November 16, 2022
All of Us Research Program, Office of The Director, National Institutes of Health (OD)
The National Institutes of Health is issuing this Notice to alert the community about an upcoming Research Opportunity Announcement (ROA) from the All of Us Research Program, a historic effort to gather data from at least 1 million people who reflect the diversity of the United States, with the goal of accelerating health research and medical breakthroughs, and enabling individualized prevention, treatment, and care. The purpose of the ROA is to solicit technology systems and direct and indirect research support services to enable and support participant engagement, enrollment, and retention as the program’s Participant and Partner Services Center (PPSC). The ROA is expected to be published in January 2023, and will be available via www.sam.gov. NIH acceptance of applications will depend on the time frame outlined in the published opportunity announcement but is estimated to be March 2023. The goal is to make awards as early as November 2023. Anticipated awards will be made utilizing the Other Transaction Authority (OTA) under Section 402(n) of the Public Health Service Act (PHSA), 42 U.S.C. 282(n). Proposed technology systems and research services must be capable of integrating with All of Us platform partners, protocol configuration, cross platform testing, staff training, and production launch within 6-12 months from the time of the award.
This Notice is being provided to allow potential offerors time to engage with the All of Us Research Program in advance of the release of the ROA.
This Notice does not commit the Government to award an agreement. This Notice is for informational purposes only. It is not a formal ROA or Request for Application. Do not submit any formal proposals or applications to this Notice. All information contained in this Notice is subject to change at any time.
Research Initiative Details
All of Us Research Program
The All of Us Research Program is a historic effort to gather data from at least 1 million people living in the U.S., with the goal of accelerating research and medical breakthroughs, and enabling individualized prevention, treatment, and care. The program is guided by a set of core values, including diversity, transparency, and accessibility. The program is creating a national research resource to inform thousands of studies, covering a wide variety of health conditions. Researchers use data from the program to learn more about how individual differences in lifestyle, environment, and biological makeup can influence health and disease. The All of Us Research Program is committed to enrolling a cohort of participants who reflect the diversity of the U.S., including groups historically underrepresented in biomedical research. The program characterizes populations that are underrepresented in biomedical research as groups that historically have low representation rates in biomedical research studies (including clinical trials). Groups underrepresented in biomedical research include (1) individuals identifying as from racial and ethnic minority groups and/or (2) sexual and gender minority groups; (3) children and older adults; and people with (4) disabilities, (5) barriers to accessing healthcare, (6) lower incomes, or (7) limited educational attainment; and/or (8) residents of rural areas.
The All of Us Research Program has enrolled more than 545,000 adult participants since 2017, and assembled a partner network of more than 100 organizations supporting community outreach and engagement, participant enrollment and retention, study operations, and longitudinal cohort management. The majority of program participants have enrolled in the All of Us Research Program with support from a network of Health Care Provider Organization partners, including Regional Medical Centers, Federally Qualified Health Centers, and U.S. Department of Veterans Affairs Medical Centers. In addition to a strong facility-based enrollment network, the All of Us Research Program now supports nationwide enrollment of eligible adults, ages 18 and up. These nationwide participants can complete initial protocol activities and provide biosamples remotely from 50 states and most U.S. territories. The All of Us Research Program has supported responsive web and native application-based digital participant experiences nationally since 2018, and has further expanded opportunities for additional remote participation over time. Examples include mailed saliva collection kits, participant-mediated electronic health records (EHR) sharing, and Computer-Assisted Telephone Interviewing (CATI) to support participant retention. A recent version of All of Us Research Program’s protocol is available for additional information.
The purpose of the PPSC ROA is to solicit technology systems and direct and indirect research support services to enable participant engagement, enrollment, and retention. The program seeks partners that can provide these capabilities quickly and accurately using existing capabilities, and do so in a way that precisely meets participants’ needs. Through PPSC, the program aims to enable support for a continuously evolving set of enrollment partnerships, participant audiences (including children), assessment methods, research services, ancillary study protocols, and return of information to participants. These will be critical capabilities that will allow the program to continue to expand. The offeror will be responsible for the transition of the existing integrations and scope of the current Participant Technology Systems Center (PTSC) award. Platforms and teams awarded under this ROA will provide essential support for program objectives to:
The PPSC ROA will consist of two cores, briefly described below. Offerors may propose partnerships within their proposal to provide research services and technology expertise across cores. NIH may also select recipients to support individual PPSC cores. All selected partners accepting an award shall be required to work collaboratively to achieve PPSC and program objectives. In the event that multiple awards are issued under the anticipated ROA, the Program Management and Delivery (PMD) Core will serve as the administrative coordinating center for PPSC, managing cross-core coordination and project delivery. The estimated budget is $30 million (total costs) for both Cores in Year 1. It is anticipated that 1 to 2 awards will be made. The ROA will be open to Higher Education Institutions (public and private), Non-profit Organizations, and For-profit Organizations (including small and large businesses).
Research Technology Systems Core
The Research Technology Systems (RTS) Core shall provide scalable and secure enterprise technology capable of supporting both centralized and locally tailored research protocols and participant support. The RTS Core must provide extensible tools to 1) meet the needs of the national program, including NIH, researchers using the program’s research platform, and communications and engagement award partners, and 2) simultaneously support hundreds of regional organizations and up to thousands of individual sites' abilities to leverage central platforms to support marketing, community outreach and engagement, participant enrollment and retention, study operations, and program monitoring and analytics. Integration of commercial and research platforms solutions are encouraged in order to best support delivery of the All of Us Research Program. Staffing for the RTS Core shall support the ability to deploy, secure, maintain, enhance, and integrate RTS platforms, in collaboration with program partners and third-party systems required to implement the All of Us Research Program. Major platform capabilities that are prioritized include, but are not limited to, the following:
Program Management and Delivery Core
The Program Management and Delivery (PMD) Core shall provide indirect and direct research support services supporting protocol operations for the All of Us Research Program.
PMD Indirect Research Support Team
The PMD Core’s indirect research support team will engage and collaborate directly with NIH and program partners providing scientific, program operations, and technical expertise necessary to leverage the RTS Core platform(s) and facilitate program and protocol development, implementation, compliance, delivery, and change management. The team will manage and support products and services including, but not limited to, public, participant, and staff-facing software tools, content management system(s), standard operating procedures, staff training, and All of Us partner collaborations.
Staffing expertise and capabilities that are prioritized include, but are not limited to, the following:
PMD Direct Research Support Team
The PMD Core’s direct research support team will provide methodological expertise, professional services, research equipment and supplies, systems for integration, and contracts or licensing agreements, as necessary. The team will conceptualize, implement, and manage scalable multimodal study delivery and innovation methods for participant enrollment, engagement, and retention across the All of Us Research Program’s Core Protocol, sub-, and ancillary studies. For the research capabilities described below, the PMD Core will holistically support protocol lifecycle activities for delivery of research services directly supporting individual participation.
The required direct research support team capabilities and levels of utilization will vary over time. Not all of the below services will be immediately deployed in support of the All of Us Research Program. However, PMD Core offerors will be expected to assemble expert teams to deploy research services using a variety of assessment tools, methods, and support resources over time. Capabilities that may be prioritized include, but are not limited to, the following:
Applications are not being solicited at this time.
All of Us Research Program
Subject: PPSC Notice (NOT-PM-23-001)