A controversial program at the University of California, Berkeley, inviting incoming freshmen and transfer students to receive a personal analysis of three genetic variants in their DNA cannot proceed as planned, the state public health department told university officials yesterday.
At a late afternoon meeting yesterday, the California Department of Public Health (CDPH) said that the genetic information that participating students would receive constitutes clinical testing, and therefore can’t be released to students outside of a clinical setting. Program organizers, however, argue that the testing is educational, not clinical.
“The CDPH was firm in its stance about our not being allowed to return test results to individual students and although we disagree, we will follow their guidance and modify our program accordingly,” Mark Shlissel, dean of biological sciences and one of the program’s organizers, wrote in an email to Nature today.
Since the program, was announced in May, concerns have been raised about whether students would be given enough context, and if need be, individual counseling in interpreting the genetic information, whether students would feel pressured into participating, and whether the consent forms adequately explained the risks and benefits of doing so, along with other ethical and legal issues. On Tuesday, Schlissel and UC Berkeley geneticist Jasper Rine, the program’s co-organizer, addressed some of these questions at a state hearing (Sacramento Bee)
The university sent out approximately 5000 testing kits but a preliminary count suggests fewer than 400 samples have been returned. “We were guessing we would receive on the order of 1000 samples,” Schlissel said in an interview yesterday. The postmark deadline was Friday, August 6, and a final count will be available at the end of the week. [UPDATE GMT 9:55 PM: the current count is about 700 tests.]
Schlissel said that regardless of the health agency’s decision, the program would go on in some form. The university can still analyze the samples and reveal aggregated rather than individual results to students, and there will also be a series of lectures and discussions in mid-September and continuing throughout the fall semester. “If we’re ordered by a government agency not to allow students [access to] part of their genomes, that will become part of the discussion,” he said.
Schlissel and Rine will be giving a press conference at noon PST to discuss the CDPH decision and amendments to the program; stay tuned for updates.
UPDATE (GMT 9:55 PM):
According to the CDPH, the university would have needed to obtain a physician’s order for the tests and would need to have the analysis done at a clinically certified lab in order to provide students with the results, Schlissel said in the press conference this afternoon.
Getting a doctor’s order retrospectively would obviously be impossible, so the program won’t be able to comply with the CDPH ruling. Also, because the three genes chosen for the program are considered medically “inoccuous,” said Rine, the university wasn’t able to find a certified lab that could conduct the analysis, despite contacting 12 such labs, He noted also that going through such a certified lab would make the test at least five times more expensive.
Schlissel and Rine said they plan to have the data analyzed at a university lab and, rather than allowing each student who sent in DNA to see his or her individual results, “will release information in aggregate about the student body as a whole.”
“Most of the benefit of this program has already been had,” Rine told reporters – “Every single student who opened the envelope had to make a judgment for themselves” regarding whether or not to get tested. The two biologists also said that the Berkeley program would undoubtedly raise wider issues of how universities around the country use genetic information, for both educational and research purposes.
Not everybody is likely to agree. Nancy Scheper-Hughes, a UC Berkeley medical anthropologist who testified at the state hearing on Tuesday, told Nature that in her view, the main recipients of an educational experience were not the students, but Schlissel and Rine themselves.
Scheper-Hughes, who will be teaching a seminar on medical ethics as part of the program, said that she and several other professors had been uncomfortable from the beginning with how the gene testing component of the program was organized. She noted that it was far from clear-cut whether the test could be considered medical or educational – with part of the ambiguity fueled by the fact that the information packet sent to students included a medical subjects’ bill of rights. Also, many of the students were minors, she noted, and several legal issues had not been fully considered.
“I don’t think we welcome our students by turning them into [research] subjects,” she said.