The participation of underrepresented minorities in clinical research.

I. INTRODUCTION 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. …