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

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)

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

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

“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

“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

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

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

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

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

Your Thoughts and Questions? Add’l GINA info available at: http://www.hhs.gov/ohrp/humansubjects/ guidance/gina.html http://www.wisbar.org/am/template.cfm? section=wisconsin_lawyer&template=/cm/ contentdisplay.cfm&contentid=75594