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.
- Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.
All health insurance companies and group health plans must follow this law by May 21, 2010. All employers with 15 or more employees must follow this law as of November 21, 2009.
Be aware that this new Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
The guidance states that IRBs are free to revise this template to meet certain situations or groups of human subjects.
Lauren Dame, JD, MPH, associate director for the Center for Genome Ethics, Law and Policy at Duke University in Durham, NC, says she thinks the suggested language does a good job of explaining GINA's protections clearly without overselling them.
"It's sort of a careful balance between trying to make it clear and in English, but recognizing that you really have to state certain things to be technically accurate," she says. "It captured the main improvements and the things that still are not covered.
When it comes to determining whether additional language is needed in the informed consent, Dame points out that certain types of research may raise issues because GINA does not cover long-term health insurance, disability insurance or life insurance.
She says that if a genetic research proposal under review is likely to raise issues in these uncovered areas – for example, Alzheimer's disease research – there should be special attention paid to that in the informed consent process.
Dame says IRBs should pay attention as the Equal Employment Opportunity Commission releases the regulations for the employment discrimination provisions of GINA to assist in explaining the law clearly to participants.
"The preamble to the regulations usually does a good job of incorporating examples," Dame says. "Those are really useful things for somebody to read through. They'll give some examples of what GINA does mean and what it doesn't mean in clear English. It may be that as people are devising information to give potential subjects, there may be examples in the preambles that are really useful ways of phrasing things."
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).You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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