Research Opportunity Annoucement (ROA) All of Us Participant and Partner Services Center No. OTA-23-002.pdf

National Institutes of Health (NIH) Office of the Director (OD)

All of Us Research Program

Research Opportunity Announcement (ROA):

All of Us Participant and Partner Services Center No. OTA-23-002

Issue Date: January 18, 2023

TABLE OF CONTENTS

SECTION 1: RESEARCH OPPORTUNITY ANNOUNCEMENT INFORMATION

1.1 Purpose

1.2 Overview

SECTION 2: ISSUING OFFICE AND POINTS OF CONTACT

2.1 Contact Information Agency

2.2 Questions

2.3 Amendments

SECTION 3: AWARD INFORMATION

3.1 Award Type

3.1.1 Authority

3.2 Funding and Period of Performance

3.2.1 Anticipated Funding

3.2.2 Period of Performance

SECTION 4: PROGRAMMATIC BACKGROUND

SECTION 5: PPSC AWARD - STRUCTURE, CAPABILITIES, AND MILESTONES

5.1 Award Structure

5.1.1 Research Technology Systems Core - Overview

5.1.2 Program Management and Delivery Core - Overview

5.2 OT Award Milestones

SECTION 6: ELIGIBILITY INFORMATION

6.1 For-Profits

6.2 Higher Education

6.3 Nonprofits

6.4 Non-Eligible Entities

SECTION 7: PRE-SUBMISSION WEBINAR

SECTION 8: COMPETITION PROCESS, CONTENT SUBMISSION REQUIREMENTS, AND

EVALUATION CRITERIA (Phases II-V are by Invitation Only)

8.1 PHASE I - WHITE PAPER

8.1.1 White Paper Email Submission

8.1.2 White Paper Format

8.1.3 White Paper Content

8.1.4 White Paper Evaluation Criteria

8.1.5 White Paper Selection

8.2 PHASE II - FULL TECHNICAL PROPOSALS (Phase is Invitation Only)

8.3 PHASE III - CAPABILITIES DEMONSTRATION AND EVALUATION (Phase is Invitation Only)

8.4 PHASE IV - FULL BUDGET/COST PROPOSAL (Phase is Invitation Only)

8.5 PHASE V - OT AWARD (Phase is Invitation Only)

SECTION 9: ADDITIONAL INFORMATION

9.1 Non-Government Advisors

9.2 Proposal Costs

9.3 Protests or Appeals

9.4 Additional Requirements

9.4.1 Organization and Governance Structure

9.4.2 Data Security and Management

9.4.3 Human Subject Requirements

9.5 Organizational and Personal Conflict of Interests

9.5.1 Organizational Conflict of Interests

9.5.2 Responsibilities of Recipients regarding Financial Conflicts of Interest (FCOI)

9.6 Terms and Conditions (Appendix A)

SECTION 1: RESEARCH OPPORTUNITY ANNOUNCEMENT INFORMATION

1.1 Purpose

The All of Us Research Program is 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 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 has enrolled a diverse cohort of more than 575,000 adult participants and has a community of nearly 4,000 researchers to date who have registered to use the data available through the Researcher Workbench. With this award, we are seeking to build on our current success to enable a next generation research enterprise providing world-class capabilities supporting participant interactions and program management that will include enrolling children and families; creating an ecosystem of ancillary studies that build upon our platform; and expanding our ability to longitudinally engage, retain, and better return value to our participants.

The purpose of this announcement is to solicit and review proposals, evaluate potential partners, and ultimately fund the future All of Us Participant and Partner Services Center (PPSC). The PPSC will provide technology systems and both direct and indirect research services to enable and support participant engagement, enrollment, and retention in collaboration with program partners. The program seeks partners that can provide these capabilities quickly and accurately using existing platforms and processes, and do so in a way that precisely meets participants’ needs across a variety of participation journeys.

Through PPSC, the program aims to enable support for a continuously evolving set of engagement, enrollment and retention 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 support delivery of a broad range of requirements identified herein.

The milestones in Year 1 of this award will facilitate a transition from the program’s current participant and study staff services – supported by multiple awards, including the Participant Technology Systems Center (PTSC) and the Participant Center (TPC) – to the PPSC award team and their resultant services. Proposed technology systems and research services must be capable of integrating with All of Us platform partners such as the Data and Research Center (DRC), configuring to the protocol, providing cross platform testing and staff training, and coordinating production launch within 8-12 months from the time of the award. Following successful production launch, the PPSC will transition existing participant user accounts from any legacy systems.

Platforms and teams awarded under this announcement will provide research technology and services supporting participant and program partner audiences including:

https://www.researchallofus.org/data-tools/data-snapshots/ https://databrowser.researchallofus.org/ https://www.researchallofus.org/data-tools/workbench/ https://allofus.nih.gov/funding-and-program-partners/participant-technology-systems-center https://allofus.nih.gov/funding-and-program-partners/participant-center https://allofus.nih.gov/funding-and-program-partners/data-and-research-center

● Prospective, New, and Existing Participants: engaging with the program in a variety of modes and settings, as well as stages of program progression based on date of consent and individual interest or barriers to longitudinal program participation

● Study Staff / Managers: facilitating and managing engagement, enrollment, and retention of individuals and groups

● Program Administrators: monitoring and evaluating progress and performance of individual staff, organizations / partners, participant segments, etc. based on program-defined key performance indicators

● Researchers: set-up, configuring, pre-testing, deploying, and managing program-approved ancillary studies using the PPSC platforms and tools

The PPSC will serve as a central and essential partner to enable our 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 the 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 retention of and support for a large, diverse, and 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

1.2 Overview

This Research Opportunity Announcement (ROA) will include five phases. The purpose is to identify potential offerors that have technologies and health research services to fulfill the scope described herein. We welcome submissions from for-profit, not-for-profit, and academic organizations among others, outlined in greater detail in Section 6.

The five phases include the following:

Phase I – Submission and Evaluation of White Papers Phase II – Submission and Evaluation of Full Technical Proposal (Invite Only) Phase III – Capabilities Demonstration and Evaluation (Invite Only) Phase IV – Submission and Evaluation of Full Budget/Cost Proposal (Invite Only) Phase V – Notification of Other Transactions (OT) Award

The NIH intends to down-select at each phase, resulting in making one or more Other Transaction (OT) awards in Phase V.

For selected proposals invited to the next phase, further instructions will be provided to offerors at the conclusion of each phase.

Depending on program requirements, the NIH reserves the right to combine the phase submissions as needed, or omit Phase II or III.

SECTION 2: ISSUING OFFICE AND POINTS OF CONTACT

2.1 Contact Information Agency

National Institutes of Health (NIH) 6710B Rockledge Drive, 4th Fl. Bethesda, MD 20817

Program Name: All of Us Research Program

Opportunity Title: All of Us Participant and Partner Services Center

Opportunity No.: OTA-23-002

Contact Information:

All of Us Awards Management Branch (AMB) Email: AOU-ROA@nih.gov Subject: OTA-23-002 - Participant and Partner Services Center

2.2 Questions

Comments or questions submitted must be concise and to the point. In addition, reference the relevant part and paragraph of the Research Opportunity Announcement (ROA).

We encourage offerors to review the ROA and submit questions as soon as feasible. Questions must be submitted to the email address listed above, in Section 2.1, at least 14 calendar days prior to the White Paper due date to ensure response; if submitted less than 14 calendar days from the deadline, they may not be answered. The due date for submission of the White Paper is located in Section 8.1.1 and will not be extended.

2.3 Amendments

Updates to this ROA will be posted to SAM.gov: https://sam.gov/content/opportunities https://sam.gov/content/opportunities https://sam.gov/content/opportunities

The ROA can also be accessed via the All of Us Funding Opportunities webpage:

https://allofus.nih.gov/funding-and-program-partners/funding-opportunities

SECTION 3: AWARD INFORMATION

3.1 Award Type

The funding instrument for the anticipated award(s) is the Other Transactions (OT) awarding mechanism. An OT award is not a grant, cooperative agreement, or contract, but instead uses Other Transactions Authority (OTA). OTA provides for the flexibility to adjust the scope of work and iteratively shift milestones during a specific timeframe, based on the requirements of the activity, to respond to the needs of the program and achieve maximum efficiency. OTs will allow the All of Us Research Program to effectively choose activities from offerors to produce a comprehensive set of awardees that can deliver the goals of the program.

3.1.1 Authority

Anticipated OT award(s) will be made pursuant to the Other Transactions Authority (OTA) granted to the NIH Director under the 21st Century Cures Act, as specified in Section 402(n) of the Public Health Service Act, 42 U.S.C. 282(n).

3.2 Funding and Period of Performance

3.2.1 Anticipated Funding

The program anticipates making one or more awards in Phase V, dependent on the number of awards required to achieve the program goals, milestones and objectives of both cores described in Section 5 and subject to funding availability. Offerors may apply to support one or both cores, depending on their organizations specific capabilities. NIH encourages offerors to partner to provide the best solution within a single proposal where possible. An organization is limited to a single submission, but may be included as a collaborating partner on more than one application.

PPSC total costs are anticipated to not exceed $37.5 million in aggregate for both award cores in the Base Period (Year 1) including:

● Research Technology Systems (RTS) Core: $17.5 million total cost

● Program Management and Delivery (PMD) Core: $20 million total cost

3.2.2 Period of Performance

The period of performance of the anticipated OT award(s) will be a fifteen (15) month base period, and may include up to four (4) twelve (12) month optional periods. The All of Us Research Program reserves the right to extend the period of performance beyond this five year period. The estimated start date is subject to the agreed upon date of final award and the availability of fiscal year (FY) funds.

https://allofus.nih.gov/funding-and-program-partners/funding-opportunities https://grants.nih.gov/funding/other-transactions.htm

The award(s) will be made for the full performance period. Option periods may or may not be utilized.

SECTION 4: PROGRAMMATIC BACKGROUND

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, (7) limited educational attainment, and/or (8) residents of rural areas.

The All of Us Research Program has enrolled more than 580,000 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 All of Us through the program’s 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 supports nationwide self-enrollment of eligible adults, ages 18 and up.

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 national enrollment using responsive web and native application-based digital participant experiences 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 Core Protocol is available for additional information.

https://allofus.nih.gov/about/core-values https://allofus.nih.gov/about/core-values https://www.researchallofus.org/data-tools/data-snapshots/ https://www.joinallofus.org/enrollment-and-engagement-partners https://allofus.nih.gov/about/all-us-research-program-protocol

The All of Us Research Program provides access to data through the Researcher Workbench, which has already served as a foundation for discovery. To date, nearly 4,000 researchers have registered to use the data and have initiated more than 3,300 research projects. The analyses and publications span many areas of medicine, including topics such as early cases of COVID-19, impact of physical activity on chronic disease, heart disease in Hispanic people, obesity, and more.

This award(s) aims to build on the program’s success to achieve future goals, including child and family enrollment, scalable ancillary studies capabilities, and ongoing strategies to engage, retain, and return value to our participants. The All of Us Research Program aims to establish a technical platform and supportive services capable of delivering a user-centered study experience through public-, participant-, and staff-facing tools across a variety of different touchpoints for many years to come.

Offerors should familiarize themselves with the program by reviewing public resources including:

● Program Overview: https://allofus.nih.gov/about/program-overview

● Partners: https://allofus.nih.gov/funding-and-program-partners

● Protocol: https://allofus.nih.gov/about/all-us-research-program-protocol

● Enrollment Site: https://www.joinallofus.org/

● Research Hub: https://www.researchallofus.org/

Previous funding announcements related to the planned All of Us PPSC:

● OTA-20-001: All of Us Participant Technology Systems Center (OT2)

● RFA-PM-16-003: Precision Medicine Initiative Cohort Program Participant Technology

Center (U24)

SECTION 5: PPSC AWARD - STRUCTURE, CAPABILITIES, AND MILESTONES

5.1 Award Structure

The PPSC OT award(s) will consist of two cores, outlined below. Offerors are encouraged to propose partnerships within their proposal to provide research services and technology expertise across cores within a single award. The NIH may also select separate offerors to support individual PPSC cores. All selected partners accepting an award must work collaboratively to achieve the program’s goals and the PPSC milestones and objectives. In the event that multiple awards are issued under this announcement, the Program Management and Delivery (PMD) core will serve as the administrative coordinating center for PPSC, managing cross-core coordination and project delivery. We welcome submissions from all offerors and teams with compelling technology or research services solutions to deliver the targeted capabilities defined below for each core, including those with gaps requiring future enhancements or partnerships as long as the milestones in Section 5.2 can be met by the requested timeline.

https://www.researchallofus.org/research-projects-directory/ https://www.researchallofus.org/publications/ https://allofus.nih.gov/ https://allofus.nih.gov/about/program-overview https://allofus.nih.gov/funding-and-program-partners https://allofus.nih.gov/funding-and-program-partners https://allofus.nih.gov/about/all-us-research-program-protocol https://www.joinallofus.org/ https://www.joinallofus.org/ https://www.researchallofus.org/ https://www.researchallofus.org/ https://allofus.nih.gov/sites/default/files/funding_opportunity_ptsc.pdf https://grants.nih.gov/grants/guide/rfa-files/rfa-pm-16-003.html

5.1.1 Research Technology Systems Core - Overview

The Research Technology Systems (RTS) core must provide scalable and secure enterprise technology capable of supporting both central program and regional partner-implemented research protocols and participant support. The RTS core must provide extensible tools to 1) meet the needs of the national program, including the NIH, program partners integrating with PPSC systems and services, 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.

As described in Section 1.1, the users of the RTS platforms, tools, and services could be grouped into audiences including:

● Prospective, New, and Existing Participants

● Study Staff / Managers

● Program Administrators

● Researchers

Integration of commercial and/or research platforms solutions are encouraged in order to best support delivery of the All of Us Research Program. Staffing for the RTS core must 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:

● Highly configurable platform that can be modified by the PMD core and approved All of Us staff, partners, administrators, and researchers without requiring new coding and testing of capabilities

● Forms authoring, preview, testing, deployment, and collection tools supporting configurable implementation of eConsent, surveys, permissions, and other protocol tasks or engagement experiences

● Study management platform for central control, activation, modification, monitoring, and auditing of participant eligibility and status of protocol tasks and program experiences for participant segments and/or individuals

● Participant management tools for direct participant engagement, monitoring, and support

○ This may additionally include tailoring or modification of individual participants’ protocol opportunities or experience in real-time.

● Configurable client software supporting flexible implementation of multiple, dynamic, and/or self-directed protocol tasks and participant experiences, such as connecting a wearable device or ordering an at-home biosample kit

● Capability to support and modify user experience design through configuration based on program requirements and style guides, best practices, and accessibility requirements

● Experimentation, randomization, statistical sampling, and A/B Testing tools to support protocol and user experience testing, delivery, and evaluation of existing and new program opportunities under consideration

● Account and identity management, authentication, and verification

● Scheduling platform that supports self-service, staff-mediated, and third-party partner integrations for protocol tasks and program experiences (e.g., biosample collection visit)

● Communications functions including, but not limited to, workflow automation and ad hoc messaging to participants through email, short message service (SMS), postal mail, and phone

● Web Content Management System (CMS) supporting web-based content and experience delivery for multiple use-cases including national and local program websites, marketing landing pages, and lead generation

● Enterprise analytics data systems and tools to be used for marketing purposes, participant engagement, experience sampling, and program reporting

● Support for integrations, tools, and interfaces to facilitate participant-mediated sharing of EHR and claims data

● Support for additional third-party integrations with program partners (e.g., Genetic Counseling Resource) and third-party services including assessment tools, return of information experiences, and data sharing authorizations (e.g., participant mediated sharing from digital health apps and devices)

● Innovative methods and tools to engage participants to generate intrinsic and extrinsic value from program participation including potential for monetary and non-monetary incentives, return of information, data sharing, informational content, etc.

● Flexible platform architecture that leverages standards-based, open source, public and/or well documented system components, Application Programming Interfaces (APIs), and Software Development Kit (SDK) resources

● Capacity to support and maintain program sandbox environment(s) for partner or third-party prototyping and testing of protocols, system integrations, and services

● Capacity to modularize and/or embed platform components within partner or third-party applications to improve program awareness, as well as participant access, engagement, and retention

● Role-based access for program staff to directly control functions such as content management, forms authoring, communications implementation, user acceptance testing, and other tasks managed collaboratively between PPSC and program partners

● Multilingual support for both participant- and staff-facing applications and tools, to extend participant program experience beyond English and Spanish languages

● Accessibility support including design, testing, implementation, and auditing, including 508 compliance

● Auditability, including third-party auditing of PPSC applications and tools for quality, compliance, and security assurance

● Expertise in cloud-based software systems and data management

● Capacity to support platform data security and privacy that exceeds Federal Information

Security Management Act (FISMA) Moderate requirements https://allofus.nih.gov/funding-and-program-partners/genomics-partners

5.1.2 Program Management and Delivery Core - Overview

The Program Management and Delivery (PMD) core must provide indirect and direct research services supporting program and protocol operations for the All of Us Research Program. Indirect research support for the PPSC constitutes a wide range of scientific, programmatic, management, implementation, analytic, and technical services that facilitate program delivery capabilities without direct engagement or interaction with program participants. Direct research support for the PPSC extends into services in which the PPSC team conceptualize, implement, and support protocol opportunities and capabilities that directly engage or interact with program participants to facilitate program delivery (e.g., phone interviewing, shipping, technical assistance, training, etc.). The capabilities and objectives of the PMD indirect and direct research support teams are outlined below.

5.1.2.1 PMD Indirect Research Support Team

The PMD core’s indirect research support team will collaborate with the NIH and program partners providing scientific, program operations, and technical expertise necessary to use the RTS core platform(s). The team will collaborate to support the consortium or directly facilitate responsibilities of the PPSC for program and protocol development, implementation, compliance, delivery, and change management. The team will manage and support products including, but not limited to, public, participant, and staff-facing software tools and content management system(s). The program anticipates the offeror to provide services in support of these products including developing standard operating procedures; providing staff training; and facilitating All of Us partner collaborations. Prioritized staffing expertise and capabilities include, but are not limited to, the following:

● Coordinating and administering research methods, and supporting program planning and protocol development associated with PPSC objectives and deliverables

● Facilitating implementation of approved program protocols through configuration based on program requirements and style guides, best practices, and accessibility requirements

● Monitoring and auditing compliance of approved program protocols

● Managing program delivery including project management and reporting

● Implementing and managing communications and marketing technology

● Configuring, implementing, and managing web content management systems (CMS)

● Designing, testing, and implementing user experience research

● Configuring the study management system

● Developing and implementing data analytics, including regular reporting and dashboards for internal program use, protocol monitoring, and user experience testing and evaluation

● Creating custom data analytics and visualization to facilitate participant engagement, enrollment, and retention

● Training and support for study staff on all relevant PPSC software, systems, and tools

● Supporting program and platform requirements for data quality monitoring, assurance, and control

● Supporting scientific and technical domain expertise necessary to meet both short and long term needs for the PPSC through extensible and flexible staffing models and capacity

● Participating in consortium scientific and technical committees

5.1.2.2 PMD Direct Research Support Team

The PMD core’s direct research support team will provide methodological expertise, professional services, 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 innovative assessment and support 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 and directly support individual participation through the delivery of research services.

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 Year 1 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. Prioritized capabilities 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 required and enabled by the RTS core

○ Supporting scalable integration, implementation, 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) methods

○ Providing multimodal survey support including in-depth reports, no-code design, and custom code capabilities; responsive survey development to multiple devices and environments; secure portals to share data and reports; and automated survey distribution across channels

○ Supporting pre-testing of participant consent and assessment instruments with diverse audiences including, but not limited to, cognitive testing and other methods of instrument evaluation for effectiveness

○ Training study staff on the use of available tools and methods for engaging individuals in their preferred mode(s) of participation

● Multilingual research protocol translation, implementation support, and delivery services, such as:

○ Extending participant program experience beyond English and Spanish languages

○ Developing and implementing key protocol components (e.g., e-consents, surveys, communications content) in three or more additional languages

○ Providing scalable staffing 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 and implementing protocols to deploy and collect data from commercial, clinical, and research technology

● 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 protocol and ancillary studies

5.2 OT Award Milestones

The OT award(s) made in Phase V must meet the milestones detailed in this section. The below milestones are provided to contextualize the PPSC award expectations and timelines for the initial project period. However, the All of Us Research Program understands that necessary information to develop a full project plan, tasks, and detailed budget/cost have not been provided at this time. Phase I White Paper submissions and evaluations do not require a milestone plan. Offeror should refer to Section 8.1.3 for White Paper content and Section

8.1.4 for White Paper evaluation criteria for guidance on Phase I submission.

Further details will be provided to offerors invited to Phase II in order to enable submission of a full technical proposal and associated project plan and detailed budget/cost estimate.

PPSC Year 1 milestones will be implemented within a phased project schedule. The below schedule accounts for key tasks for newly awarded program partners, including but not limited to, onboarding, systems integration, security approvals, protocol implementation, testing and quality assurance, partner training, pilot testing, launch, and ultimately migration of existing program participant accounts and data onto the proposed platform. Existing program partners may propose an accelerated schedule for milestone delivery based on existing systems, capabilities, and processes the offeror has at the time of award. The milestones in Year 1 will facilitate a transition from the program’s current participant and study staff services (supported by multiple awards including the PTSC and TPC) to the PPSC award team and their resultant services. The PPSC Year 1 milestones are applicable to both the Research Technology Systems (RTS) and Program Management and Delivery (PMD) cores and require collaboration and shared accountability for delivery. The NIH encourages partnering to provide the best solution within a single application/proposal.

https://allofus.nih.gov/funding-and-program-partners/participant-technology-systems-center https://allofus.nih.gov/funding-and-program-partners/participant-center

Milestone 1 - PPSC Award Onboarding and Access (Month 1)

● Objective 1.1 - Participate in the award kick-off meeting with the Program Officer

(and/or their designees) and Awards Management Team. Additionally, establish ongoing award management meetings internally across PPSC cores / organizations and externally with the Program Officer (and/or designees) and Awards Management Team.

● Objective 1.2 - Establish a PPSC management and leadership plan reflecting the PMD core as the administrative coordinating center for PPSC, managing cross-core coordination and project delivery, in accordance with NIH requirements.

● Objective 1.3 - Document which award staff require access to program tools, documentation, resources, and program meetings. Verify access and establish offboarding procedures for notification of staffing transitions.

● Objective 1.4 - Complete All of Us Research Program training for award staff.

● Objective 1.5 - Establish processes for monthly milestones and financial reporting across organizations participating in the PPSC.

Milestone 2 - Partner, Systems, and Protocol Discovery (Months 1-2)

● Objective 2.1 - Review All of Us Research Program Institutional Review Board (IRB) Core Protocol, Protocol Appendices, and associated protocol and program governance materials to document requirements associated with program opportunities and generate resources for verification and/or reimplementation of existing protocols, including, but not limited to:

○ Objective 2.1.1 - Participant eligibility, exclusion, temporal alignment, content, communications materials, etc.

○ Objective 2.1.2 - Additional platform or technical enhancement requirements necessary to meet the needs of the program.

● Objective 2.2 - Review existing system architecture, platforms, integrations, services, tools, processes, functional capabilities, content, and logic in collaboration with NIH and program partners including the Data and Research Center (DRC), PTSC, TPC, Genetic Counseling Resource (GCR), and Biobank awardees.

● Objective 2.3 - Establish a plan for integration of new RTS and PMD core platforms, services, tools, and processes into the PPSC enterprise and security boundaries as required to support the cross-core PPSC milestones.

● Objective 2.4 - Establish a plan for reuse or reimplementation of specific components of All of Us existing systems architecture, platforms, integrations, services, tools, and processes in order to meet the requirements of the program and timelines for piloting, launch, and participant migration. Project planning and approvals may follow a sprint-based and iterative progression to optimize delivery schedules, while extending Milestone 2 beyond two months.

○ Objective 2.4.1 - Review the proposed project plans and resultant systems architecture, platforms, integrations, services, tools, and processes with the Program Officer and Chief Technology Officer (or designees) for approval.

https://allofus.nih.gov/funding-and-program-partners/data-and-research-center https://allofus.nih.gov/funding-and-program-partners/participant-technology-systems-center https://allofus.nih.gov/funding-and-program-partners/participant-center https://allofus.nih.gov/funding-and-program-partners/genomics-partners https://allofus.nih.gov/funding-and-program-partners/biobank

Milestone 3 - Initial Systems Implementation, Pre-Production Testing, and Launch Preparation (Months 2-10)

● Objective 3.1 - Implement a sprint-based approach iteratively establishing components of the PPSC enterprise, incorporating the Program Officer (and/or their designees) into the process for approvals and acceptance.

○ Objective 3.1.1 - Implement approved plans established in Objective 2.4 for reuse or reimplementation of existing All of Us systems architecture, platforms, integrations, services, tools, and processes into the PPSC enterprise and security boundaries.

○ Objective 3.1.2 - Implement approved plans established in Objective 2.3 for integration of new RTS and PMD core platforms, services, tools, and processes into the PPSC enterprise and security boundaries.

● Objective 3.2 - Provision pre-production access and initiate training for required PPSC teams, approved program partners, and NIH staff to support configuration of protocol requirements, content, and experiences.

○ Objective 3.2.1 - Verify access and establish offboarding procedures for notification of staffing transitions, including, but not limited to, necessary revocation and auditing of user access to PPSC systems.

● Objective 3.3 - Establish a protocol implementation plan based on outputs of Objective

2.1 to configure, test, verify compliance, and certify readiness of all protocol requirements and participant experiences necessary to support All of Us Research Program recruitment, enrollment, and retention activities that intersect the PPSC systems, services, and teams.

○ Objective 3.3.1 - Review the proposed protocol implementation plan with the Program Officer (and/or designees) for approval.

● Objective 3.4 - Implement approved protocol implementation plan and configure, test, verify compliance, and certify readiness of all protocol requirements and participant experiences.

○ Objective 3.4.1 - Iteratively review and approve PPSC system configuration component readiness for pilot launch, incorporating the Program Officer (and/or their designees) into the process for approvals and acceptance.

● Objective 3.5 - Provision pre-production access and initiate appropriate roles-based training for required PPSC teams, approved program partners, and NIH staff to support program operations, including, but not limited to, participant outreach, engagement, enrollment, retention, monitoring, and data analytics activities.

○ Objective 3.5.1 - Verify access and establish offboarding procedures for notification of staffing transitions, including, but not limited to, necessary revocation and auditing of user access to PPSC systems.

● Objective 3.6 - Develop a plan for implementation of a limited-audience pilot test followed by a nationwide launch and redirect of enrollment traffic and activities from existing All of Us portal platforms, web properties, and staff tools to the PPSC enterprise.

○ Objective 3.6.1 - Coordinate requirements development, planning, and timeline projections with NIH and program partners, including, but not limited to, PTSC, TPC, and DRC.

○ Objective 3.6.2 - Review the proposed plan and timeline for the PPSC limited audience pilot test with the Program Officer (and/or designees) and All of Us Leadership for approval.

○ Objective 3.6.3 - Review the proposed plan and timeline for redirect of enrollment traffic with the Program Officer (and/or designees) and All of Us Leadership for approval.

Milestone 4 - Security and Privacy Planning, Implementation, Testing, and Authorization To Operate (ATO) (Months 1-10)

● Objective 4.1 - Conduct NIH and PPSC Security Team introductions, communications planning, ATO requirements, and timeline review.

● Objective 4.2 - Support iterative development, documentation, and review of required ATO materials.

● Objective 4.3 – Finalize System Security Plan (SSP) and supporting FISMA artifacts in advance of engagement with Third-Party controls assessor.

● Objective 4.4 - Support PPSC contracted third-party assessment with an additional penetration testing team.

● Objective 4.5 - Support PPSC review, mitigation, and retesting of security controls assessment and penetration testing results.

● Objective 4.6 - Support PPSC preparation of final ATO package for review(s) and approval.

● Objective 4.7 - Support integration of RTS systems and ongoing collaboration with the All of Us Security Operations Center (SOC).

● Objective 4.8 – Complete all requirements on the continuous monitoring checklist (to be provided in Phase II).

Milestone 5 - Production Testing and Pilot Launch Preparation (Month 11)

● Objective 5.1 - Deploy the ATO-approved PPSC enterprise to a production environment with limited access to PPSC’s All of Us systems architecture, platforms, integrations, services, tools, and processes.

● Objective 5.2 - Provision access to production systems for all PPSC, NIH, and partner staff required to support the PPSC pilot launch and required All of Us program operations.

○ Objective 5.2.1 - Verify access and extend offboarding procedures established in Objectives 3.2.1 and 3.5.1 to support PPSC production systems.

● Objective 5.3 - Conduct final production launch readiness testing of the PPSC enterprise, including protocol implementation, partner integrations and data transmissions, study staff tools, platforms, etc.

○ Objective 5.3.1 - Maintain a shared registry of reported and/or identified production issues with Program Officer (and their designees) and relevant All of Us award partners.

○ Objective 5.3.2 - Mitigate any pilot launch blocking bugs and/or issues identified during production testing.

● Objective 5.4 - Review and finalize the pilot launch plan and proposed timeline approved in Objective 3.6.2 with NIH and program partners engaged in the pilot launch, in preparation for the pilot launch of the PPSC enterprise.

Milestone 6 - Pilot Launch of the PPSC Enterprise (Month 12)

● Objective 6.1 - Expose the PPSC enterprise to a limited market pilot test and implement rollout based on the final pilot launch plan approved in Objective 5.4.

● Objective 6.2 - Evaluate participant and staff-facing system performance, integrations, and data quality in collaboration with NIH and program partners.

○ Objective 6.2.1 - Track reported and/or identified production issues in the registry established in Objective 5.3.1.

○ Objective 6.2.2 - Mitigate any nationwide launch blocking bugs and/or issues identified during pilot launch.

● Objective 6.3 - Provision access to production systems for all additional NIH and partner staff required to support the PPSC national launch and All of Us program operations nationwide.

○ Objective 6.3.1 - Verify access and extend offboarding procedures established in Objectives 3.2.1 and 3.5.1 to support PPSC production systems.

● Objective 6.4 - Review and finalize the national launch plan and proposed timeline, approved in Objective 3.6.3, with NIH and program partners, in preparation for the national launch of the PPSC enterprise.

Milestone 7 - Nationwide Enrollment Launch and Redirect to RTS Platform (Month 13)

● Objective 7.1 - Expose the PPSC enterprise to support all new enrollments nationwide and implement rollout based on the final national launch plan approved in Objective 6.4.

● Objective 7.2 - Evaluate participant and staff-facing system performance, integrations, and data quality, in collaboration with NIH and program partners, during the nationwide enrollment launch.

○ Objective 7.2.1 - Track reported and identified production issues in the registry established in Objective 5.3.1.

○ Objective 7.2.2 - Mitigate any participant migration blocking bugs and/or issues identified during the nationwide launch of the PPSC enterprise.

● Objective 7.3 - Review and finalize the participant migration plan and proposed timeline approved in Objective 8.1.2, with NIH and program partners, in preparation for the migration of participants from legacy All of Us platforms to the PPSC enterprise.

Milestone 8 - Participant Migration from Legacy All of Us Portal Platforms (Month 9-15)

● Objective 8.1 - Develop a plan for the phased migration of approximately 800,000 participant accounts and data from two independent legacy All of Us systems to the PPSC enterprise, including but not limited to, profile and communications preferences, consent forms and status, task completion status, survey responses, communications and user engagement data, etc.

○ Objective 8.1.1 - Coordinate migration requirements development, planning, pre-testing, monitoring and evaluation processes, and timeline projections with NIH and program partners, including, but not limited to, PTSC, TPC, and DRC.

○ Objective 8.1.2 - Support the development of a comprehensive multi-channel participant communications campaign, in collaboration with the NIH and program communications partners, which aims to reach all consented participants and ensure successful migration of participant accounts and restoration of access on the PPSC enterprise.

○ Objective 8.1.3 - Review the proposed participant account migration plan and pre-testing results with the Program Officer (and/or designees) and Chief Technology Officer for approval.

○ Objective 8.1.4 - Review the proposed plan for participant migration communications with the Program Officer (and/or designees) and Chief Communications Officer (and/or designees).

● Objective 8.2 - Implement the plan approved in Objective 8.1.3 for a phased migration of participant accounts and data from legacy All of Us systems to the PPSC enterprise.

○ Objective 8.2.1 - Monitor and evaluate participant account and data migration progress and success in collaboration with NIH and program partners.

○ Objective 8.2.2 - Track reported and identified participant migration errors in the registry established in Objective 5.3.1.

○ Objective 8.2.3 - Mitigate any participant migration errors to restore any account data and/or resolve access.

● Objective 8.3 - Implement the plan approved in Objective 8.1.4 for participant communications to support participant informedness and successful transition from legacy All of Us systems to the PPSC enterprise participant portal platform.

○ Objective 8.3.1 - Monitor campaign performance and outcomes across all communications channels and methods, and track successful account logins and access of the PPSC participant portal platform by participants in collaboration with NIH and program partners.

○ Objective 8.3.2 - Track reported and identified participant access issues and follow-up to successful resolution in collaboration with program partners, including the All of Us Support Center.

SECTION 6: ELIGIBILITY INFORMATION

The following entities are eligible to apply.

6.1 For-Profits

For-profit organizations may submit proposals under this ROA:

● Small Businesses

● For-Profit Organizations (Other than Small Business)

6.2 Higher Education

All higher education institutions may submit proposals under this ROA:

● Public/State Controlled Institutions of Higher Education

● Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

● Hispanic Serving Institutions

● Historically Black Colleges and Universities (HBCUs)

● Tribal Colleges and Universities (TCUs)

● Alaska Native and Native Hawaiian Serving Institutions

● American Indian and Alaska Native Serving Institutions

● Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

6.3 Nonprofits

Nonprofits other than Institutions of Higher Education may submit proposals under this ROA:

● Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)

● Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

● Faith-based or Community-based Organizations

● Regional Organizations

● Independent School Districts

● State or County Governments

● Indian/Native American Tribal Governments (Federally Recognized)

● Indian/Native American Tribal Governments (Other than Federally Recognized)

● Native American Tribal or Urban Indian Organizations

● City or Township Governments

● Special District Governments

● Public Housing Authorities/Indian Housing Authorities

6.4 Non-Eligible Entities

● Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

● Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

● Foreign components engaged in research or systems security operations are not allowed. Foreign components shall not be permitted access to participant data, production data systems, or environments. Foreign components are defined as those responsible for performance of any significant element or segment of the project outside of the United States either by the award recipient or by an individual employed by a foreign organization whether or not award funds are expended.

SECT…