Historically, minorities were overly represented as research subjects because they could be easily exploited, and minority health was studied to improve the health of the majority population. African Americans were particularly and consistently exploited first as
slaves, and again when emancipation of slaves raised concerns about the spread of diseases to the white population. Research ethics has been described as “born in scandal and reared in protectionism.” In the 1970s, research ethics literature tended to characterize participation in clinical trials as a risky endeavor, with much focus on the protection of “vulnerable” populations, including racial and ethnic minorities. This philosophy of protection resulted in riskier research being done on middle-aged males with middle-class incomes. Where Institutional Review Boards (IRBs) addressed the issue of subject selection at all, the focus was on limiting the scope of subjects allowed to participate on the basis that certain populations were too vulnerable to be included.
By the 1980s, the public’s perception of the benefits of clinical research to individual subjects had radically changed, with patients clamoring for access to clinical trials and to experimental drugs, driven largely by AIDS activism. The focus of ethicists shifted from protecting potential subjects, or classes of subjects, to questioning the exclusion of patients from clinical trials.
By the early 1990s, IRBs were being required to justify the exclusion of groups from clinical trials based on the ethical principle of justice, i.e., the fair distribution of anticipated benefits to the subjects. The IRB Guidebook for 1993 even asked researchers to question whether the selection process overprotected subjects considered vulnerable. A further issue began to emerge in the 1990s: If the results of research are to be of maximum benefit to society, then subjects must be representative of the
population, with the ethical focus shifting to beneficence rather than justice. The regulatory response to this shift in thinking is evidenced by the 1994 National Institutes of Health (NIH) guidelines requiring the inclusion of women and minorities as subjects in clinical research for NIH-supported research.