A plan to analyze the DNA of incoming students at the University of California, Berkeley and give them personalized results was recently scaled back amid concerns that such research amounts to a medical diagnosis -- a violation of state and federal laws.
The university has already sent more than 5,000 genetic testing kits to incoming students for the voluntary, anonymous program, which involves testing three common gene variants that would "reveal aspects of how an individual metabolizes milk, alcohol and vitamin B9 [folic acid]." About 600 students consented to the test and provided their saliva samples, according to the university, which contests the state's position that the program violates any statutes.
"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," a university press release stated.
In a statement from CDPH Policy and Programs Chief Deputy Director Kevin Reilly, he contends that human medical tests must be performed in licensed laboratories if the results are to be released to the person. A UC Berkeley campus laboratory that routinely conducts genotyping was chosen to perform the DNA tests, which is exempt from such rules under California law, the university claims.
The CDPH disagrees. "Research laboratories that do research testing only and do not report individual results are exempted from this license requirement," Reilly said in the prepared statement.
While UC Berkeley agreed not to provide personal test results, the university is asking the CDPH to provide legal authority for its interpretation of requirements that are applicable to research and teaching projects. It was unclear whether the CDPH had done so by Friday, Aug. 13.
UC Berkeley also contends that because the program -- called "Bring Your Genes to Cal" -- is an educational experiment, and because the students aren't patients and the three genetic variants aren't disease related, the university is exempt from state and federal laws the CDPH claims it would be violating.
"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," UC Berkeley Dean of Biological Sciences at the College of Letters and Science Mark Schlissel said in the release.
The university will still analyze the DNA samples in its campus research labs, present results in aggregate to students during lectures and panel discussions during the fall 2010 semester and continue the discussion of personalized medicine. But the focus of such discussions is likely to change after the CDPH's instructions, Schlissel said.
"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," Schlissel said in the release.
The DNA testing was being offered as part of UC Berkeley's yearly incoming student orientation program, which typically includes sending freshmen and transfer students a topical book or DVD in the summer to be discussed in the fall. Schlissel and genetics professor Jasper Rine teamed up to lead the DNA project, which Rine said would help students develop skills
and understanding to be "thought leaders" on the topic of personalized medicine.
"Of the 3 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 in the release. "The potential of personalized medicine will depend upon people having some level of understanding of genetic variation."
While a bit miffed by the CDPH's interpretation of the federal Clinical Laboratory Improvement Amendments (CLIA) and California Business and Professions Code regulations, UC Berkeley is also concerned such interpretations could affect other educational efforts.
"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 the release. "In effect, that would put most of the human genome off limits for meaningful educational projects."
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