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The Genomics Landscape
In the December 2024 issue of The Genomics Landscape, NHGRI Director Eric Green highlights the keynote speaker at the institute's annual symposium, Kate Rubins, a biologist and NASA astronaut who was the first person to sequence DNA in space.
… had a wonderful time catching up with so many genetics and genomics colleagues at the American Society of Human Genetics (ASHG) Annual Meeting last month in snowy Denver. In addition to meeting with the ASHG Board … and Capacity Building Efforts Related to Bioethical Issues  Building Sustainable Software tools for Open Science …
The Genomics Landscape
In the July 2021 issue of The Genomics Landscape, NHGRI Director, Eric Green, M.D., Ph.D., reflects on the legacy the LINCS program leaves as it has completed its goal of creating a large-scale, systematically generated molecular and cellular dataset.
… telework over the last 17 months will undoubtedly result in some changes to how NIH staff members function, as (like … for our work and lives.  Also, in last month’s The Genomics Landscape , I reported my intention to appoint Vence … synthesis; adaptation in modern biology and genetics; issues of race and genetic exceptionalism; the status of the …
Policy Issues
Federally-funded research with human participants must comply with regulations that protect the rights and welfare of the participants.
… The use of human participants in biomedical, clinical and social-behavioral research can … funded by or carried out at NIH, is subject to the Federal Policy for the Protection of Human Research Subjects, or … genomes as part of a research study raises a number of issues that the informed consent process needs to address, …
Policy Issues
Clinical research may yield new health-related information about volunteers who have chosen to participate in the studies.
… about volunteers who have chosen to participate in the studies. This raises the question of when and how it … and incidental findings (IFs) from genomic research. These issues are not new or unique to genomics, but advances in … to examine these questions and inform future NHGRI policy. … IRRs are the results for a specific study …
Policy Issues
In 2008, the Genetic Information Nondiscrimination Act was passed into law, prohibiting discrimination by employers and health insurers.
… Many Americans wonder if participating in genetics research or undergoing genetic testing will lead … an informed consent resource  for participants in genomics research. … Some workplaces implement wellness … discrimination by employers and health insurers. … Policy Issues …
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.
… genetic and genomic tests are becoming more common in, and out of, the clinic. Yet most genetic tests today are … in 2010 the FDA announced plans to move away from a policy of "enforcement discretion" (see next section, "FDA … analysis to verify the claims of the seller. … Policy Issues …
Staff
Dr. Dave Kaufman is a program director Division of Genomics and Society​ at the National Human Genome Research Institute.
… the National Human Genome Research Institute (NHGRI) in May of 2014, after working as an NHGRI ELSI grantee for … He also focuses on big data and stakeholder engagement issues. Visit the ELSI Research Areas  webpage for more … … Dave Kaufman, Ph.D. … Dave Kaufman, return of results policy, ethical legal and social implications, genomic …
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 … given that local IRBs will have more insight into ethical issues that require consideration (.114). Enforced compliance … follow-up (.109(f)). Tribal Sovereignty (.101(f)) The policy, as before, does not affect state or local laws and …
Policy Issues
Informed consent shows respect for personal autonomy and is an important ethical requirement in research.
… Researchers and research participants should engage in a dialogue to understand the specific considerations … For instance, the NIH Genomic Data Sharing (GDS) policy expects that researchers obtain consent when they plan … is an important ethical requirement in research. … Policy Issues …
Policy Issues
The GINA is an important U.S. civil rights law that protects individuals from discrimination based on their genetic information.
… It was first introduced into the U.S. Congress in the 1990s at a time when genetic testing and genetics … for their leadership on genetic nondiscrimination issues, but they were assisted by other members of Congress … from discrimination based on their genetic information. … Policy Issues …