Search Results
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 …
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 …
Data Sharing Policies
Sample informed consent language, aligned with each of the informational elements of consent for genomic data sharing (GDS) outlined by NIH as important to convey, in language understandable to prospective participants.
… required by the federal Food and Drug Administration (FDA). The Certificate also DOES NOT prevent your information …
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 …
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 … RFA-HG-20-044 : Defining Genomic Influence on Gene Network Regulation (U01 Clinical Trial Not Allowed) Expiration Date: …
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 …
Healthcare Provider Genomics Education Resource
Genomics plays a role in every area of nursing, whether nurses are at the bedside providing one-on-one care, treating entire populations, teaching the next generation of nurses, or making discoveries in the lab.
… decisions may increase. There is limited oversight and regulation of companies that offer DTC genetic testing and … tests approved by the U.S. Food and Drug Administration (FDA)  International Society of Nurses in Genetics (ISONG) …
15 Ways Genomics Influences Our World
Genomics is empowering farmers to improve the food supply.
… and eliminate them. The U.S. Food and Drug Administration (FDA) has an entire network set up for whole genome sequencing … tracked new outbreaks in the quest to keep our food safe. FDA scientists work closely with others from the U.S. …
News Release
Researchers are asking if the precision medicine approach will reduce or eliminate the role that race plays in prescribing drugs and in health care overall.
… decade ago, for example, the Food and Drug Administration (FDA) approved the first race-based drug for heart failure in … trend continues: A 2015 review of new drugs approved by FDA between 2008 and 2013, found that one-fifth of the new …
Fact Sheet
Pharmacogenomics is a growing area of genomic medicine that uses a patient's genomic information to help healthcare providers select the medications and dosages that are predicted to work best in each patient.
… such testing is right for them.  Caption: In 2022, 14% of FDA-approved medications had a pharmacogenomic testing …