The University of California at Berkeley has been forced, by the California Department of Public Health, to abandon significant portions of its “Bring Your Genes to Cal” orientation program for incoming freshmen. The Department of Health informed UC Berkeley that major aspects of the orientation program – described as an “experiment” by the university – are unlawful. Today the university announced significant changes to the program to comply with the state’s demands – although questions remain concerning the program.
At today’s press conference, the Berkeley Daily Planet was able to inquire into three issues: First, the university’s retreat raises new questions about the ethics of continuing the exercise at all: whether or not students are now dragged into an experiment to which they did not agree. Second, the scientific value of the project is newly in doubt. Third, possible conflicts of interest behind the project (and the forces that create them) are coming into sharper view.
“Bring Your Genes to Cal” is a novel freshmen orientation exercise in which incoming freshmen are invited to volunteer for a limited form of genetic testing. Students who sign a consent form (and underage students whose parents sign) may submit saliva samples. Three genes from those samples will be tested. The genes tested pertain to one’s ability to metabolize alcohol, lactose, and folic acid.
To date, approximately 700 incoming freshmen have returned samples and UC Berkeley researchers are predicting approximately 1000 submissions total. Students making submissions have been informed that, in exchange, they will have anonymous access to their individual results. Meanwhile, UC Berkeley will own the aggregated (anonymous) data of all participants. Consistently, throughout the project, representatives of UC Berkeley have indicated that individual test results may suggest that, for better health, students should adjust their diet.
The California Department of Health called UC Berkeley on to the carpet. In their view, the test and accompanying dietary advice comprise a clinical trial – experimental medicine. Under California state law, human subjects may participate in such experimental testing only if the testing is recommended by a licensed physician to each individual patient, and if the lab work is conducted by a certified testing laboratory. In the case of “Bring your Genes to Cal”, neither is the case: no individualized physician recommendation is required and the lab work will be done in a UC Berkeley lab rather than a certified clinical lab. Consequently, as advertised, the “Bring Your Genes to Cal” program is arguably illegal.
In a press conference today Professor Jasper Rine and Dean Mark Schlissel–the
lead scientist of the project and the dean of his department–announced that while they disagree with the Department of Health’s interpretation, they will cede to it and make “significant changes” to the program, midstream.
In particular, students who volunteer for testing will no longer be permitted access to their individual results. Their results will still be measured by the university and the university will still own the aggregate results–but students will not be permitted to see their individual results. This change, according to UC Berkeley, will satisfy the law.
In addition, Schlissel and Rine announced that there would be additional seminars on the “ethical, social, and political implications” of this form of genetic testing.
In a press conference today, the Berkeley Daily Planet posed some questions to Schlissel and Rine. Our main concerns were whether it is ethical to proceed with the program at all, whether there is any actual scientific value to the exercise, and whether (as some have charged) Rine’s role in the program presents a significant conflict of interest.
On the Ethics of Continuing the Exercise at All:
As of this writing approximately 700 students are known to have submitted samples for testing under the understanding that they would anonymously see their individual results, while UC Berkeley would own the aggregate data. Approximately 1000 students are expected to provide samples with that understanding in coming days.
Today’s change to the program means that while UC Berkeley will still own the aggregate data, students will not see their individual results. The ethical question then arises: should the exercise be continued at all—or should the university simply destroy the samples and cancel the exercise.
The Berkeley Daily Planet asked about this and Schlissel replied “Several of us discussed that at great length. We decided we would do what we told the students we would [insofar far as] testing the genes and presenting as much data as allowed. [If there are students upset at not receiving their individual results] we would refer them to the Department of Health. We would be happy to give them as much as we are permitted to.”
On the Science:
Schlissel and Rine have repeatedly described the orientation exercise as a scientific experiment. We asked what hypothesis the experiment was designed to test.
Schlissel replied that the hypothesis being tested is whether or not programs such as “Bring Your Genes to Cal” are an effective way to engage students, particularly students not majoring in biology, in the complex issues that surround genetic testing. He added that the methodology would involve the taking of attitudinal surveys.
In effect, what appears on the surface to be a biological experiment now turns out to be a sociological experiment designed primarily by biologists (in extensive consultation with colleagues of many disciplines).
Questions of Conflicts of Interest:
Schlissel and Rine have consistently described the program as testing genes of no medically actionable significance and, as Schlissel put it today, and as concerning “non-commercially important genes”.
These claims are somewhat surprising. In 2008, Rine published research that studied one of the genes in question (concerning folic acid metabolism), examining the genetic variations that exist and their possible medical consequences. One of the questions posed by this research is whether or not dietary adjustments are medically appropriate in response to the results of such a genetic test.
Rine is additionally a founder of Vitapath, a start-up firm that, initially, is “intended to help prevent Spina Bifida by identifying women who carry genetic risk factors that can be overcome with high dose folic acid”. One of the genes tested in “Bring Your Genes to Cal” falls into that category.
During the press conference, Rine remarked “I’d like to give thanks to the press for their enthusiasm to cover this story. You couldn’t buy publicity like that.” Subsequently, Berkeley Daily Planet asked Rine to address the conflict of interest questions directly.
He remarked: “Five years ago, my colleagues and I [formulated a promising genetic hypothesis] about Neural Tube Defects [such as Spina Bifida]. We applied for federal grants sufficient to test our hypothesis and were funded at 1/3 that level. It was not enough money to test our hypothesis. So, four of us established a company with venture funding to fully fund the research.”
Rine suggested that such a funding pattern was the rule more than the exception, these days.