Background

The All of Us Research Program has adopted the recommendations provided in the final report of the NIH Advisory Committee to the Director (ACD) Working Group to establish its governance structure. We are mindful of the program's mission to ensure participant inclusion at all levels and that our governance leadership and membership is diverse in expertise, institution, demographics, and experience.

All of Us is led by a chief executive officer (CEO) with the expertise and authority to provide strong, credible, and effective leadership. A Steering Committee consisting of principal investigators from all awardee institutions, NIH senior staff, and All of Us participant partners provides a forum for members to discuss program strategies and long-term goals. In addition, a smaller Executive Committee, composed of a subset of Steering Committee members and select members of the consortium, meets with the CEO as needed to identify solutions to challenges and obstacles.

To improve efficiency, the All of Us Research Program is overseen by smaller specialized groups called committees or boards that focus on various program areas:

• Committees are deliberative groups that address specific challenges and coordinate the development of specific areas of the program's operations.
• Boards are independent, standing groups that are responsible for managing defined, recurring tasks.

The flexibility of this system has allowed the details to evolve, with subordinate committees forming and sunsetting to meet the needs of the program at any given time. The current components of the All of Us governance are described below.

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Governance Groups: Leadership and Goals

The Steering Committee

Goals

• Oversee planning, coordination, and implementation of the program's overall operations.
• Provide input regarding strategic directions for the All of Us Research Program.

Co-Chairs

• Stephanie Devaney
• Paul Harris

The Executive Committee

Goals

• Ensure that the program effectively meets its objectives and mission.
• Propose solutions to challenges and obstacles.
• Provide the CEO of All of Us with strategies, options, and information to help make final programmatic decisions.

Co-Chairs

• Josh Denny
• Paul Harris

The Committee on Access, Privacy, and Security (CAPS)

Goals

• Extend All of Us' core values of protecting participant privacy, securing participant data, and building trust to the establishment and maintenance of the program's scientific resources.
• Guarantee researchers' access to the resources in a way that is educational, rewarding, responsible, and scientifically useful.

Co-Chairs

• Rosario Isasi
• Brad Malin

The Participant-Provided Information (PPI) Committee

Participant Provided Information (PPI) comprises a broad range of health-relevant information collected using modern digital technologies, including surveys, patient-reported outcomes, diaries/logs, and other self-reported approaches.

Goals

• Provide scientific value and produce new knowledge, with the goal of enabling researchers to discover and develop more effective ways to prolong health and treat disease.
• Promote long-term engagement with participants.

Co-Chairs

• Elizabeth Dean
• Tamara Litwin

The Science Committee

Goals

• Evaluate scientific opportunities the program is considering for scientific value and impact.
• Articulate and provide input on clear scientific priorities of the program that inform the development of the All of Us platform and any partnered research studies pursued by the program, including the data that participants are asked to share.
• Ensure that All of Us creates a resource that enables and anticipates broad, decades-long scientific exploration.

Co-Chairs

• Elizabeth Cohn
• Stephan Zuchner

The Resource Access Board

Goals

• Implement the resource access policies for All of Us, as developed by the Committee on Access, Privacy, and Security (CAPS) and consistent with the Data Access Framework.
• Evaluate Data Statistics and Dissemination Exception Requests.
• Monitor and review data egress events.
• Review Research Workbench workspaces for compliance with program policies and standards.
• Review programmatic banner authored manuscripts and those associated with demonstration projects.
• Provide assistance and education to data users, including review of manuscripts for compliance.
• Participate in decisions related to questionable compliance with the Data User Code of Conduct and any other end user related matters.

Co-Chairs

• Stephen Sodeke
• Milton Eder

The Publications Board

Goals

• Implement and maintain the consortium's rules governing manuscripts that report the development, management, and operations of All of Us.
• Address questions or concerns with project concepts, authorship disputes, and other outstanding issues.

Co-Chairs

• Brandy Mapes
• Elizabeth Cohn

The Incident Notifications Board

Goals

• Implement the All of Us "Participant Data Protections and Incident Notifications" plan.
• Provide input on ways to enhance participant privacy protections and data security processes.
• Evaluate incident reports and implement notification processes should a privacy incident occur.

Co-Chairs

• Sonya Jooma
• Elizabeth Cohn

Partnered Research Access Board

Goals

• Implement the Biospecimen Access Policy and the Access to Participants Policy for the All of Us Research Program.
• Review studies that require proposed project-driven contact with participants and/or biospecimen access.
• Review any proposed biospecimen usage by the All of Us Research Program itself.

Co-Chairs

• Rosario Isasi
• (TBD)