Identifying the "vulnerables" in biomedical research: the vox populis from the Tuskegee Legacy Project.

OBJECTIVES

This report presents, for the first time, findings on the vox populis as to who constitutes the "vulnerables in biomedical research"

METHODS

The 3-City Tuskegee Legacy Project (TLP) study used the TLP questionnaire as administered via random-digit-dial telephone interviews to 1162 adult Black people, non-Hispanic White people, and two Puerto Rican (PR) Hispanic groups: Mainland United States and San Juan (SJ) in three cities. The classification schema was based upon respondents' answers to an open-ended question asking which groups of people were the most vulnerable when participating in biomedical research.

RESULTS

Subjects provided 749 valid open-ended responses, which were grouped into 29 direct response categories, leading to a four-tier classification schema for vulnerability traits. Tier 1, the summary tier, had five vulnerability categories: (1) Race/ ethnicity; (2) Age; (3) SES; (4) Health; and, (5) Gender. Black people and Mainland United States PR Hispanics most frequently identified Race/Ethnicity as a vulnerability trait (42.1 percent of Black people and 42.6 percent of Mainland United States. PR Hispanics versus 15.4 percent of White people and 16.7 percent of SJ R Hispanics) (P < 0.007), while White people and SJ PR Hispanics most frequently identified Age (48.3 percent and 29.2 percent) as a vulnerability trait.

CONCLUSIONS

The response patterns on "who was vulnerable" were similar for the two minority groups (Black people and Mainland US PR Hispanics), and notably different from the response patterns of the two majority groups (White people and SJ PR Hispanics). Further, the vox populis definition of vulnerables differed from the current official definitions as used by the U.S. federal government.