ROA OTA-22-006_05-26-2022.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

ROA No. OTA-22-006

TABLE OF CONTENTS

SECTION 1: RESEARCH OPPORTUNITY ANNOUNCEMENT INFORMATION 5

1.1 Purpose 5

1.2 Solicitation Overview 5

SECTION 2: ISSUING OFFICE AND POINTS OF CONTACT 7

2.1 Contact Information 7

2.2 Questions 7

2.3 Amendments 7

SECTION 3: AWARD INFORMATION 8

3.1 Award Type 8

3.1.1 Authority 8

3.2 Funding and Period of Performance 8

3.2.1 Anticipated Funding 8

3.2.2 Period of Performance 9

SECTION 4: PROGRAMMATIC BACKGROUND 10

SECTION 5: AREAS OF INTEREST 13

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

5.1.1a Background 13 5.1.1b Participant Enrollment Activities 13

5.1.2 Technical Objectives 13

5.1.3 Technical Approach 14

5.1.4 Other Requirements 15

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 15

5.2.1 Background 15

5.2.2 Technical Objectives 16

5.2.3 Technical Approach 16

5.3 Area of Interest 3: Engage with Tribal Nations and Urban and Non-Tribal Land Based AI/AN Populations 17

5.3.1 Background 17

5.3.2 Technical Objectives 18

5.3.3 Technical Approach 19

5.3.4 Other Requirements 20

5.4 Area of Interest 4: Integrate participants and advocates into the oversight of the All of Us Research Program 21

5.4.1 Background 21

5.4.2 Technical Objectives 22

5.4.3 Technical Approach 22

SECTION 6: ELIGIBILITY INFORMATION 25

6.1 Higher Education 25

6.2 Nonprofits 25

6.3 For-Profits 25

6.4 Non-Eligible Entities 26

SECTION 7: OTHER REQUIREMENTS 27

7.1 Organization and Governance Structure 27

7.2 Data Security and Management 27

7.3 Privacy Provisions 27

7.4 Ownership of Data, Software, and Other Products 28

7.5 Human Subject Requirements 28

7.6 Termination/Expiration Requirement 28

7.7 Protests or Appeals 29

SECTION 8: PROPOSAL AND SUBMISSION INFORMATION 30

8.1 Pre-Submission Webinar 30

8.2 White Paper Submission Instructions 30

8.2.1 Key Dates/Deadlines for White Papers 30

8.2.2 White Paper Email Submission 31

8.2.3 White Paper Format 32

8.2.4 White Paper Content 32

8.2.5 Oral Presentation 33

8.3 Full Proposal Submission Instructions 33

8.3.1 Full Proposal Format 34

8.3.2 Full Proposal Content 34

SECTION 9: EVALUATION INFORMATION 37

9.1 White Paper Evaluation 37

9.1.1 White Paper Selection 37

9.2 Full Proposal Evaluation 38

9.2.1 Full Proposal Evaluation Criteria 38

9.2.2 Full Proposal Evaluation Rating 39

9.2.3 Cost/Price Evaluation 40

SECTION 10: DEFINITIONS AND ATTACHMENTS 41

10.1 Definition of Underrepresented in Biomedical Research 41

10.1.1 Represented in Biomedical Research (RBR) 41

10.1.2 Underrepresented in Biomedical Research (UBR) 41

10.1.2.1 Diversity Metrics 41

10.2 All of Us Program Definition of Disability 41

10.3 Terms and Conditions (Appendix A) 42

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 Offeror, 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 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 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; 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 to SAM.gov: https://sam.gov/content/opportunities .

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. An offeror 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, maximum 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

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

For Tasks 1, 3, 4, & 5 (note: max funding amount per award is based on responding to all tasks 1, 3, 4, & 5 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: Engage with Tribal Nations and Urban and Non-Tribal Land Based AI/AN Populations

Up to $650K

Area 4: Integrate participants and advocates into oversight of the All of Us Research Program

Up to $2M

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 option periods. The Government reserves the right to extend the period of performance beyond the five 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. Option 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 https://www.atsdr.cdc.gov/communityengagement/pdf/PCE_Report_508_FINAL.pdf https://www.atsdr.cdc.gov/communityengagement/pdf/PCE_Report_508_FINAL.pdf

All of Us , the program has a national network of trusted community organizations to motivate diverse 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.

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

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

● Enrollment site: 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 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

Funding Opportunity (OT2)

● OT-PM-17-002 : All of Us Research Program Engagement Partners (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/community-partner-fo.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-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 offerors 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 to implement, and evaluate community-specific engagement, enrollment, and retention strategies and tactics.

2. Enroll and retain 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.

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

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

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 populations.

Task 2: Engage, enroll, and retain one million or more 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. Offerors 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 offeror will curate, format, and transfer data in Observational Medical Outcomes Partnership (OMOP) format 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.

Task 3: Engage and facilitate pediatric participation in the All of Us Research Program.

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.

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.

https://www.researchallofus.org/data-tools/data-snapshots/

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 offeror(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 offeror 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 offerors 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.

5.2.3 Technical Approach

Offeror(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.

Offeror(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.

● Offeror(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.

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

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

● Offeror(s) must propose a mentorship program(s) to connect students, trainees, and fellows with established researchers on the All of Us Research Hub. Offeror(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.

● Offeror(s) must propose opportunities to incentivize collaborative research on the All of Us Researcher Workbench. For example, an offeror 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: Engage with Tribal Nations and Urban and Non-Tribal Land Based AI/AN Populations

5.3.1 Background

The All of Us Research Program is committed to health equity and building a cohort that is demographically, geographically, and medically diverse. All of Us seeks to include groups that may not have had the opportunity to benefit from breakthroughs in biomedical research because they were left out of research studies in the past, did not feel welcome to participate, or avoided participation due to harmful experiences with prior research. All of Us acknowledges the health disparities faced by American Indian and Alaska Native (AI/AN) populations and the underrepresentation of AI/AN individuals in health research. The program also appreciates the unique resiliencies and strengths developed within AI/AN communities in response to historical trauma.

All of Us is working to create a data resource that recognizes these factors as it works to accelerate health research in a non-stigmatizing way and ensure that populations historically underrepresented in biomedical research are included in the research process as partners. Having held Tribal Consultations in 2019 and with the release of its Tribal Consultation report in March 2021, the program now seeks to further engage Tribal Nations and non-reservation based AI/AN populations to advance responsible and community-led participation in All of Us .

https://allofus.nih.gov/about/diversity-and-inclusion/all-us-tribal-engagement https://allofus.nih.gov/about/diversity-and-inclusion/all-us-tribal-engagement https://allofus.nih.gov/all-us-research-program-tribal-consultation-final-report

5.3.2 Technical Objectives

● Strengthen partnerships and AI/AN community engagement in research related to precision medicine: 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 Tribal Nations and urban and non-Tribal land based AI/AN populations have greater control over the research process, the scientific agenda and ensuring that any research pursued is a priority of the community. Published work on community-based participatory research suggests that health researchers should work collaboratively and in partnership with Tribal Nations and urban and non-Tribal land based AI/AN communities to further the research needs of AI/AN individuals.

● Promote the training and career enhancement of student and/or faculty research scientists interested in addressing health research issues within Tribal Nations and urban and non-Tribal land based AI/AN communities: Opportunities are needed to enhance the cadre of scientists and health providers engaged in health research focused on AI/AN individual’s health needs, and to conduct biomedical, clinical, and behavioral research that is responsive to the needs of Tribal Nations and urban and non-Tribal land based AI/AN populations and the goals of All of Us .

Career enhancement projects may also be proposed to improve the research skills of investigators involved with AI/AN communities.

● Encourage research infrastructure and capacity building within Tribal Nations and urban and non-Tribal land based AI/AN populations, ensuring sustainability of precision medicine research:

Supporting the research infrastructure development and capacity building within Tribal Nations and urban and non-Tribal land based AI/AN populations provides tools to support research from within the communities, as well as the long-term maintenance and evolution of their research agenda.

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 Tribal Nations and urban and non-Tribal land based AI/AN 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

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

Task 1: Outreach and engagement to Tribal Nations and urban and non-Tribal land based AI/AN populations.

● Developing and implementing strategies for engaging Tribal Nations and AI/AN populations through ongoing, mutually beneficial interactions. Importantly, recruitment and retention are not required elements. 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 members after it has been explicitly agreed to in writing by the Tribe’s governing body.

● Guidelines for appropriate conduct of research with AI/AN populations have been widely documented; outreach and engagement for research must be conducted in a community-engaged manner, where the community has an equal voice as a research partner. Engagement with AI/AN populations and Tribal communities must be 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.

Where communities desire to do so, researchers should incorporate a CBPR approach to develop, adapt, and test interventions. The community/Tribe(s) must be appropriately involved in the study design and overall approach.

Task 2: Education and resource development for AI/AN populations and partners.

● Developing educational materials and resources for use in AI/AN engagement with Tribal

Nations, AI/AN researchers, and additional groups of interest.

Task 3: Development of resources for outreach and engagement of non-reservation based and urban AI/AN communities.

● Developing resources and recommendations for program leadership for engaging non-reservation based AI/AN populations including urban Indians and urban Indian organizations. Resources and recommendations must use as a consideration the input of Tribal Nations and Tribal organizations, including but not limited to Tribal Nations in the local or regional area.

● Outreach and engagement or educational activities for non-reservation based and urban AI/AN populations must be focused on education and engagement, not recruitment.

Task 4: Development of resources for Tribal partnership agreements with Tribal Nations.

● Advising and providing input to NIH program leadership regarding options and best practices for forming Tribal partnerships with Tribal Nations. Awardees may provide insight into various topics such as research priorities of interest to Tribal Nations.

Sharing research resources among existing NIH-supported investigators is strongly encouraged. As much as practicable, the offeror 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.

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 offeror(s) is working with Tribal Nations/Tribal governments then Tribal/community resolutions of support, or equivalent documents, must accompany the proposal.

● For each specific project or set of activities proposed, a Tribal resolution or Tribal letter of support from each of the Tribal governments to be served by those proposed activities should reference that particular project. Each Tribal Nation may approach the support differently, hence either a Tribal letter of support or Tribal resolution is acceptable.

● The Tribal resolution or letter should specifically reference the proposal and approval of specific activities. Since the possibility exists that some of the activities proposed within a proposal may be funded while others may not be funded, this ensures that each discrete project has secured all necessary Tribal permissions and approvals for that specific set of proposed activities, and can be considered and funded as a stand-alone project.

● If the current Tribal resolution under which a Tribal organization operates would encompass the specific proposed activities, then a copy of the current resolution submitted with the discrete project would be sufficient. The listed Tribal Nations to be served by the project must match the set of appended resolutions.

● Proposals that include more than one Tribe or community should include a resolution of support, or equivalent document from each participating Tribe and community. If the proposal includes a consortium of Tribal Nations or communities, the offeror should provide a resolution of support from each Tribe or community of the consortium.

● Offerors including participants from an extant study must submit, prior to the review, a letter from the Program Directors/Principal Investigators ( PD/PI) or steering committee of the parent study approving their participation.

● If the offeror is a Tribally sanctioned non-profit Tribal organization, specific Tribal resolution(s) of support will not be required if the current Tribal resolution(s) under which the organization operates encompasses activities proposed in the proposal. A copy of the current operational resolution(s) must be submitted with the proposal.

● Each AI/AN organization that participates in the project should also submit an individual, or sign onto, a common letter of support.

● Letters of support should also explicitly stipulate an agreed-upon timeframe for response from the Tribal Nations to inquiries or requests for approval from the offeror. The time required for approving each of these: 1) should be proposed and stated within the resolution of support (or equivalent document), 2) may differ for each of these activities, 3) may be modified only in consultation with the Tribal/community leadership, and 4) should identify an individual or entity within the Tribe or community to whom a request for waiver of the time requirement can be directed if circumstances arise.

5.4 Area of Interest 4: Integrate participants and advocates into the oversight of the All of Us Research Program

5.4.1 Background

Since 2018, the All of Us Research Program has offered an unprecedented opportunity to actively engage the public as collaborators in research. A central principle of the All of Us Research Program is to include participants as partners in all aspects of the program – from research design through governance. With guiding principles on privacy and trust and a mission to empower participants, the All of Us Research Program has been committed to promoting transparency, reciprocity, and involvement of communities in the governance, oversight, design, implementation, and evaluation of the program. This level of public engagement represents a substantial paradigm shift in biomedical research, which, until recently, had little public involvement. To become an engaged enterprise, the All of Us Research Program had to leverage extant knowledge, establish new frameworks and infrastructure for engagement, and design tools to evaluate the impact of engagement and sustained changes in how the researchers valued participant involvement.

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 biomedical research. Program participants are our partners, not subjects. Participants are co-designers for the program, and the collaborative design process is a relationship-building experience vital to trust and transparency, two of the core values of All of Us . Engagement in the All of Us Research Program has been a systematic, intentional process with the overarching goal of creating a program that reflects the needs, preferences, and priorities of participants inclusive of the range of age, social, racial, ethnic, cultural, geographical, sexuality and health statuses of individuals in the U.S.

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

Perspectives of diverse participant stakeholders who are disconnected from academia and local power structures offer researchers unique insights. Researchers co-learn with diverse community participants about their culture and social networks, and gain valuable feedback that is salient to and informed by members of marginalized communities.

5.4.2 Technical Objectives

We invite offeror(s) who can help the All of Us Research Program build upon:

1. The program’s core values, participation is open to all and participants reflect the rich diversity of the United States . This inclusive philosophy of engagement enables participation by individuals living in the United States of every race, ethnicity, sex, age, gender, sexual orientation, socioeconmic status, health status, geography, health literacy and personal competence with information technologies, and includes both healthy individuals and those with a wide range of health conditions and disabilities;

2. The program’s core value, participants have access to their information , giving participants access to their data including immediate feedback to respondents on the data they have submitted as well as archival access to scientific data related to them as an individual that is maintained by the project; and

3. The core value of participants as partners is an expectation that some program participants will participate in the design and creation process, and serve as reviewers providing feedback on program messages, methods, strategies and technologies.

5.4.3 Technical Approach

Offeror(s) must outline a plan for including participant engagement informed by these principles. The plan should:

● Provide detailed approaches for partnering with research participants and their advocates in the governance, design, conduct, oversight, dissemination, and evaluation activities in the consortium.

● Establish standardized participant engagement and recruitment evaluation approaches and data collection for work done at the consortium level and in the All of Us program overall.

● Identify and/or develop instruments designed to assess participant engagement, including specific instruments designed for families, children, and difficult to reach and underserved populations.

● Develop novel and innovative quantitative approaches to assess impact of effective and meaningful engagement within the All of Us consortium.

● Develop and implement a participant retention program in close collaboration with the Division of Engagement and Outreach, the Division of Communications, and the Steering Committee.

https://allofus.nih.gov/about/diversity-and-inclusion

● It is important to note that the above list is not exhaustive, and the offeror should identify and address any other topics or forward-looking approaches they think would be needed for skillful and successful implementation of the Consortium Participant Partner Program.

Offerors must respond to the following five tasks when proposing on Area of Interest 4:

Task 1: Ownership, strategic oversight, management, coordination, and evaluation of all consortium participant partner related activities.

● The awardee will advise and provide input to program leadership regarding direction of the program as it relates to participant engagement and serves as a central hub for all participant-related activities and evaluation of the impact of participant engagement within the program.

Task 2: Maintain infrastructure that fully integrates participants and advocates into the governance and oversight of the All of Us Research Program.

● Awardees are expected to be able to build upon the existing infrastructure to enable full and meaningful participation by participant partners and integrate their voices throughout the program and public-facing communications. This includes identifying cohorts of participants to serve nationally as consortium partners.

Task 3: Facilitate ongoing input from diverse participant representatives to enhance the design, implementation, and use of the All of Us Research Program

● The awardee must be able to develop multi-faceted, multi-level strategies for engaging participants within the consortium. They will be responsible for providing resources, expectations, and appropriate compensation to participant partners. They should also be able to provide a supportive environment for the exchange of ideas, meaningful engagement, and strategies for retention. The Awardee will be responsible for managing calls, requests for participant input, meetings, travel, and all other participant-related logistics.

Task 4: Assess the impact of the participant engagement on the design, implementation, dissemination, and evaluation of the All of Us Research Program.

● The awardee must be able to assess participant engagement within the consortium and the program overall. They must use quantitative and qualitative measures to examine impact.

The awardee must also identify some critical areas of potential impact and provide examples of changes that may occur in the program due to participant engagement.

Task 5: Contribute to the science of engaging, enrolling, and retaining UBR communities in research.

● Offerors will work closely with other awardees/consortium of the program to lead the process for 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 biomedical research and how to form bidirectional relationships and trust that are critical to sustaining participation in biomedical research among UBR communities. 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 which could serve as a roadmap for future cohorts.

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…