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 301-710-0267, 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
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Department of Health and Human Services (HHS)
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NIH... Turning Discovery Into Health®
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