UNC joins multi-institution effort to add data to All of Us Research Program

$30-million award will establish the new Center for Linkage and Acquisition of Data as part of the National Institutes of Health effort to advance health research

With a new $30-million award from the National Institutes of Health's All of Us Research Program, the University of North Carolina at Chapel Hill is joining a multi-institution effort to establish the Center for Linkage and Acquisition of Data (CLAD). Housed at the University of Colorado Anschutz Medical Campus, the new center brings together leading academic, data, security, and software organizations. The CLAD team will connect new types of information to All of Us participant data to help researchers better understand the drivers of health and disease

The All of Us Research Program is a historic effort to enroll at least one million people who reflect the diversity of the United States to accelerate research that may improve human health for all. Participants in the program already share a wealth of data with researchers – data from biosamples, surveys, wearable devices, physical measurements, and electronic health records (EHRs).

"All of Us' comprehensive data collection still doesn't give us a holistic picture of a person's health. This award is specifically geared towards linking existing data collected from participants with a variety of real-world data sources to fill in the gaps in their health history," said Emily Pfaff, PhD, co-director of Informatics and Data Science at the North Carolina Translational and Clinical Sciences (NC TraCS) Institute and assistant professor of medicine at the UNC School of Medicine.

The CLAD team plans to securely acquire this real-world data from existing datasets and sources, including environmental data, health care claims, and mortality data.

"The approach to data collection for the Center for Linkage and Acquisition of Data will allow the program to maximize participants' data and expand the utility of the All of Us dataset without asking more of our participants," said Chris Lunt, chief technology officer of the All of Us Research Program. "This will enable All of Us data to answer questions researchers don't yet have the means to investigate."

UNC-Chapel Hill will lead two critical components of CLAD. Pfaff's team at NC TraCS will collaborate with the Cecil G. Sheps Center for Health Services Research. Within the Sheps Center, Michele Jonsson-Funk, PhD, Sheps Research Fellow, and Brian Cass, Deputy Director for Data Analytics & IT, will guide the Sheps Data Analytics Team to pull claims data from commercial vendors and the Centers for Medicare & Medicaid Services. They will also be responsible for ensuring that all the real-world data being linked to the participant-contributed data is of comparable quality.

In addition, Marie Rape, RN, associate director of the NC TraCS Regulatory Service, will serve as lead in the program's compliance core, responsible for ensuring overall compliance with all applicable regulations, including those associated with HIPAA, institutional review board approval, and security and privacy issues.

"We are providing a level of oversight to make sure safeguards are in place to protect privacy, while also making it possible for data to be delivered to researchers in a responsible manner," said Rape. CLAD will acquire and process linked data within a secure platform before delivering it to the All of Us Data and Research Center, which curates data and makes it accessible through the Researcher Workbench to registered researchers. All program partners must adhere to stringent NIH and All of Us data security and privacy requirements in carrying out their work.

The data streams enabled through CLAD will further the program's efforts to build one of the most diverse biomedical data resources of its kind that can be used by researchers to gain insights into the biological, environmental, and behavioral factors that influence health.

"This project is going to benefit not only the All of Us Research Program, but also the overall field of clinical and translational science," said Pfaff. "We're going to learn methods, informatics methods as well as regulatory and ethical methods, that in the future we will be able to apply to lots of other data and projects."

The new center will be led by the University of Colorado Anschutz Medical Campus. Partners in the effort, in addition to UNC, include Axle Informatics, Datavant, Emory University, Johns Hopkins University, Medical College of Wisconsin, Oregon Community Health Information Network (OCHIN), Palantir Technologies, the University of Florida, the University of Iowa, the University of Washington, and ZeroTrust.