November 2006, Vol 96, No. 11 | American Journal of Public Health Kahn | Peer Reviewed | Human Genes and Human Rights | 1965  HUMAN GENES AND HUMAN RIGHTS  Genes, Race, and Population: Avoiding a Collision of Categories | Jonathan Kahn, JD, PhD A wide array of federal mandates have a profound impact on the use of racial and ethnic categories in bio- medical research, clinical practice, product develop- ment, and health policy. Cur- rent discussions over the ap- propriate use of racial and ethnic categories in biomed- ical contexts have largely focused on the practices of individual researchers. By contrast, our discussion focuses on relations between the daily practices of bio- medical professionals and federal regulatory mandates. It draws upon the legal doc- trine of equal protection to move beyond such debates and to propose guidelines to address the structural forces imposed by federal regulations that mandate how data about race and eth- nicity are used in biomedical research. It offers a frame- work to manage the tension involved in using existing fed- erally mandated categories of race and ethnicity alongside new scientific findings about human genetic variation. ( Am J Public Health. 2006;96:1965– 1970. doi:10.2105/AJPH.2005. 067926) CURRENT DISCUSSIONS ABOUT the appropriate use of racial and ethnic categories in biomedical contexts have largely focused on the practices of individual re- searchers. Individual research, however, takes place within larger structural contexts that shape how and when such cate- gories get taken up, circulated, and applied. In particular, more consideration needs to be given to the impact federal regulatory mandates and incentives upon how biomedical professionals use racial and ethnic categories. Prominent among these man- dates are requirements to use the social categories of race and eth- nicity provided by the Office of Management and Budget for the collection of data for publicly funded research. Use of such so- cial categories are heading for a collision with diverse categories of population that are classified in federally maintained genetic data bases. As genetic informa- tion becomes increasingly central to an ever-widening array of bio- medical enterprises, the danger of improperly confusing or con- flating social categories of race and ethnicity with genetic cate- gories of population rises accord- ingly. Drawing analogies to the legal doctrine of equal protec- tion, we offer a preliminary framework to begin discussion on how best to manage or avoid such collisions. RACE AND ETHNICITY IN BIOMEDICINE The recent Food and Drug Administration (FDA) approval of the drug BiDil with a race-specific indication to treat heart failure only in African Americans has brought to the fore a host of is- sues related to the use of racial and ethnic categories in biomed- ical research and drug develop- ment. 1 Because the BiDil applica- tion was premised on the activity of the drug at the molecular level in the trial subjects, the FDA ap- proval has, in effect, given the imprimatur of the federal govern- ment to the use of race as a bio- logical category. 2 Ironically, the FDA approval was based on a trial—the African-American Heart Failure Trial (A-HeFT)— that enrolled only self-identified African Americans. The results of this single-race design there- fore precluded the investigators from making any claims regard- ing whether BiDil works differ- ently in self-identified African Americans than in anyone else. 3 The race-specific design of the A-HeFT trial is inextricably linked to the fact that its spon- sors obtained a race-specific patent in 2000 for the use of BiDil in African Americans. 4 In granting the patent, the US Patent and Trademark Office provided an additional federal stamp of approval on the implicit use of race as a biological cate- gory. The federally granted patent also provided a powerful commercial incentive for the race-specific design of A-HeFT. 2 The story of BiDil is significant because it marks the first race- specific application to the FDA. More broadly, it brings into high relief a powerful dynamic whereby federal regulatory incentives and directives promote the increasing use of racial and ethnic categories in a biomedical context. In the case of efforts to address well- documented disparities in health outcomes, such use, although complicated, does not necessar- ily imply a biological or genetic difference between races. 5 In the context of seeking the causal mo- lecular basis for certain diseases, as in much drug development, the use of racial and ethnic cate- gories as surrogates for genetic markers presents more problem- atic issues. Some researchers be- lieve correlations between racial/ ethnic and genetic categories can serve as useful research tools 6,7 ; others contest the rigor and util- ity of such purported correla- tions, arguing that they risk natu- ralizing race and ethnicity as somehow genetic. 8–10 When fed- eral approval is sought for such uses, the power of the state be- comes implicated in marking racial or ethnic differences as genetic. Over the past several years, recurring controversies have arisen among scientists and bio- medical professionals regarding the nature of the relation, if any, between genes and race. 11 A host of articles has been pub- lished in the attempt to help bio- medical researchers clarify their use of the concepts of race and ethnicity in general 9,12,13 ; some specifically relate to genetically based concepts of popula- tion. 14–16 Several biomedical journals have published policy statements or guidelines con- cerning the use of racial and eth- nic categories. 17–19 These articles and related debates over how, when, or whether to use race and ethnicity in biomedical