November 16, 2022
None
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.
Research Objectives
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:
- Support existing and additional types of outreach and enrollment locations and networks nationwide
- Increase program awareness, lower barriers and cost of enrollment and retention activities, and maintain the diversity of All of Us participant cohort
- Enable and enhance program participation across the broad spectrum of age, cultural background, educational attainment, health status, socioeconomic status, digital access, and technical expertise
- Support existing and enable new data collection methods
- Support enrollment of special populations, including pediatric enrollment
- Sustain support for and retention of a large, diverse, nationally distributed cohort
- Enable and support a broad range of ancillary studies of varying size, complexity, and context
- Provide new engagement opportunities and ways for the program to return value to participants to enhance their experience
- Facilitate integration of research support services that enhance capacity for program delivery nationwide
ROA Summary
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:
- Forms authoring, preview, testing, deployment, and collection tools supporting configurable implementation of eConsent, surveys, permissions, and other protocol or engagement experiences
- Orchestration tools for central management and monitoring of participant eligibility and status for protocol tasks at aggregate and individual levels
- Configurable client software supporting flexible implementation of multiple, dynamic, and/or self-directed participant experiences within the constraints of the protocol.
- Account and identity management, authentication, and verification
- Experience scheduling (like biosample collection), supporting self-service, staff mediated, and third-party partner integrations
- Communications functions not limited to omni-channel workflow automation and ad hoc messaging to participants through email, short message service (SMS), postal mail, and phone
- Case management tools for ongoing participant engagement, monitoring, and support
- Web Content Management System (CMS) supporting web-based content and experience delivery
- Third-party integrations with program partners and third-party services including assessment tools, return of information experiences, and data sharing authorizations
- Enterprise analytics data and tools to be used for marketing, participant engagement, experience sampling, and reporting
- Experimentation, randomization, statistical sampling, and A/B Testing tools to support protocol and user experience testing, delivery, and evaluation
- Multilingual support for both participant- and staff-facing applications and tools
- Cloud-based software systems and data management
- Platform data security, and privacy with a minimum requirement of Federal Information Security Management Act (FISMA) Moderate
- Flexible platform architecture that leverages standards-based, open source, public and/or well documented system components, Application Programming Interfaces (API), and Software Development Kit (SDK) resources
- Permissions-based access controls to support account provisioning for programmatic functions such as content management, forms authoring, communications implementation, user acceptance testing, and other tasks managed collaboratively between PPSC and program partners
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:
- Scientific research methods, coordination, and administration of cohort research
- Protocol development, implementation, monitoring, and research compliance
- Program and project management
- Communications and marketing tool implementation and management
- Web tools, content, and experience implementation and management
- User experience design, testing, and implementation
- Customer relationship management system configuration
- Data analytics implementation, including regular reporting and/or dashboards for internal program use, protocol monitoring, and user experience
- Data science and visualization for study management and participant engagement
- Software training and support for study staff
- Data quality monitoring, assurance, and control
- Extensible staffing models to support scientific and technical domain expertise necessary to meet both short and long term needs for the PPSC.
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:
- Multimodal and facilitated participant consent and assessment methods, tools, and services such as
- Extending program services beyond Computer-Assisted Web Interviewing (CAWI) assessment enabled by the RTS Core
- Supporting scalable delivery and data ingest of Computer-Assisted Telephone Interviewing (CATI), Computer-Assisted Personal Interviewing (CAPI), Audio Computer-Assisted Self-Interviewing (ACASI), and Pencil and Paper Interviewing (PAPI)
- Providing multimodal survey support including in-depth reports, no-code design and custom code, responsive survey development to multiple devices and environments, secure portals to share data and reports, and automated survey distribution across channels
- Supporting pretesting of participant consent and assessment instruments within diverse audiences including, but not limited to, cognitive testing and other methods of instrument evaluation for effectiveness
- Offering training for study staff on use of any tools and methods deployed for triaging and supporting participants through available multimodal services and workflows
- Multilingual research protocol translation, implementation support, and delivery services such as
- Extending program support beyond English and Spanish languages
- Providing potential to support three or more additional languages for primary implementation via PAPI and CAWI
- Providing scalable staff support for demand-based CATI and CAPI delivery in supported languages
- Technology, methods, and services for behavioral, physiological, and environmental monitoring such as
- Evaluating, procuring, and/or distributing mobile and wearable devices, sensors, and applications
- Evaluating, procuring, and/or distributing indoor and home-based assessment methods, kits, and devices
- Developing protocols, deploying, and collecting data from commercial, clinical, and research technology
- Conducting point and period assessments, and collecting intensive longitudinal data
- Technology, methods, and services to enable digital access and sustainable participation such as
- Evaluating, procuring, and/or distributing mobile and home technology to enable program participation and communications
- Evaluating, procuring and/or provisioning broadband or wireless network access and support services to enhance program participation and participant retention
- Developing and delivering self-service or facilitated, remote, facility-based, or in home training and concierge support services for technologies used in the Core Protocol, sub-, and ancillary studies
Applications are not being solicited at this time.
and Human Services (HHS)
