The California Department of Public Health has instructed the University of California, Berkeley, not to proceed with a portion of its ground-breaking program to educate students about genetic testing and personalized medicine.
The program, called “Bring Your Genes to Cal,” allowed incoming students, on a voluntary and anonymous basis, to submit DNA samples, with the promise that they would receive their personal results of tests for three common genetic variants. Some 600 of more than 5,000 incoming freshmen and transfers students have already volunteered their saliva samples and signed consent forms allowing these tests.
While the university still plans to analyze the DNA samples in a campus research lab, students who voluntarily returned samples will not be allowed to see their personal results. Instead, the test results will be presented in aggregate to students during lectures and panel discussions planned for the fall 2010 semester.
The change in the program comes despite the fact that the California State Senate Education Committee yesterday defeated an Assembly bill, AB 70, sponsored by Assemblyman Chris Norby (R-Fullerton), that would have restricted the university’s right to ask students for DNA for educational purposes.
The change to UC Berkeley’s program was necessitated because the California Department of Public Health (CDPH) insisted that since students would have been given access to their own test results, the academic exercise was not exempt from laws designed to assure the accuracy and quality of diagnostic tests used in providing medical care to patients.
The state public health department is interpreting the federal Clinical Laboratory Improvement Amendments (CLIA) and the California Business and Professions Code, which mandate that medical diagnostic laboratories and the genetic tests they use be certified for accuracy and reliability.
“We’ve had discussions with the California Department of Public Health, and they have indicated that we should not give individual results to the students. Once we receive that formal direction, we will comply,” said Mark Schlissel, dean of biological sciences at UC Berkeley’s College of Letters & Science and a professor of molecular and cell biology. “It’s a shame that we were not allowed to provide students with their personalized results, which would have made this a one-of-a-kind experience for incoming students and an example of the cutting-edge type of education offered at UC Berkeley.”
The University of California has asked the CDPH to provide legal authority for its interpretation of the requirements applicable to research and teaching projects.
An Aug. 2 letter sent to the CDPH by the university emphasized that the California Business and Professions Code (CA B&P Code) exempts laboratories that perform tests for research and teaching purposes only and that do not report results to patients as part of a medical or health assessment.
Because the UC Berkeley program is an educational experiment, the students are not patients, and the three specific genetic variants are not disease related, CLIA rules and the California statute do not apply, the letter stated.
“We have taken every precaution and are committed to following the letter of the law with regard to any issue, but we believe this is a flawed reading of the statute that raises questions about who has control over teaching at the university, and in the broader sense, who has control over information about our own genes,” said Schlissel.
Although UC Berkeley will no longer provide students with information about three of their genes, the campus-wide discussion of personalized medicine will continue come September. As a result of questions raised in the last few months, the program will focus prominently on the politics of genetic testing and whether individuals, rather than physicians and public agencies, ultimately control their own genetic information, said Schlissel. He plans to invite California Department of Public Health director Dr. Mark Horton to join one of this fall’s panel discussions on personalized medicine.
“We hope that everyone will engage in our discussion,” said campus genetics professor Jasper Rine, who will deliver the keynote lecture on this topic on Sept. 13. “Berkeley has always been on the forefront of critical debates in this country, and as an academic institution, we are pleased to provide a platform for discussing such an important topic to everyone now, and certainly, in the future as this science continues to evolve.”
The DNA testing was offered by the College of Letters & Science as part of its yearly program, On the Same Page (OTSP), which typically sends incoming freshmen and transfer students a topical book or DVD in the summer to be discussed on campus in the fall. This year, Schlissel suggested a discussion of personalized medicine, which promises to revolutionize health care by using information about a person’s unique genome to tailor medical interventions, and Rine offered to test three innocuous genes as a way to draw the interest of students.
“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,” Schlissel said. “We thought that the novelty and ease of this exercise, when coupled with the important questions that such an exercise brings to the fore, would make for an unprecedented learning experience.”
In July, incoming students received a packet of information about the DNA testing program, a saliva kit, an anonymous bar code to attach to the sample, and a consent form authorizing the campus to test for three gene variants that would reveal aspects of how an individual metabolizes milk, alcohol and vitamin B9 (folic acid). The campus has scheduled a series of lectures, panel discussions and class sessions — which will go on as planned — around the subject of genetic testing.
“Of the three million genetic differences that distinguish any two people, we are testing only three common differences to give students a sense of what kind of information they might learn from their genome sequence,” Rine said. “The potential of personalized medicine will depend upon people having some level of understanding of genetic variation. Our goal is to help Berkeley students develop the skills and understanding to be thought leaders on this topic as our society comes to grips with the many fascinating dimensions to our genome sequence.”
A campus laboratory that routinely conducts genotyping was chosen to perform the DNA tests. As a research laboratory, it is exempt from CLIA rules under California statute.
“The UC Berkeley Committee for Protection of Human Subjects reviewed the proposal and approved the research protocol as a minimal-risk project for students,” Schlissel said. “The attention this program has received points out why we need such a program to discuss genetic testing and personalized medicine.”
The University of California is also concerned that the CDPH’s interpretation of CLIA and CBPC regulations could limit other educational and research projects within the 10-campus system, as well as by other colleges and universities in California.
“Because of the rapid advances in technology, CLIA labs now focus on either large-scale genome-wide analyses or gene variants responsible for clinically important disease states. The ruling of the state Department of Public Health would, in effect, disallow even those educational activities that involve only limited numbers of genes that do not have a clinical market,” Rine said. “In effect, that would put most of the human genome off-limits for meaningful educational projects.”
As originally planned, all DNA samples will be destroyed after this limited testing to further safeguard students’ privacy.