Wider Debate Swirls Over Ruling That Curtailed Berkeley's DNA Program

by jeeg 21. August 2010 01:52

After months of debate, a ruling by the California Department of Public Health last week put an end to the most controversial part of a student DNA-testing project at the University of California at Berkeley, but now another debate has opened over how academic research will be affected.

Some researchers fear that the health department's position on the Berkeley project could have broader implications for academic research in California, limiting the conditions under which subjects of research studies could learn about potential health issues. Others say those concerns are unfounded.

Berkeley's plan to teach incoming freshmen about personal genetics by allowing them to obtain personal results for three genetic markers sparked a political firestorm. The program put Berkeley in the middle of a heated national debate over the ethics of personal DNA testing, driven by rapid scientific advances and the explosive growth of the personal-testing industry.

State lawmakers unsuccessfully tried to pass a bill to discourage the project, and advocacy groups and some researchers called the program unwise and potentially unethical. Last week, state health regulators said that as long as the program provided individual test results to students, it was subject to state regulations regarding clinical diagnostic tests. Those regulations require a doctor to be actively involved in the testing, and that the testing be done in a federally certified laboratory, both of which the Berkeley program lacked.

Lawyers at the University of California contend the ruling could have far-reaching effects on academic research. Under the state's standard, they say, researchers who conduct studies on genetic material that do not now fall under the clinical regulations would be prevented from reporting results to participants, even if the results revealed a risk for a serious medical condition.

The department's position could "have a deeply chilling effect on many types of legitimate and valuable activities that are currently undertaken at academic institutions every day throughout the country," a lawyer for the university, Auburn K. Daily, wrote in an August 2 letter to the health department.

The health department position applies only to research done in California. But federal regulations that govern laboratory testing, known as the Clinical Laboratory Improvement Amendments, or CLIA, use similar language, raising concerns that the department's position could influence the interpretations of other states.

Lawyers for the university declined an interview on the matter. But Hank Greely, a bioethicist at Stanford University who has been highly critical of the Berkeley DNA program, said he shared some of the university's concerns about the apparent breadth of the Department of Public Health's ruling.

For instance, he said, some genetic studies obtain DNA samples without intending to supply the results to their subjects. But if researchers notice that a research subject has a genetic variation that puts that person at a high risk for colon cancer, the researchers may want to notify the subject, even if the study does not meet the stricter guidelines that apply to medical testing.

"If the DPH takes the view that for us to tell you anything like that, it has to be done in the clinical lab, that could be a little disconcerting," Mr. Greely said.

Some Say Worries Are Exaggerated

However, others said those concerns were overblown. Officials from the health department disagreed with the idea that their opinion had any broader implications for academic research.

Kevin Reilly, chief deputy director of policy and programs at the Department of Public Health, said in a written statement that the state law was designed to protect the public by ensuring that testing results are accurate and reliable.

"The law has a specific exemption for research laboratories that do research testing only and do not report individual results. Academic researchers on campuses across the state effectively conduct research every day under this exemption," said Mr. Reilly, who declined to comment further.

The leader of one advocacy group that had called on Berkeley to end its DNA program also rejected the university's claims, calling them a legal smoke screen designed to defend a poorly conceived program that ran headlong into existing law.

"Total foolishness," Jeremy Gruber, president of the Council for Responsible Genetics, said of the concerns over the ruling.

"It has been long and well-established policy at the state and federal level that if you are going to test DNA and report individual health results back to an individual, you need a CLIA-certified lab, and you need a medical professional at some level involved in the program," Mr. Gruber said.

Arthur L. Caplan, a bioethicist at the University of Pennsylvania, said the "recontact problem" raised by the reaction to the Berkeley program is real enough: How should researchers react when they find information that leads them to want to contact a subject?

"Researchers try to fumble around trying to decide, Are we qualified? Who's going to pay for that? It's not in our grants. Would we get in trouble?"

But Mr. Caplan said the legal questions around how researchers should be allowed to respond have long been muddy, and the Berkeley ruling would not clarify things.

"The opinion doesn't create a problem," Mr. Caplan said. "It recognizes a longstanding problem as being present in the Berkeley proposal."

 

By Josh Keller (Chronicle of Higher Education-August 19, 2010)

 

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