DNA Returned To Tribe, Raising Questions About Consent
Professor Hank Greely is quoted on the ethics of informed consent for DNA research as it relates to the settlement of a case between Arizona State University and Havasupai tribe. Jennifer Couzin-Frankel of Science reports:
A tiny tribe of Native Americans who live beneath the cliffs of the Grand Canyon is shaking up genetics research, thanks to an unusual out-of-court agreement with Arizona State University (ASU). Tribe members charged that their DNA had been collected by university researchers without proper consent; after a 6-year legal battle, the university has now agreed—among other concessions—to return more than 100 DNA samples to the Havasupai and pay $700,000.
Although some tribe members had signed consent forms allowing blood samples collected 20 years ago to be studied broadly, they claimed in court that they had been told that the DNA would be used only for diabetes research. In fact, the data were used for a variety of studies. The outcome suggests that consent forms alone may not be enough to ensure that subjects understand how their samples may be used or to protect researchers.
The case may seem a footnote to popular medical studies that collect DNA and health information from thousands of people in the hunt for new disease genes. But to dismiss it as a story about Native American beliefs "would be unfortunate," says Hank Greely, a law professor at Stanford University in Palo Alto, California, who has followed the case closely. "The same sort of thing can happen to any of us."
DNA samples matched with health histories are a precious resource, Greely says. Researchers are driven to use them as broadly as they can—whether to help ailing patients or to win tenure and grants. Pressure also comes from funding agencies, which demand that such data be shared, including through a database housed at the U.S. National Institutes of Health (NIH) called dbGaP. NIH requires that researchers it funds for genomewide association studies, which scan large stretches of the genome for disease DNA, deposit data in dbGaP. The agency is considering a similar requirement for all genomic data, says Laura Rodriguez, a genetics policy staffer at the National Human Genome Research Institute in Bethesda, Maryland, who helped design dbGaP.
Nonetheless, an uproar ensued. The Havasupai case has led other Indian tribes to refuse to participate in research. It also illustrates that "consent is not a form, it's a process," says Greely, who believes the tribe members didn't realize there might be any studies beyond diabetes, even years later. One alternative strategy for DNA research, described in a 2006 paper by a Canadian geneticist who works with aboriginal communities, is that individuals loan DNA for specific studies and retrieve their samples when the research is complete. "Research subjects need to have some ability to assert their property interests in their own biological samples," says Kimberly TallBear, who studies the role of science and technology in Native American governance at the University of California, Berkeley.
Consent forms may talk in general terms about future use of data without explicitly mentioning dbGaP or other databases—in part because these data banks didn't exist when many forms were drawn up. The generic approach seemed sufficient in the past: "There was this perception that if we go back and ask [participants], and they all say yes, did we really need to bother?" says S. Malia Fullerton, a bioethicist at the University of Washington, Seattle, who participated in the Alzheimer's work. "That's been driving a lot of thinking in the policy arena." But, she says, researchers may want to reconsider. Given that dbGaP now includes data from 188,000 individuals, if even a few percent don't want it there, "that's a lot of people," says Greely.