Skip to main content

Bioethical ‘Guardrails’ Fall Short in Direct-to-Consumer Genetic Testing, Says Nelson

Genetic information can travel far and wide, said Alondra Nelson.

Consumer genetic testing, once confined to the world of genealogy, has found its way into criminal justice, medicine, mortgage lending and multiple other sectors of society within the past 20 years.

Unfortunately, the bioethics that would guide the use of these data have not kept pace with the busy “social life” of our DNA, said social scientist Alondra Nelson at the American Association of the Advancement of Science’s Annual Meeting.

For too long, researchers who use genetic data have isolated themselves in “silos,” where the DNA that a criminologist studied was considered somehow different from the DNA in a medical anthropologist’s work. But when Nelson began to study how consumers were using their genetic test data, she found that these boundaries were often crossed.

Older African Americans, some of the earliest adopters of consumer genetic testing, were drawn to sites like AncestryDNA to learn more about their roots and ancestral homelands, she found. But they also understood that the data could contain information about their risk of breast cancer, and supported its use in a historic lawsuit for slavery reparations, Nelson said.

Her research “revealed inklings of what we now know are the growing, unintended uses of genetic data,” she said. “Genetic information, while intended for one place, could travel far and wide.”

Soon after direct-to-consumer genetic testing became available in 2002, “there was a crisis of traditional regulatory guardrails,” Nelson said. It became apparent that the rules and guidelines “that we have relied on in many cases for decades to tell us how to understand emergent science and technology could not cope with the silo crossing and the blurred boundaries that were taking place.”

Much of the traditional legal oversight of genetic testing does not apply to products that are not directly sold as medical testing. For instance, direct-to-consumer genetic testing does not have to take place in laboratories accredited through the Centers for Medicare & Medicaid Services Clinical Laboratory Improvement Amendments, although some consumer labs are accredited, said Nelson.

The U.S. Food and Drug Administration is not authorized to monitor the validity or efficacy of non-medical genetic tests, and direct-to-consumer test results are not covered by the Health Insurance Portability and Accountability Act (HIPAA). The Genetic Information Nondiscrimination Act of 2008 focuses only on protecting genetic data for health insurance and employment purposes.

At the same time, Nelson said, institutions like the police are also making unintended use of genetic data that individuals have shared in online genealogy databases. She discussed one of the most famous examples, the 2018 case of the Golden State Killer suspect, who detectives arrested after uploading the suspect’s DNA to GEDmatch, a popular site for hobbyists to share genetic results in the hopes of filling out their family trees.

Nelson also shared the story of the New Orleans filmmaker Michael Usry, who spent three years under suspicion beginning in 2014 for a cold-case murder after a false positive genetic match, based on a genetic sample that his father had offered to a Y chromosome research database.

Nelson offered several suggestions for a new bioethics to keep pace with the diverse and growing use of personal genetic data, including more studies of how our DNA travels through different social spheres. The new ethics would also draw from the lessons we are learning about the privacy of other personal data, like that shared on social apps. In a networked world, Nelson reminded the audience, “individual data always carries information about others.”

She also recommended a return to the ideas that sparked the bioethics movement, to counter the depredations of Nazi Germany revealed in the Nuremberg trials and the appalling, inhumane treatment of African American men by scientists of the U.S. Public Health Service Syphilis Study at Tuskegee.

“I think it’s important for us … to understand that bioethics was developed, our ethical codes, principles, norms, were developed to help prevent, or try to prevent, damage and harm to the least of us,” she said.

Nelson is the president of the Social Science Research Council and the Harold F. Linder professor of social science at the Institute for Advanced Study. She was elected last year to a 4-year term to the AAAS Board of Directors.

Before the plenary speech, AAAS President Margaret Hamburg presented the AAAS Lifetime Mentor Award and the AAAS Mentor Award.

[Associated image: Robb Cohen Photography & Video]