to "understand … the reasons underlying the longstanding disparity of health status in the United States" between minorities and the majority population, in order "to prevent or reduce much of the illness and death experienced by minorities in disproportion to their representation in the American population." Those reasons, according to the report, included "physiological, cultural and societal factors" (U.S. Department of Health and Human Services, 1985, vol. 1, p. 37). Therefore, Americans needed to conduct research and gather information about the health, health environment, and healthcare practices of all citizens in order to improve everyone's health.

The African-American Experience

Historically, U.S. medical researchers included—even preferred to use—minorities (for example, immigrants from Ireland, Germany, eastern Europe, and Africa) in their research studies; not until recently, however, did they select members of these groups for the humanitarian reasons delineated in the HHS task force report. In general, researchers used minorities as experimental subjects because they were easily exploited; they studied minority health when minority health threatened the majority population (for example, in times of epidemics). The African-American health experience provides a good historical example of these research practices. While examples of the use of other racial and ethnic minorities for human experimentation in the United States may be cited individually or during certain time periods, white employment of blacks for such purposes was a consistent practice that, sadly, encompasses the entire sweep of U.S. history.

Almost from the time of white settlement of the American continent, whites noted differences between themselves and blacks in health matters such as disease immunities and susceptibilities, and reactions to medications. Self-interest was an important factor in whites' use of blacks as objects of research and study in antebellum times. The following examples illustrate that self-interest. Blacks were unwilling immigrants to the New World—they were enslaved—and were, for their white owners, an economic investment. White physicians thus needed to know as much as possible about caring for their black patients when illness struck. Furthermore, blacks, especially house servants or laborers in small businesses or farms, often worked in close physical proximity to whites. It was important for whites to recognize and study the medical differences between themselves and blacks in order to understand the risk of contracting diseases brought into their homes or workplaces by ailing slaves (Savitt, 1978). Antebellum southern physicians like Josiah Clark Nott of Mobile and Samuel Cartwright of New Orleans spent parts of their careers noting and writing about black medical distinctiveness (Breeden). They and slaveholders did mostly observational and statistical studies, occasionally engaged in physical human experiments on African-Americans, and published their ideas in agricultural and medical journals (Savitt, 1982).

After Emancipation in 1865, concern about the spread of diseases prevalent among blacks to the entire population continued to motivate whites to study black illness. They noted a steep rise in such lethal diseases as tuberculosis among the newly freed population, and predicted the decline and disappearance of blacks from the United States by the turn of the twentieth century. Morbidity and mortality studies conducted by insurance companies confirmed these dire predictions and made it difficult for blacks to obtain life insurance (Haller, 1970b; Torchia, 1977). Further, African-Americans became the object of numerous medical studies and articles (Haller, 1970a; Torchia, 1977). Physicians in the late nineteenth century reported on the state of black health in their regions or in the South as a whole. Some prominent African-Americans, W. E. B. Du Bois in particular, engaged in research on the health status of blacks and published their findings to refute the misleading conclusions whites had drawn. In particular, Du Bois pointed out the inaccuracies and unscientific approach of those researchers who purportedly found blacks' brains smaller and less developed than whites' brains; reminded readers that whites also suffered greatly from consumption (tuberculosis), alcoholism, and syphilis; and pointed out that other factors besides race, especially living conditions and economic status, influenced people's health or susceptibility to disease.

Beginning in the 1890s, a significant population shift of African-Americans from the rural South to northern cities (termed the Great Migration) increased white awareness of black health problems and encouraged physicians all over the country to study diseases that affected both groups, such as tuberculosis and syphilis (Torchia, 1975, 1977; Jones). Diseases that primarily afflicted blacks, however, such as sickle-cell anemia, discovered in 1910, were not widely studied or publicized even in the black medical and lay communities. That disinterest in sickle-cell anemia did not change until the 1950s, when it was recognized as a molecular genetic disease, the first of its kind (Savitt, 1981; Scott; Wailoo). The civil rights movement of the 1950s and 1960s further raised the consciousness of white Americans about the exclusion of blacks from many aspects of American life, including healthcare and medicine. The HHS task force report of 1985 made explicit the need to include blacks in the mainstream of U.S. biomedical research.

Use of Other Minority Groups

African-Americans have a unique history as research subjects in the United States. They were not the only voiceless minority in American history, however, and not the only group used as research subjects. In the South most of the experimental subjects were black; in the North they were usually poor, recent ethnic immigrants, like the Irish, Germans, and eastern Europeans. Many of their graves were robbed by medical students or professional body snatchers known as resurrectionists, and their bodies were dissected. The segregated blacks and the poor white minorities who used the public hospitals and clinics run by U.S. medical schools became the objects of experiments and of surgical or medical demonstrations by teachers on behalf of their students (Bynum; Humphrey; Lederer; Bowman). As historian of medical research Stanley J. Reiser stated about the nineteenth and especially the early twentieth centuries: "[S]ome physicians viewed hospital patients as an experimental population from whom knowledge could be gained, and on whom students could also learn" (p. 11). This was the cost to the poor of obtaining free or low-cost medical care.

Investigators felt little need to ask these voiceless people for consent to perform experiments (Lederer). Until the 1947 Nuremberg Code—the result of blatant misuse of a minority population (Jews in Nazi Germany) for unregulated medical experimentation—there was no uniform requirement for gaining consent from research subjects in medical experiments. Even after 1947, minority groups were exploited in the United States. In one often-cited example, researchers in San Antonio, Texas, studied a group of Mexican-American women visiting a clinic to obtain birthcontrol assistance. Wishing to discover whether the reported side effects of birth-control pills were physiological or psychological, the researchers gave one group of women a placebo and instructed them to use a vaginal cream in addition. The patients in the study did not know they might receive a placebo or that using the vaginal cream alone put them at substantially greater risk for becoming pregnant. Seven women involved in the study became pregnant (Veatch).

The Tuskegee Syphilis Experiment

The most notorious example in American history of experimentation on members of a minority group without their consent was the Tuskegee Syphilis Experiment. Between 1932 and 1972 the U.S. Public Health Service (PHS) conducted an investigation into the natural history of untreated syphilis on four hundred unsuspecting black men from Macon County, Alabama. Building their research on an 1890s study of untreated syphilis among white males in Oslo, Norway, PHS officials wished to determine if racial differences existed in the natural course of the disease. The African-American men selected for the Tuskegee experiment thought that they were part of a select group receiving special medical care. In fact, they were receiving no care at all for their syphilis.

Physicians and officials from the Alabama State Board of Health, the Macon County Health Department, and the Tuskegee Institute, as well as local physicians, cooperated with the PHS in establishing the project, shunting the unwitting subjects to government physicians for their medical care, or providing the PHS with medical facilities for physical examinations and autopsies. The experiment continued even after the Nuremberg Code went into effect in 1947, after penicillin became available for the treatment of syphilis in the 1950s, and after the PHS had instituted strict guidelines on the use of human subjects in experiments funded by the NIH and other of its agencies in 1966 (Brandt; Jones; U.S. Department of Health, Education, and Welfare; Reverby). Those guidelines were reemphasized when the Tuskegee story became public in 1972, bringing home to the medical research community the importance of obtaining informed consent from research subjects, and of avoiding bias and using caution and sensitivity when considering the need for racial and ethnic medical studies.

Current Humanitarian Approach to Research Using Minority Participants

Since the 1985 HSS task force report, numerous articles have appeared discussing results of research that included minority population groups. The dilemma researchers face in reporting and interpreting their results has now become separating innate biological factors from cultural ones as determinants of the phenomena under study (e.g., disease incidence, drug efficacy, behavioral differences). There is general agreement among researchers that race is a social construct which becomes less and less meaningful in multicultural/multiethnic societies where interbreeding over decades or centuries has occurred. Definitions of white and black, for example, differ within and among countries and often are also tied to social and economic status. Diseases and behaviors express themselves for reasons that can relate to such non-biological factors as stress, diet, and living conditions. Minorities, having once served as the misused objects of research and human experimentation because it was convenient and in the self-interest of the majority population, have again been singled out to serve as research subjects for U.S. medicine—though for different and more humanitarian reasons. Interpreting and understanding the results of medical research that includes minority groups and sub-groups has now become the challenge (Benowitz; King; Osborne and Feit; Schwartz; Witzig; Wood).

todd l. savitt (1995)

revised by author

SEE ALSO: Holocaust; Information Disclosure, Ethical Issues in; Race and Racism; Research, Human: Historical Aspects;Research Policy: Vulnerable Groups; Research, Unethical; Warfare: Chemical and Biological Weapons; Whistleblowing in Healthcare

BIBLIOGRAPHY

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INTERNET RESOURCE

U.S. Department of Health and Human Services. 2000. "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research." Available from <http://grants.nih.gov/grants/funding/women-min/guidelines-update.htm>.