CDPH Alters Cal DNA Experiment

by CalWatchdog Staff | August 13, 2010 11:33 am

Laura Sucheski: After Tuesday’s debate[1] over the ethics of UC Berkeley’s “Bring Your Genes to Cal” freshman orientation activity, the California Department of Public Health nixed the plan as it stands, claiming it violates federal and state statues that govern medical experimentation and diagnostic tests.

The program problematically combines elements of a research experiment with elements of medical diagnostics.   It requires students to sign consent forms to participate as test subjects in an experiment, but it also gives subjects personalized information as a result of the experiment, which arguably classifies it as medical advice.

UC Berkeley officials argued that although the results were personalized, they tested innocuous genes that controlled traits with little connection to personal health or future diseases.

But the CDPH ruled against this argument. Given that personalized medicine from DNA sampling has not been approved by the FDA, and that the program does not provide adequate post-results counseling to prevent students from misinterpreting their results, it does not meet standards for medical advice. If the program is to continue, Berkeley will have to withhold personalized results.   Students will still be able to see the results in aggregate as a point of reference during the planned lecture series.

Of course, the university is very disappointed by the CDPH’s interpretation of the two laws, and they worry that it will obstruct valuable medical research in the future.

“We have taken every precaution and are committed to following the letter of the law with regard to any issue,” said Dr. Mark Schlissel, Dean of Biological Sciences at Berkeley, in a press release,[2] “But we believe this is a flawed reading of the statue 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.”

Source URL: https://calwatchdog.com/2010/08/13/cdph-alters-cal-dna-experiment/

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