To make progress in this debate, the University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences with the University's Center for Bioethics convened a conference on 18 April 2005 to consider “Proposals for the Responsible Use of Racial and Ethnic Categories in Biomedical Research: Where Do We Go From Here?” The conference was cosponsored by the Office of Minority Health and Multicultural Affairs at the Minnesota Department of Health. In addition to comparing proposals, attendees discussed the role of communities that participate in research in determining the proper use of racial and ethnic categories and debated legal constraints on the categories that can be used.
The University of Minnesota was a natural home for this conference, as Jay Cohn (Minneapolis, Minnesota, USA) was the lead investigator and inventor on a patent for BiDil (combining isosorbide dinitrate and hydralazine), which recently became the first drug approved by the Food and Drug Administration for individuals of a particular racial or ethnic group, in this case, African Americans with heart failure. Substantial controversy surrounds the drug and the Food and Drug Administration's action. Beyond that, researchers at large universities must meet federal research requirements, while addressing the concerns of research participants and generating solid data. Yet using Directive 15 categories may violate community expectations and generate data sorted by categories with questionable scientific validity.
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