The greater the number of samples and the more information that biobanks contain, the better they are as resources. However, more data often means more ethical issues to weigh.
"How do you get lots of people included in these and get lots of data while at the same time essentially protecting those people's privacy and also those people's presumed option to opt in or out?" asks Duke University's Robert Mitchell. "This is something that every biobank is struggling with," he adds.
Biobanks can go about obtaining informed consent in a number of ways. Traditionally, researchers have used an opt-in model — in which participants are told what a specific project is about and they consent or not to contribute to that project — but newer models, like those of broad consent, are also in use.
Mitchell and his colleagues recently presented a different approach in Science: a trade-secret model. They examined interviews conducted with people who had volunteered to be part of a registry of environmental polymorphisms at the University of North Carolina, Chapel Hill, and who were then recontacted to determine how well they understood the informed consent process they went through. "What we were struck with — and I think this is not uncommon — is that they had a somewhat different understanding of what they had done than the informed consent form had suggested," Mitchell says.
Many people thought that they'd been part of a transaction. They received $20 for being part of the study, and they thought that if the researchers found something bad, they'd let them know — there was an exchange involved.
Mitchell and his colleagues then proposed to formalize that exchange under their trade-secret model. UNC Chapel Hill's John Conley, who is a lawyer, thought that how interviewees described their DNA and how it was being used sounded somewhat like a trade secret agreement. "The idea is in the same way that if I had a trade secret, I could license it out to people," Mitchell says. "I, as a volunteer, can license this to a biobank or not. It's an attempt to provide volunteers with a kind of intellectual property." He adds that the exchange does not have to involve money.
Of course, negotiating the terms of a license with each volunteer isn't practical. To handle this, Mitchell and his colleagues drew upon a solution many tech-transfer offices use: a limited number of options for the agreement. A biobank could have two or three options that volunteers could choose from as part of the exchange. "It can be an exchange for anything that the institute thinks is reasonable that someone is willing to agree to," he adds.
In the long run, Mitchell says such an approach won't hurt the number of people who participate and may slightly increase participation in biobanks because it is more up-front and transparent than traditional informed consent processes.