Rolling ROA_OTA-22-006_AMENDMENT 6_12-19-2023.docx.pdf

National Institutes of Health (NIH) Office of the Director (OD) All of Us Research Program

Research Opportunity Announcement (ROA):

All of Us Engagement, Communications, and Enrollment Partnerships

No. OTA-22-006 Issue Date: May 26, 2022

Amendments:

(See Section 11: Summary of Changes for details)

Amendment No. 1: June 2, 2022 Amendment No. 2: July 29, 2022 Amendment No. 3: October 4, 2022 Amendment No. 4: February 3, 2023 Amendment No. 5: May 18, 2023

Amendment No. 6: December 19, 2023

ROA No. OTA-22-006

AMENDMENT 6

TABLE OF CONTENTS

SECTION 1: RESEARCH OPPORTUNITY ANNOUNCEMENT INFORMATION 2

1.1 Purpose 2

1.2 Solicitation Overview 2

SECTION 2: ISSUING OFFICE AND POINTS OF CONTACT 5

2.1 Contact Information 5

2.2 Questions 5

2.3 Amendments 5

SECTION 3: AWARD INFORMATION 5

3.1 Award Type 5

3.1.1 Authority 5

3.2 Funding and Period of Performance 5

3.2.1 Anticipated Funding 5

3.2.2 Period of Performance 7

SECTION 4: PROGRAMMATIC BACKGROUND 7

SECTION 5: AREAS OF INTEREST 10

5.1 Area of Interest 1: Community, Participant and Provider Engagement, Enrollment and Retention

5.1.1a Background 10 5.1.1b Participant Enrollment Activities 11

5.1.2 Technical Objectives 11

5.1.3 Technical Approach 13

5.1.4 Other Requirements 14

5.2 Area of Interest 2: Engage researchers from diverse backgrounds, including those from underrepresented groups, to utilize the All of Us data resources to advance precision medicine 14

5.2.1 Background 14

5.2.2 Technical Objectives 15

5.2.3 Technical Approach 16

5.3 Area of Interest 3: Engagement with Tribal Nations, American Indian and Alaska Native populations, and Indigenous Communities 16

5.3.1 Background 16

5.3.2 Technical Objectives 17

5.3.3 Technical Approach 18

5.3.4 Other Requirements 19

SECTION 6: ELIGIBILITY INFORMATION 20

6.1 Higher Education 20

6.2 Nonprofits 20

6.3 For-Profits 20

6.4 Non-Eligible Entities 20

SECTION 7: OTHER REQUIREMENTS 21

7.1 Organization and Governance Structure 21

7.2 Data Security and Management 22

7.3 Privacy Provisions 22

7.4 Ownership of Data, Software, and Other Products 24

7.5 Human Subject Requirements 24

7.6 Termination/Expiration Requirement 24

7.7 Protests or Appeals 25

SECTION 8: PROPOSAL AND SUBMISSION INFORMATION 25

8.1 Pre-Submission Webinar 25

8.2 White Paper Submission Instructions 25

8.2.1 Key Dates/Deadlines for White Papers 25

8.2.2 White Paper Email Submission 25

8.2.3 White Paper Format 25

8.2.4 White Paper Content 26

8.2.5 Oral Presentation 27

8.3 Full Proposal Submission Instructions 28

8.3.1 Full Proposal Format 29

8.3.2 Full Proposal Content 29

SECTION 9: EVALUATION INFORMATION 31

9.1 White Paper Evaluation 31

9.1.1 White Paper Selection 32

9.2 Full Proposal Evaluation 33

9.2.1 Full Proposal Evaluation Criteria 34

9.2.2 Full Proposal Evaluation Rating 35

9.2.3 Cost/Price Evaluation 35

SECTION 10: DEFINITIONS AND ATTACHMENTS 35

10.1 Definition of Underrepresented in Biomedical Research 35

10.1.1 Represented in Biomedical Research (RBR) 35

10.1.2 Underrepresented in Biomedical Research (UBR) 35

10.1.2.1 Diversity Metrics 36

10.2 All of Us Program Definition of Disability 36

10.3 Terms and Conditions (Appendix A) 36

SECTION 11: SUMMARY OF CHANGES 36

Amendment No. 1: June 2, 2022 37 Amendment No. 2: July 29, 2022 38 Amendment No. 3: October 4, 2022 40

Amendment No. 5: May 18, 2023 51 Amendment No. 6: December 19, 2023 52

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, 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 will use data from the program to learn more about how individual differences in lifestyle, environment, and biological makeup can influence health and disease.

The purpose of this announcement is to fund organizations who can help All of Us build its cohort of volunteers who reflect the rich diversity of the United States and are actively engaged as partners. These funded organizations will help design and implement strategies to raise awareness of the program through community and health care provider organizations, drive increased enrollment of participants, foster regular communication with participants, and engage the research community to use the data being gathered.

1.2 Solicitation Overview

You are invited to submit a proposal in accordance with the requirements of this RESEARCH OPPORTUNITY ANNOUNCEMENT (ROA). A ROA is a method of solicitation that announces the anticipated availability of Other Transactions (OT) awards, a special type of legal instrument other than contracts, grants, or cooperative agreements. ROAs are general in nature, identifying areas of research interest, and shall only be used when meaningful proposals with varying technical/scientific approaches can be reasonably anticipated. This ROA will remain open for 3 years from its issue date, unless otherwise updated via an amendment, and includes multiple white paper submission due dates as referenced in section 8.2.1.

This solicitation contains multiple distinct Areas of Interest (AOIs). The AOIs may be revised and/or removed, and additional AOIs may be added, to meet programmatic objectives. All updates to the AOIs will be posted via a solicitation amendment as noted in section 2.3. Offers must be submitted per the instructions in Section 8, in response to one, or more, of the research AOIs contained in this ROA. The Statement of Work (SOW), including the specific technical requirements and performance specifications, shall be developed and proposed by the Proposer, not the Government.

Proposals are NOT evaluated against each other since they are not submitted in accordance with a common SOW issued by the Government. Instead, Technical Objectives are provided in the ROA that describe individual Areas of Interest in which the Government is interested. Proposals received in response to the ROA are evaluated in accordance with the evaluation criteria for the award specified in this announcement. The Government reserves the right to conduct discussions on all, some, one, or none of the proposals received in response to this ROA. If discussions are conducted, the All of Us Research Program reserves the right to suggest modifying, adding, or deleting milestones, decision points, research plans, processes, schedules, budget, or product. The Government also reserves the right to make awards without discussions. Additionally, the Government reserves the right to accept proposals in their entirety or to select only portions of proposals for award. Multiple awards are anticipated. The selection for award(s) under this ROA will be based upon the evaluation criteria, importance to the agency programs, and the availability of funds.

SECTION 2: ISSUING OFFICE AND POINTS OF

CONTACT

2.1 Contact Information

Agency:

National Institutes Health (NIH) 6710B Rockledge Drive, 4th Fl.

Bethesda, MD 20817

Program Name: All of Us Research Program

Opportunity Title: All of Us Engagement, Communications, and Enrollment Partnerships

Opportunity No.: OTA-22-006

Contact Information:

All of Us Awards Management Branch (AMB) Email: AOU-ROA@nih.gov

2.2 Questions

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

Questions must be submitted to the email address listed above, in section 2.1, at least 14 calendar days prior to the relevant white paper/full proposal deadline, and must include “ROA # OTA-22-006” in the subject line; if submitted less than 14 calendar days from a deadline they may not be answered, and the due date for submission of the white paper and/or full proposal will not be extended.

2.3 Amendments

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

You may sign up to follow the solicitation on SAM.gov to receive timely notifications whenever changes are made to this ROA.

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

https://allofus.nih.gov/funding-and-program-partners/funding-opportunities mailto:AOU-ROA@nih.gov https://sam.gov/content/opportunities https://allofus.nih.gov/funding-and-program-partners/funding-opportunities

SECTION 3: AWARD INFORMATION

3.1 Award Type

The funding instrument for anticipated awards 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 milestones during a specific timeframe, based on the requirements of the activity, to respond to the needs of the program and the desire to achieve maximum efficiency. OTs will allow the All of Us Research Program to effectively choose activities from among potential awardees to produce a comprehensive set of awardees that can deliver the goals of the program.

3.1.1 Authority

Anticipated OT awards 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

One or more awards per Area of Interest (AOI), as described in Section 5, are anticipated, subject to the limitations of fiscal year funding. A proposer may submit a proposal on more than one AOI. Funding amount varies based on the AOI. However, lower and higher cost efforts may be considered.

Approximate total funding by AOI, per award, per year. For AOIs that include multiple tasks, funding amounts per award, per year, will be based on proposing for all tasks, unless noted otherwise:

Table 1.

Area of Interest Approximate Funding Amount per Award, per Year Note: lower and higher cost efforts may be considered.

Area 1: Community, Participant and Provider Engagement, Enrollment and Retention

For Tasks 1, 4, 5 & 6 (note: max funding amount per award is based on responding to all tasks 1, 4,5 & 6 but excluding task 2)

Up to $1M

Area 1: Community, Participant and Provider Engagement, Enrollment and Retention

For Task 2 (note: must include Task 1 community/participant engagement when responding to Task 2)

Up to $6M

Area 2: Engage researchers from diverse backgrounds, including those from underrepresented groups, to utilize the All of Us data resources to advance precision medicine

Up to $1M

Area 3: Engagement with Tribal Nations, American Indian and Alaska Native populations, and Indigenous Communities

Up to $650K

3.2.2 Period of Performance

The period of performance of the anticipated award(s) will be a twelve (12) month base period, and may include up to four (4) twelve (12) month additional periods. The Government reserves the right to extend the period of performance beyond the five (5) year period. The estimated start date of selected projects is subject to the agreed upon date of final award and the availability of fiscal year (FY) funds.

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

SECTION 4: PROGRAMMATIC BACKGROUND

The All of Us Research Program is a historic effort to gather data over many years from at least 1 million people living in the United States, with the goal of accelerating health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. Unlike research studies that are focused on a specific disease or population, All of Us will serve as a national research resource to inform thousands of studies, covering a wide variety of health conditions. Researchers will use data from the program to learn more about how individual differences in lifestyle, environment, and biological makeup can influence health and disease. Participants may be able to learn more about their own health and contribute to an effort that may advance the health of generations to come.

The NIH solicits proposals from organizations to serve as outreach, engagement, enrollment, and retention partners for the All of Us Research Program (Table 1). To ensure that the All of Us data reflects the diversity of the country, the program needs to mobilize and collaborate with trusted organizations, intermediaries, and influencers to engage and facilitate enrollment and retention of communities that are Underrepresented in Biomedical Research (UBR), with a special emphasis on communities that are not currently able the enroll. The engagement of these communities is essential for the program to meet the 21st Century Cures Act requirement to “consider the diversity of the cohort to ensure inclusion of a broad range of participants, including consideration of biological, social, and other determinants of health that contribute to health disparities.”

The All of Us Research Program is defined by impactful engagement – a bidirectional, co-equal relationship between the program and its participants. According to the Principles of Community Engagement (2nd Edition), NIH Publications No. 11-7782, community engagement is “the process of working collaboratively with and through groups of people affiliated by geographic proximity, special interest, or similar situations to address issues affecting the well-being of those people.” Community engagement requires integrating many theories, concepts, models, and principles from various areas, including sociology, cultural anthropology, psychology, health behavior, intersectionality, community-based participatory research, and communications. Well-planned community engagement has the potential to improve research quality and increase the relevance of research results to intended communities. Through authentic community engagement, the program has the opportunity to develop trust with communities, and create messages, mediums, and methods that will resonate with diverse communities, which could be applied to promote enrollment, retention, and return of information to participants.

Outreach, engagement, enrollment, and retention partners collaborate with other program awardees and divisions to involve UBR communities using engagement, outreach, enrollment, and retention strategies and tactics. These partners share the concerns of their communities with the program, which helps the program develop trustworthiness with communities with justifiable distrust of the research enterprise and to assist people in making informed decisions about participation. To help deliver on the promise of All of Us, the program has a national network of trusted community organizations to motivate diverse https://www.atsdr.cdc.gov/communityengagement/pdf/PCE_Report_508_FINAL.pdf https://www.atsdr.cdc.gov/communityengagement/pdf/PCE_Report_508_FINAL.pdf communities to enroll and remain engaged. The program is committed to ensuring that participant perspectives are considered throughout every aspect of the program and giving a voice to those who are historically underrepresented in medical research. This network of organizations helps ensure those voices are heard.

The program plans to implement five goals over the next five years:

1. Enrollment and retention

2. Gathering and curating data and specimens via the core protocol

3. Ancillary studies

4. Researcher access and impact

5. Participant return of value

Partnerships with national and community engagement organizations positions the program to understand the necessary engagement and outreach strategies for increasing involvement of UBR communities over many years. Through these engagements, we will aim to co-develop promising strategies to engage and manage relationships with a diverse set of participants. The program expects this will improve the quality and relevance of the data resources, and support the development of more customized prevention, diagnosis, and treatment strategies that may help alleviate health disparities.

By continuing to engage, enroll, and retain participants from UBR communities, the program will be well-positioned to contribute to the body of knowledge supporting the science of community engagement. This includes identifying evidence-based, promising practices and guidance for developing a bidirectional, co-equal relationship between the program and its participants to improve research quality and increase the relevance of research results to intended communities. This body of knowledge could also lead to a better understanding of engaging diverse community stakeholders who are not often involved in NIH biomedical research and how to form bidirectional relationships and trust that are critical to sustaining participation in biomedical research among UBR communities, which could serve as a roadmap for future cohorts.

Proposers should become familiar with the program by visiting the following websites:

● Program overview: https://allofus.nih.gov/

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

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

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

Further Background Information About Relevant Previous OT and Program Awardees:

● OTA-20-009: All of Us Research Program - National, State, and Local Engagement Partner Funding Opportunity (OT2)

● OT-PM-17-002: All of Us Research Program Engagement Partners (OT2)

● NOT-PM-18-001: Notice of Limited Competition: All of Us Research Program Regional https://allofus.nih.gov/ https://www.joinallofus.org/ https://www.researchallofus.org/ https://allofus.nih.gov/funding-and-program-partners https://allofus.nih.gov/sites/default/files/engagement_partner_funding_opportunity_rev.pdf https://allofus.nih.gov/sites/default/files/community-partner-fo.pdf https://grants.nih.gov/grants/guide/notice-files/NOT-PM-18-001.html

Medical Center Healthcare Provider Organizations (OT2)

● OT-PM-19-003: All of Us Research Program Engagement and Retention

Innovators (OT2)

● OT-PM-19-002: All of Us Research Program Communications and Marketing

Partners (OT2) https://allofus.nih.gov/sites/default/files/funding-opportunity-engagement-and-retention-innovators-ot2-2019.pdf https://allofus.nih.gov/sites/default/files/funding-opportunity-engagement-and-retention-innovators-ot2-2019.pdf https://allofus.nih.gov/sites/default/files/funding-opportunity-communications-and-marketing-partners-2019.pdf https://allofus.nih.gov/sites/default/files/funding-opportunity-communications-and-marketing-partners-2019.pdf

SECTION 5: AREAS OF INTEREST

The specific Areas of Interest (AOIs) are described below. White papers and subsequent proposals must address one or more of the following four Areas of Interest.

5.1 Area of Interest 1: Community, Participant and Provider Engagement, Enrollment and Retention

5.1.1a Background The purpose of community engagement is to mobilize and collaborate with trusted organizations, intermediaries, and influencers who will design strategies and tactics to engage and facilitate enrollment and retention of participants that reflect the diversity of the United States, including communities who are historically underrepresented in biomedical research (UBR). Additionally, the program engages health care providers who are well-positioned to speak with their patients and their peers about All of Us.

As a trusted group consulted by many potential participants about their health, health care providers are a crucial component of the program's engagement strategy. Engagement is built on principles that leverage strong community and provider partnerships, foster trust, embrace diverse perspectives, and inform all aspects of the All of Us Research Program.

5.1.1b Participant Enrollment Activities Enrollment activities should be focused on communities that are historically underrepresented in biomedical research to ensure reflection of the broad diversity of people living in the United States.

Enrollment and retention in the All of Us Research Program includes all of the steps along the participation pathway from consent to additional retention activities. Specifically, this includes primary consent, consent to sharing electronic health records (EHR), completion of the genomic return of information decision, ongoing completion of participant provided information (i.e., self-report surveys), physical measurement data collection, biosample collection (including blood, urine, and/or saliva if applicable), and additional programmatic activities as they become available. A solution for ongoing EHR data sharing is a required element for all Proposers focusing on enrollment. The expectation to be set at the time of enrollment is that of a true partnership and longitudinal participation with the program.

Regular communications to the participant about program updates to ensure continued engagement and contactability are necessary elements of this partnership.

5.1.2 Technical Objectives

1. Collaborate with All of Us consortium including other engagement and enrollment partners to implement, and evaluate community-specific engagement, enrollment, and retention strategies and tactics.

2. Enroll and retain adult and/or pediatric participants into the All of Us Research Program, performing physical evaluations, collecting biospecimens, and sharing electronic health record data.

3. Identify promising practices on outreach and engagement, enrollment, and retention activities and share practices with other engagement and enrollment partners

4. Mitigate limited digital access experienced by individuals who lack consistent access to computers and the internet to facilitate enrollment.

5. Engage health care providers who are well-positioned to educate, engage, and link their patients to All of Us enrollment partners and websites.

5.1.3 Technical Approach

Proposers have the option to address one or more task areas in their Technical Approach (unless the Proposer is responding to Task 2, in which case the Proposer must include Task 1):

Task 1: Conduct outreach and engagement activities to promote the enrollment of communities who are historically underrepresented in biomedical research, including minority racial and ethnic adult and/or pediatric populations.

Task 2: Engage, enroll, and retain one million or more adult and/or pediatric participants who reflect the rich diversity of the United States.

● Proposal(s) must include:

○ Diversity catchment area outlined in section 10.1 under Diversity Metrics.

○ A plan to develop and/or test the information technology (IT) and clinical infrastructure needed for specimen collection. Proposers should anticipate interactions with the Biobank and the Data and Research Center for this activity.

○ A description of the process for scheduling physical evaluation and biospecimen collection visits with participants.

○ A retention plan that indicates the amount of effort and type of activities that will be dedicated to retention-related efforts.

○ A plan on obtaining robust and comprehensive EHR data on participants. This plan must include how the Proposer will curate, format, and transfer data to the Data and Research Center (DRC), developing and testing the appropriate IT interfaces for this activity.

○ Provide well-defined engagement, enrollment, and retention milestones (# of participants proposing to enroll and retain) and define the metrics for measuring them.

○ As directed by the program, indicate commitment to develop a plan to identify strategies for collaboration with other engagement and enrollment partners and/ or consider partnership with local community health organizations with UBR populations.

Task 3: (retired; pediatrics now included in Tasks 1 and 2)

Task 4: Provide access to computers and internet to individuals with limited access to facilitate enrollment.

Task 5: Engage and collaborate with health care providers serving communities that are historically underrepresented in biomedical research (UBR) to facilitate enrollment and retention.

Task 6: Coordinate Visibility opportunities (speaking opportunities that afford the Program to increase awareness broadly to various audiences) and Partner management for engagement activities to increase program awareness and partnerships.

● Proposal must include:

○ Approach to visibility and Partnership management strategies

○ Coordination of all speaking opportunities and presentations at conferences or meetings and supporting relationship management of key partners..

○ Support on presentation development, talking points and briefing documents

○ Establishing collaborative relationships with a variety of federal agencies and community organizations.

○ Analysis and evaluation of outreach activities, including internal and external partnership.

○ Keep track of impacts and outcomes from speaking events that contribute to the overall Program goals.

5.1.4 Other Requirements

All awardees will be required to:

1. Collaborate with the All of Us consortium and other key stakeholders.

2. Assess the impact of their activities and identify promising practices.

3. Enter all program level data into the All of Us dashboards.

The following activities are excluded and not funded under the anticipated award(s):

1. Recruitment of individuals on tribal land as well as recruitment or engagement campaigns specific to individuals who live off tribal land and identify as American Indian or Alaska Native.

See Area of Interest 3, Tribal Engagement, below.

2. Providing monetary incentives for attending events.

3. Purchasing meals and refreshments for people attending events.

5.2 Area of Interest 2: Engage researchers from diverse backgrounds, including those from underrepresented groups, to utilize the All of Us data resources to advance precision medicine

5.2.1 Background

The All of Us Research Program is building a database to help transform the future of health research by equipping researchers with expansive health data from diverse populations, with a special focus on including groups historically underrepresented in biomedical research. Since the public launch of the All of Us Research Program in 2018, participant enrollment has increased steadily, making the All of Us Research Program one of the largest and most diverse datasets in the U.S. For current enrollment numbers and an overview of participant characteristics and types of data participants share with the program, please refer to the Data Snapshots tool on the All of Us Research Hub.

All of Us is working to advance health care and science by inviting researchers—from a diverse range of backgrounds and expertise—to explore the program’s data analysis platform, the All of Us Researcher Workbench. The All of Us Research Program is committed to diversity in research, from our participant cohort to our investigators. Diversity in researchers using the dataset determines not just who is using the analysis platform, but also how that platform is designed. Just as program participants are partners in designing the All of Us Research Program’s policies, diverse researchers are partners in designing the All of Us Research Hub. We are building programmatic tools with researchers, not for them. We believe that research should truly be for all of us, and that all of us are needed in the co-creation of the program’s dataset and the tools used to analyze it.

This award is designed to fund engagement partners who will establish strong collaborations to design, implement, and evaluate strategies geared toward engaging researchers from diverse backgrounds.

Engagement with broad researcher communities should be aimed at encouraging use of the All of Us Research Hub as well as soliciting feedback and insights from prospective and current users to inform resource and platform development and drive All of Us closer to building an inclusive ecosystem and an equitable platform. These strategies are meant to not only support researchers in their use of the All of Us Research Hub but also facilitate the needs of diverse researchers overall, creating both an infrastructure and an ecosystem that are co-developed with researchers from diverse backgrounds.

5.2.2 Technical Objectives

We invite Proposer(s) who can help the All of Us Research Program raise awareness about the Research Hub, engage with, and encourage diverse investigators to explore and utilize the Researcher Workbench at the local, regional, and/or national level. Each Proposer must be an expert from experienced organizations with a proven track record for engaging with researchers from diverse backgrounds, including but not limited to researchers: from racial/ethnic minority groups, from sexual/gender minority groups, and living with disability. Programmatic priority will be given to Proposers who have demonstrated experience and success in implementing unique programs to connect with individuals from diverse backgrounds, including those from groups historically underrepresented in the biomedical research workforce (reference: https://diversity.nih.gov/about-us/population-underrepresented).

New data and tools are being added to the Researcher Workbench regularly. Proposals must take into account and maintain flexibility with the current and planned future state of the Researcher Workbench infrastructure (e.g., data, tools) and accessibility, as outlined on researchallofus.org at the time of the proposal.

https://www.researchallofus.org/data-tools/data-snapshots/ https://diversity.nih.gov/about-us/population-underrepresented https://www.researchallofus.org/

5.2.3 Technical Approach

Proposer(s) must be prepared to work in close collaboration with other programmatic partners, awardees, and divisions within the All of Us Research Program consortium, especially those partners involved with the maintenance and development of the All of Us Research Hub.

Proposer(s) have the option to address one or more task areas in their Technical Approach:

Task 1: Create a network of trusted voices (e.g., universities, scientific organizations, and/or other professional societies) to raise awareness of the Research Hub and engage with diverse researchers on a nationwide scale.

● Proposer(s) must develop a plan to establish a network of organizations, and coordinate a series of network activities as part of a high-touch and high-tech outreach campaign to raise awareness about the All of Us Research Hub. Planned activities should aim to connect with prospective and current Workbench users and strengthen the diversity of the All of Us researcher cohort.

Task 2: Build research capacity for students, trainees, and fellows from diverse backgrounds to utilize the All of Us dataset.

● Proposer(s) must propose a mentorship program(s) to connect students, trainees, and fellows with established researchers on the All of Us Research Hub. Proposer(s) must develop educational tools, curricula, and other resources to support researchers to utilize the All of Us dataset, and propose ways to augment professional development and training opportunities.

Task 3: Promote team science by encouraging researchers from different disciplines and levels of formal training (including potentially citizen/community scientists) to work together to utilize the Research Hub for community-based research and health equity work.

● Proposer(s) must propose opportunities to incentivize collaborative research on the All of Us Researcher Workbench. For example, a Proposer may propose establishing mini-grant programs or networking opportunities for researchers to share resources.

The following activity is excluded and not funded under this award:

● Activities requiring infrastructure/platform changes to the Research Hub or Researcher

Workbench.

5.3 Area of Interest 3: Engagement with Tribal Nations, American Indian and Alaska Native populations, and Indigenous Communities

5.3.1 Background

All of Us is committed to advancing health equity by creating a demographically, geographically, and medically diverse cohort that prioritizes the engagement of groups that have been marginalized in biomedical research. Indigenous communities have been left out of research studies or have avoided participation due to harmful experiences in biomedical research that led to stigmatization and harm in Indigenous communities. The purpose of this area of interest is to fund community-engaged awardees who can build partnerships, resources, and strategies to engage Tribal Nations, American Indian and Alaska Native (AI/AN) populations including those residing in urban areas, and other Indigenous communities.

In this ROA, Tribes, Tribal Nations, American Indian and Alaska Native (AI/AN) populations residing in urban areas, and other Indigenous communities will collectively be referred to as AI/AN and Indigenous communities.

All of Us is working to build trust and support the development of resources required for Indigenous communities to participate and benefit from health research. The program aims to do that through expanding engagement and partnership with Tribal Nations, Tribal Colleges and Universities, AI/AN health, public health and urban organizations with a goal to accelerate health research in a non-stigmatizing way, advance responsible and community-led participation in the program, and encourage Indigenous researchers to conduct research. Through this mechanism, the program intends to establish a core of partners to achieve the following outcomes:

1. Extend All of Us activities to AI/AN and Indigenous communities including Tribal Organizations through tailored and culturally appropriate All of Us outreach.

2. Develop culturally appropriate communication assets and visibility that increase interest in All of Us.

3. Enhance education and awareness of precision medicine to increase the relevance of research benefits to Indigenous communities.

4. Increase capacity and capability to support Tribal partnerships and agreements.

5. Increase technical assistance for All of Us national and consortium partners working with AI/AN and Indigenous communities.

5.3.2 Technical Objectives

Proposer(s) are expected to strengthen partnership and engagement in research with AI/AN and Indigenous communities: fully utilizing all cultural and scientific knowledge, strengths, and competencies, such partnerships can lead to better understanding of the biological, behavioral, psychological, cultural, social, and economic factors either promoting or hindering the health status of AI/AN populations, and generate the development and evaluation of interventions to improve their health status. Appropriate engagement helps ensure that AI/AN and Indigenous communities have greater control over the research process, the scientific agenda and ensuring that any research pursued is a priority of the community.

Within the white paper, applicants must clearly identify and address areas of focus in one or more of the following strategic areas:

● Outreach and engagement to AI/AN and Indigenous communities

● Training and career development in research as it relates to precision medicine

● Education and culturally appropriate resource development for AI/AN populations and partners

● Research infrastructure and capacity building within AI/AN and Indigenous communities ensuring sustainability of precision medicine research

By involving the community in precision medicine research and integrating the training of researchers, the pool of investigators and the scientific knowledge of the communities can be increased. This approach benefits the communities in terms of research design and sustainability, by involving AI/AN and Indigenous communities in the research agenda for the proposed application. NIH is not limiting proposed projects to only Community Based Participatory Research (CBPR) projects.

5.3.3 Technical Approach

Proposer(s) have the option to address one or more task areas in their Technical Approach:

Task 1: Outreach and engagement to AI/AN and Indigenous communities.**

● Create pathways for Tribal partnerships and intergovernmental agreements

○ Development of resources for Tribal partnership agreements with Tribal Nations

○ Provide recommendations, approaches, strategies and best practices for developing partnerships with Tribal Nations

○ Awardees may provide research priorities or areas of interest communicated by

Tribal Nations

● Develop and pilot new or adapted processes in working with AI/AN and Indigenous communities to assess feasibility, acceptability, and scalability

● Develop and implement strategies for engaging AI/AN and Indigenous communities

● All outreach and engagement activities must adhere to the program’s commitment to respect Tribal sovereignty by only allowing recruitment on Tribal lands or active recruitment of Tribal citizens after it has been explicitly agreed to in writing by the Tribe’s governing body

● Engagement with AI/AN populations and Indigenous communities must be conducted in a community-engaged manner consistent with community requirements and informed by these at every step of the process. CBPR approaches are one way to ensure appropriate engagement with communities in research

**Importantly, recruitment, enrollment, and retention are not required elements.

Task 2: Training and career development in research as it relates to precision medicine:

● Create opportunities to enhance the cadre of scientists across all career stages engaged in health research focused on AI/AN and Indigenous communities

● Develop the training and career enhancement pathways of student and/or faculty research scientists across all career stages interested in addressing health research issues within AI/AN and Indigenous Communities

● Create career enhancement projects across all career stages to improve the research skills of investigators involved with AI/AN and Indigenous communities

Task 3: Education and culturally appropriate resource development for AI/AN and Indigenous populations and partners.

● Development of a suite of All of Us educational and resource materials to include focused messaging and information for interested AI/AN participants, researchers interested in working with AI/AN populations/communities, and consortium partners

Task 4: Research infrastructure and capacity building within AI/AN and Indigenous communities ensuring sustainability of precision medicine research.

● Awardee should support the research infrastructure development and capacity building within AI/AN and Indigenous communities

● Awardee should develop tools to support research from within the communities, as well as the long-term maintenance and evolution of their research agenda

● Identification of innovative engagement practices and tools that stimulate participant interest and strengthens Indigenous expertise in using research and data

Sharing research resources among existing NIH-supported investigators is strongly encouraged. As much as practicable, the awardee should seek to utilize existing core resources, including those that are supported by other NIH awards. Projects proposed do not have to be related to other projects included within the proposal. The possibility exists that one project could be funded while another project is not funded. Proposer(s) should note in the proposal when projects or parts are inextricably linked.

The following activities are excluded and not funded under the anticipated award(s):

1. Political campaigning or partisan activities

2. Providing monetary incentives for attending outreach, engagement and enrollment activities

3. Purchasing meals and refreshments for people attending events

4. Health care providers are not expected to enroll their patients into the All of Us Research

Program

5.3.4 Other Requirements

Letters of Support: If the Proposer(s) is working with Tribal Nations/Tribal governments then an appropriate letter of support must accompany the proposal. Letters of support are not required for the white paper submission, but will be required for the full proposal, if invited.

Letters of Support:

● Should specifically reference the proposal and approval of specific activities

● Proposals that include more than one Tribe or community or a consortium of Tribal

Nations or communities must provide proof of support from each Tribe or community where activities will occur

For more information on the All of Us Research Program Tribal Engagement, please visit our website at All of Us Tribal Engagement | All of Us Research Program | NIH https://allofus.nih.gov/about/diversity-and-inclusion/tribal-engagement https://allofus.nih.gov/about/diversity-and-inclusion/tribal-engagement

SECTION 6: ELIGIBILITY INFORMATION

The following entities are eligible to apply.

6.1 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)

6.2 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

6.3 For-Profits

● Small Businesses

● For-Profit Organizations (Other than Small Business)

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 are not allowed. 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.

SECTION 7: OTHER REQUIREMENTS

In addition to the stipulations below, awardees will be expected to comply with all relevant Federal, State, and local laws and regulations, and program policies.

7.1 Organization and Governance Structure

The All of Us Research Program functions as a consortium, with all awardees considered members.

Under the present structure, the program establishes committees, task forces, and boards to help oversee the development and implementation of consortium activities. The governance structure may change periodically to meet the evolving needs of the program. Awardee personnel may hold specific roles in program governance structure based on their role in their institution’s program activities. For example, the All of Us Research Program Steering Committee currently consists of the contact Program Directors/Principal Investigators (PDs/PIs) from all aspects of the awards. The All of Us Research Program consortium includes participant representatives throughout its governance structure. The All of Us Research Program has a single Institutional Review Board (IRB) that ensures prompt and thoughtful consideration of the evolving protocols and the central importance of participants as research partners in the All of Us Research Program. The single IRB includes representatives from the participant community. Each awardee will be required to either agree to an existing IRB reliance agreement with the program or establish a new IRB reliance agreement, depending on program requirements.

7.2 Data Security and Management

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

7.3 Privacy Provisions

The All of Us requires awardees to work with the program and relevant stakeholders to develop a privacy plan within six (6) months of the award based on the Precision Medicine Initiative (PMI):

Privacy and Trust Principles. The plan shall describe how the awardee will design and implement privacy controls and policy safeguards necessary to ensure secure data sharing, access, and use and data quality and integrity congruent with the PMI Privacy and Trust Principles and, where applicable, how they will comply with privacy requirements established in the Common Rule, the Public Health Service Act, the 21st Century Cures Act, the Health Information Technology for Economic and Clinical Health 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 https://allofus.nih.gov/protecting-data-and-privacy/precision-medicine-initiative-privacy-and-trust-principles https://allofus.nih.gov/protecting-data-and-privacy/precision-medicine-initiative-privacy-and-trust-principles

(HITECH), the Health Insurance Portability and Accountability Act of 1996 (HIPAA), including relevant supporting regulations, and agency and program policies.

All of Us, through the Policy Director and in coordination with the Privacy Officer and Program Officer, may require additional privacy measures not included in the PMI Privacy Trust Principles. The All of Us Research Program will regularly monitor compliance with the privacy plan and any new privacy requirements as specified by the program and agreed upon by the awardee.

The awardee will reach agreement with All of Us on requested terms, scope, and timing of privacy reviews. Failure to reach an agreement within the timeframe designated by the NIH may lead to termination of the OT award.

7.4 Ownership of Data, Software, and Other Products

Terms and conditions of Data Ownership are set forth in Appendix A.

In recognizing that Tribal governments are legally sovereign nations, potential partners should be informed that Tribal Nations may seek ownership or control of data and biological samples; therefore, the All of Us Research Program is prepared to negotiate data sharing and biological sample sharing agreements with Tribal governments as appropriate for its members.

7.5 Human Subject Requirements

The institution and personnel involved in the conduct of the research must comply with all applicable requirements of 45 CFR Part 46 and establish a reliance agreement with the All of Us Research Program central IRB, unless otherwise excepted. The NIH will issue all awardees a Certificate of Confidentiality to allow the awardees to assist in the protection of All of Us participant data and to support and defend the authority of the Certificate against legal challenges, per this Notice. Awardees may be subject to additional compliance requirements for the protection of human research participants not explicitly listed here, depending on the type of organization, the data and information to which they may have access, and other contextual specifics.

7.6 Termination/Expiration Requirement

A fundamental objective of these anticipated Other Transactions award(s) is to ensure that all specimens and data remain available without interruption to the research public, even in the event that awardees withdraw, are terminated, or can otherwise no longer manage the project. Upon termination or expiration of this OT award, NIH may take exclusive ownership, custody, and control of the resources generated by the All of Us Research Program, including specimens, data, and software, at its reasonable discretion.

For purposes of this solicitation, “exclusive custody and control” means that upon termination or expiration of this award, the departing awardee and its partners may not retain or disclose a copy of any data and may not use any specimen (or portions thereof), acquired or generated under the award.

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html

If the NIH decides to terminate this award, the termination of the award will be considered a unilateral change and the recipient will not have the right to appeal. Although a decision is made to terminate an award, the recipient must continue to comply with the Record Retention and Access, and Final Reporting requirements, and may need to sign a non-disclosure agreement to complete the termination process.

7.7 Protests or Appeals

Awards made under Other Transactions Authority (OTA) are not subject to the Federal Acquisition Regulations (FAR) or Uniform Guidance, therefore, the right to protest or appeal will not apply.

SECTION 8: PROPOSAL AND SUBMISSION

INFORMATION

The cost of preparing a submission in response to this ROA shall not be considered, proposed, billed, presented or otherwise treated as a direct charge to any resulting award.

8.1 Pre-Submission Webinar

The Government, at its sole discretion, may conduct multiple pre-submission webinars under this ROA.

Future pre-submission webinars will be announced as amendments to the ROA on SAM.gov.

8.2 White Paper Submission Instructions

8.2.1 Key Dates/Deadlines for White Papers

White papers may be submitted during the open period of the ROA, per the submission deadlines below:

Submission Year Deadlines (all are 3:00 PM Eastern Time)

Government…