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Legal Regulation of the Use of Race in Medical Research

Published online by Cambridge University Press:  01 January 2021

Extract

We have previously addressed the use of race in health care generally. Subsequent developments have made the issue even more pointed. Given the recent Food and Drug Administration (FDA) approval of BiDil as a result of a clinical trial limited to participants identifying themselves as African-American, this Symposium could not be more timely as an effort to further advance the dialogue on the issue of race in medical research. While this dialogue has informed our own analysis, we believe our distinctive contribution concerns the extent to which the law does and should constrain such use of race. Even in legal academic circles – somewhat notorious for considering problems of little practical significance – the issue has been given little thought. This piece, therefore, attempts to analyze extant legal regimes against the backdrop of medical and scientific developments.

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2006

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References

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If such research were directly linked to a questionable use, the research itself might be more problematic. A handful of cases invalidate racial data-keeping by the government. For example, Anderson v. Martin, 375 U.S. 399 (1964) invalidated racial designations in elections, and, in a case closer to the medical data context, Hamm v. Virginia State Board of Elections, 230 F. Supp. 156 (E.D. Va. 1964), aff'd sub nom. Tancil v. Woolls, 379 U.S. 19 (1964) (mem.) struck down a Virginia law that required public records regarding voting and property taxes be maintained with racial designations, although the plaintiffs were not discriminated against in any way. The same court, however, upheld racial designations in divorce records. Other courts have struck down racial collection of information, but usually in the context of a threatened or intended use against one race. See, e.g., Hall v. Pa. State Police, 570 F.2d 86 (3d Cir. 1978) (finding that a police photography program targeted at black bank customers was impermissible). Generally speaking, when the data collection has not been viewed as likely to be used in impermissible ways, racial collection and retention of data has been permitted, at least when a legitimate use can be envisioned. See Caulfield v. Bd. of Educ., 583 F.2d 605 (2d Cir. 1978) (affirming the denial of a preliminary injunction to prevent collection of racial data in connection with federal enforcement of Title VI against a school district); United States v. New Hampshire, 539 F.2d 277 (1st Cir. 1976) (noting that hypothetical misuse of racial data collected by the federal government did not justify finding unconstitutional a statute requiring such data to be provided).Google Scholar
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It is possible that some might disagree with this conclusion. Given that the existence of racial disparities has been well documented (see Lurie, N., “Editorial: Health Disparities – Less Talk, More Action,” New England Journal of Medicine 353 (2005): 727–29, at 727), there is a non-trivial argument that the investment of more resources into such research is misplaced. This would then suggest that, at a minimum, the federal government ought to cease funding such research. We believe, however, that such a move would be short-sighted. Continuing to monitor the existence of racial differences is necessary in order to determine whether efforts to eradicate such differences are successful and to help choose among potential strategies. See id., at 728–29.CrossRefGoogle Scholar
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The sole exception to this is where the hypothesis is that the difference is caused by racism. In the context of clinical research, however, we generally believe that, at least with pharmaceuticals, it is highly unlikely that a drug will or will not work for an individual because of racism. Of course, research has already shown that members of some groups appear to receive less or different treatments as a result of racism. See supra note 99. But uncovering such differences is mainly the work of what we have referred to as epidemiological research, not clinical research.Google Scholar
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