Not Everyone Trusts the Gut
American Gut leaders emphasize that results from its sample studies constitute basic research rather than any medical diagnosis. But studies of possible medical applications are under way. The Knight lab is using funding from the Crohn’s and Colitis Foundation to explore if, given just a fecal sample, researchers can determine if someone has Crohn’s disease, and what type. The lab is also collaborating with Paul Wischmeyer, M.D., of Anschutz Medical Center at University of Colorado, Denver, to perform an initial characterization of the effects of ICU stays on the microbiome.
By stressing that data collected is not medically actionable, American Gut sounds more like the direct-to-consumer testing carried out by some companies than bona fide research, Jeremy Gruber, J.D., president and executive director of the Council for Responsible Genetics, told GEN.
So too, Gruber said, does the fact American Gut charges participants for taking part, starting at $99. For $129, participants can fund two kits, the second for someone in Africa, South America or Asia. The priciest option or “perk” at $25,000 pays for “ultra-deep” sequencing—details are undisclosed pending future publication—of a microbiome sample, aimed at generating as many individual bacterial genomes as possible.
“They’re not offering back your data alone. They’re offering back an interpretation. And any time there’s an interpretation of medical data, or medically related data, there should be some oversight to ensure that it’s factually correct, that it’s put in proper context, that the individual truly understands what they’re receiving. It’s not entirely clear that’s the case here,” Gruber said.
Gruber added that the collection of a significant amount of personal information “raises concerns regarding what exactly are the privacy protections that are in place, to make sure that what is being promised actually occurs, what processes are being used to de-identify the information, and what is being told to the consumer to encourage them to participate in the project.” Genetic data, he added, should be protected as strongly as personal medical records and Social Security numbers.
Many of Gruber’s arguments mirror those asserted in an NPR report by three other bioethicists— Hank Greely of Stanford University; Pilar Ossorio of the University of Wisconsin, Madison; and Eric Juengst of University of North Carolina, Chapel Hill. They questioned how participants’ data can be kept confidential, whether their DNA might inadvertently go public, who owns the data, and why children’s data are being collected.
In response, American Gut’s leaders issued a statement noting that every aspect of the project is voluntary, that no human DNA will be sequenced from samples, that any DNA sequenced from pricier perks will be removed as in the Human Microbiome Project, that project data is free and owned by no one, and that data will remain confidential under protocols approved and monitored by CU’s Institutional Review Board.
“These protocols assure the data are safely collected and properly de-identified, and that identifying information is stored in a confidential manner—in this case, on access-controlled servers sitting in a university-run data center that is monitored 24/7 and which requires keycard access,” Dr. Knight, McDonald, and Leach said in a statement. “We do appreciate that no project can ensure privacy 100%, but we are making every effort to do this, which involves considerable extra effort.”
As for seeking payment from participants, McDonald told GEN American Gut lacks the funding to pay participants: “I would absolutely love to be in a position where we could offer some type of monetary compensation for participation in the project. But it is simply not feasible for the American Gut at this point,” McDonald said.
As of November 11, the project raised $615,450 in donations from more than 6,700 people and four companies that supported individuals seeking to participate but unable to give toward American Gut. That’s one indication that there’s public interest in the project. Not to mention the 18,000 people who initially requested more information last year. The project hopes to collect samples from 20,000 people.
The best way to reach that goal, and go beyond, is by communicating clearly how participants’ data will be protected—and working toward lowering the cost through additional foundation funding; McDonald said NIH funding was unlikely given the dearth of exclusion criteria, though years of flat budgets aren’t encouraging. The additional funding could support the longer-range medical research needed to translate the raw data of American Gut into more usable knowledge that benefits participants, from improving their diet to treating their disease.