The Trouble with UNinformed Consent in Direct-to-Consumer Genetic Testing

Today we are bombarded with online terms of service, contracts, and privacy policies. Whether we are signing up for Spotify or online fitness classes, clauses of click-through legalese lead to the inevitable checkbox – I have read the details and I agree.

…but it turns out, most of us don’t actually read them.

In a 2017 gag by a UK-based Wi-Fi company, 22,000 people who signed up for free internet also committed to 1000 hours of community service cleaning toilets at festivals and scraping gum off the street. In a 2018 study, researchers found 98% of college students, while registering for a new (fictitious) social network called NameDrop, agreed to give up their future first-born child.

The dry, incomprehensible (we’ll come back to this), lengthy text and the fact that everything seems to come with terms and conditions, has led to widespread consent fatigue. 

And depending on what’s buried in that fine print, the consequences (as illustrated above) can be significant. 

Uninformed consent

What does this mean for direct-to-consumer (DTC) genetic testing?

In my field, informed consent is paramount to the genetic testing process. In a typical genetic counseling session, we review the purpose of the test, benefits and limitations, potential results, possible implications for the patient and their family members, privacy concerns and insurance issues. The goal is to provide the patient with enough information to give their voluntary permission (i.e.: consent) to proceed with testing. 

It’s the same for genetic studies, where informed consent (an ethical tenet of research) helps participants decide whether or not to take part in a study knowing the potential risks and benefits. When needed, genetic counselors or study staff walk participants through the consent process addressing the complexities specific to genomic research.  

But DTC genetic testing is different. At-home DNA tests, which can reveal aspects of your ancestry or uncover your genetic risk for certain health conditions, are ordered directly by the consumer without the support of a healthcare provider.

Before ordering a DNA test kit, people are asked to review and agree to the company’s terms of service, privacy policy and, if applicable, research consent form. At 23andMe, for example, customers can opt into 23andMe Research studies, where their de-identified genetic data and answers to surveys contribute to large analyses by 23andMe and outside research partners. Reportedly 80% of customers agree to research. 

However, many experts are worried that customers don’t really understand what they are agreeing to. So much for informed consent.

This was evident in 2018, when 23andMe announced GlaxoSmithKline would have exclusive rights to their customer’s data (only those who consented to research) for drug targets. 23andMe customers claimed they were unaware they had agreed to this – but, of course, they had.  

Buried in the fine print

In their position statement on DTC genetic testing, the American College of Medical Genetics and Genomics (ACMG) stresses “the consumer should be fully informed regarding what the test can and cannot say about his or her health”. 

We agree. 

There are potential harms to making an uninformed decision to have DTC genetic testing. At the bare minimum, before spitting in a tube or swabbing their cheek, consumers need to know: 

1. they may get unexpected, even life-altering, results;
2. their results may impact their family members (not just themselves);
3. their results may be difficult to understand or inaccurate and they should consult a doctor or a genetic counselor for help interpreting them;
4. their results may have insurance implications; and
5. how their genetic data will be stored, used, and shared is important to consider

In the US, there is a hodgepodge of laws related to DNA privacy, but none address the specific privacy issues raised by DTC genetic testing. The few laws that do exist related to genetic testing are focused on discrimination, but not privacy.  With no federal privacy legislation nor consensus on how to protect consumers’ best interests from policymakers, DTC genetic testing companies’ terms of services and privacy policies vary widely in content and quality. 

A 2017 study on 71 DTC genetic testing companies found the industry is completely “falling short of the basic requirements for consumer protection”. Another study of 30 DTC genetic testing websites found a significant lack of transparency on the risks and benefits of genetic testing. 

The American Society of Human Genetics (ASHG) recommends, in their DTC genetic testing position statement, “the FDA and FTC should work together to develop guidelines for DTC testing companies to follow, to ensure that their claims are truthful and not misleading and that they adequately convey the scientific limitations for particular tests”. 

The incomprehensible text

Studies show, even when people do read online terms and conditions, they may not understand the content due to the complex nature and high level of the language used. 

The FDA regulates health-related DTC genetic tests. During the authorization process, the FDA “looks at whether the test offers accurate descriptive information that can be easily understood by a consumer without the involvement of a health care provider”. This is measured through FDA user and label comprehension studies of the test report and support materials. However, support materials may or may not include online terms of service, privacy policies and/or consent forms.

In 23andMe’s Terms of Service, under Risks and Considerations, they write in their first bullet, “Once you obtain your genetic information, the knowledge is irrevocable.” Arguably, as important as understanding your DNA results, is knowing clearly what you’re getting into in the first place.

What will it take?

So even if you read the fine print, experts in the U.S. argue that current privacy policies do not fully inform consumers about the risk of giving their genetic information to DTC genetic testing companies, and the use of densely-worded terms of service, privacy policies and consent forms is incomprehensible (unless you have a law degree). 

Industry leaders and legislators need to assess current policies and practices to establish ways to protect DTC genetic testing consumers’ privacy and promote informed decision-making. 

And DTC genetic testing companies need to rework their online contracts to be more accessible and effective. User and label comprehension studies can help with both content and design, as the interview-based approach generates practical and insightful recommendations directly from the user themselves.

If we can get this right, knowledge about our DNA can be empowering, but we must remember, it is user comprehension that is powerful.  

Want to know more about user or label comprehension studies? They’re kind of our thing. Whether you’re preparing for an FDA pre-market submission or simply want to make consumer-driven and meaningful improvements to your content, we’ve got you covered with our iterative user comprehension process. To schedule a consultation with SoundRocket’s genetic test FDA experts, contact us here!