All of Us Research Program Governance

Background

In establishing its governance structure, the All of Us Research Program has adopted the recommendations contained in the final report of the NIH Advisory Committee to the Director (ACD)  Working Group pdf | 1.05 MB pdf | 1.05 mb. 

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 serves as the governing body of All of Us, coordinating program activities and facilitating deliberation among stakeholders within the consortium. Steering Committee members include principal investigators from all awardee institutions, NIH program staff, and All of Us participant representatives. In addition, a smaller Executive Committee, composed of a subset of Steering Committee members and chaired by the CEO, meets as necessary to identify solutions to challenges and obstacles and make recommendations to the CEO.

To improve efficiency, the Steering Committee may establish subordinate groups to oversee various areas of the All of Us Research Program. These groups work together under the direction of the Steering Committee to achieve the program’s objectives. There are two types of subordinate groups:

  • Committees are deliberative groups that address challenges, make recommendations, and coordinate the development of specific areas of the program’s operations
  • Boards are standing groups that are responsible for managing defined, recurring tasks over an extended period

While the basic governance structure has not changed over the life of the program, the system allows for flexibility to meet the evolving needs of All of Us. Subordinate groups are formed and sunsetted as needed. The current components of the All of Us governance are described below.

The subordinate committees fall into two categories:

  • Committees: Deliberative bodies formed with the approval of the Steering Committee, granted limited decision-making authority on specific topic areas
  • Boards: Independent standing bodies formed with the approval of the Steering Committee, to manage defined, recurring tasks over an extended period of time

While the basic governance structure has not changed over the life of the program, 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 a given time. The current components of the AOURP governance are described below.

Governance Missions

Goals

  • Oversee planning, coordination, and implementation of the program’s overall operations
  • Recommend strategic directions for the All of Us Research Program

Co-Chairs

  • Joshua Denny
  • Stephanie Devaney

Goals

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

Co-Chairs

  • Joshua Denny
  • Stephanie Devaney

Goals

  • Extend AOURP’s 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, and scientifically useful

Co-Chairs

  • Rex Chisholm
  • Brad Malin

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

  • Incorporates principles of inclusion, diversity, and cultural sensitivity, particularly for communities historically underrepresented in biomedical research in development of PPI instruments
  • Promotes long-term engagement with participants
  • Provides scientific value and produces new knowledge, with the goal of enabling researchers to discover and develop more effective ways to prolong health and treat disease

Co-Chairs

  • Brian Ahmedani
  • Rob Cronin

Goals

  • Articulate the scientific goals that inform the development of the All of Us platform and any pilot studies pursued within the program, including the data that participants are asked to share
  • Ensure that AOURP creates a resource that enables and anticipates broad, decades-long scientific exploration

Co-Chairs

  • Mona Fouad
  • Jordan Smoller

Goals

  • Ensuring that AOURP can successfully collect the unique, individualized data made available by the ever-growing ecosystem of digital health technologies.
  • Ensuring that the program can encourage participant engagement through the return of individualized information in ways made possible by DHTs.

Co-Chairs

  • Chris Lunt
  • Steve Steinhubl

Goals

  • Implement the program’s policy for overseeing or managing the participant experience through evaluation and assessment mechanisms.
  • Curate, coordinate, review, and direct the systems and methods used to implement, track, and analyze the data relating to participants’ and potential participants’ interactions with the program.
  • Advise and provide recommendations on behalf of AOURP regarding the development of new surveys, questionnaires, tools, or other feedback mechanisms to understand and enhance the participant journey.

Co-Chairs

  • John Chaffins
  • Brandy Mapes

Goals

  • Implement the resource access policy for AOURP, as developed by CAPS and consistent with the Data Access Framework.

Co-Chairs

  • Rosario Isasi
  • Harvey Murff

Goals

  • Implement the program's policy governing oversight of internal AoU Consortium Training Resources. 
  • Assess the training needs of AoU Consortium members and ensure that appropriate training content is developed, deployed, and maintained to meet those needs.

Co-Chairs

  • Holly Garriock
  • Amanda Wilson

Goals

  • Implement and maintain the consortium publication policy, which governs manuscripts that report the development, management, and operations of AOURP.
  • Address questions or concerns with project concepts, authorship disputes, and other outstanding issues

Co-Chairs

  • Dennis McNamara
  • Elizabeth Cohn

Goals

  • Implement the AOURP “Participant Data Protections and Incident Notifications” plan.
  • Make recommendations that increase participant privacy protections and data security processes
  • Evaluate incident reports and implement uniform notification processes should a privacy incident occur

Co-Chairs

  • Rosayma Lopez-Ramirez
  • Elizabeth Cohn