and Human Services (HHS)
EXPIRED
EARLY CHILDHOOD EDUCATION AND SCHOOL READINESS PLANNING GRANTS
RELEASE DATE: January 7, 2002
RFA: RFA-HD-02-005
PARTICIPATING INSTITUTES AND CENTERS (ICs):
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov)
Administration for Children and Families (ACF)
(http://www.acf.dhhs.gov)
Assistant Secretary for Planning and Evaluation (ASPE)
(http://www.aspe.dhhs.gov)
Department of Education
(http://www.ed.gov/)
Letter of Intent Receipt Date: April 15, 2002
Application Receipt Date: May 14, 2002
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) 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
Participating ICs/Agencies intend jointly to stimulate sustained,
multidisciplinary, programmatic research on the effectiveness and efficacy of
existing, modified or newly developed comprehensive and integrative curricula
or integrative curriculum modules for use with children from birth to age
five to promote learning and development across domains associated with
school readiness. These domains include: language and communication,
emerging and early literacy, early mathematical knowledge, cognitive skills
and conceptual knowledge, to include science concepts, self-regulation of
attention, behavior and emotion, social competency, fine and gross motor
development, motivation and positive dispositions toward learning. A special
emphasis is on approaches that promote language, emerging and early literacy,
early mathematical knowledge, and other aspects of cognitive development,
while simultaneously developing self-regulatory and social competencies,
motivation and positive dispositions toward learning, especially for children
at risk for school failure. This solicitation encompasses the identification
of comprehensive strategies for use with children from birth to promote the
development of linguistic, social, communicative, cognitive, and perceptual-
motor competencies that are the early bases of learning during the
preschool years.
A primary goal is to understand the complex combination of individual and
contextual factors that interact with curriculum components to influence
effectiveness. The research stimulated should produce knowledge that can be
used systematically to educate the early childhood education and care
workforce, parents, and other adults responsible for children"s learning in
formal and informal early childhood education and care settings. This
solicitation encourages the establishment of researcher-practitioner
partnerships in the context of early childhood programs developed at federal,
state, and community levels, to include Head Start, Early Head Start, or
other state early childhood initiatives serving populations at risk for
school failure, as well as partnerships with center-based child-care, and
family day care settings.
This RFA will support activities necessary to prepare for a future
solicitation for complex, large-scale, multi-site effectiveness trials.
Obtaining a planning grant through this RFA is not required to respond to the
future solicitation.
RESEARCH OBJECTIVES
Background
During the last decade, scientists and practitioners across disciplines
relevant to child development, early childhood education, and early childhood
intervention have worked toward a conceptualization of school readiness
intended to guide research and practice. To participate in and benefit from
formal schooling, children need to be physically healthy and develop strong
foundations across multiple, broadly defined domains that include: language
and communication, emerging and early literacy, early mathematical knowledge,
cognitive skill and conceptual knowledge, social competency, self-regulation
of attention, behavior, and emotion, motivation to learn, and positive
dispositions toward learning. However, at entry to kindergarten, children
from poor families and minority groups often show fewer of the competencies
and dispositions associated with school achievement. Early delays are
quickly magnified as these children move through the early grades and become
more likely than their more affluent and majority peers to score lower on
tests of academic achievement, such as reading skill, receive special
education, repeat school grades, and be diagnosed with mental retardation and
learning disabilities.
Most educators and scientists across relevant disciplines agree that early
childhood is a critical time to begin preventing achievement gaps.
Comprehensive services programs intended to close these gaps typically offer
a combination of child-focused early childhood education, parent-focused
intervention, and other health and social services. One of the highest
priorities for those programs is ensuring that all children have the early
experiences necessary for developing the emerging literacy, language, and
cognitive skills essential for succeeding in school. However, data derived
from recent evaluations of such programs underscore the need for approaches
to early childhood education and care that more systematically develop this
knowledge. Addressing this need is especially crucial given the rapid
emergence of state initiatives for universal preschool and other programs
targeting poor children from birth to five, and given the increased use of
formal and informal out-of-home group care.
Research indicates that to structure environments and interactions that
promote learning, adults need strategies for developing positive
relationships with children, and for developing children"s motivation, social
competency, and self-regulation of attention, behavior, and emotion,
including strategies for classroom or group management that reduce aggressive
and disruptive behavior. Thus, scientifically validated approaches are
needed that the adults responsible for promoting children"s learning and
development in each early childhood education and care setting can implement
reliably to develop the full range of knowledge, skills, dispositions, and
behaviors essential for meeting the challenges of kindergarten and the
early grades.
Overview of Relevant Research
A large body of evidence across relevant disciplines provides a basis for
addressing this need. For example, developmental sequences have been
identified that specify the early content knowledge, skills, and dispositions
from birth to age five that are predictors or precursors of learning and
development in each domain associated with school achievement. Strategies
have been identified for structuring environments and interactions with
adults and peers to promote learning and development in these domains, and
for encouraging engagement in and positive dispositions toward learning
activities. Qualities of children"s social relationships with peers and
adults have been identified that influence the quality and potential
effectiveness of adult-guided interactions intended to promote learning.
Intensive early childhood interventions targeted toward children and families
in poverty have been shown to influence a variety of school-related outcomes,
including cognition and language, social competency, and regulation of
emotion and behavior. The most effective interventions are implemented with
strong fidelity by trained staff, include goal-oriented curricula informed by
child development research, ensure that children"s nutritional and other
health needs are met, and often include a parent-focused component to support
children"s development.
Despite a large relevant research base, gaps remain between current knowledge
and the knowledge required to provide the education and professional
development essential for structuring environments and interactions that
reliably promote learning and development across all domains that are
foundations of school achievement. For example, many current approaches to
early childhood education and care and models for intervening with parents
have a general basis in theories of development, however, specific
combinations of strategies embedded in these approaches have not been
evaluated to determine which components produce specific learning and
development outcomes. In addition, many existing curriculum models and
parent-interventions focus on only one or two content areas, typically either
language and early literacy skills or social-emotional competence, although
learning and development is connected across cognitive, linguistic,
affective, and social domains, and despite the fact that all are essential
for promoting children"s preparation for school.
Moreover, general styles of interacting with children often have been
polarized into direct instruction and child-centered approaches each with
exclusive characteristics, further separating goals for early childhood
education into cognitive-linguistic and social-emotional domains. That is,
direct instruction approaches have been too generally associated with
directive, punitive and controlling behavior that pressures children to
engage in developing knowledge and learning specific skills before reaching
a level of maturity believed to be essential for benefiting from the
activity. Child-centered approaches have been too generally associated with
warm, responsive, nurturing care to promote social development and emotional
health, and little emphasis on developing language, early literacy and
cognitive skills. The most current and prevalent judgment of scientists and
practitioners is that adults need a full repertoire of strategies for
intentionally structuring environments and guiding interactions to meet
children"s individual needs for learning across all domains.
Sustained, programmatic research is needed that builds upon the most rigorous
scientific evidence across disciplines to identify comprehensive and
integrative approaches that are enjoyable and engaging to children, that are
responsive to children"s individual characteristics and needs, and that
develop the full range of knowledge, skills, and dispositions known to lead
to early school adaptation and achievement.
Research Scope
To address this need, this RFA encourages planning for sustained,
programmatic, multidisciplinary research to evaluate the effectiveness of
existing, modified, or newly developed comprehensive and integrative
curricula or integrative curriculum modules for use with children from birth
to age five. The curriculum should be designed to promote learning and
development in two or more of the following domains: language and
communication, emerging and early literacy, early mathematical knowledge,
cognitive skills and conceptual knowledge, to include science concepts. Each
application should focus on one or more of the social, affective, and
motivational components of school readiness to determine how implementation
also facilitates (1) self-regulation of attention, behavior, and emotion, (2)
social communication and competency, (3) motivation and positive dispositions
toward learning.
In addition to supporting the evaluation of curricula for use in center-based
settings, this RFA supports planning for the evaluation of existing,
modified, or newly developed, comprehensive and integrative curricula or
curriculum modules intended for use by parents or other adults responsible
for promoting children"s learning and development in family day care and
informal care settings. These may be evaluated for independent use or as a
component linked to a comprehensive and integrative curriculum or curriculum
module implemented in a center-based setting.
For the purposes of this RFA, the term "curriculum" refers to: (1) a set of
goals and objectives for the content knowledge, skills, behaviors, and
attitudes to be promoted, (2) a set of benchmarks for guiding and assessing
incremental progress toward attaining these goals and objectives, (3) a
repertoire of strategies that adults can use in a dynamic and flexible manner
to intentionally structure environments and interactions to meet curriculum
goals, and (4) supporting materials to facilitate the implementation of those
strategies. The term is defined broadly to encompass comprehensive
strategies for intentionally structuring environments and interactions from
the time of birth to develop early linguistic, social, communicative,
perceptual-motor, cognitive skills, and conceptual knowledge that are
foundations of learning during the later preschool years. The goals,
objectives, and benchmarks should be justified on the basis of the most
rigorous scientific knowledge concerning developmental continua, progressions
or sequences, and processes and conditions for promoting children"s progress
in each targeted domain.
Applicants must build on existing evidence across relevant disciplines to
design evaluations that answer these overarching questions:
o Which components of integrative curricula or integrative curriculum
modules, and which combinations of associated adult-guided interactions are
necessary to promote learning and development, for which children, in which
settings, and under which conditions?
o What education, training, and administrative or other structural supports
are needed to implement the approach fully and effectively?
o What education and professional development models provide the knowledge
and skill required for full and effective implementation?
Research Focus
A major goal of this solicitation is to plan multidisciplinary, programmatic
research that can specify which approaches are most or least beneficial for
which children, in which circumstances, and why. Therefore, a developmental-
ecological conceptual approach is strongly encouraged to guide the design of
effectiveness trials that can address these questions:
o What are the mediating processes through which specific curriculum
components influence learning and development in each domain?
o Which individual difference factors and multiple levels of contextual
factors act alone or in combination to influence child outcomes, fidelity of
implementation, or replication and generalization of the results?
Contextual factors may include but are not limited to characteristics of
parents, homes, families, communities, schools, teachers, administrators,
classrooms, and policies at multiple levels, to include program
administrative policies or broader local, state or federal policies that
affect intervention implementation or benefit accrued from the intervention.
Individual difference factors may include but are not limited to initial
levels of competence, rates of learning, gender, temperament, pre-maturity,
behavioral disorder, illness, and disability. Applicants are especially
encouraged to consider what adaptations to the approach are necessary for
children with disabilities to participate in and benefit from the curriculum.
Though promoting physical health is not a necessary component of the
interventions solicited by this RFA, all applicants should consider that
factors such as good prenatal care, adequate nutrition, protection from
disease and infection, lack of exposure to toxins and early detection of
biological/physiological impairments have the potential to facilitate early
learning and moderate the effectiveness of interventions intended to promote
school readiness.
o What education and professional development are required to meet the needs
of diverse populations, to include children with disabilities and children
from varied minority, ethnic and cultural backgrounds? How do potential
discrepancies between home and school environments concerning goals for and
approaches to promoting children"s learning and development affect
implementation and effectiveness of the intervention?
o What are the social competencies, regulatory behaviors, motivational
dispositions and qualities of children"s social relationships with adults and
peers that promote or impede the effectiveness of approaches intended to
promote the development of language, emerging literacy, early mathematical
knowledge, and other aspects of cognitive development? What education,
professional development, and structural supports are needed to help adults
establish and maintain the positive relationships with children and parents
that are essential for implementing the curriculum effectively?
Within the context of these planning activities, applicants may focus on the
early assessment and diagnosis of emotional and behavioral problems, and
mental disorders that may affect social and emotional development and
readiness for school, and risk or resilience for mental disorder.
Applications with this focus should distinguish components of the curriculum
that may be effective for the prevention and/or treatment of emotional and
behavioral problems in young children, and mental disorders that affect early
school functioning such as anxiety, depression, inattention, hyperactivity,
and impulsivity, and pervasive developmental disorders. These applications
should be responsive to recommendations of the National Advisory Mental
Health Council in the report "A Blueprint for Change: Research on Child and
Adolescent Mental Health" (see http://www.nimh.nih.gov/childhp/blueprint.cfm),
and should consider the report entitled " Off to a Good Start: Research on the
Risk Factors for Early School Problems and Selected Federal Policies Affecting
Children"s Social and Emotional Development and Their Readiness for School" (see
http://www.nimh.nih.gov/childhp/goodstart.cfm), that was commissioned in part by
the co-sponsors of this initiative.
This list is not exclusive or exhaustive, and it is not expected that each
application will address the entire range of issues discussed in this RFA.
However, applicants must plan proposals and establish the multidisciplinary
expertise required to: (1) answer each overarching question listed under
Research Scope, and (2) identify and develop conceptual models, research
designs, and methodological approaches appropriate for specifying the
components, processes, and conditions responsible for the short- and long-
term effectiveness of the intervention.
Activities to be Supported
This RFA will support activities necessary to prepare for large
multidisciplinary individual research projects or coordinated multiple
project approaches to complex, large-scale, multi-site effectiveness trials.
Specific activities supported include, but are not limited to:
o Establishment of multidisciplinary scientific collaborations,
o Identification of sites and establishment of researcher-practitioner
collaborations,
o Ascertainment of research populations and identification of appropriate
sampling strategies,
o Selection, validation, development, and piloting of relevant
instrumentation, especially for use with diverse populations, to include
children with disabilities,
o Development of detailed conceptual models to guide research design and
hypothesis testing,
o Design of protocols for well-controlled randomized experiments and/or
quasi-experiments, to include identification of feasible strategies for
achieving randomization, establishing criteria for matching comparison
groups, strategies for minimizing selective attrition, and strategies for
maintaining and evaluating fidelity of the intervention.
o Development of plans for data analysis to include identification of
quantitative expertise required for analyzing complex multivariate data sets
and using state of the art techniques for measuring change,
o Development of plans to specify complete costs of implementing the
intervention in additional settings, including all materials and professional
development, and plans to conduct cost-benefit analyses as appropriate,
o Identification of administrative facilities, procedures, and on-site and
off-site personnel.
Application Considerations
Each applicant should ensure that the application includes plans to address
the following methodological and organizational issues:
o Research Population
This RFA especially encourages the establishment of researcher-practitioner
partnerships with early childhood education and care settings that have been
developed at federal, state, or community levels, including but not limited
to Head Start, Early Head Start, or other state early childhood initiatives
for younger children, center-based child care, family day care and informal
child-care that include populations at risk for school failure. It is
anticipated that samples will include large numbers of individuals who are
from minority groups and/or lower socio-economic levels to ensure that
findings will be useful for addressing educational disparities that exist for
these groups. Applications may include focused study of subgroups that meet
the definition of preschoolers with disabilities under Part B of the
Individuals with Disabilities Education Act (IDEA) and infants and toddlers
who are served under Part C of IDEA. Applicants are encouraged to select a
core research population that provides the opportunity to conduct
longitudinal analyses on subgroups of samples large enough to test complex
interactions among individual and contextual factors that promote or impede
intervention effectiveness.
o Selection Criteria
To facilitate complete and independent replication, applicants must plan to
rigorously define samples and subgroups using clear operational definitions,
and to describe and justify subject selection criteria with respect to sample
characteristics that include, but are not limited to, age, gender, ethnicity,
socioeconomic status, geographic region, and disability. Applicants are
expected to plan to identify detailed eligibility and exclusion criteria for
participants and research sites. Applications should include plans to
thoroughly describe all relevant structural and process features of the
intervention setting. These features include but are not limited to staff
configuration, availability of various services or resources, education and
training backgrounds of those responsible for implementing the intervention,
and existing approaches to providing education and care.
o Approaches to Integration
Current approaches to integration differ in the explicitness and degree of
integration both within a single domain, such as language, or literacy, or
math, and across cognitive-linguistic and social-emotional domains. One
intention of this program is to encourage multidimensional approaches to
promoting and evaluating the full set of knowledge, skills, and dispositions
within each domain, from the onset of initial foundational competencies in
each domain through the development of advanced forms. Therefore,, existing
curricula targeting one or more of the cognitive-linguistic domains may be
further developed, implemented, and evaluated with consideration of how the
implementation facilitates one or more of the following: (1) self-regulation
of attention, behavior, and emotion, (2) social communication and competency,
(3) motivation and positive dispositions toward learning. Likewise,
approaches that currently target social-emotional competence may be further
expanded to target two or more of the cognitive-linguistic domains.
Further development and evaluation of other widely used and advocated, but
understudied, approaches to integration also are encouraged. For example,
goals for learning across two or more distinct domains, such as literacy and
math, or literacy, language, and fine and gross motor development, are
sometimes incorporated into a single curriculum module. Such approaches
include but are not limited to project or theme-based approaches, typically
implemented with the intention of building on a child"s expressed interest in
a particular area. This initiative encourages further development and
evaluation of these curricula, under the condition that the approach is
consistent with the definition of "curriculum" and all other requirements
provided under Research Scope, above.
These examples of integrative approaches are neither inclusive nor
exhaustive. Applicants should provide, define, and justify their particular
approach to integration in detail on the basis of the most rigorous and
relevant scientific evidence supporting its potential for effectively
promoting early school achievement.
o Research Methodology and Approaches
Applicants should design randomized experiments and/or well-controlled quasi-
experiments, combined as appropriate with detailed observational, micro-
genetic, survey, and qualitative methodologies. Qualitative methodologies
are encouraged as a complement to quantitative methodologies to aid in the
identification of factors that explain intervention effectiveness or
ineffectiveness, to include factors that affect the fidelity of
implementation, or the replication and generalization of intervention
effects. Applicants may establish criteria for evaluating the
trustworthiness and credibility of data obtained with qualitative methods,
the transferability of the data, and adequacy of the data for testing the
hypothesis.
Systematic planned variations are encouraged to test the value-added
contribution that each intervention component makes to children"s outcomes.
Therefore, applicants may consider designs that specify, as appropriate to
the focus of the project, the unique contribution to outcomes made by (1)
each component embedded within the curriculum module, (2) each curriculum
module embedded within the comprehensive curriculum, and (3) each parent-
implemented intervention linked to a comprehensive integrative curriculum or
integrative curriculum module offered in a center-based setting.
Longitudinal designs or combinations of cross-sectional and longitudinal
designs will be necessary to meet the overarching objective of this research.
The use of recently developed statistical methodologies is encouraged for
analyzing how individual and contextual factors interact with intervention
components to influence individual developmental trajectories that identify
individual rates and patterns of change. Designs should allow evaluation of
how the duration, intensity, and timing of children"s participation in the
intervention influence short- and long-term outcomes.
One goal of this RFA is to support plans for longitudinal studies that
evaluate long-term outcomes as children transition from preschool into
kindergarten and enter formal schooling. Applications with this focus should
include plans to identify appropriate functional measures of children"s
school adaptation and achievement to distinguish which components of the
early childhood intervention predict specific school-related outcomes.
Characteristics of kindergarten and early elementary school environments
should be evaluated to determine how these potentially moderate long-term
outcomes. All applications are not required to plan for following children
through the period of transition to formal schooling. An equally important
focus is on the conditions under which the purposeful structuring of
environments and interactions with infants and toddlers provide foundations
for developing the knowledge, skills, attitudes, and behaviors that are the
basis for learning and development during the later preschool years.
Applicants are encouraged to consider that the implementation of a curriculum
designed to produce specific outcomes can have unintended positive and
negative effects. For example, some approaches to integration may result in
enjoyable activities for children but not meet the goal of developing the
specific knowledge or skills essential for early school achievement and for
which the approach was designed. However, highly structured approaches with
a very narrow focus, such as learning the alphabet, can have unintended
negative consequences, such as a reduction in the use of diverse and complex
language that research shows is crucial for learning and development.
Therefore, applicants are encouraged to evaluate outcomes within and across
domains both to identify the full range of positive, intended effects and to
identify any probable unintended outcomes of the implementation.
o Measurement
Applicants may propose to identify, further validate, and/or develop
essential instrumentation for evaluating intervention effects on children"s
learning and development. Applicants should select multiple measures of
child development and learning from multiple perspectives to include parent
and teacher report as well as direct observations and assessments, which
should be included whenever appropriate and possible. Applicants should
select and/or develop instrumentation linked directly to operationally
defined curriculum goals for learning and development. Direct observations
and individual assessments may be developed that measure transitions in
learning and development from the onset of initial competencies through more
advanced forms.
Appropriate instrumentation may be unavailable either because data do not
exist to judge appropriate usage or because instruments have unacceptable
psychometric properties for subgroups expected to participate in future
large-scale trials. In this case, applicants may plan to validate existing
measures of children"s learning and development for use with diverse
populations, to include direct assessments and observations as well as parent
and teacher reports.
Standard observation assessments may be developed for intended use by trained
adults to evaluate each child"s progress and to adjust implementation
strategies to meet curriculum goals. In addition, applicants may identify or
develop standard observational assessments to evaluate the fidelity of
implementation.
MECHANISM OF SUPPORT
This RFA will use the NIH Exploratory/Developmental Research Grant (R21)
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. Plans developed via support from this RFA can inform
future solicited and unsolicited applications that propose large-scale
randomized trials and quasi-experiments that meet the objectives of this
research initiative. The anticipated award date is September 2002.
This RFA uses just-in-time concepts. It also uses the modular budgeting
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, all applications with direct costs in each year of $250,000 or
less must use the modular format.
FUNDS AVAILABLE
The participating ICs and agencies intend to commit approximately $2.5
million (total costs) in FY 2002 to fund 10 to 12 new grants in response to
this RFA: NICHD, $1 million, ACF, $1 million, ASPE, $250,000, and NIMH
$250,000. An applicant may request a project period of one year and a budget
for direct costs of up to $125,000. Although the financial plans of the ICs
and agencies 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 or foreign
o Faith-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any established researcher 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. If research organizations
involve curriculum developers or distributors in the project, objectivity of
the evaluation must not be jeopardized. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
Meeting for Investigators
Principal Investigators of projects funded through this RFA will be expected
to attend one meeting to share conceptual frameworks, to share approaches to
developing and implementing comprehensive and integrative curricula, and to
establish core instrumentation intended to maximize the systematic collection
of converging data across projects. Requests for funds for travel to this
meeting should be included in the application budget request.
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:
Melissa K. Welch-Ross, Ph.D.
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B05, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-2307
FAX: (301) 480-7773
E-mail: [email protected]
Michael L. Lopez, Ph.D.
Director, Commissioner"s Office of Research & Evaluation
Administration on Children, Youth & Families
330 C Street, SW, Room 2128
Washington, DC 20447
Telephone: (202) 205-8212
FAX: (202) 205-9721
E-mail: [email protected]
Cheryl A. Boyce, Ph.D.
Developmental Psychopathology and Prevention Research Branch
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Blvd., Room 6200, MSC 9617
Bethesda, MD 20892-9617
Telephone: (301) 443-0848
FAX: (301) 480-4415
E-mail: [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 5E03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1485
FAX: (301) 402-4104
E-mail: [email protected]
o Direct your questions about financial or grants management matters to:
Ms. Mary Daley
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1305
FAX: (301) 402-0915
E-mail: [email protected]
Ms. Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
E-mail: [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 IC 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:
Melissa K. Welch-Ross, Ph.D.
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B05, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-2307
FAX: (301) 480-7773
E-mail: [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,
E-mail: [email protected].
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular grant format. The modular grant format simplifies the preparation of
the budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the
research grant application instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular
grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
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 Blvd., Room 5E03, 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 participating ICs and agencies. 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 NICHD National Advisory 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: If the aims of the application are achieved, will the
investigation contribute conceptual frameworks, methods, assessments, and/or
products that have potential to advance both scientific knowledge and practice?
(2) APPROACH:
o Has the applicant provided a thorough description of the curriculum and
approach to integration? Is the potential merit of these for supporting
early school readiness adequately justified on the basis of rigorous
scientific evidence across relevant disciplines?
o Are there plans to identify and develop detailed conceptual models,
research designs and methodological approaches most useful for identifying
the components, processes, and conditions responsible for the short- and
long-term effectiveness of the curriculum?
o Do plans include strategies for ascertaining and maintaining subjects from
subgroups at risk for school failure?
o Are there an adequate justification and explanation of why the proposed
planning activities are essential before beginning large-scale, multi-site
evaluations that are responsive to this RFA? To what degree will the
specific activities proposed facilitate the conceptualization, design or
implementation of studies that can address each overarching research question
under Research Scope, and as appropriate, the central questions under
Research Focus, above?
(3) INNOVATION: Will the project that planning activities will support
result in the development of new conceptual models, methodological
approaches, measurements, assessments, technologies, or products?
(4) INVESTIGATOR: Do the investigators have the appropriate training and
expertise needed to conduct the large-scale, multi-site trials that planning
activities will support? Does the application include a thorough evaluation
of the additional multidisciplinary content and methodological expertise
required to design, execute, and evaluate the intervention, and a description
of plans to secure such expertise during the planning period?
(5) ENVIRONMENT:
o How adequate and/or appropriate are the established sites and/or potential
research sites to be secured during the planning period? Have the applicants
provided a thorough evaluation of barriers in the research environment that
may affect the successful conduct of the research? Have they described
actions that will be taken to remove or reduce these barriers during the
planning period? Have they thoroughly described all other activities that
will be undertaken to ensure that the environments contribute to the
probability of success?
o Are approaches proposed for establishing relationships with research sites
and implementers of the intervention both feasible and adequate for
supporting all aspects of the project (e.g., subject recruitment, provision
of adequate professional development, evaluation of implementation fidelity,
assessment of outcomes, etc.)?
o Do the investigators plan to take advantage of unique features of the
research environment and to secure all essential and useful collaborative
arrangements? Is there evidence of institutional support, to include support
for establishing essential researcher-practitioner collaborations?
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.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: April 15, 2002
Application Receipt Date: May 14, 2002
Peer Review Date: July 2002
Council Review: September 2002
Earliest Anticipated Start Date: September 2002
AWARD CRITERIA
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
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. 93.865 (NICHD) and 93.242 (NIMH) 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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