Release Date:  October 10, 2001

RFA:  RFA-HD-01-024 (This RFA has been renewed, see RFA-HD-05-025)

National Institute of Child Health and Human Development
Fogarty International Center

Letter of Intent Receipt Date:  February 11, 2002
Application Receipt Date:       March 18, 2002
Expiration Date:                March 19, 2002


The National Institute of Child Health and Human Development (NICHD) and the 
Fogarty International Center (FIC), in partnership with the Bill and Melinda 
Gates Foundation, invite applications from United States (U.S.) scientists 
partnered with foreign scientists in Eastern Europe and Africa for 
participation in the Global Network for Women"s and Children"s Health Research 
(Global Network).  The purpose of this solicitation is to complement the 
existing Global Network with the addition of Research Units from Eastern 
Europe, the Newly Independent States, and Africa. The Global Network, also 
supported by the National Center for Complementary and Alternative Medicine 
(NCCAM) and the National Institute of Dental and Craniofacial Research 
(NIDCR), consists of 10 Research Units and one Data and Coordinating Center 
that together form an innovative and flexible research network involved in the 
most critical public health problems of women and children. Through 
competitive cooperative agreements, international, multidisciplinary teams of 
investigators will work collaboratively to answer scientific and/or public 
health questions to help improve health, and to prevent premature disease and 
death among women and children, primarily in developing countries.  The 
efforts of the Global Network awardees will continue to focus on safe 
pregnancy and birth outcomes, within the broader context of women"s and young 
children"s health.

The Global Network will work to increase and enhance opportunities for 
scientific linkages, interaction, knowledge development and transfer, and 
collaborative partnerships between U.S. and foreign investigators and 
institutions.  It also is intended to strengthen and expand the global 
infrastructure for women"s and children"s health research.  Applications for 
Global Network Research Unit grants will require full collaboration between 
scientists in the U.S. and foreign investigators in developing countries.
The overall goal of the Global Network is to expand scientific knowledge 
relevant to improving health outcomes for women and children in developing 
countries.  Other critical goals in establishing this network are:  (1) to 
develop sustainable research infrastructure and public health intervention 
capabilities in developing countries, and (2) to strengthen international 
collaborative research arrangements that focus on the leading causes of 
morbidity and mortality in pregnancy and early childhood.  A key objective for 
the network, and a requirement for the Research Units, is to design, 
implement, and evaluate evidence-based health interventions.  These 
interventions must have a strong scientific and epidemiologic basis for their 
use in the foreign country.  The primary endpoints in these research studies 
must relate to demonstrable improvement in important public health measures in 
the population under study.  

This RFA is not intended to support operations or health services research.  
It is intended to support biomedical and behavioral research, clinical and 
translational research, and associated evaluation research.  It will not fund 
predominantly epidemiologic research, such as observational or surveillance 
studies.  It will not fund studies of food or micronutrient supplementation in 
children over two years of age or studies with the evaluation of either new or 
existing health care delivery programs or health care utilization as a primary 
aim, applications proposing such activities will be returned without review.  
Applications that do not contain an evidence-based intervention will be 
returned without review.  The transfer of technology to developing countries 
should be carefully justified, both ethically and scientifically, the proposed 
use of interventions that have been previously abandoned in developed 
countries will not be reviewed or funded.

NICHD will facilitate coordination of the Global Network"s activities with 
relevant governmental agencies (e.g., the Centers for Disease Control and 
Prevention and the U.S. Agency for International Development), international 
organizations including the World Health Organization (WHO), United Nations 
Children"s Fund (UNICEF), the World Bank, and the Global Forum for Health 
Research, and other public and private sector institutions.  NICHD will assure 
that the activities of the network are coordinated with the activities of 
other relevant and complementary NIH-supported international research 
programs.  Among these programs are the International Collaborations in 
Infectious Disease Research (ICIDR) program, the HIV Prevention Trials Network 
(HPTN), the Tuberculosis Research Unit (TBRU) program, the Comprehensive 
International Program of Research on AIDS (CIPRA), managed by NIAID, and the 
cooperative research and training programs managed by the FIC.  


The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of Healthy People 2010, a PHS-led national 
activity for setting priority areas.  This Request for Applications (RFA) is 
related to several priority areas.  Potential applicants may obtain "Healthy 
People 2010" at


Applications may be submitted by domestic, for-profit and non-profit 
organizations, public and private, such as universities, colleges, and 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Foreign institutions are not eligible to 
apply for these grants, except in partnership with a U.S. applicant.  
Racial/ethnic minority individuals, women, and persons with disabilities are 
encouraged to apply as Principal Investigators. 

Applications for a Global Network Research Unit grant must be submitted 
jointly by collaborating teams of investigators that include the applicant 
U.S. Principal Investigator and a developing country scientist resident at an 
established institution in a developing country.  These collaborating teams 
are identified as "Research Units" in the context of this RFA.  For the 
purposes of this RFA, developing countries are defined as the resource-poor 
nation states of North and sub-Saharan Africa, Central/Eastern Europe, and the 
Newly Independent States (NIS) of the former Soviet Union.   

U.S. and developing 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 RFA and returned to applicants 
without review.  Although the lead U.S. and foreign country investigators will 
collaborate closely, the application must be submitted by the U.S. 
institution.  The U.S. awardee institution is responsible for developing and 
maintaining affiliation(s) with an established foreign collaborating 
institution(s), for example, a college or university, research institute, 
health department, 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, it is 
necessary for applicants to provide evidence 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.

Applications may be submitted by institutions that already have a Global 
Network grant, however, there should be no overlap of personnel between the 
currently funded and proposed Research Units. 

Applicants with a strong base of support from the NICHD or other parts of the 
NIH for research related to (or with implications for) improving the health of 
women and children are also encouraged to apply.


This RFA will use the National Institutes of Health (NIH) cooperative research 
project grant (U01) award mechanism.  The U01 is a cooperative agreement 
mechanism, an "assistance" mechanism (rather than an "acquisition" mechanism) 
that is used when substantial NIH scientific and/or programmatic involvement 
with the awardee is anticipated during the performance of the activity.  Under 
the cooperative agreement, the NIH purpose is to support and/or stimulate the 
recipient"s activity by involvement in the activity and otherwise working 
jointly with the award recipient in a partner role, but the NIH is not to 
assume direction, prime responsibility, or a dominant role in the activity.  
Consistent with this concept, the dominant role and prime responsibility for 
the activity resides with the awardees for the project as a whole, although 
specific tasks and activities in carrying out the studies will be shared among 
awardees and the NIH.  Details of the cooperative agreement are discussed in 
this document under "Terms and Conditions of Award," below.  


The NICHD intends to commit approximately $1.5 million in total costs [direct 
plus Facilities and Administrative (F&A) costs] in FY 2002 to fund two to four 
Research Unit grants in response to this RFA.  As part of this funding, the 
Bill and Melinda Gates Foundation is contributing $15 million over a three-
year period to help establish the Global Network.  FIC is contributing 
$100,000 to this effort for FY 2002.

An applicant for a Research Unit grant may request a project period of up to 
five years and a budget for direct costs of up to $500,000 in the first year, 
with incremental increases not exceeding three percent in each subsequent 
year.  It is expected that a significant proportion of these direct costs will 
be expended at the foreign site.  Applications with budget requests for direct 
costs exceeding $500,000 will be returned without review.  

Because the nature and scope of the research proposed may vary, it is 
anticipated that the size of awards also will vary.  Awards pursuant to this 
RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications.  At this time, it is not known 
if competing renewal applications will be accepted and/or if, or in what form, 
this RFA will be reissued. 



According to a recent report of the Global Forum for Health Research, of the 
approximately six billion people living in the world today, more than 1.3 
billion live in extreme poverty, and 70 percent of these poor are women.  
These women are not only poor, often in poor health, and powerless, but also 
have the primary responsibility for caring for their children and families.  
Although there have been successes during the past 30 years in improving the 
health of women and children worldwide, there remains an unfinished agenda of 
unnecessary, preventable deaths, illness, and disability that 
disproportionately affects poor women and children, especially in the 
developing regions of the world.

An estimated 12 million children under the age of five and 500,000 women, 
primarily in developing countries, die each year from infectious diseases, 
nutrition-related illnesses, and reproductive and perinatal health problems.  
Seventy percent of these deaths among children in developing countries are 
attributable to vaccine-preventable childhood infections, pneumonia, diarrheal 
diseases, malaria, and malnutrition.  These conditions, and others associated 
with early childhood, are expected to remain the major killers of children 
under age five through 2020.  They are associated with more than one third of 
the disease burden globally and approximately one half of the disease burden 
in the poorest regions of the world, including India and sub-Saharan Africa, 
where the rate of improvement in child mortality is slowing.  A large 
proportion of these illnesses and deaths is preventable.

According to World Bank reports, maternal mortality remains the human 
development indicator that shows the greatest gap between developing and 
developed countries.  The perinatal health problems that contribute most to 
maternal deaths in the developing world include intrapartum bleeding, sepsis, 
eclampsia, obstructed labor, and postpartum hemorrhage.  In many parts of the 
developing world, women are totally responsible for the well being of their 
children.  They may themselves suffer from a number of health-related 
problems, including those produced by births too early, too late or too 
closely spaced, by unsafe family planning practices, by being last in the 
family to have access to food and health services, and by partners who 
transmit diseases.  The death of a reproductive age woman significantly lowers 
the chances of survival of her infants and children, especially those who are 
ill, leaves orphans, and causes intense family distress, often with 
multigenerational impact. 

The WHO estimates that more than five million children die within the first 
few weeks of life each year, and there are an additional four million annual 
fetal deaths.  Most (98 percent) of these deaths occur in developing 
countries.  These deaths are caused most often by infectious diseases, 
pregnancy-related complications, and delivery-related complications, including 
intrapartum asphyxia, birth trauma, and premature birth.  Infectious diseases 
are associated with 30 to 40 percent of all neonatal deaths, or 1.5 to two 
million deaths per year.  The infections responsible for most of the early 
mortality are acute respiratory infections (ARI), neonatal tetanus, and 
sepsis, diarrhea, and meningitis.  These infectious diseases also contribute 
to the enormous burden of disease among infants.  Recent studies show that 
oral infections, such as periodontal diseases, are associated with premature 
and low birth weight (less than 2500 grams, LBW) deliveries.  LBW is one of 
the principal contributors to neonatal morbidity and mortality worldwide and 
accounts for up to 70 percent of neonatal deaths in some countries.  The 
problem of LBW is intergenerational and related to many factors throughout the 
lifecycle.  LBW infants tend to become poorly nourished children with 
developmental problems and then adults who produce small infants.  A number of 
other health problems also are associated with LBW.

A 1999 report by the Child Health Research Project indicates that other 
factors that may increase child illness and death include poor maternal 
health, untreated maternal infections, including HIV/AIDS and its many 
sequelae, other sexually transmitted diseases (STDs), and urinary tract 
infections, lack of immunizations among adolescent girls and adult women, 
unsafe and unsanitary delivery practices, fetal and maternal malnutrition, and 
failure to breast feed exclusively.  

Problems at the family and community level that may contribute to early infant 
and child morbidity and mortality also may be related to women"s status, 
domestic violence, social and cultural norms, lack of adequate health 
information, poor decision-making skills and health-care seeking behaviors or 
limited choices, lack of trained and poorly equipped health care workers, and 
inadequate access to good quality medical care.  Underlying these causes are 
widespread poverty, illiteracy, lack of access to education, and gender 
discrimination, often faced disproportionately by women and girls in many 

Research is urgently needed to help improve the health of women and children, 
particularly in developing countries.  Many questions remain unanswered even 
though the extremely high levels of maternal, fetal, and infant morbidity and 
mortality often occur despite the existence of efficacious interventions for 
prevention or treatment.  In some instances, the results of efficacy studies 
have not been translated into feasible interventions for resource-poor 
settings where the burden of these conditions is the heaviest.  In other 
cases, feasible interventions have been developed, yet are relatively 
ineffective, or basic knowledge or understanding still is inadequate. It is 
increasingly clear that economic investment in early intervention or 
prevention is sound and that, in some situations, relatively inexpensive 
health interventions can have enormous impact. Expanding the Global Network of 
linked U.S. and developing country scientists and institutions will help 
facilitate high quality, sustainable collaborative research that will address 
many of these problems and issues.  Recognizing that the focus of the program 
is on the needs of developing countries, it is anticipated that its research 
findings may help inform efforts to improve the health of U.S. women and 
children at higher risk for morbidity and mortality.

Objectives and Scope

The primary scientific objectives of this RFA encompass a range of studies 
related to women and young children, with an emphasis on the perinatal and 
neonatal periods, but up to and including breast feeding and weaning. The 
Global Network"s initial research commitment emphasizes the development, 
testing, and adaptation of cost-effective, integrated biomedical, behavioral, 
social, and public health interventions to reduce premature morbidity and 
mortality among reproductive age women and young children in developing 
countries.  Thus, applications based predominantly or solely in clinical 
research centers or laboratories in the U.S. will not be considered responsive 
to the RFA. 

The Global Network will function as an affiliated group that fosters 
communication, innovation, and research excellence.  Applications will be 
reviewed and funded under the network for the single, meritorious research 
study proposed by each applicant in response to this RFA.  If funds become 
available, other studies may be added over time and conducted in one, several 
or all network sites, depending upon whether or not the proposed research 
topic is relevant to health needs in more than one locality.  Current common 
activities in which new grantees should expect to participate are the 
evaluation of overlapping outcome variables between sites and tobacco use 
across sites.

Priority will be given to scientific activities that have the greatest 
likelihood of improving pregnancy and birth outcomes in developing countries. 
 This may include research activities designed to prevent maternal and early 
childhood deaths and/or to improve the health of reproductive age women and of 
children up to the age of weaning.  All research conducted under the auspices 
of the network must be designed such that meaningful and sustainable health 
improvements in the study population are likely to have a measurable health 
outcome.  Surrogate or intermediate outcomes must be well defined and well 
justified scientifically.  Current topics in the Global Network Research Units 
are:  prevention of postpartum hemorrhage, reduction of cleft lip and cleft 
palate, including behavioral change in health care providers, reduction of 
perinatal and neonatal sepsis, reduction of preeclampsia, neonatal care, and 
reduction of low birth weight.

Suitable topics for proposed research projects include, but are not limited 
to, the following:

o Prevention or reduction of leading causes of maternal morbidity and 

o Interventions that improve the outcome of high-risk pregnancies.

o Studies, with measurable health impact endpoints, focused on assessing and 
improving birth practices, routine postpartum care of the neonate, and other 
reproductive health behaviors.

o Studies that investigate health enhancing aspects or the adverse health 
consequences of traditional medicine and its practice, particularly related to 
women and children.

o Prevention and reduction of fetal loss and infant mortality, including 
studies of dental and cranio-facial diseases and defects that contribute to 
neonatal and infant morbidity and mortality.

o Prevention or amelioration of infections, including, but not limited to, 
syphilis, HIV, gonorrhea, and chlamydia, which may be passed from mother to 

o Prevention and treatment of infectious diseases in pregnant women and young 
children up to weaning, including, but not limited to, malaria, diarrheal 
diseases, acute respiratory tract infections, sepsis, and vaccine-preventable 

Each Global Network Research Unit applicant should propose one fully developed 
research study 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.  The application should provide a research plan that 
includes an evidence-based statement of the health problem and research 
hypothesis, the proposed study population, the study design, methodology, and 
recruitment protocols, data collection, analysis, and reporting plans, 
suggested timelines and staffing plans, plans for enhancing research capacity 
at the foreign site, plans for sustaining the intervention after the funding 
period is over, and a proposed budget for the life of the project.  The Global 
Network Data and Coordinating Center will be the primary contact for data 
collection and management.  Evidence of collaboration and multidisciplinary 
expertise related to the proposed project should be provided.  The quality of 
the research plan will be an important focus of the peer review of the 

Organizational Components

The Global Network currently consists of 10 Research Units composed of 
multidisciplinary teams of collaborating U.S. scientists linked with 
developing country investigators (each Research Unit is led by a U.S. 
Principal Investigator and a Senior Foreign Investigator at the developing 
country site), a single Data Center, which provides research support services 
for the Global Network, and the NIH (represented by the NICHD Staff Science 
Coordinator and Staff Science Collaborators from NICHD and the other NIH co-

Guidance and Management Structure

The overall guidance and management of the Global Network is provided by a 
Steering Committee, a Network Advisory Group, and a Data and Safety Monitoring 

o  The Steering Committee serves as the Global Network"s central point for 
communication, exchange of ideas, development and management of joint 
protocols and research activities, and problem resolution.  The Steering 
Committee is composed of the U.S. Principal Investigator and the Senior 
Foreign Investigator of each Global Network Research Unit, the Principal 
Investigator of the Data Center, and the NICHD collaborating Staff Science 
Coordinator.  Each Principal Investigator, Senior Foreign Investigator, and 
the NICHD Staff Science Coordinator has one vote.  A chairperson is appointed 
to a minimum of a one-year term, by NICHD.  Representatives of other NIH co-
sponsors, a representative of the Network Advisory Group, and selected Data 
Center staff may participate in Steering Committee meetings as non-voting 

The Steering Committee will meet at least once annually and will participate 
in telephone or electronic conferences, as needed.  Guidelines for 
publications and collaborative activities will be developed during the first 
year.  In the event that opportunities arise and funds become available for 
additional research, the Steering Committee will approve the protocols for the 
use of such funds.  If Steering Committee subcommittees need to be formed to 
address particular issues, they shall be established, as needed, subject to 
the approval of the Steering Committee chairperson and the NICHD Staff Science 
Coordinator.  Annual meetings will include discussions of research progress.  
New Research Units should be expected to participate in these and future 
common activities.

o  A multidisciplinary Network Advisory Group, appointed by the Director, 
NICHD, shall provide scientific oversight of the research and administrative 
activities of the Global Network.  The Network Advisory Group will meet at 
least once yearly and will consist of individuals familiar with the kinds of 
international collaboration and research undertaken by Global Network 
grantees. The purpose of the Network Advisory Group is to provide periodically 
an independent, expert review and assessment of new proposed research activity 
and of the progress of research projects supported by the Global Network, and 
to offer guidance to the Steering Committee regarding current and future 
network research objectives, priorities, collaborations, and potential shared 

o  A Data and Safety Monitoring Board (DSMB), established by NICHD, will 
advise the Global Network Steering Committee and Research Units, including the 
Data Center, on research design issues, data quality and analysis, and ethical 
and human subject issues.  It also will monitor the safety of any ongoing 
clinical trials.  DSMB membership will include, but not be limited to, 
individuals with expertise in clinical trial design and conduct, relevant 
basic, medical, and behavioral sciences research, and ethics and cultural 
competency issues, particularly in relation to the conduct of research with 
developing country populations.  The Data Center will prepare reports and 
provide coordination, support, and funding for travel and logistics 
arrangements related to DSMB meetings and actions. 


Minimum requirements for Research Unit applicants are as follows:

o 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 RFA.  Relevant research studies should be 
described and related publications listed.  

o Organizational Capability

Applicants should describe their research organization, and that of the 
developing country institutional partner, and include plans, information, and 
documentation that indicate their institutional or organizational capability 
to accomplish the proposed research successfully.

Applicants also should describe how they will utilize membership in the Global 
Network to enhance the productivity of the network and advance the objectives 
of the program.

o History of Collaboration

Applicants must describe any relevant international collaborative research 
activity undertaken between the U.S. applicant Principal 
Investigator/institution and its developing country partner Senior Foreign 
Investigator/institution. Evidence of successful domestic and/or international 
research network or multi-center 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. PI should clearly document previous time spent, 
activities, and outcomes at the foreign site.

o Evidence of Foreign Institutional Support

Applicants must demonstrate the foreign research partner institution’s 
commitment to and support for the proposed collaborative research study.  
Documentation from key administrative personnel at the foreign institution 
should indicate support for research staff participation in the Global Network 
and authorize some potential use of institutional resources.  Examples of such 
resources may include administrative staff assistance, equipment, supplies, 
access to office, clinic or laboratory space, etc.  Applicants also should 
provide evidence of support for their research collaboration from the 
appropriate foreign government authorities, as well as any international 
organization(s), with a regional or country mission or component that is 
proposed to be involved in the study.  

o Appropriate Staff 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. Principal Investigator and the developing country Senior Foreign 
Investigator, as well as their respective project staff, to develop and 
implement the research proposed to be undertaken within the Global Network

o Multidisciplinary Approach and Staffing

Applicants must demonstrate a multidisciplinary approach to the design and 
implementation of their proposed collaborative study.  A staffing plan should 
be included that indicates formation of  a multidisciplinary team of 
biomedical and behavioral scientists, physicians, and public health personnel. 
 This team must be capable of conducting the described research and, when 
appropriate, providing clinical services to women and children on site or in 
the community.  Steps to ensure effective communication and cooperation across 
disciplines should be identified. Prior successful experience with 
multidisciplinary research activities should be indicated.  

o Awareness of Ethical and Cultural Issues in Global Research

Applicants must demonstrate an awareness of and must describe their experience 
with any ethical and cultural issues that need to 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 and animal subject 
considerations, design and use of research methods and instruments, data 
analyses and interpretation, and dissemination and application of findings to 
benefit the study populations, sustainability planning, as well as the 
international and domestic research and healthcare-providing communities.  Any 
relationship of the study topic to national or local health policy should be 
clearly explained.

o Capacity for Communications 

Applicants should include a description of existing and anticipated 
technological and staff  resources for the establishment and maintenance of 
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 communications 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 Center, and the NIH.


It is expected that scientists from the U.S. institutions will travel to their 
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.  Applicants should indicate the purpose of any proposed staff 
travel and proposed duration of stay at the U.S. or foreign research unit 


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 time of award, a 
consortium agreement must be in place between the U.S. grantee and the foreign 
site(s). Budget requests should include, at a minimum, the following:

o Estimated travel costs and related expenses for any proposed staff travel, 
as described above. In addition, budget requests should include funds to 
support travel of the Principal Investigator and the Senior Foreign 
Investigator of each Research Unit to periodic meetings, in the Washington, 
D.C. area, of the Steering Committee, usually a three-day annual meeting.

o Salary support for the U.S. Principal Investigator, the Senior Foreign 
Investigator, study coordinator(s), outreach/recruitment workers, and any 
other proposed professional and support staff, with appropriate justification. 

o Laboratory and screening costs for study participation.

o Expenses related to communications, supplies, equipment, and subject 
reimbursement/compensation anticipated in the research.

o Resources for a physician independent of the study (Safety Monitor) to 
evaluate adverse events.

o Expenses related to activities to strengthen research capacity at the 
foreign site.

o Expenses related to sustainability planning.

Percent Effort

U.S. Principal Investigators of the Global Network Research Units must expend 
at least 25 percent effort annually on the award over the entire period of 
support, with a significant effort expended at the foreign site.  The Senior 
Foreign Investigators of the Research Units must be substantially involved, 
spending at least 25 percent effort annually on the award over the entire 
period of support. 

Terms and Conditions of Award 

Cooperative agreements are assistance mechanisms and are subject to the same 
administrative requirements as grants.  The following terms and conditions 
will be incorporated into the award statement and provided to each Principal 
Investigator as well as the institutional officials at the time of the award. 
 These terms are in addition to, and not in lieu of, otherwise applicable OMB 
guidelines, HHS Grant Administration Regulations at 45 CFR Part 74 and 92, and 
other HHS, PHS, and NIH grant administration policies.  Business management 
aspects of these awards will be administered by the NICHD Grants Management 
Branch in accordance with HHS, PHS, and NIH Grant Administration policies.  It 
is envisioned at this time that all awarded funds will be administered by the 
NICHD Grants Management Branch or by the Grants Management Offices of the 
other co-sponsoring NIH ICs when those Institutes or Centers provide primary 

The cooperative agreement funding mechanism will require collaboration among 
the NICHD Staff Science Coordinator, the Staff Science Collaborators of the 
involved NIH Institutes and Centers (ICs), the Data Center Principal 
Investigator, and the U.S. Principal Investigators and Senior Foreign 
Investigators of the Global Network Research Units.  The NICHD Staff Science 
Coordinator, in cooperation with the NIH co-sponsoring ICs, will coordinate 
the activities of the Global Network, and will facilitate communication and 
the exchange of information.

1.  The Primary Rights and Responsibilities of the Awardees

All awardees will agree to accept the participatory and cooperative nature of 
the group process.   All awardees are required to submit annual progress 
reports to NICHD and the other co-sponsoring NIH IC(s), as appropriate, and to 
provide study and site performance information as stipulated by NICHD.

A.  The Global Network Research Unit 

Each Global Network Research Unit will be led by an U.S. Principal 
Investigator and a Senior Foreign Investigator at the developing country site. 
 The Research Units specifically will:

o Develop and implement research protocols, interventions, and evaluation 
strategies, with all protocol documents including, at a minimum, an 
introduction section with background and rationale, a statement of the study 
objectives, criteria for selection of subjects and enrollment procedures, 
clinical and laboratory evaluations to be performed, plans for data 
collection, management, and monitoring, and for reporting of adverse events, a 
complete description of the study treatment, and statistical considerations, 
including general design issues, endpoints, sample size, accrual and power, 
monitoring and analysis, and stopping rules.  Some of these activities are 
shared with the Data Center.

o Specify plans for compliance with all Food and Drug Administration 
regulations and for the provision of an adequate supply, if the proposed 
research includes an investigational new drug.

o As a shared activity with the Data Center, when appropriate, collect, 
analyze, and interpret data, and disseminate research results from Global 
Network studies, while assuring quality control.

o Present research concepts, plans, progress, and results to the Steering 

o Publish and disseminate results of both independent and shared research.  
When joint protocols are completed, publish in collaboration with other 
involved Global Network Research Units.

o Collaborate with other awardees and the NIH.

o Retain custody of and rights to data developed under these awards subject 
only to the Government rights of access consistent with current HHS, PHS, and 
NIH policies.

o Implement any network-approved shared 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 Center.

o Obtain institutional assurance from OHRP and local institutional review 
board (IRB) approval of all study protocols implemented at U.S. or foreign 
sites and comply with both IRB and Global Network policies and procedures.

o Generate, if feasible, additional research proposals, including shared 
protocols, for consideration for inclusion in the Global Network.

o Participate in conference calls, and attend network meetings held at least 
once annually.

B.  The Data and Coordinating Center 

The Data Center will provide research support services to the Global Network. 
 These will include establishment and maintenance of a centralized information 
management system to help the Global Network Research Units collect, edit, 
store, analyze, publish, and disseminate results from their individual 
projects as well as from shared research.  It will assist the program staff of 
the NICHD and other NIH co-sponsors in monitoring research progress, and will 
work to ensure data integrity, accuracy, and accessibility among all Research 
Unit sites.  It will offer technical assistance and analytical support for all 
sites, as needed.  The Data Center will provide particular attention to the 
needs of developing country sites, for the purpose of helping develop and 
enhance their capacity for data collection and analysis.  Initially, the Data 
Center will support primarily the individual research projects undertaken by 
Global Network Research Units.  However, as the Network becomes more 
established and the capacity of the Research Units to undertake common 
protocols is strengthened, the Data Center must be prepared to respond to the 
needs of shared research projects.

All activities of the Data Center must be closely coordinated with the NICHD 
Staff Science Coordinator.  In support of all research projects undertaken by 
the Global Network, the Data Center staff will:

o Support the activities of the Network Advisory Group, Steering Committee, 
and the DSMB through provision of materials/documentation support, meeting 
planning and logistics, and conference call coordination.

o Provide advice on study design, data collection, data analysis, and 
publication development to all Global Network research projects.

o Prepare, design, and disseminate operations manuals, data collection forms, 
databases, and results reporting summaries for Global Network research 

o Compile for the Network Advisory Group and Steering Committee, the DSMB, the 
NICHD and the other participating NIH sponsors, site visit reports, monthly 
and quarterly subject enrollment reports, meeting summaries, quarterly 
Research Unit performance and progress reports, and other reports as needed.

o Maintain or assure maintenance of high quality databases resulting from any 
collaborative research, supervise all data collection procedures, and arrange 
for the most efficient transfer of study data where indicated.

o Ensure that all Global Network sites and investigators fully comply with 
DHHS and NIH regulatory requirements, including informed consent, reporting of 
adverse events, human and animal subject safety and welfare provisions, and 
the requirements of international collaboration.

o Provide training to all Research Unit site personnel as needed on data 
management and analysis, and quality control and quality assurance.

o In coordination with the NIH co-sponsors, provide periodic on-site 
monitoring to the Research Units for those studies being performed at that 

o Participate in regular conference calls and attend network meetings.

2.  NIH Staff Involvement 

It is anticipated that a number of program staff from the NICHD and from the 
co-sponsoring NIH Institutes and Centers also will be involved in the Global 
Network program, primarily as staff science collaborators.  Each research 
study will have a staff science collaborator involved, and every protocol will 
be reviewed by NIH according to NIH regulations and standard practices.

A.  NICHD Staff Involvement:  Staff Science Coordinator, Staff Science 
Collaborators, and Program Official

Staff Science Coordinator:

The NICHD Staff Science Coordinator will serve as the principal representative 
of the Institute and NIH and, in consultation with relevant NICHD program 
staff and representatives of the other NIH co-sponsors, will provide overall 
programmatic oversight, coordination, and assistance to the Global Network.  
Specifically, the NICHD Staff Science Coordinator will:

o Facilitate communication, cooperation, and the exchange of information among 
network members and between the network components and other existing programs 
to support collaborative efforts.

o Participate as a voting member of the Steering Committee.

o Consult with NICHD program staff and NIH co-sponsors, who may be designated 
as staff science collaborators assigned to specific studies, when needed for 
optimal implementation of study designs.

o Assist the Steering Committee in the selection and approval of research 
topics and the development and review of protocols for any specific studies.

o Together with the Steering Committee chairperson, approve formation and 
membership of any Steering Committee subcommittees.

o Oversee site participation and performance with the support of the Data 

o Participate in study design, data analysis, interpretation, and publication 
of study results.

NICHD Staff Science Collaborators:

Other NICHD staff may be assigned as staff science collaborators for Network 
grants assigned to them in their areas of scientific expertise.  They may 
participate in Steering Committee meetings as non-voting members.  
Specifically, the NICHD Staff Science Collaborators will, in consultation and 
collaboration with the NICHD Staff Science Coordinator:

o Provide programmatic oversight and assistance to awardees assigned to the 

o Provide advice, when needed, for optimal implementation of intervention 

o Assist in overseeing site participation and performance, as needed, with the 
support of the Data Center.

o Participate, as needed, in study design, data analysis, interpretation, and 
publication of study results relevant to the research conducted by their 
respective grantees.

NICHD Program Official:

NICHD will designate a Program Official, who will assume the administrative 
stewardship responsibilities and obligations for the Global Network

B.  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, in 
consultation and collaboration with the NICHD Staff Science Coordinator:

o Provide programmatic oversight and assistance to awardees assigned to their 
respective NIH Institutes.   

o Provide advice, when needed, for optimal implementation of intervention 

o Assist in overseeing site participation and performance, as needed, with the 
support of the Data Center.

o Participate, as needed, in study design, data analysis, interpretation, and 
publication of study results relevant to the research conducted by their 
respective grantees.

3.  Collaborative Responsibilities

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

Steering Committee members will:

o Assist in the identification of priority research issues related to women"s 
and children"s health in developing countries.

o Approve the direction of joint research efforts and facilitate the conduct 
and monitoring of these studies.

o Approve all Global Network policies and procedures.

o Approve the research plans based on feasibility and clinical relevance, and 
provide advice on implementation strategies.

o Identify a need and propose members for Steering Committee 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 Staff Science Coordinator and the Steering Committee chairperson.  

4.  Arbitration Process

When agreement between an awardee and NICHD staff cannot be reached on 
scientific/ programmatic issues that may arise after the award, an arbitration 
panel will be formed.  The panel will consist of one person selected by the 
Principal Investigator, one person selected by NICHD staff, and a third person 
selected by these two members.  The decision of the arbitration panel, by 
majority vote, will be binding.  This special arbitration procedure in no way 
affects the right of an awardee to appeal an adverse action in accordance with 
PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR 
Part 16.

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided indicating that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
a complete copy of the updated Guidelines is available at  The 
revisions relate to NIH-defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups, if applicable, and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

With regard to the population of a partner foreign country, the definition of 
minority groups may be different than in the U.S.  If there is scientific 
rationale for examining subpopulation group differences within the foreign 
population, investigators should consider designing their studies to 
accommodate these differences.


It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by 
NIH, unless there are scientific and/or ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the Inclusion of Children as Participants in 
Research Involving Human Subjects," published in the NIH Guide for Grants and 
Contracts, March 6,1998, and available at:

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  


All investigators proposing research involving human subjects should read the 
policy that was published in the NIH Guide for Grants an Contracts, June 5, 
2000 (Revised August 25, 2000), available at:  


All applications and proposals for NIH funding must be self-contained within 
the specified page limitations.  Unless otherwise specified in an NIH 
solicitation, Internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.


The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA. 
It is important for applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at: 

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the application. 
 In addition, applicants should think about how to structure informed consent 
statements and other human subjects procedures given the potential for wider 
use of data collected under this award.


Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the U.S. Principal Investigator and the Senior Foreign Investigator, 
the identities of other key personnel and participating U.S. and foreign 
institutions, and the number and title of this RFA.  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 NICHD staff 
to estimate the potential review workload and plan the review.

The letter of intent is to be sent to Dr. Susan Meikle, at the address listed 
under INQUIRIES, below, by February 11, 2002.


The PHS 398 research grant application instructions and forms (rev.5/2001) at are to be used in 
applying for these grants.  This version of the PHS 398 is available in an 
interactive, searchable PDF format.  Beginning January 10, 2002, the NIH will 
return applications that are not submitted on the 5/2001 version.   For 
further assistance contact GrantsInfo, telephone (301) 710-0267, E-mail:  

Application Instructions 

Instructions accompanying the research grant application form PHS 398 (rev. 
5/2001), including page limitations, are to be used in applying for these 
grants, with the modifications described below:

o For the purpose of this RFA, “key personnel” is defined as follows:  “All 
personnel involved in each application, regardless of whether salary support 
is requested.”  Names of all personnel should be included in the application 
with their specific responsibilities in support of the research effort 
outlined and with their percent time and effort specified.  Alphabetized 
biographical sketches for all personnel should follow the budget 

o All information pertinent to the special requirements should be included in 
the research plan of the application and not in an appendix.

Submission Instructions

The RFA label available in the PHS 398 (rev. 5/01) application package must be 
stapled to the bottom of the face page of the application and must display the 
RFA number HD-01-024.  A sample RFA label is available at  Please note this is 
in the pdf format.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title and number must be typed on 
line 2 of the face page of the application form and the YES box must be 

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed photocopies, in one package to:

BETHESDA, MD  20892-7710
BETHESDA, MD  20817  (for express/courier service)

At the time of submission, two additional copies of the application should be 
sent to:

Robert Stretch, Ph.D.
Acting Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 5E03, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service)

Applications must be received by March 18, 2002.  If an application is 
received after that date, it will be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must include 
an introduction addressing the previous critique.


Upon receipt, applications will be reviewed for completeness by the CSR, and 
for responsiveness by NICHD and the other participating Institutes and 
Centers.  Incomplete and/or non-responsive applications will be returned to 
the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NICHD, in accordance with the review criteria stated below.  As part of 
the initial merit review, all applications will receive a written critique and 
may undergo a process in which only those applications deemed to have the 
highest scientific merit will be discussed, assigned a priority score, and 
receive a second level review by the appropriate National Advisory Council or 

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered in assigning the overall score, 
weighting them as appropriate for each application.  Note that the application 
does not need to be strong in all categories to be judged likely to have major 
scientific or public health impact and thus deserve a high priority score.  
For example, an investigator may propose to carry out important work that by 
its nature is not innovative but is essential to move the field forward.

(1) Significance:  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that drive 
this field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?  Is the scientific hypothesis clear and focused?

(3) Innovation:  Does the project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work and percent effort proposed appropriate 
to the experience level of the Principal Investigator and other researchers 
(if any) and the requirements of the RFA?

(5) Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 

In addition to the above criteria, applications for the Global Network 
Research Units will be reviewed with respect to the following: 

o Quality of the scientific basis for the evidence-based intervention. 

o Adequacy and breadth of understanding of existing global research related to 
women’s and children’s health in developing countries.

o Availability of and access to relevant and sufficient populations for 
studies related to women’s and children’s health in developing countries.

o Strength and adequacy of plans for study site management, collaboration, and 

o Adequacy of plans for implementing the proposed study and capacity to 
undertake shared research over time.

o Evidence of prior successful scientific collaboration involving the U.S. 
investigators and foreign researchers in a developing country.

o Demonstrated awareness of ethical and cultural issues and concerns related 
to the conduct of research within developing countries, especially focused on 
the foreign site(s) proposed in the application.

o Evidence of foreign institutional commitment to the research effort and to 
the Global Network, e.g., letters of support and other documentation of 

o Demonstrated willingness and ability to adhere to the terms and conditions 
of the Cooperative Agreement award.

o Quality of sustainability plan.  

In addition to the above criteria, in accordance with NIH policy, all 
applications will be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects also will be 

o The reasonableness of the proposed budget and its duration in relation to 
the proposed research, adequacy of plans and procedures for monitoring 
expenditures at both the domestic and foreign sites.

o Adequacy of the proposed protection for humans, animals, or the environment, 
to the extent they may be adversely affected by the project proposed in the 


Letter of Intent Receipt Date:    February 11, 2002
Application Receipt Date:         March 18, 2002
Peer Review Date:                 June/July 2002
Council Review:                   September 2002
Earliest Anticipated Award Date:  September 2002


Applications will be considered for award based on the following criteria:

o scientific and technical merit, as determined by peer review, 
o responsiveness to the goals and objectives of the RFA,
o program balance, relevance, and priorities,
o geographic distribution,
o complementarity with other NIH-supported international research networks, 
o availability of funds. 


Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Susan Meikle, M.D., M.S.P.H.
Pediatric, Adolescent, and Maternal AIDS Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 4B5OJ, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-0431
FAX:  (301) 496-8678

Direct inquiries regarding fiscal matters to:

Ms. Shelley Carow
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8A01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 402-4165
FAX:  (301) 402-0915


This program is described in the Catalog of Federal Domestic Assistance 
Numbers 93.865 and 93.864 (NICHD).  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act, as amended (42 USC 241 
and 284) and administered under NIH grants policies and Federal Regulations 42 
CFR 52 and 45 CFR Parts 74 and 92.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care or early childhood 
development services are provided to children.  This is consistent with the 
PHS mission to protect and advance the physical and mental health of the 
American people.

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