NEW YORK (GenomeWeb News) – The University of California at Berkeley will significantly modify its plan to run genetic tests on 5,000 incoming freshmen this year as part of an educational program after state health regulators judged that the plan involved clinical and medical information that required special handling, the University said in a conference call yesterday.
After meeting with the California Department of Public Health on Wednesday and unsuccessfully making its case for the program, Berkeley agreed that it would not share the test results directly with the incoming students, but it still plans to run the tests anonymously and to conduct other related educational projects.
The tests were intended to give freshman an educational experience about medicine, science, and science policy by testing 5,000 volunteers for three particular genetic variants for metabolism of alcohol, lactose, and folic acid.
But soon after the plan was announced last spring it began to draw fire from outside groups. Critics said that the project would inevitably lead to invasions of student privacy, and that it was unethical because it amounted to the university performing research on its students without appropriate consent.
CDPH told Berkeley that its core problem was that the program was not allowed under CLIA laws, UC Berkeley Dean of Biological Sciences and Molecular Biology Professor Mark Schlissel explained yesterday.
"We cannot or should not provide individual test results back to students," he said in explaining CDPH's position, "unless we had ordered the tests through a physician, and a licensed clinical testing lab performed the evaluation themselves. "
"Neither of those things are possible at this stage," he said, explaining that the test packets had already been sent out, and that 1,000 would already have been returned in a week's time. He added that the cost of sending these tests out to a separate lab would have prohibited the entire project. Schlissel also said that the school weighed using CLIA-certified commercial labs to handle the tests but decided that it would be far too expensive.
Although Schlissel said that the school still disagreed with CDPH, and said it will still conduct the tests for these three variants, it will not violate the law by returning the results to the individual students.
"We will use the results in the aggregate form, talking statistically about the student population as a whole," he said.
"The rest of our program will consist of public seminars and panel discussions addressing the ethical, legal, and social implications of this work. We'll have a panel on behavior and genes. We'll have a panel on genes and the [scientific] literature," said Schlissel.
Jasper Rine, a UC Berkeley professor of genetics, genomics, and development, explained that the program would not be a waste of time.
"In fact, most of the benefit of this program has already been had, because every single student that opened an envelope had to make a judgment for themselves: 'Do I want to subject myself to genetic testing of three variants (that we think are really quite innocuous)? Or do I not?'" Rine said.
DNA testing "is going to become increasingly important in the years ahead as we learn more about the genome, the technologies improve, and the impact on everyday life increases," Schlissel said.
"We train a large number of students that head off into medical school and the allied health professions and we want them to start thinking about DNA-based information," and how that could potentially impact health and the biotech and pharmaceutical industries, he continued.
Schlissel said that although the program was only a one-year project, Berkeley will be mindful of how it designs programs to be sure that they are consistent with the rule of law, and that it will also work to get clarity from the CDPH about whether what the school is doing is education and research and therefore is exempt, or whether it does "fall under this rather strict interpretation of the existing law."
One of the groups that had been critical of the original genetic testing plan, the Center for Genetics and Society, released a statement applauding, with qualifiers, the school's decision to rein in the project.
"This program was misconceived and hastily constructed from the beginning," Jesse Reynolds, a policy analyst at the Center, which also is based in Berkeley, said in a statement.
"We and others raised concerns about inadequate informed consent, potential breaches of privacy, and possible conflicts of interests. Many of these have been resolved by the fact that the incoming students will no longer receive individual genetic information. However, some matters remain. Regardless of its flaws, the original informed consent procedure was for a particular research project. The program is now different, and, at the very least, the university's institutional review board needs to revisit this issue," Reynolds said.
"This unfortunate episode should be a wake-up call to both policy makers and the general public that the development and use of new human genetic technologies cannot be left to the researchers alone," added CGS' Executive Director Richard Hayes
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