Researchers from a pharmaceutical company were concerned when they realized that some people in their multi-center trial would be black if enrolled at an east coast site but white if enrolled at a west coast site. University of Wisconsin researchers were puzzled to realize that individuals in Northern Wisconsin who described themselves as white, and of French Canadian descent, had nearly identical ancestry to members of the Lake Superior Chippewa Tribes. A medical scientist from University of Texas was concerned about the validity of his data because he felt that many subjects who self-identified as Hispanic were “really Native American.” Both the NIH and the FDA inclusion guidelines direct investigators to collect data using the OMB directive 15 categories for ethnicity and race, but how useful and informative are these categories and how should researchers really apply them? How useful are categories designed for U.S. populations and the U.S. political context when clinical trials are, increasingly, a global enterprise?
Pilar Ossorio's presentation will examine some ways in which race and ethnicity may or may not be informative in biomedical research, and will discuss how researchers can achieve their goals while complying with federal inclusion guidelines.
Pilar N. Ossorio, Ph.D., J.D. is currently a Visiting Professor of Law at the University of California, San Francisco. She is also Associate Professor of Law & Bioethics, Program Faculty with the Graduate Program in Population Health, and Assistant Professor of Law & Bioethics (appointed in the Law School and the Medical School), at the University of Wisconsin in Madison, Wisconsin.