Double Helix Trouble
Close to 1,000 incoming students have submitted saliva samples to the University of California at Berkeley for genetic testing as part of an unusual educational experience for freshmen, but they won't be getting the results they expected. The California Department of Public Health decided Thursday that the students will not be provided with their individual genetic results.
As part of this year's “On the Same Page” initiative for a common freshman experience, students (voluntarily) were to have had three of their genes analyzed. The idea was to promote a discussion about personalized medicine. The plan was for students to be given their individual analyses, but now the results will be discussed only based on aggregated information from all participants.
“They said that we were providing students with information that could affect the treatment of disease or the evaluation of health,” said Mark Schlissel, dean of biological sciences in Berkeley’s College of Letters and Science. “We disagree with the California Department of Public Health.”
According to the department, laboratories conducting clinical testing -- which can diagnose a disease or monitor treatment -- must be licensed and have certification for reliability and accuracy. Excluded are labs running samples for research and teaching purposes, but the Department of Public Health concluded that Berkeley’s project does not fit these exemptions due to the potential for medical interpretation.
The university’s collection of genetic samples targets only three genes: metabolism of folate, tolerance of lactose and metabolism of alcohol. Jasper Rine, UC Berkeley professor of genetics, genomics and development, said the gene variants are innocuous.
“We considered all possible misuses of this information,” he said. “We decided we could manage the risk that a student could learn that they have an upset stomach when they drink milk.”
The leaders of the project looked at about 12 laboratories other than the on-campus research lab they had initially chosen to see if a licensed CLIA lab could help them maintain the original aim of the project. But not only would it be five times more expensive, the labs declined to test “just a handful of genetic variants,” and required larger samples that would include genes with medical significance, Rine said, adding that this would be inappropriate for an educational exercise.
“We won’t violate the law, but we will modify the program in light of the conversation,” Schlissel said.
“On the Same Page” will continue its program with the aggregate analysis, panel discussions and seminars. Schlissel said the setback may inspire less student engagement in the project, as well as potential disappointment over not getting what they were promised. But he said the controversy itself may actually enhance the experience, as it paves the way for broader discussions.
“It opens up a whole lot of questions,” he said. “Who has the authority to tell an individual what they’re allowed to know about themselves?”
Critics of the program, who had feared for students' privacy, praised the Department of Public Health’s decision. Jeremy Gruber, president of the Council for Responsible Genetics, said the department had issued similar commands to consumer genetic testing labs several years ago.
“This should by no means come as a surprise to the university,” Gruber said. “The university didn’t do its homework. The university was caught with not having sufficiently reviewed the regulatory environment to even understand what would be required to process the DNA samples, and now they’re left to scramble.”
Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said that even though Berkeley’s project would probably not have been harmful to the students, it was likely to set a precedent on genetic testing “in a cavalier way.” He added that with only an aggregate analysis, the program is still likely to be effective. “It’s less sexy, but it’s interesting.”
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