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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 …
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) …
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 …
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 …
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 …
Policy Issues
Patients with genetic disorders and members of the public have diverse about germline genome editing.
… December 2015, prohibits the Food and Drug Administration (FDA) from reviewing research that involves the creation or …
The Genomics Landscape
In the January 2024 issue of The Genomics Landscape, NHGRI Director Eric Green announces the appointment of Dr. Adam Phillippy as the founding director of the Center for Genomics and Data Science Research (CGDSR).
… exciting news from the U.S. Food and Drug Administration (FDA), which approved two gene therapies for the treatment of … Genomics and Data Science Research NIH statement on new FDA-approved gene therapies for sickle cell disease NHGRI …
News Release
Researchers at the National Institutes of Health (NIH) question advertisements by direct-to-consumer genetic ancestry kits that claim to know what it really means to be American Indian.
… are considered recreational, they aren’t regulated by the FDA. With no regulatory body to oversee their methods, Hull …