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Max Researcher, at the Prestigious University’s Genomic Research Institute, plans a study of gene networks within the human genome thought to be involved in metabolic regulation.[i],[ii] The National Human Genome Research Institute fund Max’s study and the Institute as part of a broad coalition of U.S. universities and research institutes conducting genomic sequencing to further the study of an array of diseases. Max’s study will compare the genes across individuals to identify potentially significant variations that may shed light on mechanisms and risks for metabolic syndromes (e.g., increased blood pressure, insulin regulation, fat storage patterns) associated with serious conditions like heart disease, stroke, and diabetes.[iii],[iv],[v] Max will recruit and collect blood and saliva samples from participants that will allow her to test for genetic biomarkers of interest and combine data from these genetic samples with genetic data obtained from the coalition database; she may collect additional data types (e.g., clinical, environmental). No data whatsoever from HIPAA covered entities are used in this study. Participants volunteer for the study on the basis of responding to public advertising.

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[iii] Department of Health and Human Services. National Human Genome Research Institute. Funding Opportunity: Centers for Common Disease Genomics. http://grants.nih.gov/grants/guide/rfa-files/RFA-HG-15-001.html

[iv] National Institutes of Medicine, National Library of Medicine. Genetics Home Reference. https://ghr.nlm.nih.gov/handbook/genomicresearch?show=all

[v] National Human Genome Research Institute. http://www.genome.gov/27563453

[vi] The Precision Medicine Initiative Cohort Program – Building a Research Foundation for 21st Century Medicine. Precision Medicine Initiative (PMI) Working Group Report to the Advisory Committee to the Director, NIH. September 17, 2015. http://www.nih.gov/sites/default/files/research-training/initiatives/pmi/pmi-working-group-report-20150917-2.pdf

[vii] The Secretary’s Advisory Committee for Human Research Protections (SACHRP).  http://www.hhs.gov/ohrp/sachrp/index.html

 

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ory Committee for Human Research Protections (SACHRP).  http://www.hhs.gov/ohrp/sachrp/index.html