TY - JOUR
T1 - Commentary
T2 - Ethical and legal considerations for the inclusion of underserved and underrepresented immigrant populations in precision health and genomic research in the United States
AU - Wagner, Jennifer K.
N1 - Funding Information:
The 21stCentury Cures Act (Pub. L. 114-255, 130 Stat. 1033 et seq. (2016)) is particularly important to the inclusion of immigrants in ge nomic research and precision health initiatives. Generally speaking, legal status is not itself considered pro tected health information under the Health Information Portability and Accountability Act (HIPAA). As per the 21st Century Cures Act §2012, the NIH automatically is sues a “Certificate of Confidential ity” for collection of identifiable, sensitive information collected for biomedical, behavioral, and clini cal research funded wholly or par tially by the NIH. Compliance by NIH-funded researchers with the nondisclosure responsibilities is mandatory, and data collected in such a study cannot be disclosed without the participant’s consent even as part of most legal proceed ings. Participants need not be US citizens or reside in the US in order to fall under a certificate’s protec tive umbrella, and the protections are to last in perpetuity.26While certificates protect any copies of the data, placement of research data into an EHR might compromise the confidentiality shield in ways not yet thoroughly understood.
Funding Information:
This work was funded in part by Grant No. 5R00HG006446-05 from the Na tional Human Genome Research Institute (NHGRI). The content of this article is the author’s responsibility and might not represent the official views of the author’s funding sources, employers, clients, or any other person or entity. The author has no financial, personal, academic, or other conflicts of interest in the subject matter discussed in this manuscript. The author is grateful to the organizers of the “Law, Genomic Medicine & Health Equity: How Can Law Support Genomics and Precision Medicine to Advance the Health of Underserved Populations” symposium for the opportunity to contribute to the discussion. The author discloses receipt of an honorarium for contributing this work as part of the symposium but otherwise has no competing or conflicts of interest to disclose.
Publisher Copyright:
© 2019 Ethnicity and Disease, Inc.. All rights reserved.
PY - 2019
Y1 - 2019
N2 - There has been growing recognition of the importance of diversity and inclusion of underrepresented minority populations, including immigrants, in genomic research and precision medicine. Achieving diversity has been difficult and has led some scholars to question whether the law is a help or a threat to the inclusion of underserved and underrepresented immigrant populations. In this commentary, I provide an overview of some of the many relevant legal issues affecting the inclusion of immigrants in genomic research and precision health initiatives, such as the All of UsSM Research Program. Development of research recruitment, retention, and data collection plans without also considering the legal and sociopolitical context within which such efforts are to be carried out is risky. Advancing health policy with a goal of eliminating health disparities (or, at a minimum, ensuring that health disparities are not exacerbated by genomic or precision health technologies) requires us to acknowledge the negative effects that immigration policy and criminal justice policy have on the involvement of immigrants in such research and on their health directly. I conclude that it is not a question of whether the law is a help or a threat but, rather, whether we collectively will prioritize authentic diversity and inclusion policies and also insist on compliance with the laws intended to ensure the human right of every individual – regardless of immigration status or national origin – to share in the advancement of science.
AB - There has been growing recognition of the importance of diversity and inclusion of underrepresented minority populations, including immigrants, in genomic research and precision medicine. Achieving diversity has been difficult and has led some scholars to question whether the law is a help or a threat to the inclusion of underserved and underrepresented immigrant populations. In this commentary, I provide an overview of some of the many relevant legal issues affecting the inclusion of immigrants in genomic research and precision health initiatives, such as the All of UsSM Research Program. Development of research recruitment, retention, and data collection plans without also considering the legal and sociopolitical context within which such efforts are to be carried out is risky. Advancing health policy with a goal of eliminating health disparities (or, at a minimum, ensuring that health disparities are not exacerbated by genomic or precision health technologies) requires us to acknowledge the negative effects that immigration policy and criminal justice policy have on the involvement of immigrants in such research and on their health directly. I conclude that it is not a question of whether the law is a help or a threat but, rather, whether we collectively will prioritize authentic diversity and inclusion policies and also insist on compliance with the laws intended to ensure the human right of every individual – regardless of immigration status or national origin – to share in the advancement of science.
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U2 - 10.18865/ed.29.S3.641
DO - 10.18865/ed.29.S3.641
M3 - Review article
C2 - 31889769
AN - SCOPUS:85077207458
SN - 1049-510X
VL - 29
SP - 641
EP - 650
JO - Ethnicity and Disease
JF - Ethnicity and Disease
ER -