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The Genomics Landscape
In the February 2, 2023 edition of The Genomics Landscape, NHGRI Director, Eric Green, M.D., Ph.D., talks about the new NIH Data Management and Sharing (DMS) Policy and how it emphasizes the importance of good data management practices.
… date for the new NIH Data Management and Sharing (DMS) Policy occurred last month – January 25, 2023. The DMS Policy emphasizes the importance of good data management … data to explore new frontiers of discovery. Though the policy was published two years ago, many may still be unsure …
Staff
Leonard Ross is the director of the Ethics Branch at the National Human Genome Research Institute.
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… ethical conduct, human resources, conflicts of interest, federal policy … Leonard Ross is the director of the Ethics Branch at …
Staff
Rebecca Hong is a scientific program analyst in the Policy and Program Analysis Branch at the National Human Genome Research Institute.
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… Rebecca Hong is a scientific program analyst for the Policy and Program Analysis Branch (PPAB) at the National … Institute (NHGRI). Her responsibilities in PPAB include policy analysis, policy development, coding and reporting, workshop …
Staff
Cristina Kapustij was the chief of the Policy and Program Analysis Branch at the National Human Genome Research Institute until June 2024.
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… Cristina Kapustij, M.S., is chief of the Policy and Program Analysis Branch at the National Human … Kapustij spearheads the branch’s efforts to understand the policy implications of genomics research and technologies, … policy responses to potential changes in state and federal legislation; coordinated interactions with the Food …
Policy Issues
Most genetic tests today are not regulated, meaning that they go to market without any independent analysis to verify the claims of the seller.
… analysis to verify the claims of the seller. … Several federal agencies regulate genetic tests: the Food and Drug … Centers for Medicare and Medicaid Services (CMS), and the Federal Trade Commission (FTC). Genetic and Genomic tests, … in 2010 the FDA announced plans to move away from a policy of "enforcement discretion" (see next section, "FDA …
Staff
Elena Ghanaim is the Policy Advisor for Data Science and Sharing within the Office of Genomic Data Science (OGDS) at the National Human Genome Research Institute (NHGRI)
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… Elena Ghanaim is the Policy Advisor for Data Science and Sharing within the Office … (NHGRI). She spearheads NHGRI’s scientific data sharing policy development, oversight, and implementation. Ms. … NIH and grantee partners on data sharing and privacy policy issues. For the last three years, she has advised the …
Policy Issues
Revisions to the Common Rule modernize, simplify, and enhance oversight for human subjects research in the United States.
… The final version of the Common Rule was published in the Federal Register on January 19, 2017, following the … a one-time posting requirement to make them available on a federal website. Broad Consent (.116(d)) The Final Rule … follow-up (.109(f)). Tribal Sovereignty (.101(f)) The policy, as before, does not affect state or local laws and …
Policy Issues
Participating in genomics research is an opportunity to support exploration of the genome and help scientists understand, prevent, detect and treat disease.
… research? Research participants are protected by a set of federal regulations, known as the Common Rule, which ensures … such as in the case of a subpoena. There is also a Federal law called the Health Insurance Portability and … understand, prevent, detect and treat disease. … Policy Issues …
Policy Issues
Clinical research may yield new health-related information about volunteers who have chosen to participate in the studies.
… to examine these questions and inform future NHGRI policy. … IRRs are the results for a specific study … for returning IRRs and IFs. … Currently, the only federal law regarding return of genetic IRRs and IFs is the … that the research that it funds comply with all applicable federal, state, and local laws, which includes CLIA. NHGRI …
News Release
American Indians and Alaska Natives IRB training programs at NIH ensure the welfare of people participating in federally regulated research.
… came when she reviewed the January 2017 final rule for the Federal Policy for the Protection of Human Subjects, 45 C.F.R. 46 … said. "We couldn't just say, 'here's how we do it in the federal government.'" The NIH IRB training program began …