ROA OTA-23-002 Frequently Asked Questions dated 18 January 2023.pdf

18 January 2023 All of Us Participant and Partner Services Center (OTA-23-002) - Frequently Asked Questions

Question 1.

Will the Participant and Partner Services Center (PPSC) award replace existing All of Us Research Program awards and systems?

Response 1.

The milestones in year 1 of the PPSC 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.

Question 2.

Are for-profit entities and small businesses eligible for the Participant and Partner Services Center (PPSC) award?

Response 2.

The award is open to all entities listed in the ROA Section 6: Eligibility Information, including for-profit organizations and small businesses. There is no specific set-aside for small businesses in this award.

Question 3.

Are applicants expected or required to apply for both cores of the Participant and Partner Services Center (PPSC) Research Opportunity Announcement?

Response 3.

Offerors may apply to support one or both cores, depending on their organizations’ specific capabilities. An organization is limited to a single submission, but may be included as a collaborating partner on more than one application.

Offerors are encouraged to propose partnerships within their proposal to provide research services and technology expertise across cores within a single award. 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.

Question 4.

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

Will the program provide potential collaborating partners for applicants?

Response 4.

No. Applicants are encouraged to seek out collaborating partners that they are confident they can work with well. Offerors may apply to support one or both cores, depending on their organizations’ specific capabilities.

Question 5.

In general, what is the program expecting from the Participant and Partner Services Center (PPSC) award?

Response 5.

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.

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

○ 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.

Question 6.

Is the Participant and Partner Services Center (PPSC) award expected to implement and manage the participant consent process?

Response 6.

Yes, the PPSC will implement the program's digital consent experiences presented to participants. Additionally, the PPSC will support the program to conceptualize, implement, and manage scalable multimodal methods and services to expand access and support preferences for program participation among potential and existing participants.

Question 7.

Is the All of Us Research Program planning to support pediatric enrollment in the cohort?

Response 7.

Yes. Dr. Sara Van Driest recently joined the All of Us Research Program to lead pediatric efforts as our Director of Pediatrics, and the program intends to begin work immediately to enable child enrollment over the next year.

Question 8.

What are the training needs and related expectations for the Participant and Partner Services Center (PPSC) to provide training for All of Us Research Program awardee partners and staff?

Response 8.

Approximately 800-1,000 trained program staff are actively supporting program delivery across 60 or more partner organizations and over 300 partner facilities nationwide. An initial role-based training program will be required for all users of PPSC-deployed systems. Protocol updates, platform enhancements, and staff turnover will require a commitment to continuously maintained and available training resources for program staff.

Question 9.

What are the security requirements for the Participant and Partner Services Center (PPSC) awardee and platform?

Response 9.

Maintaining the trust of All of Us participants and ensuring the security of their data are essential elements of the program. All partners in the All of Us Research Program are required to adhere to the policies and procedures to maintain compliance with the following All of Us Research Program principles.

● Precision Medicine Initiative: Data Security Policy Principles and Framework

● Precision Medicine Initiative: Privacy and Trust Principles

The awardee(s) will work closely with the All of Us Research Program DRC, external providers of data, and may work with other program partners to support secure transfer of data and tools. Applicants for the PPSC must describe their organizations’ information technology (IT) platform, approach to data security, and prior experience with the security requirements described earlier and below. Technical details that will enable secure and reliable data exchange with the program partners (e.g., DRC) and external providers of data will be provided.

https://allofus.nih.gov/news-events/announcements/nihs-all-us-research-program-selects-first-director-pediatrics https://allofus.nih.gov/protecting-data-and-privacy/precision-medicine-initiative-data-security-policy-principles-and-framework-overview https://allofus.nih.gov/protecting-data-and-privacy/precision-medicine-initiative-privacy-and-trust-principles

All of Us will require the awardee(s) to describe how it will design and implement technical and policy safeguards necessary to ensure data security, as required to comply with the Precision Medicine Initiative Security Policy Principles and Framework.

Awardees are expected to understand and apply guidelines from the National Institute of Standards and Technology (NIST) for meeting Federal Information Security Management Act (FISMA) Moderate requirements. Prior to system use and interconnection with the All of Us Research Program, an Authorization to Operate (ATO) from NIH will be required along with documentation describing the current security monitoring and practices in place in accordance with FISMA review standards.

Awardee(s) should be prepared to follow the NIST Risk Management Framework and comply with the All of Us Security Authorization Process to meet security compliance.

Additionally, awardee(s) must adhere to continuous monitoring policies that include monthly reporting of asset inventory, account management reporting, training and awareness, incident response, configuration change, and risk management.

Question 10.

What are the All of Us Research Program expectations for the new Participant and Partner Services Center (PPSC) system to migrate legacy platform data?

Response 10.

Account migrations will be implemented following successful production launch and transition of all new enrollments to the PPSC platform. The program will expect migration of all account data for participants, which is projected to be between 800,000 to 1,000,000 accounts at the time of migration.

Question 11.

What is the approximate size of the datasets maintained by the existing Participant Technology Systems Center (PTSC) and the Participant Center (TPC) platforms currently supporting the program? What are the current data structures (relational, NoSQL, Object storage, search indexes, etc.?)

Response 11.

This information will be provided in detail in a later phase of the competition process.

Question 12.

Who are the existing All of Us Research Program partners that the Participant and Partner Services Center (PPSC) awardee will need to integrate with?

Response 12.

A list of program partners is available on our website. Information on necessary integration partners and endpoints will be provided in detail in a later phase of the competition process.

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

Question 13.

Is there a list of mobile and wearable devices that the All of Us Research Program will want the awardee to support distribution and integrate with?

Response 13.

This information will be provided in detail later in a later phase of the competition process. For awareness, the current All of Us Research Program protocol supports participant authorization and data ingestion from Fitbit, Apple Health, and Google Fit platforms and accounts.

Question 14.

For Account and Identity Management – is there a requirement for integration with Federal systems such as Login.gov or NIH services?

Response 14.

There is no required integration with NIH or federal services, such as Login.gov. The All of Us Research Program is in the process of integrating an identity verification service to support program requirements for some protocol activities, and the awardee will need to support this capability or offer a viable alternative for ID proofing.

Question 15.

Is there an expectation that the Participant and Partner Services Center (PPSC) award will manage the Electronic Health Records provided to the program by partner Health Provider Organizations (HPO)?

Response 15.

No, this is currently not in scope for the PPSC award. The HPO partner sites will continue to work directly with the DRC to share EHR data at this time.

Question 16.

Is there an expectation that the Participant and Partner Services Center (PPSC) awardee will support bi-directional flow of data with the other technology partners of the program?

Response 16.

Yes. Many operational processes for the All of Us Research Program require transactional data exchange directly between program partner data systems. In addition, the program wants participants to have access to the data that it collects from or associated with them.

In some cases, this will require providing participants data directly collected by the PPSC systems. In other cases, the PPSC will be sharing data or providing access to information collected or generated in program partner systems, such as return of physical measurements collection during in-person visits or return of genomics results through integration with the All of Us Genetic Counseling Resource (GCR).

Question 17.

Are the All of Us Research Program Participant and Partner Services Center (PPSC) and the Center for Linkage and Acquisition of Data (CLAD) opportunities linked in any way?

Response 17.

The PPSC and CLAD are independent program opportunities. Please see NOT-PM-23- 002 for more details on CLAD.

Question 18.

Are the All of Us Research Program’s current participant platforms hosted in the cloud?

Do you have a preferred cloud vendor?

Response 18.

The existing participant and study staff applications and platforms supported under the Participant Technology Systems Center (PTSC) and the Participant Center (TPC) awards are hosted and managed using the Amazon Web Services platform. The program currently hosts all Data and Research Center (DRC) platforms, data and analytic tools on Google Cloud Services, and is in the process of expanding to support Azure and Amazon Web Services.

Awardees are not limited in their choice of cloud provider and are welcome to work with whichever vendor they prefer. Fluency in the different cloud providers is worth noting within your application.

Question 19.

Will the Participant and Partner Services Center (PPSC) award be expected to aggregate and deliver participant data to researchers?

Response 19.

No, the responsibility for developing, supporting and maintaining researcher platforms, data, and access is managed by the Data and Research Center (DRC).

Question 20.

What are some new data types that the All of Us Research Program is hoping to collect in the future?

Response 20.

https://allofus.nih.gov/funding-and-program-partners/genomics-partners https://grants.nih.gov/grants/guide/notice-files/NOT-PM-23-002.html https://grants.nih.gov/grants/guide/notice-files/NOT-PM-23-002.html https://allofus.nih.gov/funding-and-program-partners/participant-technology-systems-center https://allofus.nih.gov/funding-and-program-partners/participant-center

The program is working to finalize a scientific roadmap that will help provide clarity on when and what types of new data we aim to collect directly, generate, or link using privacy preserving methods. We also anticipate that a significant amount of data will be collected through ancillary studies, working in collaboration with other institutes and centers of the NIH.

Question 21.

Is the All of Us Research Program collecting biosamples anywhere in addition to on-site collections at health provider organization partners?

Response 21.

The existing protocol and program partnerships provide the opportunity to send a home saliva collection or blood collection kit to participants via mail. Home saliva collections are returned to the biobank using United States Post Office (USPS) services. Participants requesting blood collection kits are required to schedule an appointment and bring their collection kit to a partner clinical laboratory site which conducts the collection protocol.

The partnerships, cost of the collection kits, and shipping are covered under existing All of Us awards and do not need to be budgeted by the PPSC. The PPSC will be required to integrate with the program’s kit fulfillment and clinical collection partners to facilitate kit ordering, tracking, participant communications, and appointment scheduling in the context of blood collections. Additional details regarding integration requirements and partners will be provided in detail in a later phase of the competition process.

Question 22.

Is the All of Us Research Program open to using existing commercial or research platforms to support delivery of the requested Participant and Partner Services Center capabilities?

Response 22.

The program seeks partners who can provide the requested PPSC 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. The program is open to and encourages using existing commercial and research platforms as components of the PPSC solution to accelerate readiness. Proposed systems must have an existing set of capabilities that may not be complete, but can be tailored or enhanced to support the program’s specific needs during year 1 of the PPSC award.

Question 23.

How does the All of Us Research Program envision a transition process from the existing award to a new award?

Response 23.

The OT award milestones outlined in section 5.2 of the Participant and Partner Services Center Research Opportunity Announcement define the expectations for the PPSC onboarding, discovery, project planning, implementation, integration, training and testing, pilot, and full launch phases expected to be conducted over the first year of the PPSC award. Following successful production launch, the PPSC will transition existing participant user accounts from any legacy systems through a closely coordinated process with program partners.

Question 24.

Does the All of Us Research Program have existing technologies in place for Computer- Assisted Telephone Interviewing (CATI), Computer-Assisted Personal Interviewing (CAPI), Audio Computer-Assisted Self-Interviewing (ACASI), and Pencil and Paper Interviewing (PAPI) that we will integrate with, or will these need to be provided?

Response 24.

The All of Us Research Program currently offers CATI capabilities and services for participants. PPSC awardees will need to be capable of reproducing equivalent or enhanced tooling for CATI relative to the existing capabilities, and provide capacity to extend participant support to the additional assessment modes outlined in the PPSC Program Management and Delivery Core.

Question 25.

Will the All of Us Research Program restrict ancillary studies to be solely conducted in collaboration with NIH Institutes and Centers? Or is the program also open to other sources and proposals for ancillary study?

Response 25.

As a program, we are just beginning to expand our capacity for ancillary studies and as a result our current ancillary studies are collaborative projects with NIH institutes, centers, and offices. However, the program is working toward expansion of ancillary studies. One of those goals is to develop and launch a scalable ancillary studies program that expands the cohort and delivers additional phenotypic, lifestyle, environmental, and biologic data.

We anticipate that as we work toward that goal, we will establish the methods and processes that will allow a broad audience of researchers from academic, nonprofit, and for-profit organizations to propose and potentially support ancillary studies.

Question 26.

Is the awardee expected to interact with the program’s IRB for permission to provide experiences for participants?

Response 26.

Yes, in some cases the awardee may need to work with the All of Us Research Program IRB. The All of Us Research Program also has a Research Compliance Team that supports primary interactions with the IRB. The PPSC award should anticipate a close working relationship with the All of Us Research Compliance team and program partners when supporting requested capabilities including, but not limited to:

○ 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.

Question 27.

Is the Participant and Partner Services Center (PPSC) awardee expected to return information, like Electronic Health Records (EHR) to the participants?

Response 27.

Yes, All of Us Research Program is committed to sharing data with participants, including survey responses, Electronic Health Records (EHR), and more. In some cases, the return of information will be done by an integration with another program partner.

For example, the return of genomic data is supported through an integration with the All of Us Genetic Counseling Resource (GCR) partner, Color Health.

Question 28.

Will the Participant and Partner Services Center (PPSC) awardee innovate new data collection methods?

Response 28.

The first phase of the award will be to reestablish the existing protocol, but there will be future opportunities for the awardee to contribute to new data collection methods.

Question 29.

Does the All of Us Research Program have a definition for participant retention?

Response 29.

Yes. If necessary, this information will be provided in detail in a later phase of the competition process.

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