Experts Call for Stricter Regulation of Genetic Testing
Imagine donating a sample of your DNA to help researchers study the genetics of diabetes. The disease is common among your friends and family, and you are proud of your role in finding out why.
Now, imagine that some time later, you learn your DNA has been used for studies on other topics, such as schizophrenia, human migration and inbreeding. Although your name is no longer attached to the sample, scientists are using your DNA to draw conclusions about your community and your ancestors. Some of these studies violate your cultural beliefs.
That is what happened to the Havasupai Tribe of Arizona. In 2004, they sued Arizona State University, the institution that originally collected the DNA, for failing to provide ethical oversight on the use of the samples. The case is still working its way through the courts.
Given the proliferation of private corporations that promise insight into consumers’ genetic origins, the need for a clear set of rules governing genetic ancestry testing is becoming more urgent, Sandra Soo-Jin Lee, Ph.D., of the Stanford Center for Biomedical Ethics wrote in a new study, published in the journal Science.
Genetic ancestry tests, which can cost just a few hundred dollars and require only a simple cheek swab, are gaining popularity among genealogy hobbyists and curiosity-seekers. But without clear rules and regulations, consumers may not be getting what they were promised. “Direct-to-consumer genetic ancestry tests fall into an unregulated no-man’s land,” Lee and her colleagues wrote, “with little oversight and few industry guidelines to ensure the quality, validity and interpretation of information sold.”
Lee and her co-authors respond to recent guidelines issued by the American Society of Human Genetics to discuss how policies governing ancestry testing, including genetics research, are inadequate. While the Federal Office of Human Research Protections requires researchers to obtain consent from DNA donors, the rules governing how scientists can then use these samples are anything but clear.
In the Havasupai case, for instance, samples were not tagged with individuals’ names, so scientists believed they were free to use them for later, unrelated studies. Because scientists can now identify the ancestry behind the DNA, however, such samples can be used to draw conclusions about small, possibly vulnerable groups of people.
According to Lee and her colleagues, developing a set of rules is challenging because of the conflicting interests of the various groups involved: for-profit companies, academic scientists, casual consumers, and specific ethnic or racial subsets of the population.
To bring the sides together, the authors call for stronger federal oversight. “We encourage regulatory agencies such as the Federal Trade Commission, the Food and Drug Administration, and the Centers for Disease Control to help set industry standards for responsible and accountable practices in genetic ancestry testing,” co-author Kimberly TallBear, Ph.D., assistant professor of science, technology and environmental policy at UC-Berkeley is quoted as saying. Such leadership will be necessary to manage conflicts among groups that have given “little indication” they are willing to compromise.
SOURCE: Science, July 3, 2009