All of Us Research Program Protocol
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.
Download the All of Us Research Program Operational Protocol pdf | 1.43 MB (Updated 3/28/2018)
Download a summary of the Operational Protocol pdf | 199.69 KB
Download Protocol Element: Sample Primary Consent Form pdf | 260.29 KB
Download Protocol Element: Sample HIPAA EHR Part 2 Supplement pdf | 271.21 KB
The protocol was 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.
Learn more about the All of Us Research Program