Search Results
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
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 …
Genomics and Medicine
The NHGRI Genomic Medicine Working Group has compiled a list of interesting advances.
… of interesting advances and helpful educational resources in genomic medicine. To submit notable accomplishments for … notable accomplishments: 2023 Genomic Medicine Year in Review 2022 Genomic Medicine Year in Review 2021 Genomic … Milestones In Medicine, Clinical Implementation Of Genomics, Pharmacogenomics, Oncology Sequencing, …
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 …
Research Funding
The centers study in innovative ways to address important ethical, legal, and social issues related to advances in genomics.
… Program has funded research grants from investigators in a wide range of disciplines. Many of these projects have … rapidly to the large number of emerging and evolving ELSI issues is critical. All of these factors contribute to a need … genomic sciences, clinical research, clinical and health policy, ethics, law, the humanities, economics, political …
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 …
The Genomics Landscape
In the July 2020 edition of The Genomics Landscape, NHGRI Director Eric Green recalls the White House event announcing the draft human genome sequence.
… call to your attention to a recently published editorial in Science that describes a new NIH guidance that holds … the NHGRI ELSI Research Program, and discussion of a policy on review of ISCC materials and dissemination. The … improving genomic literacy of healthcare providers … ACMG issues statement regarding genomic data and electronic health …