By KATIE KUEHNER-HEBERT, a freelance writer based in San Diego with more than two decades of journalism experience
and expertise in financial writing
Stanford University this summer began offering a class to medical and graduate students that gives them the option of studying their personal genotype data. University of California, Berkeley is incorporating a discussion on personal genetic testing in its incoming-student orientation program this fall and mailed saliva-sample kits to every incoming freshman and transfer student.
Universities contemplating classes or assignments involving student testing of their own DNA should be prepared to handle increased risks stemming from privacy concerns, unintended consequences from incorrect readings of the tests and perception of coercion, according to experts and a risk manager.
"Although there are data-protection laws and emerging safeguards against genetic discrimination, obtaining and storing this kind of personal information will charge schools with yet another set of confidentiality and privacy protection concerns," said Robert B. Smith, an attorney who leads the college and university practice group at Nelson Kinder Mosseau & Saturley PC in Boston.
In addition to ensuring that standard policies for data protection are met, risk managers at universities should also consult with bioethics professionals to determine the appropriate standards and practices for collecting, storing and disclosing genetic information, Smith said.
The unintended consequences of young, relatively immature adults learning about genetic disposition to certain conditions, particularly if such tests prove inaccurate, will also likely complicate the risk management landscape for colleges and universities.
Several universities have recently introduced courses or assignments enabling students to study their own genotypes, under the notion that the students would best learn about the merits--and potential risks--of personalized medicine if they studied their own DNA. Some of the universities are offering the courses to future doctors and researchers to optimize their skills and heighten their awareness of the various ethical and legal issues surrounding the field.
Stanford's class will discuss the potential risks of genetic testing as well as various ethical and legal issues before students obtain the results of their personal genotypes, according to a July 6 article in Scientific American. Students will be offered one-on-one counseling afterward, according to the article. Genotypes will not be researched further as the DNA will be destroyed, but the students' information will be stored on computer for a study on the educational merits of the class.
A Stanford administrator in charge of the new program was not available for comment, according to spokeswoman Susan Ipaktchian. She added, however, that students in the new elective course are given the option of using either their own data or publicly available genome data for the classroom exercises, with instructors "blinded" as to which type of data individual students are using.
At Berkeley, participating students will be able to learn about their tolerance to folic acid, lactose and alcohol from the genetic tests. Berkeley students' DNA, like the DNA of students participating at Stanford, will be destroyed but the information will be stored on a computer.
Berkeley officials insist no further research will be conducted on the samples, but the informed consent form given to students states that the tests are part of "a medical research study in the area of personalized medicine," according to the Scientific American article.
Allen Bova, director of risk management and insurance for Cornell University in Ithaca, N.Y., said that institutions should explicitly state in their informed consent forms who will be able to access the student's genetic information and how exactly the information will be used.
Institutions should also specify on the consent forms how they plan to safeguard the information.
"For informed consent forms to be enforceable, the more specific they are, the better," Bova said.
An area to which risk managers are going to need to pay particular attention is dealing with the unintended consequences of students--some of them barely adults--making lifelong decisions after reviewing the results of their genetic tests, the experts said.
For example, Berkeley is testing whether students have an enzyme that breaks down alcohol. Students who receive negative results may decide that it's OK to drink too much.
"What if a student found not to have the variation binge drinks, dies and the family sues saying, 'Your testing gave them false security about their ability to drink,' " Smith said.
Bova advises universities to draw up appropriate quality controls to make sure the genetic testing is accurate--to the extent that such testing can be.
Institutions also need to clearly state on informed consent forms that participation in genetic testing is voluntary, said Smith
Even so, students might feel pressured to participate in DNA testing for fear they will lose respect in the eyes of their professors.
Mark Schlissel, dean of biological science at the College of Letters and Science at Berkeley, responded after this article was initially published:
"We will test on a voluntary and anonymous basis three single nucleotide polymorphisms--or three single-letter differences in the genetic code--out of about three billion letters of genetic code. We are not testing for the predisposition to alcoholism; rather, we are testing whether the students' cheeks will become rosy when they drink. That information was mailed out with the test kits, and the professor who will lecture on that in orientation will address that again. There will also be a panel discussion involving social scientists speaking about the diverse social, ethical, legal and risk management issues involved in genetic testing."
"We of course, are concerned about students' privacy and potential exposure to liability related to this teaching program. ...The language in the actual (informed consent) document that went out to students did not have that wording (detailed in the Scientific American article).In the final letter, we explained explicitly that the samples will only be used to test these nucleotide markers, and the remaining samples will be destroyed. At no point in the process is the name attached to someone's sample--there is anonymous bar coding, and the only other copy of the bar coding is held by the students themselves. They have to type in the bar code number on a Web site in order to get their test results. So there isn't any opportunity for other people to get a hold of their information."
July 20, 2010
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