Gina Exception update and information
You’ve all probably heard the term GINA in relation to research that includes genetic testing, but what is GINA? GINA stands for ‘Genetic Information Non-Disclosure Act’ and was approved by the U.S. congress and passed into law in 2008 mainly in response to three factors: 1) The exponential growth in the field of genetic sequencing technology, 2) Decreasing costs of said technology that made genetic sequencing feasible for use in clinical care, and 3) Fears of genetic information being used for the purpose of discrimination, either by employers or health/life insurance companies. The legislation basically makes it illegal to make decisions about employment or insurance premiums based on genetic information, and forbids an insurance company from requiring a member to submit to genetic testing.
Since CHR does genetic testing as part of research and Kaiser provides health insurance , we are in the trusted position of having genetic information and providing insurance. To manage this potential conflict of interest, we comply with additional reporting requirements. Each KP region’s IRB is required to notify Program Office/KFRI no less than 60 days prior to the first genetic test being initiated on an individual project so KFRI can file the information with the appropriate federal agencies. Study teams can help by making it clear in their IRB application what kind of genetic testing, if any, will be done for the study.