Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title

Re-Competition of Global Network for Women’s and Children’s Health Research (UG1)

Activity Code

UG1 Clinical Research Cooperative Agreements - Single Project

Announcement Type

Reissue of RFA-HD-13-006.

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-HD-18-009

Companion Funding Opportunity

None 

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

93.865  

Funding Opportunity Purpose

This funding opportunity announcement (FOA) invites applications from U.S. institutions to support Research Units (RUs) within the Global Network for Women’s and Children’s Health Research at NICHD.  RUs will consist of U.S.-based research centers applying in partnership with research centers in low income countries as defined by the World Bank.  The RUs within the Global Network will participate in addressing the major causes of maternal, neonatal, infant, and early childhood morbidity and mortality through the conduct of clinical research.  The grantees will become part of a cooperative network in scientific partnership with the NIH to conduct multi-enter observational studies and randomized clinical trials evaluating disease process, health and wellness outcomes, and results from interventions in resource-poor settings.      

Key Dates

 

Posted Date

July 18, 2017

Open Date (Earliest Submission Date)

October 27, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

November 27, 2017, 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)

Not Applicable  

Scientific Merit Review

March 2018

Advisory Council Review

May 2018

Earliest Start Date

July 2018

Expiration Date

November 28, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow 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 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

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

Research Objectives

The objective of this initiative is to stimulate and expand research which addresses gaps in the scientific knowledge around disease processes and treatment strategies that have implications for the health outcomes of mothers and their infants globally. The primary goal of this research program will be to conduct cost-effective, high impact, multi–center, large scale clinical studies targeted at understanding the best method to reduce maternal and infant mortality and morbidity among global populations with the highest burden of death and disability. 

Other critical goals are to: (1) develop sustainable research capacity and public health intervention capabilities in developing countries, (2) strengthen international collaborative research efforts that focus on the leading causes of morbidity and mortality in pregnancy and early childhood, and (3) identify and address gaps in maternal and child research. A key objective for the network Research Units (RUs) is to collaboratively design, develop, and conduct multiple protocols, as well as to evaluate and implement evidence-based health interventions and pertinent formative and translational research studies, including implementation research. These studies must have a strong scientific and epidemiologic basis for their use in a foreign country and should be culturally appropriate. The primary endpoints in these studies must be associated with demonstrable improvement in important public health measures in the population under study.

Background

Among the top priorities of the United Nation’s Millennium Development Goals (MDGs) were to significantly impact maternal and child health by 2015 by reducing maternal mortality by three -quarters and under 5 mortality by two thirds, respectively. Since then, a new initiative has been created by the United Nations titled the Sustainable Development Goals (SDGs). The 17 Sustainable Development Goals (SDGs) with 169 targets are broader in scope and go further than the MDGs by addressing the root causes of poverty and the universal need for development that works for all people. The goals cover the three dimensions of sustainable development: economic growth, social inclusion and environmental protection.  

The new goals are universal and apply to all countries, whereas the MDGs were intended for action in developing countries only. A core feature of the SDGs is their strong focus on means of implementation—the mobilization of financial resources—capacity-building and technology, as well as data and institutions. Some estimates show that compared to the 1990s, there are 17,000 fewer children dying today. Despite such improvements, globally, more than six million children die before their fifth birthday. Among these, an increasing proportion of child deaths occur in sub-Saharan Africa and Southern Asia. Four out of every five deaths of children under age five occur in these regions.  Although the maternal mortality rates have fallen by almost 50% since 1990, in Eastern Asia, Northern Africa and Southern Asia, maternal mortality has declined only by about two-thirds the rate in 1990. In developing regions of the world, the maternal mortality ratio – the proportion of mothers who do not survive childbirth compared to those who do – remains 14 times higher than in the developed regions. Globally, the percentage women receiving the recommended amount of antenatal health care they require has been increasing (up to 83% in advanced nations by 2012), yet only about 50% of pregnant women in developing regions receive the recommended care.

Therefore, there is an urgent need to develop, through well-designed studies, improved diagnostic and treatment strategies for some of the most important causes of women and children’s poor health outcomes.

Scope

The Global Network conducts common research protocols that address the major causes of morbidity and mortality among women and young children in the developing world. Grantees will be part of a Global Network that will include clinical Research Units (dyads of U.S. and foreign teams) and an independently funded Data Coordinating Center (DCC). The Global Network is intended to strengthen and enhance the global infrastructure and research capacity for women's and children's health research. It will increase opportunities for scientific linkages, interaction, knowledge development and transfer, and collaborative partnerships among U.S. and foreign investigators and institutions.

This initiative calls for a broad array of interventional studies to be conducted across sites in the competitively selected developing countries. The studies will address health conditions in women and young children, with an emphasis on the perinatal and neonatal periods, and early childhood up to and including 3 years of age. Proposed interventions should emphasize the development, testing, adaptation and implementation of cost-effective, integrated biomedical, behavioral, social, and public health interventions that may reduce causes of morbidity and mortality among women of reproductive age and young children.

The Global Network emphasizes a multidisciplinary, team-based approach. Disciplines may include pediatrics, family medicine, obstetrics, infectious diseases, epidemiology, nutritional science, environmental science, pharmacology, and the behavioral and social sciences. Global Network teams should be based primarily at the institution of the Senior Foreign Investigator (SFI) as it is not the intention of this FOA to support multi-disciplinary teams of investigators in the U.S.  The Global Network will function as a collaborative group that fosters communication, innovation, and research excellence. Applicants should expect to participate in clinical trials that may be conducted in several or all network sites. Grantees must be willing to work collaboratively and with cultural sensitivity.

Applications for meritorious multi-center research studies that are relevant to the health needs of more than one locality will be reviewed and funded under the Network. All research conducted under the auspices of the Global Network must be designed such that health improvements in the study population are meaningful, sustainable, and likely to represent a measurable and significantly improved health outcome. Surrogate or intermediate outcomes must be well defined and scientifically well justified.

Priority will be given to scientific activities that have the greatest likelihood of improving pregnancy and child outcomes in low income countries. Suitable topics for proposed research projects include, but are not limited to, the following:

  • Prevention or reduction of leading causes of maternal morbidity and mortality, including but not limited to, malnutrition, infectious diseases, hypertensive disorders, obstructed labor, hemorrhage, anemia, cervical cancer, and cancers exacerbated by environmental exposures.
  • Studies focused on assessing and improving pregnancy management, including reduction of infection, emergency care, birth practices, resuscitation, and postpartum care of the mother, neonate, and young infant.
  • Prevention and reduction of unplanned pregnancy, fetal loss, stillbirths, preterm delivery, intrauterine growth retardation and birth defects.
  • Prevention, diagnosis and treatment of infectious diseases in infants and young children up to 3 years, including, but not limited to, sepsis, acute respiratory tract infections, vaccine-preventable infections, diarrheal diseases, malaria and other parasitic diseases.
  • Nutritional interventions that enhance pregnancy outcomes and infant growth, development, energy, and immunity. 
  • Prevention and treatment of environmental exposures in girls and women of reproductive age and young children up to 3 years, including, but not limited to, tobacco, indoor air pollution, toxic chemicals, and water-borne infectious agents.
  • Within GN clinical trials, conduct research that describes major individual, social and cultural factors (such as belief systems, affordability, availability, and access) influencing health-seeking behavior.
  • Studies to evaluate cost-effective, new point of care technologies for rapid detection of sepsis, pneumonia, malaria, tuberculosis, methodology for diagnosis of air pollution and poor oxygenation to improve identification of maternal, infant, and young child morbidity.
  • Studies of interventions for identification and treatment of perinatal mood, anxiety, and/or psychotic disorders in varied care settings; treatment adherence; and clinical outcomes for mental disorders and comorbid conditions.  
  • Studies of early risk factors for mental disorders and neurocognitive function in children.

The Global Network may initiate new protocols in the first year of the new funding period. The topics of these protocols will be decided and prioritized after review by the Global Network Steering Committee, the External Expert Advisory Committee and with final approval by NICHD prior to implementation.

Network Organization

The Global Network will consist of Research Units (RUs) composed of multidisciplinary teams of collaborating U.S. scientists linked to investigators and their institutions in low income countries as full and equal partners; an independently funded single Data Coordinating Center that will provide research support services and methodological and statistical expertise for the Global Network; and the NIH (represented by the NICHD Project Scientist and the NICHD Program Officials). The Global Network Research Units may include additional consultants needed at specific time periods.

Steering Committee

The Steering Committee will serve as the Global Network's central point of communication; exchange of ideas; development, review and management of common protocols; research and training activities; and problem resolution. The Steering Committee reviews all presentations and publications via the Publications Subcommittee and NICHD clearance mechanisms. The Steering Committee is composed of the U.S. PD/PI and SFI of each RU, the PD/PI of the Data Coordinating Center, and the NICHD Project Scientist, each of whom have one vote. A Chairperson who is not participating as a PD/PI will be appointed by NICHD for a minimum term of 2 years.  The Steering Committee will meet twice annually in person and will participate in telephone or video conferences as needed between Steering Committee meetings. During the meetings, research progress and problems are reviewed for each site.

Data Coordinating Center

The Global Network Data Coordinating Center funded through a separate FOA has the responsibility to provide the Network's organizational, statistical, and technical support, including the shared funding of information technology staff and site training, and regulatory adherence. In addition, the Data Coordinating Center will financially support specialty consultations, specialty services, and other study needs. It also is responsible for assisting the sites in developing and implementing common protocols, implementing site monitoring and quality assurance procedures, developing data management systems and databases, and developing analytic capacity. The Data Coordinating Center will be responsible for the creation and integrity of study databases, analytic capacity, and support of and attendance at all Network meetings.

Data and Safety Monitoring Board

A Data and Safety Monitoring Board (DSMB) will be established to monitor the safety of ongoing clinical trials. The members of DSMB will be chosen by the NICHD based on their expertise in: clinical trial design and conduct; basic and translational science in maternal and child health; perinatal and pediatric epidemiology; global health; bioethics; and cultural competency issues particularly with relevance to resources-limited populations. The DSMB will advise the NICHD and the Global Network including the Data Coordinating Center, on research design issues, data quality and analysis, and ethical and human subject issues. The Data Coordinating Center provides coordination, support, travel funding, and logistical arrangements for the DSMB and the EEAC (see below) meetings and activities. In addition, the Network has established policies and procedures that govern its operations, including publication. These documents are under periodic review, and may be amended and supplemented by the Steering Committee, with approval by NICHD.

Expert External Advisory Committee 

An Expert External Advisory Committee (EEAC) will advise the Steering Committee on the identification and prioritization of topics for research. The NICHD leadership chooses the members of the EEAC with input from the Steering Committee. The members will be individuals with expertise in clinical trials, biostatistics, epidemiology, obstetrics, pediatrics, infectious diseases, social sciences, behavioral sciences, basic sciences, and ethics. The EEAC will have no more than 5 members and will elect a Chair. The Chair of the EEAC will serve for a minimum of 2 years. Additional members will participate based on the need for specific expertise.

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
Renewal of RFA HD-13-006

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NICHD intends to commit approximately $4.8 million in total costs (direct plus Facilities and Administrative (F&A) costs) in FY 2018 to fund new and/or renewal awards.

Award Budget

Applications for the RUs may request a budget for direct costs of up to $155,000 per year for RU base costs and $410,000 direct costs under Other Expenses as restricted funds, to be used for multiple protocols including a maternal neonatal health registry. Application budgets need to reflect actual needs of the proposed budget.  

Award Project Period

Each RU applicant may request a project period of up to five 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:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   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   eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are   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.

The PD/PI must be a physician (MD).  If the application is multi-PI, at least one of the PD(s)/PI(s) must be a physician (MD).   Senior Collaborators (SCs) and the Senior Foreign Investigator may be physicians (MDs) or PhDs.  The PD/PI/SCs and SFI should have clinical expertise in obstetrics, pediatrics, family medicine, neonatology, or infectious disease/immunology.  

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

Buttons to access the online ASSIST system or to download application forms 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 Research (R) 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:

Tonse N. K. Raju, MD, DCH
Chief, Pregnancy and Perinatology Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6710B Rockledge Drive, Room 2330, MSC 7002
Bethesda, MD. 20892 (For courier service use 20817)
Telephone: 301-402-1872
Email: rajut@mail.nih.gov

Page Limitations

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

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.

Each domestic applicant must have a foreign collaborator to be eligible. Such foreign components are allowed, subject to required approvals through Foreign Award and Component Tracking System (FACTS). Recruitment of subjects will be exclusively in the foreign site.   

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. 

C Senior Collaborators and the Senior Foreign Investigator may be physicians (MDs) or PhDs.  The SFI should have clinical expertise in obstetrics, pediatrics, family medicine, neonatology, or infectious disease/immunology.

R&R Budget

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

Applicants should provide separate budgets for the domestic site and the foreign site. Plans and procedures for monitoring budgetary expenditures at the domestic and foreign sites must be clearly specified. At the time of award, a consortium agreement must be in place between the U.S. grantee and the foreign site(s). Budget requests should include the following:

 A guideline for budget allowances are provided below: 

  • U.S. PD/PI:   U.S. PDs/PIs of the Global Network Research Units must expend no less than 2.4 person-months effort annually on the award over the entire period of support (as above), with a significant effort expended at the foreign site. 
  • SFI:  SFIs of the Research Units must be substantially involved, spending 3 person-months effort annually on the award over the entire period of support (a portion of this amount may be reallocated to a co-SFI)
  • U.S. study coordinator/research nurse:  3.6 person-months effort
  • SFI study coordinator:  12 person-months effort
  • SFI data management/information technology coordinator:  3 person-months effort
  • SFI data entry clerk:  6 person-months effort
  • Supplies and small equipment (itemized and justified):  Not to exceed $3,000
  • Travel costs (a total of two PD/PI and two SFI trips to DC metro area and one PD/PI trip to the international site):  $20,000
  • Expenses related to activities to strengthen research capacity at the foreign site:  $2,000
  • Other costs (itemized and individually justified):  Not to exceed $4,000.

Applications for the RU's should include a request for up to $410,000 per year direct costs under Other Expenses for restricted protocol funds. These funds are to be included for NICHD budgetary planning purposes only and may be adjusted upwards/downwards as necessary. Once an application has been favorably recommended and is being considered for funding, the RU will be required to complete protocol budgets for those protocols underway in the Network.

The annual negotiated protocol budgets will consist of specific protocol-related allowances (protocol costs) and will be awarded as such. Successful applicants will be required to project patient enrollment for a specific protocol during a specified time frame. Federal agencies shall use the negotiated rates for F&A costs in effect at the time of the initial award throughout each competitive cycle of the project; F&A costs for the foreign component will be limited to eight percent.

It is anticipated that the effort of the PD/PI and SFI will support at least one common protocol. An additional 0.6 person-months effort as investigator salary may be awarded annually to the foreign site. Similar additional 0.6-months effort as investigator salary may be awarded annually for additional common protocols to be implemented at the sites, as appropriate. These decisions are to be made based on available funds.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy:

Scientific Productivity and Investigator Capabilities

Applicants must describe a plan for implementing project that address a current critical or emerging health problem related to the needs of women and/or young children in the foreign collaborator's country and other low income countries within the GN Investigator. Provide evidence of having implemented such plans in other recent research projects. They should also describe recent research productivity in one or more areas related to the scientific scope and objectives set forth in this FOA. Experience in research in the developing world and evidence of scientific productivity in studies in maternal and child health in the developing world are essential, and must also be provided.

Provide descriptions of clinical trials and multi-center research studies conducted in developing countries along with evidence of prior successful scientific collaboration involving other the U.S. investigators and foreign researchers, Do the investigators have adequate awareness of the ethical and cultural issues related to the conduct of research within those countries? Is there commitment of PD/PI and SFI to attend all GN meetings and to participate fully in subcommittees?

Applicants who are current Global Network members should describe their participation and contribution to the Network in detail (e.g., attendance at Steering Committee meetings, active participation in standing subcommittees, leading protocols, participation in common protocols, mentoring of junior investigators, etc.), including their particular contributions to Global Network trials and studies, patient enrollment, etc. Publications resulting from GN activities in the last funding cycle should be described; full citations should be included in the Progress Report Publication List attachment.

New applicants must describe their recent experience and participation in randomized clinical trials, preferably of a multicenter nature. Specific roles (PD/PI, participating site, steering committee, writing committee, trial design and development) should be described for each study. Publications resulting from participation in the randomized clinical trials should be described and cited in this section; full citations should be included in Bibliography and References Cited attachment.  

Organizational Capability

Applicants should describe their research organization and that of the low-income country institutional partner, and include plans, information, and documentation that indicate their institutional or organizational capability to manage funds and to accomplish the proposed research successfully. Provide descriptions of available consultants with expertise in obstetrics, gynecology, neonatology, general pediatrics, public health, infectious diseases and immunology to enable launching and implementing diverse multi-center protocols. Details of administrative capability for obtaining Institutional Review Board approvals should be mentioned Applicants should briefly describe how they will complement the existing expertise in the Global Network to enhance the productivity of the network and advance the objectives of the program. Describe available access to relevant and sufficient subject (patient) populations for studies on women and children's health in the collaborating countries, and describe the available administrative, clinical, pharmacy and data organizational management facilities and their capacity and quality to support Global Network studies. Describe if there are institutional assurances to provide support and resources to the RU in such areas as fiscal administration, personnel management, space allocation, procurement, planning, budgeting, and auditing. Describe the nature of commitment of the foreign government/health care system to implement positive research findings.

History of Collaboration

Applicants must describe any relevant international collaborative research activity undertaken between the U.S. applicant institution and its low-income country partner SFI/institution. Evidence of successful international research network or multicenter research activity also should be provided. Contributions and collaborations in areas such as protocol design, study recruitment, data analysis and interpretation, and publication should be highlighted. Documentation of recruitment and retention rates in clinical trials should be provided. The U.S. PD/PI should clearly document previous time spent, activities, and outcomes at the foreign site.

Nature of Foreign Institutional Support

Applicants must describe the foreign research partner's institutional commitment to and support for the proposed collaborative research study. Documentation from key administrative personnel at the foreign institution must indicate support for research staff participation in the Global Network and authorize use of institutional resources. Examples of such resources may include administrative staff assistance, access to patient populations, equipment, supplies, access to free office, clinic, pharmacy or laboratory space, etc. Applicants are encouraged to include past or ongoing examples of such support from foreign institutions and their respective collaborators, such international professional agencies or organizations.  These details should be included in the supporting letters.

Appropriate Multidisciplinary Expertise and Capability

Applicants must describe the nature of expertise of the research team including availability of multidisciplinary biomedical and behavioral scientists, physicians and public health personnel to act as consultants when needed. The research team must also possess expertise in designing multi-site clinical research protocols, especially in low-income settings.

Population Available for Clinical Trials

Applicants must describe populations of pregnant women and children up to 3 years of age who are available to them and their multidisciplinary colleagues to perform community, primary care-focused or health facility multi-center protocols as described in the scope section. Investigators must describe their patient recruitment plans both from their own institutions and from other sites if needed.

Awareness of Ethical and Cultural Issues in Global Research

Applicants must briefly describe their experience as a group with any ethical and cultural issues that should be considered in the design, implementation, analysis, and publication of research studies undertaken with women and children in developing countries. Such experience may include  framing of appropriate research questions, recruitment and retention of study populations, informed consent and other human subject and animal welfare considerations, design and use of research methods and instruments, the need for appropriate clinical monitoring, data analyses and interpretation, sustainability planning, dissemination and application of findings to benefit the study populations and the international and domestic research and healthcare provider communities. Any relationship of the study topic to national or local health policy should be clearly explained.

Capacity for Communication

Applicants should include a description of existing and anticipated technological and staff resources to establish and maintain computer-based and other communications linkages to facilitate information and research data sharing between the U.S. and developing country sites. Applicants must provide an assurance of e-mail capability at all sites. Technological and resource needs and limitations related to communication and data management also should be indicated.  

Special Strengths

Applicants are encouraged to describe special or unique strengths that may be relevant to the GN.

Special administrative strengths or experience and participation in administrative aspects of clinical research (e.g., institutional review boards, data and safety monitoring committees, advisory board for clinical research, clinical research committees) should be highlighted. 

Letters of Support:

Letters of Support from key administrative personnel at the US and foreign institutions must be submitted to confirm institutional commitment and availability of resources.  Letters should include the following:

  • Institutional assurance to provide support and resources to the RU in such areas as fiscal administration, personnel management, space allocation, procurement, planning, budgeting, and auditing.
  • Letters of support should describe how the foreign entities (including foreign governments, if applicable) will implement research findings into health care.

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, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies.  CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.  Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.  NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository).  NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection.  The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.  Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

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.

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 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 the policy.

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 project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the project address a current critical or emerging health problem related to the needs of women and/or young children in the foreign collaborator's country and other low income countries within the GN Investigator(s)? 

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?  Do the PD/PI and SFI have experience with multicenter randomized clinical trials conducted in developing countries?  Is there evidence of prior successful scientific collaboration involving the U.S. investigators and foreign researchers in a developing country? Does the PD/PI or SFI have clinical expertise in obstetrics, pediatrics, family medicine, neonatology, infectious disease/immunology?  Are consultants available with expertise in the above areas to assist in the design and implementation of diverse multi-center protocols responsive to this FOA? Do the investigators have adequate awareness of the ethical and cultural issues related to the conduct of research within those countries? Is there commitment of PD/PI and SFI to attend all GN meetings and to participate fully in subcommittees?  

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions 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? 

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?  Does the project have an appropriate multicenter design?  Does the project involve community, primary care or other health facilities without placing undue burden on the population? Is the proposed site appropriate for participation in the Global Network with the goals, structure, organization, and likely enrolled populations? Are there acceptable plans for the recruitment and retention of subjects, study site management, collaboration, and communication with other clinical sites, with the NICHD Steering Committee and with the Global Network Data Coordination center? Are there adequate plans to report to the NICHD and the Steering Committee, as well as prior to each Steering Committee meeting, regarding accumulated data and Research Unit performance? 

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?   Is there access to relevant and sufficient subject populations for studies on women and children's health in the collaborating countries? Are the administrative, clinical, pharmacy and data organizational management facilities of adequate capacity and quality? Is there institutional assurance to provide support and resources to the RU in such areas as fiscal administration, personnel management, space allocation, procurement, planning, budgeting, and auditing? Is there evidence of commitment of the foreign government/health care system to implement positive research findings? 

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

For Renewals, the committee will consider the progress made in the last funding period.

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 NICHD, 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  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 National Advisory Child Health and Human Development Council (NACHHD). 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.
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.5. 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.

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

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 HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the 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:

  •  Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
  • Identification of Priority areas for research
  • Developing and implementing the network protocols including meeting recruitment goals based on information provided at the time of application
  • Collection and transmission of the data to the data-coordinating center
  • Analysis of data and publication of results of the GN trials

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

NICHD Project Scientist

The NICHD Project Scientist(s) will provide technical assistance and participate as one voting member of the Steering Committee. Specifically, the NICHD Project Scientist will:

  • Assist with the identification of important areas of study.
  • Assist in the development of study protocols.
  • Assist in the development and review of protocol budgets, including the identification of study costs and special institutional needs.
  • Assist in the review and evaluation of each stage of the program before subsequent stages are started, in conjunction with the Steering Committee and the Advisory Board.
  • Assist in publications and reporting results to the community of investigators and health care recipients.
  • Assist in the conduct of the trials, including ongoing review of progress; possible redirection of activities to improve performance and cooperation; and frequent communication with other members of the Steering Committee.
  • Participate on the Steering Committee and all active subcommittees.
  • Together with the Steering Committee Chairperson, approve formation and membership of any Steering Committee subcommittees; participate in study design, data analysis, interpretation, and publication of study results.
  • Facilitate communication, cooperation, and the exchange of information among Network members and between the Network components and other existing programs to support collaborative efforts;
  • Review and assess Serious Adverse Event (SAE) reports forwarded by the DCC for submission to the FDA when necessary;

NICHD Program Official 

The NICHD will appoint a Program Official, apart from the Program Scientist, who will:

  • Carry out continuous review of all activities prior to the initiation of a trial and throughout the conduct of the trial to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines.
  • Perform other duties required for normal program stewardship of grants.
  • Assure the scientific merit of the trials, including the option to withhold support of a participating center if technical performance requirements such as protocol compliance, enrollment targets, or randomization of subjects are not met.
  • Initiate a decision to modify or terminate a study based on the advice of the data center, Data and Safety Monitoring Committee (DSMC), and/or Expert External Advisory Committee (EEAC).  

Areas of Joint Responsibility include:

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

The management of the Global Network includes committees with the following functions:

Steering Committee

The Steering Committee will be responsible for protocol development. The Steering Committee will have primary responsibility for the conduct of protocols and the preparation of publications. The Steering Committee will be composed of all PD(s)/PI(s), one representative from the data coordinating center, and one NICHD staff. A member of the NICHD Grants Management Branch advises the Steering Committee on funding matters. An outside chairperson, who is not participating as a PD/PI, will be selected by the NICHD Director.

Data Coordinating Center

The Global Network Data Coordinating Center has the responsibility to provide the Network's organizational, statistical, and technical support, including the shared funding of information technology staff and site training, and regulatory adherence. In addition, the Data Coordinating Center will financially support specialty consultations, specialty services, and other study needs. It also is responsible for assisting the sites in developing and implementing common protocols, implementing site monitoring and quality assurance procedures, developing data management systems and databases, and developing analytic capacity.

Data and Safety Monitoring Board

A Data and Safety Monitoring Board (DSMB) will monitor the safety of ongoing clinical trials. It also will advise the NICHD and the Global Network, including the Data Coordinating Center, on research design issues, data quality and analysis, and ethical and human subject issues.

Expert External Advisory Committee 

An External Advisory Board (EEAC) will advise the Steering Committee on the identification and prioritization of topics for research. Members of the EEAC will be chosen by NICHD with input from the Steering Committee and will comprise individuals with expertise in clinical trials, biostatistics, epidemiology, obstetrics, pediatrics, infectious diseases, social sciences, behavioral sciences, basic sciences, and ethics.

In addition, the NICHD Global Network has established policies and procedures that govern its operations, including publications. These policies and procedures can be amended by NICHD with input from the Steering Committee.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NICHD may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NICHD staff voting, one NICHD 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 RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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.

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

Section VII. Agency Contacts

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

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 Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)

Tonse N. K. Raju, MD, DCH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-1872
Email: rajut@mail.nih.gov

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.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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