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	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-05-025
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-HD-12-200
Companion FOA	RFA-HD-12-201, U01 Research Project Cooperative Agreements
Number of Applications	Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility. An institution may not apply for both RFA-HD-12-200 and the companion RFA HD-12-201. Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.865
FOA Purpose	The purpose of this solicitation is to recompete the Global Network for Women’s and Children’s Health Research. The NICHD invites applications from investigators willing to participate under a cooperative agreement in an ongoing multicenter international research network designed to perform randomized clinical trials and intervention studies focused on reducing the major risks to maternal, neonatal, infant, and early childhood health in the low and lower-middle income countries. This FOA solicits applications from U.S. institutions to support Research Units within the Global Network. Individual Research Units (RU) will consist of U.S.-based research centers in partnership with research centers in low and lower-middle 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. The grantees will form a cooperative network in scientific partnership with NICHD to conduct common, randomized clinical trials evaluating interventions in resource-poor settings. The catchment populations for the RUs will include a diversity of ethnic, linguistic and cultural groups.

Posted Date	May 23, 2011
Letter of Intent Due Date	July 11, 2011
Application Due Date(s)	August 11, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	October/November 2011
Advisory Council Review	January 2012
Earliest Start Date(s)	April 1, 2012
Expiration Date	August 12, 2011
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.

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

The NICHD invites applications from investigators willing to participate under a cooperative agreement in an ongoing multicenter international research network designed to perform randomized clinical trials and intervention studies focused on reducing the major risks to maternal, neonatal, infant, and early childhood health in low and lower-middle income countries. The purpose of this solicitation is to recompete the Global Network for Women’s and Children s Health Research. 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 that will use common protocols to contribute to the evidence base for sound clinical, programmatic, and policy decisions.

This FOA solicits applications from U.S. institutions to support Research Units within the Global Network. Individual Research Units (RU) will consist of U.S.-based research centers in partnership with research centers in low and lower-middle 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. The grantees will form a cooperative network in scientific partnership with NICHD to conduct common, randomized clinical trials evaluating interventions in resource-poor settings. The catchment populations for the RUs will include a diversity of ethnic, linguistic and cultural groups.

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 fully developed research proposal 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 and lower-middle income countries. The proposal should be appropriate for the Global Network in that it requires a multicenter design. The application should provide a research proposal 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; data collection, analysis, and reporting plans; suggested timelines and staffing plans; plans for enhancing research capacity at the foreign sites; plans for sustaining the intervention after the funding period is over; and a proposed budget for the life of the project. Evidence of collaboration and multidisciplinary expertise should be provided. It is critically important that the proposed intervention be community- or primary care facility-based and not place undue burden on the population or cause disruption of local facilities. The quality of the research proposal will be one important focus of the peer review of the application. There is no guarantee that the research proposal will be accepted as a common protocol by the Global Network. However, funded RUs will be invited to submit the protocols from their application to the Protocol Review Subcommittee and Steering Committee for review and consideration. The Global Network Data Coordinating Center will assist in data collection and management, including statistical expertise, and research protocol management.

The NICHD expects that the Global Network may initiate new common protocols in the first year of the new funding period. The topics of these protocols will be decided and prioritized cooperatively by the Global Network Steering Committee and the External Advisory Board and implemented after NIH review (see below).

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 2008 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, 8.8 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. According to the 2009 UNICEF report, nearly one-half the population of the world’s 49 least-developed countries is under the age of 18, characterizing these countries as rich in children who are at risk of poor child survival and development outcomes. They have the highest rates of child mortality and out-of-school children and 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, 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 percent of all under five 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-five 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, whose effects are largely irreversible.

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 developing country sites.

Originally funded to perform diverse, site-specific individual protocols, the Global Network has transitioned to the conduct of common research protocols (conducted by 3-4 Research Units) to more efficiently 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 up to seven (7) clinical Research Units (RUs, dyads of U.S. and foreign teams) and a 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.

The overall goal of the Network is to expand scientific knowledge relevant to improving health outcomes for women and children in low and lower-middle 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 is to collaboratively design, develop, and conduct multiple simultaneous common 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. This Network will bring the required numbers of subjects into rigorously designed common protocols and thus address pressing research questions in pregnant women and very young children more quickly and efficiently than could individual centers acting alone.

The Global Network will function as a collaborative group that fosters communication, innovation, and research excellence. Grantees should expect to propose and participate in multiple common protocols that may be conducted in several or all network sites. Grantees must be willing to work collaboratively and with cultural sensitivity.

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 premature 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, statistics, 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.

Applications for meritorious common 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 and lower-middle 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 anemia , 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 unwanted 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.
• Early interventions to enhance child outcomes, including parental caretaking and parental mental health.
• 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 rapid diagnostic methodologies (e.g., tests for sepsis, pneumonia, malaria, tuberculosis, air pollution, oxygenation) to improve identification of maternal, infant, and young child morbidity.

The Global Network will consist of up to 7 Research Units (RUs) composed of multidisciplinary teams of collaborating U.S. scientists linked to investigators in low and lower-middle income countries as full and equal partners; a 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 Program Scientist, the Project Officer(s), and Staff Science Collaborators from NICHD/NIH). 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 Program 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 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 quality assurance procedures, including site monitoring; 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 by NICHD 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 DSMB and 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 the NICHD 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 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. 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.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New Renewal Applications currently funded under prior issuances of this FOA are permitted in response to this FOA. The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NICHD intends to commit approximately $4.3 million dollars in total costs [direct plus Facilities and Administrative (F&A) costs] in FY 2012 to fund 5 new and/or renewal awards.
Award Budget	Applications for the RUs may request a budget for direct costs of up to $170,000 per year for RU base costs and $420,222 direct costs under Other Expenses as restricted funds, to be used for common protocols. These funds are to be included for the NICHD budgetary planning process. Application budgets need to reflect actual needs of the proposed budget. Final award budgets for protocols will be negotiated at a later date and may be adjusted upwards/downwards as necessary.
Award Project Period	Each RU applicant may request a project period of up to 5 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.

Higher Education Institutions:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

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)
• 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

Only U.S. institutions may apply on behalf of the RU partnership pairs. Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

The NICHD invites applications both from current members of the Global Network (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 and lower-middle 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 and lower-middle income countries are defined as resource-limited nations in sub-Saharan Africa, South Asia and Latin America. Foreign investigators 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 low and lower-middle income country scientists and 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. 

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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) 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 least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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.

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

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

Only one application per institution (normally identified by having a unique DUNS number or NIH-IPF number) is allowed..

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. NIH will not accept any application that is essentially the same as one already reviewed. Applicants applying for this FOA may not apply for the companion FOA RFA-HD-12-201.

Research that is predominantly epidemiologic, such as observational or surveillance studies, will be considered non-responsive to the FOA and will not be reviewed. Applications that propose only to evaluate health care delivery programs or health care utilization and do not evaluate a human experimental intervention will also be considered non-responsive. With guidance from an External Advisory Board and the Global Network Steering Committee, the PD/PIs and the SFIs of the Global Network for Women's and Children's Health Research (GN) will identify research topics of high priority, and design, implement, and evaluate the impact of common protocols.

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

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.

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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Linda L. Wright, MD
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 4B05J, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-402-0830
FAX:  301-480-7773
Email: [email protected]

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: 301-496-1485
FAX: 301-402-4104
Email: [email protected]

All page limitations described in the PHS398 Application Guide must be followed. with the following exceptions or additional requirements:

• The U10 research strategy section may not exceed 12 pages, including graphs, diagrams, figures and charts.

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

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.

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.

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.

This initiative is not subject to intergovernmental review.

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.

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.

Applications for Global Network Research Units must address the following:

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, mentoring of Global Network junior investigators, 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 and lower-middle 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 special administrative strengths or experience as well as participation in administrative aspects of clinical research Institutional Review Boards (IRBs), advisory boards for clinical research, clinical research committees, and special consent procedures, the ability to clear research supplies through customs, and to produce drugs or equipment in-country should be supplied. A description of aspects of the health system in the developing country that will impact the ability to conduct community and health facility-based research should also be provided. Applicants should also describe how they will utilize membership and 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 PD/PI institution and its low and lower-middle income country partner SFI/institution. Evidence of successful domestic and/or 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.

Appropriate Multidisciplinary Expertise and Capability

The application must be submitted by a U.S. applicant institution on behalf of the U.S. and foreign country collaborative partners. 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

Applicant Research Units must describe at-risk populations of pregnant women and children to 3 years of age who are available to them and their multidisciplinary colleagues to perform community and primary care-focused common protocols 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 demonstrate an awareness of and 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. This includes issues related to 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, at a minimum, assurance of or planning for 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.

Data Resources

Applicants must present plans and commitment to develop and implement a future database from all common protocols that is accessible to the public within 2 years of publication of the primary manuscript, in collaboration with the Steering Committee and NICHD.

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. The terms of award will specify that NICHD approval is required prior to rebudgeting funds into or out of the travel category.

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.

Budget Request

Research Unit applicants should provide separate budgets for the domestic site and the foreign site. The use of budget summary tables and other descriptive tools is strongly encouraged to clarify institutional and research-related expenses. 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:

• U.S. PD/PI:   2.4 person months effort;
• SFI:  3 person months effort (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 $5,000
• 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):  $10,000
• Expenses related to activities to strengthen research capacity at the foreign site:  $2,000
• Expenses related to sustainability planning:  $1,000
• Other costs (itemized and individually justified):  Not to exceed $3,000.

Applications for the RUs may request a budget for a project period of up to 5 years. A budget for direct costs up to $170,000 per year for RU base costs and $420,222 direct costs under Other Expenses as restricted funds, to be used for common protocols should be included. These funds are to be included for the NICHD budgetary planning process. Application budgets need to reflect actual needs of the proposed budget. Final award budgets for protocols will be negotiated at a later date and may be adjusted upwards/downwards as necessary.

The annual negotiated protocol budgets will consist of specific protocol-related allowances (protocol costs) and will be awarded based as such. Each RU PD/PI will be required to project patient enrollment for a specific protocol during a specified time frame; continuation and the level of funding will be based on actual enrollment. Future years' base budgets of the RUs should be limited to the first year base budget costs, with an annual increment of base salary and travel costs not to exceed 3% (the maximum amount available for equipment, supplies, and other costs will not increase). 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 U.S. 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.

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

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:

Applications for meritorious common 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.

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).

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 and lower-middle income countries?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

• 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?
• Are the PD/PI or SFI physicians with expertise in obstetrics, pediatrics, family medicine, maternal-fetal medicine/perinatology, neonatology, infectious disease/immunology, or gastroenterology?
• Are consultants available with expertise in the above areas as well as environmentalists, epidemiologists, behavioral and social scientists, etc., to assist in the design and implementation of diverse common protocols responsive to this FOA?
• Do the investigators have experience, capacity, and commitment to community-based interventions beyond hospital-based community outreach?
• Do the investigators have adequate understanding of existing global research related to women's and children's health in developing countries and awareness of the ethical and cultural issues and concerns related to the conduct of research within those countries?
• Do the applicants have the ability to assist the NICHD in securing services of special experts to supplement the expertise of the Steering Committee?
• Is there demonstrated potential and commitment to initiate common protocols and to participate in jointly-determined research designs and data sharing?
• Are there plans to acquire Good Clinical Practices and Good Laboratory Practices certification?
• 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? 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?

• Does the project have a multicenter design?
• Does the project involve community or primary care facilities without placing undue burden on the population or cause disruption of local facilities?
• Is there sufficient scientific basis for the proposed intervention?
• Is the proposed protocol appropriate for implementation in the Global Network with the goals, structure, organization, and likely enrolled populations?
• Are there acceptable plans for the recruitment and retention of subjects?
• Will the subject population to be studied be available?
• Are there adequate plans for study site management, collaboration, and communication?
• Is there a long-term sustainability plan?
• What is the quality of the RU's participation in the current grant period (current network members) or in similar recent collaborative research (new members)?
• Do the participants demonstrate a willingness and ability to cooperate with other network sites, the Data Coordinating Center, and the NICHD in a manner summarized in this FOA?
• Are there appropriate plans for the participants to work with the Data Coordinating Center on developing and maintaining data management and quality control systems, clinical and data monitoring, and recruitment and tracking of participants?
• Are there adequate plans to report monthly to the NICHD and the Steering Committee, as well as prior to each Steering Committee meeting, regarding accumulated data and Research Unit performance?
• Do the nvestigators and institutional officials demonstrate their acceptance of negotiated funding of common protocols?
• Are there plans, commitment, and capacity to develop and implement a future database from all common protocols that is accessible to the public within 2 years of publication of the primary manuscript, in collaboration with the Steering Committee and NICHD?

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 to the RU in such areas as fiscal administration, personnel management, space allocation, procurement, planning, budgeting, and auditing?
• Is there institutional commitment to the goals of the Global Network, including the collaborative model described in this FOA?
• Do the applicants demonstrate commitment to work collaboratively with the NICHD, the other PDs/PIs and SFIs in the Global Network, and the Data Coordinating Center to achieve the goals of this solicitation?
• Is there evidence of foreign institutional commitment to the research effort and to the Global Network, e.g., letters of support and other documentation of commitment to provide resources, e.g., space, staffing, in kind resources?
• Is there evidence of commitment of the foreign government/health care system to implement positive research findings?

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.

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

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.

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

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/priority score.
• Will receive a written critique.

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 National Advisory Child Health and Human Development (NACHHD) Council . 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.
• Commitment to the goals of the Global Network
• Geographic balance and diversity

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. 

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

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 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

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 U01), 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 and lower-middle income country site. Specifically, the Research Units will have primary responsibility for:
• Identifying priority areas for research;
• Developing and implementing research protocols, interventions, and evaluation strategies;
• Presenting research concepts, plans, progress, and results to the Protocol Review Subcommittee and Steering Committee;
• Projecting patient enrollment for common protocols during a specified time frame; continuation and level of funding should reflect actual recruitment;
• Implementing any Network-approved common study protocols, where feasible, including the recruitment and monitoring of study participants, associated data collection, and study-associated quality control measures at the study sites, in collaboration with the Data Coordinating Center;
• Specifying plans for compliance with all Food and Drug Administration regulations and for working with the Data Coordinating Center to secure any necessary drugs;
• Obtaining institutional assurance from the Office for Human Research Protections (OHRP) and local IRB approval of all study protocols implemented at U.S. or foreign sites and complying with both IRBs' policies and procedures;
• Complying with Network policies and procedures;
• Submitting abstracts and manuscripts to the Publication Subcommittee and to NICHD for clearance; publication and dissemination of results of both independent and shared research. When common protocols are completed, publication of results in collaboration with other involved Global Network Research Units;
• As a shared activity with the Data Coordinating Center and NICHD, collection, analysis, and interpretation of data, publication and dissemination of research results from Global Network studies;
• Participating in conference calls, attending Network meetings held at least twice annually, and submitting trip reports within four weeks of international travel associated with the Global Network;
• Participating in activities to enhance independent research capacity at the developing world site, including facilitating the identification and mentoring of promising junior investigators, and reporting sustainability planning and benchmarks for Research Units, as described in the terms and conditions of award;
• Working to ensure that the results of Network research are implemented in country to improve the outcome of mothers and children;
• Submitting annual progress reports to NICHD; and
• Providing study and site performance information.

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 from the co-sponsoring NIH ICs will be involved in the Global Network program, primarily as Staff Science Collaborators. Each research study will have a Staff Science Collaborator involved. Every protocol will be reviewed by NIH according to NIH policies and standard practices.

NICHD Project Scientist:

The NICHD Project Scientist will serve as the principal representative of NICHD and NIH and will have substantial programmatic and scientific involvement that is above and beyond the normal stewardship role in awards and will, in consultation with relevant NICHD program staff and representatives of the other NIH co-sponsors, provide overall programmatic oversight, coordination, and assistance to the Global Network.

Specifically, the NICHD Project Scientist will:

• Facilitate communication, cooperation, and the exchange of information among Global Network members and between the Global Network components and other existing programs to support collaborative efforts;
• Participate as a voting member of the Steering Committee;
• Consult with NICHD Program Official and NIH co-sponsors, who may be designated as Staff Science Collaborators assigned to specific studies, when needed for optimal implementation of study designs;
• Assist the Steering Committee in the selection and approval of important research topics and the development and review of protocols for any specific studies;
• Together with the Steering Committee Chairperson, approve formation and membership of any Steering Committee subcommittees;
• 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 External Advisory Board ;
• 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 in the Steering Committee and all active subcommittees;
• Oversee site participation and performance with the support of the Data Coordinating Center; and
• Participate in study design, data analysis, interpretation, and publication of study results.

NICHD Program Official(s):

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

• Assurance of scientific merit of the trials, including the option to withhold support to a participating institution if technical performance requirements such as protocol compliance, enrollment targets, or randomization of subjects are not met;
• Continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines;
• Review and assess Serious Adverse Event (SAE) reports forwarded by the DCC and prepare reports for submission to the FDA when necessary;
• Initiation of a decision to modify or terminate a study based on the advice of the Data Coordinating Center, DSMB, and/or External Advisory Board with the mutual consent of the Steering Committee and NICHD Program Scientist and
• Other duties required for normal program stewardship of grants for the Global Network.

NICHD Scientific Liaison Officers:

Other NICHD 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. Specifically, the NICHD Scientific Liaison Officers will, in consultation and collaboration with the NICHD Project Scientist and Program Official:

• Provide programmatic oversight and assistance to awardees assigned to the NICHD;
• Collaborate with the Program Scientist and other team members for defining/developing the appropriate study designs, objectives, endpoints, patient population, efficacy, toxicity and safety indicators;
• Review and assess Serious Adverse Event (SAE) reports forwarded by the DCC and prepare reports for submission to the FDA when necessary;
• Assist in overseeing site participation and performance, as needed, with the support of the Data Coordinating Center;
• Review and assess Serious Adverse Event (SAE) reports forwarded by the DCC and prepare reports for submission to the FDA when necessary;
• Participate, as needed, in data analysis, interpretation, and publication of study results relevant to the research conducted by their respective grantees.

NIH Co-sponsor Staff Science Collaborators:

Program representatives of the other NIH co-sponsors may serve as Staff Science Collaborators for grants assigned to their respective NIH Institutes and Centers. They may participate in Steering Committee meetings as non-voting members. Specifically, the NIH Staff Science Collaborators will:

• Provide programmatic oversight and assistance to awardees assigned to their respective NIH Institutes in consultation and collaboration with the NICHD Project Scientist;
• Provide advice, when needed, for optimal implementation of intervention designs;
• Assist in overseeing site participation and performance, as needed, with the support of the Data Coordinating Center; and
• Participate, as needed, in study design, data analysis, interpretation, and publication of study results relevant to the research conducted by their respective grantees.

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 NICHD 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 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 PI for a minimum term of one year. 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:

• Agree to accept the participatory and cooperative nature of the group process and agree to collaborate with other awardees, the Data Coordinating Center, and the NIH;
• Assist in the identification of priority research issues related to women's and children's health in low and lower-middle income countries;
• Approve the direction of joint research efforts and facilitate the conduct and monitoring of these studies;
• Adhere to all Global Network policies and procedures;
• Approve the research plans based on feasibility and clinical relevance, and provide advice on implementation strategies;
• Identify needs and propose subcommittees to undertake specific activities or to review issues, policies, or procedures of particular interest to the Global Network, subject to the approval of the NICHD Project Scientist and the Steering Committee Chairperson; and
• Agree to accept and implement policies approved by the Steering Committee.

Data and Safety Monitoring Board:

A Data and Safety Monitoring Board (DSMB) is established by the NICHD 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 DSMB meetings and actions.

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 the NICHD and the Steering Committee.

External Advisory Board:

An External Advisory Board ( EAB) will advise the Steering Committee in the identification and prioritization of topics for research. Members of the EAB will be chosen by the 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. The EAB will have no more than 5 members who will elect the 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.

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 in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

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.

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

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: [email protected]

Linda L. Wright, M.D.
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-0830
Email: [email protected]

Sherry Dupere, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1485
Email: [email protected]

Mario Martinez
Supervisory Grants Management Specialist
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-4078
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.