Limited English Proficiency and Disparities in Clinical Research

Shin H. B. Bruno R. , U.S. Census Bureau, Language Use and English-Speaking Ability: 2000, Census 2000 Brief , October 2003, available at <http://www.census.gov/prod/2003pubs/c2kbr-29.pdf> (last visited November 18, 2008).

Perkins J. , “Ensuring Linguistic Access in Health Care Settings: An Overview of Current Legal Rights and Responsibilities,” The Kaiser Commission on Medicaid and the Uninsured, August 2003, available at <http://www.kff.org/uninsured/kcmu4131report.cfm> (last visited November 18, 2008).

See supra note 1.

U.S. Census Bureau, Ability to Speak English by Language Spoken at Home: 2000 , at Table 1a, revised February 2006, available at <http://www.census.gov/population/www/cen2000/briefs/phc-t37/tables/tab01a.pdf> (last visited November 18, 2008).

See supra note 2, at 2.

Guzman B. , U.S. Census Bureau, The Hispanic Population, Census 2000 Brief , May 2001, available at <http://www.census.gov/prod/2001pubs/c2kbr01–3.pdf> (last visited November 18, 2008).

“Nationwide Survey Shows Minorities Get Shortchanged on Medical Services,” Health Care Policy Report (BNA) 13, no. 56 (1995).

Flores G. Laws M. B. Mayo S. J. Zuckerman B. Abreu M. Medina L. Hardt E. J. , “Errors in Medical Interpretation and Their Potential Clinical Consequences in Pediatric Encounters,” Pediatrics 111, no. 1 (2003): 6–14.

See Flores G. , “Language Barriers to Health Care in the United States,” New England Journal of Medicine 355, no. 3 (2006): 229–231; Cohen A. L. Rivara F. Marcuse E. K. McPhillips H. Davis R. , “Are Language Barriers Associated with Serious Medical Events in Hospitalized Pediatric Patients?” Pediatrics 116, no. 3 (2005): 575–579; Cooper L. A. Powe N. R. , “Disparities in Patient Experiences, Health Care Processes, and Outcomes: The Role of Patient-Provider Racial, Ethnic, and Language Concordance,” Commonwealth Fund Reports, no. 753, July 2004, available at <http://www.cmwf.org/programs/minority/cooper_raceconcordance_753.pdf> (last visited November 18, 2008).

See Killien M. Bigby J. A. Champion V. Fernandez-Repollet E. Jackson R. D. Kagawa-Singer M. Kidd K. Naughton M. J. Prout M. , “Involving Minority and Underrepresented Women in Clinical Trials: The National Centers of Excellence in Women's Health,” Journal of Women's Health & Gender-based Medicine 9, no. 10 (2000): 1061–1070; Chronic Disease Prevention and Control Research Center at Baylor College of Medicine, Intercultural Cancer Council, Major Deficiencies in the Design and Funding of Clinical Trials: A Report to the Nation Improving on How Human Studies Are Conducted , April 2008, available at <http://www.bcm.edu/edict/PDF/EDICT_Project_White_Paper.pdf> (last visited November 18, 2008).

See supra note 8; Flores G. Abreu M. Schwartz I. Hill M. , “The Importance of Language and Culture in Pediatric Care: Case Studies from the Latino Community,” Journal of Pediatrics 137, no. 6 (2000): 842–848; Flores G. , “The Impact of Medical Interpreter Services on the Quality of Health Care: A Systematic Review,” Medical Care Research and Review 62, no. 3 (2005): 255–299; Gany F. Kapelusznik L. Prakash K. Gonzalez J. Orta L. Y. Tseng C. H. Changrani J. , “The Impact of Medical Interpretation Method on Time and Errors,” Journal of General Internal Medicine 22, Supplement 2 (2007): 319–323; and see generally Fadiman A. , The Spirit Catches You and You Fall Down (New York: Farrar, Straus, and Giroux, 1997).

Of course there may be a selection bias in clinical research where persons with LEP are not offered participation in the trial because of LEP and not because of any legitimate exclusion criteria. This, if true, is in itself evidence of a Title VI infraction for entities covered by the statute (unless English proficiency is a scientifically valid inclusion criterion for the study in question.)

Wolf M. S. Williams M. V. Parker R. M. Parikh N. S. Nowlan A. W. Baker D. W. , “Patients' Shame and Attitudes toward Discussing the Results of Literacy Screening,” Journal of Health Communication 12, no. 8 (2007): 721–732.

Wilson E. Chen A. H. Grumbach K. Wang F. Fernandez A. , “Effects of Limited English Proficiency and Physician Language on Health Care Comprehension,” Journal of General Internal Medicine 20, no. 9 (2005): 800–806; Roberts C. M. , “Meeting the Needs of Patients with Limited English Proficiency,” Journal of Medical Practice Management 17, no. 2 (2001): 71–75; Brach C. Fraser I. Paez K. , “Crossing the Language Chasm,” Health Affairs, 24, no. 2 (2005): 424–434.

Guiliano A. R. Mokuau N. Hughes C. Tortolero-Luna G. Risendal B. Ho R. C. S. Prewitt T. E. McCaskill-Stevens W. J. , “Participation of Minorities in Cancer Research: The Influence of Structural, Cultural, and Linguistic Factors,” Annals of Epidemiology 10, no. 8 (2000): S22–S34; Frayne S. M. Burns R. B. Hardt E. J. Rosen A. K. Moskowitz M. A. , “The Exclusion of Non-English-Speaking Persons from Research,” Journal of General Internal Medicine 11, no. 1 (1996): 39–43.

Mozes A. , News Article, “Report Claims Clinical Trials Miss Many Populations,” HealthDay News, April 1, 2008, available at <http://healthday.com/Article.asp?AID=614031> (last visited November 18, 2008).

Intercultural Cancer Council, Cancer Fact Sheets, available at <http://iccnetwork.org/cancerfacts> (last visited November 18, 2008).

U.S. Census Bureau, Profile of General Demographic Characteristics: 2000 , at Table DP-1, available at <http://censtats.census.gov/data/US/01000.pdf> (last visited November 18, 2008).

See Weiss N. S. Koepsell T. D. Psaty B. M. , “Generalizability of the Results of Randomized Trials,” Archives of Internal Medicine 168, no. 2 (2008): 133–135; Dhruva S. S. Redberg R. F. , “Variations Between Clinical Trial Participants and Medicare Beneficiaries in Evidence Used for Medicare National Coverage Decisions,” Archives of Internal Medicine 168, no. 2 (2008): 136–140.

Though the scientific imperative is lessened in particular cases of exclusion of LEP participants who are white or whose genetic pharmacogenomic profiles are already adequately represented among trial participants, I contend that there remains a scientific necessity to include LEP persons generally, even though it may not be true severally.

Rotimi C. N. , “Understanding and Using Human Genetic Variation Knowledge in the Design and Conduct of Biomedical Research,” Eliminating Disparities in Clinical Trials (EDICT) Online Reading Room, available at <http://www.bcm.edu/edict/PDF/Scientific_Rationale.pdf> (last visited November 18, 2008); Rosenberg N. A. Pritchard J. K. Weber J. L. Cann H. M. Kidd K. K. Zhivotovsky L. A. Feldman M. W. , “Genetic Structure of Human Populations,” Science 298, no. 5602 (2002): 2381–2385.

International HapMap Project, available at <http://hapmap.org/> (last visited November 18, 2008).

Ouyang C. Krontiris T. G. , “Identification and Functional Significance of SNPs Underlying Conserved Haplotype Frameworks across Ethnic Populations,” Pharmacogenetics and Genomics 16, no. 9 (2006): 667–682.

Ginsburg G. S. McCarthy J. J. , “Personalized Medicine: Revolutionizing Drug Discovery and Patient Care,” Trends in Biotechnology 19, no. 12 (2001): 491–496.

See supra note 23.

Beckman M. , News Article, “The Race for Ancestral Genetics in Clinical Trials,” Journal of the National Cancer Institute 98, no. 18 (2006): 1270–1271.

Brennan R. L. , Generalizability Theory (New York: SpringerVerlag, 2001).

It might be charged that I am being unduly “deterministic” in my contention that LEP participants are likely to correspond with underrepresented ancestral genetic groups. However, I do not mean that LEP participants are somehow genetically different from English-proficient persons from the same (or any other) ethnicity. I am simply making the argument that, in the current clinical research environment, where certain genetic profiles are already underrepresented, any blanket exclusion of LEP persons will undoubtedly exacerbate the problem of generalizability of research results.

See Race, Ethnicity, and Genetics Working Group, Review Article, “The Use of Racial, Ethnic, and Ancestral Categories in Human Genetics Research,” American Journal of Human Genetics 77, no. 4 (2005): 519–532. Note, however, that I do not argue that simply lifting the language barriers to clinical research will solve the scientific problem of generalizability. There are many other barriers to the participation of certain minorities in clinical trials that will undoubtedly continue to conspire against adequate inclusion and thus generalizability. For an excellent, though non-comprehensive compilation of the myriad barriers to clinical research, see Ford J. G. Howerton M. W. Bolen S. Gary T. L. Lai G. Y. Tilburt J. Gibbons M. C. Baffi C. Wilson R. F. Feuerstein C. J. Tanpitukpongse P. Powe N. R. Bass E. B. , “Knowledge and Access to Information on Recruitment of Underrepresented Populations to Cancer Clinical Trials,” Evidence Report/Technology Assessment No. 122, prepared for the Agency for Healthcare Research and Quality (AHRQ), June 2005, available at <http://www.ahrq.gov/downloads/pub/evidence/pdf/recruit-cantrials/recruit.pdf> (last visited October 9, 2008).

I recognize that the scientific rationale for the inclusion of LEP participants in clinical research is, as of this writing, only a prima facie imperative. That is, it is certainly conceivable that alleleic frequencies get effectively “washed out” as we move upward along the axis I described of ancestral genetic group ethnicity LEP participant, or that any alleleic frequency profiles along this axis have no impact on pharmacokinetic profiles (though already there is ample evidence to suggest otherwise), or that any possible pharmacokinetic profiles that may be more prevalent in a particular sub-population are already sufficiently represented in today's relatively homogenous clinical trial populations. My point here is that while any of these possibilities may invalidate my proposed scientific necessity for the inclusion of LEP participants in clinical trials, there remains a prima facie imperative until that time when we can disprove it by any of the aforementioned empirically determined possibilities.

§601 of Title VI of the Civil Rights Act of 1964.

65 Federal Register 52762, 52763 (August 30, 2000). “In the course of its enforcement activities, OCR has found that persons who lack proficiency in English frequently are unable to obtain basic knowledge of how to access various benefits and services for which they are eligible, such as the State Children's Health Insurance Program (SCHIP), Medicare, Medicaid or Temporary Assistance to Needy Families (TANF) benefits, clinical research programs, or basic health care and social services.”34. See generally, Lederer S. E. , Subjected to Science: Human Experimentation in America before the Second World War (Baltimore: Johns Hopkins University Press, 1995).

Brody B. A. , The Ethics of Biomedical Research: An International Perspective (New York: Oxford University Press, 1998): At 186. See, however, Walsh C. Ross L. F. , “Are Minority Children Under- or Overrepresented in Pediatric Research?” Pediatrics 112, no. 4 (2003): 890–895, which shows that at least in some cases, minority participants continue to be overrepresented in certain clinical trials.

National Institutes of Health Revitalization Act , 42 U.S.C. § 289a-2 (1993); Public Law 103–43; 59 Federal Register 14508 (as republished March 28, 1994), available at <http://vlex.com/vid/19246381> (last visited November 18, 2008).

Executive Order 13166, 65 Federal Register, 50121 (August 16, 2001).

Executive Order 13166.

Lamentably, even after several reminder letters from the Assistant Attorney General's office and formal deadline extensions, many federally funded agencies have not complied with the requirement to submit LEP guidance per Executive Order 13166. For updates on agency LEP guidance, see <http://www.usdoj.gov/crt/cor/13166.htm> (last visited November 18, 2008).

68 Federal Register 47311, 47323 (August 8, 2003). The Office of Civil Rights at the U.S. Department of Health and Human Services make available pamphlets in a variety of languages that outline the obligations that Title VI lay out for federally funded institutions and the mechanisms by which persons who have been discriminated against can file complaints with the Office. See <http://www.hhs.gov/ocr/generalinfo.html> (last visited November 18, 2008).

45 CFR §80.3(b)(2). Health care was a principal focus of the 2003 guidance. See Rosenbaum S. , “Reducing Discrimination Affecting Persons with Limited English Proficiency: Federal Civil Rights Guidelines under Title VI of the 1964 Civil Rights Act,” Public Health Reports 119, no. 1 (2004): 93–96. In 2001, the United States Supreme Court narrowed the scope of the proscription for de facto discriminatory practices in Alexander v. Sandoval, 532 U.S. 275 (2001). In that case, after the promulgation of the Civil Rights Act of 1964, Alabama amended its constitution to make English the official language of Alabama. Alabama's Department of Public Safety took this to justify a requirement that all driving tests must be administered and taken in English. A bare majority of the U.S. Supreme Court held that even if the Alabama Department of Public Safety's failure to provide driving tests in Spanish amounted to a violation of Title VI of the Civil Rights Act of 1964, no private right of action to enforce the regulation existed. However, subsequent Executive Orders, federal regulations, and the 2003 guidance make clear that the onus to remove language barriers in health care lies squarely with federally funded health care facilities and providers. See Executive Order 13166, 65 Federal Register , 50121 (August 16, 2001); 65 Federal Register 52762 (August 30, 2002); 68 Federal Register 47311, 47312.

68 Federal Register 47311–47323 (August 8, 2003). U.S. Department of Health and Human Services, Office for Civil Rights, Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons , 2003, available at <http://www.hhs.gov/ocr/lep/revisedlep.html> (last visited November 18, 2008).

68 Federal Register 47311.

Lau v. Nichols , 414 U.S. 563 (1974).

Alexander v. Sandoval , 532 U.S. 275 (2001).

See for example, U.S. Commission on Civil Rights, “The Health Care Challenge: Acknowledging Disparity, Confronting Discrimination, and Ensuring Equality — Vol. II, The Role of Federal Civil Rights Enforcement Efforts,” September 1999, at Chapter 4; Smedley B. D. Stith A. Y. Nelson A. R. , Institute of Medicine, Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care (Executive Summary) (Washington, D.C.: National Academy Press, 2003): At 12–13 (which concludes that the DHHS's OCR “has suffered from insufficient resources to investigate complaints of possible violations” and recommends increased funding for this purpose.)

See United States Department of Health & Human Services, FY 2007 Budget in Brief: Office for Civil Rights, available at <http://www.hhs.gov/budget/07budget/ocr.html#civilRights> (last visited November 18, 2008).

Bustillos D. , “Surveying the Policy Landscape for Eliminating Disparities in Clinical Trials,” Eliminating Disparities in Clinical Trials (EDICT) Online Reading Room, available at <http://www.bcm.edu/edict/PDF/Policy_Landscape.pdf> (last visited November 18, 2008).

§601 of Title VI of the Civil Rights Act of 1964; 68 Federal Register 47311.

65 Federal Register 52762, 52765.

68 Federal Register 47311.

68 Federal Register 47311, 47313.

National Institutes of Health Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research , 59 Federal Register 14508 (as republished March 28, 1994); Public Law 103–43 § 492B(d)(2).

See Eliminating Disparities in Clinical Trials (EDICT) policy research, which is concerned with examining and proposing cost-effective solutions, available at <http://www.bcm.edu/edict> (last visited November 18, 2008).

65 Federal Register 52762, 52766–67.

Watson S. D. , “Reforming Civil Rights with Systems Reform: Health Care Disparities, Translation Services & Safe Harbors,” Washington and Lee Racial and Ethnic Ancestry Journal 9, no. 13 (2003): 13–34, at 32.

Oliva N. L. , “When Language Intervenes: Improving Care for Patients with Limited English Proficiency,” American Journal of Nursing 108, no. 3 (2008): 73–75; Taylor S. L. Lurie N. , “The Role of Culturally-Competent Communication in Reducing Ethnic and Racial Healthcare Disparities,” American Journal of Managed Care 10, Special Supplement (2004): SP 1–4.

Saha S. Komaromy M. Koepsell T. D. Bindman A. B. , “Patient-Physician Racial Concordance and the Perceived Quality and Use of Health Care,” Archives of Internal Medicine 159, no. 9 (1999): 997–1004; Laveist T. A. Nuru-Jeter A. , “Is Doctor-Patient Race Concordance Associated with Greater Satisfaction with Care?” Journal of Health and Social Behavior 43, no. 3 (2002): 296–306.

65 Federal Register 52762, 52765–66.

For example, the Texas Tech University Health Sciences Centers in west Texas have implemented an institution-wide policy to have relevant clinical trial materials translated into Spanish, the area's second most popular language.

See California Constitution, art. I, § 31.

Joint Commission on the Accreditation of Health Care Organization, “Provision of Care, Treatment, and Services,” 2007, at Standard PC.6.10. “The patient receives education and training specific to the patient's needs and as appropriate to the care, treatment, and services provided.”80. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Department of Health, Education, and Welfare, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research , OPRR Reports, 1979, at Part B, 3, available at <http://ohsr.od.nih.gov/guidelines/belmont.html> (last visited November 18, 2008).