Rolling ROA_OTA-22-006_AMENDMENT 7 06-13-2024.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 Amendment No. 7: June 13, 2024

ROA No. OTA-22-006

AMENDMENT 7

TABLE OF CONTENTS

SECTION 1: RESEARCH OPPORTUNITY ANNOUNCEMENT INFORMATION 4

1.1 Purpose 4

1.2 Solicitation Overview 4

SECTION 2: ISSUING OFFICE AND POINTS OF CONTACT 6

2.1 Contact Information 6

2.2 Questions 6

2.3 Amendments 6

SECTION 3: AWARD INFORMATION 7

3.1 Award Type 7

3.1.1 Authority 7

3.2 Funding and Period of Performance 7

3.2.1 Anticipated Funding 7

3.2.2 Period of Performance 8

SECTION 4: PROGRAMMATIC BACKGROUND 9

SECTION 5: AREAS OF INTEREST 12

5.3 Area of Interest 3: Engagement with Tribal Nations, American Indian and Alaska Native populations, and Indigenous Communities 12

5.3.1 Background 12

5.3.2 Technical Objectives 13

5.3.3 Technical Approach 13

5.3.4 Other Requirements 15

SECTION 6: ELIGIBILITY INFORMATION 16

6.1 Higher Education 16

6.2 Nonprofits 16

6.3 For-Profits 16

6.4 Non-Eligible Entities 17

SECTION 7: OTHER REQUIREMENTS 18

7.1 Organization and Governance Structure 18

7.2 Data Security and Management 18

7.3 Privacy Provisions 18

7.4 Ownership of Data, Software, and Other Products 19

7.5 Human Subject Requirements 19

7.6 Termination/Expiration Requirement 19

7.7 Protests or Appeals 20

SECTION 8: PROPOSAL AND SUBMISSION INFORMATION 21

8.1 Pre-Submission Webinar 21

8.2 Technical Assessment Paper Submission Instructions 21

8.2.1 Key Dates/Deadlines for Technical Assessment Papers 21

8.2.2 Technical Assessment Paper Email Submission 21

8.2.3 Technical Assessment Paper Format 22

8.2.4 Technical Assessment Paper Content 22

8.2.5 Oral Presentation 23

8.3 Full Proposal Submission Instructions 24

8.3.1 Full Proposal Format 24

8.3.2 Full Proposal Content 25

SECTION 9: EVALUATION INFORMATION 28

9.1 Technical Assessment Paper Evaluation 28

9.1.1 Technical Assessment Paper Selection 28

9.2 Full Proposal Evaluation 29

9.2.1 Full Proposal Evaluation Criteria 29

9.2.2 Full Proposal Evaluation Rating 30

9.2.3 Cost/Price Evaluation 31

SECTION 10: DEFINITIONS AND ATTACHMENTS 32

10.1 Definition of Underrepresented in Biomedical Research 32

10.1.1 Represented in Biomedical Research (RBR) 32

10.1.2 Underrepresented in Biomedical Research (UBR) 32

10.1.2.1 Diversity Metrics 32

10.2 All of Us Program Definition of Disability 33

10.3 Terms and Conditions (Appendix A) 33

SECTION 11: SUMMARY OF CHANGES 34

Amendment No. 1: June 2, 2022 34 Amendment No. 2: July 29, 2022 34 Amendment No. 3: October 4, 2022 36 Amendment No. 5: May 18, 2023 46 Amendment No. 6: December 19, 2023 48 Amendment No. 7: June 13, 2024 68

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 Technical Assessment 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 Technical Assessment 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 Technical Assessment 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.

mailto:AOU-ROA@nih.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 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 as described in Section 5, are anticipated, subject to the limitations of fiscal year funding. A proposer may only submit a proposal under AOI 3.

Funding amount is listed below. However, lower and higher cost efforts may be considered.

Table 1.

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

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 Area of Interest (AOI) for this opportunity is described below. Technical Assessment Papers and subsequent proposals must only address the following Area of Interest.

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 Technical Assessment 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 Technical Assessment 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

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 Technical Assessment Paper Submission Instructions

8.2.1 Key Dates/Deadlines for Technical Assessment Papers

Technical Assessment 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 Responses

2022 August 31, 2022 November 30, 2022

A receipt of confirmation will be sent via email within 7 calendar days.

A decision on whether the Proposer has received a Tier I or Tier II designation l,(See Section

9) as a result of the Technical Assessment Paper evaluation, will be provided within 120 calendar days of the submission deadline.

2023 February 28, 2023 August 31, 2023

2024 February 29, 2024 August 30, 2024

2025 February 28, 2025 May 23, 2025

8.2.2 Technical Assessment Paper Email Submission

In order to remove technical barriers and afford the opportunity for all to submit a Technical Assessment Paper, Technical Assessment Papers shall be submitted via email at AOU-ROA@nih.gov, in accordance with the deadlines in section 8.2.1. The maximum size for any single email message including attachments is 100MB. Each Technical Assessment Paper must state that it is submitted in response to this ROA and cite the particular Area of Interest that the Technical Assessment Paper is addressing.

See section 8.2.4 for Technical Assessment Paper content requirements. Titles given to the Technical Assessment Paper should be descriptive of the work they cover and should not be merely a copy of the title of this solicitation. A receipt of confirmation will be sent within 7 calendar days.

The subject line of each Technical Assessment Paper submission email must be labeled as follows:

“ROA OTA-22-006 Technical Assessment Paper by [insert name of organization] - AOI [insert number]”

Do not send the following:

● Hard copies of Technical Assessment Papers (including Facsimiles). Only electronic submissions will be accepted and reviewed;

● ZIP files; or

● Password protected files.

8.2.3 Technical Assessment Paper Format

● Paper Size: 8.5 x 11 inch paper

● Margins: 1 inch

● Spacing: single-spaced

● Font: Times New Roman, 12 point

● Page limit: 5 pages (excluding cover page, resumes, bibliographies, and table of contents)

● MS Office or Adobe PDF formats

8.2.4 Technical Assessment Paper Content

The Technical Assessment Paper provides a brief technical discussion of the Proposer's objective, approach, level of effort, and the nature and extent of the anticipated results.

1. Cover Page: The cover page shall be labeled “Technical Assessment Paper” and shall include the ROA number, proposed title, technical and business points of contact, telephone number(s), and e-mail address(es).

2. Technical Concept: Concept and a description of the activities proposed for the Area of Interest.

mailto:AOU-ROA@nih.gov

3. Programmatic Section: An estimated project schedule (e.g., Gantt chart) that clearly shows the plans to perform the program tasks within the proposed period of performance.

The following chart (tailored as appropriate), detailing a summary of planned milestones and estimated direct and indirect costs. Proposers must provide a brief rationale describing how the estimate was calculated. Should full proposal costs vary significantly from the Technical Assessment Paper estimates, it may be grounds for the Government to reconsider whether the project is suitable for award.

Year Summary of Planned Milestones Total Estimated Costs (Includes Direct and

Indirect Costs)

Year 1 (Base) $

Year 2 (if applicable)

Year 3 (if applicable)

Year 4 (if applicable)

Year 5 (if applicable)

TOTAL $

4. Resumes: A single page summary resume (including previous relevant experience and pertinent publications) for each Principal Investigator.

8.2.5 Oral Presentation

The All of Us Research Program requests that Principal Investigators (PIs) be prepared to provide expanded presentations of their selected Technical Assessment Papers, if requested. The purpose of the oral presentation is to provide additional information and address how the proposed strategies will affect the All of Us Research Program. The time, location, and briefing format of the oral presentations, if requested, will be provided at a later date via email notification.

Note: The Government does not intend to provide technical feedback on Technical Assessment Paper submissions. However, Proposers will receive notification should the Government decide not to request a full proposal.

8.3 Full Proposal Submission Instructions

Proposers will be notified via email if, after its review of the Technical Assessment Paper submission, the Government is interested in receiving a full proposal. Full proposals submitted in response to this ROA, must present separate detailed technical and business proposals designed to meet the Technical Objectives described for the AOI proposed.

The full proposal must be submitted via the NIH eRA ASSIST System. To submit a proposal via ASSIST, the applicant organization must be registered in eRA Commons (see instructions); please plan accordingly, as registration approval does not occur immediately upon request. Organizations already registered in eRA Commons do not need to reregister. Once the organization is registered, the individual(s) with the role of Signing Official (SO) and Program Director/Principal Investigator (PD/PI) must be affiliated with the organization and have eRA Commons credentials to complete the submission process.

Use the ROA number, OTA-22-006, in the field requesting “Funding Opportunity Announcement #”.

Here are instructions for submitting via the NIH eRA ASSIST system. In the future, instructions will also be available in the ASSIST online help (look for the OTA section). Technical help is available at the eRA Service Desk.

If the Proposer is notified of the All of Us Research Program’s interest in receiving a full proposal, the due date for receipt will be sent via email. The Proposer will be given at least 45 calendar days from notification to submit a full proposal. Once the final full proposal evaluation process is completed, the Proposer will be notified via email of their project’s selection or non-selection. In order to receive an award from the Government, the Proposer organization must obtain a Unique Entity Identification (UEI) number, formerly known as Data Universal Numbering System (DUNS), by registering on SAM.gov.

8.3.1 Full Proposal Format

● Paper Size: 8.5 x 11 inch paper

● Margins: 1 inch

● Spacing: single-spaced

● Font: Times New Roman, 12 point

● Page limit (33 pages) - cover page and table of contents are excluded from page limitations:

○ Abstract - 1 page

○ Specific Aims - 3 pages max https://public.era.nih.gov/commonsplus/public/registration/initRegistration.era https://era.nih.gov/files/OTA-Submissions.docx https://era.nih.gov/erahelp/ASSIST/default.htm https://grants.nih.gov/support/index.html https://sam.gov/content/entity-registration

○ Organization Description - 1 page

○ Technical Approach - 12 pages max

○ Technical Experience - 3 pages max

○ Key Personnel - 5 pages max

○ Milestone Timeline & Risk Chart in section 8.3.2, for base year period and proposed additional periods- 3 pages max

○ Cost Proposal - Unlimited

● Adobe PDF files are required for eRA ASSIST submission [Note:MS Office formats may be requested post submission, if necessary for in-depth review (e.g., Excel spreadsheets to verify calculations)]

8.3.2 Full Proposal Content

Titles given to the full proposals should be descriptive of the work they cover and should not be merely a copy of the title of this solicitation.

1. Cover Page: The cover page shall be labeled “FULL PROPOSAL” and shall include the ROA number, proposed title, technical and business points of contact, telephone number(s), and e-mail address(es).

2. Abstract: A succinct and accurate description of the proposed work which communicates the public health relevance of the project to the public.

3. Specific Aims: State the application's broad, long-term objectives and specific aims, making reference to the health relatedness of the project (i.e., relevance to the mission of the agency).

Describe the research design and methods for achieving the stated goals. Be sure that the specific aims reflect the key focus of the proposed project so that the application can be appropriately categorized.

4. Organization Description: Description of the applicant organization(s), including a summary of their mission statement, a brief history, their projects of note, and lasting impacts, especially with historically underrepresented groups in biomedical research. Also include if the organization has local, regional, or national resources or network of organizations to help plan, implement, and evaluate engagement and outreach activities.

5. Technical Approach: A clear description of the technical approach being proposed in response to the specific Area of Interest (1-4). This section should provide the technical foundation and justification for pursuing this particular approach/direction and why one would expect it to enable the Area of Interest proposal to be met.

6. Technical Experience: Past experiences that relate directly to the Area of Interest with several examples of previous performance supporting this work.

7. Key Personnel (provide key personnel and sub-recipient):

a. Biosketches of key personnel

b. One or multiple Program Directors/Principal Investigators (with a level of effort of at least 10% each).

c. An overall leadership structure and management plan. For proposals with multiple

PDs/PIs, a leadership plan that incorporates a conflict resolution plan is required (no page limit).

d. Proposed sub-recipient(s)

8. Statement of Work (SOW) and Planned Milestones:

a. The proposal must include a statement of work that directly ties to the proposed milestones. The SOW will not count toward the full proposal page count or be evaluated.

b. Planned milestones, associated measurable goals, expected completion timeline (start and finish date), any associated risks to completing the milestone, and estimated direct and indirect costs for each milestone for Year 1, and projections for all additional years proposed, based on how the Proposer envisions the project will progress. Milestones should be in a SMARTIE format – (Specific, Measurable, Reasonable, Timed and emphasizing Inclusivity, and Equity).

Note: Each task must have its own planned milestone table. A sample is provided below however, an updated template may be provided at the time when a full proposal is requested.

Planned Milestone

Measurable Goal

Timeline Risk to Milestone

Estimated Cost

9. Cost Proposal:

The cost proposal must include projected expenditures for each year (base year and potential year periods ), based on the proposed scope of work, and must include:

a. Breakdown for all personnel by labor category, salary, % of effort, fringe. Note: All salaries shall not exceed the NIH Salary Cap.

b. Detailed line item budget that shows costs related to travel, sub-recipients, consultants, materials, equipment, other direct costs, indirect costs, etc.

https://grants.nih.gov/grants/policy/salcap_summary.htm

c. Provide budget detail by Task.

d. Proposers should build a milestone-driven, cost-allocated plan for proposals. Cost models can be cost-sharing, fixed-price, or adjustable (cost-reimbursable), or have a hybrid approach. A five-year cost proposal including indirect costs should be submitted. The budget narrative must be specific enough for the reviewers to understand the connection between the funds requested and activity to be conducted.

Note: Additional information on proposed costs may be requested at any point during the full proposal stage, up to the time of award.

SECTION 9: EVALUATION INFORMATION

9.1 Technical Assessment Paper Evaluation

Technical Assessment Papers will be reviewed by a panel of subject matter experts with relevant knowledge of the Area of Interest (AOI) proposed. The review panel will evaluate the Technical Assessment Paper on the AOI, relevance to the All of Us programmatic priorities, technical description of the effort, and estimated budget, based on the following metrics:

A. Program Relevance:

1. The extent to which the proposed effort fills an unmet programmatic need;

2. The proposed solutions clearly address the priorities outlined in the AOI.

B. Overall Technical Merits:

1. The soundness, feasibility, and validity of the proposed plans, methods, techniques, and procedures of the technical approach;

2. The reasonableness of the proposed schedule.

C. Capabilities and Related Experience:

1. The qualifications, experience, and expertise of the proposed technical/key personnel;

2. The Proposer’s experience in relevant efforts with similar resources.

9.1.1 Technical Assessment Paper Selection

Proposers whose Technical Assessment Papers are deemed to have significant merit may be invited to submit a full proposal. However, submission of a full proposal by the Proposer does not commit the Government to make an award.

Technical Assessment Papers will receive one of the following designations as a result of the evaluation:

● Tier I: Demonstrates an overall approach that appears to be adequate and is expected to meet or exceed program goals and objectives. The estimated costs are considered appropriate or are lower than what is considered appropriate to complete the proposed tasks. The Government may request a full proposal based on Government need and funding. Tier I rated Technical Assessment Papers will remain valid for a period of one year from the ROA submission date in Section 8.2.1 the Technical Assessment Paper was submitted. The Government may not request full proposals on all Tier I rated Technical Assessment Papers.

● Tier II: The overall approach lacks completeness, contains deficiencies, and/or does not appear to be a feasible solution that could meet program goals and objectives. The estimated costs are higher than what is considered appropriate to successfully complete the tasks, or exceeds available funding limits. The Government will not pursue a full proposal.

9.2 Full Proposal Evaluation

The primary basis for selecting proposals for acceptance will be the evaluation criteria, importance to the All of Us Research Program, and funds availability.