To protect consumers, governments must step in to address the risks of nucleic acid testing.
The market for personal genomics, also known as direct-to-consumer testing, is booming, and millions of individuals worldwide have used these DNA testing services. The process is simple: With a normal online order, consumers receive a kit, provide a saliva sample, and return it to the company for analysis. As one of the major players in the market put it: “It’s just saliva. No blood. No needles.”
Users who are attracted to these personalized genetic tests can have high expectations. Through these tests, companies offer to help users manage and improve their health, discover their genetic risks, learn about their ancestry, and achieve higher athletic performance. Indeed, some researchers argue that personalized genomics will change people’s lives.
But there is more to these services than meets the eye. Our research suggests that consumers and government regulators should be vigilant about companies that sell genetic tests to individuals. The direct-to-consumer genetic testing market is one in which enormous financial interests, public health, and sensitive personal data collide. This intersection results in a market equilibrium that harms consumers.
Consumers are often unaware of the risks and limitations of these tests. For starters, consumers don’t pay enough attention to the legal arrangements—privacy policies, consumer contracts, informed consent forms—that govern these tests. Our study indicates that these legal texts usually contain complex and ambiguous language in multiple lengthy documents buried in unclear links.
Moreover, users often misunderstand the meaning and importance of the services they consume. Genetic data and genetic test results are complex, but most consumers do not have sufficient scientific education and understanding of statistical risk.
Furthermore, most providers test just a portion of an individual’s genome. Consumers are unlikely to realize that this limits the usefulness of many tests. Thus, consumers may often form unfounded and unrealistic expectations.
Another limitation is that most tests for complex diseases are not standardized, but companies test different things. Consumers get contradictory results from different companies, which reduces the usefulness of such tests.
Companies fuel consumer misunderstanding by providing disproportionate and inaccurate positive messages about testing and relatively little information about the risks and limitations involved. To facilitate consumer enthusiasm, providers often also use scientific language that impresses consumers with the promise of personalized and accurate medical advice.
These products can also pose multiple data risks that consumers are not likely to notice. Consumers may not realize, for example, that companies can store genetic data indefinitely.
In addition, consumers may not appreciate that the contracts they “accept” allow companies to use genetic data, other personal data, and physical samples for medical research. Thus, service providers may make use of people’s genetic information in ways that may reveal sensitive personal information.
Moreover, service providers can cooperate with insurance companies. Consumers may not realize that their genetic information can affect their insurance coverage and premiums. As if that wasn’t enough, some services have stated in their contracts that consumers who don’t disclose genetic tests to their insurance companies may be committing fraud.
Importantly, the importance of genomic data goes beyond the individual tested, and the potential impacts of personalized genomic services should concern society as a whole. The overall impact of the sensitive data hoard on millions of consumers makes potential data leaks all the more serious. The higher the value of the data, the more likely it is that third parties – including hackers, terrorists, and other criminals and ill-intentioned – will attempt to obtain it.
It is unlikely that companies will accurately assess the harm they are doing to consumers. This score increases when companies want to believe that their services are purely business or that they contribute to the well-being of consumers.
Consumers aren’t the best at avoiding risk either. One cannot and should not expect consumers to acquire scientific knowledge and skills, to read lengthy, complex and hidden texts, and to show constant suspicion and skepticism as a precondition for taking a DNA test.
This issue is exactly where regulation can help. To address this failure, governments must introduce consumer data rights designed for personalized genetic testing. The move should come alongside other regulatory measures, such as compliance audits, mandatory codes of conduct, and model privacy policies and contracts for the industry.
Regulations must empower consumers and strengthen their control over their genetic data, and give consumers the right to access, transfer and erase their genetic data.
After all, a DNA test Not “Just saliva.”
The authors received funding from the Borrin Foundation for this research, but the opinions expressed in this article are those of the authors and do not represent the views or endorsement of the Borrin Foundation.