Get to know GINA: What it does – and doesn't do
Genetic nondiscrimination act shouldn't be oversold
The Genetic Information Nondiscrimination Act (GINA) of 2008 protects Americans against discrimination in employment and health insurance coverage based on genetic information.
It also provides new protection to potential subjects in genetic research. There is hope that GINA's passage last year may make people less fearful of participating in such studies.
But the challenge for IRBs is to explain that new protection without overstating it in the informed consent process, says Lauren Dame, JD, MPH, associate director for the Center for Genome Ethics, Law and Policy at Duke University in Durham, NC.
"While IRBs should feel that the risks of informational misuse of genetic information have gone down, it's not zero," Dame says. "So even though GINA has passed, it does not offer absolute protection for what is really quite personal and sensitive information."
The law, which has been in the works for several years, was passed last year, but began to take effect this year, with full protections scheduled to be in place by May 2010.
Earlier this year, the Office for Human Research Protections (OHRP) released guidance on GINA and how it should be interpreted by IRBs and investigators. That guidance recommends that IRBs reviewing research that involves the collection of genetic information should take into account GINA's protections when assessing risk.
The guidance details information protected by GINA:
- An individual's genetic tests, including those conducted as part of a research study;
- Genetic testing of a person's family members, fetuses of pregnant individuals or embryos created through assisted reproductive technology;
- Information collected about an individual's family members who have a disease or disorder;
- Information about participation in clinical research that includes genetic services (including testing, counseling or education).
The law generally forbids health insurers or health plans from requesting or requiring genetic information from an individual or using genetic information for decisions regarding coverage, rates or pre-existing conditions. It prohibits employers of 15 or more employees from using genetic information for hiring, firing or other employment decisions.
At the same time, however, the OHRP guidance points out the limitations of GINA, and urges IRBs not to oversell its benefits in informed consent.
Dame, who has made a presentation to her own IRB on the subject, says the OHRP guidance does a good job of balancing GINA's benefits and limitations.
"It makes two basic points – one is that to the extent that the risks we're concerned about with genetic testing and research are informational rather than a physical risk of some sort, GINA does reduce the risk," she says. "In that regard, it reduces what has been the major risk of people participating in genetic trials.
"On the other hand, I thought it also did a good job of emphasizing that it doesn't take care of everything."
Limitations
Built into the new law are deadlines for enacting protections: Title I, which covers health coverage, began taking effect in May and will continue rolling out through May 2010, depending on when the health insurer's annual coverage period begins, Dame says. Title II, which covers employment, takes effect Nov. 21.
Even genetic testing conducted before those dates cannot be used once the law takes effect, OHRP guidance points out. But there is the possibility that actions could be taken by insurers or employers before GINA is fully effective, and informed consent documents should make note of that, Dame says.
"I would say in practical terms during this transition period, there would have to be different language (in informed consent)," she says. "Some of the language would be the same – what GINA is, when it was passed. But there probably would have to be some language that all of the protections of GINA do not go into effect until certain dates.
"IRBs are just going to have to deal with a slightly changing template as we approach full coverage."
In addition, GINA does not cover workplaces with fewer than 15 employees, and this would need to be explained in the informed consent.
And Dame notes that GINA protects individuals who may have genetic predisposition to a disease, but not those who already have the disease. It's a fine point, she says, but an important one.
"If you're participating in some kind of research looking at a disease that has a very strong genetic component and you don't have the disease yet, but you do have the genetic component, GINA is protecting that information," Dame says. "but if you're in that study because you have the disease and they're also doing research on your genes, the fact that you have the disease, unless it's protected in other ways by other laws, could cause you to be discriminated against."
Other uses
Dame says one serious limitation of GINA is that it only covers discrimination in health coverage and employment. She says there may be other entities that have an interest in genetic information, and disclosure could still pose certain risks. For example, the OHRP guidance specifically points out that life insurance, disability insurance and long-term care insurance are not covered under GINA.
"I could certainly imagine if somebody was participating in a study about Alzheimer's disease, that's information that a long-term care company might very well want to know," Dame says. "It would be a little misleading to say, 'We're testing your genes for APOE alleles (which are related to an increased risk of Alzheimer's disease) but don't worry, you're covered by GINA.' Because that's not entirely accurate."
Dame notes that it's hard to know right now all the potential risks that may someday exist for the disclosure of genetic information. As a result, IRBs shouldn't attempt to imagine every possible scenario, they should be aware that this is an area of medicine and law that is continuing to change.
"The point I would make is because it's a transition period, they can't expect to come up with one answer that's going to be correct forever – they're going to have to revisit this," she says. "We're theorizing how these problems might arise and trying to deal with them and that makes it difficult. Because it might be that they're going to come up in a way we just didn't think about."
But she notes that in any case, the risks of disclosure are small, and that IRBs will continue to carefully monitor plans for protecting personal health information, including genetic information.
While there's little evidence that discrimination based on genetic information was frequent or widespread, Dame says studies had shown that people were concerned about the possibility, and that it contributed to reluctance to participate in genetic research.
"I think one of the effects of GINA is that it sets a really clear norm for health insurers and employers, which is you can't use genetic information to hurt people," Dame says. "We're just not going to go down that road. And while it doesn't appear that many in those groups were going to go down that road, GINA probably did a good thing by stopping them before anyone got started."
For more information, see the OHRP guidance on GINA at http://www.hhs.gov/ohrp/humansubjects/guidance/gina.html.
The Genetic Information Nondiscrimination Act (GINA) of 2008 protects Americans against discrimination in employment and health insurance coverage based on genetic information.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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