DEVELOPMENT OF COMMUNITY CHILD HEALTH RESEARCH  

RELEASE DATE:  May 7, 2002
 
RFA:  HD-02-008  
 
PARTICIPATING INSTITUTES AND CENTERS (ICs): 

National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov) 

LETTER OF INTENT RECEIPT DATE:  June 17, 2002 

APPLICATION RECEIPT DATE:  July 23, 2002
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to become Principal Investigators
o Special Requirements 
o Where to send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of Child Health and Human Development (NICHD) invites 
cooperative agreement applications for the development of a community-linked 
collaboration to investigate disparities in maternal and child health.  The 
purpose of the solicitation is to support community-research institution 
partnerships that will work together over a two and one-half year span to 
plan a multi-site, multi-level study that examines how community, family, and 
individual level influences interact with biological influences and result in 
health disparities in pregnancy outcome and infant and early childhood 
mortality and morbidity.  The long-term goals are to decrease fetal and 
infant mortality and improve child health in minority urban and rural 
communities.  

RESEARCH OBJECTIVES

Nature of the Research Problem

Attempts to explain disparities in child health arising along racial, ethnic 
and socio-economic gradients have proliferated during the last decade.  Many 
approaches arising from biomedical and social-behavioral perspectives have 
made progress in developing a satisfying explanation, but usually such 
attempts have fallen short of a complete explanation.  At the same time, the 
need for greater involvement of minority communities in health disparities 
research has become increasingly appreciated.  Such involvement can help 
assure that the science addresses relevant issues in their communities and 
that an effective platform to translate scientific findings is created.  In 
order to address these needs, it is necessary to field a study that blends 
biomedical and socio-behavioral science and establishes partnerships with 
disadvantaged communities from the earliest stages of the study.  This RFA 
invites applications from research sites that wish to combine these factors 
into a multi-site, multi-method study of community child health that is 
predicated on community partnerships with the scientific team.

Background

Racial and ethnic disparities in maternal and child health are widespread.  
Disparities appear to be closely related to the social conditions associated 
with poor communities and fragmented families.  For example, infant deaths 
are highest among many of our nation"s urban and rural minorities.  Sudden 
Infant Death Syndrome (SIDS) is the leading cause of post-neonatal mortality, 
accounting for approximately 28 percent of such deaths.  SIDS rates vary 
widely by race and ethnicity.  According to 1999 period linked files, the 
rate of SIDS was 1.3/1000 live births among blacks, 0.56/1000 among whites, 
0.37/1000 among Hispanics, and 0.31/1000 among Asian/Pacific Islanders.  
Among American Indians and Alaskan Natives, SIDS is the leading cause of 
overall infant mortality, with a rate of 1.47/1000 live births, which is 
almost three times that of whites.  The basis for the racial disparity is not 
fully determined.  Gains in reducing the disparity will come from continued 
efforts in the implementation and evaluation of the "Back to Sleep" campaign, 
expanded research into the etiology and pathogenesis of SIDS, and the 
development of new prognostic, therapeutic, and preventive strategies.   

Although many of the remaining deaths in the post-neonatal period are due to 
a range of diagnoses such as infections, accidents, neglect, and abuse, the 
diagnosis of a large proportion of the deaths is still undetermined.  It is 
important to understand the contributions of biological, medical, behavioral, 
and social factors in all causes of unexpected early childhood deaths in 
high-risk communities.  In this way, complete diagnosis and effective 
interventions can be achieved.   

In addition, fetal death rates are higher among blacks compared with whites.  
The rate of fetal deaths 20 weeks or greater in 1998 was 12.3/1000 live 
births plus fetal deaths among black mothers and 6.7/1000 live births plus 
fetal deaths among white mothers.  The late fetal mortality rate (28 weeks 
gestation or greater) is also higher among blacks (5.3/1000 compared with 
3.4/1000).  Some studies show that unexplained antenatal stillbirths, which 
represent about half of late fetal deaths, share characteristics with SIDS.

Preterm birth affects 11.6 percent of all births in the United States and is 
a major contributor to infant morbidity and mortality.  Within preterm birth, 
there is a significant health disparity, with preterm births at less than 32 
weeks occurring almost 2.5 times more often to African American mothers than 
whites.  Prematurity, intrauterine growth retardation, and their 
complications supercede all other conditions (including congenital anomalies) 
as the primary cause of infant morbidity and mortality in the African 
American population, with deaths attributed to short gestation and low 
birthweight almost four times that of white infants.  While technology has 
contributed significantly to improving neonatal survival over the past 
several decades, especially in relation to those diseases and disorders that 
are specific sequelae of preterm birth and low birthweight, a 
disproportionate contribution to the overall post-neonatal deaths and infant 
morbidity from infection, respiratory problems, child abuse, etc. occurs in 
survivors of prematurity and low birth weight.  Additionally, these infants 
are also at higher risk for SIDS in the post-neonatal period.  Despite 
improvements in the cause-specific rates of fetal, infant, and early 
childhood mortality and morbidity in recent years, the health disparities 
remain. 

Scientific Knowledge to be Achieved Through Research Supported by the RFA

The family and community are important influences on child health.  The 
family and community also frame the context through which private and public 
resources are mobilized to address child health problems.  Research on 
community and family effects on child health has demonstrated that these 
influences are real and the next logical step for such research to take is to 
ask how they work to produce child health outcomes.  Traditional research on 
infant mortality and morbidity has focused on either the environmental 
factors, i.e. individual, family or community influences, or on the biologic 
etiologies and mechanisms.  Such approaches have failed to acknowledge the 
important synergism of these different sources of vulnerability.  This 
deficiency is most apparent in health disparities where traditional 
approaches have failed to explain adequately the causes of these disparities.  
The next logical step for research to take is to specify social and 
behavioral processes that combine to produce biological pathways by which 
disparities in health arise at birth and through early childhood.  The work 
supported by this RFA will create a foundation that will support such a study 
in the future.  

Each Collaborating Site (CS) will have assembled an interdisciplinary team 
that is well versed in the considerable body of research on child health that 
exists in the biomedical and social-behavioral sciences.  Each CS will have 
articulated sample studies that demonstrate how the 
community/family/individual pathways produce biological activity that 
influences child health.  The work of the Community Child Health Research 
Collaboration will be to identify a feasible research work plan that combines 
both the biomedical and social-behavioral approaches into a new type of study 
that addresses the deficiencies in the contributing research traditions. 

Objectives of this Research Program

This RFA represents phase 1 of the development of a community-linked research 
collaboration for maternal and child health.  The purpose of the solicitation 
is to create a community linked collaboration of cooperative agreements that 
will work together over a 2 1/2 year span to plan a multi-site, multi-level 
study that examines how community, family, and individual level influences 
interact with biological influences and result in health disparities in 
pregnancy outcome and infant and early childhood mortality and morbidity.  
The goal of the phase 1 research program is to blend the substantive theory, 
measurement regimes, and study designs found in the biomedical, social, and 
behavioral sciences into a study of infant mortality and child health in 
order to improve our understanding of the complicated interplay of 
environmental and genetic factors that produce biological outcomes.

The products of phase 1 will be a plan of action that describes the 
hypotheses, design, and content of a multi-site, multi-level study and 
preliminary work at each site that creates a foundation upon which to build 
such a study.  The scope of the solicitation includes the blending of social, 
behavioral, and biomedical approaches into a coherent community-linked study.  
The concept of community used in the research includes not only geographic 
neighborhoods and catchment areas, but also the set of institutions that 
affect health directly or indirectly.

The objectives of the studies to be planned within the Community Child Health 
Research Collaboration in phase 1 are to increase knowledge regarding the 
prevalence, causes, and pathogenesis of (1) unexpected death of the fetus in 
late pregnancy, infants at birth, and children ages zero to three years, (2) 
other infant deaths that are unrelated to neonatal events, and (3) infant and 
early childhood morbidity in high-risk minority populations.  

NICHD is interested in promoting studies that include the contribution of 
underlying genetic factors, prenatal and newborn conditions, and infectious 
agents, and their interaction because these factors may illuminate approaches 
for health gains through screening and therapeutic intervention.  The multi-
site, multi-level study in phase 2 will examine how community, family, and 
individual level influences interact with biological influences and result in 
health disparities in pregnancy outcome and infant and early childhood 
mortality and morbidity.  The research requested in phase 1 by this RFA will 
create a plan of action to implement the work of phase 2.

Another phase 2 objective is to provide communities with trained researchers 
and the scientific infrastructure to monitor and improve public health.  
Researchers who are representative of the communities in which these health 
problems are evident provide valuable perspectives and insights that increase 
the relevance, validity, and acceptance and acceptability of research efforts 
and facilitate the implementation of interventions.  The RFA requests that 
investigators plan for the development of a research-integrated training 
program for minority investigators that advances the scientific goals of this 
solicitation by strengthening the scientific infrastructure needed to 
maintain and improve the health of the public.

Specifically, the objectives of the RFA for phase 1 are:

o  Establish functional community partnerships to conduct research aimed at 
reducing disparities in maternal and child health,

o  Conduct exploratory studies of community perceptions of health disparities 
and the factors viewed as most salient in contributing to them and assess 
issues of salience to the community that may affect the research goals and 
design,

o  Formalize the collaboration structure and operations,

o  Develop a set of testable hypotheses for phase 2, 

o  Develop design strategies and instruments for phase 2 to include 
conducting pilot studies,

o  Develop plans for a training program to provide promising minority 
investigators with opportunities to increase their research skills and 
competencies by their active involvement in the planned research efforts and 
through more traditional educational experiences, 

o  Develop plans to create a common core study supplemented by site-specific 
research,

o  Produce a report summarizing the achievements toward these objectives and 
an assessment of the feasibility of proceeding to phase 2, 

o  Develop plans for pooling data across sites and for sharing data with 
investigators outside of the study.

Types of Research Approaches Sought

Applicants should consider the following research approaches when developing 
sample research studies:  epidemiology, mechanistic studies employing 
measures of infection, immune function, genetic susceptibility, pathology, 
and physical, social, psychological, and cultural determinants of health 
behavior.  It is desirable to blend the following types of approaches that 
are commonly found in the social sciences with biomedical approaches, e.g. 
population-based analysis, ethnography, network analysis, and multi-level 
analysis.

Examples of Research Topics

Examples of health outcomes that can be the target of phase 1 activities 
include, but are not limited to, the following:

o  Preterm delivery,

o  Intra-uterine growth retardation,

o  Stillbirth (fetal death at or later than 20 weeks),

o  Specific causes of infant mortality that demonstrate health disparity,

o  Infant and early childhood morbidity to include:  failure to thrive, 
hearing or vision impairment, fetal alcohol syndrome (FAS), cerebral palsy, 
inadequate immunization, recurrent infections, reactive airway disease and 
other respiratory problems, injures or repeated hospitalizations, 

o  Primary prevention of infant and early childhood mortality and morbidity, 
particularly among the economically disadvantaged who would benefit most from 
such interventions.  The community and family are thought to be central in 
implementing preventive approaches to child health.  The research 
collaboration assembled through this RFA should be prepared to identify 
approaches to prevention that might be useful to explore in phase 2 of this 
study.

Project Organization

The purpose of the cooperative agreement grants for phase 1 is to develop the 
resources and infrastructure for participation in the Community Child Health 
Research Collaboration in phase 2.  Only those applicants who are successful 
in receiving phase 1 support will be eligible to compete for participation in 
phase 2.  The Community Child Health Research Collaboration will develop and 
conduct protocols with common elements, which address the needs of the 
minority populations served by Collaborating Sites.

The applicant Collaborating Site (CS) for the phase 1 grant should be a 
partnership between an academic institution and a community institution(s).  
The Principal Investigator (PI) will represent the academic institution and 
should have a demonstrated record of working with the community.  The co-
Principal Investigator (co-PI) will represent the community institution.   
The community institution can be defined by geographic limits and/or by a 
functional mission.   

These individuals will serve as the responsible leaders for the CS.  It is 
expected that both the PI and co-PI will partner to identify scientific 
objectives and create a platform for communication with the community in all 
stages of the scientific endeavor.

The partner/affiliated academic institution (subsequently referred to as the 
"academic institution") must have a track record of social, behavioral, and 
biomedical research and research training.

A Steering Committee will be assembled from among phase 1 awardees.  In the 
planning phase, the Steering Committee will provide a forum to share program 
activities and potential directions for phase 2.  The Committee will consist 
of the Principal Investigators and Co-Principal Investigators of all awarded 
grants, and NIH staff.  Each site and NIH will have one vote on the Steering 
Committee.  The Steering Committee will be charged with the task of combining 
multiple perspectives and research agendas across sites into a coherent plan 
of action.

MECHANISM OF SUPPORT
 
This Request for Applications will use the National Institutes of Health 
(NIH) Cooperative Research Project Grant (U01) award mechanism.  As an 
applicant you will be solely responsible for planning, directing, and 
executing the proposed project.  This RFA is a one-time solicitation.  NICHD 
may create a future opportunity (phase 2) to implement the plan of action 
created by the collaboration established by this RFA.  The anticipated award 
date is April 1, 2003.  

The NIH U01 is a cooperative agreement award mechanism in which the Principal 
Investigator retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with NIH staff being 
substantially involved as a partner with the Principal Investigator, as 
described under the section "Cooperative Agreement Terms and Conditions of 
Award."     

FUNDS AVAILABLE 
 
NICHD intends to commit approximately $750,000 in total costs [Direct plus 
Facilities and Administrative (F & A) costs] in FY 2003 to fund four to six 
new grants in response to this RFA.  An applicant should request a project 
period of two and one-half years and a budget for direct costs of up to 
$125,000 per year for the first and second years of the project.  For the 
third year, up to $63,000 direct costs should be requested.  Because the 
nature and scope of the proposed research will vary from application to 
application, it is anticipated that the size of each award will also vary. 
Although the financial plans of the NICHD 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.  

ELIGIBLE INSTITUTIONS
 
You may submit an application if your institution has any of the following 
characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals,    
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic 
o Faith-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   

SPECIAL REQUIREMENTS

Minimum Catchment Populations

Clinical study centers with urban populations should have a catchment 
population with at least 8,000 births per year, and those with rural 
populations at least 3,000 births per year in order to apply.

Budget

Applicants should request funds for travel up to $10,000 per year for the PI, 
Co-PI, and one to two staff to attend regular Steering Committee meetings in 
Bethesda, MD that will occur every three months and will involve interaction 
with the staff of NICHD and related public and private organizations. 
Applicants should budget for the site and team specific activities that will 
occur in parallel with the Bethesda meetings. 

Data Collection and Sharing

It is anticipated that there will be a Data Coordinating and Analysis Center 
in phase 2.  In phase 1, the awardees will develop plans for the activities 
of the Center and address issues related to human subject protection, 
including confidentiality and community needs, and data sharing with 
investigators outside of the Collaboration.

Cooperative Agreement Terms and Conditions of Award 

Cooperative agreements are assistance mechanisms and are subject to the same 
administrative requirements as grants.  The special Terms and Conditions of 
Award are in addition to, not in lieu of, otherwise applicable OMB 
administrative guidelines, HHS, PHS, and NIH grant regulations, policies, and 
procedures, with particular emphasis on HHS regulations at 42 CFR Part 74 and 
92.  Facilities and Administrative cost (indirect cost) award procedures will 
apply to cooperative agreement awards in the same manner as for grants. 
Business management aspects of these awards will be administered by the NICHD 
Grants Management Branch in accordance with HHS, PHS, and NIH grant 
administration requirements. 

The cooperative agreement funding mechanism will require collaboration among 
the NICHD Project Scientists and the Principal Investigators of the 
Collaborating Sites.  The NICHD Project Scientists will coordinate the 
activities of the Collaboration, 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, as appropriate, and to provide study and site performance 
information as stipulated by NICHD.

The Principal Investigator of each Collaborating Site will play an important 
role in the design of the phase 1 plan of action.  Each Principal 
Investigator will have primary responsibility for work that establishes a 
community link at their site and to gather preliminary information necessary 
to prepare their site for phase 2 studies.  The awardees will retain custody 
of, and primary rights to their data developed under this award, subject to 
Government rights of access, consistent with current HHS, PHS, and NIH 
policies.  

Each investigator will have the right to publish based on the work of their 
individual research programs, according to the publication policies developed 
by the Steering Committee.  Each Principal Investigator will also work 
cooperatively to propose a phase 2 plan of action involving all of the 
participating sites.

The Collaborating Sites specifically will:

o  Develop active community links at their site to sustain and plan phase 2 
activities.

o  Work cooperatively with other Collaboration sites to create a plan of 
action and study protocol for phase 2.

o  Gather information and operationalize constructs with respects to the 
community environment at their site to support phase 2 operations. 

o  Carry out pilot studies developed by the Steering Committee.
 
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 Collaboration Sites.

o  Collaborate with other awardees and the NIH.

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 
Collaboration policies and procedures.

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

o  Attend and participate in all Collaboration conference calls and Steering 
Committee meetings.  

2.  NICHD Responsibilities

NICHD Project Scientist

The NICHD Collaboration Project Scientists will be staff from the Pregnancy 
and Perinatology Branch and the Demographic and Behavioral Sciences Branch of 
NICHD.  The Project Scientist is a partner within the Collaboration 
representing the government"s interest in the substantive work of the 
Collaboration.  The primary role of the Project Scientist is to facilitate 
the work of the Collaboration.  He/she will:

o  Assist in all functions of the Steering Committee, including:  reviewing 
and commenting on each stage of the program before subsequent stages are 
started, recommending the options of adding, modifying or terminating aspects 
of the program.

o  Assist with accomplishing the objectives of phase 1 so that the 
collaboration is prepared to embark on action for phase 2.

o  Assist in the analysis, interpretation, and reporting of findings in the 
scientific literature and other media to the community at large and the 
public policy community within the Federal government.

NICHD Project Officer

NICHD will appoint a Project Officer, apart from the Project Scientists, who 
will:

o  Have the option to withhold support to a participating institution if 
technical performance requirements, such as compliance with the protocol, are 
not met.

o  Carry out continuous review of all activities to ensure objectives are 
being met.

o  Exercise the normal stewardship responsibilities of an NIH Program 
Officer.

3.  Collaborative Responsibilities

The overall guidance and management of the Collaboration will be provided by 
a Steering Committee as described below:

Steering Committee Responsibilities 

Planning and implementation of the cooperative aspects of the study will be 
done by a Steering Committee consisting of the Principal Investigator/co-
Principal Investigator from each participating awardee institution and the 
NICHD Project Scientists.  NICHD will have one vote that will be split evenly 
between the two NICHD Project Scientists.  The Steering Committee will:  

o  Plan the design and implementation of the plan of action for phase 2.

o  Participate in decision-making regarding gathering preliminary information 
at the participating sites and operationalizing key constructs regarding the 
community and other environmental factors at participating sites.

o   Formulate publication policy and appoint a Publication Subcommittee, as 
judged necessary by the Steering Committee.  Publish results, conclusions, 
and interpretations of the cooperative planning activity.  Due publication 
credit will be given to all work done cooperatively.

o  Agree to accept the coordinating role of the committee and the cooperative 
nature of the group process.

Data Safety and Monitoring Committee 

A Data Safety and Monitoring Committee (DSMC) will be established by NICHD, 
if needed, and will advise the Collaboration on research design issues, data 
quality and analysis, and ethical and human subject issues. 

4.  Arbitration Procedures

When agreement between an awardee and NICHD staff cannot be reached on 
programmatic and scientific-technical issues that may arise after the award, 
an arbitration panel will be formed. The panel will consist of one person 
selected by the Principal Investigators, one person selected by the NICHD 
staff, and a third person selected by these two members.  The decision of the 
arbitration panel, by majority vote, will be binding.  These special 
arbitration procedures in no way affect the awardees right 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. 

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

V. Jeffery Evans Ph.D., J.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1176
FAX:  (301) 496-0962  
Email:  [email protected]

or

Marian Willinger, Ph.D.
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6896
FAX:  (301) 496-3790
Email:  [email protected]

o Direct your questions about peer review issues to:

Robert Stretch, Ph.D.
Acting Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda MD 20892-7510
Rockville MD 20852 (for express/courier service)
Telephone:  (301) 496-1485
Email:  [email protected]

o Direct your questions about financial or grants management matters to:

Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17K, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5482
FAX:  (301) 480-4782
Email:  [email protected]

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o 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 by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

V. Jeffery Evans, Ph.D., J.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1176
FAX: (301) 496-0962
Email:  [email protected]

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: [email protected].

SUPPLEMENTAL INSTRUCTIONS: 

Applications must provide and/or address the following:

o  Descriptions of catchment populations (size and demographic 
characteristics) to include the number of births per year, term and preterm, 
within racial/ethnic groups,

o  Documented late fetal and infant mortality rates, within racial/ethnic 
groups:  overall and cause-specific for 1992-1999,

o  Descriptions of the staff and programs in place for the recruitment and 
evaluation of families and infants at risk within the community,

o  Demonstrated capacity to conduct obstetric, pediatric, and social and 
behavioral research, documentation of the formation of an interdisciplinary 
team combining appropriate biomedical, social, and behavioral expertise to 
include their expertise and strengths.

o  Demonstration of how the PI and co-PI at each site will function in the 
working arrangement such that each will have an equal voice in the 
development of a research and training infrastructure for conducting the 
community-linked studies, identification of areas to be studied and the 
development of hypotheses to be tested, and the implementation of protocols 
to be carried out,

o  Plans for gathering demographic information at each site and for measuring 
community and family constructs within each study population,

o  The Research Methods section of the application should include 
descriptions of two sample research studies that will lead to improved 
pregnancy outcome and early childhood health.  The sample research studies 
will serve as a starting point for deliberations within the Steering 
Committee and will enable reviewers to evaluate the substantive approaches 
that the site is best equipped to perform.  Investigators will not be 
expected to perform these studies at their site during phase 1.  These sample 
studies should be designed based on a theoretical total catchment of the 
Collaboration of 25,000 pregnancies/year for four years of enrollment, and 
should utilize outcome estimates based on the site-specific data provided 
above.  The application should contain sections addressing background and 
significance, specific aims, and research approaches, including the 
measurement of key constructs and processes and strategies for data 
collection and analysis, to accomplish the following:  (1) apply theory from 
the social and behavioral sciences to explain how community/family/individual 
influences interact with biological processes that determine birth outcomes 
and early life health and development, and/or (2) apply theory from the 
social and behavioral science to explain how community/ family/individual 
influences affect therapeutic or preventive interventions, and/or (3) provide 
evidence for the significance of these theoretical constructs to their 
community.  The  descriptions of sample research studies should be limited to 
14 pages for both sample studies.  The page limit for the entire research 
plan is 25 pages.  

o  Evidence of a working relationship between the community organization and 
affiliate research institution that is capable of supporting research, 
training, and information dissemination,

o  Plans for developing a training program with affiliated institutions, 
including objectives of training, the integration of the training objectives 
with the research objectives of the proposed projects, a description of types 
or professional backgrounds of trainees, the general research skills to be 
acquired through training, and the current unmet research training needs to 
be impacted by the training effort

o  The Collaborating Site may represent a consortium of sites within a 
community.
 
USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  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. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH:  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 must be 
sent to:

Robert Stretch, Ph.D.
Acting Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda MD 20892-7510
Rockville MD 20852 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this RFA.  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.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NICHD.  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:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Child Health and 
Human Development Council
 
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 your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  Does research proposed address an important problem? If 
the aims of the sample studies are achieved, how do they advance scientific 
knowledge and improve the public health?  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 analytic 
plans outlined in the sample studies appropriate to the aims of the Community 
Child Health Research collaboration as outlined in the RFA?  Are the sample 
studies feasible in the context of the community served by your application.  
Do you acknowledge potential problem areas and consider alternative tactics?

(3) INNOVATION:  Does your project employ novel concepts? Do the sample 
studies employ novel approaches or methods? Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
Principal Investigator and to that of other researchers (if any)?  Is an 
appropriate multidisciplinary team assembled to carry out the work? 

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

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  The 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.

o INCLUSION:  The adequacy of plans to include subjects from both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate for 
the scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
included in the section on Federal Citations, below.)

o BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

OTHER REVIEW CRITERIA:  

o The potential of the site to fit into a multi-site study of community child 
health.

o The value of the investigating team to a multi-level, multi-method 
investigation of community child health and the ability to contribute to an 
inter-disciplinary research effort.

o The adequacy of plans to establish a functioning community partnership.

o The adequacy of plans for the development of a research-integrated training 
program for minority investigators that advances the scientific goals of this 
solicitation by strengthening the scientific infrastructure needed to 
maintain and improve the health of the public.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  June 17, 2002
Application Receipt Date:  July 23, 2002
Peer Review Date:  November 2002
Council Review:  January 2003
Earliest Anticipated Start Date:  April 1, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  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 clinical research projects unless a 
clear and compelling justification is 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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are 
available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. 
The amended policy incorporates: the use of an NIH definition of 
clinical research, updated racial and ethnic categories in compliance with 
the new OMB standards, clarification of language governing NIH-defined Phase 
III clinical trials consistent with the new PHS Form 398, and updated roles 
and responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and 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 that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within 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.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

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 
RFA is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance Nos. 93.864 and 93.865, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  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 described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.  

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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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