| Federal regulations governing human research require that subject selection be equitable, meaning that the risks and benefits are distributed in society fairly. Nevertheless, numerous factors cause disproportionate representation of racial and ethnic minorities in certain types of clinical research studies. An unfair distribution of the risks and benefits of biomedical research is unjust in two ways. First, it violates the theoretical principle of justice. Secondly, it can lead to study results that are not broadly generalizable, and which put segments of the population at risk. Thus, the question of equitable inclusion of minorities in clinical research is significant not only for moral reasons, but also for reasons of public health and safety. In this study, I review the historical underpinnings of the current regulatory environment for human research in the U.S., the legal requirements and moral imperative for equitable subject selection, the problem of disproportionate minority representation in clinical research, and the implications of this problem. Based on the findings, I propose steps for fostering more equitable rates of minority group member participation in biomedical research. |
