Spotlighting Structural Constraints on Decisions About Participation in Genomic and Precision Medicine

References

• Beskow, L. M., J. Y. Friedman, N. C. Hardy, L. Lin, and K. P. Weinfurt. 2010. Developing a simplified consent form for biobanking. PLoS One 5 (10):e13302. doi: 10.1371/journal.pone.0013302.
   PubMed Web of Science ®Google Scholar
• Bohnhoff, J. C., J. M. Taormina, L. Ferrante, D. Wolfson, and K. N. Ray. 2019. Unscheduled referrals and unattended appointments after pediatric subspecialty referral. Pediatrics 144 (6):e20190545. doi: 10.1542/peds.2019-0545.
   PubMed Web of Science ®Google Scholar
• Cakici, J. A., D. Dimmock, S. Caylor, M. Gaughran, C. Clarke, C. Triplett, M. M. Clark, S. F. Kingsmore, and C. S. Bloss. 2023. Assessing diversity in newborn genomic sequencing research recruitment: Race/ethnicity and primary spoken language variation in eligibility, enrollment, and reasons for declining. Clinical Therapeutics 45 (8):736–44. doi: 10.1016/j.clinthera.2023.06.014.
   PubMed Web of Science ®Google Scholar
• Chapman-Davis, E., Z. N. Zhou, J. C. Fields, M. K. Frey, B. Jordan, K. J. Sapra, S. Chatterjee-Paer, A. D. Carlson, and K. M. Holcomb. 2021. Racial and ethnic disparities in genetic testing at a hereditary breast and ovarian cancer center. Journal of General Internal Medicine 36 (1):35–42. doi: 10.1007/s11606-020-06064-x.
   PubMed Web of Science ®Google Scholar
• Coulombe, F., and A. M. Laberge. 2024. The need to consider context: A systematic review of factors involved in the consent process for genetic tests from the perspective of patients. AJOB Empirical Bioethics 15 (2):93–107. doi: 10.1080/23294515.2023.2297935.
   PubMedGoogle Scholar
• Dolan, D. D., M. K. Cho, and S. S.-J. Lee. 2023. Innovating for a just and equitable future in genomic and precision medicine research. The American Journal of Bioethics 23 (7):1–4. doi: 10.1080/15265161.2023.2215201.
   PubMed Web of Science ®Google Scholar
• Dolan, D. D., R. H. Lee, M. K. Cho, and S. S.-J. Lee. 2024. Understanding the gap: A cross-sectional survey exploring the results dissemination practices and translation goals of ELSI scholars. AJOB Empirical Bioethics. 15 (2):147–153. doi: 10.1080/23294515.2024.2355898.
   Google Scholar
• Emanuel, E. J. 2004. Ending concerns about undue inducement. The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 32 (1):100–5. doi: 10.1111/j.1748-720X.2004.tb00453.x.
   PubMed Web of Science ®Google Scholar
• Erwin, D. J., C. LaMaire, A. Espana, T. N. Eble, and S. U. Dhar. 2020. Financial barriers in a county genetics clinic: Problems and solutions. Journal of Genetic Counseling 29 (4):678–88. doi: 10.1002/jgc4.1279.
   PubMedGoogle Scholar
• Fernandez, C. V., E. Kodish, and C. Weijer. 2003. Informing study participants of research results: An ethical imperative. Irb 25 (3):12–9.
   PubMedGoogle Scholar
• Fraiman, Y. S., and M. H. Wojcik. 2021. The influence of social determinants of health on the genetic diagnostic odyssey: Who remains undiagnosed, why, and to what effect? Pediatric Research 89 (2):295–300. doi: 10.1038/s41390-020-01151-5.
   PubMed Web of Science ®Google Scholar
• Garrison, N. A., K. S. Barton, K. M. Porter, T. Mai, W. Burke, and S. R. Carroll. 2019. Access and management: Indigenous perspectives on genomic data sharing. Ethnicity & Disease 29 (Suppl 3):659–68. doi: 10.18865/ed.29.S3.659.
   PubMedGoogle Scholar
• Godard, B., J. Marshall, and C. Laberge. 2007. Community engagement in genetics research: Results of the first public consultation for the Quebec CARGaGENE project. Community Genetics 10 (3):147–58. doi: 10.1159/000101756.
   PubMedGoogle Scholar
• Gene Hallford, H., M. A. Coffman, A. J. Obregon-Tito, A. H. Morales, and L. W. Dean. 2020. Access barriers to genetic services for Spanish-speaking families in states with rapidly growing migrant populations. Journal of Genetic Counseling 29 (3):365–80. doi: 10.1002/jgc4.1195.
   PubMed Web of Science ®Google Scholar
• Grant, P., S. Langlois, L. D. Lynd, J. C. Austin, and A. M. Elliott. 2021. Out-of-pocket and private pay in clinical genetic testing: A scoping review. Clinical Genetics 100 (5):504–21. doi: 10.1111/cge.14006.
   PubMed Web of Science ®Google Scholar
• Haga, S. B., J. M. O’Daniel, G. M. Tindall, I. R. Lipkus, and R. Agans. 2011. Public attitudes toward ancillary information revealed by pharmacogenetic testing under limited information conditions. Genetics in Medicine: Official Journal of the American College of Medical Genetics 13 (8):723–8. doi: 10.1097/GIM.0b013e31821afcc0.
   PubMed Web of Science ®Google Scholar
• Hauser, D., A. O. Obeng, K. Fei, M. A. Ramos, and C. R. Horowitz. 2018. Views of primary care providers on testing patients for genetic risks for common chronic diseases. Health Affairs (Project Hope) 37 (5):793–800. doi: 10.1377/hlthaff.2017.1548.
   PubMed Web of Science ®Google Scholar
• Hiratsuka, V. Y., J. A. Beans, J. W. Blanchard, J. Reedy, E. Blacksher, J. R. Lund, and P. G. Spicer. 2020. An Alaska Native community’s views on genetic research, testing, and return of results: Results from a public deliberation. PLoS One 15 (3):e0229540. doi: 10.1371/journal.pone.0229540.
   PubMed Web of Science ®Google Scholar
• Hoeyer, K., B.-O. Olofsson, T. Mjörndal, and N. Lynöe. 2004. Informed consent and biobanks: A population-based study of attitudes towards tissue donation for genetic research. Scandinavian Journal of Public Health 32 (3):224–9. doi: 10.1080/14034940310019506.
   PubMed Web of Science ®Google Scholar
• Hull, L. E., and J. L. Vassy. 2018. Toward greater understanding of patient decision-making around genome sequencing. Personalized Medicine 15 (1):57–66. doi: 10.2217/pme-2017-0037.
   PubMed Web of Science ®Google Scholar
• Isler, M. R., K. Sutton, R. J. Cadigan, and G. Corbie-Smith. 2013. Community perceptions of genomic research: Implications for addressing health disparities. North Carolina Medical Journal 74 (6):470–6. doi: 10.18043/ncm.74.6.470.
   PubMedGoogle Scholar
• Jabloner, A., and A. Walker. 2023. The pitfalls of genomic data diversity. The Hastings Center Report 53 (5):10–3. doi: 10.1002/hast.1511.
   PubMed Web of Science ®Google Scholar
• Jenkins, B. D., C. G. Fischer, C. A. Polito, D. R. Maiese, A. S. Keehn, M. Lyon, M. J. Edick, M. R. G. Taylor, H. C. Andersson, J. N. Bodurtha, et al. 2021. The 2019 US medical genetics workforce: A focus on clinical genetics. Genetics in Medicine: Official Journal of the American College of Medical Genetics 23 (8):1458–64. doi: 10.1038/s41436-021-01162-5.
   PubMed Web of Science ®Google Scholar
• Joseph, G., R. J. Pasick, D. Schillinger, J. Luce, C. Guerra, and J. K. Y. Cheng. 2017. Information mismatch: Cancer risk counseling with diverse underserved patients. Journal of Genetic Counseling 26 (5):1090–104. doi: 10.1007/s10897-017-0089-4.
   PubMed Web of Science ®Google Scholar
• Kaufman, D., J. Murphy, J. Scott, and K. Hudson. 2008. Subjects matter: A survey of public opinions about a large genetic cohort study. Genetics in Medicine: Official Journal of the American College of Medical Genetics 10 (11):831–9. doi: 10.1097/GIM.0b013e31818bb3ab.
   PubMed Web of Science ®Google Scholar
• Khoury, M. J., S. Bowen, W. D. Dotson, E. Drzymalla, R. F. Green, R. Goldstein, K. Kolor, L. C. Liburd, L. S. Sperling, and R. Bunnell. 2022. Health equity in the implementation of genomics and precision medicine: A public health imperative. Genetics in Medicine: Official Journal of the American College of Medical Genetics 24 (8):1630–9. doi: 10.1016/j.gim.2022.04.009.
   PubMed Web of Science ®Google Scholar
• Largent, E. A., C. Grady, F. G. Miller, and A. Wertheimer. 2012. Money, coercion, and undue inducement: A survey of attitudes about payments to research participants. Irb 34 (1):1–8.
   PubMedGoogle Scholar
• Lee, E. 2019. Our flawed approach to undue inducement in medical research. Bioethics 33 (1):13–8. doi: 10.1111/bioe.12468.
   PubMed Web of Science ®Google Scholar
• Lee, S. S.-J., M. K. Cho, S. A. Kraft, N. Varsava, K. Gillespie, K. E. Ormond, S. Wilfond, and D. Magnus. 2019. “I don’t want to be Henrietta Lacks”: Diverse patient perspectives on donating biospecimens for precision medicine research. Genetics in Medicine: Official Journal of the American College of Medical Genetics 21 (1):107–13. doi: 10.1038/s41436-018-0032-6.
   PubMed Web of Science ®Google Scholar
• Lemke, A. A., W. A. Wolf, J. Hebert-Beirne, and M. E. Smith. 2010. Public and biobank participant attitudes toward genetic research participation and data sharing. Public Health Genomics 13 (6):368–77. doi: 10.1159/000276767.
   PubMed Web of Science ®Google Scholar
• Mackley, M. P., B. Fletcher, M. Parker, H. H. Watkins, and E. Ormondroyd. 2017. Stakeholder views on secondary findings in whole-genome and whole-exome sequencing: A systematic review of quantitative and qualitative studies. Genetics in Medicine: Official Journal of the American College of Medical Genetics 19 (3):283–93. doi: 10.1038/gim.2016.109.
   PubMed Web of Science ®Google Scholar
• Macklin, R. 1981. On paying money to research subjects: ‘Due’ and ‘undue’ inducements. Irb 3 (5):1–6.
   PubMedGoogle Scholar
• Maiese, D. R., A. Keehn, M. Lyon, D. Flannery, and M. Watson. 2019. Current conditions in medical genetics practice. Genetics in Medicine: Official Journal of the American College of Medical Genetics 21 (8):1874–7. doi: 10.1038/s41436-018-0417-6.
   PubMed Web of Science ®Google Scholar
• Mancini, J., I. Pellegrini, F. Viret, N. Vey, L. M. Daufresne, C. Chabannon, and C. Julian-Reynier. 2011. Consent for biobanking: Assessing the understanding and views of cancer patients. Journal of the National Cancer Institute 103 (2):154–7. doi: 10.1093/jnci/djq498.
   PubMedGoogle Scholar
• Master, Z., L. Campo-Engelstein, and T. Caulfield. 2015. Scientists’ perspectives on consent in the context of biobanking research. European Journal of Human Genetics: EJHG 23 (5):569–74. doi: 10.1038/ejhg.2014.143.
   PubMed Web of Science ®Google Scholar
• McCarthy, A. M., M. Bristol, S. M. Domchek, P. W. Groeneveld, Y. Kim, U. N. Motanya, J. A. Shea, and K. Armstrong. 2016. Health care segregation, physician recommendation, and racial disparities in BRCA1/2 testing among women with breast cancer. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 34 (22):2610–8. doi: 10.1200/JCO.2015.66.0019.
   PubMed Web of Science ®Google Scholar
• McDonald, K. E., A. E. Schwartz, and M. Sabatello. 2022. Eligibility criteria in NIH-funded clinical trials: Can adults with intellectual disability get in? Disability and Health Journal 15 (4):101368. doi: 10.18865/ed.29.S3.659.
   PubMed Web of Science ®Google Scholar
• McMahon, C., N. Foti, M. Jeske, W. R. Britton, S. M. Fullerton, J. K. Shim, and S. S.-J. Lee. 2023. Interrogating the value of return of results for diverse populations. AJOB Empirical Bioethics 15 (7):108–119. doi: 10.1080/23294515.2023.2279965.
   PubMedGoogle Scholar
• Mikat-Stevens, N. A., I. A. Larson, and B. A. Tarini. 2015. Primary-care providers’ perceived barriers to integration of genetics services: A systematic review of the literature. Genetics in Medicine: Official Journal of the American College of Medical Genetics 17 (3):169–76. doi: 10.1038/gim.2014.101.
   PubMed Web of Science ®Google Scholar
• Murphy, J., J. Scott, D. Kaufman, G. Geller, L. LeRoy, and K. Hudson. 2009. Public perspectives on informed consent for biobanking. American Journal of Public Health 99 (12):2128–34. doi: 10.2105/AJPH.2008.157099.
   PubMed Web of Science ®Google Scholar
• National Academies of Sciences, Engineering, and Medicine. 2018. Understanding disparities in access to genomic medicine: Proceedings of a workshop. Washington, DC: The National Academies Press. doi: 10.17226/25277.
   Google Scholar
• Neuhaus, C. P., and J. T. Crane. 2021. Experiences at a Federally Qualified Health Center support expanded conception of the gifts of precision medicine. The American Journal of Bioethics 21 (4):70–2. doi: 10.1080/15265161.2021.1891348.
   PubMed Web of Science ®Google Scholar
• Oladayo, A. M., S. Prochaska, T. Busch, W. L. Adeyemo, L. J. J. Gowans, M. Eshete, W. Awotoye, V. Sule, A. Alade, A. A. Adeyemo, et al. 2024. Parents and provider perspectives on the return of genomic findings for cleft families in Africa. AJOB Empirical Bioethics 15 (7):133–146. doi: 10.1080/23294515.2024.2302993.
   PubMedGoogle Scholar
• Omorodion, J., L. Dowsett, R. D. Clark, J. Fraser, A. Abu-El-Haija, A. Strong, M. H. Wojcik, A. S. Bryant, and N. B. Gold. 2022. Delayed diagnosis and racial bias in children with genetic conditions. American Journal of Medical Genetics. Part A 188 (4):1118–23. doi: 10.1002/ajmg.a.62626.
   PubMed Web of Science ®Google Scholar
• Parker, L. S., P. L. Sankar, J. Boyer, J. D. Jean McEwen, and D. Kaufman. 2019. Normative and conceptual ELSI research: What it is, and why it’s important. Genetics in Medicine: Official Journal of the American College of Medical Genetics 21 (2):505–9. doi: 10.1038/s41436-018-0065-x.
   PubMed Web of Science ®Google Scholar
• Penon-Portmann, M., J. Chang, M. Cheng, and J. T. Shieh. 2020. Genetics workforce: Distribution of genetics services and challenges to health care in California. Genetics in Medicine: Official Journal of the American College of Medical Genetics 22 (1):227–31. doi: 10.1038/s41436-019-0628-5.
   PubMed Web of Science ®Google Scholar
• Rajagopalan, R. M., J. Cakici, and C. S. Bloss. 2024. A vision for empirical ELSI along the R&D pipeline. AJOB Empirical Bioethics 15 (2):81–86. doi: 10.1080/23294515.2023.2297931.
   PubMedGoogle Scholar
• Ravitsky, V., and B. S. Wilfond. 2006. Disclosing individual genetic results to research participants. The American Journal of Bioethics 6 (6):8–17. doi: 10.1080/15265160600934772.
   PubMed Web of Science ®Google Scholar
• Roberts, J. L., S. Pereira, and A. L. McGuire. 2017. Should you profit from your genome? Nature Biotechnology 35 (1):18–20. doi: 10.1038/nbt.3757.
   PubMed Web of Science ®Google Scholar
• Sabatello, M., Y. Zhang, Y. Chen, and P. S. Appelbaum. 2020. In different voices: The views of people with disabilities about return of results from precision medicine research. Public Health Genomics 23 (1-2):42–53. doi: 10.1159/000506599.
   PubMed Web of Science ®Google Scholar
• Sanderson, S. C., M. A. Diefenbach, R. Zinberg, C. R. Horowitz, M. Smirnoff, M. Zweig, S. Streicher, E. W. Jabs, and L. D. Richardson. 2013. Willingness to participate in genomics research and desire for personal results among underrepresented minority patients: A structured interview study. Journal of Community Genetics 4 (4):469–82. doi: 10.1007/s12687-013-0154-0.
   PubMedGoogle Scholar
• Savulescu, J. 2001. The fiction of "undue inducement": Why researchers should be allowed to pay participants any amount of money for any reasonable research project. American Journal of Bioethics 1 (2):1g–3g. doi: 10.1162/152651601300169211.
   Google Scholar
• Sedig, L. K., E. H. De Loney, S. B. Bailey, K. Spector-Bagdady, B. Ghita, L. K. Krienke, and R. Hutchinson. 2022. Perspectives from a predominantly African American community about biobank research and a biobank consent form. Ethics & Human Research 44 (4):26–33. doi: 10.1002/eahr.500134.
   PubMedGoogle Scholar
• Simon, C. M., J. L’heureux, J. C. Murray, P. Winokur, G. Weiner, E. Newbury, L. Shinkunas, and B. Zimmerman. 2011. Active choice but not too active: Public perspectives on biobank consent models. Genetics in Medicine: Official Journal of the American College of Medical Genetics 13 (9):821–31. doi: 10.1097/GIM.0b013e31821d2f88.
   PubMed Web of Science ®Google Scholar
• Stewart, C. A., K. E. Cooper, M. B. Raymond, F. E. Fletcher, and V. L. Bonham. 2020. Pragmatic clinical trial-collateral findings: Recognizing the needs of low-resource research participants. The American Journal of Bioethics 20 (1):19–21. doi: 10.1080/15265161.2019.1687786.
   PubMed Web of Science ®Google Scholar
• Thomas, S. P., T. Ranson, R. Willard, F. Fletcher, and V. L. Bonham. 2024. Patient perceptions on the advancement of noninvasive prenatal testing for sickle cell disease among Black women in the United States: Implications for constrained choices. AJOB Empirical Bioethics 15 (2):120–132. doi: 10.1080/23294515.2024.2302996.
   PubMedGoogle Scholar
• Truog, R. D., A. S. Kesselheim, and S. Joffe. 2012. Research ethics. Paying patients for their tissue: The legacy of Henrietta Lacks. Science 337 (6090):37–8. doi: 10.1126/science.1216888.
   PubMedGoogle Scholar
• Tsosie, K. S., J. M. Yracheta, J. A. Kolopenuk, and J. Geary. 2021. We have “gifted” enough: Indigenous genomic data sovereignty in precision medicine. The American Journal of Bioethics 21 (4):72–5. doi: 10.1080/15265161.2021.1891347.
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. 2023. FDA approves first gene therapies to treat patients with sickle cell disease. Last Modified December 8, 2023. Accessed February 28, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease.
   Google Scholar
• Wendler, D. S. 2020. The claims of biospecimen donors to credit and compensation. Trends in Genetics: TIG 36 (9):630–2. doi: 10.1016/j.tig.2020.06.005.
   PubMed Web of Science ®Google Scholar
• Williams, J. K., W. G. Feero, D. L. Veenstra, A. Starkweather, and A. Cashion. 2018. Considerations in initiating genomic screening programs in health care systems. Nursing Outlook 66 (6):570–5. doi: 10.1016/j.outlook.2018.06.008.
   PubMed Web of Science ®Google Scholar
• Wojcik, M. H., M. Bresnahan, M. C. Del Rosario, M. M. Ojeda, A. Kritzer, and Y. S. Fraiman. 2023. Rare diseases, common barriers: Disparities in pediatric clinical genetics outcomes. Pediatric Research 93 (1):110–7. doi: 10.1038/s41390-022-02240-3.
   PubMed Web of Science ®Google Scholar
• Yu, J. H., J. Crouch, S. M. Jamal, H. K. Tabor, and M. J. Bamshad. 2013. Attitudes of African Americans toward return of results from exome and whole genome sequencing. American Journal of Medical Genetics. Part A 161A (5):1064–72. doi: 10.1002/ajmg.a.35914.
   PubMed Web of Science ®Google Scholar