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Crafting informed consent under GINA.

IRB Advisor

| July 01, 2009 | COPYRIGHT 2009 AHC Media LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

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.

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Source: HighBeam Research, Crafting informed consent under GINA.

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