National Adventure: All of Us Research Program Launches Prioritizing Diversity, Security
By Allison Proffitt
May 6, 2018 The National Institutes of Health opened national enrollment for the All of Us Research Program today with a nationwide launch featuring events in New York; Birmingham, Ala.; Nashville, Tenn.; Detroit, Mi.; Kansas City, Mo.; Chicago; and Pasco, Wash. The launch events were broadcast on the All of Us website and Facebook live.
The first meeting of the over-100 All of Us healthcare, academic, corporate, and community partners was on July 6, 2016, said Eric Dishman, during his launch-day address from Detroit. “We’re not even two years old yet!” Dishman left Intel in April 2016 to run the then-unnamed precision medicine cohort program for NIH. Today, two years after his appointment, Dishman called leading the All of Us vison a dream come true.
“It is the highest honor to lead and build this national treasure. Powered by the volunteerism of one million or more people, the impact of this public resources will not go down only in the medical books, but also—I believe—in the history books,” Dishman said.
Dishman’s powerful message is always driven by his own personal story of what he has called “imprecision medicine”. He was diagnosed with a rare form of kidney cancer when he was 19 and spent years fighting his tumors before he gained access to whole genome sequencing and eventually a kidney transplant.
“The sad truth is, stories like mine are still very rare,” he said today. “Precision medicine is in its early days. Far too many people are getting trial-and-error treatments for most conditions and diseases that are based on the average patient, based on research studies of people who may or may not be like them at all. But none of us are average. We need a healthcare system that responds to our uniqueness.”
Dishman’s vision for All of Us reflects his own experience in many ways, not just in his grander goal of unique treatments.
“I have been part of so many clinical trials and studies as a cancer patient where everything that I gave them went into a black hole. But at All of Us, we’re developing the systems to give you access to all of your health information, including any health records we collect,” he said. He promised to return genetic information including family traits, ancestry, and risk factors gleaned from blood tests and environment exposures revealed by other lab work. “You will have the opportunity to see what researchers are doing with All of Us data, and find out what they learn over time,” he said.
Security Goals And Promises
Data security is a top-of-mind concern, of course, and Dishman and other speakers repeatedly emphasized that data would have “obvious identifiers” such as name, address, and phone number removed before researchers can access the data pool. What Dishman did not promise, though, was 100% data security.
“We have done and will keep doing rigorous security testing. But I want you to understand, we will always be transparent with you. There is no such thing as 100% guarantee against today’s hackers. So we’ve created procedures and policies to quickly notify you in the event a breach should ever threaten your data or your identity.”
Josh Denny, a professor of bioinformatics at Vanderbilt University, currently leads the All of Us Research Program Data and Research Center. Denny spoke at the Nashville, Tenn. All of Us launch event, and said that data security is of paramount importance.
“One of my jobs… is to collect, organize, and protect these data for the people,” Denny said. “We want to leverage modern data science techniques so leading computer scientists can leverage machine learning and natural language processing, the things in vogue in computer science, and apply those to health and make health better. Security is Job One. We are working with the best of breed security experts internally and externally. Data are encrypted at rest and in transit. We are constantly monitoring systems and testing for vulnerabilities and addressing any potential concerns as we monitor.”
Dishman put it bluntly: “If we lose your trust, we will lose the future of science.”
A Diverse Data Pool
But the future of science depends not just on data security, but data diversity. The program’s aim is to enroll one million or more volunteers and oversample communities that have been underrepresented in research to make the program the largest, most diverse resource of its kind.
Many early All of Us participants spoke in videos broadcast during the launch emphasizing the importance of diversity in sample collection, and their hopes that their own population groups would be better-represented by the science and medicine to come from the program.
“Imagine a world where everyone participates in the development of new discoveries and therapies and everyone benefits,” said Dara Richardson-Heron, chief engagement officer of the All of Us Research Program, from the New York launch event at Abyssinian Baptist Church in Harlem. “Our mission is not just to find one million or more people to volunteer to share medical information with the program. Our mission is to find one million or more people who reflect the rich diversity of our nation, who will not only participate in the program, but partner with us and help us create an opportunity to change health and healthcare for the benefit of everyone.”
The All of Us Research Program is seeking adults of all ages, races, ethnicities, sexual orientations, socioeconomic and health statuses, and regions of the country to submit data. “We know all too well that where a person lives has a potential to have an enormous impact on their overall health,” Richardson-Heron said. “We must make sure that all communities are well-represented in our program, particularly those who have been historically under-represented in biomedical research so that everyone has the opportunity to benefit from any new scientific discoveries and treatments.”
Moving Out Of Beta
The All of Us Research Program has been in beta testing mode for about a year, and more than 25,000 participants have already submitted data, the program reports. Today’s launch opens the program to anyone ages 18 and older, regardless of health status.
Participants are asked to share different types of health and lifestyle information, including online surveys and data from electronic health records (EHRs), which will continue to be collected over the course of the program.
The surveys will cover a range of topics to learn more about participants’ overall health and habits and where they live and work. The EHR data will offer useful information related to medical histories, side effects and treatment effectiveness. At different times over the coming months and years, some participants will be asked to visit a local partner site to provide blood and urine samples and to have basic physical measurements taken, such as height and weight. To ensure that the program gathers information from all types of people, especially those who have been underrepresented in research, not everyone will be asked to give physical measures and samples. In the future, participants may be invited to share data through wearable devices and to join follow-up research studies, including clinical trials. Children will also eventually be able to enroll and the program will add more data types, such as genetic data.
“This is the first, exciting step in a very long journey to understand the health of one million people over their lifetime,” said Francis Collins, director of NIH at the Harlem launch event. “The bottom line is I think All of Us is tremendously exciting and innovative, and I hope each of you who are listening will join us in this new national adventure, whether as a participant or a researcher, or maybe both.”