1. Genetic Information Nondiscrimination Act (GINA)
Background
Implementation Plan
IRB Member Perspective

2. GINA Background Signed into law May 21st, 2008 Purpose:
Protects Americans against discrimination
based on genetic information
Title I: Prohibits Health Insurance
discrimination (eff. entirely May 21st, 2010)
Title II: Prohibits Employment discrimination (eff. November 21st, 2009)

3. Existing Protections WI state law (1991):
Focus is on genetic tests
Prevents Insurers and Employers from:
Requiring or requesting a person to obtain a genetic test
Disclosing that a test was taken or asking for test results (if a genetic test is obtained)
Federal law (GINA) is broader

4. New GINA Protections Health Insurers & Employers may not:
Request or require genetic information
Use genetic information for health insurance decisions (eligibility, premiums)
Use genetic information for employment
decisions (hire, fire, promotions, etc.)
GINA prohibits discrimination regardless of “when” the genetic information was obtained

5. “Genetic Information” is defined as:
Genetic Tests
Family History of Disease or Disorders
Participation in Genetic Services
Tests analyzing DNA, RNA, chromosomes, proteins, or metabolites that detect genotypes, mutations, or chromosomal changes

6. “Genetic Information” is NOT:
Sex or Age of an individual
Routine tests NOT detecting genotypes, mutations, or chromosomal changes
E.g., blood counts, cholesterol, liver
enzymes
Analysis of proteins or metabolites directly related to manifestation of a disease, disorder or pathological condition

7. GINA Limitations Doesn’t protect against discrimination in:
Life Insurance
Disability Insurance
Long Term Care Insurance
Employers with < 15 employees
GINA does not prohibit discrimination on the basis of an already manifested genetic disease or disorder

8. GINA Implications For Investigators, & IRB’s
Responsibility to inform subjects of new protections and limitations
GINA & IRB Review criteria:
Risk to subjects is reduced…

9. GINA Implications OHRP recommends informing subjects
Research obtaining genetic information
Via Written Consent
Language provided
Consider new and active studies (open
enrollment)
Studies w/waivers not affected

10. Summary: GINA reduces risk OHRP recommends consent language
Protections and limitations
OHRP recommends consent language
ORIP Sample consent modified
Coincides with OHRP recommendation

11. Your Thoughts and Questions?
Add’l GINA info available at:
guidance/gina.html
section=wisconsin_lawyer&template=/cm/ contentdisplay.cfm&contentid=75594