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National Advisory Council for Human Genome Research
The Director's Report-Related Documents contain links to materials supplemental to Dr. Eric Green's Director's Report presentation to the National Advisory Council for Human Genome Research in February 2024.
… 10 Re-Envisioning NIH-Supported Postdoctoral Training 11 FDA Proposed Rule for LDT Oversight and Regulation FDA Proposed Rule Association for Molecular Pathology …
The Genomics Landscape
In the September 2023 edition of The Genomics Landscape, NHGRI Director Eric Green, recaps the April 2023 virtual reunion of the leaders of the five genome-sequencing centers (G5), where they tell the untold story on how they ushered the Human Genome Project across the finish line in 2003.
… trial not allowed and clinical trial required NIH, CDC and FDA for small business innovation research grant applications …
Fact Sheets
Cloning describes a number of different processes that can be used to produce genetically identical copies of a biological entity.
… experts in cloning, the U.S. Food and Drug Administration (FDA) decided in January 2008 that meat and milk from cloned … goats, are as safe as those from non-cloned animals. The FDA action means that researchers are now free to using …
The Genomics Landscape
In the April 2019 edition of The Genomics Landscape, NHGRI Director Eric Green previews the redesigned genome.gov website and its new features.
… Rob Stein GDPR: Crossing the Data Sharing Bridge, One Regulation at a Time Genome: Unlocking Life's Code March 2019 …
For Health Professionals
The ISCC-PEG Pharmacogenomics (PGx) Project Group has developed peer-reviewed online education for healthcare practitioners to advance pharmacogenomics in clinical practice.
… resources from the Food and Drug Administration (FDA), the Clinical Pharmacogenetics Implementation Consortium …
Clinical Research
The Institutional Review Board (IRB)Â is responsible for protecting the rights and welfare of the human subjects of research protocols that are conducted by intramural investigators in NHGRI and a number of other institutes.
… (OHRP) OHRP Approved Federal-Wide Assurances (FWAs) FDA Guidance for IRBs, Clinical Investigators and Sponsors  FDA Investigator-Initiated Investigational New Drug (IND) …
National Advisory Council for Human Genome Research
The Director's Report Related documents contain links to materials supplemental to Dr. Eric Green's Director's Report presentation to the National Advisory Council for Human Genome Research in May 2019.
… Food and Drug Administration and National Cancer Institute FDA Commissioner Gottlieb, Who Raised Alarms about Teen … Vaping, Resigns NCI Director Norman Sharpless Named Acting FDA chief  5 New Director, NIH Center for Scientific Review … Gasperini - A Genome-Wide Framework for Mapping Gene Regulation via Cellular Genetic Screens ENCODE Consortium …
For Patients and Families
​Clinical research is research conducted with human subjects, or material of human origin, in which the researcher directly interacts with human subjects.
… done after the drug or treatment has been approved by the FDA and marketed for public use. These studies continue … for Genomics Research ). The Food and Drug Administration (FDA) provides details about informed consent with the … information page: Informed Consent for Clinical Trials [fda.gov].  … Clinical researchers at the National Human …
The Genomics Landscape
In the September 2021 issue of The Genomics Landscape, NHGRI Director, Eric Green, M.D., Ph.D., details how social media provides NHGRI staff with a space to talk about their work, make genomics topics easy to understand, and show how genomics can positively affect people.
… of Health (NIH) and the Food and Drug Administration (FDA) to gather information about some cutting-edge biomedical … research technologies. Specifically, the NIH and FDA Joint Leadership Council Next-Generation Sequencing and …
Research Funding
NHGRI is initiating a new program-the Impact of Genomic Variation on Function (IGVF) Consortium to develop a framework for systematically understanding the effects of genomic variation on genome function and how these effects shape phenotypes.
… of variants and elements impacting transcriptional regulation in dynamic cellular systems HG011966 Lea Starita … Cancer Research Deciphering the genomics of gene network regulation of T cell and fibroblast states in autoimmune … better understand the impact of genetic variation on gene regulation. In collaboration with other IGVF teams they will …