American Journal of Law & Medicine

The participation of underrepresented minorities in clinical research.


The past decade witnessed unprecedented growth in medical research involving human subjects, (1) promising the development of new treatments that extend and improve the quality of life, as well as prevent disease. Recent biomedical breakthroughs such as the mapping of the human genome, improved understanding of pharmacokinetics and molecular biology, and novel theories about the mechanisms of diseases such as cancer have led to a proliferation of clinical trials. Such research provides the necessary bridge from scientific theory to practical medical application, (2) and it is essential that these efforts benefit all persons who suffer from the studied diseases.

In addition to the potential long-term pay-offs, clinical trials may offer immediate dividends to enrolled subjects. The opportunity to participate in medical research carries with it a variety of potential risks and benefits. Because clinical trial participation potentially results in significant individual benefits, including access to state-of-the-art care and improved disease monitoring, fairness demands equal opportunity for inclusion whenever scientifically appropriate. For people without health insurance, clinical trials may serve as a portal to the healthcare system. Although far from ideal, clinical trials may provide individual trial participants, particularly those who lack health insurance of any kind, with their sole opportunity to obtain regular healthcare, including potentially efficacious treatment of their particular condition. (3) Clinical trial participants also seem to enjoy better health outcomes than their peers who receive the same therapy outside of the study. (4) This "inclusion benefit," though unrelated to the specific clinical purposes of the study, represents a distinct and valuable bonus to those with limited access to healthcare services. (5)

Of course, not all clinical research offers the prospect of therapeutic benefit. Some study protocols pose serious risks to health, and research designed simply to improve scientific understanding offers no possible benefit to individual participants. The challenge is to fashion a system of oversight and participation that ensures justice in access to scientifically sound clinical trials that may provide individual benefits, while guarding against the imposition of unfair burdens or risks for any one group of participants. In the past, commentators have devoted a good deal of attention to the inclusion of women in clinical trials. (6) This Article will focus instead on the issues surrounding the participation of racial and ethnic minorities in medical research.

Ensuring participation in medical research by racial and ethnic minorities represents an essential goal along the path to better overall health for these populations. (7) Numerous studies demonstrate that African-Americans, for example, suffer from a variety of health problems at disproportionately higher rates than whites. (8) The infant mortality rate among African-Americans is double that of whites, and African-Americans can expect to live six fewer years on average than whites. (9) African-Americans die from complications of diabetes at three times the rate of whites, (10) and experience higher incidences of several cancers, including breast, colorectal, and lung cancers, as well as the highest death rates from all cancers combined. (11) Moreover, the latest statistics on HIV infection suggest that African-Americans account for a disproportionately high seventy-five percent of new cases from heterosexual transmission and forty percent of cases among gay men. (12)

Equally disheartening, numerous studies demonstrate that African-American patients do not receive the same care as white patients when they seek medical treatment. (13) Studies document racial disparities in the use of coronary drugs and complex coronary procedures, (14) organ transplantation, (15) the provision and availability of pain medications, (16) and in many other healthcare contexts. Although health policy-makers and researchers now recognize and attempt to address these disparities in both rates of disease and access to care, (17) these trends increase the stakes of research participation for racial and ethnic minorities.

Evidence suggests, however, that racial and ethnic minorities have less opportunity to participate in potentially beneficial clinical research. (18) For reasons of scientific and practical convenience, minority groups were commonly excluded from clinical trials until the mid-1990s. (19) More recently, in recognition of the fact that minority participation in medical research enhances scientific understanding of variations in disease and treatment response among races and out of concern for healthcare justice, the government has instituted policies designed to encourage the inclusion of minorities in clinical trials. (20) Even so, the research community must proceed with caution in any efforts to equalize participation, both because of the inherent risks of medical research to individual participants and because some efforts at racial inclusion may have unintended negative consequences.

The notorious Tuskegee syphilis study, along with the research abuses in Nazi Germany and other publicized examples of research misconduct, continue to impact the decisions of African-Americans and other minority groups to participate in present day medical research. (21) Some government policies recognize that racial and ethnic minorities may require additional research protections because circumstances make them vulnerable to exploitation. Unfortunately, despite current efforts to guard against research coercion and the inappropriate inclusion of vulnerable research populations, allegations of improprieties occasionally continue to surface. (22)

This pendulum swing, from research abuses perpetuated against minorities to the overcautious (and convenient) exclusion of certain racial groups, leaves the research community with the difficult task of achieving a more ethically and scientifically sophisticated understanding of the proper role of race in medical research. Scientists and those involved in developing clinical research policy must not ignore the reality of racial variations in disease and treatment response. At the same time, they must avoid using these differences as an excuse for exclusion. To address the central problem--namely the occasional overrepresentation of minority populations in past research efforts and under-representation in contemporary biomedical studies--clinical investigators must ensure that only scientific rationales, rather than reasons of convenience, cost, or bias, dictate the enrollment of people of varying races and ethnicities. Although the potential for research abuse still exists, a considered approach to the inclusion of racial and ethnic minorities in clinical trials, taking into account relevant cultural and scientific factors, ultimately can ensure that medical innovation benefits people of all races.

A variety of factors have contributed to the scientific community's deliberate exclusion of African-Americans from certain types of studies and to the understandable reluctance of African-Americans to participate in clinical research. Part II will examine these factors and consider appropriate responses that may encourage African-Americans and other minorities to reconsider research participation. Part III will explore the scientific debate over the appropriate role of race in medical research and consider the impact of this debate on minority participation. Finally, Part IV will provide an overview of existing research protections for vulnerable populations, examine some of the assumptions that current research policy makes about the connection between race and vulnerable status, and suggest some improvements that may help to foster inclusiveness while avoiding future research abuses.


For a variety of reasons, some members of racial or ethnic minority groups may choose not to participate in clinical research or may encounter barriers to participation. Distrust in the medical system, coupled with a separate trend of under-inclusion of minorities in research for reasons of scientific convenience, leads to sporadic and sometimes altogether absent minority participation in clinical trials. A number of other factors contribute to lower participation rates among racial and ethnic minorities, including financial issues, lower rates of referrals to research protocols from clinicians and lack of information about clinical trials. The lack of minority participation in research, whether by choice or necessity, may create serious consequences for individuals and may exacerbate trends of poorer minority health.

Lower rates of minority participation in clinical trials cross a variety of medical specialties and persist even now with respect to many categories of research. For example, although people with HIV infection are at least four times as likely to be members of an underserved minority population, these populations are underrepresented in clinical trials of investigational therapies for HIV infection. (23) In 1996, only twenty-three percent of participants in HIV medication trials were African-American, a markedly low participation rate relative to the incidence of the disease in this population. (24) Recent data on clinical trial participation suggest that, in addition to disparities in HIV treatment trials, there has been little improvement in other types of research, including trials of asthma and lupus treatments, occupational cancer studies and cancer prevention studies. (25) Clinical trials for heart failure therapies also tend to exclude non-white patients. One analysis of data from multiple research protocols found that, although racial and ethnic minorities comprise thirty percent of heart failure patients, research protocols for this disease enrolled mainly white participants. (26) These sorts of participation disparities also continue to occur in trials of other drug therapies. In a 1989 analysis of clinical trials for a variety of prescription drugs, the investigators found that the percentage of African-American participants ranged from a low of three percent up to 100 percent in one study. (27) In twenty-three out of the thirty-five clinical trials for which racial data was available, African-American participants in the study population were underrepresented compared with the population in the surrounding community, and twenty out of the thirty-five studies had a lower percentage of African-American participants than the average nationwide population of African-Americans. (28) Of thirteen studies that examined the efficacy and/or safety of antihypertensive drugs (for which race-based differences in drug response were well-recognized even then), only eight of them enrolled at least one African-American subject, and investigators attempted to identify race-based differential drug response in only one study. (29)

Financial barriers may account for some of the observed disparities in minority participation. Regardless of whether an individual has health insurance, clinical trials offer free or reduced-cost access to experimental therapies that are otherwise unavailable and for which insurance reimbursement is unlikely. (30) Because research grants usually cover only the costs of the studied therapeutic agent, however, participants must find other ways to pay for any necessary hospitalization or routine care associated with the research, and insurers frequently object to paying for research-associated hospitalization and routine care. (31) People without the economic resources to pay costs out of pocket may be prevented from participating in medical research because of shrinking insurance coverage for the associated costs of clinical trial. (32) Although the federal government now mandates Medicare coverage for the costs of routine patient care for beneficiaries enrolled in research protocols, and a few states have enacted similar requirements for insurers more generally, (33) many people with insurance still lack such coverage and the uninsured also must pay out of pocket to participate.

The attitudes of treating physicians also may play a role. Referrals from healthcare professionals play an essential role in facilitating clinical trial participation, (34) but evidence suggests that physicians sometimes refer their minority patients to clinical trials less frequently than their white patients, in part based on a belief that racial and ethnic minorities are less interested in participation. (35) Physician reluctance to refer minorities to clinical trials may also reflect concerns about participants' willingness or ability to adhere to medication dosing schedules and nutritional requirements and to have reliable transportation to facilitate required protocol visits. (36)

To make matters worse, pharmaceutical companies sometimes discourage the recruitment of diverse subject populations. For example, sponsors of clinical trials for HIV therapies encourage researchers to recruit participants with characteristics perceived to increase the likelihood of protocol compliance and to eschew participants in "marginalized populations" such as members of minority groups, low-income persons and non-English speaking populations. (37) Investigators therefore continue to prefer white, homosexual, college-educated males as participants in clinical trials of AIDS therapies. (38) Several programs have attempted to increase African-American and other minority recruitment into clinical trials for HIV therapies using media appeals, educational outreach and community-based programs to encourage participation, (39) but such efforts have not had much impact to date.

Recent research documents significant levels of health illiteracy in the United States, (40) which may prevent individuals from learning about and participating in clinical research. An individual's ability to read and comprehend health-related materials, such as medication instructions and informed consent forms, may be substantially weaker than their general literacy. (41) Persons with lower incomes and lower levels of educational attainment generally also have substantially lower rates of health literacy than higher income, well-educated individuals. (42) Moreover, patients with lower general literacy levels tend to have higher levels of chronic disease, so those who most need healthcare may be least able to obtain and comprehend health-related information, (43) including information about access to experimental therapies. Although the data demonstrate a significant correlation between minority race and lower economic status and educational attainment, (44) the research community should avoid stereotyping or making paternalistic assumptions about any individual's ability to make informed and reasoned decisions to participate in medical research.

Recent studies also suggest that racial minorities are significantly less likely to be aware of the availability of newly-approved drugs, experimental drugs, or clinical trials for HIV treatments, or to have participated in an HIV clinical trial. (45) The Internet now provides a wealth of information about experimental therapies and clinical research, but this resource does little to assist those without ready access to it. Web-savvy patients may question their physicians about alternative or experimental therapies or may pursue such opportunities independently. Unfortunately, the growing racial divide in patient access to Internet-based information, (46) including vast quantities of information about clinical trials, (47) may further marginalize low income, ill-educated patients.

Apart from the above barriers which inhibit voluntary participation, members of the African-American community and other racial and ethnic groups may consciously avoid participation in medical research for several reasons. …

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