‘It’s a No-Man’s Land’: The Pitfalls of Genetic Data-Sharing and Informed Consent
The National Institutes of Health’s All of Us Research Program aims to eventually capture the DNA and health data of 1 million participants.1,2
Investigators carefully considered how to best inform people of whether or how their information would be shared, says Anita L. Allen, JD, PhD, who served on the initiative’s institutional review board. “Any time people give up sensitive information, or confidential or private information, without fully understanding the implications in terms of discrimination or third-party sharing for advertising or marketing, there are privacy concerns. And they are very real concerns,” says Allen, professor of law and philosophy at University of Pennsylvania.
It is unclear how well participants really understand all the potential risks of sharing their DNA. “It’s always tricky. How many average Americans really understand the data analytics, or how putting information in the cloud could make it vulnerable?” Allen asks.
Many future uses of DNA already are on the horizon, says Leslie P. Francis, PhD, JD, distinguished professor of law and philosophy at the University of Utah. These include polygenic risk-scoring for psychiatric or other traits, increasingly good prediction of life course outcomes (e.g., risks of earlier death), understanding of varying susceptibilities to infectious disease, or forensic use of DNA outside of heinous crimes. It is impossible for investigators to cover all these possibilities in informed consent discussions.
This is where effective storytelling can come in handy. Francis suggests sharing an anecdote like this on consent forms: “Our knowledge of genetics is expanding rapidly. Right now, we cannot effectively predict what we will learn in the future. However, it is likely there will be surprises. For example, we can use DNA databases to try to identify people whose DNA has been found at crime scenes. The DNA of a distant relative was used to capture the ‘Golden State Killer.’ If you think you might be uncomfortable about surprises from new knowledge of this kind, you should think carefully about agreeing to unlimited future uses of your DNA.”
There always will be limitations to informed consent when it comes to the complexities of genetic information privacy. “What do we do about that? We don’t over-rely on consent,” Allen says.
Researchers are ethically obligated to be sure that what they are asking people to consent to is just, fair, appropriate, and respectful of human rights. “We need to be extremely thoughtful in how we do it, since not everybody understands the implications of data disclosure. Genetic data in the U.S. right now is very much a subject for concern,” Allen says.
People may be giving up their own information too freely, especially genetic information, when they do not understand the implications. “I don’t say this to wag my finger. I myself find it very fun and useful to share my DNA with other people, which would have been inconceivable to do 20 years ago,” Allen says. “But there is less of a sense that generic information is exceptional and sensitive.”
Not even privacy researchers know all the possible future harms to participants. “We are letting down our guard, for better or worse,” Allen observes. “Until we adopt stronger laws, there will be very little we can say is pre-emptively protected when it comes to our data. It’s a no-man’s land out there.”
- Denny JC, Rutter JL, Goldstein DB, et al. The “all of us” research program. N Engl J Med 2019;381:668-676.
- National Institutes of Health All of Us Research Program. Protecting data and privacy.
It is unclear how well participants really understand all the potential risks of sharing their DNA. Researchers are ethically obligated to be sure that what they are asking people to consent to is just, fair, appropriate, and respectful of human rights.
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