The All of Us Research Program Initial Protocol

August 4, 2017

See the latest protocol information at our All of Us Research Program Operational Protocol page.

Transparency is one of the foundational values of the All of Us Research Program. And as I speak with different communities about our work, I’m eager to address the many great comments and questions I get—about everything from who can join and what data we’re gathering, to how we’re protecting the data and who can access it. Now that our initial research protocol (updated version added on 6/7/18) has been approved by our institutional review board, I’m glad to share the key elements of it with you as an additional source of information about those and other topics, along with some Frequently Asked Questions

  • A protocol is a scientific document with in-depth plans for a specific research effort. Writing one is an important first step in the research process, to help researchers explain what they want to learn and how they’ll carry out their work.
  • When the proposed research involves people, a special committee called an institutional review board, or IRB—charged with protecting the rights and welfare of research participants—examines the protocol to make sure the research plans are ethical.


In the protocol you’ll find many details typically included in these kind of documents, such as the program’s enrollment and data collection plans. There are a few other things that might be of interest as well:

  • Consent forms: Everyone who joins the program needs to have full information to understand what participation involves and any potential benefits and risks. Our basic consent form outlines all these things in plain language for people to consider before joining the study. We created a second form for participants to provide secure access to their electronic health records as part of their involvement in the program. In addition, we’ve developed a short video to highlight and explain key concepts for potential participants.
  • Surveys: Online surveys will be another important way we collect information from participants. Included in this initial version of the protocol are our first three—covering basic demographic information, overall health, and certain lifestyle factors (tobacco, drug, and alcohol use). We developed these surveys by reusing or adapting questions that have been previously validated in other large research programs, including the National Health and Nutrition Examination Survey, the National Health Interview Survey, the Behavioral Risk Factor Surveillance System, the Million Veteran Program, and the UK Biobank.

This is just the first version of our protocol. Many of our plans are still in development, and we’ll update the protocol as things progress. In future versions, we intend to include:

  • Additional surveys
  • Broader eligibility criteria
  • Plans for genomic and other lab tests of participants’ blood and urine samples
  • Plans to pilot test wearable devices for real-time data collection
  • More details about our data access policies

. . . and a lot more. We’ll also develop further materials in the future to describe the origins and rationale for parts of the protocol, and about our protocol’s relationship to other studies’ protocols and standards.

I’d like to thank all of the partners across our consortium who had a hand in helping develop the protocol, building on the early work of the Precision Medicine Initiative Working Group of the Advisory Committee to the Director and informed by input from the All of Us Research Program Advisory Panel and the public. Thanks also to the members of our IRB for their dedication and service.

Until next time,


Eric Dishman
All of Us Research Program

Note: A version of this document that is accessible by people using screen readers will be available soon.