October 23, 2024
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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 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 participants 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 Programs 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:
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:
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 Biobanks 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:
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:
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:
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:
Proposals are not being solicited at this time.
Please direct all inquiries to:
Subject: All of Us Biobank (NOT-PM-25-001)