NEW YORK (GenomeWeb News) – Recognizing that traditional informed consent policies for medical research are not likely to be adequate for genomic biobanks, a group of legal and bioethics researchers at Duke University and the University of North Carolina have proposed that a trade-secret model could be employed as an alternative.
One of the central issues confronting genomics research centers on the handling of donors' genetic information in biobanks, and, in particular, how to draft informed consent policies that provide privacy and comfort to donors. Potential donors want to know that their genetic information is secure, and that it will not be used to identify them, be used against them in any way, or be used for nefarious purposes — and some people do not participate in research because of these concerns.
"Although traditional research promised confidentiality and/or anonymity to participants, advances in DNA technology may render these safeguards meaningless," Robert Mitchell of the Duke University Institute for Genome Sciences and Policy and English Department, and colleagues wrote in the current issue of Science. "As a consequence, many ethicists argue that traditional informed consent may be illusory if not impossible, and that different approaches to the ethics of genetic sample collections are needed."
One such approach suggested by the authors is to consider genetic information provided to biobanks as individually-held trade secrets, and the terms of their use could be clarified if they were licensed for research use.
They suggest that if people's genetic information is treated as a trade secret that they possess, then compensating them for participating in biobanking could be the basis for a workable model for using that information for research.
"It can't be much worse than the status quo, and it doesn't seem all that complicated," John Conley, a professor of law at the University of North Carolina-Chapel Hill and at the UNC Center for Genomics and Society, and co-author on the paper told GenomeWeb Daily News on Thursday.
"The status quo says 'we can't predict all the risks nor protect you fully against those we can predict—but trust us.' We begin with the same acknowledgment of risk and uncertainty, but ask, 'what do you want in exchange for assuming that risk?" the authors wrote in the paper.
Conley said that in recent studies they found that patients who donated to biobanks often described their genetic information as being a "secret" that they held, or as their "essence."
When these subjects discussed the conditions under which they would let researchers use their DNA, they used language that sounded to Conley, and other lawyers involved in the study, just like the language in a trade-secret license.
"Think the Coke formula," said Conley. "Coca-Cola has kept the formula secret since the 1800s. But they let the bottlers use it to make Coke, pursuant to these very restrictive terms and conditions. And this is exactly what people seemed to be saying. I would let researchers use it (DNA information) subject to certain terms and conditions."
Although the term "compensation" is controversial when used in informed consent issues, Conley admits, he said that every person in the study in which he was involved said that compensation was important, whether they ended up providing a sample or not.
Conley said that the proposal is based on the assumption that the DNA in question (the proposal does not include the samples) is the patient's property, and that beyond any agreements they retain ownership of their property. The researchers would compensate the potential donors only to acquire rights to the information as the patient grants them.
This process should not require one-on-one negotiations between investigator and donor, which would be a time-consuming and complicated process. Instead, a potential donor would be presented with a limited menu of two or three boilerplate-style options for connecting compensation to the access and use of their information.
"At one extreme, you get a fair amount of compensation, in exchange for that you relinquish almost all control, or all control. At the other extreme, you don't get that much compensation, but you retain a lot of control. So the more you give to the researcher, the more you get in compensation," Conley explained.
"This happens to be the way a lot of universities already do business with their own patented technology," he added.
Conley said that there is no reason to believe that compensating donors would be much more expensive. It may be that people would be willing to accept small amounts of compensation, or that for them compensation would mean access to their own results, and others may want to know their results will be used in research that benefits particular communities.
Other ideas that have been proposed for handling biobank DNA have included a plan to enhance regulations to protect donors and a plan to treat biobanks as charitable trusts in which the managers of these banks become trustees tasked with seeing to the public benefit.
The first model would call for donors to give a general permission or broad consent authorization for a range of research activities, and for enhanced regulations to be implemented requiring that donors could learn about prospective research and even remove their information or samples. The charitable trust model would involve the appointment of advisory boards and internal ethical review boards, and they would allow biobanks to adopt bylaws to serve their own needs.
"The bottom line for us is that the present regime is an apple cart that would benefit from upsetting," said Conley, admitting that this would be "a radically different approach."
"Ethically, the key thing here is that this model has at its core value subject autonomy," he said."We're not asking people to donate a liver. We're asking healthy subjects to give DNA samples. Why can't we treat them like consenting adults who are fully competent to enter into an exchange, a bargain, on terms that they see fit?"