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Policy Issues
NHGRI has created the IDE Greenhouse as an educational resource to help increase understanding of the regulation in the genomics context.
… sequencing (NGS) and other genomic tests to be in vitro diagnostic devices (IVDs), a type of medical device. … to help understand the regulation in the context of genomics. Genomic studies that were either successfully … understanding of the regulation in the genomics context. … Policy Issues …
The Genomics Landscape
In the September 3, 2020 edition of The Genomics Landscape, Dr. Eric Green talks about the Impact of Genomic Variation on Function (IGVF) Consortium, the 2020 Genomic Innovator Awards and more.
… from home. If you are seeking some virtual connections to genomics, I would like to offer some “remote learning” … 30th anniversary of the launch of the Human Genome Project in October 2020. Check out the latest oral histories by … and she continues to play a key role in data sharing policy development and implementation as co-chair of NHGRI’s …
The Genomics Landscape
In the June 2021 issue of The Genomics Landscape, NHGRI Director, Eric Green, M.D., Ph.D. details the upcoming appointment of acting NHGRI Deputy Director, Vence Bonham Jr., J.D. and what it means for the institute.
… is the 5th session of the “ Bold predictions for human genomics by 2030 ” seminar series, which takes place on … include webinars and Twitter chats (see additional details in the story below). All the best, … Embrace the … Vence is familiar with NHGRI’s long-standing leadership on issues related to diversity in genomics. Most recently, he …
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
The 9 steps a bill can go through before becoming a law, using the Genetic Information Non-Discrimination Act of 2003 as an example.
… Nondiscrimination Act (GINA), a law that was passed in 2008 and impacts the field of genomics, provides an excellent example of the legislative … Non-Discrimination Act of 2003 as an example. … Policy Issues …
The Genomics Landscape
In the June 2020 edition of The Genomics Landscape, NHGRI Director Eric Green details NHGRI's new Diversity in Genomics Workforce Initiative.
… difficult time, with the events of the last week in cities across the United States on top of the illness, … and inclusion a priority. As I have mentioned in previous issues of The Genomics Landscape , several government … Library of Medicine (NLM) is proposing a change in policy related to its Sequence Read Archive (SRA). The SRA …
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
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 …