This week, the University of California, Berkeley will mail saliva sample kits to every incoming freshman and transfer student. Students can choose to use the kits to submit their DNA for genetic analysis, as part of an orientation program on the topic of personalized medicine. But U.C. Berkeley isn't the only university offering its students genetic testing. Stanford University's summer session started two weeks ago, including a class on personal genomics that gives medical and graduate students the chance to sequence their genotypes and study the results.
The idea behind the two novel projects is that students will learn about optimizing treatment based on one's genetic profile most effectively if they are studying their own DNA—an idea that has met with both praise for educational innovation and criticism centering on potential ethical issues.
"The concerns did not revolve around whether students should be taught about genetic testing—everyone agreed about that," says Gilbert Chu, a Stanford professor of medicine and biochemistry. "The concerns surround allowing students to undergo genetic tests themselves. I don't think it's been an easy road to get to this, and I don't think we know whether it's going to be successful."
George Annas, a bioethicist at the Boston University School of Public Health, worries that the projects are premature. "This potentially is a model that other schools will copy. I think it's an innovative idea that can get students engaged, but from my perspective they are facing a very steep learning curve about how to do this. I don't think they're ready."
Stanford and Berkeley faced the same essential ethical dilemmas in creating their programs: avoiding coercion, protecting students' privacy and adequately preparing students to interpret the results of their tests. But the two universities took markedly different approaches to designing and executing their respective projects
Outsourcing vs. testing on campus
Berkeley's project is essentially a modified version of the summer homework many colleges assign to new students in an attempt to foster intellectual discussion and class cohesion. This year, instead of asking students to read the same book or watch the same movie for later debate on campus, Berkeley sent approximately 5,500 incoming freshmen and transfer students DNA sampling kits. The hope is to spark discussion during orientation on how genetic testing works, the results of the students' tests and their decisions on whether or not to participate. The "Bring Your Genes to Cal" program is the first mass genetic testing project by any national university. Although the program is entirely voluntary and confidential it has alarmed some bioethics watchers, who cite concerns about privacy, student health and the ambiguous nature of the project.
"This year we decided to take on the topic of personalized medicine, which in the future will allow doctors to tailor their treatments," explains Mark Schlissel, dean of biological sciences at Berkeley and one of the program's organizers. "We wanted to provide an actual genetic test of the type that will become routine in the future and provoke very personal thought processes."
After difficulty finding an affordable outside company that would agree to complete the genetic testing, Berkeley settled on a genetics laboratory in its School of Public Health. The Berkeley lab will test students' DNA for three specific gene variants that affect how the body metabolizes and uses alcohol, folic acid (vitamin B9) and lactose.
Any student choosing to participate uses the provided kit to collect their saliva in the provided container and mail the sample to Berkeley with a unique bar code attached—a duplicate of which the student keeps. Reportedly, test results will not be linked with any names—they will only be tied to the confidential bar codes that students use to identify their results online. All participating students must provide informed consent and minors must obtain additional permission from their parents.
Stanford's project, in contrast, is only open to medical and graduate students in the form of an eight-week elective summer class called "Genetics 210: Genomics and Personalized Medicine," in which about 50 students have enrolled, with a dozen more auditing. Students in the class can choose to have their genotype analyzed by Navigenics or 23andMe—personal genomics companies that provide individualized risks for various health conditions and sensitivity to drugs (23andMe also provides additional information about ancestry). The results of their tests will be incorporated into the class curriculum, although students can also opt to study publicly available genetic data in lieu of analyzing their own. Professors will not know what decision the students make. The idea behind the class is to prepare a new generation of physicians and scientists with the understanding that they need to properly analyze and interpret genetic data.
"When individuals want expert advice on their genetic test results they are going to turn to physicians or professors, so it's particularly important for these individuals to be adequately prepared," says Keyan Salari, a sixth-year MD/PhD student who originally proposed the course and is now its director.
Stuart Kim, a Stanford professor of developmental biology and genetics who served as Salari's faculty sponsor, says the goal is to make sure Stanford students are prepared to handle the future of personalized medicine. "The students are going to need extensive training," he adds.
Two approaches to anticipated controversy
Despite enthusiasm from many Stanford students and professors, the course did not receive approval without significant deliberation. "This is all new waters," Kim says. "I didn't think there would be such a controversy over writing this course, but it turned into a big debate."
In fact, after Salari originally proposed the class last fall, a Stanford task force of about 30 basic scientists, clinical scientists, genetic professors, genetics counselors, bioethicists, legal counselors and students spent several months working through the various ethical issues and establishing safeguards to protect students. In contrast, the organizers of Berkeley's project incurred criticism because they spent hardly any time considering the potential reaction to their new orientation program.
Kimberly Tallbear, a professor of science, technology and environmental policy at Berkeley, explains that neither Mark Schlissel nor any of the project's other organizers consulted with Berkeley's bioethics community. "Schlissel said several times they were surprised about the controversy," Tallbear says. "I said to him, 'Well doesn't that tell you that you needed input from us? Because we could have told you about the controversy and debate.'"
In response, Schlissel says that Berkeley does "not organize educational programs by inviting all 1,500 professors to participate in the design." The project was approved by Berkeley's Committee for Protection of Human Subjects Institutional Review Board, which included bioethicists of its own, Schlissel adds.
Three bioethics issues
Apart from the preparation—or lack thereof—that shaped the new programs, three main issues concern critics in the bioethics community: The manner in which universities are asking for genetic data from students; what will happen to that information; and how students will understand and respond to the results of their tests.
Berkeley is offering genetic testing to its students free of charge, a decision that could persuade students to participate, many bioethicists argue, because many may jump at the opportunity to obtain for free what is usually costly.
Furthermore, some argue that the assignment borders on coercion. Any pressure from peers or the university to participate in the program should not be overlooked, say critics like Arthur Caplan, a bioethicist at the University of Pennsylvania (Penn). There's already considerable excitement about the program on Facebook, according to Joanna Maltbaek, an incoming Berkeley freshman from Mountain View, Calif., who says she will most likely participate in the "Bring Your Genes to Cal" program. "I like that it's a way for incoming freshmen to get involved in something important," Maltbaek says. "I can already see people wanting to go to campus and discuss it, and I think people might feel pressured, especially because Berkeley isn't offering an alternative [to the class-wide summer assignment]."
Students enrolled in Stanford's elective must pay a $99 fee to have their genotypes analyzed by 23andMe or Navigenics. "These tests are normally offered to the general public at $500 or $600," Chu says. "If students could get the testing for free there was some concern that it would encourage students to neglect all the risks involved." When Salari pointed out that 23andMe recently advertised their genetic testing package for $99—a promotional offer for DNA Day on April 23—the course's organizers decided that would be an appropriate fee to request of students, just as many must pay for the materials they use in laboratory classes.
Beyond the incentives and pressures students might feel to participate in genetic testing, critics have called attention to a second kind of ethical dilemma: the question of how the universities will use the resulting data.
In Berkeley's case, the matter is complicated by conflicting statements about exactly what kind of project the university is organizing. The program's founders insist it is not a research or medical project, but the informed consent document all participating students must sign explicitly characterizes the project as "a medical research study in the area of personalized medicine…providing free of charge information on three of your genes in which variants are common in the human population and which affect aspects of your health that you can address by simple, safe and effective dietary means."
"If you look at the language in the informed consent, it looks like it's a study," Tallbear says. "I don't understand—it's not clear at all. If it's unclear to us who deal with consent forms all the time, how will it look to 18-year-olds?"