All of Us Agreements and Policy Glossary

  • Updated

Please click here for a downloadable .pdf version.
 

Definitions

All of Us analytical platform(s) and analytical platform(s): The Researcher Workbench and/or any other analytical environment provided by the All of Us Research Program for research use.

All of Us biospecimens and biospecimens: Biospecimens donated by All of Us Research Program participants. Biospecimens may be shipped from the All of Us Biobank to authorized users to conduct approved partnered research studies.

All of Us Partnered Research Access Board (PRAB): The board responsible for implementing the All of Us policies pertaining to biospecimen access and participant contact, including provisions related to the review and monitoring of partnered research study proposals.

All of Us Research Program (All of Us): A longitudinal effort, funded by the National Institutes of Health, to collect and compile data and biospecimens from one million or more people living in the United States. All of Us makes these research resources available to researchers to accelerate biomedical research and improve health.

All of Us Researcher Workbench: A cloud-based analytical platform through which All of Us research resources are made available.

All of Us Research Hub: The collection of All of Us Research Program resources made available on researchallofus.org.

All of Us research resources and research resources (unless otherwise specified): Collectively, data, files, software, analytical platforms, and/or other tools provided by the All of Us Research Program, its partners, and/or its collaborators to inform or aid in the conduct of biomedical and health research.

All of Us Resource Access Board (RAB): The governance body charged with overseeing and adjudicating compliance with the All of Us resource access policies. Its responsibilities include, but are not limited to, conducting project audits, responding to authorized user inquiries regarding compliance with the All of Us policies and terms of resource use, and reviewing potential violations of said policies and terms.

All of Us synthetic data: Synthetic data generated from the real All of Us participant dataset using methods that help ensure the re-identification risks posed by the resulting synthetic data are extremely low. All of Us synthetic data are generated either directly by or in collaboration with the All of Us Research Program and made available to authorized users through an All of Us analytical platform.

Authorized user: A person who is authorized to access research resources made available by the All of Us Research Program, its partners, and/or its collaborators. After fulfilling the appropriate requirements, authorized users may be granted credentials to access one or more data tiers (RT, CT, CT+, Synthetic), a subset of the All of Us data as part of a partnered research study, or All of Us biospecimens. Traditional data access credentials (RT and/or CT), CT+ access credentials, synthetic data access credentials, access credentials granted for activities pursuant to a partnered research study, and biospecimen access credentials are not interchangeable; authorized users may be required to complete separate or supplemental steps to gain additional access credentials.

Authorized (biospecimen/data/CT+ data/synthetic data) user: See authorized user.

Biomedical and/or health research: The systematic collection or analysis of data to develop generalizable knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness.1 Biomedical and/or health research may include methods development, education, and training, in addition to hypothesis-driven and exploratory research.

Data (unless otherwise specified) and available data: Data made available by the All of Us Research Program, its partners, and/or its collaborators for research use by authorized users.

Dataset (unless otherwise specified) or available dataset: Organized collections of related data points, curated by the All of Us Research program, its partners, and/or its collaborators, and made available for research use.

Data tiers: Curated sets of participant data made available for biomedical and health research through All of Us analytical platform(s). Data tiers are distinguished from one another predominantly by access requirements and the type and level of obfuscation of the included data.

  • Public Tier (Data Browser): A data tier containing only summary statistics and aggregate information about the All of Us participant cohort. The Public Tier can be accessed by anyone; it does not require authorized user credentials.
     
  • Registered Tier (RT): A data tier containing a limited set of individual-level participant data–including data from electronic health records, wearables, and surveys, as well as physical measurements taken at the time of participant enrollment–that are subjected to a greater level of privacy-preserving generalization and obfuscation than data in the Controlled Tier. The Registered Tier can only be accessed by researchers with the requisite authorized user credentials.
     
  • Controlled Tier (CT): A data tier containing more granular, minimally obfuscated individual-level participant data. The Controlled Tier includes additional, more sensitive data elements, such as genomic data, that build upon those available in the Registered Tier. The Controlled Tier can only be accessed by researchers with the requisite authorized user credentials.
     
  • Controlled Tier Plus (CT+): A data tier through which authorized users may request access to more sensitive and granular data types in order to facilitate specialized research projects. Access to the CT+ tier requires additional application steps above the RT and CT access process.

Identifiable private information (IPI): Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information (45 CFR § 46.102).

Identifiable, sensitive information: Information that is about an individual and that is gathered or used during the course of research, and: A) through which an individual is identified; or B) for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual (adapted from 42 U.S.C. § 241(d)(4)).

Key personnel: Individuals who contribute in a substantive, meaningful way to the development or execution of a partnered research study.

Marketing: To make a communication about a product or service that encourages recipients of the communication to purchase or use the product or service (45 CFR §164.501).

Participant(s) and research participant(s): Participants enrolled in the All of Us Research Program and/or participants reflected in the datasets of All of Us partners and/or collaborators.

Partnered research study (PRS): Initiatives funded by a study sponsor external to All of Us that build on existing All of Us data, participant populations, biospecimens, and other research resources in partnership with the program.

Partnered research study investigator and investigator: An individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the partnered research study. Investigators are always considered key personnel.

Personally identifiable information (PII): Information that can be used to distinguish or trace the identity of an individual (e.g., name, Social Security number, biometric records, etc.), either alone, or when combined with other personal or identifying information that is linked or linkable to a specific individual (2 CFR § 200.1).2

Professional misconduct: Harassment, discrimination, or other inappropriate conduct—including but not limited to sexual harassment, racial discrimination, intimidation, bullying, and other unproductive, disruptive, and/or violent behaviors—committed within or in a manner that directly impinges upon the work environment. For more information on supporting a safe and respectful workplace, please find additional resources here.

Protected health information (PHI): Individually identifiable health information that is transmitted by electronic media, maintained in electronic media, or transmitted or maintained in any other form or medium (45 CFR § 160.103).

Research: A study to be conducted in part or in full using All of Us research resources. Research using certain research resources, including biospecimens, must adhere to specific access processes and policies above and beyond research with RT or CT data, which may include review and approval by the RAB, PRAB, and/or other oversight bodies.

Researcher: Authorized users involved in carrying out biomedical or health research using the All of Us research resources.

Research misconduct: Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results (42 CFR § 93.103), or other instances of academic or scientific misconduct including but not limited to data use violations, data management incidents, institutional policy violations, or legal or regulatory violations pertaining to the conduct of research.

Synthetic data: Artificial data designed to reproduce certain statistical relationships between data points in a parent dataset.

Work products: Publications, conference papers, presentations, methods, techniques, educational curricula, and other research-related output3 resulting in part or in full from the research conducted with the research resources.

Workspace: A user-created analytical sandbox within an All of Us analytical platform, like the Researcher Workbench, where authorized users can virtually pull in subsets of available participant or synthetic data and perform analyses.


Footnotes

  1. National Institutes of Health. (n.d.). Mission and goals. Retrieved July 21, 2026, from https://www.nih.gov/about-nih/mission-goals
  2. Adapted from: National Institutes of Health. (2023). 2.1.2 Recipient staff. In NIH grants policy statement. Retrieved July 21, 2026, from https://grants.nih.gov/grants/policy/nihgps/html5/section_2/2.1.2_recipient_staff.htm
  3. National Institutes of Health. (n.d.). Research performance progress report (RPPR). Retrieved July 21, 2026, from https://grants.nih.gov/grants-process/post-award-monitoring-and-reporting/reportingrequirements/research-performance-progress-report-rppr

Was this article helpful?

0 out of 0 found this helpful

Have more questions? Submit a request

Comments

0 comments

Article is closed for comments.