Researchers should always check with their local institutional review board to ensure compliance with local requirements for conduct of research. We have provided the template language below as a resource to use for local IRB applications.
“The Registered Tier and Controlled Tier data available on the Research Hub contains data from participants who have consented to be involved in the All of Us Research Program, including data from electronic health records (EHRs), surveys, and physical measurements. All data available to researchers has had direct identifiers removed and has been further modified to minimize re-identification risks. This includes removing all explicit identifiers in both EHRs and participant provided information, all free-text fields, geolocation data smaller than U.S. state level, living situations, race and ethnicity subcategories, active duty military status, cause of death, and diagnosis codes subject to public knowledge. Additionally, the following demographic fields are generalized: race and ethnicity, education, employment, and information regarding sex at birth, gender identity, and sexual orientation. Also, all dates are systematically shifted backwards by a random number between 1 and 365, and data from participants over the age of 89 are removed. The All of Us Research Program data will be accessed for research strictly using the Researcher Workbench (researchallofus.org). External data can be brought into this secure environment; however, researchers are restricted from importing any individually identifiable information and from row-level linkage of the external data. Data searches, cohort building, and analysis will solely take place on the Researcher Workbench, a secure cloud-based resource with statistical analysis software available for use with All of Us data. Researchers are granted access to the Researcher Workbench after their affiliated institution signs a Data Use and Registration Agreement, and they create an account, including setting up two-factor authentication, verify their identity through Login.gov or ID.me, complete the All of Us Responsible Conduct of Research training, and sign a Data User Code of Conduct, which prohibits any re-identification of All of Us participants. For more information, please visit researchallofus.org.”
