Search Results
Policy Issues
Revisions to the Common Rule modernize, simplify, and enhance oversight for human subjects research in the United States.
… The final version of the Common Rule was published in the Federal Register on January 19, 2017, following the … a one-time posting requirement to make them available on a federal website. Broad Consent (.116(d)) The Final Rule … follow-up (.109(f)). Tribal Sovereignty (.101(f)) The policy, as before, does not affect state or local laws and …
Policy Issues
Clinical research may yield new health-related information about volunteers who have chosen to participate in the studies.
… to examine these questions and inform future NHGRI policy. … Currently, the only federal law regarding return of genetic IRRs and IFs is the … that the research that it funds comply with all applicable federal, state, and local laws, which includes CLIA. NHGRI … to an evidence base that may be used to inform future policy decisions. NHGRI is also participating in discussions …
News Release
American Indians and Alaska Natives IRB training programs at NIH ensure the welfare of people participating in federally regulated research.
… came when she reviewed the January 2017 final rule for the Federal Policy for the Protection of Human Subjects, 45 C.F.R. 46 … said. "We couldn't just say, 'here's how we do it in the federal government.'" The NIH IRB training program began …
Fact Sheet
Several regulations and policies stipulate the information that must be given to research participants prior to their enrolling in a study.
… or data are de-identified); however, there may be other policy or ethical reasons for conveying that such research … are deceased.  While informed consent is not required by federal regulations for research with de-identified samples … In accordance with the NIH Genomic Data Sharing (GDS) policy , researchers who intend to use human-derived …
MINC
Use the resources to help you design an education program or policy for your setting.
… the resources to help you design an education program or policy for your setting.  Resource Title Type Cost Action … Module Pdf Free Fox Chase PA: Risk Assessment Program Policy Free Genetics Home Reference Online Free Genetics of … the resources to help you design an education program or policy for your setting. …
Talking Glossary
La Ley de No Discriminación por Información Genética (GINA) es una legislación federal de los Estados Unidos que protege a las personas de la discriminación con base en su información genética persona en lo que respecta a los seguros de salud y el empleo.
… por Información Genética (GINA) es una legislación federal de los Estados Unidos que protege a las personas de … por Información Genética (GINA) es una legislación federal de los Estados Unidos que protege a las personas de … por Información Genética (GINA) es una legislación federal de los Estados Unidos que protege a las personas de …
Health
Genomic medicine involves using genomic information as part of clinical care and the health outcomes and policy implications of that clinical use.
… therapeutic decision-making) and the health outcomes and policy implications of that clinical use. Already, genomic … on engagement of the public, healthcare providers and policy makers in genomics topics: Education and Community Involvement Branch (ECIB) and Policy and Program Analysis Branch (PPAB) . Resources and …
Administrative
The Management Analysis and Workforce Development Branch provides advisory services, develops policies and procedures, and coordinates implementation at NHGRI.
FAQ
Frequently asked questions from the May 23, 2023 informational webinar, ELSI Research and the New NIH Data Management and Sharing (DMS) Policy.
… the large number of resources available regarding the DMS Policy, where should I start? NIH resources regarding the DMS Policy are available on the NIH Scientific Data Sharing site. … with the e-Learning Webinars, Slide Sets and Overviews on policy requirements, the NIH-wide list of FAQs, and the …
Events
Data sharing has been a central tenet of the field of genomics since the Human Genome Project.