All of Us Research Program Engagement Partners (OT2)

All of Us Research Program Background

The All of Us Research Program is a historic effort to gather health-related data from 1 million or more people living in the United States, over many decades, to accelerate research and improve health. The program will be open to people both healthy and sick, from all communities, to reflect the rich diversity of the country.

Unlike a single research study focused on one specific disease or population, the All of Us Research Program will serve as a national research resource to inform thousands of studies, covering a wide variety of health conditions that affect many different people.

Participants will have opportunities over many years to provide data about themselves that will help researchers learn more about how individual differences in lifestyle, environment, and biological make-up can influence health and disease. By taking part, participants can learn more about their own health and contribute to an effort that will advance the health of generations to come.

Over the past year, the NIH has issued awards to build the foundational partnerships and infrastructure needed to launch the Program. The awards support a Data and Research Support Center, Participant Technologies Center, a network of Health Care Provider Organizations (HPOs), and a Biobank. NIH has also issued awards to external communications firms to support All of Us Research Program branding, communications, and public relations.

The All of Us Research Program values a highly interactive participation model, which is unique for a project of this scale. Participants will be providers of information about their health and experiences, sources of proposed research studies, mediators of access to their health care data, contributors to overall data quality control, donators of data from mobile and wearable devices, and recipients of their own data as well as aggregate data and scientific results, according to their preferences.

Data provided by participants will make up the core dataset and will be stored in a secure computing environment under rigorous standards to protect individual privacy. The Program will utilize a variety of data collection methods throughout its duration, including research questionnaires, collection of baseline and longitudinal data from electronic health records, physical measurement, collection and analyses of blood or other samples, and, over time, data from mobile technologies.

Enrolling in All of Us

Enrollment in the All of Us Research Program is expected to begin in 2017. Individuals will be able to enroll in the All of Us Research Program in one of two ways: through an All of Us Research Program Health Provider Organization (HPO) or through a Direct Volunteer (DV) path. There are currently three types of HPOs within the All of Us Research Program: regional medical centers, community health centers, and U.S. Department of Veterans Affairs Medical Centers. These HPOs have committed to sharing the All of Us Research Program opportunity with their members or patients and/or their families. Individuals who enroll through an HPO are likely to do so in conjunction with a scheduled visit to a health care provider. The Program currently has HPOs in 18 states for year 1 with 28 states anticipated in years 2-5.

Individuals enrolling through the Direct Volunteer path will enroll through an app, a website, or a toll-free call center. The digital portals will be in English and Spanish, and the call center will also have English and Spanish language capability, with the expectation that additional languages will be added after the Program’s initial launch. The call center will be able to answer questions about the All of Us program as well as to facilitate enrollment.

Participants will be asked to consent to participate, complete brief survey modules, and provide data from their electronic health records, if they have them. In addition, they may be asked to undergo a baseline physical measurement and provide blood, urine, and/or saliva samples (biospecimens). Individuals who join the program through the DV path will have their baseline physical measurement and their biospecimen collections facilitated by the Program and conducted at participating Walgreens stores or designated commercial laboratories, or, in some cases, during a home visit.

If more than one million participants enroll in the All of Us Research Program, the Program may not have sufficient funding to collect biospecimens and physical measurements from all participants. In the initial phase of the Program, only volunteers 18 years or older will be eligible to participate; children will be included in the future.

Volunteers are expected to participate in the study over many years. They may also choose to be re-contacted about future research studies. Participation in any future study is entirely optional. Participants who complete the baseline physical measurement and supply biospecimens will be provided a one-time payment of $25 to help defray the cost of their participation.

Value to Participants

Individuals who participate in the All of Us Research Program will have access to information and data collected from them. A million participants will have their genomes sequenced, several years from now. Participants will be informed of any studies that use their data and the results of those studies.

Initial Program research suggests that the following factors motivate potential participants:

• An opportunity to fight disease and improve the health of future generations.
• An opportunity to ensure that one’s community is included in the studies that lead to new understanding and new treatments.
• A chance to learn some of one’s own health indicators.
• The chance to be part of a movement designed to make our health care more precise, more tailored, and more effective.

The All of Us Research Program is not medical treatment. Participants will not get direct medical benefit from taking part. However, participants may indirectly benefit from taking part by learning about their own health and contributing information that helps scientists and doctors understand more about what keeps people healthy or makes them sick.

Purpose and Objectives of All of Us Research Program Engagement Partners

The purpose of this Funding Opportunity is to enable Partners to educate, motivate, and facilitate enrollment in the All of Us Research Program. The All of Us Research Program seeks to enroll volunteers that reflect the diversity of the United States, including those historically underrepresented in biomedical research. The HPOs have a diversity commitment in their recruitment plans, as well as their own partnerships with local organizations. We seek additional partners to complement these efforts, especially in priority geographic areas.  (https://www.nih.gov/research-training/allofus-research-program/funding/priority-geographic-targets)

Awardees under this Funding Opportunity as well as from the HPOs and DV will be expected to share best practices and lessons learned through collaboration and, more formally, through the All of Us governance structure.

Engagement partners are needed to:

• Educate and inspire community leaders and members about the All of Us Research Program, its value, and the opportunity to participate.
• Serve as a community-specific resource for potential participants.
• Facilitate the enrollment of individuals into the All of Us Research Program.
• Educate health care providers (physicians, nurses, physician assistants, etc.) about the All of Us Research Program, its implications for their patients and providers, and the means by which patients and patient’s family members can enroll.

These activities could be conducted in a variety of ways. Applicants should recommend approaches that are the best fit with the community of interest, the applicant’s abilities, and any partners involved. Example engagement activities include:

• All of Us Research Program-specific education events (in person or online).
• Sustained communications programs inclusive of media outreach, social media implementation, and/or member communication.
• Train-the-trainer programs (across multiple chapters and/or networks).
• Presentations at major conferences.
• Creating an All of Us Research Program booth or other presence at existing events (i.e., community health fair, walk for a cure, or reading night).
• Developing and implementing an All of Us Research Program communications effort using existing organization tools (e.g., existing newsletters, website, or educational programs).
• Training and supporting an All of Us Research Program community ambassador.
• Hosting “enrollment facilitation night” in the community.
• Funding of dedicated staff time or employment of community members to support outreach activities.
• In-language support for developing tools, media outreach, participant enrollment, and/or train-the-trainer programs.
• Developing and offering of Continuing Medical Education, Continuing Nursing Education, or Continuing Education Units.

Whatever the approach, applicants are required to make measureable commitments, such as: to train x trainers, to educate x community members, to facilitate the enrollment of x community members, to plan x community events, to generate x website visits, to educate x nurses, etc., and to include a timetable for meeting these commitments through specific activities.  

Applicant organizations are encouraged to partner with other eligible groups as needed to engage the community of interest. For all applications, one organization must serve as the lead applicant and fiscal sponsor. All participating organizations must be identified along with an explanation for why the partner(s) were chosen.

Existing Communications Tools & Requirements for New Materials

NIH leads overall communications efforts for the All of Us Research Program and will provide support to awardees through technical assistance, standard language and branding guidelines, and design files for communications materials (including, but not limited to, fact sheets, brochures, videos, and infographics). Printing expenses will be incurred by the awardees; applicants should include these estimates in their cost proposal.

NIH may also provide awardees access to the All of Us Research Program Mobile Asset—i.e., a traveling exhibit on wheels—for limited periods of time, depending on schedule and availability.

Any new communications products developed by the awardee will require advance approval by the All of Us Research Program communications team at NIH and potentially also the Program’s Institutional Review Board (IRB) to ensure consistency and accuracy in messaging. Engagement partner communications products will be required to follow the Program’s branding and co-branding guidelines.

Funding Mechanism Details & Key Dates

The Other Transaction award mechanism allows significant ongoing involvement from NIH staff and provides the NIH the flexibility to alter the course of the project in real time to meet the overarching goal. This may mean that awarded activity could be expanded, modified, partnered, not supported, or discontinued based on program needs, emerging methods or approaches, and availability of funds. Performance during the award period will be reviewed on an ongoing basis, and course corrections will be made as necessary.

**DUNS and SAM number registration can take several weeks. Please see the registration link for helpful instructions. Awards require a DUNS or SAM registration. The registration link is specific to grants: however, the process for DUNS and SAM registration for this OT award is the same. Candidates should begin the registration process several weeks prior to this deadline to ensure completion in time to provide this information to NIH.

Key Elements to Include in the Application

*Local applications are those that address a community of fewer than 20,000 in one geographically contiguous area. Regional/national scale applications address a community of greater than 20,000 or more than one geographic area.

Milestones & Timetables

Applicants are required to submit an engagement plan with measureable commitments and a quarterly timetable for meeting these commitments through specific activities. Each plan should be specifically designed to best engage the community of interest, but these elements must be included in all proposals:

• An initial communications plan should be completed and approved by the All of Us Research Program by the end of the first quarter of the award. This plan should include a list of the communications materials needed to execute the engagement plan as well as any desired use of the Mobile Asset.
• Education activities should commence no later than the second quarter of effort.

Reporting

Awardees will be asked to provide regular progress reports to the All of Us Research Program.

Privacy & Security

Among other important aspects of participant engagement are privacy, trust, and security. To this end, applicants should be familiar with these principles:  

• Precision Medicine Initiative: Privacy and Trust Principles:
  https://obamawhitehouse.archives.gov/sites/default/files/microsites/finalpmiprivacyandtrustprinciples.pdf
• Precision Medicine Initiative: Data Security Policy Principles and Framework:
  https://obamawhitehouse.archives.gov/sites/obamawhitehouse.archives.gov/files/documents/PMI_Security_Principles_Framework_v2.pdf

The purpose of this Funding Opportunity is to enable Partners to educate, motivate, and facilitate enrollment in the All of Us Research Program. Partners awarded under this announcement should not collect or retain health-related information as part of this effort. If awardees collect or retain non health-related personal information of All of Us volunteers, they may be subject to privacy and security requirements designed to protect that information. 

Program Organization and Governance Structure

The All of Us Research Program functions as a Consortium, with all awardees as members with specific roles in its governance structure. For example, the Program Steering Committee consists of the Program Directors/Principal Investigators (PDs/PIs) from each of the major awards. Committees are established by the All of Us Research Program Consortium Steering Committee to oversee the development and implementation of specific Consortium activities. Successful applicants to this funding opportunity will be expected to serve in the governance structure of the Consortium. 

Ownership of Data, Software, and Other Products

NIH will own all rights in data, software and other products (collectively “Works”) made or developed under this award, subject to a paid-up, nonexclusive, irrevocable worldwide license to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, by or on behalf of the awardee. The parties further agree that these Works are “works made for hire” as defined by the Copyright Act. Award recipients agree that no commercial IP (e.g., data, software or other products), whether owned by the awardee or a third party except those specifically referenced in the application, will be utilized without express prior permission of NIH.

Precision Medicine Initiative, PMI, All of Us, the All of Us logo, and The Future of Health Begins with You are service marks of the U.S. Department of Health and Human Services.