Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Objective, Background, and Scope

The Environmental influences on Child Health Outcomes (ECHO) Program plans to extend and expand the ECHO Cohort in its next phase (2023-2029) to further investigate the roles of a broad range of early exposures from society to biology, including the preconception period, on ECHO’s five key child health outcomes among diverse populations. The objective of this open-competition FOA is to solicit applications for Cohort Study Sites of the Environmental influences on Child Health Outcomes (ECHO) Program to 1) lead collaborative ECHO Cohort science, 2) recruit new pregnant participants from diverse populations, their resulting offspring, and, if available, the conceiving partner, 3) develop and implement the ECHO Cohort Preconception Pilot Study, and 4) implement the ECHO Cohort Data and Biospecimen Collection Protocol ("ECHO Cohort Protocol") using the ECHO Cohort consortium’s central data capture system, e.g., REDCap Central, among all participants. This FOA supports only collaborative ECHO Cohort science, not site-specific science. In this FOA, the term "diverse populations" includes health disparity populations as defined by NIH.

Existing ECHO UH3 Pediatric Cohort awardees or subrecipients proposing only to follow currently enrolled ECHO Cohort participants should apply to RFA-OD-22-019. Existing ECHO UH3 Pediatric Cohort awardees or subrecipients proposing to follow currently enrolled ECHO Cohort participants AND to recruit new pregnant participants, their resulting offspring, and, if available, the conceiving partner, who recruited pregnant participants during the first phase of the ECHO Cohort consortium (2016-2022) should apply to the limited-competition RFA-OD-22-018. The NIH ECHO Program Office encourages each applicant to submit only one Cohort Study Site application. The Program Office defines an ECHO Cohort Study Site as an institution at which participant recruitment and follow up takes place at one or multiple locations, e.g., the Cohort Study Site could be a medical system with recruitment taking place at its clinics. If an applicant includes more than one Cohort Study Site in their application, they must justify the multi-site structure.

Background

In 2016 NIH launched the nationwide ECHO Program with the mission to enhance the health of children for generations to come. ECHO Pediatric Cohort investigators established the ECHO Cohort by combining data and biospecimens from multiple pre-existing and ongoing maternal-child cohort studies, driven by the ECHO Cohort Protocol. ECHO investigators explore how a broad range of early environmental exposures from society to biology influence five pediatric outcome areas: pre-, peri- and postnatal, upper and lower airways, obesity, neurodevelopment, and positive health. ECHO focuses on exposures from preconception to age five and child health outcomes from the prenatal period through adolescence. The scientific impact of the ECHO Cohort relies upon data and biospecimen availability which ECHO makes available in two ways: 1) on the ECHO Cohort Data Platform a highly secure, FISMA moderate cloud environment available to ECHO analysts, along with the ECHO Biorepository; and 2) a nearly-anonymized, controlled access public use dataset located in NICHD’s Data and Specimen Hub available to the broader scientific community. To date, the ECHO Cohort datasets comprise data on over 50,000 children, plus their family members, and nearly that number of biospecimens.

The ECHO Program now seeks to extend longitudinal follow up of existing ECHO Cohort participants and expand the ECHO Cohort by adding new pregnant participants. [The next phase of the ECHO Cohort consortium will extend its reach by following nearly 40,000 existing ECHO Cohort child participants for an additional 7 years.] The ECHO Cohort will also expand to include a new diverse sample of approximately 20,000 pregnant participants, and, if available, the conceiving partner, recruited during early pregnancy with follow-up of their resulting offspring.

Derived from the postpartum period of these 20,000 pregnant participants, the ECHO Cohort will also include a preconception pilot study of approximately 10,000 potential pregnant participants and, if available, their conceiving partners who areat moderate to high probability of having a subsequent child during the study period (2023-2029). NIH anticipates at least 3,000 births from this preconception pilot study, followed through the end of the ECHO Cohort study period (2023-2029), including a minimum follow up to one year of age.The ECHO Program Office expects these combined strategies to result in the ECHO Cohort consisting of~60,000 children ranging from the preconception period through adolescence plus their caregivers.

ECHO is committed to diversity, equity, inclusion, and accessibility and, as such, encourages community-engaged recruitment and retention strategies that will enhance the diversity of the ECHO Cohort participants; research that addresses health equity and health disparities; and enhancements to the diversity of the scientific workforce in children’s health (NOT-OD-20-031).

Scope

This FOA and its companion FOAs will continue to support the ECHO Cohort to allow investigations into the effects of a broad range of early environmental exposures, beginning during the preconception period, on child health outcomes. ECHO is interested in a broad range of exposures including physical and chemical, societal, medical, psychosocial, behavioral, and biological. ECHO will continue to focus on its five key child health outcomes: pre-, peri- and postnatal, upper and lower airways, obesity, neurodevelopment, and positive health. The ECHO Cohort consortium will continue to emphasize solution-oriented research that can inform programs, policies, and practices.

To achieve success, the NIH expects all ECHO awardees to employ outstanding practices of team science, including mutual respect, cooperation, and collaboration, with all consortium members. The ECHO Cohort consortium will include

ECHO Cohort Study Sites to lead collaborative ECHO Cohort science; follow up existing ECHO participants; recruit new pregnant participants with emphasis on diverse populations, their resulting offspring, and, if available, the conceiving partner; develop and implement the ECHO Cohort Preconception Pilot Study; and implement the ECHO Cohort Protocol using ECHO’s central data capture system.

An ECHO Coordinating Center to provide comprehensive operational leadership and an organizational infrastructure to manage and coordinate all ECHO Cohort activities. The Coordinating Center’s main roles are to provide program oversight and effective project management for all aspects of the ECHO Cohort Program; support multiple ECHO Cohort committees and serve as the centralized ECHO Cohort communications center; and administer the Opportunities and Innovation Fund for early career scientists.

An ECHO Data Analysis Center to lead, standardize, and integrate ECHO Cohort Protocol data capture, management, and storage through a central data system; provide analytic support and expertise to analysis proposals approved by the ECHO Cohort consortium; and enrich research infrastructure and data science to facilitate broader sharing of ECHO Cohort data and resources with the scientific community.

An ECHO Measurement Core to develop and refine measures for the ECHO Cohort Protocol, including methods to implement the measures; assist all ECHO Cohort Study Sites, Cores, and Centers in implementing and evaluating the ECHO Cohort Protocol; and lead strategic decision-making to incorporate new and revised measures to advance ECHO Cohort science while moderating participant and staff burden.

An ECHO Laboratory Core to provide leadership, project management, and infrastructure for all activities related to ECHO Cohort biospecimens and data generated from biospecimen assays. The main roles of the ECHO Laboratory Core are to facilitate collection and processing of biospecimens; manage the ECHO Cohort Biorepository; perform or facilitate a wide range of biospecimen assays to support ECHO Cohort analyses; and coordinate biospecimen information and assay results.

It is essential that applicants for this FOA familiarize themselves with the companion FOAs, including the goals and requirements for the Cohort Study Sites, Coordinating Center, Data Analysis Center, Measurement Core, and Laboratory Core and how they function together within the ECHO Cohort consortium.

At the start of the funding period, Cohort Study Sites will implement the ECHO Cohort Protocol, from pregnancy through adolescence, i.e., 20 years, 11 months 30 days. NIH expects that the ECHO Cohort consortium will develop and implement a Steering Committee-approved preconception phase of the ECHO Cohort Protocol within the first year of the study period.

The ECHO Cohort Protocol will consist of two types of essential data elements and biospecimens, Core and Specialized. All Cohort Study Sites must collect all Core data elements and biospecimens on all participants. Cohort Study Sites must collect the Specialized data elements and biospecimens specified by the ECHO Cohort Protocol within their specialized exposure and outcome areas, from all participants.

The Core data elements in the ECHO Cohort Protocol will include exposure and outcome elements that are key to analyses that will employ the large sample size of the ECHO Cohort. Such elements will include sociodemographics, dates of birth and study visits, addresses, health histories, psychosocial and family environment, lifestyle and other behaviors, physical and neurodevelopmental health, and well-being. Core biospecimens will include DNA from the biological parents; the pregnant participant's whole blood, urine, hair, and toenails; children’s DNA, whole blood or blood spot, urine, hair, toenails, and shed teeth. NIH encourages Cohort Study Sites to collect placenta, cord blood, and breastmilk on a sub-sample of participants.

For this FOA, ECHO Cohort Study Site applicants must propose to specialize in at least one exposure area and at least one outcome area. To facilitate this specialization, the ECHO Cohort Protocol will include suites for Specialized Exposure and Specialized Outcome areas specifying the essential data elements and biospecimens to collect in each area. These Specialized areas will include more extensive elements or more detailed measures than the Core elements. The Specialized Exposure areas that Cohort Study Sites recruiting new pregnant participants can propose are a) Physical & Chemical, e.g., air pollution and household chemicals; b) Lifestyle, e.g., nutrition, sleep, and physical activity; or c) Psychosocial, e.g., stress, social support, and discrimination. Specialized Outcome areas include ECHO’s five key child health outcomes area: pre-, peri- and postnatal, upper and lower airways, obesity, neurodevelopment, and positive health. Cohort Study Sites must collect all data elements specified by the ECHO Cohort Protocol within their specialized exposure and outcome areas, from all participants.

In response to this FOA, in the context of Core and Specialized data elements in the ECHO Cohort Protocol, applicants should propose research questions about the influences that environmental exposures occurring from preconception/pregnancy through early childhood can have on health outcomes from birth through adolescence. Applicants to this FOA must select at least one Specialized Exposure area and at least one Specialized Outcome area.

NIH anticipates that the preconception pilot study will include physical and chemical, lifestyle, psychosocial, and biological exposures on both parents.

Cohort Study Site Aims

Applicants should propose innovative science that takes advantage of the nature of the ECHO Cohort, a large, diverse longitudinal study with nationwide coverage that will continue to follow up existing ECHO Cohort child participants and recruit new pregnant participants, through implementing standardized data and biospecimen collection that adheres to the ECHO Cohort Protocol.

For this FOA all proposed specific aims must relate to advancing collaborative ECHO Cohort science and completing operational tasks. Specifically, Aim 1 should incorporate research question(s) that leverage ECHO Cohort Protocol core data elements, Aim 2 should incorporate question(s) that leverage proposed specialized exposure and/or specialized outcome areas, and Aim 3 should relate to how the ECHO Cohort Study Site will ensure adequate recruitment of new pregnant/preconception participants, with emphasis on diversity, and implement the ECHO Cohort Protocol with high fidelity. Aim 4, an exploratory aim, should incorporate research questions related to preconception exposures and one or more ECHO outcomes.

Applicants to this FOA should address how they will lead collaborative ECHO Cohort science; recruit new pregnant participants with special emphasis on diverse populations their resulting offspring, and, if available, the conceiving partner; and implement the ECHO Cohort Protocol using the ECHO Cohort consortium’s central data capture system (e.g., REDCap Central). Cohort Study Sites should also address how they will follow the NIH and ECHO data sharing and use policies.

The NIH ECHO Program Office encourages each applicant to submit only one Cohort Study Site application. The Program Office defines an ECHO Cohort Study Site as an institution at which participant recruitment and follow up takes place at one or multiple locations, e.g., the Cohort Study Site could be a medical system with recruitment taking place at its clinics. If an applicant includes more than one Cohort Study Site in their application, they must justify the multi-site structure and include a project management plan.

Applicants to this FOA should address how they will work with the Coordinating Center, the Data Analysis Center, the Measurement Core, and the Laboratory Core to implement the ECHO Cohort Protocol and to address solution-oriented scientific questions related to how a broad range of early environmental exposures influence child health outcomes for the following focus areas: pre-, peri- and postnatal, upper and lower airways, obesity, neurodevelopment, and positive health.

Cohort Study Site Schedule

Below is the study data collection schedule that all Cohort Study Sites must follow.

• Pregnancy two visits, including one as early as possible, no later than 20 completed weeks of pregnancy
  • Preconception up to three visits between the end of the first ECHO pregnancy and start of a potential subsequent ECHO pregnancy during the study period (2023-2029)
• Perinatal one visit from birth (including presentation for delivery), through the end of 45 weeks after mother's last menstrual period (post-LMP)
• Infancy two visits from 46 weeks post-LMP to 11 months 30 days
• Annual visits from age 12 months through age 20 years, 11 months 30 days

This FOA defines a study visit as the collection of all the ECHO Cohort Protocol core elements and specialized exposure and outcome elements. The study visit could be in person, remote, or a combination of the two for data and biospecimen collection.

All applicants should provide a detailed Study Visit Plan outlining how they will complete study visits. Applicants should also address how they will quickly deploy Steering Committee-approved changes to the ECHO Cohort Protocol to capture time-sensitive exposures, e.g., public health emergencies.

Shared Accountability and Governance

ECHO anticipates using a shared accountability model, including a plan, do, study, act approach, to support achievement of consortium goals. The ECHO Cohort Steering Committee will drive the ECHO Cohort consortium’s scientific direction by setting strategic research priorities and annual scientific objectives. To fulfill this responsibility, the Steering Committee may establish a series of subcommittees, working groups, or task forces to generate research ideas, specify ECHO Cohort Protocol needs, integrate scientific knowledge, review research products, and disseminate scientific results.

The ECHO Cohort Steering Committee’s annual scientific objectives may include

• Setting a target number of distinct types of ECHO Cohort analyses, e.g.,
  • Influences of multiple exposures on ECHO health outcome areas
  • Influences of exposures on more than one ECHO health outcome areas
  • Analyses that address urgent public health issues that relate to any one or more of ECHO’s five health outcome areas
• Ensuring ECHO Cohort analyses address scientific questions related to, e.g.,
  • Health disparities and health equity
  • Social determinants of health
  • Natural experiments or health crises
  • Novel chemicals
  • Resilience or reversibility
  • Health trajectories or developmental plasticity
  • Preconception exposures
• Focusing analytic resources on solution-oriented ECHO Cohort analyses designed to inform programs, policies, and practices to enhance child health

To enable the Steering Committee’s strategic scientific priorities and annual research objectives, the NIH ECHO Program Office will establish consortium-level operational objectives related but not limited to

• Study participants, including participants from diverse populations
  • Recruiting newly pregnant or preconception participants
  • Enrolling children into the ECHO Cohort
  • Retaining participants through the end of the study period
• Data collection, completeness, and usability
  • Approving the Preconception phase of the ECHO Cohort Protocol
  • Ensuring data quality and fidelity of implementing the ECHO Cohort Protocol for pregnancy, preconception, and child participants
  • Making ECHO Cohort data available for analysis
• Biospecimen collection and use
• Publication and dissemination of ECHO Cohort data analyses

An ECHO Cohort Operations Committee will enable achievement of the Steering Committee’s scientific priorities and the operational objectives that the NIH ECHO Program Office sets. To fulfill this responsibility, the Operations Committee may establish subgroups to assure consortium-wide progress toward objectives relating to participant enrollment and retention, biospecimen storage and use, consortium-wide data availability, analysis and manuscript pipelines, or consortium policies. The Operations Committee will facilitate the function of a central dashboard that displays real-time consortium-wide progress toward the annual ECHO Cohort consortium's scientific and operational objectives. The Operations Committee will regularly evaluate the extent of achievement of the ECHO Cohort consortium's objectives, identify barriers to success, and implement solutions. The dashboard will allow the Steering Committee, Operations Committee, and NIH ECHO Program staff to closely monitor the contributions of all ECHO Cohort consortium awardees toward achievement of all scientific and operational objectives.

In addition to monitoring progress toward consortium-level objectives, the NIH ECHO Program Office will closely monitor the extent to which each Cohort Study Site meets criteria for success during the UG3 and UH3 phases of the program. NIH ECHO Program staff will ask Cohort Study Site PI/PDs encountering barriers to develop resolution plans to ensure achievement of success. If barriers to success remain unresolved, the NIH may implement a capitation model to enhance Cohort Study Site productivity or recommend withholding support, suspension, or termination of an award for failure to adhere to award conditions.

Phases of Award

Funding for the initial UG3 phase will allow Cohort Study Sites to, recruit new pregnant and preconception participants, their resulting offspring, and, if available, the conceiving partner, implement the ECHO Cohort Protocol to collect requisite data and biospecimens, and produce and disseminate ECHO Cohort science. NIH will consider successful UG3 projects for transition to the UH3 phase, which will focus on intensifying strategies that Cohort Study Sites implement during the UG3 phase, including expanded productivity. Applicants responding to this FOA should address criteria for both the UG3 and UH3 phases.

UG3 Phase

The Program Office will assess the ability of each ECHO Cohort Study Site to meet the following criteria during the UG3 phase:

• Use of the ECHO Cohort consortium’s central data capture system to populate the ECHO Cohort Data Platform
• Use of the ECHO Cohort consortium's single Institutional Review Board (sIRB) including sIRB approval of ECHO Cohort Protocol and informed consent and/or assent forms
• Demonstration of ability to obtain informed consent for data and biospecimen collection for participants
• Recruitment and retention of pregnant participants, the offspring, and, if available, the conceiving partner
• Collaboration in the Steering Committee development of ECHO Cohort Protocol for the preconception period
• Implementation of the ECHO Cohort Protocol which includes collection of complete, high-quality data and biospecimens, including both Core and Specialized elements
• If applicable, harmonization of data
• Publication of ECHO Cohort manuscripts
• Leadership and participation in ECHO committees and working groups

Award of the UG3 does not guarantee subsequent UH3 funding. NIH ECHO Program staff will administratively review the extent to which each Cohort Study Site meets the criteria for success during the UG3 phase and make final decisions based upon funding availability and Cohort Study Site progress.

UH3 Phase

The UH3 phase should focus on how the applicant will expand development, production, and dissemination of ECHO Cohort science, and continued high recruitment and retention rates, and fidelity to the ECHO Cohort Protocol to collect requisite data and biospecimens. During the UH3 phase, the NIH ECHO Program Office will assess the extent to which each ECHO Cohort Study Site expands productivity in domains related but not limited to the UG3 success criteria.

Selected Research Examples

The ECHO Program is interested in solution-oriented research questions that take advantage of the large sample size, diversity, and longitudinal nature of the ECHO Cohort. Specifically, the Program is interested in how a broad range of early environmental exposures, e.g., societal, physical and chemical, medical, psychosocial, behavioral, and biological, are related to the five key ECHO outcomes through various pathways. The ECHO Program is particularly interested in research ideas that examine multiple exposures and multiple outcomes.

Applicants should consider proposing solution-oriented science that may focus on, but not limited to, the following themes: health disparities and health equity, social determinants of health, natural experiments/health crises, novel chemicals, resilience/reversibility, health trajectories/developmental plasticity, and preconception exposures. Applicants can propose collaborative science based upon data available on the ECHO Cohort Data Platform.

Example Research Questions

• How does?exposure to?contaminants of emerging concern?during?pregnancy or early childhood alone or in combination influence?children s?neurodevelopment??
• To what extent is a mother’s diet and weight trajectory during preconception or pregnancy associated with childhood obesity? How much do epigenetics mediate these associations?
• How do racial and other forms of discrimination embed in human biology to affect preterm birth? To what extent do community and family assets such as social support mitigate these associations?
• To what extent does too little or fragmented infant sleep influence development of asthma, obesity, and neurocognitive outcomes?
• To what extent is substance use by prospective parents before conception associated with infant measures of neurodevelopment?

Plan for Enhancing Diverse Perspectives (PEDP)

The ECHO Program is committed to diversity equity, inclusion, and accessibility. The ECHO Program recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the ECHO Program encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

• Transdisciplinary research projects and collaborations among researchers from array of scientific fields
• Engagement from different types of institutions and organizations, e.g., research-intensive, undergraduate-focused, minority-serving, community-based
• Individual applications and partnerships that enhance geographic and regional heterogeneity
• Investigators and teams composed of researchers at different career stages
• Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women
• Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators

This FOA requires a PEDP as part of the application. Applicants are strongly encouraged to read the FOA instructions carefully and view the available PEDP guidance material.

Applications must include a PEDP submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation, aswell as considered among programmatic matters with respect to funding decisions.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• 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)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• 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)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

S. Sonia Arteaga, PhD
Email: [email protected]

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

For this specific FOA, the Research Strategy section is limited to 30 pages.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Other Attachments:

Plan for Enhancing Diverse Perspectives (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based)
• Description of any planned partnerships that may enhance geographic and regional diversity
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce
• Proposed monitoring activities to identify and measure PEDP progress benchmarks
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s)
• Publication plan that enumerates planned manuscripts and proposed lead authorship
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

NIH strongly encourages inclusion of multidisciplinary teams with clinical research expertise in recruitment and retention of diverse populations, and scientific expertise in ECHO's exposures and/or outcomes and/or methods, including epidemiology and data science, and/or cross-cutting issues such as health equity.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Applicants should budget in two distinct major categories. The first major category is for a consistent budget of no more than $375,000 in direct costs per year to support academic activities, including analysis proposal and manuscript development, ECHO committee work, mentoring, and scientific leadership. In this category, applicants may budget for personnel such as the following: PD(s)/PI(s), co-investigators, project managers or coordinators, data managers and analysts, biostatisticians, pre/postdoctoral individuals, and consultants for collaborative intellectual activities. PD(s)/PI(s) must declare a minimum effort of 2.4 person-months (20 percent) per year. Applications proposing Multiple PD(s)/PIs(s) must have a minimum combined PD/PI effort of 2.4 person months. Applicants should provide support for key staff to attend ECHO Cohort Consortium Science Meetings in the Bethesda, MD area at least twice a year throughout the project period, including the launch meeting anticipated in Fall 2023.

The second major category is for a budget proportional to the number of study participants in the proposed plan. This category includes costs related to implementation of the ECHO Cohort Protocol, including but not limited to all field staff needed for tasks related to recruitment, enrollment, retention, and data and biospecimen collection; devices for remote data collection; equipment and supplies; and participant incentives and participant travel. Applicants should budget by life stage for the following direct costs per participant. This amount will support the field work for the collection of all Core and Specialized elements on all participants as the ECHO Cohort Protocol specifies.

• Pregnancy direct costs of up to $1,500 per visit for at least two visits during pregnancy, including the first visit before 20 weeks of completed gestation.
  • Preconception (interval between first ECHO pregnancy and subsequent ECHO pregnancy) direct costs of up to $750 per visit for up to three visits
• Perinatal direct costs of up to $1,000 for one visit
• Infants direct costs of up to $1,500 per visit for a total of two visits
• For children 12 months or older, direct costs of up to $750 per visit for one visit per year.

As part of the two categories, applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

In addition to the two major categories, in year 1 applicants may also budget up to $100,000 for start-up costs, e.g., community or clinical engagement, hiring and training, regulatory activities, materials.

Applicants should include all costs required for the proposed research in the application and should fully justify all costs.

NIH grants cannot pay IRB fees from direct costs. NIH considers IRB fees as indirect costs.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy

Specific Aims

Applicants should propose innovative science that takes advantage of the nature of the ECHO Cohort, a large, diverse longitudinal study with nationwide coverage. Applicants should also focus on recruiting new pregnant participants, enrolling preconception participants, and implementing the ECHO Cohort Protocol. With regard to recruitment of new pregnant participants and enrollment of preconception participants, applicants should propose enrollment of the resulting offspring and, if available, recruitment of the conceiving partner, for follow up per the ECHO Cohort Protocol.

For this FOA all proposed specific aims must relate to advancing collaborative ECHO Cohort science and completing operational tasks. Specifically, Aim 1 should incorporate research question(s) that leverage ECHO Cohort Protocol core data elements, Aim 2 should incorporate question(s) that leverage proposed specialized exposure and/or specialized outcome areas, and Aim 3 should relate to how the ECHO Cohort Study Site will ensure adequate recruitment of new pregnant/preconception participants, with emphasis on diversity, and implement the ECHO Cohort Protocol with high fidelity. Aim 4, an exploratory aim, should incorporate research question(s) that relate to preconception exposures of one or more ECHO outcomes.

If the applicant proposes to include more than one Cohort Study Site, the applicant must justify the multi-site structure and include a project management plan.

UG3 Phase

For the proposed UG3 phase, applicants should describe their plans for

• Using the ECHO Cohort consortium’s central data capture system, e.g., REDCap Central, and processes. Applicants should demonstrate ability, including any relevant trainings or certifications, to use the common data capture system to populate the ECHO Cohort Data Platform.
• Using the ECHO Cohort consortium's sIRB, including sIRB approval of final ECHO Cohort Protocol and consent and/or assent.
• Implementing the ECHO Cohort Protocol. Applicants should describe how they will follow the ECHO Cohort Protocol to collect data and biospecimens on all participants. This description should include
  • Capacity to follow the ECHO Cohort Protocol including staffing and resources
  • Ability to complete all relevant trainings
  • Assurance to provide complete, high-quality data and biospecimen collection
• Publishing ECHO Cohort manuscripts. Applicants should demonstrate their familiarity with data on the ECHO Cohort Data Platform, they should describe what solution-oriented analyses they will propose using the ECHO Cohort Data Platform.
• Addressing how the applicant would follow the NIH and ECHO data sharing and use policies, which should include the ability for ECHO analysts to use appropriately protected personally identifiable information in a FISMA moderate environment.
• Implementing a Diversity, Equity, Inclusion, and Accessibility perspective consistent with the PEDP into the recruitment and follow up of all ECHO Cohort participants, development of research ideas, and dissemination of findings.
• Leading and participating in ECHO committees and working groups. Applicants should demonstrate their expertise and willingness to lead and participate in ECHO committees and working groups.

Regarding pregnant participants, resulting offspring, and conceiving partners, applicants should describe their plans for

• Recruiting pregnant participants beginning before 20 weeks of completed gestation. Applicants should also specify their strategies to enroll diverse populations, including any community-engaged strategies. Please describe
  • The study population and any special characteristics, e.g., low socioeconomic status, underserved urban or rural, racial and ethnic minorities.
  • Experience and expertise of staff with recruiting pregnant participants
  • Estimation of sample size for how many pregnant participants the applicant will recruit and consent and a justification for the estimate.
  • Potential recruitment locations, outlining the number of potential participants from each location. State the estimated number of births from the recruitment location. Include any letters of support from medical practices where recruitment will occur. If there are competing pregnancy studies include a description of how the applicant will address those challenges.
• Enrolling the resulting offspring from pregnant participants for follow up in the ECHO Cohort. Descriptions should include
  • Experience and expertise of staff with enrolling offspring of pregnant participants
  • Estimation of sample size for how many offspring of pregnant participants the applicant will enroll and a justification for the estimate.
• Following up these child participants, including ability to achieve very high retention rates.
• Recruiting the conceiving partner if available. Descriptions should include
  • Experience and expertise of staff with recruiting conceiving partners into research studies
  • Estimation of sample size for how many conceiving partners the applicant will recruit and consent and a justification for the estimate.

Regarding potential preconception participants, applicants should describe their plans for

• Determining moderate to high likelihood of a subsequent pregnancy from recruited pregnant ECHO Cohort participants
• Working with other ECHO Cohort Study Sites, Cores, and Centers to develop the preconception phase of the ECHO Cohort Protocol within the first year of the funding period
• Enrolling and following up preconception participants for up to three study visits
• Experience and expertise of staff with recruiting biological parents prior to pregnancy into research studies
• Implementing the preconception phase of the ECHO Cohort Protocol

UH3 Phase

For the UH3 phase, applicants should describe how they will continue and intensify activities from the UG3 phase, including

• Retaining participants with special emphasis of diverse populations
• Recruiting new pregnant participants
• Recruiting participants at moderate to high likelihood of a subsequent pregnancy into the preconception pilot
• Enrolling children into the ECHO Cohort Protocol
• Recruiting conceiving partner if available
• Completing collection of high-quality data and biospecimens on all participants
• Publishing of ECHO Cohort manuscripts
• Leading and participating in ECHO committees and working groups

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities, including the PEDP.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
  
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for

• Directing the activities of the ECHO Cohort Study Site, including: (i) establishing and implementing processes for decision-making, communication and collaboration; (ii) establishing and implementing processes and systems for tracking the implementation of ECHO Cohort activities, identifying problems/deficiencies, and determining the need for and implementing corrective actions; (iii) assessing and allocating resources, reviewing their adequacy, and determining needed adjustments; (iv) establishing and implementing financial management capacity and systems to track and project resources and expenditures; (v) implementing and managing an information system to support day-to-day ECHO Cohort Study Site activities; (vi) cooperating with the ECHO Cohort Steering Committee and Operations Committee; the ECHO External Scientific Board; the ECHO Coordinating Center PD/PI; the ECHO Data Analysis Center PD/PI; the ECHO Measurement Core PD/PI; and the ECHO Laboratory Core PD/PI; (vii) establishing procedures for assessing the ECHO Cohort Study Site progress and productivity.

• Implementing the full scope of ECHO Cohort activities including recruitment and retention of participants; standardized, quality-assured collection of ECHO Cohort Protocol-specified data and biospecimens on all participants; appropriate handling of biospecimens, tabulation of biospecimen information, and transfer of biospecimens to ECHO laboratories and biorepositories; and development and dissemination of ECHO Cohort publications as supported by the ECHO Cohort Cores and Centers and in full cooperation with ECHO Coordinating Center-led project management.

• Ensuring effective cooperation and collaboration across all ECHO Cohort Study Sites, Cores, and Centers, within ECHO scientific focus areas; with the NIH ECHO Director and the NIH ECHO Program staff; and with the ECHO Cohort Steering Committee and Operations Committee.

• Ensuring that the performance of ECHO Cohort activities complies with all Federal regulatory requirements and guidelines for the conduct of human subjects research, as well as NIH policies and procedures.

• Providing reports, as directed, to the NIH ECHO Director, the NIH ECHO Program staff, the ECHO Coordinating Center, the ECHO Data Analysis Center, or others regarding overall ECHO Cohort activities, e.g., tabular summaries of study progress, protocol deviation, site safety or adverse event monitoring reports, and budget summaries.
• Providing updates at least annually on implementation of the PEDP to the NIH ECHO Director or NIH ECHO Program staff.

• Ensuring the training or certification of ECHO Cohort Study Site staff and including a list of all training programs and written assessments in the Annual Progress Report.

• Expecting the NIH ECHO Program staff's regular review of Cohort Study Site performance. NIH may move participant-related funds from one site to another to adjust for variability in site performance.

• If the NIH ECHO Program Office determines that capitation for research costs is necessary to improve Cohort Study Site performance, ensuring cooperation with the policy for capitation of research costs, including payment of capitation via the ECHO Coordinating Center.

• Using a single central Institutional Review Board (sIRB) so that ECHO Cohort research can proceed as effectively and expeditiously as possible by reducing unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects protections.

• Using the ECHO Cohort consortium’s central data capture system and processes to collect all ECHO Cohort Protocol-specified data and to deposit data including personally identifiable information onto the secure, FISMA moderate ECHO Cohort Data Platform. Recipients acknowledge that analysis of ECHO Cohort data within the FISMA moderate ECHO Cohort Data Platform will include use of research participants personally identifiable information, such as date of birth and address.

• Ensuring that ECHO makes its near-anonymized de-identified ECHO Cohort study data and biospecimens available to the broader scientific community through an NIH-selected, controlled-access public data repository within a time period that the NIH ECHO Director approves.

• Awards issued under this FOA will be incrementally funded for up to seven years. These awards will not be Multi-Year Funded.
• Awards issued under this FOA will be excluded from the Streamlined Noncompeting Award Process (SNAP).
• NIH will not allow automatic carry over. An NIH Grants Management Official must review and approve all carry over requests, regardless of the size and/or dollar threshold.

• There will be no automatic first no-cost extensions. The NIH Grants Management Specialist must review and approve all extensions.

• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The NIH ECHO Director, NIH ECHO Program staff, and other NIH staff may assist with ECHO Cohort operations and consortium-wide studies in one or more of the five ECHO scientific focus areas.

• NIH staff will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond the normal program stewardship role for grants.

• NIH anticipates that decisions regarding ECHO Cohort activities will involve consensus-making and that the NIH staff members will participate in this process.

• In various matters related to study approval and oversight, the NIH staff will have final decision authority, as described below.

• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• The NIH ECHO Director and the NIH ECHO Program staff, in collaboration with ECHO PDs/PIs, will participate in deliberations and decision-making regarding the multiple substantive, operational, resource, and administrative responsibilities of this NIH initiative.

• NIH ECHO Program staff or their designees will collaborate with ECHO Cohort Study Site staff to ensure the provision of appropriate information, materials and training regarding NIH policies and procedures for the conduct of human subject research.

• Cooperative Agreements require close interactions among the recipient, recipients from the companion FOAs, and NIH. Shortly after the award, the PDs/PIs and NIH ECHO Program staff will form the ECHO Cohort Steering Committee.

• NIH expects key personnel to serve on committees, subgroups, working groups, taskforces, and interest groups, according to their expertise.

• All responsibilities are divided between recipients and NIH staff as described above.

ECHO Cohort Steering Committee

The ECHO Cohort Steering Committee will drive ECHO’s scientific direction by setting strategic research priorities and annual scientific objectives.

• ECHO Cohort Consortium PI/PDs may elect one or two chairs of the ECHO Cohort Steering Committee. If two chairs, one will be from Cohort Study Sites and one from Cores or Centers. If one chair, it will be an external chair and cannot be an NIH official. The NIH ECHO Director can advise the ECHO Cohort Consortium PI/PDs on the expected qualifications or conflicts of interest of a potential internal or external chair. The NIH ECHO Program Office expects Steering Committee chairs to demonstrate outstanding skills in leadership, teamwork, and cooperation.

• NIH anticipates that the ECHO Cohort Steering Committee will comprise approximately 12 rotating voting members with a majority Cohort Study Site representation. The Steering Committee may include the NIH ECHO Director or a designee from the NIH ECHO Program staff, the PI/PD of the Coordinating Center, the PI/PD of the Data Analysis Center, the PI/PD of the Measurement Core, and the PI/PD of the Laboratory Core.

• The NIH ECHO Director or a designee from the NIH ECHO Program staff will serve as a non-voting member of the ECHO Cohort Steering Committee. If the Steering Committee has an external chair, that person would also serve as non-voting member except in instances requiring a casting vote, when the votes on each side of a decision are equal.

• The Steering Committee, with ECHO Coordinating Center facilitation, will host ECHO Cohort Consortium Science Meetings at least twice annually, with the first meeting in Fall 2023.

• To fulfill its responsibilities, the Steering Committee may establish a series of committees, working groups, and task forces to generate research ideas, engage stakeholders including research participants in developing and disseminating research, specify ECHO Cohort Protocol needs, integrate scientific knowledge, review ECHO Cohort research products, and disseminate scientific results.

ECHO Cohort Operations Committee

The ECHO Cohort Operations Committee will manage ECHO Cohort operations to enable achievement of the Steering Committee’s strategic priorities and annual scientific objectives, as well as the operational objectives that the NIH ECHO Program Office sets.

• NIH anticipates that the PI/PD of the Coordinating Center will chair the operations committee and, as such, that the ECHO Coordinating Center will provide comprehensive operational leadership and an organizational framework to coordinate and manage all ECHO Cohort activities.

• NIH anticipates that the ECHO Cohort Operations Committee will comprise approximately 9 rotating voting members with majority of ECHO Cohort Core and Center representation. The Operations Committee may include the NIH ECHO Director or a designee from the NIH ECHO Program staff and representatives of the ECHO Cohort Study Sites, Coordinating Center, Data Analysis Center, Measurement Core, and Laboratory Core.

• The Operations Committee, with leadership from the ECHO Coordinating Center, will facilitate the function of a central dashboard that shows real-time consortium-wide progress toward annual ECHO Cohort scientific and operational objectives, allowing the ECHO Cohort Steering Committee, Operations Committee, and NIH ECHO Program staff to closely monitor the contributions of all ECHO Cohort consortium recipients toward achievement of consortium objectives.

• The Operations Committee will regularly evaluate the extent of achievement of ECHO Cohort consortium objectives, identify barriers to success, and propose solutions to the ECHO Cohort Steering Committee.

• To fulfill its responsibilities, the Operations Committee may establish a series of subgroups to address operational domains that may relate to one or more of the following: ECHO Cohort participant recruitment, enrollment, and retention; data collection; biospecimen collection, storage, and use; consortium-wide data and biospecimen availability; ECHO Cohort analysis and manuscript pipelines; and consortium policies; among others.

ECHO Cohort Study Site Pods

The ECHO Cohort governance structure will include multiple small groups of Cohort Study Site PDs/PIs of approximately equal size ("Pods") to enhance bi-directional communication between them and the Steering Committee and Operations Committee. The Pods may be led by Cohort Study Site representatives serving on the Steering and Operations Committees.

ECHO External Scientific Board

The ECHO External Scientific Board will review the ECHO Cohort consortium's progress and provide feedback to the NIH ECHO Director, NIH ECHO Program staff, and the appropriate NIH Institute/Center/Office Council on the ECHO Cohort consortium’s programmatic strategies. The External Scientific Board may be a working group of the NIH Council of Councils or an Advisory Council of an NIH Institute, and as such, would include at least one member of that Council.

• The External Scientific Board will provide advice on the ECHO Cohort consortium’s programmatic strategies to ensure long-term success and overcome challenges, which include:

• Fostering a culture of collaboration and synergy

• Attending to numerous stakeholders, such as Congress, researchers, professional societies and participants

• Capitalizing on expertise within, as well as outside NIH

• Incorporating all ECHO Cohort Study Sites, Cores, and Centers under one umbrella

• Ensuring sustained success and wise use of resources

• Other duties of the External Scientific Board may include:

• Offering input on the ECHO Cohort consortium's structure, activities, and study design, both during ECHO Cohort Protocol development and during the analysis of study results

• Providing findings to ensure that resources that the program delivers are as useful as possible for end users

• Assessing data security policies and procedures

• Safeguarding the interests of study participants and the safety of ECHO Cohort Protocol procedures

• Ensuring adequacy of study progress in terms of recruitment and retention, data and biospecimen availability, and publications

• Assessing issues pertaining to the balance of scientific value with participant burden

• Monitoring the impact of proposed ancillary studies and sub-studies on participant burden and overall achievement of the main study goals

• Tracking overall scientific directions of the study

• The NIH ECHO Director may invite External Scientific Board members to attend some ECHO Cohort Consortium Science Meetings.

• The NIH ECHO Director and NIH ECHO Program staff will review the External Scientific Board charter periodically and may amend or terminate the charter, pending final approval of the NIH ECHO Director.

Observational Study Monitoring Board

NIH may establish an independent Observational Study (or Data and Safety) Monitoring Board (OSMB) to monitor and provide recommendations to ECHO regarding participant recruitment/enrollment and retention, safety, data quality, and other issues, as appropriate. The OSMB may also review the Steering Committee-approved ECHO Cohort data collection protocol, informed consent templates, objectives and related progress, and monitoring plans prior to the start of recruitment.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

S. Sonia Arteaga, PHD

Environmental influences on Child Health Outcomes (ECHO) Program, Office of the Director, National Institutes of Health

[email protected]

Lynda R Hardy
National Library of Medicine (NLM)
Phone: 301-594-1297
E-mail: [email protected]

Elizabeth L. Neilson, PhD, MPH, MSN
Office of Disease Prevention (ODP)
Phone: 301-827-5578
Email: [email protected]

Kathryn Stein, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-4653
Email: [email protected]

Somdat Mahabir, Ph.D., M.P.H
National Cancer Institute
Telephone: 240-276-6941
Email: [email protected]

Kimberly A Gray, PhD
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984-287-3262
E-mail: [email protected]

Beda Jean-Francois
National Center for Complementary & Integrative Health (NCCIH)
Phone: 202-313-2144
Email: [email protected]

Sung Sug (Sarah) Yoon, RN, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: [email protected]

Voula K. Osganian, M.D., Sc.D., M.P.H.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-827-6939
E-mail: [email protected]

Aruna Natarajan, MD, PhD
Division of Lung Diseases
Telephone: 301-827-0180
Email: [email protected]

Andrew Bremer, M.D. Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-7886
Email: [email protected]

William C. Dunty, Jr., Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-7351
Email: [email protected]

Deborah E. Linares, PhD
National Institute on Minority Health and Health Disparities
Phone: 301-402-2516
Email: [email protected]

Alkis Togias, MD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3587
Email: [email protected]

David A. Jett, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-496-6035
Email: [email protected]

Chingyi Agnes Shieh
Office of Research on Women's Health (ORWH)
Phone: 301-496-9186
E-mail: [email protected]

Rajeev K Agarwal, Ph.D.
Office of Research on Women's Health (ORWH)
Phone: 301-451-7058
E-mail: [email protected]

Center for Scientific Review (CSR)

Email: [email protected]

Bonnie J. Jackson

Eunice Kennedy Shriver National Institute of Child Health and Human Development

National Institutes of Health

Phone: 301.496.5482 | Mobile: 301.640.6552

Email: [email protected]

Samantha J Tempchin
National Library of Medicine (NLM)
Phone: 301-496-4222
E-mail: [email protected]

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Phone: 240-276-6277
Email: [email protected]

Jenny L Greer
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984.287.3332
E-mail: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: [email protected]

Tracie McGraw
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-435-0770
E-mail: [email protected]

Ron Caulder
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8020
Email: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: [email protected]

Sam Ashe
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-4799
Email: [email protected]

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.