Perspectives on Precision Medicine in a Tribally Managed Primary Care Setting

References

• All of Us Research Program Investigators. 2019. The “All of Us” research program. New England Journal of Medicine 381 (7):668–76.
   PubMed Web of Science ®Google Scholar
• Attride-Stirling, J. 2001. Thematic networks: An analytic tool for qualitative research. Qualitative Research 1 (3):385–405. doi: 10.1177/146879410100100307.
   Google Scholar
• Avey, J. P., V. Y. Hiratsuka, J. A. Beans, S. B. Trinidad, R. F. Tyndale, and R. F. Robinson. 2016. Perceptions of pharmacogenetic research to guide tobacco cessation by patients, providers and leaders in a tribal healthcare setting. Pharmacogenomics 17 (4):405–15. doi: 10.2217/pgs.15.177.
   PubMed Web of Science ®Google Scholar
• Bardill, J., and N. A. Garrison. 2015. Naming indigenous concerns, framing considerations for stored biospecimens. The American Journal of Bioethics 15 (9):73–5. doi: 10.1080/15265161.2015.1062164.
   PubMed Web of Science ®Google Scholar
• Beans, J. A., V. Y. Hiratsuka, C. R. Apok, K. Caindec, D. A. Dillard, and R. F. Robinson. 2018. Community dissemination in a tribal health setting: A pharmacogenetics case study. American Indian and Alaska Native Mental Health Research 25 (1):80–94. doi: 10.5820/aian.2501.2018.80.
   PubMed Web of Science ®Google Scholar
• Bentley, A. R., S. Callier, and C. N. Rotimi. 2017. Diversity and inclusion in genomic research: Why the uneven progress? Journal of Community Genetics 8 (4):255–66. doi: 10.1007/s12687-017-0316-6.
   PubMed Web of Science ®Google Scholar
• Blanchard, J. W., G. Tallbull, C. Wolpert, J. Powell, M. W. Foster, and C. Royal. 2017. Barriers and strategies related to qualitative research on genetic ancestry testing in indigenous communities. Journal of Empirical Research on Human Research Ethics 12 (3):169–79. doi: 10.1177/1556264617704542.
   PubMed Web of Science ®Google Scholar
• Boyer, B. B., G. V. Mohatt, R. L. Pasker, E. M. Drew, and K. K. McGlone. 2007. Sharing results from complex disease genetics studies: A community based participatory research approach. International Journal of Circumpolar Health 66 (1):19–30. doi: 10.3402/ijch.v66i1.18221.
   PubMed Web of Science ®Google Scholar
• Claw, K. G., M. Z. Anderson, R. L. Begay, K. S. Tsosie, K. Fox, N. A. Garrison, A. C. Bader, J. Bardill, D. A. Bolnick, J. Brooks, et al. 2018. A framework for enhancing ethical genomic research with Indigenous communities. Nature Communications 9 (1):2957. doi: 10.1038/s41467-018-05188-3.
   PubMed Web of Science ®Google Scholar
• Driscoll, D. L., V. Hiratsuka, J. M. Johnston, S. Norman, K. M. Reilly, J. Shaw, J. Smith, Q. N. Szafran, and D. Dillard. 2013. Process and outcomes of patient-centered medical care with Alaska Native people at Southcentral Foundation. Annals of Family Medicine 11 (Suppl 1):S41–S9. doi: 10.1370/afm.1474.
   PubMed Web of Science ®Google Scholar
• Eby, D. K. 2007. Primary care at the Alaska Native Medical Center: A fully deployed "new model" of primary care. International Journal of Circumpolar Health 66 (Suppl 1):4–13. http://www.ncbi.nlm.nih.gov/pubmed/18154227.
   PubMed Web of Science ®Google Scholar
• Fiore, R. N., and K. W. Goodman. 2016. Precision medicine ethics: Selected issues and developments in next-generation sequencing, clinical oncology, and ethics. Current Opinion in Oncology 28 (1):83–7. doi: 10.1097/cco.0000000000000247.
   PubMed Web of Science ®Google Scholar
• Fohner, A. E., R. Robinson, J. Yracheta, D. A. Dillard, B. Schilling, B. Khan, S. Hopkins, B. B. Boyer, J. Black, H. Wiener, et al. 2015. Variation in genes controlling warfarin disposition and response in American Indian and Alaska Native people: CYP2C9, VKORC1, CYP4F2, CYP4F11, GGCX. Pharmacogenetics and Genomics 25 (7):343–53. doi: 10.1097/fpc.0000000000000143.
   PubMed Web of Science ®Google Scholar
• Gottlieb, K. 2013. The Nuka System of Care: Improving health through ownership and relationships. International Journal of Circumpolar Health 72 (1):21118. doi: 10.3402/ijch.v72i0.21118.
   PubMed Web of Science ®Google Scholar
• Gottlieb, K., and M. Tierney. 2015. Healthcare at its best: Southcentral Foundation’s core concepts training. Reflections 13 (2):35–45.
   Google Scholar
• Hennink, M. M., B. N. Kaiser, and V. C. Marconi. 2017. Code saturation versus meaning saturation: How many interviews are enough? Qualitative Health Research 27 (4):591–608. doi: 10.1177/1049732316665344.
   PubMed Web of Science ®Google Scholar
• Hiratsuka, V. Y., J. A. Beans, R. F. Robinson, J. L. Shaw, I. Sylvester, and D. A. Dillard. 2017. Self-determination in health research: An Alaska Native example of tribal ownership and research regulation. International Journal of Environmental Research and Public Health 14 (11):1324. doi: 10.3390/ijerph14111324.
   PubMed Web of Science ®Google Scholar
• Hiratsuka, V. Y., J. Brown, and D. Dillard. 2012. Views of biobanking research among Alaska native people: The role of community context. Progress in Community Health Partnerships: Research, Education, and Action 6 (2):131–9. doi: 10.1353/cpr.2012.0025.
   PubMedGoogle Scholar
• Hiratsuka, V. Y., J. K. Brown, T. J. Hoeft, and D. A. Dillard. 2012. Alaska native people's perceptions, understandings, and expectations for research involving biological specimens. International Journal of Circumpolar Health 71:18642. doi: 10.3402/ijch.v71i0.18642.
   PubMed Web of Science ®Google Scholar
• Hiratsuka, V. Y., S. B. Trinidad, J. P. Avey, and R. F. Robinson. 2016. Application of the PEN-3 model to tobacco initiation, use, and cessation among American Indian and Alaska Native adults. Health Promot Pract 17 (4):471–81. doi: 10.1177/1524839916648909.
   PubMed Web of Science ®Google Scholar
• Hodge, F. S. 2012. No meaningful apology for American Indian unethical research abuses. Ethics & Behavior 22 (6):431–44. doi: 10.1080/10508422.2012.730788.
   Web of Science ®Google Scholar
• James, R., R. Tsosie, P. Sahota, M. Parker, D. Dillard, I. Sylvester, J. Lewis, J. Klejka, L. Muzquiz, P. Olsen, et al. 2014. Exploring pathways to trust: A tribal perspective on data sharing. Genetics in Medicine 16 (11):820–6. doi: 10.1038/gim.2014.47.
   PubMed Web of Science ®Google Scholar
• Kraft, S. A., M. K. Cho, K. Gillespie, M. Halley, N. Varsava, K. E. Ormond, H. S. Luft, B. S. Wilfond, and S. Soo-Jin Lee. 2018. Beyond consent: Building trusting relationships with diverse populations in precision medicine research. The American Journal of Bioethics 18 (4):3–20. doi: 10.1080/15265161.2018.1431322.
   PubMed Web of Science ®Google Scholar
• Khoury, M. J., M. F. Iademarco, and W. T. Riley. 2016. Precision public health for the era of precision medicine. American Journal of Preventive Medicine 50 (3):398–401. doi: 10.1016/j.amepre.2015.08.031.
   PubMed Web of Science ®Google Scholar
• Lyles, C. R., M. R. Lunn, J. Obedin-Maliver, and K. Bibbins-Domingo. 2018. The new era of precision population health: Insights for the All of Us Research Program and beyond. Journal of Translational Medicine 16 (1):211. doi: 10.1186/s12967-018-1585-5.
   PubMed Web of Science ®Google Scholar
• Mello, M. M., and L. E. Wolf. 2010. The Havasupai Indian tribe case-lessons for research involving stored biologic samples. The New England Journal of Medicine 363 (3):204–7. doi: 10.1056/NEJMp1005203.
   PubMed Web of Science ®Google Scholar
• Mitchell, F. M. 2012. Reframing diabetes in American Indian communities: A social determinants of health perspective. Health & Social Work 37 (2):71–9. doi: 10.1093/hsw/hls013.
   PubMed Web of Science ®Google Scholar
• National Institutes of Health, Office of Extramural Research. 2001. NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research. Bethesda, MD: National Institutes of Health, Office of Extramural Research.
   Google Scholar
• Paneth, N., and S. H. Vermund. 2018. Human molecular genetics has not yet contributed to measurable public health advances. Perspectives in Biology and Medicine 61 (4):537–49. doi: 10.1353/pbm.2018.0063.
   PubMed Web of Science ®Google Scholar
• Popejoy, A. B., and S. M. Fullerton. 2016. Genomics is failing on diversity. Nature 538 (7624):161–4. doi: 10.1038/538161a.
   PubMed Web of Science ®Google Scholar
• Prince, A. E. R., and B. E. Berkman. 2018. Reconceptualizing harms and benefits in the genomic age. Personalized Medicine 15 (5):419–28. doi: 10.2217/pme-2018-0022.
   PubMed Web of Science ®Google Scholar
• Pritchard, D. E., F. Moeckel, M. S. Villa, L. T. Housman, C. A. McCarty, and H. L. McLeod. 2017. Strategies for integrating personalized medicine into healthcare practice. Personalized Medicine 14 (2):141–52. doi: 10.2217/pme-2016-0064.
   PubMed Web of Science ®Google Scholar
• Rodriguez, L. L., L. D. Brooks, J. H. Greenberg, and E. D. Green. 2013. Research ethics. The complexities of genomic identifiability. Science 339 (6117):275–6. doi: 10.1126/science.1234593.
   PubMed Web of Science ®Google Scholar
• Sankar, P. L., and L. S. Parker. 2017. The precision medicine initiative’s All of Us Research Program: An agenda for research on its ethical, legal, and social issues. Genetics in Medicine 19 (7):743–50. doi: 10.1038/gim.2016.183.
   PubMed Web of Science ®Google Scholar
• Santos, L. 2008. Genetic research in native communities. Progress in Community Health Partnerships: Research, Education, and Action 2 (4):321–7. doi: 10.1353/cpr.0.0046.
   PubMedGoogle Scholar
• Shaibi, G. Q., I. J. Kullo, D. P. Singh, R. R. Sharp, E. De Filippis, I. Cuellar, V. Hernandez, S. Levey, C. R. Breitkop, J. E. Olson, et al. 2018. Developing a process for returning medically actionable genomic variants to Latino patients in a Federally Qualified Health Center. Public Health Genomics 21 (1-2):77–84. doi: 10.1159/000494488.
   PubMed Web of Science ®Google Scholar
• Shaw, J. L., R. Robinson, H. Starks, W. Burke, and D. A. Dillard. 2013. Risk, reward, and the double-edged sword: Perspectives on pharmacogenetic research and clinical testing among Alaska Native people. American Journal of Public Health 103 (12):2220–5. doi: 10.2105/ajph.2013.301596.
   PubMed Web of Science ®Google Scholar
• Sirugo, G., S. M. Williams, and S. A. Tishkoff. 2019. The missing diversity in human genetic studies. Cell 177 (1):26–31. doi: 10.1016/j.cell.2019.02.048.
   PubMed Web of Science ®Google Scholar
• Smirnoff, M., I. Wilets, D. F. Ragin, R. Adams, J. Holohan, R. Rhodes, G. Winkel, E. M. Ricci, C. Clesca, and L. D. Richardson. 2018. A paradigm for understanding trust and mistrust in medical research: The community VOICES study. AJOB Empirical Bioethics 9 (1):39–47. doi: 10.1080/23294515.2018.1432718.
   PubMedGoogle Scholar
• Spratt, D. E., T. Chan, L. Waldron, C. Speers, F. Y. Feng, O. O. Ogunwobi, and J. R. Osborne. 2016. Racial/ethnic disparities in genomic sequencing. JAMA Oncology 2 (8):1070–4. doi: 10.1001/jamaoncol.2016.1854.
   PubMed Web of Science ®Google Scholar
• Taylor, H. A. 2009. Inclusion of women, minorities, and children in clinical trials: Opinions of research ethics board administrators. Journal of Empirical Research on Human Research Ethics 4 (2):65–73. doi: 10.1525/jer.2009.4.2.65.
   PubMed Web of Science ®Google Scholar
• The Tribal Collaboration Working Group. 2018. Considerations for meaningful collaboration with tribal populations. https://allofus.nih.gov/sites/default/files/tribal_collab_work_group_rept.pdf
   Google Scholar
• Woodahl, E. L., L. J. Lesko, S. Hopkins, R. F. Robinson, K. E. Thummel, and W. Burke. 2014. Pharmacogenetic research in partnership with American Indian and Alaska Native communities. Pharmacogenomics 15 (9):1235–41. doi: 10.2217/pgs.14.91.
   PubMed Web of Science ®Google Scholar
• Zebrowski, A. M., D. E. Ellis, F. K. Barg, N. R. Sperber, B. A. Bernhardt, J. C. Denny, P. R. Dexter, G. S. Ginsburg, C. R. Horowitz, J. A. Johnson, et al. 2019. Qualitative study of system-level factors related to genomic implementation. Genetics in Medicine 21 (7):1534–40. doi: 10.1038/s41436-018-0378-9.
   PubMed Web of Science ®Google Scholar