Letter from Dean Mark Schlissel
Dear Students,
I am writing to you about some changes we've been directed to make to the College of Letters and Science's On The Same Page -- Bring Your Genes to Cal program. The idea behind this teaching program is to welcome you to the academic community at Cal by inviting you to participate in a series of discussions about Personalized Medicine, the set of rapidly improving DNA based technologies that will allow physicians in the years ahead to better prevent, diagnose and treat disease by using the information available in a person's own DNA. As you may recall, last month we sent you information about the program, along with a saliva collection kit and a consent form. We offered you the opportunity to, on an entirely voluntary and anonymous basis, send in a sample of your saliva from which we would purify DNA and then test it for each of three common gene variants affecting your ability to metabolize milk products, alcohol, and the vitamin folic acid. We had promised to allow those students who sent in samples to obtain their test results after a series of educational events we have planned for mid-September including a lecture in Wheeler Hall by Genetics Professor Jasper Rine.
Since this unusual education program involved testing human material, we sought the opinion of Berkeley's Committee for the Protection of Human Subjects (CPHS) who approved our plans as well as the wording of the consent form we sent you.
This program has generated a large amount of public interest and debate, covered extensively in the news media. Some people think that it is inappropriate to solicit DNA samples from incoming students for this purpose regardless of the privacy safeguards we put in place, CPHS approval, and your informed consent. Others think this to be a very creative way to engage our students in thoughtful consideration of a series of important and timely issues.
Earlier this week, we were informed by the California Department of Public Health that they consider these DNA tests to be medical tests, and that we are not allowed to return individual results to you unless the tests had been ordered by a doctor and performed by a licensed clinical testing lab. This ruling relies on an interpretation of legal statutes that is entirely different from the interpretation of the same statutes by UC's top lawyers. However, we must, of course, follow the interpretation of the statutes by the agency charged with their administration. Since the three genes we are testing are not routinely tested in medical practice, we were unable to find a licensed clinical lab to perform these tests and of course, a physician did not order them.
Thus, I am very sorry to inform you that we will not be able to give those of you who submitted samples access to their test results. Nonetheless, we currently plan to analyze the samples in a research lab on campus and present the aggregated results to you during Professor Rine's lecture. The remaining DNA would then be destroyed as promised. In order to do this, we must first seek the permission of the Committee for the Protection of Human Subjects since this represents a significant change to the plan that they originally approved. If they deny this request, then we will have to destroy the samples and not perform any analyses.
The public controversy generated by the OTSP program and the decision of the California Department of Public Health raise a series of fascinating issues that will be included in the conversation we will all have when you arrive on campus. If you have any questions before then, you can contact Alix Schwartz at alix@berkeley.edu.
We hope that you each had a wonderful summer and look forward to seeing you all on the Berkeley campus very soon. Be on the lookout for more information about On The Same Page -- Bring Your Genes To Cal events when you arrive.
Sincerely,
Mark Schlissel M.D., Ph.D.
Dean of Biological Sciences
