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)
National Institute of Mental Health (NIMH)

Funding Opportunity Title

Global Network for Women’s and Children’s Health Research (U10)

Activity Code

 U10 Cooperative Clinical Research – Cooperative Agreements

Announcement Type

Reissue of RFA-HD-07-016

Related Notices
  • June 20, 2012 - This Notice is to clarify the language of the funding opportunity announcement (FOA) RFA-HD-13-006. See Notice NOT-HD-12-020.
Funding Opportunity Announcement (FOA) Number

RFA-HD-13-006

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3 Section III. 3. Additional Information on Eligibility.

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

93.865, 93.242    

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 in partnership with research centers in low income foreign countries. 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 form a cooperative network in scientific partnership with NIH to conduct multi-center  randomized clinical trials evaluating interventions in resource-poor settings.  The purpose of this FOA is to compete 7 sites of the Global Network for Women’s and Children’s Health Research.

Key Dates
Posted Date

May 31, 2012

Letter of Intent Due Date

June 30, 2012

Application Due Date(s)

July 31, 2012  

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October / November  2012   

Advisory Council Review

January 2013  

Earliest Start Date(s)

April 2013  

Expiration Date

August 1, 2012 

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 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 program is to contribute to the resolution of maternal and early childhood health problems and accelerate achievements of Millennium Development Goals (MDG) 4 and 5, by establishing a network of Research Units (paired U.S.-based and foreign centers) that will use multi-center trials  to contribute to the evidence base for sound clinical, programmatic, and policy decisions.

The overall goal of the Network is to expand scientific knowledge relevant to improving health outcomes for women and children in low income countries. Other critical goals are to: (1) develop sustainable research infrastructure 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

The fourth and fifth priorities of the United Nation’s Millennium Development Goals (MDGs) are to significantly impact maternal and child health by 2015 by reducing maternal mortality by three -quarters and under 5 mortality by two thirds, respectively. Achievement of these goals cannot be considered in isolation but rather in the context of progress in parallel goals of poverty reduction, universal primary education, gender empowerment and equality, combating HIV-AIDS and ensuring environmental stability. Efforts of the United Nations, the World Health Organization, government institutions and agencies, non-governmental organizations, private sector stakeholders and the global health community at large are all actively being channeled towards finding and applying the interventions that would have the biggest impact in the shortest possible time. The 2011 MDG report states that the goals are achievable if the financial commitments from developed countries are delivered as promised. In his recent address to the United Nations in September, 2010 United Nations Secretary General Ban Ki-Moon reiterated the need to integrate delivery of health services, improve access of women and infants to life-saving interventions, strengthen health systems, particularly the health workforce, and encourage an innovative approach to product development.

Although many developing  countries – including some of the poorest nations – are advancing steadily towards the MDGs each year, the 2011 MDG report states that 8.1 million children and 342,000 women still die from preventable and/or treatable diseases and illnesses. Sub-Saharan Africa, South Asia and the least developed countries have fallen behind other developing regions and industrialized countries on most indicators.  More than 50% of UNICEF funding in 2010 went to programs in sub-Saharan Africa and a quarter went to Asia - where the most disadvantaged children live. Children in these regions  have the highest rates of child mortality, the lowest rates of access to basic health care, maternity services, safe drinking water and basic sanitation.

In sub-Saharan Africa, 50 percent of maternal deaths occur on the day of birth. The maternal mortality rate is 50 times higher in developing  countries than in industrialized countries. Antenatal care offers opportunities to improve the health of women by providing  patient – health care interactions that have the potential to improve the prevention and management of HIV infection and malaria, the detection of pre-eclampsia and management of eclampsia, awareness of the need for skilled birth attendants who can manage emergencies such as post-partum hemorrhage, and nutrition education on the benefits of iron and folate supplementation – the latter being particularly important in low-income countries where micronutrient deficiencies are common. Despite this, less than half of all pregnant women in the world receive the WHO-recommended minimum of four antenatal visits.  Antenatal care coverage has improved since 1990, and now at least two-thirds of women see a skilled health provider at least once during pregnancy. Women living in rural areas are, however, much less likely to receive antenatal care than their urban counterparts.

The proportion of neonatal deaths is increasing, accounting for 41 per cent of all under 5 deaths in 2008. At least 40% of newborn deaths occur on the day of birth. Most children in developing  countries continue to die from preventable or treatable causes, with pneumonia and diarrhea as the two main killers.  Undernutrition contributes to more than one-third of all under-5 deaths. Stunting, an indicator of chronic undernutrition, remains a problem of larger magnitude than underweight. In the developing  world, children living in rural areas are almost 1.5 times as likely to be stunted as those in urban areas.  Children under 2 years of age are most vulnerable to stunting, the effects of which are largely irreversible after age 2.

In light of this enormous burden of morbidity and mortality among women and children in the developing  world, continued innovative and implementation research is urgently needed to provide the evidence base to determine the efficacy of interventions, guide their implementation and scale up, and inform health policy and planning.  The Global Network is comprised of U.S. and developing country research teams and institutions that facilitate high quality, sustainable collaborative research to address many of these problems and issues while simultaneously building the professional capacity and infrastructure in deevloping country sites.

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 at least  seven (7) 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 should 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:

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 by the Global Network Steering Committee and the External Advisory Board and implemented cooperatively with NIH staff after peer review (see below).

Network Organization

The Global Network will consist of at least 7 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 and NIMH Program Official(s). 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 NIH 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  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 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) has been established to monitor the safety of ongoing clinical trials. It also advises the NIH and the Global Network, including the Data Coordinating Center, on research design issues, data quality and analysis, and ethical and human subject issues. The DSMB members have expertise in clinical trial design and conduct; relevant basic, medical, and behavioral sciences research; and ethics and cultural competency issues, particularly with relevance to developing  country populations. The Data Coordinating Center provides coordination, support, travel funding, and logistical arrangements for the DSMB and the EAB (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 at the discretion of NIH and the Steering Committee.

External Advisory Board

An External Advisory Board (EAB) will advise the Steering Committee on the identification and prioritization of topics for research. Members of the EAB will be chosen 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. The EAB will have no more than 5 members who will elect a Chair. The Chair of the EAB will serve for a minimum of 2 years. Additional members will participate based on the need for specific expertise.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New
Renewal

The OER Glossary and the PHS398 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 $4.9 million in total costs (direct plus Facilities and Adminsitrative (F&A) costs) in FY 2013 to fund at least 7 new and/or renewal awards.

NIMH intends to  commit approximately $500,000 for FY 2013.    

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

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Applications are invited both from current members of the Global Network (competing renewal applications) and from prospective members (new applications). Refer to Section IV.6 for minimum requirements for Research Unit applicants.

Global Network Research Unit (RU) Applicants

Applications for a Global Network Research Unit grant must be submitted jointly by collaborating teams of investigators that include the applicant U.S. PD/PI and a Senior Foreign Investigator (SFI), who must be a national of a low income country residing in his/her own country. These collaborating teams are identified as “Research Units” in the context of this FOA. For the purposes of this FOA, low income countries are defined as resource-limited nations in sub-Saharan Africa, South Asia and Latin America. Investigators and their institutions  from the low income countries are expected to function as full and equal partners with the collaborating U.S. investigators. Only one RU grant will be awarded per institution.

U.S. and foreign institutions applying for a Network grant must provide strong evidence (e.g., established research collaborations) of their likelihood to succeed and their ability to work in effective international partnership with each other. The roles and responsibilities of collaborating scientists and institutions must be clearly defined. Research Unit applications that do not propose U.S.-foreign scientist collaborations will be considered non-responsive to the FOA and returned to applicants without review. The application must be submitted by the U.S. institution, which is responsible for developing and maintaining affiliation(s) with an established foreign collaborating institution(s), for example a college or university, research institute, ministry of health or hospital. This affiliation(s) and the appropriate and necessary institutional and governmental endorsements should be clearly specified and well documented in the application. Specifically, applicants must provide evidence and commitment from the partner institutions that a working agreement has been established with the foreign government to expedite deputation of personnel, equipment and supplies at the local site, to monitor and verify expenditures, and to manage other legal and procedural matters.  

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 must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PD/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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.

All PD(s)/PI(s) and the Senior Foreign Investigator must be physicians (MDs). For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 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

Only one application is permitted per institution.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.  

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

The letter of intent should be sent to:

Marion Koso-Thomas, M.D., M.P.H
Global Network for Women's and Children's Health Research
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child and Human Development (NICHD)
National Institutes of Health
6100 Executive Boulevard, 4B09B
Bethesda, MD  20892
Rockville, Maryland 20852 (for express/courier service)
Telephone: 301-435-6873
Fax: 301-480-7773
Email: kosomari@mail.nih.gov   

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies  of the Appendix files must be sent to:

Sherry Dupere, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service; non-USPS service)
Telephone: 301-451-3415
FAX: 301-402-4104
Email: duperes@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

Detailed Budget for Initial Budget Period

Follow instructions in the PHS 398 Application Guide, with the following modifications:

Travel

It is expected that scientists from the U.S. institutions will travel to the research site's foreign country counterparts for periodic consultations and collaborative work with the resident scientists in research directly related to the objectives of the grant award. It is anticipated that foreign country scientists also might travel to the U.S. for purposes of training or collaborative work related to the grant award. All travel must be justified in detail in the application, including the purpose of any proposed staff travel and proposed duration of stay at the U.S. or foreign research unit site.

Budget Request

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:

The first year budget at the time of application will be limited to a Base Budget with maximum allowances as follows:

Applicants may request a project period of up to 5 years and a base budget for direct costs up to $155,000 in the first year.  Applications for the RU's should include a request for $410,000 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.

Percent Effort

U.S. PD/PIs of the Global Network Research Units must expend  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. The SFIs of the Research Units must be substantially involved, spending 3 person-months  effort annually on the award over the entire period of support. It is anticipated that this will support the effort of the PD/PI and SFI to conduct at least one common protocol. An additional 0.6 person-months effort as investigator salary may be awarded annually to the foreign site for each additional common protocol successfully implemented at the sites, as appropriate. The PD/PI of a common protocol may receive an additional 0.6 person-months  effort annually for the duration of the common protocol, as appropriate

Budget for Entire Proposed Period of Support

Follow instructions in the PHS 398 Application Guide.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Research Strategy

Within the Research Strategy section, applications for Global Network Research Units must address the items below.  Use of the indicated subheadings is strongly recommended.    

Research Concept

To provide an idea of the capabilities of the applicant RU to participate in the development and design of common protocols, each applicant should propose one research concept addressing 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. The concept should be appropriate for the Global Network in that it requires a multicenter design. The research concept (2-5 pages)  should provide a research plan that includes an evidence-based statement of the health problem (including preliminary data); research hypothesis; specific aims; proposed study population; study design, methodology, and recruitment plans. The quality, appropriateness and scientific relevance of the research concept will contribute to the overall evaluation of the application but will not be scored separately.  Implementation of any research concept within the GN will be decided and prioritized cooperatively by the Global Network Steering Committee.

Scientific Productivity

Applicants must demonstrate a capacity to develop and implement studies focused on the health of women and children, and provide evidence of 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 demonstrated.

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 contribution to Global Network trials and studies, patient enrollment, etc. Relevant research studies should be described and all related publications listed.

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 should be listed that resulted from participation in the studies.

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. 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.

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.

Evidence of Foreign Institutional Support

Applicants must demonstrate 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, equipment, supplies, access to free office, clinic, pharmacy or laboratory space, etc. Applicants also should provide evidence of support for their research collaboration from the appropriate foreign government authorities (monetary and non-monetary), as well as any international organization(s), with a regional or country mission or component that is proposed to be involved in the study. Applicants should submit commitment of the foreign government/health care system to implement positive research findings.

Appropriate Multidisciplinary Expertise and Capability

Applicants must present evidence of the professional expertise, experience, and capacity of both the U.S. PD/PI and the developing country SFI to develop and implement the research proposed to be undertaken within the Global Network.

Applicants must demonstrate a multidisciplinary approach to the design and implementation of their proposed collaborative study. They should provide a list of available multidisciplinary biomedical and behavioral scientists, physicians, and public health personnel to act as consultants in the design and implementation of common protocols. This team must be capable of conducting the described research, and must be familiar with the clinical services for women and children at the site or in the community where the research will be conducted, as well as to design protocols that include the other GN sites. Steps to ensure effective communication and cooperation across disciplines should be identified. Prior successful experience of the consultants with multidisciplinary multicenter research activities and implementation of research findings should be indicated.

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 demonstrate the ability to recruit patients from outside their own institutional sites.

Awareness of Ethical and Cultural Issues in Global Research

Applicants must briefly describe their experience 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. This information will help the NIH co-sponsors to assess available and potential technology, and to determine what resources might be needed to support communication among the Global Network Research Units, the Data Coordinating Center, and the NIH.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Foreign Institutions

 Not Applicable

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

Acceptance of the Budgetary Mechanism -- Assurance of cooperation with negotiated protocol budgets for each individual protocol, in addition to a base budget, should be provided from the departmental and institutional offices of sponsored research programs. The appropriate Federal cost policies and regulations governing NIH grant programs will be applied.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

For this particular announcement, note the following:

The Global Network is comprised of U.S. and developing country research teams and institutions that facilitate high quality, sustainable collaborative research to address many of these problems and issues while simultaneously building the professional capacity and infrastructure in developing country sites. Funded grantees will be part of a Global Network that will include at least seven (7) clinical Research Units (dyads of U.S. and foreign teams) and an independently funded GN 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. 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.

To provide an idea of the capabilities of the applicant RU to participate in the development and design of common protocols, each applicant should propose one Research Concept (2-5 pages) to 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. Applicants must demonstrate a multidisciplinary approach to the design and implementation of their Research Concept. The quality, appropriateness, and scientific relevance of the Research Concept will contribute to the overall evaluation of the application but should not be scored separately.  Implementation of any Research Concept within the GN will be decided and prioritized cooperatively by the Global Network Steering Committee.  

Overall Impact - Overall

Reviewers will provide an overall impact/priority 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 - Overall

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? 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)

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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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? 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? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? 

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?

Additional Review Criteria - Overall

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/priority score, but will not give separate scores for these items.

Research Concept 

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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 - Overall

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/priority 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) Genome Wide Association Studies (GWAS).

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 NICHD in consultation with NIMH,, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PD/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

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 reciPD/PIent'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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (NIH U10), 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:

Each Global Network Research Unit will be led by a U.S. PD/PI and a SFI at the low income country site. Specifically, the Research Units will have primary responsibility for:

Awardees will retain custody of and have primary rights to the data under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

A number of program staff from the NICHD and NIMH will be involved in the Global Network program.  Each research study will have a Project Scientist involved. Every protocol will be reviewed by NIH according to NIH policies and standard practices.

NICHD Project Scientist

The NICHD Project Scientist will, in consultation with relevant NICHD and NIMH program staff,  provide overall programmatic oversight, coordination, and assistance to the Global Network.

Specifically, the NICHD Project Scientist will:

NICHD/NIMH Program Officials(s)

Additionally, an NICHD/NIMH Program Official(s) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. This role is separate from the Program Scientist and will include the following:

Global Network Scientific Liaison Officers 

Other NICHD and NIMH program staff may be designated as Scientific Liaison Officers (Medical Officer or Program Officers) to provide scientific input in their areas of expertise. They may participate in Steering Committee meetings as non-voting members.  In consultation and collaboration with the NICHD Project Scientist and Program Official(s), the Global Network Scientific Liaison Officers will:

Areas of Joint Responsibility include:

In addition to the above specified rights, responsibilities, and involvement, the Global Network components have collaborative responsibilities. These include interaction with the External Advisory Board, the DSMB, and membership on the Steering Committee.

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, through the Publication Subcommittee and NIH clearance process, reviews all presentations and publications. The Steering Committee is composed of the U.S. PD/PI and SFI of each Research Unit, the PD/PI of the Data Coordinating Center, and the NICHD Project Scientist, each of whom have one vote. NICHD will appoint a Chairperson who is not participating as a PD/PI for a minimum term of two years. Representatives of other NIH co-sponsoring Institutes and Centers (ICs) may participate as non-voting members.

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.

The Steering Committee members will:

Data and Safety Monitoring Board

A Data and Safety Monitoring Board (DSMB) has been established to monitor the safety of ongoing clinical trials. It also advises the NIH and the Global Network, including the Data Coordinating Center, on research design issues, data quality and analysis, and ethical and human subject issues. The DSMB members have expertise in clinical trial design and conduct; relevant basic, medical, and behavioral sciences research; and ethics and cultural competency issues, particularly with relevance to developing  country populations. The Data Coordinating Center provides coordination, support, travel funding, and logistical arrangements for the DSMB and the EAB (see below) meetings and activities.

External Advisory Board

An External Advisory Board (EAB) will advise the Steering Committee on the identification and prioritization of topics for research. Members of the EAB will be chosen with input from the Steering Committee and NIH and will comprise individuals with expertise in clinical trials; biostatistics; epidemiology; obstetrics; pediatrics; infectious diseases; social sciences; behavioral sciences; basic sciences; and ethics. The EAB will have no more than 5 members who will elect a chair. The Chair of the EAB will serve for a minimum of 2 years. Additional members will participate based on the need for specific expertise.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual 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 Non-Competing Continuation Grant Progress Report (PHS 2590) 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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Marion Koso-Thomas, MD, MPH
Eunice Kennedy Shriver National Institute of Child and Human Development (NICHD)
Telephone: 301-435-6873
Email: kosomari@mail.nih.gov

Pamela Collins, MD
National Institute of Mental Health (NIMH)
Telephone: 301-443-2847
Email: collinspy@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)

Mario Martinez
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-4078
Email: martinem@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 Parts 74 and 92.


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