GINA

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GINA

  1. 1. Genetic Information Nondiscrimination Act (GINA) <ul><li>Background </li></ul><ul><li>Implementation Plan </li></ul><ul><li>IRB Member Perspective </li></ul>
  2. 2. GINA Background <ul><li>Signed into law May 21 st , 2008 </li></ul><ul><li>Purpose : </li></ul><ul><ul><li>Protects Americans against discrimination </li></ul></ul><ul><ul><li> based on genetic information </li></ul></ul><ul><ul><li>Title I : Prohibits Health Insurance </li></ul></ul><ul><ul><li> discrimination (eff. entirely May 21 st , 2010) </li></ul></ul><ul><ul><li>Title II : Prohibits Employment discrimination (eff. November 21 st , 2009) </li></ul></ul>
  3. 3. Existing Protections <ul><li>WI state law (1991): </li></ul><ul><ul><li>Focus is on genetic tests </li></ul></ul><ul><ul><li>Prevents Insurers and Employers from: </li></ul></ul><ul><ul><ul><li>Requiring or requesting a person to obtain a genetic test </li></ul></ul></ul><ul><ul><ul><li>Disclosing that a test was taken or asking for test results (if a genetic test is obtained) </li></ul></ul></ul><ul><li>Federal law (GINA) is broader </li></ul>
  4. 4. New GINA Protections <ul><li>Health Insurers & Employers may not: </li></ul><ul><ul><li>Request or require genetic information </li></ul></ul><ul><ul><li>Use genetic information for health insurance decisions (eligibility, premiums) </li></ul></ul><ul><ul><li>Use genetic information for employment </li></ul></ul><ul><ul><li> decisions (hire, fire, promotions, etc.) </li></ul></ul><ul><li>GINA prohibits discrimination regardless of “when” the genetic information was obtained </li></ul>
  5. 5. “ Genetic Information” is defined as: <ul><li>Genetic Tests </li></ul><ul><li>Family History of Disease or Disorders </li></ul><ul><li>Participation in Genetic Services </li></ul><ul><li>Tests analyzing DNA, RNA, chromosomes, proteins, or metabolites that detect genotypes, mutations, or chromosomal changes </li></ul>
  6. 6. “ Genetic Information” is NOT: <ul><li>Sex or Age of an individual </li></ul><ul><li>Routine tests NOT detecting genotypes, mutations, or chromosomal changes </li></ul><ul><ul><li>E.g., blood counts, cholesterol, liver </li></ul></ul><ul><ul><li> enzymes </li></ul></ul><ul><li>Analysis of proteins or metabolites directly related to manifestation of a disease, disorder or pathological condition </li></ul>
  7. 7. GINA Limitations <ul><li>Doesn’t protect against discrimination in: </li></ul><ul><ul><li>Life Insurance </li></ul></ul><ul><ul><li>Disability Insurance </li></ul></ul><ul><ul><li>Long Term Care Insurance </li></ul></ul><ul><ul><li>Employers with < 15 employees </li></ul></ul><ul><li>GINA does not prohibit discrimination on the basis of an already manifested genetic disease or disorder </li></ul>
  8. 8. GINA Implications <ul><li>For Investigators, & IRB’s </li></ul><ul><li>Responsibility to inform subjects of new protections and limitations </li></ul><ul><li>GINA & IRB Review criteria: </li></ul><ul><ul><li>Risk to subjects is reduced… </li></ul></ul>
  9. 9. GINA Implications <ul><li>OHRP recommends informing subjects </li></ul><ul><ul><li>Research obtaining genetic information </li></ul></ul><ul><ul><li>Via Written Consent </li></ul></ul><ul><ul><li>Language provided </li></ul></ul><ul><ul><li>Consider new and active studies (open </li></ul></ul><ul><ul><li>enrollment) </li></ul></ul><ul><ul><li>Studies w/waivers not affected </li></ul></ul>
  10. 10. Summary: <ul><li>GINA reduces risk </li></ul><ul><ul><li>Protections and limitations </li></ul></ul><ul><li>OHRP recommends consent language </li></ul><ul><li>ORIP Sample consent modified </li></ul><ul><ul><li>Coincides with OHRP recommendation </li></ul></ul>
  11. 11. Your Thoughts and Questions? <ul><li>Add’l GINA info available at: </li></ul><ul><ul><li>http://www.hhs.gov/ohrp/humansubjects/ guidance/gina.html </li></ul></ul><ul><ul><li>http://www.wisbar.org/am/template.cfm? section=wisconsin_lawyer&template=/cm/ contentdisplay.cfm&contentid=75594 </li></ul></ul>

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