All of Us Research-HSC

Access to the Researcher Workbench is available only to registered researchers affiliated with an organization with a Data Use and Registration Agreement (DURA), a legal and binding agreement that outlines organizational responsibilities, as well as permitted and prohibited uses of the data.

The All of Us Data and Research Center (DRC), coordinated through Vanderbilt University Medical Center, reviews DURA applications and contracts with organizations. After a DURA is in place, researchers affiliated with the organization who seek data access must register by verifying their identity, signing a Data User Code of Conduct (DUCC), and completing required All of Us training on conducting research ethically and responsibly.

HSC researchers:      

• If using the Registered Tier, no IRB application is necessary    
• If using the Controlled Tier, go through HRRC using Exemption Category 4 (secondary data use) and add the template language in the application 

Main campus researchers: 

• If using the Registered Tier, no IRB application is necessary 
• If using the Controlled Tier, it is highly recommended that researchers go through main campus IRB using Exemption Category 4 (secondary data use) and add the template language in the application 

Template language that we will suggest for IRB applications: 

The investigators recognize that they will not be conducting human subjects research with All of Us data for two reasons: (1) The research will not directly involve participants, only their data; and (2) the data available in the Researcher Workbench has been carefully checked and altered to remove identifying information while preserving its scientific utility. Nevertheless, PIs using All of Us data are encouraged to apply the ethical principles of research with human participants to their work.

The NIH IRB information and determination letter, should it be needed for manuscript submission, can be found here: NIH Letter (PDF).

The All of Us Research Hub stores health data from a diverse group of participants from across the United States.

• Data Access Tiers
  • Public Tier: The dataset contains only aggregate data with identifiers removed. These data are available to everyone through Data Snapshots and the Data Browser, an interactive tool on the Research Hub.
  • Registered Tier: The curated dataset contains deidentified individual-level data, available only to approved researchers on the Researcher Workbench. The Registered Tier currently includes data from electronic health records (EHRs), wearables, and surveys, as well as physical measurements taken during participant enrollment.
  • Controlled Tier: The dataset contains genomic data in the form of whole genome sequencing (WGS) and genotyping arrays, previously suppressed demographic data fields from EHRs and surveys, and unshifted dates of events.
• Data Methods
  • To ensure the Research Hub collects the highest quality data possible, the All of Us Research Project employs a comprehensive data methodology to curate data for registered researchers.