Last week, the California Department of Public Health ruled that UC Berkeley's plan to have incoming freshmen study their own genetic code meant the program has to comply with state regulations for clinical diagnostic tests — a doctor had to be involved in the testing and the testing had to be done in a federally-certified lab. Since the Berkeley program lacked both the doctors and the lab, the program was cut short. But now researchers are pondering the effects of the ruling on academic research in general, says the Chronicle of Higher Education's Josh Keller. Going by the state's standards, lawyers at the University of California contend, researchers conducting studies on human genetic material would be prohibited from telling the subjects about any potential medical risks they might carry. But others say the concerns are "overblown," Keller says. The law was designed to protect patients by making sure that labs are CLIA-certified and the results are as accurate as possible, says California's public health department. Keller quotes bioethicist Arthur Caplan, who says the ruling doesn't create a problem — the issue of how to report back to study subjects with medical news has always existed — but does recognize that a problem exists.
It's Not Just About Berkeley Anymore
Aug 20, 2010