It's Not You, It's Me: Necessity of Including Cultural Factors in Clinical Research
![handle is hein.journals/lieq30 and id is 181 raw text is: 179
It's Not You, It's Me:
Necessity of Including Cultural
Factors in Clinical Research
Shard6 C. Thomast
Introduction
An estimated 20-30% of all United States clinical trials are
outsourced to countries such as Poland, India, and Mexico.' For
both domestic and outsourced clinical trials, language barriers and
a lack of cultural understanding are a constant source of
problems.2 In 1993, the National Institutes of Health
Revitalization Act (NIHRA) was passed with a provision requiring
minorities and women to be included in clinical research.' Section
131 of the Act was passed in an attempt to prevent and correct the
frequent exclusion and improper treatment of minority
participants in clinical research.4 The Act applies to research
being conducted or supported by the National Institute of Health,'
and provides that minorities should be included as subjects, unless
an exception applies rendering the requirement inapplicable.' In
practice, researchers still have difficulty including diverse
t. J.D. expected 2012, University of Minnesota Law School. The author would
like to thank her friends, family, and the staff and editors of Law & Inequality: A
Journal of Theory and Practice. The author would also like to thank Professor
Michele Goodwin, Professor Ralph Hall, and Sara DeSanto for their assistance with
this article.
1. Karen Politis Virk, Global Clinical Trials: The Challenge of Language,
LANGUAGE CONNECTIONS, http://www.languageconnections.com/descargas/Global%
20Clinical%20trials%20challenge%20of%2Olanguage.pdf (last visited Sept. 22,
2011) (citing Press Release, Thomson CenterWatch, Thomson CenterWatch Tracks
Emerging Markets of Clinical Research (Apr. 19, 2007) (on file with author)).
2. Compare Virk, supra note 1 (discussing the challenges of international
clinical research), with Ctr. for Translational Sci. Activities, Community
Engagement and Minority Inclusion, MAYO CLINIC, http://ctsa.mayo.edu/resources/
community-engagement-minority-inclusion.html (last visited Sept. 22, 2011)
(providing guidance for clinical researchers within the United States).
3. National Institutes of Health Revitalization Act of 1993, 42 U.S.C. § 289a-2
(2006).
4. NAT'L INSTS. OF HEALTH OFFICE OF THE DIR., U.S. DEP'T OF HEALTH &
HUMAN SERVS., OUTREACH NOTEBOOK FOR THE INCLUSION, RECRUITMENT AND
RETENTION OF WOMEN AND MINORITY SUBJECTS IN CLINICAL RESEARCH 3-4 (2002)
[hereinafter OUTREACH NOTEBOOK].
5. Id.
6. 42 U.S.C. § 289a-2(b).](ViewImageLocal?handle=hein.journals/lieq30&div=10&collection=&method=preview&ext=.png&size=3)
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It's Not You, It's Me: Necessity of Including Cultural Factors in Clinical Research
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