Genetic Information and Nondiscrimination Act (GINA) Guidance

What is GINA?
The Genetic Information Nondiscrimination Act of 2008 is a Federal law that prohibits discrimination in health coverage and employment based on genetic information.  Its purpose is to provide baseline protections against genetic discrimination.  Health coverage provisions of GINA were implemented between 5/22/09 and 5/21/10 and employment coverage provisions were implemented 11/21/09.  Genetic information obtained prior to these dates were grandfathered and protected.

GINA works in the following ways:

• Generally prohibits discrimination in health coverage and employment on the basis of genetic information
• Generally prohibits health insurers or health plan administrators from requesting or requiring genetic information of an individual or the individual’s family members, or using it for decisions regarding coverage, rates, or preexisting conditions
• Prohibits most employers from using genetic information for hiring, firing, or promotion decisions, and for any decisions regarding terms of employment
  

How does GINA define genetic information?
The statute defines ‘genetic information’ as information about:

• an individual’s genetic tests (including genetic tests done as part of a research study);
• genetic tests of the individual’s family members (defined as dependents and up to and including 4th degree relatives); 
• genetic tests of any fetus of an individual or family member who is a pregnant woman, and genetic tests of any embryo legally held by an individual or family member utilizing assisted reproductive technology; 
• the manifestation of a disease or disorder in family members (family history); 
• any request for, or receipt of, genetic services or participation in clinical research that includes genetic services (genetic testing, counseling, or education) by an individual or family member
  

Genetic information does NOT include information about the sex or age of any individual

Is anything NOT protected under GINA?
The following is NOT protected under GINA:

• The results of routine tests that do not measure DNA, RNA, or chromosomal changes, such as complete blood counts, cholesterol tests, and liver-function tests.
• Analyses of proteins or metabolites that are directly related to a manifested disease, disorder, or pathological condition that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved
  

What are GINA’s limits?
The employment provisions generally do not apply to employers with fewer than 15 employees.  Additionally, the law does NOT:

• Extend health coverage non-discrimination protections to life insurance, disability insurance and long-term care insurance
• Mandate coverage for any particular test or treatment
• Prohibit health insurers or health plan administrators from obtaining and using genetic test results in making health insurance payment determinations
• Prohibit the health insurer from determining eligibility or premium rates for an individual based on the manifestation of a disease or disorder in that individual for health coverage provided by a health insurer to individuals
  

Finally, for employment-based coverage provided by group health plans, the law permits the overall premium rate for an employer to be increased because of the manifestation of a disease or disorder of an individual enrolled in the plan, but the manifested disease or disorder of one individual cannot be used as genetic information about other group members to further increase the premium.

What do I need to do if my study involves DNA analysis?
The UW HS IRBs have model consent form language available here.