In response to a state Department of Public Health ruling, the University of California at Berkeley is significantly scaling back a controversial student DNA-testing program it had planned for the fall.
In the modified "Bring Your Genes to Cal" program, students can still voluntarily submit DNA samples that will be screened for three genetic markers, but the university will not give them the individual test results it had promised. Instead, the university will release only aggregate results from all tests, Berkeley officials said Thursday.
The program—which had come under criticism from lawmakers and others, including the director of Stanford's Center for Biomedical Ethics—asked incoming students to voluntarily submit DNA samples with the understanding that they would receive personal results for three genetic tests. Those tests would tell students how well their bodies metabolized alcohol, folate, and lactase, and were meant to serve as an educational tool in a freshman orientation on personalized medicine.
But in a ruling on Wednesday, the Department of Public Health said that because students would have been granted access to their own DNA test results, the program was subject to regulations regarding clinical diagnostic tests, and that Berkeley had failed to comply with those regulations.
The regulations, intended to promote the welfare of patients and the accuracy of diagnostic tests, mandate that clinical DNA tests take place in certified laboratories and at the request of a patient's physician. Because Berkeley's program did neither, the department ruled that student participants in the program could not receive their own DNA test results.
At a news conference on Thursday, Mark Schlissel, dean of biological sciences at Berkeley, and other science professors expressed their disappointment in the health department's decision. They argued that their DNA project should be exempt from the diagnostic-testing regulations because it served an educational rather than a medical purpose. The genes to be tested have no known connection to a disease, they said, so the tests were of questionable medical value.
Mr. Schlissel said the health department's decision could have a "chilling effect" on biomedical research in California because that research depends on the voluntary consent of test subjects, many of whom may not get doctor's notes before getting DNA tests.
But the central issue, he said, is more basic: "The department's decision raises the question, Who has the authority to tell people what they have the right to know about themselves?"
Earlier, in a news release, Mr. Schlissel said he and others had hoped the project would increase students' enthusiasm for science by giving them a hands-on experience with genetic testing. "We decided to bring this topic to life by offering students the opportunity to voluntarily and anonymously send in a sample of their own DNA," he said.