Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)
Office of Strategic Coordination (Common Fund)

Funding Opportunity Title

Environmental Influences on Child Health Outcomes (ECHO) Data Analysis Center (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices

  • December 17, 2015 - Notice of Frequently Asked Questions Posted to the Environmental influences on Child Health Outcomes (ECHO) Program Website and Upcoming ECHO Webinars. See Notice NOT-OD-16-039.
  • December 16, 2015 - Notice of New Application Forms Package for RFA-OD-16-005. See Notice NOT-OD-16-036.

Funding Opportunity Announcement (FOA) Number

RFA-OD-16-005

Companion Funding Opportunity

RFA-OD-16-001, UG1 Clinical Research Cooperative Agreements - Single Project

RFA-OD-16-002, U24 Resource-Related Research Projects – Cooperative Agreements

RFA-OD-16-003, U24 Resource-Related Research Projects – Cooperative Agreements

RFA-OD-16-004, UG3/UH3 Exploratory/Developmental  Phased Award Cooperative Agreement

RFA-OD-16-006, U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

PA-16-046, Administrative Supplements  

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.113, 93.121, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279,  93.286, 93.307, 93.310, 93.313, 93.350, 93.361, 93.393, 93.395, 93.399, 93.837, 93.838, 93.839, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867, 93.879

Funding Opportunity Purpose

The purpose of this FOA is to support a Data Analysis Center (DAC) for the Environmental Influences on Child Health Outcomes (ECHO) program.  The ECHO DAC will provide the data repository and the data analysis functions for all common ECHO activities.

NIH is establishing the new ECHO program to investigate the longitudinal impact of prenatal, perinatal, and postnatal environmental exposures on pediatric health outcomes with high public health impact. To do so, NIH will support multiple synergistic, prospective longitudinal studies using extant cohorts that represent variable environmental exposures (e.g., physical, chemical, biological, behavioral, social). These studies will collaborate on standardization and collection of core data elements to answer research questions of how environmental exposures impact one or more of four key pediatric outcomes. The program will be overseen by a Steering Committee of Investigators and an NIH Program Director, and an External Scientific Board. A separate, but related research effort, will support an IDeA States National Pediatric Clinical Research Network to help address access gaps for rural children by leveraging the infrastructure at existing IDeA state centers.

ECHO is being supported through 7 FOAs, including this FOA inviting applications for the ECHO Data Analysis Center. In addition, FOAs are being released to solicit applications to support new research questions for existing cohorts (Pediatric Cohorts), a Coordinating Center, a Patient Reported Outcomes (PRO) Core, an IDeA States Pediatric Clinical Research Network Data Coordination and Operating Center, and IDeA States Pediatric Clinical Research Network Sites, as well as supplements to the Children's Health Exposure Analysis Resource (CHEAR).

Key Dates
Posted Date

December 7, 2015

Open Date (Earliest Submission Date)

March 15, 2016

Letter of Intent Due Date(s)

March 15, 2016

Application Due Date(s)

April 15, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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.

AIDS Application Due Date(s)

April 15, 2016, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on this date.

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.

Scientific Merit Review

July 2016

Advisory Council Review

September 2016

Earliest Start Date

September 2016

Expiration Date

April 16, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

The objective of this FOA is to support the Data Analysis Center (DAC) of the NIH Environmental Influences on Child Health Outcomes (ECHO) program.  The ECHO DAC will provide the data repository and the data analysis functions for all common ECHO activities.

Following the closure of the National Children's Study (NCS) in fiscal year (FY) 2015, Dr. Francis Collins, the NIH Director, emphasized the importance of and need for research addressing the links between the environment and child health and development. To make the best use of the NCS-appropriated funds for FY 2015, NIH established new programs and enhanced existing programs focusing primarily on the development of tools to enhance measurement of environmental exposures (e.g., physical, chemical, biological, psychosocial), and the study of environmental influences on placental and in utero development to identify the "seeds" of future diseases and conditions.

The new ECHO program for FY 2016 continues to leverage investments made in extant programs while providing the flexibility to investigate key questions of interest at the intersection of environmental health and pediatric research. NIH will support multiple synergistic, longitudinal studies using extant cohorts that represent a broad range of environmental exposures (e.g., physical, chemical, biological, behavioral, social). All longitudinal studies will test the hypothesis of how environmental exposures impact childhood health outcomes. Studies will include a strategy for collection of a targeted set of data (Core Elements) as a component of the project and will agree to collaboration on standardization through Steering Committee participation. These Core Elements will include:

  • Demographics [e.g., race, gender, ethnicity, socioeconomic status, geographic location/diversity]
  • Typical Early Development [e.g., growth, milestones, sleep, nutrition, activity level]
  • Optional Sub-Element: Microbiome
  • Genetic Influences on Early Childhood Development
  • Optional Sub-Element: Epigenetics [e.g., maternal "exposome"]
  • Environmental Factors [e.g., physical, chemical, biological (including in utero), psychosocial, natural and built environments]
  • Patient Reported Outcomes (PROs) [e.g., PROMIS Adult and Pediatric Self- and Proxy-Reported Health representing Physical, Mental and Social Health Domains]

The cohort studies will focus on one to four key pediatric outcomes to assess range of functioning over time. These Focus Areas are:

  • Upper and Lower Airway [e.g., asthma, allergies, sleep disordered breathing]
  • Obesity [e.g., nutrition, diabetes, metabolic risk factors]
  • Pre-, Peri-, and Postnatal Outcomes [e.g., birth defects, childhood outcomes]
  • Neurodevelopment [e.g., autism, ADHD, depression, social/behavioral development, cognition]

The FY 2016 plan aims to provide the flexibility and opportunity to investigate key questions of interest at the intersection of environmental health and pediatric research, while also leveraging additional features and capabilities of the studies. For example, the studies could:

  • Take maximal advantage of existing tissue banks collected across pregnancy (e.g., cervicovaginal secretions, maternal DNA, cord blood, placenta, child DNA, child stool specimens) and data sets by funding additional analyses
  • Serve as a test bed for validating new technologies, tools, and approaches for efficient and effective environmental and pediatric monitoring
  • Use systems approaches to develop multi-variable models to predict disease development
  • Recruit participating women with subsequent pregnancies to investigate outcomes of second children to serve as a comparison cohort to first pregnancy children

An additional opportunity for creating an IDeA States National Pediatric Clinical Research Network also will be supported. This national network for pediatric research will help address access gaps for rural children through a national network for pediatric research embedded at IDeA locations and link existing IDeA state centers with experts in clinical trials.

This set of companion FOAs aims to create a consortium of sites and investigators to conduct longitudinal studies of the effects that early environmental exposures (including in utero exposures) have on later child development and health outcomes.  The consortium will consist of:

  • Pediatric Cohort: extant cohorts will be followed prospectively, with assessments of exposures and outcomes.  Pediatric cohorts will each conduct individual prospective longitudinal studies targeting at least one focus area and will participate with the other awardee clinical sites to conduct mutually agreed upon collaborative studies of a synthetic cohort of pooled sites. [RFA-OD-16-004]
  • Coordinating Center: a central site responsible for organizing and managing activities and logistics for collaborative components of the consortium, including oversight and coordination of all ECHO programs, multi-cohort study design and protocol and informed consent development, administrative management of multiple-site/-project studies, evaluation of progress, data quality and completeness, and sample storage. The ECHO Coordinating Center will include an Opportunities and Infrastructure Fund to support pilot projects and to introduce new tools and technologies in the context of the ECHO program. [RFA-OD-16-006]
  • Data Analysis Center: responsible for managing data from ECHO pediatric cohorts, developing and applying novel analytic methods for combining and analyzing existing and new longitudinal data from disparate extant cohorts, and for conducting multi-level analyses on pooled consortium data to address the impact of early life exposures on childhood health outcomes. [this FOA]
  • CHEAR Core: serve as a resource for analyzing personal environmental exposures from existing and prospective collections [PA-16-046]
  • PRO Core: responsible for maintaining and providing PROs, assisting with the incorporation of PROs into study design, coordinating the mode of administration, and updating existing and validating emerging child PROs [RFA-OD-16-003]
  • Data Coordinating and Operations Center for the IDeA States Pediatric Clinical Trials Network: a central site within the IDeA program that provides data coordination functions for pediatric clinical trials, technical instruction, adherence to state-of-the-art data standards, quality assurance, and an operational interface between the IDeA system and other entities. [RFA-OD-16-002]

Clinical Sites for the IDeA States Pediatric Clinical Trials Network: sites at which teams of dedicated pediatric research staff will be established to augment geographic diversity of clinical trials [RFA-OD-16-001]

Specifically, the DAC will have the following responsibilities:

  • Assist the ECHO Coordinating Center and the Steering Committee in the development of clinical research protocols to capture ECHO Core Elements data from all Pediatric Cohorts by conducting sample size and statistical power calculations and by developing a complete statistical analysis plan to accompany every research protocol conducted across ECHO Pediatric Cohort sites.
  • In collaboration with the ECHO Coordinating Center, develop, validate and apply Quality Assurance and Quality Control methodologies to be used in the data entry processes for ECHO Core Elements, as well as for other across-ECHO collaborative projects supported by the ECHO Opportunities and Infrastructure Fund. Applicants for the ECHO DAC are strongly encouraged to also apply to the ECHO Coordinating Center FOA   
  • In collaboration with the ECHO Coordinating Center, provide data entry training to ECHO Pediatric Cohort staff.
  • Develop and maintain the ECHO database that will contain Core Elements data to be collected by all ECHO Pediatric Cohorts, as well as data from other across-ECHO collaborative projects conducted across specific ECHO focus area sites or supported by the ECHO Opportunities and Infrastructure Fund.
  • Establish, validate and maintain a common, standardized electronic interface for transferring Core Element data into the ECHO database; this includes both data that were captured by the Cohorts prior to their participation in ECHO, as well as data that will be acquired in the context of new, prospective ECHO protocols.  This responsibility involves:
  • Development and utilization of data dictionaries (meta-data) that describe the formatting and contents of uploaded data for all systems.
  • Compliance with privacy and accessibility regulatory requirements and/or Public Laws (e.g. Section 508 amendment to the Rehabilitation Act, Privacy Impact Assessment, Title 21 CFR Part II, Privacy Act, Health Insurance and Portability and Accountability Act (HIPAA) etc.
  • Testing, validating, and optimizing data capture systems to provide immediate feedback on user errors logic errors, and out-of-range data, including across-form consistency.  
  • Establish collaboration and electronic communication routes for transferring ECHO data from and to the CHEAR and the PRO ECHO Cores, as well as the ECHO Genetics Core; meta-data requirements and compliance with privacy and accessibility regulatory requirements will apply in these data transferring tasks, as described above. 
  • Develop and document a data security plan with appropriate security processes and procedures.  This includes:
  • Availability of general information technology security expertise.
  • Using the National Institute for Standards and Technology Special Publication 800-18 guidance on appropriate topic areas and a plan of action and milestones that would address security plan vulnerabilities.
  • Developing a plan for disaster recovery that meets project needs for availability, confidentiality, and data/application location.
  • Developing a plan and assign responsibilities for information technology security at each ECHO Pediatric Cohort site and at the ECHO core facilities.
  • Provide complete statistical analysis support for across-ECHO primary and secondary analyses of the ECHO Core Elements data (including genetics data) and for data from other across-ECHO collaborative projects supported by the ECHO Opportunities and Infrastructure Fund, as pre-determined by the statistical analysis plan; collaborate with the CHEAR and the PRO ECHO Cores, as well as the ECHO Genetics Core in the analysis of across-ECHO data.  In addition:
  • Establish a mechanism to process requests for secondary/ancillary analyses not addressed in the analysis plan requiring that such requests contain a scientific question/hypothesis, and lists of variables, time points and proposed comparisons.
  • Establish plans to set priorities for analyses by an ECHO Steering Committee working group that includes DAC representation and takes into account the total Full Time Equivalents of statistical and statistical programming effort dedicated to these tasks. 
  • Assist the ECHO Steering Committee and individual investigators at the ECHO Pediatric Cohorts in the preparation of public presentations and manuscripts deriving from the analysis of the ECHO Core Elements and of other across-ECHO collaborative projects supported by the ECHO Opportunities and Infrastructure Fund.
  • In accordance with the ECHO data sharing policy, develop a public domain database with de-identified data and data visualization tools that will be available to the ECHO investigators, as well as to investigators outside ECHO.
  • Participate as a co-chair of and a voting member in the functions of the ECHO Steering Committee, as well as serve on the Executive Committee.

Applicants for the ECHO Data Analysis Center are strongly encouraged to also apply to the ECHO Coordinating Center FOA.  Note that each application to these two FOAs should be self-contained.

 
This FOA will not support:
  • Data analyses of studies conducted within each ECHO Pediatric Cohort that do not represent collaborative work between ECHO cohorts.
  • Data analyses of clinical trials conducted under the ECHO-associated IDeA pediatric clinical trials network. 
See Section VIII. Other Information for award authorities and regulations.
Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIH intends to commit up to $5,000,000 in FY 2016 to fund one award.

Award Budget

Application budgets are limited to $3,000,000 in direct costs for Year 1, $6,250,000 in direct costs for Year 2, and $9,500,000 in direct costs for other project years. Application budgets need to reflect the actual needs of the proposed project.

Award Project Period

The project period may not exceed 7 years. 

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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)

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)
  • 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
Foreign Institutions

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 not allowed.

Required Registrations

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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – 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. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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.

Eligible Individuals (Program Director/Principal Investigator)

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 underrepresented racial and ethnic groups as well as individuals with disabilities 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.  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 NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the "Apply for Grant Electronically" button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

Alkis Togias, MD
Telephone: 240-627-3587
Fax: 301-480-4258
Email: togiasa@niaid.nih.gov

Page Limitations

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

  • 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.  

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.

Applicants should consider budgeting for support of 2-3 ECHO-wide clinical protocols that will collect and analyze Core Elements data from approximately 50,000 ECHO pediatric cohort participants from up to 30 pediatric cohort awardees, over the entire period of the Cooperative Agreement. Applicants should also consider budgeting for the statistical support of 1-2 clinical protocols within each of the Scientific Focus Areas (up to 7-8 clinical sites and approximately 10,000 participants per Scientific Focus Area) over the entire period of the Cooperative Agreement.  Finally, the ECHO DAC will need to support the pilot projects that will be funded by the ECHO Opportunities and Infrastructure Fund (OIF) including a) helping with the statistical design of those protocols, b) creating the appropriate databases for data entry and c) conducting the statistical analyses.  In preparing the budget use the following information when estimating the budget. It is anticipated that, every year, with the exception of Year 1 and Year 5 of the award, the OIF will support up to 10 pilot studies (probably no more than 100 participants per study) of up to 2 years duration.  Approximately 50% of those studies will require ECHO DAC support.

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 Data Analysis Center. Use separate specific aims to address the database functions and the statistical analysis functions of the Center.

Research Strategy:  Describe the overall organizational status of the proposed ECHO DAC.  Include:

(i)  An overall organizational chart showing all organizational entities and the proposed PD(s)/PI(s), the Leaders of the various DAC functions, and staff serving in a senior role.

(ii)  A description of overall plans for the governance of the Center, including lines of authority and reporting, decision-making processes, and communication processes within the Center and between the DAC and the ECHO NIH Program Director and NIH Team, as well as between the DAC and the members of the ECHO Steering and Executive Committees.  Propose specific plans and procedures to support effective interaction between the DAC and the ECHO Coordinating Center.

(iii)  A detailed description of the relevant expertise, experience and accomplishments 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.  If the applicant organization also submits an application for the ECHO Coordination Center FOA (RFA-OD-16-006), include a discussion of specific advantages offered to ECHO if the applicant organization were to support both the Coordinating Center and the DAC.

Database Functions

Describe the proposed ECHO databases and plans for data entry and security.  Include:

(i)  Plans for the development and maintenance of the ECHO database as the primary ECHO data repository.  Include description and capabilities of the platform to be used, prior experience with this platform, and discuss problems that have been previously encountered and solutions reached.

(ii)  Plans and procedures to establish, validate and maintain a common, standardized electronic interface for transferring data into the ECHO database and establish and test its security and compatibility with privacy and accessibility regulatory requirements. Specifically address issues of compatibility with other common platforms and approaches to solving compatibility problems assuming that each of the ECHO Pediatric Cohorts and the ECHO Cores to be awarded may already have developed databases for data collection and storage.  Provide a timeline for the development of the ECHO database including a timeline for its effective interaction with the ECHO Pediatric Cohorts and all ECHO Cores. 

(iii)  A description of processes to develop and maintain online, interactive data visualization tools to be used with the ECHO database that will be available to both the ECHO investigators and to investigators outside ECHO.  Discuss prior experience and provide examples of such tools.  Discuss expected challenges and approaches in providing solutions.  Provide timelines for the development of such tools.

(iv)  A description of processes to develop, validate and apply Quality Assurance and Quality Control methodologies to be used in the data entry processes for ECHO Core Elements, as well as for other across-ECHO collaborative projects supported by the ECHO Opportunities and Infrastructure Fund.

(v)  Plans for collaboration with the ECHO Coordinating Center to provide data entry training to ECHO Pediatric Cohort staff.

Statistical Analysis Functions

Describe all statistical support and data analysis aspects of ECHO.  Include:

(i)  Plans to support the development of across-ECHO research protocols with sample size and statistical power calculations and to develop protocol-specific statistical analysis plans.  Provide description of most appropriate statistical methodologies to address the scientific goals of ECHO focusing on the relationship of physical, chemical, biological, behavioral, social, natural and built environments to pediatric health outcomes including typical childhood early development as well as childhood conditions as described in the ECHO focus areas (upper and lower airway conditions, obesity, pre-, peri-, and postnatal outcomes and neurodevelopmental conditions).  Include statistical designs for analyzing genetics data to be provided by the ECHO genetics Core in the context of the above-described outcomes.

(ii)  Discuss common, expected statistical design and analysis problems and difficulties associated with clinical studies addressing the above-described needs and provide approaches to overcome and/or improve identified problems/difficulties and optimize the yield using establish and emerging statistical methodologies.  Provide examples of experience that the proposed Center has had with such problems and solutions attained.

(iii)  Plans and procedures to assist the ECHO Pediatric Cohorts in data curation/cleaning prior to database lock.

(iv)  A description of the assistance that the proposed Center will provide to the ECHO Steering Committee and to individual investigators at the ECHO Pediatric Cohorts in the preparation of public presentations and the development of abstracts and manuscripts deriving from across-ECHO analyses of the ECHO Core Elements and of other across-ECHO collaborative projects.  Describe processes for reviewing the accuracy and completeness of descriptive data and statistical analysis data in any form of reporting on the results of across-ECHO research studies.  Describe the assistance that the DAC will provide in the development of periodic study status reports, ethics committee updates, and interim (if required) and final study reports. 

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.

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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.

In addition:

  • Grants funded under this FOA will not be awarded with the Streamlined Noncompeting Award Process (SNAP) authorities (NIH Grants Policy Statement 8.4.1.2 Streamlined Non-Competing Award Process).
  • Grantees will not be able to submit a modified progress report.
  • Grantees will not be provided the authority outlined in the NIH Standard Terms of Award to extend the final budget period of the previously approved project period one time for up to 12 months beyond the original expiration date shown in the Notice of Award. All extensions, including the first extension, will require NIH prior approval.
  • Grantees will not have authority to automatically carryover funds. All carryover actions require NIH prior approval.
  • Grantees must submit annual Federal Financial Reports (FFRs).
  • All grant funds must be expended within the approved project period on a first-in, first-out basis. Unobligated funds reported on the FFR must be returned to NIH.
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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number 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.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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).

Scored Review Criteria

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.

Significance

Does the proposed Center address the needs of the ECHO research program that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the ECHO research program?

Do the specific aims support the goals of the ECHO program to investigate the longitudinal impact of prenatal, perinatal, and postnatal environmental exposures on pediatric health outcomes with high public health impact?  What advantages will the Data Analysis Center bring to the research community for the storage, maintenance, analysis, interpretation, curation, and integration of data generated by the ECHO Program?     

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the research team have experience processing, integrating, and analyzing longitudinal data from synthetic cohorts on environmental exposures, genomics (e.g., genome-wide SNP genotyping), and gene-environment interaction? Does the research team have an established record of collaborating with clinical researchers or epidemiologists studying diverse topics?

Innovation

Does the application propose novel data analysis, database development concepts or data management strategies in support the ECHO research program the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application for data analysis, database development or data management strategies proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?  Will the proposed strategies, methods, and analyses support the overall goals of the ECHO program to investigate the longitudinal impact of prenatal, perinatal, and postnatal environmental exposures on pediatric health outcomes with high public health impact?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Is the proposed plan for establishment and support of communication among all participants in the program appropriate? 

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Are the computing and data storage resources sufficient to support the ECHO program? 

Additional Review Criteria

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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:

  • 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.
  • Will receive a written critique.

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.
  • Documentation that computing and data storage capabilities sufficient to support the technical needs of the ECHO program will be available throughout the life of the ECHO program.
  • Potential for coordination with the ECHO Coordinating Center
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 grantee's business official.

Awardees 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.

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: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

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, and other DHHS, 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 awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

  • Directing the activities of the ECHO Data Analysis Center, including: (i) establishing and implementing processes for decision-making, communication and collaboration; (ii) establishing and implementing processes and systems for tracking the implementation of Center support functions, 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 Center resources and expenditures; (v) implementing and managing an information system to support day-to-day Center activities; (vi) establishing and managing portals for study-specific documents/materials; (vii) reporting to and obtaining input from the ECHO Steering Committee (including the Executive Committee), the External Scientific Board, the ECHO Coordinating Center PD/PI, the ECHO Genetics Core PD/PI, the ECHO PRO Core PD/PI, the ECHO CHEAR Core PD/PI, the ECHO Pediatric Cohort site PDs/PIs, and the IDeA States Pediatric Clinical Trials Network DCOC PD/PI; and (viii) establishing procedures and metrics for assessing Center progress and productivity.
  • Providing the full scope of ECHO data management and analysis support including cross-project analyses for ECHO Pediatric Cohort sites and managing the ECHO database; ensuring appropriate and effective coordination and collaboration with the NIH ECHO Program Director and the NIH ECHO Team, the ECHO Steering Committee, the ECHO Coordinating Center PD/PI, the ECHO Genetics Core PD/PI, the ECHO PRO Core PD/PI, the ECHO CHEAR Core PD/PI, and the ECHO Pediatric Cohorts PDs/PIs (across all ECHO cohorts and within ECHO scientific focus areas); and ensuring that the performance of support functions complies with all Federal and, where appropriate, country-specific regulatory requirements and guidelines for the conduct of human subjects research, as well as NIH policies and procedures.
  • Providing reports to the NIH ECHO Program Director and the NIH ECHO Team regarding Coordinating Center and overall ECHO activities (e.g. tabular summaries of study progress, protocol deviation and site monitoring reports), as well as budgetary summaries as requested.
  • Ensuring the appropriate training/certification of Data Analysis Center staff designated to provide data management and data analysis support, and including a list of all training programs and written assessments in the Annual Progress Report.
  • Data generated under the support of ECHO will become publicly accessible to outside investigators, through the ECHO database, within a pre-specified period that will be negotiated with the NIH ECHO Program Director before the award is issued.

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

NIH assistance to the ECHO operations will be provided by the ECHO Project Director and the NIH ECHO Team, as well as by NIH Project Scientists or other NIH staff that may be assigned to across-ECHO studies or studies within one of the four 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. It is anticipated that decisions regarding the Data Analysis Center activities will be reached by consensus 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.

  • Concept Proposals and Study Protocols:  NIH Project Scientists will: (i) participate in the development, review and approval of the concept proposals and research protocols of all across-ECHO studies and of ECHO-supported studies that will entail a particular ECHO scientific focus area; (ii) provide final approval prior to initiation for across-ECHO studies as well as for ECHO-supported studies within each ECHO scientific focus area; (iii) approve timelines for protocol development, implementation and completion; (iv) participate in the data analysis process and the development of manuscripts resulting from ECHO-supported studies.
  • Study Monitoring and Management: (i) The NIH ECHO Team and NIH Project Scientists, through the ECHO Coordinating Center, will monitor compliance with OHRP and NIH requirements for human subject research, accurate protocol implementation and internal quality assurance across all ECHO-supported studies.  This includes: participating in the development of and approving Data and Safety Monitoring Plans prior to study initiation; determining the need to conduct for-cause clinical site visits, participating in such visits, and approving recommendations for remedial actions. (ii) NIH staff will participate in ECHO Study Management Teams to manage the day-to-day implementation of ECHO-supported studies that will be conducted across all ECHO Pediatric Cohorts or across-Cohort studies that address an ECHO scientific focus area.
  • IND/IDE Sponsorship: Aside from the IDeA States Pediatric Clinical Trials Network, the ECHO Pediatric Cohort sites are not likely to conduct clinical trials requiring IND/IDE sponsorship.  However, in the rare event that this becomes a necessity, the ECHO NIH Program Director will determine on a case by case basis whether the regulatory sponsor for a clinical trial conducted under IND/IDE will be an NIH IC or an ECHO Pediatric Cohort Investigator.  If the regulatory sponsorship responsibility is assigned to a NIH IC, NIH Project Scientists/Medical Monitors will obtain, through the ECHO Coordinating Center and the ECHO Data Analysis Center, regular reports on serious adverse events and protocol deviations, and will decide on the final disposition of SAE Reports for all IND/IDE studies.
  • Study Termination:  NIH reserves the right to terminate, curtail or suspend an ECHO-supported study for any reason, including but not limited to risks to subject safety, occurrence of unforeseen safety or ethical issues, scientific question is no longer relevant or the objectives will not be met, failure to comply with Federal regulations or Terms and Conditions of Award, and reaching a major study endpoint before schedule with persuasive statistical significance.
  • Access to Data:  The NIH ECHO Team and NIH Project Scientists will have the right of access to all data (raw and analyzed) generated under this cooperative agreement and may periodically review these data.
  • Grant Stewardship: Additionally, a NIH 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.

The ECHO NIH Program Director, with approval by the NIH Director, will establish an ECHO External Scientific Board.  The External Scientific Board will submit its recommendations to the ECHO NIH Program Director, who will then inform the members of the ECHO Steering Committee.  Recommendations by the External Scientific Board are consultative.

Areas of Joint Responsibility include:

  • The NIH ECHO Program Director and the NIH ECHO Team, in collaboration with the PDs/PIs of all ECHO awards, will participate in deliberations and decision-making regarding the multiple substantive, operational, financial and administrative responsibilities of this NIH initiative.
  • NIH Project Scientists and/or their designees will collaborate with ECHO Data Analysis Center staff to ensure the provision of appropriate information, materials and training regarding NIH policies and procedures for the conduct of human subject research.
  • Close interactions amongst the awardee, awardees from the companion FOAs, and NIH will be required. Shortly after the award, the PDs/PIs and NIH program staff will form the ECHO Steering Committee, which ultimately will report to the NIH Director.

ECHO Steering Committee

  • The ECHO Steering Committee will be co-chaired by the NIH ECHO Program Director, the PI/PD of the Coordinating Center, and the PI/PD of the Data Analysis Center. It also will be composed of the PIs/PDs of the PRO Core, CHEAR Core, the Genetics Core, the IDeA States Pediatric Clinical Trials Network DCOC, and each of the cohort sites, who all will have 1 vote. The NIH ECHO Program Director and the NIH ECHO Team will serve as non-voting members of the ECHO Steering Committee.
  • An Executive Committee of the Steering Committee also will be established, and will be composed of the three co-chairs and a representative from each of the funded elements – one each from the PRO Core, the Genetics Core, CHEAR Core, and the IDeA States Pediatric Clinical Trials Network DCOC, as well as one PI/PD collectively representing the cohort sites.
  • The Executive Committee will invite expert consultants as needed, coordinate with the External Scientific Board, assist as necessary with annual progress reports, and appoint and charge members of subcommittees.
  • These subcommittees will facilitate development, implementation, and monitoring of specific ECHO functions as needed. Suggested subcommittees include:
  • Data Measurement and Sharing: members from each cohort site, the CC, the DAC, and the PRO Core; responsible for selecting core measures and establishing protocols for data collection, quality control (QC), and sharing; CC and DAC would implement the protocols, conduct training and QC, etc.
  • Biostatistics and Design: members from each cohort site, the CC, the DAC, and the PRO Core; responsible for (1) developing analysis plans for each of the core measures, including biospecimens and environmental samples, (2) reviewing and providing advice on the analysis plans for each of the participating cohorts, (3) conducting methods research based on issues that arise during the course of the project, (4) serve as a consulting body for any of the PDs/PIs seeking input on analysis issues
  • Publications: members from each cohort site, CC, DAC, and the PRO Core; responsible for developing publication policies and procedures, review of abstract and manuscript proposals for cross-project papers and presentations, review of proposed ancillary studies, and review of proposed pilot studies
  • Focus Areas: members from the cohorts in each Focus Area and the CC; separate subcommittees for each of the 4 Focus Areas to support regular interactions among investigators interested in the same Focus Areas
  • Project Coordinators: members would include the coordinators from the cohort sites and a CC representative; meet regularly for exchange of information about their studies, and help each other identify best practices for a variety of logistical issues including retention, training, data collection, etc.
  • IDeA States Network: members from the participating IDeA states sites, IDeA states DCOC, and the CC; meeting regularly for exchange of information about their projects, best practices, etc.
  • Key personnel will be expected to serve on subcommittees, as appropriate, according to their expertise.
  • The Steering Committee will meet in person quarterly during the first year and at least annually thereafter. Monthly teleconferences will be held for the Steering Committee and its subcommittees, and these may be more frequent at times to facilitate planning, etc. The Coordinating Center (CC) will be responsible for arranging and facilitating the meeting and teleconferences. Applicants should plan to attend an initial planning meeting of the Steering Committee in Bethesda, Maryland in fall 2016.
  • The Steering Committee will have responsibility for developing the overall scientific direction of the program; assuring compliance with program policies and procedures; designing study protocols; implementing studies; ensuring data quality and completeness; planning for analysis and interpretation of data; and reporting results in presentations and publications.
  • The Steering Committee must work cooperatively and interactively during the first year to develop the final protocols and all of the materials necessary to begin the prospective human studies within 12-18 months after award. The final plan, with a study timeline and milestones, will be submitted and must be approved by the NIH ECHO Program Director and the NIH Director, with involvement of the NIH ECHO Team and relevant IC program staff, before the second year of funds will be awarded.
  • First year planning activities include, but are not limited to:
  • Developing clinical and laboratory protocols and plans for data collection and management
  • Standardizing collection of core data elements
  • Overseeing plans to address the various bio-ethical issues and concerns (e.g., handling of sensitive data, participatory risk, involvement of vulnerable populations, incidental findings) that are likely to arise during the conduct of the research
  • Obtaining approvals as needed at the ECHO Pediatric Cohort site institutions, such as IRB approvals
  • Preparing a Manual of Operations with primary responsibility residing with the CC
  • Developing a detailed plan for storage and shipping of all biospecimens
  • Developing detailed plans for the thorough analysis of data
  • Agreeing to abide by a common data sharing plan
  • Developing a detailed timeline with concrete milestones for the entire study

External Scientific Board

  • Five to seven external experts will serve as the External Scientific Board (ESB), and will be selected and appointed by the NIH ECHO Program Director and NIH Director.
  • The ESB will review and offer input on ECHO structure, function, and studies, both during protocol development and during the analysis of results.  Members of the Board will provide input based on their individual areas of expertise, as needed over the course of the program.  They will assist the NIH regarding processes and substantive issues that arise during the project and will help ensure that the resources to be delivered by the program are as useful as possible for the end users.
  • External Scientific Board members may be invited to attend some ECHO Steering Committee meetings. 

Data and Safety Monitoring Board

  • In the event the ECHO activities include clinical trials, an independent DSMB will be established to monitor and provide recommendations to the NIH regarding participant recruitment/enrollment, safety, data quality, and other issues, as appropriate. The DSMB will also review the Steering Committee-approved common protocol, informed consent templates, milestones, and monitoring plans prior to the start of recruitment.  It is recommended that, if possible, a single central Institutional Review Board (IRB) is used to streamline the protocol approval process and to standardize the monitoring of human subjects' protection in the ECHO program.

Development of Milestones

  • Because this Consortium will require specific achievable goals (e.g., timely recruitment of participants, expected annual throughput), milestones should be proposed by the applicant. Milestones are goals that are quantifiable for measuring success, and include associated annual or semi-annual quantitative criteria.
  • Final milestones will be designed during the first year in the planning phase. After review and approval by the NIH, the final set of approved milestones will be specified in the Notice of Award.
  • Progress towards achieving the final set of milestones will be evaluated by NIH program staff on an annual basis. If justified, future year milestones may be revised based on data and information obtained during the previous year. If, based on the progress report, the project does not meet the milestones, funding for the project may be either restricted or discontinued.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the ECHO awards) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The panel members will be a designee of the ECHO Steering Committee, 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 awardee.  This special dispute resolution procedure does not alter the awardee'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, awardees 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 progress report, 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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 $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)

Telephone: 301-435-0714

Scientific/Research Contact(s)

Alkis Togias, MD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3587
Email: togiasa@niaid.nih.gov

Peer Review Contact(s)

Valerie Durrant
Center for Scientific Review (CSR)
Telephone: 301-827-6390
Email: durrantv@csr.nih.gov

Financial/Grants Management Contact(s)

Donna Sullivan
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2979
Email: DSullivan@niaid.nih.gov

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.

Authority and Regulations

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.

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