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Research Training
A fellowship that will prepare fellows to use genetic, genomic and pharmacogenomic approaches to advance minority health and health equity.
… Office of Minority Health and Health Equity (FDA OMHHE) , is open for applications. The fellowship … unique experiences by working closely with mentors at both FDA OMHHE, Center for Drug Evaluation and Research (CDER) and … broadly related to: Fellows will gain experience in FDA OMHHE’s and NHGRI's Intramural Research Program efforts …
The Informed Consent Resource
Explore the basic elements of informed consent that are required by the Common Rule and that are relevant to genomics.
… or not possible and what the process is. OHRP and the FDA have both provided guidance related to withdrawal from … the analysis described in the IRB-approved protocol. The FDA guidance also states that destruction of samples that …
News Release
NIH will award $38.5 million over five years to the Developmental Genotype-Tissue Expression (dGTEx) project, which aims to build a widely available resource of human developmental gene expression in a multitude of tissues for use in basic and clinical research.
News Release
Researchers analyzing human, fly, and worm genomes have found these species have key genomic processes in common, reflecting their shared ancestry.
… Nature , offer insights into embryonic development, gene regulation and other biological processes vital to … how chromatin is organized and how it influences gene regulation in the three species. Using both modENCODE and … a third study, scientists explored similarities in genome regulation. Scientists focused on transcription-regulatory …
Research Funding
The three research domains to be considered for support by the NHGRI Ethical, Legal and Social Implications Research Program.
… Genomics and the Rights of Individuals and Groups Law, Regulation and Policy Governing Genomics Industry, Commerce … examine system-level influences on: the direction and regulation of genomic science, research and technology … Clinical Laboratory Improvement Amendments [CLIA], FDA regulations, EU General Data Protection Regulation …
Healthcare Provider Genomics Education Resource
An FAQ designed to help healthcare professionals understand the diverse landscape of direct-to-consumer (DTC) genetic testing and the benefits and limitations of these tests.
… Timeline of direct-to-consumer genetic testing (DTC-GT). FDA = Food and Drug Administration; GAO = US Government … at $1,000.  2010:  The Food and Drug Administration (FDA) initiated regulatory proceedings against DTC-GT … to locate the suspect. 7 Additionally, there is little regulation of these services.  Raw-data results still need …
News Release
NIH will fund researchers to develop computational approaches to figure out which differences in DNA make people more susceptible to disease.
… inherited genetic variants that cause changes in gene regulation associated with cancer. Georgia Institute of …
Clinical Research
The Protocol Service Center provides assistance in the development and administration of study protocols requiring NIH Institutional Review Board approval.
… Assistance with regulatory requirements associated with FDA-regulated research and with compliance with NIH and HHS …
For Patients and Families
​Pharmacogenomics combines the science of how drugs work, called pharmacology, with the science of the human genome, called genomics.​
… called HER2. The U.S. Food and Drug Administration (FDA) also recommends genetic testing before giving the … is adjusted according to the patient's genetic makeup. The FDA also advises doctors to test colon cancer patients for … for using drugs to improve human health. In 2007, the FDA revised the label on the common blood-thinning drug …
Fact Sheet
mRNA vaccines inject cells with instructions to generate a protein that is normally found on the surface of SARS-CoV-2, the virus that causes COVID-19.
… acts like any other mRNA that your cells make. … Yes. The FDA approval process involves careful review of clinical … vaccines? … Can mRNA vaccines change your DNA? … Are FDA-approved mRNA vaccines safe and effective? … How have … in the United States by the Food and Drug Administration (FDA) are mRNA vaccines. … Fact Sheet … Understanding COVID-19 …