Introducing “All of Us”

A new program led by the National Institutes of Health aims to gather DNA and other health information from 1 million people to advance precision medicine.

Image courtesy of the National Institutes of Health

Evelyn Ortiz, 61, says she has always been “big on volunteering,” but she has never taken on a mission as big as All of Us, a new nationwide effort to enlist 1 million people to participate in research gathering DNA and other health information for a massive database to advance precision medicine.

To recruit participants, Evelyn rides around on her motorized scooter, passing out flyers in her church. She also accompanies friends and neighbors to NewYork-Presbyterian/Columbia University Irving Medical Center, where she enrolled in the groundbreaking research effort. And she hopes to organize a workshop with her pastor to educate congregants about the goal of All of Us, namely to create the largest, most diverse database in the U.S. so that leading researchers can develop more individualized treatments for cancer, heart disease, and other medical conditions.

“It isn’t easy,” she says of persuading people to take the time to travel to the hospital to fill out a questionnaire about their lifestyle and personal and family medical history, provide urine and blood samples, and grant access to their electronic medical records. Height, weight, and blood pressure also might be measured.

“I’m trying to convince people, ‘It’s not going to do you any harm and it may do you some good,’” she says. “I tell them [precision medicine] is the medicine of the future, but you need people to volunteer in order to do the research. How did we get this far in medicine? By research, right?”

Engaging an Underserved Community

After enrolling participants in a test phase over the last year, the All of Us Research Program officially launched May 6 across the United States. A nationwide initiative of the National Institutes of Health (NIH), the program is being led in New York City by Columbia University Irving Medical Center, Weill Cornell Medicine, NYC Health + Hospitals Harlem, and NewYork-Presbyterian. NIH Director Francis Collins kicked off the program at Harlem’s Abyssinian Baptist Church at an opening day event that featured a community health fair and entertainment.

The New York City Consortium enrolled about 2,700 participants during the pilot phase. More than half of the enrollees are Hispanic, Asian, and African-American, communities that are traditionally underrepresented in large genomic studies. The NYC Consortium will receive federal grants totaling $60 million to sign up nearly 100,000 people over the next five years.

After soliciting feedback from participants and community leaders, the NYC Consortium plans to broaden its outreach to provide multilingual information at street fairs, church gatherings, and drugstores. Evelyn was asked to join a participant advisory board after she complained that the questionnaire she filled out wasn’t available in Spanish, an oversight that was soon corrected.

All of Us is designed to accelerate and broaden the use of precision medicine, which takes an individualized rather than a “one size fits all” approach to healthcare. It is an emerging approach to disease treatment, prevention, and care that considers differences in people’s lifestyles, environments, and biological makeup, including genes. But to make it work on a large scale, a massive trove of genetic and other health information is needed.

“I think we are undergoing a transformation in care where, increasingly, the interventions we offer will be provided in a way that’s predicated on the cause of disease in each individual patient,” says David Goldstein, Ph.D, and the lead principal investigator for the All of Us New York City Consortium, and the director of the Institute for Genomic Medicine at Columbia University Vagelos College of Physician and Surgeons.

David Goldstein, the lead principal investigator for the All of Us New York City Consortium

“It’s already the case, that in a lot of therapeutic areas, looking at the genomic data can have direct implications for how patients are managed,” says Goldstein, whose institute researches precision medicine for conditions including epilepsy, kidney disease, liver disease, and complications during pregnancy. “We (genetically) sequence patients that have, for example, unexplained epilepsy, and often identifying the genetic cause will tell you what medicines are likely to work and likely not to work. They might give you guidance about the order in which to try medicine.”

The U.S. Congress has authorized $1.5 billion over 10 years for the program, and the NIH has funded more than 100 organizations throughout the United States to be partners, including the New York City Consortium. The data collected will create one of the world’s largest and most demographically diverse biobanks of detailed health and genetic information. The data and samples will be securely stored at Mayo Clinic in Rochester, Minnesota, providing a vast library for researchers across the country to study the basis for a spectrum of health conditions and develop treatments that target lifestyle and genetic drivers of disease. It is expected to support thousands of studies across a wide range of health topics.

This research means “a great deal,” says M. Elizabeth Ross, M.D., Ph.D, and the Nathan Cummings Professor in Neurology and the director of the Center for Neurogenetics in the Feil Family Brain & Mind Research Institute at Weill Cornell Medicine. “One of the things that my field has come to realize in the last five to eight years is the importance of genetic background in knowing whether or not a particular small variant that we see in an individual could cause a medical condition that is already present or put him or her at risk for a disease. And it’s really important to know how frequently or infrequently that variant shows up in a given population. There are currently many ‘holes’ in our understanding of these differences.”

Program participants will have access to their own health information, summary data about the participating community, and information about studies and findings that come from All of Us.


“The All of Us Research Program will be an engine that accelerates healthcare research and medical breakthroughs, and will generate paradigm shifts in our understanding of healthcare delivery across our communities.”

— Dr. M. Elizabeth Ross


Building a Diverse Database

For the research data to be meaningful, it must reflect a broad range of the country’s population, both healthy and those with disease. All of Us is making extra efforts to enroll participants from groups it refers to as underrepresented in biomedical research, meaning people in minority and lower-socioeconomic communities. Diseases show up differently among ethnic groups — sometimes at an earlier age or progressing more rapidly or responding differently to a particular medical regimen — and understanding what causes this is a key element of the program.

“Creating a large and diverse database is one of the major driving forces behind All of Us,” says Rainu Kaushal, M.D. and chair of the Department of Healthcare Policy and Research at Weill Cornell Medicine, who, with Dr. Ross, is co-principal investigator of the Weill Cornell arm of the All of Us Research Program for the NYC Consortium. “There are important factors among different demographics that need to be taken into account in the treatment of common disorders like diabetes and hypertension or in the prevention of Alzheimer’s.”

“We also want to be able to use the information that is collected to address inequities and inadequacies in the way that healthcare is delivered,” Dr. Kaushal adds. “By following volunteers over time, we gain knowledge of what works and what doesn’t work to treat and keep people healthy.”

Evelyn Ortiz, an All of Us participant advisory board member

An Engine to Accelerate Research

Diagnosed with cerebral palsy as a baby, Evelyn underwent a dozen surgeries at NewYork-Presbyterian/Columbia University Irving Medical Center, where she was born, to correct the direction of her ankle and leg bones to enable her to walk. Last fall, Evelyn was at the hospital for an X-ray when she spotted an information table promoting All of Us, which inspired and motivated her to get involved. Evelyn says she is grateful for the medical care she received at the hospital and sees her work with the program as a way of giving back — beyond the volunteer work she has done there in the past. Today, she says she is determined to aid in the program’s goal to amass data to help expand the use of precision medicine.

“I think if we can accomplish that, that would be amazing,” she says, citing among those wishes the possibility of making better medicines and treatments for cerebral palsy. “And you know how many other things we could prevent through this?”

The question most often asked by people before they sign up for All of Us is, how secure is the health and genetic information? There are multiple levels of controls for maintaining data privacy. Participants’ names and other identifying information will be removed from their data before it is stored and replaced with a code. A master list linking the codes to the names will be kept separate and secure. Researchers can apply to gain access to the de-identified data. But to learn the participants’ identities, by accessing their electronic medical records, for example, will require additional, rigorous approvals.

“The All of Us Research Program will be an engine that accelerates healthcare research and medical breakthroughs, and will generate paradigm shifts in our understanding of healthcare delivery across our communities, large and small,” Dr. Ross says. “It will enable us to individualize healthcare one person at a time. NewYork-Presbyterian is dedicated to contributing to this next revolution in biomedical research. This is going to change the capabilities for healthcare delivery in the 21st century.”

People interested in participating in the All of Us Research Program can do so at NewYork-Presbyterian/Columbia University Irving Medical Center, NewYork-Presbyterian/Weill Cornell Medical Center, NewYork-Presbyterian/Lower Manhattan Hospital, and NYC Health + Hospitals/Harlem. A website, joinallofus.org/nyc, has information about the program and allows people to enroll and schedule an appointment in New York City. For information on the national program and other sites, please visit joinallofus.org.