The All of Us Research Program Protocol provides a detailed look at the program’s plans for building a robust research resource of data from one million or more participants reflecting the diversity of the United States.
A protocol is a scientific document with in-depth plans for a specific research effort. It can help researchers explain what they want to learn and how they’ll carry out their work.
Although the All of Us Protocol is written for researchers, it may be of interest to others. It has a wealth of information about the program, from who can join and what data All of Us will collect to how the program will protect that data and who will be able to access it.
The All of Us Protocol is revised periodically as the program makes updates and adds new features.
Downloads
- Get an overview of the program’s plans, including timeline, enrollment criteria, data collection, and more in the Summary of the Operational Protocol (PDF, 224 KB).
- Read a detailed explanation of the program’s plans in the All of Us Research Program Operational Protocol (PDF, 2.44 MB). This document was last updated on 12/3/2021.
- Read an overview of plans for inclusion of participants under the age of 18, including timeline, enrollment criteria, data collection, and more in the All of Us Research Program Operations Pediatrics Protocol (PDF, 712 KB).
- These protocols were reviewed by the Institutional Review Board (IRB) of the All of Us Research Program. The All of Us IRB follows the regulations and guidance of the NIH Office for Human Research Protections for all studies, ensuring that the rights and welfare of research participants are overseen and protected uniformly. Parts of the protocol have been redacted for security and privacy protection.
Learn more about the All of Us Research Program
- All of Us Consent Process
- All of Us Surveys
- Data Security Policy and Framework
- Privacy and Trust Principles
- FAQ
Questions? Contact us.