GLOBAL NETWORK FOR WOMEN"S AND CHILDREN"S HEALTH RESEARCH
Release Date: October 10, 2001
RFA: RFA-HD-01-024 (This RFA has been renewed, see RFA-HD-05-025)
National Institute of Child Health and Human Development
(http://www.nichd.nih.gov)
Fogarty International Center
(http://www.nih.gov/fic)
Letter of Intent Receipt Date: February 11, 2002
Application Receipt Date: March 18, 2002
Expiration Date: March 19, 2002
PURPOSE
The National Institute of Child Health and Human Development (NICHD) and the
Fogarty International Center (FIC), in partnership with the Bill and Melinda
Gates Foundation, invite applications from United States (U.S.) scientists
partnered with foreign scientists in Eastern Europe and Africa for
participation in the Global Network for Women"s and Children"s Health Research
(Global Network). The purpose of this solicitation is to complement the
existing Global Network with the addition of Research Units from Eastern
Europe, the Newly Independent States, and Africa. The Global Network, also
supported by the National Center for Complementary and Alternative Medicine
(NCCAM) and the National Institute of Dental and Craniofacial Research
(NIDCR), consists of 10 Research Units and one Data and Coordinating Center
that together form an innovative and flexible research network involved in the
most critical public health problems of women and children. Through
competitive cooperative agreements, international, multidisciplinary teams of
investigators will work collaboratively to answer scientific and/or public
health questions to help improve health, and to prevent premature disease and
death among women and children, primarily in developing countries. The
efforts of the Global Network awardees will continue to focus on safe
pregnancy and birth outcomes, within the broader context of women"s and young
children"s health.
The Global Network will work to increase and enhance opportunities for
scientific linkages, interaction, knowledge development and transfer, and
collaborative partnerships between U.S. and foreign investigators and
institutions. It also is intended to strengthen and expand the global
infrastructure for women"s and children"s health research. Applications for
Global Network Research Unit grants will require full collaboration between
scientists in the U.S. and foreign investigators in developing countries.
The overall goal of the Global Network is to expand scientific knowledge
relevant to improving health outcomes for women and children in developing
countries. Other critical goals in establishing this network are: (1) to
develop sustainable research infrastructure and public health intervention
capabilities in developing countries, and (2) to strengthen international
collaborative research arrangements that focus on the leading causes of
morbidity and mortality in pregnancy and early childhood. A key objective for
the network, and a requirement for the Research Units, is to design,
implement, and evaluate evidence-based health interventions. These
interventions must have a strong scientific and epidemiologic basis for their
use in the foreign country. The primary endpoints in these research studies
must relate to demonstrable improvement in important public health measures in
the population under study.
This RFA is not intended to support operations or health services research.
It is intended to support biomedical and behavioral research, clinical and
translational research, and associated evaluation research. It will not fund
predominantly epidemiologic research, such as observational or surveillance
studies. It will not fund studies of food or micronutrient supplementation in
children over two years of age or studies with the evaluation of either new or
existing health care delivery programs or health care utilization as a primary
aim, applications proposing such activities will be returned without review.
Applications that do not contain an evidence-based intervention will be
returned without review. The transfer of technology to developing countries
should be carefully justified, both ethically and scientifically, the proposed
use of interventions that have been previously abandoned in developed
countries will not be reviewed or funded.
NICHD will facilitate coordination of the Global Network"s activities with
relevant governmental agencies (e.g., the Centers for Disease Control and
Prevention and the U.S. Agency for International Development), international
organizations including the World Health Organization (WHO), United Nations
Children"s Fund (UNICEF), the World Bank, and the Global Forum for Health
Research, and other public and private sector institutions. NICHD will assure
that the activities of the network are coordinated with the activities of
other relevant and complementary NIH-supported international research
programs. Among these programs are the International Collaborations in
Infectious Disease Research (ICIDR) program, the HIV Prevention Trials Network
(HPTN), the Tuberculosis Research Unit (TBRU) program, the Comprehensive
International Program of Research on AIDS (CIPRA), managed by NIAID, and the
cooperative research and training programs managed by the FIC.
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.
Applications for a Global Network Research Unit grant must be submitted
jointly by collaborating teams of investigators that include the applicant
U.S. Principal Investigator and a developing country scientist resident at an
established institution in a developing country. These collaborating teams
are identified as "Research Units" in the context of this RFA. For the
purposes of this RFA, developing countries are defined as the resource-poor
nation states of North and sub-Saharan Africa, Central/Eastern Europe, and the
Newly Independent States (NIS) of the former Soviet Union.
U.S. and developing country scientists and institutions applying for a network
grant must provide strong evidence (e.g., established research collaborations)
of their likelihood to succeed and their ability to work in effective
international partnership with each other. The roles and responsibilities of
collaborating scientists and institutions must be clearly defined. Research
Unit applications that do not propose U.S.-foreign scientist collaborations
will be considered non-responsive to the RFA and returned to applicants
without review. Although the lead U.S. and foreign country investigators will
collaborate closely, the application must be submitted by the U.S.
institution. The U.S. awardee institution is responsible for developing and
maintaining affiliation(s) with an established foreign collaborating
institution(s), for example, a college or university, research institute,
health department, or hospital. This affiliation(s) and the appropriate and
necessary institutional and governmental endorsements should be clearly
specified and well documented in the application. Specifically, it is
necessary for applicants to provide evidence that a working agreement has been
established with the foreign government to expedite deputation of personnel,
equipment, and supplies at the local site, to monitor and verify expenditures,
and to manage other legal and procedural matters.
Applications may be submitted by institutions that already have a Global
Network grant, however, there should be no overlap of personnel between the
currently funded and proposed Research Units.
Applicants with a strong base of support from the NICHD or other parts of the
NIH for research related to (or with implications for) improving the health of
women and children are also encouraged to apply.
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 $1.5 million in total costs [direct
plus Facilities and Administrative (F&A) costs] in FY 2002 to fund two to four
Research Unit grants in response to this RFA. As part of this funding, the
Bill and Melinda Gates Foundation is contributing $15 million over a three-
year period to help establish the Global Network. FIC is contributing
$100,000 to this effort for FY 2002.
An applicant for a Research Unit grant may request a project period of up to
five years and a budget for direct costs of up to $500,000 in the first year,
with incremental increases not exceeding three percent in each subsequent
year. It is expected that a significant proportion of these direct costs will
be expended at the foreign site. Applications with budget requests for direct
costs exceeding $500,000 will be returned without review.
Because the nature and scope of the research proposed may vary, it is
anticipated that the size of awards also will vary. Awards pursuant to this
RFA are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications. At this time, it is not known
if competing renewal applications will be accepted and/or if, or in what form,
this RFA will be reissued.
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.
The WHO estimates that more than five million children die within the first
few weeks of life each year, and there are an additional four million annual
fetal deaths. Most (98 percent) of these deaths occur in developing
countries. These deaths are caused most often by infectious diseases,
pregnancy-related complications, and delivery-related complications, including
intrapartum asphyxia, birth trauma, and premature birth. Infectious diseases
are associated with 30 to 40 percent of all neonatal deaths, or 1.5 to two
million deaths per year. The infections responsible for most of the early
mortality are acute respiratory infections (ARI), neonatal tetanus, and
sepsis, diarrhea, and meningitis. These infectious diseases also contribute
to the enormous burden of disease among infants. Recent studies show that
oral infections, such as periodontal diseases, are associated with premature
and low birth weight (less than 2500 grams, LBW) deliveries. LBW is one of
the principal contributors to neonatal morbidity and mortality worldwide and
accounts for up to 70 percent of neonatal deaths in some countries. The
problem of LBW is intergenerational and related to many factors throughout the
lifecycle. LBW infants tend to become poorly nourished children with
developmental problems and then adults who produce small infants. A number of
other health problems also are associated with LBW.
A 1999 report by the Child Health Research Project indicates that other
factors that may increase child illness and death include poor maternal
health, untreated maternal infections, including HIV/AIDS and its many
sequelae, other sexually transmitted diseases (STDs), and urinary tract
infections, lack of immunizations among adolescent girls and adult women,
unsafe and unsanitary delivery practices, fetal and maternal malnutrition, and
failure to breast feed exclusively.
Problems at the family and community level that may contribute to early infant
and child morbidity and mortality also may be related to women"s status,
domestic violence, social and cultural norms, lack of adequate health
information, poor decision-making skills and health-care seeking behaviors or
limited choices, lack of trained and poorly equipped health care workers, and
inadequate access to good quality medical care. Underlying these causes are
widespread poverty, illiteracy, lack of access to education, and gender
discrimination, often faced disproportionately by women and girls in many
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. Expanding the Global Network of
linked U.S. and developing country scientists and institutions will help
facilitate high quality, sustainable collaborative research that will address
many of these problems and issues. Recognizing that the focus of the program
is on the needs of developing countries, it is anticipated that its research
findings may help inform efforts to improve the health of U.S. women and
children at higher risk for morbidity and mortality.
Objectives and Scope
The primary scientific objectives of this RFA encompass a range of studies
related to women and young children, with an emphasis on the perinatal and
neonatal periods, but up to and including breast feeding and weaning. The
Global Network"s initial research commitment emphasizes the development,
testing, and adaptation of cost-effective, integrated biomedical, behavioral,
social, and public health interventions to reduce premature morbidity and
mortality among reproductive age women and young children in developing
countries. Thus, applications based predominantly or solely in clinical
research centers or laboratories in the U.S. will not be considered responsive
to the RFA.
The Global Network will function as an affiliated group that fosters
communication, innovation, and research excellence. Applications will be
reviewed and funded under the network for the single, meritorious research
study proposed by each applicant in response to this RFA. If funds become
available, other studies may be added over time and conducted in one, several
or all network sites, depending upon whether or not the proposed research
topic is relevant to health needs in more than one locality. Current common
activities in which new grantees should expect to participate are the
evaluation of overlapping outcome variables between sites and tobacco use
across sites.
Priority will be given to scientific activities that have the greatest
likelihood of improving pregnancy and birth outcomes in developing countries.
This may include research activities designed to prevent maternal and early
childhood deaths and/or to improve the health of reproductive age women and of
children up to the age of weaning. All research conducted under the auspices
of the network must be designed such that meaningful and sustainable health
improvements in the study population are likely to have a measurable health
outcome. Surrogate or intermediate outcomes must be well defined and well
justified scientifically. Current topics in the Global Network Research Units
are: prevention of postpartum hemorrhage, reduction of cleft lip and cleft
palate, including behavioral change in health care providers, reduction of
perinatal and neonatal sepsis, reduction of preeclampsia, neonatal care, and
reduction of low birth weight.
Suitable topics for proposed research projects include, but are not limited
to, the following:
o Prevention or reduction of leading causes of maternal morbidity and
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 Prevention and reduction of fetal loss and infant mortality, including
studies of dental and cranio-facial diseases and defects that contribute to
neonatal and infant morbidity and mortality.
o Prevention or amelioration of infections, including, but not limited to,
syphilis, HIV, gonorrhea, and chlamydia, which may be passed from mother to
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.
Each Global Network Research Unit applicant should propose one fully developed
research study to address a current critical or emerging health problem
related to the needs of women and/or young children in the foreign
collaborator"s country. The application should provide a research plan that
includes an evidence-based statement of the health problem and research
hypothesis, the proposed study population, the study design, methodology, and
recruitment protocols, data collection, analysis, and reporting plans,
suggested timelines and staffing plans, plans for enhancing research capacity
at the foreign site, plans for sustaining the intervention after the funding
period is over, and a proposed budget for the life of the project. The Global
Network Data and Coordinating Center will be the primary contact for data
collection and management. Evidence of collaboration and multidisciplinary
expertise related to the proposed project should be provided. The quality of
the research plan will be an important focus of the peer review of the
application.
Organizational Components
The Global Network currently consists of 10 Research Units composed of
multidisciplinary teams of collaborating U.S. scientists linked with
developing country investigators (each Research Unit is led by a U.S.
Principal Investigator and a Senior Foreign Investigator at the developing
country site), a single Data Center, which provides research support services
for the Global Network, and the NIH (represented by the NICHD Staff Science
Coordinator and Staff Science Collaborators from NICHD and the other NIH co-
sponsors).
Guidance and Management Structure
The overall guidance and management of the Global Network is provided by a
Steering Committee, a Network Advisory Group, and a Data and Safety Monitoring
Board.
o The Steering Committee serves as the Global Network"s central point for
communication, exchange of ideas, development and management of joint
protocols and research activities, and problem resolution. The Steering
Committee is composed of the U.S. Principal Investigator and the Senior
Foreign Investigator of each Global Network Research Unit, the Principal
Investigator of the Data Center, and the NICHD collaborating Staff Science
Coordinator. Each Principal Investigator, Senior Foreign Investigator, and
the NICHD Staff Science Coordinator has one vote. A chairperson is appointed
to a minimum of a one-year term, by NICHD. Representatives of other NIH co-
sponsors, a representative of the Network Advisory Group, and selected Data
Center staff may participate in Steering Committee meetings as non-voting
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.
New Research Units should be expected to participate in these and future
common activities.
o A multidisciplinary Network Advisory Group, appointed by the Director,
NICHD, shall provide scientific oversight of the research and administrative
activities of the Global Network. The Network Advisory Group will meet at
least once yearly and will consist of individuals familiar with the kinds of
international collaboration and research undertaken by Global Network
grantees. The purpose of the Network Advisory Group is to provide periodically
an independent, expert review and assessment of new proposed research activity
and of the progress of research projects supported by the Global Network, and
to offer guidance to the Steering Committee regarding current and future
network research objectives, priorities, collaborations, and potential shared
projects.
o A Data and Safety Monitoring Board (DSMB), established by NICHD, will
advise the Global Network Steering Committee and Research Units, including the
Data Center, on research design issues, data quality and analysis, and ethical
and human subject issues. It also will monitor the safety of any ongoing
clinical trials. DSMB membership will include, but not be limited to,
individuals with expertise in clinical trial design and conduct, relevant
basic, medical, and behavioral sciences research, and ethics and cultural
competency issues, particularly in relation to the conduct of research with
developing country populations. The Data Center will prepare reports and
provide coordination, support, and funding for travel and logistics
arrangements related to DSMB meetings and actions.
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 describe any relevant international collaborative research
activity undertaken between the U.S. applicant Principal
Investigator/institution and its developing country partner Senior Foreign
Investigator/institution. Evidence of successful domestic and/or international
research network or multi-center research activity also should be provided.
Contributions and collaborations in areas such as protocol design, study
recruitment, data
analysis and interpretation, and publication should be highlighted.
Documentation of recruitment and retention rates in clinical trials should be
provided. The U.S. PI should clearly document previous time spent,
activities, and outcomes at the foreign site.
o Evidence of Foreign Institutional Support
Applicants must demonstrate the foreign research partner institution’s
commitment to and support for the proposed collaborative research study.
Documentation from key administrative personnel at the foreign institution
should indicate support for research staff participation in the Global Network
and authorize some potential use of institutional resources. Examples of such
resources may include administrative staff assistance, equipment, supplies,
access to office, clinic or laboratory space, etc. Applicants also should
provide evidence of support for their research collaboration from the
appropriate foreign government authorities, as well as any international
organization(s), with a regional or country mission or component that is
proposed to be involved in the study.
o Appropriate Staff Expertise and Capability
The application must be submitted by a U.S. applicant institution on behalf of
the U.S. and foreign country collaborative partners. Applicants must present
evidence of the professional expertise, experience, and capacity of both the
U.S. Principal Investigator and the developing country Senior Foreign
Investigator, as well as their respective project staff, to develop and
implement the research proposed to be undertaken within the Global Network
o Multidisciplinary Approach and Staffing
Applicants must demonstrate a multidisciplinary approach to the design and
implementation of their proposed collaborative study. A staffing plan should
be included that indicates formation of a multidisciplinary team of
biomedical and behavioral scientists, physicians, and public health personnel.
This team must be capable of conducting the described research and, when
appropriate, providing clinical services to women and children on site or in
the community. Steps to ensure effective communication and cooperation across
disciplines should be identified. Prior successful experience with
multidisciplinary research activities should be indicated.
o Awareness of Ethical and Cultural Issues in Global Research
Applicants must demonstrate an awareness of and must describe their experience
with any ethical and cultural issues that need to be considered in the design,
implementation, analysis, and publication of research studies undertaken with
women and children in developing countries. This includes issues related to
framing of appropriate research questions, recruitment and retention of study
populations, informed consent and other human and animal subject
considerations, design and use of research methods and instruments, data
analyses and interpretation, and dissemination and application of findings to
benefit the study populations, sustainability planning, as well as the
international and domestic research and healthcare-providing communities. Any
relationship of the study topic to national or local health policy should be
clearly explained.
o Capacity for Communications
Applicants should include a description of existing and anticipated
technological and staff resources for the establishment and maintenance of
computer-based and other communications linkages to facilitate information and
research data sharing between the U.S. and developing country sites.
Applicants must provide, at a minimum, assurance of or planning for e-mail
capability at all sites. Technological and resource needs and limitations
related to communications also should be indicated. This information will
help the NIH co-sponsors to assess available and potential technology, and to
determine what resources might be needed to support communication among the
Global Network Research Units, the Data Center, and the NIH.
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). Budget requests should include, at a minimum, the following:
o Estimated travel costs and related expenses for any proposed staff travel,
as described above. In addition, budget requests should include funds to
support travel of the Principal Investigator and the Senior Foreign
Investigator of each Research Unit to periodic meetings, in the Washington,
D.C. area, of the Steering Committee, usually a three-day annual meeting.
o Salary support for the U.S. Principal Investigator, the Senior Foreign
Investigator, study coordinator(s), outreach/recruitment workers, and any
other proposed professional and support staff, with appropriate justification.
o Laboratory and screening costs for study participation.
o Expenses related to communications, supplies, equipment, and subject
reimbursement/compensation anticipated in the research.
o Resources for a physician independent of the study (Safety Monitor) to
evaluate adverse events.
o Expenses related to activities to strengthen research capacity at the
foreign site.
o Expenses related to sustainability planning.
Percent Effort
U.S. Principal Investigators of the Global Network Research Units must expend
at least 25 percent effort annually on the award over the entire period of
support, with a significant effort expended at the foreign site. The Senior
Foreign Investigators of the Research Units must be substantially involved,
spending at least 25 percent effort annually on the award over the entire
period of support.
Terms and Conditions of Award
Cooperative agreements are assistance mechanisms and are subject to the same
administrative requirements as grants. The following terms and conditions
will be incorporated into the award statement and provided to each Principal
Investigator as well as the institutional officials at the time of the award.
These terms are in addition to, and not in lieu of, otherwise applicable OMB
guidelines, HHS Grant Administration Regulations at 45 CFR Part 74 and 92, and
other HHS, PHS, and NIH grant administration policies. Business management
aspects of these awards will be administered by the NICHD Grants Management
Branch in accordance with HHS, PHS, and NIH Grant Administration policies. It
is envisioned at this time that all awarded funds will be administered by the
NICHD Grants Management Branch or by the Grants Management Offices of the
other co-sponsoring NIH ICs when those Institutes or Centers provide primary
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 an U.S. Principal
Investigator and a Senior Foreign Investigator at the developing country site.
The Research Units specifically will:
o Develop and implement research protocols, interventions, and evaluation
strategies, with all protocol documents including, at a minimum, an
introduction section with background and rationale, a statement of the study
objectives, criteria for selection of subjects and enrollment procedures,
clinical and laboratory evaluations to be performed, plans for data
collection, management, and monitoring, and for reporting of adverse events, a
complete description of the study treatment, and statistical considerations,
including general design issues, endpoints, sample size, accrual and power,
monitoring and analysis, and stopping rules. Some of these activities are
shared with the Data Center.
o Specify plans for compliance with all Food and Drug Administration
regulations and for the provision of an adequate supply, if the proposed
research includes an investigational new drug.
o As a shared activity with the Data Center, when appropriate, collect,
analyze, and interpret data, and disseminate research results from Global
Network studies, while assuring quality control.
o Present research concepts, plans, progress, and results to the Steering
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 institutional assurance from OHRP and local institutional review
board (IRB) approval of all study protocols implemented at U.S. or foreign
sites and comply with both IRB and Global Network policies and procedures.
o Generate, if feasible, additional research proposals, including shared
protocols, for consideration for inclusion in the Global Network.
o Participate in conference calls, and attend network meetings held at least
once annually.
B. The Data and Coordinating Center
The Data Center will provide research support services to the Global Network.
These will include establishment and maintenance of a centralized information
management system to help the Global Network Research Units collect, edit,
store, analyze, publish, and disseminate results from their individual
projects as well as from shared research. It will assist the program staff of
the NICHD and other NIH co-sponsors in monitoring research progress, and will
work to ensure data integrity, accuracy, and accessibility among all Research
Unit sites. It will offer technical assistance and analytical support for all
sites, as needed. The Data Center will provide particular attention to the
needs of developing country sites, for the purpose of helping develop and
enhance their capacity for data collection and analysis. Initially, the Data
Center will support primarily the individual research projects undertaken by
Global Network Research Units. However, as the Network becomes more
established and the capacity of the Research Units to undertake common
protocols is strengthened, the Data Center must be prepared to respond to the
needs of shared research projects.
All activities of the Data Center must be closely coordinated with the NICHD
Staff Science Coordinator. In support of all research projects undertaken by
the Global Network, the Data Center staff will:
o Support the activities of the Network Advisory Group, Steering Committee,
and the DSMB through provision of materials/documentation support, meeting
planning and logistics, and conference call coordination.
o Provide advice on study design, data collection, data analysis, and
publication development to all Global Network research projects.
o Prepare, design, and disseminate operations manuals, data collection forms,
databases, and results reporting summaries for Global Network research
projects.
o Compile for the Network Advisory Group and Steering Committee, the DSMB, the
NICHD and the other participating NIH sponsors, site visit reports, monthly
and quarterly subject enrollment reports, meeting summaries, quarterly
Research Unit performance and progress reports, and other reports as needed.
o Maintain or assure maintenance of high quality databases resulting from any
collaborative research, supervise all data collection procedures, and arrange
for the most efficient transfer of study data where indicated.
o Ensure that all Global Network sites and investigators fully comply with
DHHS and NIH regulatory requirements, including informed consent, reporting of
adverse events, human and animal subject safety and welfare provisions, and
the requirements of international collaboration.
o Provide training to all Research Unit site personnel as needed on data
management and analysis, and quality control and quality assurance.
o In coordination with the NIH co-sponsors, provide periodic on-site
monitoring to the Research Units for those studies being performed at that
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 Institutes and Centers also will be involved in the Global
Network program, primarily as staff science collaborators. Each research
study will have a staff science collaborator involved, and every protocol will
be reviewed by NIH according to NIH regulations and standard practices.
A. NICHD Staff Involvement: Staff Science Coordinator, Staff Science
Collaborators, and Program Official
Staff Science Coordinator:
The NICHD Staff Science Coordinator will serve as the principal representative
of the Institute and NIH and, in consultation with relevant NICHD program
staff and representatives of the other NIH co-sponsors, will provide overall
programmatic oversight, coordination, and assistance to the Global Network.
Specifically, the NICHD Staff Science Coordinator will:
o Facilitate communication, cooperation, and the exchange of information among
network members and between the network components and other existing programs
to support collaborative efforts.
o Participate as a voting member of the Steering Committee.
o Consult with NICHD program staff and NIH co-sponsors, who may be designated
as staff science collaborators assigned to specific studies, when needed for
optimal implementation of study designs.
o Assist the Steering Committee in the selection and approval of research
topics and the development and review of protocols for any specific studies.
o Together with the Steering Committee chairperson, approve formation and
membership of any Steering Committee subcommittees.
o Oversee site participation and performance with the support of the Data
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 Institutes
and Centers. They may participate in Steering Committee meetings as non-
voting members. Specifically, the NIH Staff Science Collaborators will, in
consultation and collaboration with the NICHD Staff Science Coordinator:
o Provide programmatic oversight and assistance to awardees assigned to their
respective NIH Institutes.
o Provide advice, when needed, for optimal implementation of intervention
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
When agreement between an awardee and NICHD staff cannot be reached on
scientific/ programmatic issues that may arise after the award, an arbitration
panel will be formed. The panel will consist of one person selected by the
Principal Investigator, one person selected by NICHD staff, and a third person
selected by these two members. The decision of the arbitration panel, by
majority vote, will be binding. This special arbitration procedure in no way
affects the right of an awardee to appeal an adverse action in accordance with
PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR
Part 16.
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 indicating that inclusion
is inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html),
a complete copy of the updated Guidelines is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The
revisions relate to NIH-defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups, if applicable, and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
With regard to the population of a partner foreign country, the definition of
minority groups may be different than in the U.S. If there is scientific
rationale for examining subpopulation group differences within the foreign
population, investigators should consider designing their studies to
accommodate these differences.
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.
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
All investigators proposing research involving human subjects should read the
policy that was published in the NIH Guide for Grants an Contracts, June 5,
2000 (Revised August 25, 2000), available at:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
the specified page limitations. Unless otherwise specified in an NIH
solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at:
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, and telephone
number of the U.S. Principal Investigator and the Senior Foreign Investigator,
the identities of other key personnel and participating U.S. and foreign
institutions, and the number and title of this RFA. Although a letter of
intent is not required, is not binding, and does not enter into the review of
a subsequent application, the information that it contains allows NICHD staff
to estimate the potential review workload and plan the review.
The letter of intent is to be sent to Dr. Susan Meikle, at the address listed
under INQUIRIES, below, by February 11, 2002.
APPLICATION PROCEDURES
The PHS 398 research grant application instructions and forms (rev.5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in
applying for these grants. This version of the PHS 398 is available in an
interactive, searchable PDF format. Beginning January 10, 2002, the NIH will
return applications that are not submitted on the 5/2001 version. For
further assistance contact GrantsInfo, telephone (301) 710-0267, E-mail:
GrantsInfo@nih.gov.
Application Instructions
Instructions accompanying the research grant application form PHS 398 (rev.
5/2001), including page limitations, are to be used in applying for these
grants, with the modifications described below:
o For the purpose of this RFA, key personnel is defined as follows: All
personnel involved in each application, regardless of whether salary support
is requested. Names of all personnel should be included in the application
with their specific responsibilities in support of the research effort
outlined and with their percent time and effort specified. Alphabetized
biographical sketches for all personnel should follow the budget
justification.
o All information pertinent to the special requirements should be included in
the research plan of the application and not in an appendix.
Submission Instructions
The RFA label available in the PHS 398 (rev. 5/01) application package must be
stapled to the bottom of the face page of the application and must display the
RFA number HD-01-024. A sample RFA label is available at
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:
Robert Stretch, Ph.D.
Acting Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Applications must be received by March 18, 2002. If an application is
received after that date, it will be returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must include
an introduction addressing the previous critique.
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
may undergo a process in which only those applications deemed to have the
highest scientific merit will be discussed, assigned a priority score, and
receive a second level review by the appropriate National Advisory Council or
Board.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. Each of these
criteria will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application. Note that the application
does not need to be strong in all categories to be judged likely to have major
scientific or public health impact and thus deserve a high priority score.
For example, an investigator may propose to carry out important work that by
its nature is not innovative but is essential to move the field forward.
(1) Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that drive
this field?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics? Is the scientific hypothesis clear and focused?
(3) Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator appropriately trained and well suited
to carry out this work? Is the work and percent effort proposed appropriate
to the experience level of the Principal Investigator and other researchers
(if any) and the requirements of the RFA?
(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
In addition to the above criteria, applications for the Global Network
Research Units will be reviewed with respect to the following:
o Quality of the scientific basis for the evidence-based intervention.
o Adequacy and breadth of understanding of existing global research related to
women’s and children’s health in developing countries.
o Availability of and access to relevant and sufficient populations for
studies related to women’s and children’s health in developing countries.
o Strength and adequacy of plans for study site management, collaboration, and
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 Demonstrated willingness and ability to adhere to the terms and conditions
of the Cooperative Agreement award.
o Quality of sustainability plan.
In addition to the above criteria, in accordance with NIH policy, all
applications will be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects also will be
evaluated.
o The reasonableness of the proposed budget and its duration in relation to
the proposed research, adequacy of plans and procedures for monitoring
expenditures at both the domestic and foreign sites.
o Adequacy of the proposed protection for humans, animals, or the environment,
to the extent they may be adversely affected by the project proposed in the
application.
SCHEDULE
Letter of Intent Receipt Date: February 11, 2002
Application Receipt Date: March 18, 2002
Peer Review Date: June/July 2002
Council Review: September 2002
Earliest Anticipated Award Date: September 2002
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.
Pediatric, Adolescent, and Maternal AIDS Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 4B5OJ, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-0431
FAX: (301) 496-8678
E-mail: meikles@mail.nih.gov
Direct inquiries regarding fiscal matters to:
Ms. Shelley Carow
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8A01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 402-4165
FAX: (301) 402-0915
E-mail: carows@mail.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance
Numbers 93.865 and 93.864 (NICHD). Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act, as amended (42 USC 241
and 284) and administered under NIH grants policies and Federal Regulations 42
CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the
American people.
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