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Crafting informed consent under GINA
OHRP's suggested language is a good place to start
The Office for Human Research Protections (OHRP) recently released guidance for IRBs and investigators on how to deal with the new Genetic Information Nondiscrimination Act (GINA).
The guidance includes suggested template language for informed consent documents:
"A new Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:
*Health insurance companies and group health plans may not request your genetic information that we get from this research.
*Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.
Source: HighBeam Research, Crafting informed consent under GINA.