Key Dates

Related Announcements

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Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

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 proposals that can maintain the existing All of Us Biobank and continue to expand it to support the collection, processing, storage, access and distribution of high quality and diverse de-identified biospecimens, which can be used to address a wide range of scientific questions to promote the acceleration of health research, medical breakthroughs, and improve public health. The ROA is expected to be published in November 2024, and will be available via www.sam.gov. NIH acceptance of proposals will depend on the timeframe outlined in the published opportunity announcement but is estimated to be December 2024. The goal is to make a single award as early as May 2025. The anticipated award 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 facilities and logistical services networks must be capable of securely maintaining and storing over the approximately 14 million existing participant’s aliquoted samples, processing up to 1,500 daily participant collections across the nation, integrating with All of Us platform partners, protocol configuration, cross platform testing, staff training, and production launch of all biospecimen related workflows and supporting efforts within 12 months from the time of the award.

This Notice is being provided 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, Notice of Funding Opportunity, 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 and biospecimens from 1 million or more 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 has created a national research resource to inform thousands of studies, covering a wide variety of health conditions. Researchers use data and biospecimens 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)  adults 65 years of age and above; 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 840,000 adult participants since 2017, with close to 600,000 providing biospecimens.  In order to accomplish the goal of enrolling 1 million or more participants from diverse backgrounds, the program has 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). Participants nationwide can complete initial protocol activities and provide biospecimens remotely, through blood and saliva kit-based workflows, 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 the use of FDA-approved home biospecimen collection devices, custom-designed biospecimen collection kits mailed directly to participants’ homes, 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 Biobank ROA is to solicit proposals that can maintain the existing biobank and continue to expand the All of Us Biobank to support the biospecimen collections, processes, workflows, methods, services, long-term storage, access and distribution of high-quality diverse biospecimens leading to the generation and dissemination of data derived from these samples. The Program seeks partners that have the capacity and capabilities to provide essential support for program objectives to:

• Provide established collection kits, bulk biospecimen collection supplies, and daily domestic sample courier and carrier shipment logistics across 50 states and U.S. territories to ensure specimens arrive and are processed in the most expedient, efficient, and safe manner possible, in accordance with all federal and state regulations
• Establish and maintain state-of-the-art laboratory and IT infrastructure, including secure data connections with other applicable All of Us partners, capable of supporting on average 800-1,200 participant collections per day (1,500 participant collections per day burst capacity including redundancy), with highly automated and scalable workflows to meet the program’s demand for processing, labeling, aliquoting, storing, and distributing high-quality and highly diverse biospecimens, all while adhering to established protocols and laboratory best practices
• Build out and refine scalable biospecimen workflows for pediatric populations, adult reassessment, recollection based on sample quality control (QC) and quality assurance (QA)  failures, and a variety of programmatically crucial ancillary studies
• Utilize a robust, high-quality, and secure laboratory information management system for detailed tracking of de-identified specimen receipt, processing, storage, retrieval, and distribution, while protecting participant confidentiality
• Implement a comprehensive Quality Management Program to ensure the highest standards in all processes, and safeguard the collection with robust backup systems, plans for disaster recovery, and a geographically dispersed secondary biospecimen storage location
• Work collaboratively with All of Us Research Program partners and other NIH research awardees to share biobanking expertise, biobanking specific infrastructure and data, and biospecimen access to advance the program’s goals

ROA Summary

The Biobank ROA will outline the requirements for three core aims described below. Proposers may propose partnerships within their proposal to meet research objectives and provide biobanking expertise across aims. The anticipated maximum award period is 5 years. NIH may commit up to $50 million in FY 2025 to fund 1 award with initial year one funding. Current and future year amounts will depend on annual appropriations. The ROA will be open to Higher Education Institutions (public and private), Non-profit Organizations, and For-profit Organizations (including small and large businesses).

Maintain Existing Biospecimen and Sustain Biobank Operations

When applicable, the proposer will be responsible for the transition from the existing biobank, including all scope, workflows, processes, and physical biospecimens. The existing Biobank has supported the All of Us Research Program in collecting, evaluating and processing 3.8 million primary biospecimen collections, including blood, urine, and saliva from eligible adults and children (birth to age 6). From these collections, over 14 million aliquoted samples have been prepared and processed, with a portion distributed for downstream analyses, and the remainder securely stored for future research access. NIH expects proposers to provide evidence and/or a virtual demonstration of their capabilities in potentially managing this transition, while maintaining long-term storage, and distribution of biospecimens at scale.

In addition, NIH requires the proposer to propose solutions for promptly adapting to the established biospecimen workflows of the Program, while ensuring the continuity and sustainability of biobanking operations. Support activities at scale should include, but are not limited to:

• Kit Provisioning: Provide customized kits and prepaid return mailers for remote biospecimen collection-- ensuring efficient package shipping, receiving, and processing to meet program demands.
• Biospecimen Logistics: Develop and implement biospecimen pick-up and shipment logistics for both self-guided participants, as well as those associated with Health care Provider Organization enrollment centers, that are scalable and compliant with the All of Us core protocol.
• Biospecimen Processing: Process biospecimens using established protocols to produce high-quality materials suitable for subsequent analysis, while preserving their biological properties.
• Storage and Facility Maintenance: Store biospecimens under optimal conditions to minimize loss, damage, or contamination; Maintain storage facilities that comply with safety, biohazard containment guidelines, and all applicable federal, state, and local regulations; and Ensure the mechanical functioning of freezers and other storage equipment, including alarm and back-up systems, for disaster recovery.
• Data Management and Security: Maintain high-quality, robust, and secure information systems for tracking sample receipt, processing, storage, and distribution; Ensure accurate data entry and database maintenance, with rapid retrieval capabilities for biospecimens and their associated metadata; and Protect research participant confidentiality, providing security and backup systems.
• Coordination and Quality Assurance: Work closely with the Data and Research Center (DRC) to link biospecimens with associated metadata located at the enrollment centers; and Execute all tasks with rigorous QC/QA programs, ensuring the highest standards in every aspect of biospecimen management.

Biobank Expansion: Pediatric, Reassessment, and Ancillary Studies

The All of Us Research Program anticipates iterative enhancements, integrations, potential replacements or establishments of new biospecimen-related workflows, processes and pipelines to further support the expanding scope of the program. NIH seeks proposers capable of innovating and applying novel or emerging technologies, techniques, and processes to further scale and expand the Biobank’s capabilities in three distinct programmatic areas described below.

Pediatrics

In late 2023, the All of Us Research Program embarked on an exciting new milestone by opening limited enrollment to pediatric participants for the first time in its 5+ year history. Currently, the program has established biospecimen collection workflows for the pediatric participants from birth to 6 years of age. NIH seeks proposers who cannot only leverage these existing protocols and workflows, but also develop new methods, workflows, and standard operating protocols (SOPs) for the pediatric age groups of 7 to 12 and 13 to adult. The team(s) awarded under this ROA will provide essential support for pediatric program objectives to:

• Develop and evaluate pediatric biospecimen collection devices and methods for blood, saliva, and urine, while ensuring age and weight parameters and procedural safety are of paramount importance.
• Establish dedicated logistical workflows specific to pediatric participants, ensuring the collection and storage of high-quality biospecimens.
• Work closely with NIH All of Us Pediatric program staff to create detailed pediatric SOPs, covering biospecimen collection methods, the number and types of collection tubes, and the frequency of collections tailored to each age and weight group.
• Continuously monitor and assess the quality of pediatric biospecimen collections, promptly identifying issues and implementing effective solutions.
• Support the program in managing the complexities of collecting, shipping, processing, and storing biospecimens under diverse conditions.
• Efficiently manage high demand and rapidly adapt to changing priorities within the program.
• Innovate and refine biospecimen collection strategies to meet the evolving needs of pediatric research.
• Uphold the highest standards in pediatric research to ensure the safety, integrity, and success of the program.

Adult Participant Reassessment

One important attribute of the All of Us Research Program is the longitudinal nature of the cohort design. The ability to follow-up with participants over time while collecting structured time-series data and biospecimens increases the scientific utility of the data and biospecimen resources, and allows for myriad research questions to be interrogated. The team(s) awarded under this ROA will play a pivotal role in supporting the program objectives to:

• Develop a comprehensive framework for adult specific biospecimen reassessment, detailing the types of biospecimens to be collected, collection methods, volumes, and frequencies.
• Evaluate and identify remote biospecimen collection devices that ensure high-quality specimen collection and logistics, while optimizing cost-effectiveness.
• Innovate and implement new collection methods to broaden the reach of biospecimen collection and enhance the depth and diversity of the biospecimen resource.
• Assess the feasibility, suitability, and utility of collection devices across the diverse adult cohort, ensuring alignment with programmatic objectives and goals.
• Design scalable and flexible workflows to ensure efficient, high-throughput processing, storage, and access to biospecimens.
• Collaborate closely with other program partners to ensure biospecimen-related metadata is accurately collected, annotated, curated, and securely transmitted to the All of Us Data Research Center (DRC) through a high-capacity, near real-time data exchange system.

Ancillary Studies

Since 2021, the All of Us Research Program has a new capacity - Ancillary studies, which are partnered, supplemental projects that build upon and/or expand All of Us data, participants, biospecimens, and other resources by supporting new research avenues conducted and data generated under the auspices of the program. This expansion of the program provides opportunities for scientific investigators to engage the historic, longitudinal, and diverse All of Us participant cohort and address impactful scientific objectives with novel tools and data. As such, the Biobank program will expand its scope to meet the rigorous demands of modern scientific advancements in the dynamic realm of biomedical research. To support this expanded scope, the team(s) awarded under this ROA will collaborate and support diverse ancillary studies in support the program objectives, including but not limited to:

• Expand Biobank Research and Development (R&D) efforts to support a wide range of ancillary studies, necessitating comprehensive R&D development and active involvement within the broader ancillary studies framework
• Enhance the Application Programming Interface (API) between the Biobank’s Laboratory Information Management System (LIMS) and the DRC to better support researchers in study design and sample selection.
• Integrate and consolidate data across program partners to create a comprehensive dataset that bolsters robust biomedical research.
• Innovate and refine biospecimen processing, storage, and distribution strategies and workflows to ensure seamless alignment with the highest standards of modern biomedical research.
• Advance biospecimen processing pipelines to meet the complex requirements of cutting-edge multi-omics technologies.
• Improve and expand access to high-quality biospecimens for biomedical research communities.

Collaboration and Support

Additional supportive and collaborative efforts and activities are expected to ensure that the proposers both reactively and proactively meet the various demands and requirements of the All of Us Research Program, including but not limited to the following:

• Biobank Dashboards: The proposer is expected to develop and maintain robust IT dashboards, which provide real-time monitoring and analytics of all aspects of the biospecimen workflow, including collection, processing, quality control, storage, and distribution activities. These dashboards should integrate seamlessly with existing data systems and offer user-friendly interfaces for tracking key performance indicators, ensuring transparency, and facilitating decision-making processes across the program.
• API with Other Partners: To enable seamless data exchange and collaboration, the proposer must establish and maintain Application Programming Interfaces (APIs) with other relevant All of Us program partners. These APIs should be designed to ensure secure, efficient, high capacity, and accurate transfer of data, supporting integrated workflows and enhancing the overall efficiency of biospecimen management across various collection sites.
• Training: The proposer is responsible for providing comprehensive training programs tailored to the specific needs of the collection workflows, methods, and logistics. These training initiatives should equip All of Us staff across all partner sites with the necessary knowledge and skills to implement biospecimen collection workflows in accordance with the program's standards, ensuring consistency and quality in every step of the process.
• Development of Documents: The proposer must develop and maintain a suite of essential documents, including Standard Operating Procedures (SOPs), incident reports, and Material Transfer Agreements (MTAs). These documents are critical to ensuring standardized operations, effective incident management, and the legal and ethical transfer of biospecimens between entities, thereby upholding the integrity and reliability of the program's operations.

Proposals are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Subject: All of Us Biobank (NOT-PM-25-001)

Email: [email protected]