Search Results
Staff
Rebecca Hong is a scientific program analyst in the Policy and Program Analysis Branch at the National Human Genome Research Institute.
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… Rebecca Hong is a scientific program analyst for the Policy and Program Analysis Branch (PPAB) at the National … Institute (NHGRI). Her responsibilities in PPAB include policy analysis, policy development, coding and reporting, workshop …
Policy Issues
Most genetic tests today are not regulated, meaning that they go to market without any independent analysis to verify the claims of the seller.
… analysis to verify the claims of the seller. … Several federal agencies regulate genetic tests: the Food and Drug … Centers for Medicare and Medicaid Services (CMS), and the Federal Trade Commission (FTC). Genetic and Genomic tests, … in 2010 the FDA announced plans to move away from a policy of "enforcement discretion" (see next section, "FDA …
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 …
Staff
Elena Ghanaim is the Policy Advisor for Data Science and Sharing within the Office of Genomic Data Science (OGDS) at the National Human Genome Research Institute (NHGRI)
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… Elena Ghanaim is the Policy Advisor for Data Science and Sharing within the Office … (NHGRI). She spearheads NHGRI’s scientific data sharing policy development, oversight, and implementation. Ms. … NIH and grantee partners on data sharing and privacy policy issues. For the last three years, she has advised the …
Policy Issues
Participating in genomics research is an opportunity to support exploration of the genome and help scientists understand, prevent, detect and treat disease.
… research? Research participants are protected by a set of federal regulations, known as the Common Rule, which ensures … such as in the case of a subpoena. There is also a Federal law called the Health Insurance Portability and … understand, prevent, detect and treat disease. … Policy Issues …
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. … IRRs are the results for a specific study … for returning IRRs and IFs. … 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 …
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 … at institutions that are not subject to HIPAA (including federal labs), but portions of the HIPAA Privacy Rule may …
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 … Information Nondiscrimination Act (abbreviated GINA) is federal legislation in the United States that protects … por Información Genética (GINA) es una legislación federal de los Estados Unidos que protege a las personas de …
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. … Use the resources to help you …