GLOBAL NETWORK FOR WOMEN’S AND CHILDREN’S HEALTH RESEARCH

Release Date:  March 15, 2000

RFA:  HD-00-007 (This RFA has been renewed, see RFA-HD-05-025)

National Institute of Child Health and Human Development
National Institute of Allergy and Infectious Diseases
National Cancer Institute
National Institute of Dental and Craniofacial Research
National Institute of Mental Health
National Center for Complementary and Alternative Medicine
Fogarty International Center

Letter of Intent Receipt Date:  April 14, 2000
Application Receipt Date:       July 13, 2000

PURPOSE

The National Institute of Child Health and Human Development (NICHD), the 
National Institute of Allergy and Infectious Diseases (NIAID), the National 
Cancer Institute (NCI), the National Institute of Dental and Craniofacial 
Research (NIDCR), the National Institute of Mental Health (NIMH), the 
National Center for Complementary and Alternative Medicine (NCCAM), and the 
Fogarty International Center (FIC), in partnership with the Bill and Melinda 
Gates Foundation, invite applications for participation in a Global Network 
for Women’s and Children’s Health Research (Global Network).  The purpose of 
this solicitation is to establish an innovative and flexible research network 
that will be responsive to the most critical existing and emerging health 
needs and public health problems of women and children, globally.  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.  Initial 
efforts will focus on safe pregnancy and birth outcomes, within the broader 
context of women’s and young children’s health.

Grantees will be part of a Global Network that will include basic and 
clinical biomedical and behavioral Research Units and a Data and Coordinating 
Center (Data Center).  The Global Network will increase and enhance 
opportunities for scientific linkages, interaction, knowledge development and 
transfer, and collaborative partnerships between United States (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.  Global Network Data Center applications will not 
require foreign collaborators. 

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 will be the establishment of Research Units to design, 
implement, and evaluate evidence-based health interventions.  This objective 
will be achieved by the network through research activities that pose and 
answer questions with significant and measurable health-related outcomes in 
women, children, and families in developing countries.  The primary endpoints 
in these research studies must relate to demonstrable improvement in 
important health measures in the population under study.  This RFA is not 
intended to support operations or health services research.  It is intended 
to support basic biomedical and behavioral research, clinical and 
translational research, and associated evaluation research.  It will not fund 
predominantly epidemiologic research studies.

The release of this Request for Applications (RFA) coincides with the re-
issuance of the International Maternal and Child Health Research and Training 
Program (IMCHRT) RFA TW-00-007 
(http://grants.nih.gov/grants/guide/rfa-files/RFA-TW-00-007.html), a 
complementary and closely related research training program jointly sponsored 
by the Fogarty International Center (FIC) and the NICHD.  This training program 
seeks to increase the expertise of scientists in developing countries in 
biomedical, behavioral, and prevention research related to women and children, 
to support collaborative training between U.S.-based and foreign scientists, 
and to establish or strengthen the research capacity in the home countries of 
trainees.  The training and research capacity-building efforts of the IMCHRT 
are intended to facilitate maternal and child health research, such as will 
be undertaken through the Global Network.     
 
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.  The Global 
Network’s NIH co-sponsoring Institutes and Centers (ICs) also 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, managed by 
NIAID, and the cooperative research and training programs managed by the FIC.  

HEALTHY PEOPLE 2010

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 
http://www.health.gov/healthypeople.

ELIGIBILITY REQUIREMENTS

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.  Applicant institutions may 
apply for 1) only a Data Center grant, 2) only a Research Unit grant, or 3) 
both a Data Center grant and a Research Unit grant, which will require 
separate applications and will be reviewed independently.  If applications 
are submitted by the same institution for both a Data Center and a Research 
Unit grant, there should be no overlap of personnel proposed in each grant 
application.

Global Network Research Unit Applicants

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 Latin America, the Caribbean, North and sub-Saharan Africa, 
the Middle East, South and South East Asia including China, Oceania, 
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. grantee 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.

FY 1999 IMCHRT program grantees are strongly encouraged to submit 
applications for Global Network Research Unit grants and to describe how 
their training efforts and experiences relate to and support proposed 
research activities under the network.  It is recommended that applicants
for a Global Network award who are not previous IMCHRT grantees also apply 
for an FY 2001 IMCHRT training award.  Although applicants may apply for 
either a Global Network Research Unit grant or an IMCHRT grant, priority will 
be given to institutions that submit meritorious applications in response to 
both the Global Network RFA and the FY 2001 IMCHRT RFA.  NICHD may make 
awards to institutions without IMCHRT awards and FIC may make IMCHRT awards 
to institutions without a Global Network award.  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 also 
are encouraged to apply. 

Global Network Data Center Applicants

Domestic organizations with capacity to maintain close communication with NIH 
and with prior experience in functioning as a research support services 
provider, and statistical coordinating and assistance center for multi-center 
research (including randomized controlled trials and observational studies of 
both a medical and behavioral nature), are encouraged to submit a separate 
application under this RFA for establishment and operation of the Data 
Center.  

MECHANISM OF SUPPORT

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.

FUNDS AVAILABLE

The NICHD intends to commit approximately $8 million in total costs [direct 
plus Facilities and Administrative (F&A) costs] in FY 2001 to fund one Data 
Center grant and 8 to 10 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.  
The co-sponsoring NIH ICs also plan to commit additional funds to support one 
or more meritorious Research Unit grants of specific interest and relevance 
to their research missions.  NCCAM intends to commit up to $1 million in FY 
2001 to support one or two Research Unit grants designed specifically to 
investigate aspects of traditional medicine and related practices in 
developing countries.  NIMH intends to commit approximately $850,000 in FY 
2001 to support studies related to its mental illness and HIV/STD research 
mandate in developing countries.  NIAID intends to commit approximately 
$500,000 in FY 2001 to support research related to infectious diseases among 
women and young children in developing countries.  NCI intends to commit 
approximately $250,000 in FY 2001 to support research related to the 
prevention and reduction of tobacco use among women and girls in developing 
countries.  NIDCR intends to commit approximately $200,000 in FY 2001 to 
support research related to the causes and prevention of craniofacial defects 
in developing countries.  The FIC co-sponsorship of the Global Network 
consists of the substantial complementary support provided by the FIC IMCHRT, 
which includes training and research capacity building efforts intended to 
facilitate maternal and child health research such as will be undertaken 
under the Global Network program. 

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.  An applicant for the Data Center may 
request a project period of up to five years and a budget for direct costs of 
up to $1 million in the first year, with incremental increases not exceeding 
three percent in each subsequent year.  

Because the nature and scope of the research proposed may vary, it is 
anticipated that the size of  awards also will vary.  Although the financial 
plans of the RFA co-sponsors provide support for this program, 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. 

RESEARCH OBJECTIVES

Background

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. 

Behavioral factors also can increase health risk for women and young 
children.  Although currently low (seven percent), the prevalence of 
cigarette smoking among women in the developing world is increasing, 
particularly among younger, more affluent women, living in urban 
environments.  Additionally, traditional forms of tobacco use, such as 
chewing tobacco, are common among women in some developing countries. At 
present, about three million deaths occur worldwide annually from tobacco 
use, including 500,000 among women.  By 2020, worldwide deaths associated 
with tobacco use are expected to increase to 10 million annually, with most 
of the increased mortality occurring in developing countries.  An increased 
prevalence of smoking among women in the developing world, if not prevented 
or reduced, inevitably will have enormous negative implications for the 
health of women and children.  The burden of tobacco-related chronic 
illnesses will grow.  Maternal tobacco use will contribute to increased risk 
of low birth weight, placental abnormalities, premature delivery, spontaneous 
abortion, perinatal death, and Sudden Infant Death Syndrome.  To maintain or 
decrease the current relatively low prevalence of tobacco use, research is 
needed on factors that influence initiation of tobacco use, and on strategies 
that focus on smoking prevention and cessation among women and girls in 
developing countries.

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.  
The WHO estimates that over 80 percent of the world’s population may rely on 
traditional medicine as its primary source of medical care.  The practice of 
traditional medicine varies greatly among countries and from region to region 
because of the influence of culture, history, and philosophy, among other 
factors.  In developing countries, where an estimated 63 percent of infants 
are born at home and an estimated 80 percent of children die at home, advice 
and assistance concerning reproductive health, birth practices, and infant 
and child care may be available only from local community health workers, 
traditional medical practitioners, or members of a woman’s extended family. 

Families might initially consult a traditional practitioner for the 
prevention or alleviation of disease symptoms and only seek care from a 
western-style medical practitioner for unresponsive, very serious, or 
chronically debilitating conditions.  It is important, therefore, to study, 
understand, and evaluate the interactions and outcomes of traditional medical 
practices, independently and in relation to “western” medical practice, 
within a country’s or a region’s cultural context when seeking to improve the 
health of women and children.  Any research on traditional medicine needs to 
consider the health outcomes of traditional medical practice, and the 
knowledge, skills, and experience of the practitioners involved, with expert 
practitioners of traditional medicine incorporated into such studies.

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 
countries.

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. Establishment of a 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 will emphasize 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, as well as the 
interests of network investigators and the NIH in undertaking shared studies.

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. 

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

o Etiology of, and prevention or reduction of, leading causes of maternal 
morbidity and mortality.

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 Etiology of, and prevention and reduction of, fetal loss and infant 
mortality.

o The role of enhanced nutritional status in the reduction and treatment of 
LBW and maternal anemias, decreasing the susceptibility to and consequences 
of infectious diseases, and improvement of the health and development of 
women, neonates, and young children.

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

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 
infections.

o Impact of neonatal resuscitation on infant survival and on child health 
outcomes.

o Studies on HIV/STDS and mental illness of significant health impact in 
women and young children in developing countries.

o Prevention and reduction, or maintenance of current relatively low 
prevalence, of tobacco use among women and girls in developing countries.

o Studies on the cause and prevention of craniofacial birth defects, such as 
cleft lip and cleft palate, including studies evaluating the effects of 
maternal nutrition status, dietary supplementation, and exposure to 
environmental agents.

o Studies on the association of oral infections (e.g., periodontitis) in the 
mother and increased risk for preterm LBW babies. 

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, and a proposed budget for the life of the project.  
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 application.  

Organizational Components
 
The Global Network will consist of multiple Research Units composed of 
multidisciplinary teams of collaborating U.S. scientists linked with 
developing country investigators (each Research Unit will be led by a U.S. 
Principal Investigator and a Senior Foreign Investigator at the developing 
country site), a single Data Center, which will provide 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-sponsors).   

Guidance and Management Structure

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

Steering Committee

The Steering Committee will serve 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 will be 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 will have one vote.  A chairperson will 
be appointed to a minimum of a one-year term, by NICHD.  Representatives of 
other NIH co-sponsoring ICs, a representative of the Network Advisory Group, 
and selected Data Center staff may participate in Steering Committee meetings 
as non-voting members.

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.

Network Advisory Group

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 and to NIH 
regarding current and future network research objectives, priorities, 
collaborations, and potential shared projects.  

Data Safety and Monitoring Board

A Data Safety and Monitoring Board (DSMB), established by NICHD, will advise 
the NIH and the Global Network, 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. 

SPECIAL REQUIREMENTS

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 include descriptions of 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.

o Evidence of Foreign Institutional Support

Applicants must demonstrate commitment to and support for the proposed 
collaborative research study from the foreign research partner institution.  
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, as well as the international and 
domestic research and healthcare-providing communities. 

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 
what resources might be needed to support communication among the Global 
Network Research Units, the Data Center, and the NIH.

Minimum requirements for Data Center applicants are as follows:

o Evidence of Successful Past Performance

Data Center applicants must demonstrate prior experience and provide evidence 
of successful past performance as a data and coordinating center in multi-
center studies during the previous five years.  Any relevant experience 
related to international multi-center trials should be described.

o Appropriate Staff Expertise and Capability

The Data Center will consist of a Principal Investigator, a project 
coordinator, and other staff deemed necessary to carry out its mission.  The 
proposed Data Center staff must be prepared to cooperate effectively in all 
network functions with NICHD and the Global Network Research Units.  The 
Principal Investigator and other staff must have appropriate expertise and 
capability in biostatistics, study development and support, data management, 
data analysis, and project management, including, but not limited to staff 
and site training and quality assurance procedures. 

o Capacity and Ability to Manage Data and Communications

Data Center applicants must have the ability to assist in designing 
protocols, data collection forms, manuals of operation, and data collection 
systems, including distributed data entry.  Applicants must have experience 
in developing and maintaining data quality control systems.  The applicants 
also must provide evidence of data management and program support 
capabilities by describing standard operating procedures that address: 1) 
plans for data collection, management, analysis, and data quality control, 
and 2) plans for supporting an electronic mail/communications system to 
participants of the Global Network.

o Evidence of Reporting and Publications Capabilities

Data Center applicants must provide evidence of their capacity to generate 
monthly reports on subject enrollment for several concurrent studies, 
quarterly reports on enrollment and Global Network Research Unit performance 
(including effort to reallocate study resources), appropriate reports for the 
use of the DSMB, Network Advisory Group, and Steering Committee meetings, and 
other special reports, as required.  The applicants must demonstrate 
successful experience in assisting investigators in preparing manuscripts for 
publication.

o Experience in Providing Logistical and Other Support Services

Data Center applicants must provide evidence of successful experience in 
arranging logistical support services for multi-center research, for example, 
meeting and conferencing support, assuring the appropriate preparation and 
delivery of study medications to research sites participating in joint 
clinical trials.

o Evidence of On-site Monitoring Capabilities

Data Center applicants must have experience and demonstrate capability in 
organizing and conducting on-site monitoring of multi-center research 
studies. 

o Evidence of Technology Transfer and Data Management Training Capabilities 

Data Center applicants must demonstrate their capability to assist the Global 
Network Research Unit sites to enhance their data management and 
communications activities.  Evidence of training and technical assistance 
expertise and experience in this area must be provided.

o Evidence of Management Capability

Data Center applicants must provide evidence of superior ability 1) to 
estimate appropriate and reasonable resources needed for individual projects 
in their role as the Data Center for the Global Network, 2) to manage those 
resources efficiently during the research, 3) to adjust the assigned staff 
and other resources in response to changing work needs as the projects 
undertaken by network members unfold, 4) to report these resource allocations 
to NICHD periodically, and 5) to subcontract with outside organizations to 
supplement these resources, as needed.

Travel

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 site. 

Budget

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).  Budgets submitted by Research Unit 
applicants 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.

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.

Data Center applicants should provide a budget, presented with precision and 
clarity  that includes, at a minimum, the following:

o Salary and administrative support for the Principal Investigator, project 
coordinator, and other staff as required to meet the first-year 
responsibilities of the Data Center.

o Estimated travel costs and related expenses for the Principal Investigator 
and other Data Center staff for travel to required meetings.  

o Travel and logistical support expenses for members of the DSMB and the 
Network Advisory Group.  For the purposes of this RFA, applicants should 
estimate three meetings per year for the DSMB, with a membership of six 
domestic and two international travelers, and one meeting per year for the 
Network Advisory Group, with six domestic and two international travelers.  

o Expenses related to communications, supplies, equipment, and other items 
identified as essential to the establishment and operation of the Data 
Center.  

o Clearly specified plans and procedures for monitoring of Data Center 
budgetary expenditures.
 
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. The Data Center Principal Investigator must expend at 
least 40 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 funding.

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 a 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 
Committee.

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 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 co-sponsoring NIH ICs 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 
projects.

o Compile for the Network Advisory Group and Steering Committee, the DSMB, 
the NICHD and the other participating NIH ICs, 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 
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 
site.

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 ICs 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  

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 co-sponsoring NIH ICs, 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 
Center.

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 
NICHD.

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

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 ICs.  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 ICs.   

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

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

The specific terms and conditions above and the details of arbitration 
procedures below pertaining to the scope and nature of the interaction 
between the co-sponsoring NIH ICs and participating sites will be 
incorporated into the notice of grant award.  These procedures will be in 
addition to the customary programmatic and financial negotiations that occur 
in the administration of grants.  Arbitration procedures will be invoked only 
when agreement cannot be reached on scientific and/or programmatic issues 
that may arise between awardees and the NICHD Staff Science Coordinator after 
the award has been made.  In that event, an arbitration panel will be formed 
consisting of one person selected by the Principal Investigators, one person 
selected by the NICHD Staff Science Coordinator, and a third person selected 
by those two members.  The decision of the arbitration panel, by majority 
vote, will be binding.  

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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 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 
“NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research,” published in the Federal Register of March 28, 1994 (FR 59 14508-
14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 
18, 1994, and available at:  
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.

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.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

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: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

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

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title, 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. The letter of intent also should indicate 
whether prospective applicants intend to apply for a Global Network Research 
Unit grant and/or a Data and Coordinating Center grant.  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 avoid conflict of interest in 
the review.  

The letter of intent is to be sent, by April 14, 2000, to:

Mr. F. Gray Handley
Associate Director for Prevention Research and International Programs
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 2A01, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 435-7566
Fax:  (301) 435-0009
E-mail:  handleyg@exchange.nih.gov

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research, on the Internet at: 
http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the 
Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-
7910, telephone 301-435-0714, E-mail: GrantsInfo@nih.gov.

Application Instructions for All Applications

Instructions accompanying the research grant application form PHS 398 (rev. 
4/98), including page limitations, are to be used in applying for these 
grants, with the modifications described below:

o On line 2 of the application face page, the network component applied for 
must be clearly identified as either “Research Unit” or “Data Center.”  If an 
institution intends to apply for more than one of the components, the 
institution must submit separate applications for each component.  This 
information is in addition to the RFA number and title that must be provided 
on line 2.

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 (limited to two pages each) should 
follow the budget justification.  

Submission Instructions

The RFA label available in the PHS 398 (rev. 4/98) application package must 
be stapled to the bottom of the face page of the application and must display 
the RFA number HD-00-007.  A sample RFA label is available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  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 
marked.

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
BETHESDA, MD 20817  (for express/courier service)

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

L. R. Stanford, Ph.D.
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)
Telephone: (301) 496-1485

Applications must be received by July 13, 2000.  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.

REVIEW CONSIDERATIONS

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 a process may be used in which only those applications deemed to 
have the highest scientific merit will be assigned a priority score and 
receive a second level of review by the appropriate National Advisory Council 
or Board.

Review Criteria

Specific Criteria for Evaluation of Research Unit Applications

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?

(3) Innovation:  Does the project employ novel concepts, approaches or 
method?  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 proposed appropriate to the experience level of the 
Principal Investigator and other researchers (if any)?

(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 support?

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

o Quality of the scientific contribution to the health of women and children.

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 communication.

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 
commitment.

o Evidence of commitment and capability to expand global health research 
capacity in the developing country(ies), focused on women’s and children’s 
health, as indicated by the percent effort to be expended at the foreign site 
by the Principal Investigator and other U.S. personnel.

o Adequacy of plans and procedures for monitoring expenditures at both the 
domestic and foreign sites.

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

Specific Criteria for Evaluation of Data Center Applications 

o Quality of the scientific and operational contribution to the Global 
Network.

o Adequacy of site support, governance support, and staff training plans, 
including onsite training.

o Flexibility of plans to respond to the changing analytic needs of the 
Global Network.

o Adequacy of plans to guarantee the quality and integrity of collected data.

o Adequacy of plans to maintain accurate and timely information on the 
progress of studies and site performance.

o Adequacy of experience in and plans for conducting periodic onsite 
monitoring of multi-site studies
  
o Demonstration of innovative analytic approaches to evaluating research 
data.

o Adequacy of the qualifications and research experience of the management 
and analytic team.

o Adequacy of plans to facilitate and maintain close communication with NIH 
and among the other Global Network components. 

o Adequacy of previous experience with design, administration, management and 
coordination of multi-site studies.

o Evidence of high quality past performance in relevant NIH activities.

o Adequacy of the proposed resources, including staffing, for supporting the 
Global Network.

o Evidence of ability to strengthen  the data management and analysis 
capacity of the Global Network foreign sites, including plans for training, 
in order to increase their self-sufficiency over time.

o Adequacy of plans and procedures for monitoring Data Center expenditures.

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

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 
evaluated.

o The reasonableness of the proposed budget and its duration in relation to 
the proposed research.

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 application.

SCHEDULE

Letter of Intent Receipt Date:    April 14, 2000
Application Receipt Date:         July 13, 2000
Peer Review Date:                 October 2000
Council Review:                   January 2001
Earliest Anticipated Award Date:  February 1, 2001

AWARD CRITERIA

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, 
and
o availability of funds. 

INQUIRIES

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.
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 4B03, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 496-0431
FAX:  (301) 496-3790
E-mail:  meikles@mail.nih.gov 

Direct inquiries regarding fiscal matters to:
Mr. Andrew C. Jones
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8A01, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 435-6995
FAX:  (301) 402-0915
E-mail:  aj30i@nih.gov 

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
Numbers 93.865 and 93.864 (NICHD), 93.856 (NIAID), 93.399 (NCI), 93.121 
(NIDCR), 93.242 (NIMH), and 93.213 (NCCAM).  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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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