LEARNING DISABILITIES: MULTIDISCIPLINARY RESEARCH CENTERS
Release Date: January 18, 2000
RFA: HD-00-003
National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
Letter of Intent Receipt Date: February 28, 2000
Application Receipt Date: April 21, 2000
PURPOSE
The Child Development and Behavior Branch (CDB) of the Center for
Research for Mothers and Children (CRMC), National Institute of Child
Health and Human Development NICHD), invites research grant
applications to develop new knowledge in the areas of definition,
classification, epidemiology, prevention (and preventative strategies),
early intervention, etiology, diagnosis, and treatment of children who
display learning disabilities (LD) in component oral language abilities
(phonology, morphology, semantics, syntax, pragmatics), reading (word
attack skills, word recognition skills, reading fluency and
automaticity, reading comprehension), written expression abilities
(spelling, composition), and mathematics (basic calculation skills,
mathematical reasoning), and combinations and relationships among them.
The specific focus of this RFA is on the discovery of cognitive,
linguistic, perceptual, behavioral, genetic, hormonal, and
neurobiological mechanisms that are influential in the expression of
learning disabilities and the development of preventive and treatment
approaches to ameliorate these disorders.
This RFA will result in grants supporting a combination of site-
specific research and collaborative efforts with other research sites
currently within the NICHD Learning Disability and Reading Research
Networks.
Within the context of these Learning Disabilities multidisciplinary
research centers, the National Institute of Mental Health (NIMH)
encourages research on the diagnosis, assessment, and intervention for
problems of inattention, hyperactivity, and impulsivity, including the
psychiatric diagnosis of attention deficit hyperactivity disorder
(ADHD). Such studies should attempt to advance the scientific
understanding of underlying mechanisms and risk processes related to
ADHD, and may include basic research on dimensions of attention
regulation and related systems that have implications for the etiology,
identification, prevention and/or treatment of ADHD, and basic or
applied research on etiology, risk factors, diagnosis and/or prevention
of ADHD.
HEALTHY PEOPLE 2000
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000," a
PHS-led national activity for setting priority areas. This Request for
Applications (RFA), Learning Disabilities: Multidisciplinary Research
Centers, is related to several priority areas. Potential applicants
may obtain a copy of Healthy People 2000" at
http://odphp.osophs.dhhs.gov/pubs/hp2000.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic for-profit and non-profit
organizations such as universities, colleges, hospitals, schools,
laboratories, units of state and local governments, and eligible
agencies of the Federal Government. Foreign institutions are not
eligible to apply for these grants. Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as Principal Investigators.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) Specialized
Research Center Grant (P50) award mechanism. Responsibility for the
planning, direction, and execution of the proposed project will be
solely that of the applicant. The total project period for an
application submitted in response to this RFA may not exceed five
years. Potential applicants may obtain the NICHD P50 Specialized
Research Center Grant Guidelines at
http://www.nichd.nih.gov/funding/dsr_p50_guide.htm
FUNDS AVAILABLE
The NICHD intends to commit up to approximately $6 million Total Costs
(Direct plus Facilities and Administrative) in FY 2001 to fund four new
and/or competing continuation grants in response to this RFA. An
applicant may request a project period of up to five years and a budget
for direct costs of up to $1 million, excluding Facilities and
Administrative costs on consortium arrangements. Because the nature
and scope of the research proposed may vary, it is anticipated that the
size of awards also will vary. Although the financial plans of 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 applications of high scientific and technical
merit.
The NIMH intends to commit up to approximately $1 million in FY 2001 in
support of Centers that include a focus on basic or applied research on
the etiology, risk factors, identification/diagnosis and/or
interventions for ADHD and its symptoms. Although the financial plans
of the NIMH provide support for this program, awards persuant to this
RFA are contingent upon the availability of funds and receipt of a
sufficient number of applications of outstanding scientific and
technical merit.
RESEARCH OBJECTIVES
Background
The National Institute of Child Health and Human Development (NICHD),
NIH, has had a longstanding interest in the study of normal language
and reading development, learning disabilities, and disorders that
adversely affect the development of listening, speaking, reading,
writing, and mathematics abilities in approximately 15 to 20 percent of
children in the United States. Since its inception in l963, the NICHD
has funded research to delineate the basic biological and behavioral
mechanisms that underlie normal language and normal reading development
and specific deficits in attention, perception, language, cognition,
and academic skills, particularly reading. In January l987, a National
Conference on Learning Disabilities, co-sponsored by the Interagency
Committee on Learning Disabilities (of which the NICHD was designated
as the lead agency) and the Foundation for Children with Learning
Disabilities (FCLD, now NCLD), was held on the NIH campus. The
proceedings of this conference were combined with other sources to
provide a comprehensive document titled "Learning Disabilities: A
Report to the U.S. Congress" (l987). A major recommendation included
in this report called for a systematic effort to conduct research to
develop a valid and reliable definition and classification system that
could provide a theoretical, conceptual, and empirical framework for
the identification of different types of learning disabilities, as well
as the identification of distinctions and interrelationships
(comorbidities) between types of LD and other childhood disorders,
including general academic underachievement, disorders of attention,
mental retardation, genetic disorders, and emotional disturbance. In
addition, the "Report to Congress" called for a systematic effort to
develop rigorous research strategies and intervention trials to examine
the responses of children with LD to different forms of treatment.
Based on the l987 "Report to Congress" recommendations, NICHD funded
three Multidisciplinary Learning Disability Research Centers (LDRCs) in
l988 to initiate studies on the definition, classification, and
etiology of LD and related disorders. These three centers joined
several program projects that, beginning in 1964, had been focused on
the specific study of normal reading development, language processes
related to reading, and dyslexia. In l993, two additional research
programs were funded to study the effects of treatment interventions on
children with language-based reading deficits, with a third
intervention project added in 1995.
Research Scope
Studies conducted at the LDRCs, program projects, and reading
intervention sites over the past three decades have yielded discoveries
in several domains, summarized below according to research targets.
Likewise, remaining gaps in the extant knowledge base which require
additional systematic research also are identified for each domain.
The research needs identified in the following sections are examples of
research topics that applicants should consider when developing their
responses to this initiative. The examples provided are not
exhaustive.
o Classification/Definition: Lessons Learned
1. The definition and classification of different types of LD,
dyslexia, and attentional problems should be accomplished within a
longitudinal developmental framework that does not require adherence to
a priori assumptions reflected in current definitions. The development
of valid definitions requires that studies be conducted with
representative groups of children over time and that document, with
robust measurements and measurement models, how individual differences
among children emerge, change, respond to treatment, and influence
further development. In developing definitions, a critical emphasis
should be placed on the identification of valid inclusionary criteria.
To date, the preponderance of the NICHD definitional studies have
focused on the definition and classification of disorders in basic
reading skills with comorbid attentional problems. Similar efforts now
must be deployed to develop reliable and valid inclusionary definitions
of learning disabilities in mathematics, written language, and reading
comprehension. Such efforts should also be designed to identify and
describe comorbidities of these specific learning disabilities with
attentional problems and specific genetic disorders affecting social,
emotional, linguistic, and behavioral development.
2. With respect to LD in basic reading skills (dyslexia), current
exclusionary definitions appear to be invalid if discrepancy criteria
are used. Reading disabled (RD) children with and without a
discrepancy between IQ and reading achievement do not differ in
information processing subskills (e.g., phonological and orthographic
processing) that are critical to the reading of single words.
Likewise, genetic and neurophysiological studies have not indicated
differential etiologies for RD children with and without IQ-Achievement
discrepancies. In addition, recent intervention studies undertaken
with RD children with and without discrepancies indicate that presence
and magnitude of the discrepancy between IQ and reading achievement
does NOT predict response to treatment. It remains to be seen whether
discrepancies between IQ and achievement constitute valid markers in
the areas of oral language, reading comprehension, written expression,
mathematics, or whether discrepancies are worthwhile predictors of
response to treatment/interventions in these domains.
o Reading and Language-Related Processes: Lessons Learned
1. LDRC longitudinal, epidemiological studies show that RD (dyslexia)
affects at least 10 million children, or approximately one child in
five. These epidemiological data need to be further refined to
identify specific linkages between reading failure and sociocultural,
economic, and demographic factors. Of particular import is the
identification of specific effects of home literacy practices, parents
reading levels and practices, the specific effects of poverty on
reading failure, and the identification of risk and protective factors
within these contexts.
2. While public schools identify approximately four times as many boys
as girls as RD, LDRC and program project longitudinal and
epidemiological studies show that as many girls manifest RD as boys.
What is not as well understood are the factors that predispose boys to
a higher rate of identification. Questions related to severity,
classroom behavior, teacher expectations and perceptions, and the
influence of comorbidities need to be addressed explicitly during this
next five-year research cycle
3. RD appears to reflect a persistent deficit rather than a
developmental lag in linguistic (phonological) skills and basic reading
skills. LDRC and program project longitudinal studies show that of the
children who are diagnosed RD in the third grade, 74 percent remain
disabled in the ninth grade. Given these findings, several questions
remain and should be considered for study during the next five-year
research cycle. For example, what are the characteristics of those
children who are no longer diagnosed RD? Was their disability less
severe in contrast to children with persistent RD? Were particular
treatments/interventions more effective with the compensated RD
children than with those children who remained RD? Do compensated RD
children show differences in neurophysiological, linguistic, cognitive,
and/or behavioral features? What are the best predictors of outcome?
Do predictors change as a function of type of intervention/treatment?
Importantly, what are the conditions under which older children and
adults can improve reading skills and what are the characteristics of
the instructional programs in this regard with respect to intensity,
duration, degree of explicitness, degree of integration among
components of reading, and the instructional unit of analysis
(letter/sound, onset-rime, syllable, word) employed in developing word
reading skills?
4. Children with RD differ from one another and from other non-
disabled readers along a continuous distribution, and do not aggregate
together to form a bi-modal distribution or a distinctive "hump" at the
tail of the normal distribution. Given that RD occurs along a
continuum, it will be important to understand in future studies which
"cut-points" are most valid and useful for establishing levels of
severity for diagnostic and treatment planning purposes. Intervention
studies would be helpful in this regard.
5. The ability to read and comprehend depends substantially upon rapid
and automatic recognition and decoding of single words. Slow,
laborious, and inaccurate decoding are powerful predictors of
difficulties in reading comprehension. While this finding has been
replicated across the LDRCs, program projects, and reading intervention
sites, an identification of the multiple cognitive , linguistic,
genetic and neurobiological sources that are required for comprehension
and their relative importance to comprehension is not fully understood.
More detailed and comprehensive studies are needed in this area,
particularly with respect to the impact of individual differences in
vocabulary development, extent of background knowledge, development and
use of semantic, grammatical, and syntactical skills in deriving
meaning from print, knowledge of writing conventions, verbal reasoning
ability, and memory for verbal material, and the genetic and
neurobiological factors that influence development in these domains.
Applicants should consider research efforts to clarify these issues.
6. The ability to decode single words accurately and fluently appears
dependent upon the ability to segment words and syllables into abstract
constituent sound units (phonemes). Converging evidence from the
LDRCs, program projects, and reading intervention sites indicates that
combined deficits in phonological awareness, letter and number naming,
and print awareness serve as substantial predictors of reading failure.
In future studies, it will be critical to determine whether the
phonological deficit reflects a specific linguistic deficiency that
interferes with the development of reading in and of itself, or whether
deficits in phonology actually reflect deficiencies at lower levels of
processing (e.g., rapid temporal processing of information irrespective
of modality). Within this context it is also critical to identify the
relative influences of, and relationships between, deficits in
phonological processing and timing and rate factors, particularly with
respect to predicting individual differences in reading fluency and
automaticity. Studies that identify the genetic, hormonal, and
neurobiological underpinnings of phonological and rate deficits also
need to be expanded to address these issues.
7. Related to the rate and timing issues noted above, LDRC, program
project, and reading intervention site data indicate that orthographic
processing influences how reading develops in children. Given this
consistent finding, research is needed to fully define and identify the
role of orthographic processing in both single word reading and
comprehension, as well to identify and delineate other visual
processing factors that may contribute to the developmental reading
process. Neurobiological, hormonal, genetic, cognitive, and treatment
studies will be instrumental in this regard.
o Attentional Problems and Comorbid RD and ADHD: Lessons Learned
1. The reviews of the literature conducted by the LDRCs and program
projects indicate that a precise classification system and definition
of problems in attention are not yet available. A classification
methodology that assesses BOTH internal and external validity of
dimensional AND categorical models must be applied to the task.
Further, any classification effort must be informed by a well developed
model incorporating behavioral, environmental, neurobiological,
genetic, and hormonal influences and their interrelationships. These
efforts should be expanded during the five-year research cycle relevant
to this RFA. Until these definitional issues are clarified, any
findings discussed with respect to attentional problems must be
interpreted with caution.
2. RD and ADHD, as one type of attentional problem, often co-exist,
but the two disorders appear distinct and separable with respect to the
effects of ADHD on cognitive tasks. For example, it has been found
that ADHD children perform poorly on rote verbal learning and memory
tasks, but relatively well on naming and phonological awareness tasks.
The converse appears to be the case for children with RD. Clearly,
research is needed to understand whether differential neurobiological
and genetic mechanisms underlie disorders of attention versus other
types of learning disabilities. It will also be critical to understand
whether comorbidity between RD and disorders of attention predispose a
child to particular treatment response patterns. Likewise, research is
critically needed to identify the specific relationships that exist
between individual differences in attention and the development of
mathematics and written language capabilities.
3. The severity and cognitive morbidity of RD are exacerbated by
comorbid ADHD, with the co-occurance of the two disorders more frequent
among males. Thus, level of severity may be one reason that more males
than females are identified as RD. Neurobiological, hormonal, and
genetic research will be critical to understanding the gender
difference for comorbid RD, ADD and ADHD, and treatment studies will be
critical in determining the types of interventions necessary to
remediate severe RD with ADD/ADHD. During this next five-year research
cycle, it will be critical to expand this same type of effort to the
study of mathematics and written language disabilities with and
without comorbid ADHD.
o Genetics: Lessons Learned
1. A multiple regression analytic procedure has been developed via
NICHD support that allows for the analysis of the genetic etiology of
deviant scores as well as individual differences in language/reading
functions. This is a highly unique and flexible methodology that can
be extended to assess a wide range of possible main effects and
interactions and to test for differential genetic and environmental
influences. Expansion of these types of models and procedures to the
identification of heritability factors in reading comprehension,
mathematics, and written language disorders, as well as disorders of
attention, will be critical during the five-year grant cycle relevant
to this RFA.
2. Similarly, twin studies have found strong evidence for genetic
etiology of reading disability, with deficits in phonological awareness
reflecting the greatest degree of heritability. There is also
behavioral and molecular genetic evidence for degrees of heritability
for orthographic processing, but this relationship is not well
understood. Efforts to uncover the genetic influence in the
development of these components of reading must be continued, with
efforts also being deployed to better understand the heritability of
rate and fluency factors. Linkage between genetic findings and
neurobiological development in children is also of high importance.
Integrated genetic and neuroimaging studies should be considered in
this regard.
3. Some data suggest that at least one type of reading disability can
be linked to the HLA region of Chromosome 6, reflecting a possible
association with autoimmune disorders. Recent evidence obtained from
twin and kindred siblings with severe deficits in reading performance
show strong evidence for a Quantitative Trait Locus on Chromosome 6.
These studies need to be continued and replicated in combination with
the search for additional chromosomal regions. Moreover, studies
improving on this type of methodology also should be applied to the
identification of quantitative trait loci for deficits in cognitive
components of mathematics development, written language, and attention.
o Neurobiology (Neuroanatomy, Neurophysiology, Neuroimaging): Lessons
Learned
1. Learning to read requires, among other skills, an awareness that
spoken words can be decomposed into the phonological constituents that
the alphabetic characters represent. Phonological awareness is
typically lacking in LD children with reading disorders (RD) making it
difficult for them to link the alphabetic characters with the sounds of
speech. Recent advances in the application of functional neuroimaging
modalities (e.g., fMRI) have indicated that neural activation patterns
differ significantly between RD children and normal readers.
Specifically, RD children show relative under-activation in posterior
brain regions (Wernicke’s area, angular gyrus, striate cortex) and
relative over-activation in anterior regions (inferior frontal gyrus).
Post-mortem studies and investigations employing brain morphometry and
electrophysiology converge on these findings, particularly with respect
to differences identified between RD and normal readers in temporo-
parieto-occipital brain regions.
It will be critical during the next LDRC research cycle to replicate
and extend these findings by employing a number of neuroimaging
modalities (e.g., MRI, fMRI, MEG, MRS, Diffusion Tensor Imaging) and
dependent measures to assess the organization of cognitive and
linguistic skills critical to reading in the brain. Moreover, in
addition to identifying the neural organization for specific skills
critical to basic reading development, studies designed to delineate
the neural substrates and changes that are necessary for the
development of automaticity and expertise in the application of these
reading skills are critically needed. Likewise, studies to delineate
component cognitive and linguistic processes involved in reading
comprehension and their neural activation signatures in disabled and
non-disabled readers are needed.
2. Preliminary data suggest that changes in reading behavior produced
by well-defined early interventions are reflected in changes in neural
activation in those brain regions implicated in the development of
basic reading skills. Integrated intervention-neuroimaging studies
need to be replicated and expanded to better understand the specific
impact of behavioral perturbation on brain development and function,
and to determine whether the intensity and duration of the intervention
required to produce both behavioral and neural changes vary as a
function of chronological age.
3. Advances in the application of structural and functional imaging
modalities need to be expanded and applied to the study of brain-
behavior relationships relevant to disorders in the development of
mathematics, written language, and attentional skills. Likewise,
neuroanatomical, neurophysiological, neuropsychological, and
educational studies of development and disorders in executive function
and social, nonverbal communication are critically needed.
o Interventions and Instructional Studies: Lessons Learned
1. Since 1993, NICHD-initiated reading intervention studies have
focused on the need to identify the instructional components that are
most beneficial for well-defined children in well-defined settings at
different points in reading development. Converging data derived from
several NICHD reading intervention sites indicate that for many (but
not all) young children at-risk for reading failure, early explicit
instruction designed to teach phoneme awareness, the alphabetic
principle, and word recognition skills, within the context of a
complete reading program, increases decoding skills, word recognition
abilities, and, to some extent, reading comprehension skills.
Moreover, studies with older disabled readers (grades 3 through 5)
indicate that many (but not all) older children can significantly
improve their basic reading skills with intensive intervention
approaches that emphasize explicit remediation of phonological
processing abilities and the systematic integration of these skills
with instruction in phonics, textual reading, and reading
comprehension.
Within this context, several critical research opportunities exist
which may be addressed in response to this RFA. First, several studies
have found that interventions that are targeted primarily to the
development of phonological, decoding, and word reading skills are not
sufficient, in and of themselves, to ensure transfer of these skills to
the fluent reading of textual reading formats. Indeed, the development
of fluency and automaticity in RD children remains poorly understood.
This is unfortunate given that reading comprehension is critically
dependent not only on word reading skills, but also on reading fluency
and language comprehension abilities. A major goal of this RFA is to
stimulate intensive research efforts to delineate the instructional
conditions that are necessary to produce improvements in ALL aspects of
reading, with a significant focus on the development of reading
fluency, automaticity, and reading comprehension strategies.
2. While increased efforts must be deployed to better understand the
development of reading fluency, automaticity and comprehension skills,
intervention efforts also must be expanded to the development of well-
defined mathematics and written language skills in children at-risk for
failure in these academic domains. Applicants are encouraged to
consider the design of intervention studies in these areas.
Research Focus
As has been noted, current knowledge related to the etiologies,
developmental courses, and diagnostic characteristics of children with
LD who display primary deficits in written expression, reading
comprehension, and mathematics is less well developed than that which
is now known about aspects of oral language (e.g., phonology) and basic
reading development. As such, there exists a need to initiate studies
of these types of LD, particularly with respect to establishing
reliable and valid definitions and classification systems, reliable and
valid measurement strategies and instruments, identifying critical
etiological factors (cognitive, linguistic, genetic, neurobiological,
experiential) associated with impairments in these domains, mapping the
developmental course of skill and concept acquisition, and determining
response to well-defined treatment interventions. For the purposes of
this RFA, applicants are encouraged to incorporate studies of reading
comprehension, written expression, and/or mathematics in their research
plan even if the major emphasis of the proposal also targets basic
reading skills and/or disorders of attention. Applicants are
encouraged to utilize state-of-the-art quantitative and qualitative
research methodologies, and studies that combine methodologies are
particularly encouraged.
In preparing applications in response to this RFA, applicants should
ensure that the following methodological and organizational issues are
addressed:
1. Research Population
The selection of the research population should be based upon the need
to conduct integrated prospective, developmental, longitudinal
investigations incorporating neurobiological, cognitive/behavioral, and
early (and later) treatment/intervention studies with children who
manifest LD in one or more of several domains to include oral language,
basic reading skills, reading comprehension, written expression, and
mathematics development, as well as deficits in attention. Within this
context, longitudinal studies may be initiated with preschool and
kindergarten children, with the children being followed as they enter
and proceed through the early grades. Cross-sectional studies of LD
children of different ages ranging across the elementary and middle
school age-span also should be considered, but such studies must be
related meaningfully to the questions being asked within the
longitudinal studies.
It is expected that not all children within the research population
will manifest the entire range of oral language, written language, and
mathematics deficits detailed above. Likewise, children selected for
study likely will vary across cultural, familial, ethnic, racial,
economic, and other demographic characteristics that could influence
development. As such, there likely will be subgroups and subtypes of
children with significantly different patterns of demographic
characteristics, academic deficits, different patterns of comorbidity,
levels of severity, and different psychological/cognitive processing
deficits. Therefore, applicants should consider research protocols
that are capable of identifying well-defined subgroups and subtypes
that exist within the sample. Investigators also should consider
casting the sampling net wide enough to insure a representative number
of subtypes and contrast groups within the study population. For
example, of interest are studies of subtypes of LD children of varying
demographic characteristics, intellectual abilities, with primary
deficits in one or more academic domains who display no comorbid
deficits, a single comorbid deficit, or a combination of comorbid
deficits in attention, behavior, and social competencies, etc..
2. Subject Selection Criteria
The samples for study must be defined rigorously so that complete
replication can be accomplished. Within this context, applicants
should provide clearly documented and operationalized definitions for
their subject selection criteria. These definitions and criteria must
be specified in an a priori manner. The selection of "school-
identified" or "clinic-identified learning disabled children is
clearly discouraged unless the demographic and diagnostic
characteristics in these cases matches the applicant"s
a priori established selection criteria. Likewise, criteria for
selection of contrast group(s) must be specified in an a priori manner.
All children selected for study must be defined with reference to age,
gender, grade level, length of time in special education placement (if
applicable), type of current special education placement (if
applicable), previous special education placement(s)(if applicable) to
include intensity and duration, ethnicity, socio-economic status,
primary learning disability, comorbid disabilities, severity of
disability, familial and/or genetic findings, physical/neurological
findings, intellectual status, cognitive-linguistic status,
neurophysiological and neuropsychological status, levels of academic
achievement in oral language, reading, mathematics, and written
language, and presence or absence of attention deficit disorder.
3. Measurement Criteria
Standardized tests, laboratory tasks, observational measures, interview
schedules, and other assessment procedures (e.g., dynamic assessment
procedures, case studies, ethnographic studies) must be selected on the
basis of known reliability, validity, trustworthiness, and
appropriateness for the samples under study. If reliability, validity
and trustworthiness of the measurement/assessment/observational
procedures are initially unknown, the application must include specific
plans for establishing these measurement properties. The valid
measurement of change over time is critical to much of the research
solicited via this RFA since the study of developmental course and
treatment effectiveness is of primary concern. If instructional
treatment studies are proposed, applicants should be aware of and
employ robust procedures for separating treatment effects from the
effects of development, in general. The use of growth curve models and
longitudinal data is encouraged as is the collection if sufficient data
prior to, during, and following the instructional/treatment study to
allow for estimation of change over time.
SPECIAL REQUIREMENTS
1. Annual meetings for Investigators
Principal Investigators from Centers funded through this RFA will be
expected to attend an annual NICHD meeting to share findings, research
approaches, and core instrumentation. The first meeting is expected to
take place in January 2001 to discuss core instrumentation and
replication strategies. Provision for funds for travel to this annual
meeting at the NIH should be included in the application budget request
and budget justification.
2. Advisory Boards
Because of their complexity and size, Research Center (P50) grants
require guidance and interaction with senior members of the scientific
community not directly involved in the conduct of the proposed research
operations. For the purposes of this RFA, applicants should propose
and design an External Advisory Board to provide outside counsel and
periodic review of the Research Center activities and progress.
Applicants are not to select or contact proposed Advisory Board members
at this time. Details of the operation of the Board, including size,
structure, function, and frequency of meetings should be specified, as
well as the type of expertise and level of seniority of Board members
to be recruited. Members of the Advisory Board are to be selected and
confirmed within three months of the award date and notification sent
to program staff at NICHD. Provision for costs of the Advisory Board
are to be included in the application budget request and budget
justification.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH-supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification are provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should
read the NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research, that was published in the Federal
Register of March 28, 1994 (FR59 14508-14513) and in the NIH Guide for
Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available at
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age
of 21) must be included in all human subjects research, conducted or
supported by 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 was published
in the NIH Guide for Grants and Contracts, March 6, 1998, and is
available at http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators may also obtain copies of these policies from the NICHD
program staff listed under INQUIRIES. Program staff may also provide
additional relevant information concerning the policy.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the
identities of other key personnel and participating institutions, and
the number and title of this RFA. Although a letter of intent is not
required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows NICHD
staff to estimate the potential review workload and avoid conflict of
interest in the review.
The letter of intent is to be sent to G. Reid Lyon, Ph.D., at the
address listed under INQUIRIES, by February 28, 2000 .
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these P50 grants. These forms are available at most
institutional offices of sponsored research, on the Internet at
http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the
Division of Extramural Outreach and Information Resources, National
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD
20892-7910, telephone 301-710-0267, E-mail: Grantsinfo@nih.gov.
Applications for the P50 grant are to be prepared in a manner
consistent with the information presented in the NICHD P50 Specialized
Research Center Grant Guidelines, available from the contacts listed
under INQUIRIES, below, and at
http://www.nichd.nih.gov/funding/dsr_p50_guide.htm.
Submission Procedures
The RFA label available in the PHS 398 (rev. 4/98) application form
must be stapled to the bottom of the face page of the application and
must display the RFA number HD-00-003. A sample RFA label is available
at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note
this is in the pdf format. Failure to use this label could result in
delayed processing of the application such that it may not reach the
review committee in time for review. In addition, the RFA title and
number must be typed on line 2 of the face page of the application form
and the YES box must be marked.
Submit a signed, typewritten original of the application, including the
checklist, and three signed photocopies, in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application
should be sent to:
Director
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E-03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: 301/435-6911.
Applications must be received by April 21, 2000. If an application is
received after that date, it will be returned to the applicant without
review.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude
submission of substantial revisions of applications already reviewed,
but such applications must include an introduction addressing the
previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR
and for responsiveness by NICHD staff. Incomplete and/or non-
responsive applications will be returned to the applicant without
further consideration.
Applications that are complete and responsive to this RFA will be
evaluated for scientific and technical merit by an appropriate review
group convened by the NICHD in accordance with the review criteria
stated below. As part of the initial merit review, a process may be
used by the initial review group in which applications receive a
written critique and undergo a process in which only those applications
deemed to have the highest scientific merit will be discussed, assigned
a priority score, and receive a second level review by the National
Advisory Child Health and Human Development Advisory Council.
Review Criteria
Applications submitted in response to this RFA will be evaluated
according to the review criteria described in the NICHD P50 Specialized
Research Center Grant Guidelines, available from the contacts listed
under INQUIRIES, below, and at
http://www.nichd.nih.gov/funding/dsr_p50_guide.htm.
SCHEDULE
Letter of Intent Receipt Date: February 28, 2000
Application Receipt Date: April 21, 2000
Peer Review Date: June 2000
Council Review: September 2000
Earliest Anticipated Start Date: December 2000
AWARD CRITERIA
Criteria that will be used to make award decisions include scientific
and technical merit as determined by peer review, availability of
funds, and programmatic priorities.
INQUIRIES
Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.
Direct inquiries regarding programmatic and scientific issues to:
G. Reid Lyon, Ph.D.
Chief, Child Development and Behavior Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Building, Room 4B05, MSC 7510
Bethesda, MD 20892-7510
Telephone: 301-496-9849
Fax: 301-480-7773
E-mail: rl60a@nih.gov
Direct inquiries regarding research specific to ADHD to:
Farris Tuma, Sc.D.
Developmental Psychopathology and Prevention Research Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6200, MSC 9617
Bethesda, MD 20892
Telephone: 301-443-9232
Fax: 301-480-4415
E-mail: ftuma@nih.gov
Direct inquiries regarding fiscal and administrative matters to:
E. Douglas Shawver
Grants Management Branch
National Institute of Child Health and Human Development
6100 Building, Room 8A17, MSC 7510
Bethesda, Maryland 20892-7510
Telephone: 301-496-1303
Fax: 301-402-0915
E-mail: ds117g@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance
No. 93.365, Research for Mothers and Children. Awards are made under
authorization of the Public Health Service Act, Title IV, Part A
(Public Law 78-410, as amended by Public Law 99-158, 42, USC 241 and
285) and administered under NIH grants policies and Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to
the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products. In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education, library,
day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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