NEW YORK (GenomeWeb News) – More guidance and oversight are needed to make sure that genetic ancestry tests are carried out ethically and accurately, according to a policy paper appearing online today in Science.
A team of bioethics and anthropology researchers from Stanford University, the University of California at Berkeley, the University of Texas at Austin, New York University, and the University of Wisconsin argued that a sound public policy should be developed around existing genetic ancestry testing recommendations — such as those issued by the American Society for Human Genetics at its annual meeting last fall.
"The ASHG statement identifies key issues surrounding the science of ancestry estimation and represents an important first step," lead author Sandra Soo-Jin Lee, a researcher at the Stanford Center for Biomedical Ethics, and her co-authors noted. "However, an effective public policy for the growing market of genetic ancestry tests must build on the ASHG's recommendations and must generate specific mechanisms and approaches."
Genetic ancestry is increasingly entering research and recreational realms. For instance, Lee and her colleagues noted that such tests are currently being used for everything from biomedical and forensics research to genealogical studies and immigration control.
Some direct-to-consumer genetic testing companies are relying on genetic ancestry information, too, not only to help interpret the risk posed by specific genetic variants, but in some cases to offer consumers a glimpse at their ancestry and family history.
"Despite the proliferation of companies providing genetic ancestry information, DTC genetic ancestry tests fall into an unregulated no-man's land, with little oversight and few industry guidelines to ensure the quality, validity, and interpretation of information sold," Lee and her co-authors wrote.
In their policy paper, the researchers focused on issues related to the responsibility and accountability of those collecting samples and doing genetic tests, the need to come up with standard ways to assess genetic ancestry data, and the role of government agencies, if any, in developing DTC genetic ancestry test guidelines.
The team highlighted ethical issues that can spring from DNA sample collection and reuse, using the Havasupai Tribe as an example. In that case, researchers from Arizona State University and elsewhere came under fire for allegedly using samples collected for diabetes research for additional studies of schizophrenia, human migration, and inbreeding. The tribe's lawsuit against the Arizona Board of Regents was dismissed in 2007 but re-instated by an appeals court last November.
"It is a scientific imperative that we enact enforceable policies that determine what constitute responsible and accountable collection and secondary use of DNA samples," Lee and her colleagues argued.
They noted that previously collected genetic samples aren't considered human subjects research by the US Department of Health and Human Services' Office for Human Research Protections, leaving a gray area with respect to informed consent and other requirements.
The team also touched on the need to develop common terms for sharing genetic ancestry information between academic researchers, research subjects, industry representatives, consumers, and others.
Finally, the researchers contend that specific systems should be put in place to enforce genetic ancestry guidelines. For their part, the authors called on agencies such as the Federal Trade Commission, the US Food and Drug Administration, and the US Centers of Disease Control and Prevention to increase oversight and regulation of ancestry testing.
"New regulations … will help shape how practitioners are able to communicate genetic ancestry testing results to consumers," the authors concluded. "Political will and leadership toward addressing fundamental differences in perspectives may ultimately determine whether a gold standard for genetic ancestry testing can be achieved."