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 FOA is to solicit applications for an ECHO Measurement Core. Working collaboratively with other members of the ECHO Cohort Consortium, the ECHO Measurement Core will 1) develop and refine measures for the ECHO Cohort Protocol, including methods to implement the measures; 2) assist all Cohort Study Sites, Cores, and Centers in implementing and evaluating the ECHO Cohort Protocol, which comprises standardized measures at specified study visits; and 3) lead strategic decision-making to incorporate new and revised measures to advance ECHO Cohort science while moderating participant and staff burden.

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 in the diversity of the scientific workforce in children’s health. In this FOA, the term "diverse populations" includes health disparity populations as defined by NIH.

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 are at 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.

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 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 and Specialized data elements and biospecimens on 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 breast milk on a sub-sample of participants.

The ECHO Cohort Protocol will include Specialized Exposure and Specialized Outcome areas specifying the essential data elements and biospecimens that ECHO Cohort Study Sites will collect in each area. These Specialized areas will include more extensive elements or more detailed measures than the Core elements. The NIH ECHO Program Office anticipates the Specialized Exposure areas to include a) Physical & Chemical, e.g., air pollution and household chemicals; b) Lifestyle, e.g., nutrition, sleep, 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.

Specifically, the ECHO Measurement Core will have, but not be limited to, the following responsibilities:

1. Develop and refine measures for the ECHO Cohort Protocol, including methods to implement the measures

A. Lead development of a preconception section of the protocol in collaboration with other ECHO Cohort consortium investigators completed within the first 6 months of award so that the consortium can implement the protocol by the end of the first year

B. Lead development of new, validated, and reproducible measures to support revisions of the ECHO Cohort Protocol, as needed. Design and validate instruments to address conceptual and assessment gaps as needed, particularly for the preconception life stage and for father assessments

C. Modify existing ECHO Cohort Protocol measures to improve their collection and use

For all objectives under this responsibility area:

• Provide the necessary expertise, research services, and resources in the selection, development, and validation (as appropriate) of measures for inclusion in the protocol
• Ensure inclusion of validated measures that are essential in addressing health disparities, health equity, and social determinants of health
• Propose valid and culturally appropriate data collection methods for all and particularly for diverse populations
• Conduct research to ensure measurement instruments are useful, valid, reproducible and culturally sensitive for diverse participant groups
• Provide translation into Spanish and other languages as needed for participant-facing instruments in a timely manner
• Develop and validate remote assessments, mostly leveraging existing validated tools that are innovative and cost-effective, for appropriate use in ECHO, for example:
  • Behavioral and lifestyle measures for physical activity, sleep, diet, smoking, etc. e.g., wearables such as actigraphy
  • Clinical measures, e.g., use of Labor and Delivery electronic medical records
  • Environmental exposure measurements for pollution, pesticides, other chemicals, etc. e.g., sensors and wearables such as silicon wrist bands
  • Other technology such as phone apps and Computer Assisted Technology, for achieving maximum scientific value while moderating burden
• Provide consultation and technical support to Cohort Study Sites, Cores, and Centers in ECHO Cohort Protocol measures.
• Adhere to the extent possible to the use of NIH data standards including common data elements, such as those available through the PhenX Toolkit (www.phenxtoolkit.org) and the NIH CDE repository (cde.nlm.nih.gov)

2. Assist all ECHO Cohort Study Sites, Cores, and Centers in implementing and evaluating the ECHO Cohort Protocol, which comprises standardized measures at specified study visits

• Assist Cohort Study Sites, Cores, Centers and the Steering and Operations Committees in finalizing versions of the ECHO Cohort Protocol to capture core data elements among all participants at all ECHO Cohort Study Sites and specialized elements from all participants
• Collaborate with all Cohort Study Sites, Cores, and Centers to determine optimal study visit structure and choreography to implement the protocol, which follows a prescribed data and biospecimen collection schedule
• Collaborate with the Coordinating Center to develop manual(s) of operating procedures associated with the measurements in the ECHO Cohort Protocol, and provide or support training for Cohort Study Site staff on data collection
• Assist Coordinating Center and Data Analysis Center in evaluating protocol implementation fidelity
• Assist Data Analysis Center in conducting QA/QC of the ECHO Cohort Protocol data
• Collaborate with Cohort Study Sites, Cores, and Centers in providing data harmonization of varying measurements across protocol versions
• Contribute to overall data analysis and interpretation, and preparation of publications and resources originating in the ECHO Cohort consortium

3. Lead strategic decision-making to incorporate new and revised measures to advance ECHO Cohort science while moderating participant and staff burden

• In collaboration with other Cores and Centers, develop a process and system that rapidly develops and deploys a data and biospecimen collection strategy and tools for time sensitive research needs that may arise
• Identify and evaluate important developments in measurement fields for potential integration of novel measurements and approaches into the ECHO Cohort Protocol
• Collaborate with Cohort Study Sites, Cores, and Centers to strategize enhancing the ECHO Cohort Protocol to support scientific objectives of the Steering Committee
• Collaborate with the Coordinating Center and Data Analysis Center to create a technology pipeline that allows for rapid adoption of new or improved approaches to data collection and analysis to support the consortium.
• Ensure data collection strategies that are validated for diverse populations

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.

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:

Christina H. Park, Ph.D.
Telephone: 301-435-4013
Email: [email protected]

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed , with the following exceptions:

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.

R&R Budget

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

PEDP implementation costs:

• 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).

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:

Specific Aims: Briefly describe the Specific Aims of the proposed ECHO Measurement Core as outlined under Objective, Background, and Scope in Section I, the approaches for achieving the aims, and how the aims will support the ECHO Cohort consortium to achieve its overall goal of investigating 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 pre-, peri- and postnatal, upper and lower airways, obesity, neurodevelopment, and positive health among diverse populations.

Research Strategy: Describe the organization of the proposed ECHO Measurement Core and an approach to perform the tasks outlined in the Objective, Background, and Scope in Section I. Applicants should include:

• An overall organizational chart showing all organizational entities and the proposed PD(s)/Pl(s), the leaders of the various Measurement Core functions, and staff serving in a senior role. Propose specific plans and procedures to support effective interaction among the Measurement Core and the Cohort Study Sites, Cores, and Centers.

• A detailed description of the relevant expertise, experience, and capabilities of the applicant organization in the planning, direction, coordination, management, and provision of the full scope of the research support provided for in this application.

• A well delineated plan for performing tasks under each of the three major responsibility areas of the Measurement Core, as described under the Objectives and Scope:

1) Develop and refine measures for the ECHO Cohort Protocol, including methods to implement the measures; 2) assist all Cohort Study Sites, Cores, and Centers in implementing and evaluating ECHO Cohort Protocol, which comprises standardized measures at specified study visits; and 3) lead strategic decision-making to incorporate new and revised measures to advance ECHO Cohort science while moderating participant and staff burden. Applicants should include:

• A description of principles and framework under which they will plan, implement, and evaluate each responsibility area for contributing to ECHO Cohort science. Propose metrics for evaluating tasks and responsibilities. Describe plan for reports on progress, milestone accomplishments and timeline, and identification of any challenges and proposed solutions with regards to the protocol enhancements and for advancing measurement science. Describe an approach for creating culturally sensitive measures and for reducing bias and enhancing validity of the ECHO Cohort Protocol data collection measures across diverse population groups and across life stages.

• A description of the plan for how the proposed Measurement Core would follow the NIH and ECHO data sharing and use policies.

• If applying as a renewal, the applicant should document their progress during the first seven years in the ECHO Cohort consortium (FY2016-2022)

• If the applicant organization also applies to the ECHO Coordinating Center FOA, Data Analysis Center FOA, or Laboratory Core FOA, include a discussion of specific advantages offered to ECHO if the applicant organization was to support both the Measurement Core in addition to the other ECHO Cohort Core or Center(s).

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.