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Seeing Beyond the Margins: Challenges to Informed Inclusion of Vulnerable Populations in Research

Published online by Cambridge University Press:  01 January 2021

Sarah Gehlert  and
Jessica Mozersky
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Abstract

Although the importance of including vulnerable populations in medical research is widely accepted, identifying how to achieve such inclusion remains a challenge. Ensuring that the language of informed consent is comprehensible to this group is no less of a challenge. Although a variety of interventions show promise for increasing the comprehensibility of informed consent and increasing a climate of exchange, consensus is lacking on which interventions should be used in which situations and current regulations provide little guidance. We argue that the notion of individual autonomy — a foundational principle of informed consent — may be too narrow for some vulnerable populations by virtue of its failure to acknowledge their unique histories and current circumstances. It has a different meaning for members of structured groups like American Indians than for unstructured groups, such as African Americans, whose complicated histories foster group identity. Ensuring broad participation in research and selecting appropriate methods for obtaining informed consent — namely, methods aligned with the source of vulnerability and level of risk — require new ways of thinking that might produce guidelines for matching informed consent models and processes with subpopulations.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 46 , Issue 1: The Future of Informed Consent in Research & Translational Medicine: A Century of Law, Ethics & Innovation , Spring 2018 , pp. 30 - 43
Copyright
Copyright © American Society of Law, Medicine and Ethics 2018

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References

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Prisoners (1976), available at <https://videocast.nih.gov/pdf/ohrp_research_involving_prisoners.pdf> (last visited January 8, 2018); National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Children (1977), available at <https://videocast.nih.gov/pdf/ohrp_research_involving_children.pdf> (last visited January 8, 2018); National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979), available at <https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/> (last visited January 8, 2018); National Bioethics Advisory Commission, Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity (1998), available at <https://bioethicsarchive.georgetown.edu/nbac/capacity/TOC.htm> (last visited January 8, 2018).+(last+visited+January+8,+2018);+National+Commission+for+the+Protection+of+Human+Subjects+of+Biomedical+and+Behavioral+Research,+Research+Involving+Children+(1977),+available+at++(last+visited+January+8,+2018);+National+Commission+for+the+Protection+of+Human+Subjects+of+Biomedical+and+Behavioral+Research,+The+Belmont+Report:+Ethical+Principles+and+Guidelines+for+the+Protection+of+Human+Subjects+of+Research+(1979),+available+at++(last+visited+January+8,+2018);+National+Bioethics+Advisory+Commission,+Research+Involving+Persons+with+Mental+Disorders+That+May+Affect+Decisionmaking+Capacity+(1998),+available+at++(last+visited+January+8,+2018).>Google Scholar
All of Us Research Program, National Institutes of Health, About the All of Us Research Program, available at <https://allofus.nih.gov/about/about-all-us-research-program> (last visited January 8, 2018).+(last+visited+January+8,+2018).>Google Scholar
Massey, P. M., “Where Do U.S. Adults Who Do Not Use the Internet Get Health Information? Examining Digital Health Information Disparities from 2008 to 2013,” Journal of Health Communication 21, no. 1 (2016): 118–124; R. F. McCloud et al., “Beyond Access: Barriers to Internet Health Information Seeking among the Urban Poor,” Journal of the American Medical Informatics Association 23, no. 6 (2016): 1053-1059.CrossRefGoogle Scholar
Grady, C. et al., “Informed Consent,” New England Journal of Medicine 376, no. 9 (2017): 856–867.Google Scholar
Hudson, L. D. et al., “Are Benefits Conferred with Greater Socioeconomic Position Undermined by Racial Discrimination among African American Men?” Journal of Mens' Health 9, no. 2 (2012): 127–136; L. D. Hudson and S. Gehlert, “Considering the Role of Social Determinants of Health in Black-White Breast Cancer Disparities,” in R. Bangs and L. E. Davis, eds., Race and Social Problems: Restructuring Inequality (New York: Springer, 2015): 227-246.CrossRefGoogle Scholar
U.S. Census Bureau, Poverty Thresholds by Size and Number of Children, Threshold for 2015, available at <https://www2.census.gov/programs-surveys/cps/tables/time-series/historical-poverty-thresholds/thresh15.xls> (last visited January 8, 2018).+(last+visited+January+8,+2018).>Google Scholar
Proctor, B. D., Semega, J. L., and Kollar, M. A., Income and Poverty in the US: 2015, CURRENT POPULATION REPORTS, No. P60-256 (Washington, D.C.: U.S. Census Bureau, 2016), available at <https://www.census.gov/content/dam/Census/library/publications/2016/demo/p60-256.pdf> (last visited January 8, 2018).Google Scholar
National Center for Health Statistics, Health, United States, 2015 (Hyattsville, MD: National Center for Health Statistics, 2016), Figure 18, at 22. Data from the National Vital Statistics System.Google Scholar
Edin, K. J. and Shaefer, L., $2.00 a Day: Living on Almost Nothing in America (New York: Houghton Mifflin Harcourt Publishing Company, 2015): at xxii.Google Scholar
Alcaraz, K., Kreuter, M. W., and Bryan, R., “Use of GIS to Identify Optimal Settings for Cancer Prevention and Control in African American Communities,” Preventive Medicine 49, no. 1 (2009): 54–57.Google Scholar
Olshansky, S. J. et al., “Differences in Life Expectancy Due to Race and Educational Differences Are Widening, and Many May Not Catch Up,” Health Affairs 31, no. 8 (2012): 1803–1813.CrossRefGoogle Scholar
Case, A. and Deaton, A., “Mortality and Morbidity in the 21st Century,” Brookings Papers on Economic Activity, BPEA Conference Drafts, March 23-24, 2017, available at <https://www.brookings.edu/wp-content/uploads/2017/03/casedeaton_sp17_finaldraft.pdf> (last visited January 8, 2018).+(last+visited+January+8,+2018).>Google Scholar
Sacks, T. K., “Race and Gender Concordance: Strategy to Reduce Healthcare Disparities or Red Herring? Evidence from a Qualitative Study,” Race and Social Problems 5, no. 2 (2013): 88–99.CrossRefGoogle Scholar
See, e.g., Grady, C., “Money for Research Participation: Does It Jeopardize Informed Consent?” American Journal of Bioethics 1, no. 2 (2001): 40–44; M. Kuczewski, “Is Informed Consent Enough? Monetary Incentives for Research Participation and the Integrity of Biomedicine,” American Journal of Bio-ethics 1, no. 2 (2001): 49-51.CrossRefGoogle Scholar
Sears, J. M., “Context is Key for Voluntary and Informed Consent,” American Journal of Bioethics 5, no. 1 (2005): 47–48, at 47.CrossRefGoogle Scholar
Luna, F., “Elucidating the Concept of Vulnerability: Layers Not Labels,” International Journal of Feminist Approaches to Bioethics 2, no. 1 (2009): 121–139.CrossRefGoogle Scholar
Mozersky, J. et al., “Toward an Ethically Sensitive Implementation of Noninvasive Prenatal Screening in the Global Context,” Hastings Center Report 47, no. 2 (2017): 41–49.Google Scholar
See id.Google Scholar
Paasche-Orlow, M. K., Taylor, H. A., and Brancati, F. L., “Readability Standards for Informed-Consent Forms as Compared with Actual Readability,” New England Journal of Medicine 348, no. 8 (2003): 721–726.CrossRefGoogle Scholar
Ryan, C. L. and Bauman, K., Educational Attainment in the United States: 2015, Population Characteristics, CURRENT POPULATION REPORTS, no. P20-578, March 2016, available at <https://www.census.gov/content/dam/Census/library/publications/2016/demo/p20-578.pdf> (last visited January 8, 2018).+(last+visited+January+8,+2018).>Google Scholar
U.S. Department of Agriculture, Rural Education at a Glance, 2017 Edition, ECONOMIC INFORMATION BULLETIN no. 171, April 2017, available at <https://www.ers.usda.gov/publications/pub-details/?pubid=83077> (last visited January 8, 2018).+(last+visited+January+8,+2018).>Google Scholar
Oh, S. S. et al., “Diversity in Clinical and Biomedical Research: A Promise Yet to Be Fulfilled,” PLoS Medicine 12, no. 12 (2015): e1001918, doi:10.1371/journal.pmed.1001918.Google Scholar
National Institutes of Health Revitalization Act of 1993, Pub. L. No. 103-43, 107 Stat. 122, 134 (1994) (codified at 42 U.S.C. § 289a-2(c) (2015)).Google Scholar
Chen, M. S. et al., “Twenty Years Post-NIH Revitalization Act: Enhancing Minority Participation in Clinical Trials (EMPaCT): Laying the Groundwork for Improving Minority Clinical Trial Accrual: Renewing the Case for Enhancing Minority Participation in Cancer Clinical Trials,” Cancer 120, no. S7 (2014): 1091–1096.CrossRefGoogle Scholar
Perrin, A., Social Media Usage: 2005–2015, October 8, 2015, available at <http://www.pewinternet.org/2015/10/08/social-networking-usage-2005-2015/> (last visited January 8, 2018).+(last+visited+January+8,+2018).>Google Scholar
Viswanath, K. et al., “Internet Use, Browsing, and the Urban Poor: Implications for Cancer Control,” Journal of the National Cancer Institute Monographs no. 47 (2013): 199–205; Y. Ishikawa et al., “Are Socioeconomic Disparities in Health Behavior Mediated by Differential Media Use? Test of the Communication Inequality Theory,” Patient Education & Counseling 99, no. 11 (2016): 1803-1807; R. F. McCloud et al., “Beyond Access: Barriers to Internet Health Information Seeking Among the Urban Poor,” Journal of the American Medical Informatics Association 23, no. 6 (2016): 1053-1059.Google Scholar
National Telecommunications and Information Administration, U.S. Department of Commerce, “National Broadband Map,” database, available at <https://www.ntia.doc.gov/category/national-broadband-map> (last visited January 8, 2018).+(last+visited+January+8,+2018).>Google Scholar
Bayer, R. and Galea, S., “Public Health in the Precision-Medicine Era,” New England Journal of Medicine 373, no. 6 (2015): 499–501.CrossRefGoogle Scholar
See id.Google Scholar
Srinivasan, S. et al., “Small Is Essential: Importance of Sub-population Research in Cancer Control,” American Journal of Public Health 105, no. S3 (2015): S371–S373.Google Scholar
Pew Research Center, Public and Scientists' Views on Science and Society, January 29, 2015, available at <http://www.pewinternet.org/files/2015/01/PI_ScienceandSociety_Report_012915.pdf> (last visited January 8, 2018). (last visited January 8, 2018).' href=https://scholar.google.com/scholar?q=Pew+Research+Center,+Public+and+Scientists'+Views+on+Science+and+Society,+January+29,+2015,+available+at++(last+visited+January+8,+2018).>Google Scholar
Alford, S. Hensley et al., “Participation in Genetic Testing Research Varies by Social Group,” Public Health Genomics 14, no. 2 (2011): 85–93.CrossRefGoogle Scholar
Persky, S. et al., “Effects of Patient-Provider Race Concordance and Smoking Status on Lung Cancer Risk Perception Accuracy among African-Americans,” Annals of Behavioral Medicine 45, no. 3 (2013): 308–317.CrossRefGoogle Scholar
See Alcaraz, Kreuter, and Bryan, supra note 10.Google Scholar
See, e.g., Kaiser, B.L., Thomas, G.R., and Bowers, B.J., “A Case Study of Engaging Hard-to-Reach Participants in the Research Process: Community Advisors on Research Design and Strategies (CARDS),” Research in Nursing & Health 40, no. 1 (2017): 70–79; E. D. Paskett et al., “Recruitment of Minority and Underserved Populations in the United States: The Centers for Population Health and Health Disparities Experience,” Contemporary Clinical Trials 29, no. 6 (2008): 847-861; A. K. Yancey, A. N. Ortega, and S. K. Kumanyika, “Effective Recruitment and Retention of Minority Research Participants,” Annual Review of Public Health 27 (2006): 1-28.Google Scholar
Manrai, A.K. et al., “Genetic Misdiagnosis and the Potential for Health Disparities,” New England Journal of Medicine 375, no. 7 (2016): 655–665.CrossRefGoogle Scholar
Mancuso, N. et al., “The Contribution of Rare Variation to Prostate Cancer Heritability,” Nature Genetics 48, no. 1 (2016): 30–35.CrossRefGoogle Scholar
Kurian, A. W., “BRCA1 and BRCA2 Mutations across Race and Ethnicity: Distribution and Clinical Implications,” Current Opinions in Obstetrics & Gynecology 22, no. 1 (2010): 72–78.CrossRefGoogle Scholar
John, E. M. et al., “Prevalence of Pathogenic BRCA1 Mutation Carriers in 5 US Racial/Ethnic Groups,” JAMA 298, no. 24 (2007): 2869–2876.CrossRefGoogle Scholar
Malone, K. E. et al., “Prevalence and Predictors of BRCA1 and BRCA2 Mutations in a Population-Based Study of Breast Cancer in White and Black American Women Ages 35 to 64 Years,” Cancer Research 66, no. 16 (2006): 8297–8308.CrossRefGoogle Scholar
Kittles, R. A. et al., “Race, Skin Color and Genetic Ancestry: Implications for Biomedical Research on Health Disparities,” California Journal of Health Promotion 5 (2007): 9–23.Google Scholar
Green, R. C. et al., “ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing,” Genetics in Medicine 15, no. 7 (2013): 565–574.Google Scholar
See, e.g., Burke, W. et al., “Recommendations for Returning Genomic Incidental Findings? We Need to Talk!” Genetics in Medicine 15, no. 11 (2013): 854–859; S. M. Wolf, W. Burke, and B. A. Koenig, “Mapping the Ethics of Translational Genomics: Situating Return of Results and Navigating the Research-Clinical Divide,” Journal of Law, Medicine & Ethics 43, no. 3 (2015): 486-501.CrossRefGoogle Scholar
Johnson, K. J. and Gehlert, S., “Return of Results from Genomic Sequencing: A Policy Discussion of Secondary Findings for Cancer Predisposition,” Journal of Cancer Policy 2, no. 3 (2014): 75–80.CrossRefGoogle Scholar
Hall, M. J. et al., “BRCA1 and BRCA2 Mutations in Women of Different Ethnicities Undergoing Testing for Hereditary Breast-Ovarian Cancer,” Cancer 115, no. 10 (2009): 2222–2233.CrossRefGoogle Scholar
Board of Directors, American College of Medical Genetics and Genomics, “ACMG Policy Statement: Updated Recommendations Regarding Analysis and Reporting of Secondary Findings in Clinical Genome-Scale Sequencing,” Genetics in Medicine 17, no. 1 (2014): 68–69.Google Scholar
Kurian, A. W. et al., “Gaps in Incorporating Germline Genetic Testing into Treatment Decisions-Making for Early-Stage Breast Cancer,” Journal of Clinical Oncology (2017), doi: 10.1200/JCO.2016.71.6480.Google Scholar
Beauchamp, T. L., “Informed Consent: Its History, Meaning, and Present Challenges,” Cambridge Quarterly of Healthcare Ethics 20, no. 4 (2011): 515–523.CrossRefGoogle Scholar
See Grady et al., supra note 4.Google Scholar
See Paasche-Orlow, Taylor, and Brancati, supra note 19.Google Scholar
Beskow, L. M. et al., “Developing a Simplified Consent Form for Biobanking,” PloS One 5, no. 10 (2010): e13302, doi:10.1371/journal.pone.0013302.Google Scholar
Ittenbach, R. F. et al., “Readability and Understanding of Informed Consent among Participants with Low Incomes: A Preliminary Report,” Journal of Empirical Research on Human Research Ethics 10, no. 5 (2015): 444–448.Google Scholar
Kripalani, S. et al., “Clinical Research in Low-Literacy Populations: Using Teach-Back to Assess Comprehension of Informed Consent and Privacy Information,” IRB: Ethics & Human Research 30, no. 2 (2008): 13–19.Google Scholar
Dugosh, K. L. et al., “Measuring Coercion to Participate in Research within a Doubly Vulnerable Population: Initial Development of the Coercion Assessment Scale,” Journal of Empirical Research on Human Research Ethics 5, no. 1 (2010): 93–102.CrossRefGoogle Scholar
Sudore, R. L. et al., “Use of a Modified Informed Consent Process among Vulnerable Patients: A Descriptive Study,” Journal of General Internal Medicine 21, no. 8 (2006): 867–873.Google Scholar
Rounsaville, D. B. et al., “Making Consent More Informed: Preliminary Results from a Multiple-Choice Test Among Probation-Referred Marijuana Users Entering a Randomized Clinical Trial,” Journal of the American Academy of Psychiatry and the Law 36, no. 3 (2008): 354–359.Google Scholar
Steinke, E. E., “Research Ethics, Informed Consent, and Participant Recruitment,” Clinical Nurse Specialist 18, no. 2 (2004): 88–97.CrossRefGoogle Scholar
Heerman, W. J., White, R. O., and Barkin, S. L., “Advancing Informed Consent for Vulnerable Populations,” Pediatrics 135, no. 3 (2015): e562–e564.Google Scholar
See Paasche-Orlow, Taylor, and Brancati, supra note 19.Google Scholar
See Grady et al., supra note 4; Kaye, J. Whitley, E. A., Lund, D., Morrison, M., Teare, H., Melham, K., “Dynamic Consent: A Patient Interface for Twenty-First Century Research Networks,” European Journal of Human Genetics 23, no. 2 (2015): 141–146.CrossRefGoogle Scholar
See Grady et al., supra note 4.Google Scholar
See “All of Us,” supra note 2.Google Scholar
See Grady et al., supra note 4.Google Scholar
El Emam, K. et al., “A Review of Evidence on Consent Bias in Research,” American Journal of Bioethics 13, no. 4 (2013): 42–44; H. F. Lynch, B. E. Bierer, and I. G. Cohen, “Confronting Biospecimen Exceptionalism in Proposed Revisions to the Common Rule,” Hastings Center Report 46, no. 1 (2016): 4-5.Google Scholar
See Grady et al., supra note 4.Google Scholar
Botkin, J. R. et al., “Public Attitudes Regarding the Use of Electronic Health Information and Residual Clinical Tissues for Research,” Journal of Community Genetics 5, no. 3 (2014): 205–213; C. Grady et al., “Broad Consent for Research with Biological Samples: Workshop Conclusions,” American Journal of Bioethics 15, no. 9 (2015): 34-42; C. M. Simon et al., “Active Choice but Not Too Active: Public Perspectives on Biobank Consent Models,” Genetics in Medicine 13, no. 9 (2011): 821-831.CrossRefGoogle Scholar
Brown, K. M. et al., “Differences in Preferences for Models of Consent for Biobanks between Black and White Women,” Journal of Community Genetics 7, no. 1 (2016): 41–49.CrossRefGoogle Scholar
Catz, D. S. et al., “Attitudes about Genetics in Underserved, Culturally Diverse Populations,” Community Genetics 8, no. 3 (2005): 161–172.Google Scholar
Kaphingst, K. A. et al., “Effects of Informed Consent for Individual Genome Sequencing on Relevant Knowledge,” Clinical Genetics 82, no. 5 (2012): 408–415.CrossRefGoogle Scholar
Gaskell, G. et al., “Publics and Biobanks: Pan-European Diversity and the Challenge of Responsible Innovation,” European Journal of Human Genetics 21, no. 1 (2013): 14–20; K. Hoeyer, “The Role of Privacy and Informed Consent in Danish and Swedish Biobank Practices: Exploring Donor Perspectives,” Medical Law International 10, no. 4 (2010): 269-285; K. Hoeyer and L. F. Hogle, “Informed Consent: The Politics of Intent and Practice in Medical Research Ethics,” Annual Review of Anthropology 43 (2014): 347-362; C. McCarty et al., “Community Consultation and Communication for a Population-Based DNA Biobank: The Marshfield Clinic Personalized Medicine Research Project,” American Journal of Medical Genetics A 146A, no. 23 (2008): 3026-3033.CrossRefGoogle Scholar
Koenig, B. A., “Have We Asked Too Much of Consent?” Hastings Center Report 44, no. 4 (2014): 33–34; B. A. Koenig, “Fixing Research Subjects Protection in the United States: Moving Beyond Consent,” Mayo Clinic Proceedings 88, no. 5 (2013): 428-430; K. C. O'Doherty et al., “From Consent to Institutions: Designing Adaptive Governance for Genomic Biobanks,” Social Science & Medicine 73, no. 3 (2011): 367-374.CrossRefGoogle Scholar
Koenig, “Have We Asked,” supra note 71.Google Scholar
See O'Doherty, supra note 71.Google Scholar
Ross, L. F. et al., “Human Subjects Protections in Community-Engaged Research: A Research Ethics Framework,” Journal of Empirical Research on Human Research Ethics 5, no. 1 (2010): 5–18.Google Scholar
See Grady et al., supra note 4.Google Scholar
See supra note 3.Google Scholar
Santos, L., “Genetic Research in Native Communities,” Progress in Community Health Partnerships 2, no. 4 (2008): 321–327.Google Scholar
Salant, T. and Gehlert, S., “Collective Memory, Candidacy, and Victimisation: Community Epidemiologies of Breast Cancer Risk,” Sociology of Health and Illness 30, no. 4 (2008): 599–615.CrossRefGoogle Scholar
See Grady et al., supra note 4.Google Scholar
See, e.g., Komenaka, I. K. et al., “Participation of Low-Income Women in Genetic Cancer Risk Assessment and BRCA 1/2 Testing: The Experience of a Safety-Net Institution,” Journal of Community Genetics 7, no. 3 (2016): 177–183.CrossRefGoogle Scholar
See Ross et al., supra note 65; Ross, L. F. et al., “The Challenges of Collaboration for Academic and Community Partners in a Research Partnership: Points to Consider,” Journal of Empirical Research on Human Research Ethics 5, no. 1 (2010): 19–31; L. F. Ross et al., “Nine Key Functions for a Human Subjects Protection Program for Community-Engaged Research: Points to Consider,” Journal of Empirical Research on Human Research Ethics 5, no. 1 (2010): 33-47.CrossRefGoogle Scholar
See id.Google Scholar