Search Results
FAQ
On October 10, 2024, NHGRI hosted a pre-application webinar for the Population Genomic Screening in Primary Care NOFOs: RFA-HG-24-021, RFA-HG-24-022, and RFA-HG-24-023. These FAQs contain questions answered during that webinar.
… - Eligibility Information” can apply to the NOFOs. Will FDA review/approval of return of results to participants be … In other words, will the project need an IDE w/ the FDA? Most likely no, but if a study proposes to use a … the investigator of the study must consider FDA's IDE regulation before proceeding with enrollment. In the context …
News Release
Top genome scientists from over 20 countries have joined forces in an effort to improve cooperation and coordination of genomic medicine research worldwide.
… and overall policies on such issues as data-sharing, regulation and cost-benefit analysis. Not coincidentally, … Institutes of Health and the Food and Drug Administration (FDA) sponsored a workshop in March on this disease. Videos of …
Policy Issues
There are laws and policies that serve to protect the privacy of individuals' genomic information.
… their genetic information. DTC genetic tests have limited regulation , and the growth of the DTC genetic testing …
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]. …
Research at NHGRI
The Democratizing Education for Sickle Cell Disease Gene Therapy project developed patient-focused educational materials for the sickle cell community.
… In December 2023, the U.S. Food and Drug Administration (FDA) approved two gene therapies to treat sickle cell …
Event
On Tuesday, February 6, 2024, the National Human Genome Research Institute hosted an eConsult webinar to provide an overview of three notice of funding opportunities (RFA-HG-24-001, PAR-24-106 and PAR-24-107). Questions were answered during the webinar.
… : PHS 2023-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications … : PHS 2023-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications …
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 …
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 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 …
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 …