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Giving informed consent to biobank participants
As genetic research changes, IRBs must keep up
As IRBs review the rollout of new biobanks, they need to ensure that people who agree to participate in them truly understand what that means.
But in the fast-moving world of genetic research, the extent of the research can change dramatically in just a few years, making it harder to truly inform participants, says Kelly Ormond, MS, CGC, associate professor of genetics at Stanford University School of Medicine in Stanford, CA.
It's difficult to explain to participants just how their data will be used, since researchers don't even know all the potential uses right now, Ormond says.
"The biggest challenge with the biobank is, we're basically saying, we want to collect this information from you and we really have no idea what we're going to do with it, potentially," she says. "We may or may not come up with some results and we may or may not tell you those results.
"I could be assessing your DNA for psychiatric illness, I could be assessing it for dementia or for your cardiovascular disease risks, and those may mean very different things to you than they do to me, or somebody else."
Ormond says investigators and IRBs need to be ready to adapt to the changing research landscape and devise ways to keep participants informed along the way.
"Most of us when we do research think 'I've got this project, I'm going to do it this way and it will last X number of years,'" Ormond says. "Biobanks can last much longer than traditional research projects and it may be that in a few years our way of thinking about this is completely different.
"There should be regular reviews and some way to work in a flexibility to acknowledge how our thoughts are changing about this."
Ormond also recommends involving someone with a clinical genetics background in the process and says IRBs should think carefully about whether and how to release results to participants, an issue many biobanks are currently grappling with.
Many unclear on potential risks
In an effort to get a feel for what biobank participants understand about their decision, Ormond and her colleagues surveyed 200 people who had recently enrolled in the NUgene Project, the biobank created at Northwestern University in Chicago.1 Ormond, who at the time was involved with NUgene's advisory board, says the goal was to address a real dearth of information about what prompts people's decisions to enroll in a biobank.
"There wasn't any data out there and biobanks were sort of on the new side back in 2001 when we started thinking about this," she says. "We really didn't have any idea what people's understanding was. Why did people think they were doing this and what did they think they might get out of it?"
They found that the participants understood the basics of what they were doing — donating blood that later would be used for genetic research — and most realized that their medical records would be accessed later. But many were unclear on potential risks of participation and the likelihood of personal benefit, particularly the possibility that participants might receive individual results from genetic testing.
Most expressed confidence in the biobank's privacy protections, but Ormond says their confidence appeared to be based more in their faith in the institution than in an understanding of the protections outlined in the informed consent.
"I think a lot of it came across as institutional trust to me," she says.
NUgene's informed consent gave participants the option of stating whether they would want to be contacted in the future if results were found that could "have a significant impact on my healthcare." Although that possibility was described as a very rare occurrence, a third of respondents specifically said they hoped for results or to be recontacted. More than half believed they would learn from their participation which genetic diseases they might develop.
Ormond says there's no consensus yet on whether to give out information to participants, much less how to do it properly.
"It worries me that we could be giving out information that is not really a result and I think that is something that IRBs really have to grapple with," she says. "Do we information-dump on people and just give them access to everything because maybe at some point in the future it could be information that's valuable to you? And who then is responsible for helping them make sense of that information?"
Ormond says one useful approach to this problem might be to conduct research on the return of research results itself – to look at how it's done by different biobanks and survey the reactions of participants.
"Most biobanks haven't gotten to that point yet, and I'm not sure when we will, but I think that's part of the challenge," she says. "How do you go back and say, 'Your sample was part of this study – we have some results, would you like them or not?'
"I hope that people collect research data about all the different ways in which that could happen, so we can really figure it out. Because I don't think we know the right way yet."