Learning Disabilities: Multidisciplinary Research Centers

RFA Number: RFA-HD-04-027

Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

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

Announcement Type
This is a reissue of RFA-HD-00-003, released on January 18, 2000.

Update: The following update relating to this announcement has been issued:

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: October 19, 2004
Letters Of Intent Receipt Date(s): February 11, 2005
Application Receipt Dates(s): March 11, 2005
Peer Review Date(s): June/ July 2005
Council Review Date(s): September 2005
Earliest Anticipated Start Date: December 1, 2005
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: March 12, 2005

Due Dates for E.O. 12372
Not Applicable

Executive Summary

For further assistance, contact Grantsinfo, Telephone (301) 435-0714, Email: Grantsinfo@nih.gov

Telecommunications for the hearing impaired: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

  Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2.Cost Sharing
    3. Other - Special Eligibility Criteria

  Section IV. Application and Submission Information
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

  Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative Requirements
     A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. Award Criteria
    4. Reporting

  Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

  Section VIII. Other Information - Required Federal Citations
 

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

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, etiology, diagnosis, epidemiology, early identification, prevention (and preventive strategies), and remediation of children who display learning disabilities (LDs) in component oral language abilities (phonology, morphology, vocabulary, pragmatics), reading (word attack skills, word recognition skills, reading fluency and automaticity, reading comprehension), and written expression abilities (formulation and expression, spelling, graphomotor skills) and relationships among these LDs and other disabilities.

This RFA encourages research on the development and validation of classification systems and definitions for LDs affecting basic oral language abilities related to reading and writing (e.g., vocabulary), basic reading skills, reading fluency, reading comprehension, and written expression, with and without cormorbid deficits in attention and/or mathematics.

Within this context, comparisons of the internal and external validity characteristics of inclusionary domain-specific definitions of different types of LDs are needed. Of particular interest are longitudinal multidisciplinary studies that examine the validity and utility of response to instruction (RTI) models. A major focus of this research should be to determine how these types of classification and definition models and/or combinations of the models (a) distinguish LDs from low achievement and other disorders that affect learning, (b) inform treatment decisions, and (c) predict response to treatment. To accomplish these goals, it must be possible to classify children with different types of LDs using criteria derived from multiple classification and definition models.

This RFA solicits applications that identify basic biological, behavioral/social, and environmental mechanisms that influence the expression of LDs in word level reading skills, reading fluency, vocabulary, reading comprehension, and written expression. Applicants are encouraged to explicitly link basic and applied research protocols to increase internal, external, and ecological validities of candidate classification and definition models. For example, programmatic multidisciplinary research to identify genetic, neurobiological, cognitive, linguistic, perceptual, behavioral, instructional, social, and environmental characteristics of children, adolescents, and adults who respond or do not respond to well-defined prevention, early intervention, or remediation approaches is encouraged.

Because the CDB Branch has developed a new research program in learning disabilities in mathematics development and disorders, investigator-initiated applications with a primary research focus on Math LDs should be directed to that program (http://www.nichd.nih.gov/crmc/cdb/cdb.htm). However, studies that examine comorbidities between mathematics deficits, and/or social-emotional difficulties, and/or attentional disorders (ADD/ADHD) with LDs in reading and/or written expression are encouraged.

This RFA is expected to result in grants supporting multidisciplinary and coordinated programs of research supported through the P50 center grant mechanism. The proposed research must include three or more related, integrated, and high quality research projects that provide multidisciplinary, yet unified and interdisciplinary interaction, and at least one core resource.

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. Since its inception in l963, the NICHD has funded normative studies to delineate the basic biological and behavioral mechanisms that underlie individual differences in oral language and normal reading development as well as 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 National Center for Learning Disabilities [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 and 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. In 2000, three continuing LDRCs (Yale University, University of Washington, University of Colorado) and one new LDRC (Georgetown University) were supported for a five-year cycle.

Studies conducted at the LDRCs, dyslexia program projects, and reading intervention sites over the past three decades have yielded a number of discoveries and advances. These advances include the delineation of critical cognitive and linguistic factors in the normal acquisition of basic reading abilities and reading failure and their neurobiological and genetic correlates. In addition, prevention and remediation studies that have addressed deficits in word level reading skills have produced converging evidence on the importance of phonemic awareness, the development of the alphabetic principle, reading fluency, vocabulary, and reading comprehension strategies in learning to read. However, comprehensive models of the specific mechanisms that influence development in fluency, vocabulary, and comprehension have yet to be articulated. Furthermore, by integrating multi-modality neuroimaging protocols into both descriptive and treatment studies, NICHD-supported scientists have obtained evidence for specific neural systems related to the development of some componential reading skills and the malleability of these systems in response to well-defined interventions. Studies of the comorbidity between reading disabilities, mathematics deficits, and disorders of attention have also yielded important information. Both behavioral and molecular genetic studies continue to converge on earlier findings that genetic factors influence reading acquisition, particularly through effects on the development of phonemic awareness and orthographic processing.

Research Scope

Both basic and applied studies of LDs in different domains of reading and written expression are encouraged. Multidisciplinary research to elucidate cognitive, linguistic, neurobiological, and genetic mechanisms in the development of word level reading and reading-related skills continue to be of interest to the NICHD LD Center initiative. However, if studies of word level processes are proposed, they should be integrated explicitly with multidisciplinary studies of individual differences in oral language development (e.g., vocabulary, syntax), reading fluency, and reading comprehension to identify relationships among these reading and reading-related domains. Of additional interest are studies of LDs in written expression with respect to the etiology, developmental course, and response to treatment characteristics of this type of LDs, as well as relationships with LDs in oral language and reading. Any study of individuals with LDs in reading and written expression must give careful consideration to the role of oral language skills (e.g., vocabulary, syntax, etc.) in the development of reading and writing abilities.

It will be important, although not required, to cast the sampling net widely to provide opportunities to identify comorbidities between different types of LDs and oral language disorders, disorders of attention, and LDs in mathematics to determine the impact of multiple deficits on severity, developmental course, and instructional requirements.

Research Focus

The research solicited by the RFA should focus on designing and conducting integrated multidisciplinary studies that (a) improve on current classification and definition models for LDs; (b) extend both basic and applied research on LDs beyond studies of word level reading skills to reading fluency, vocabulary, reading comprehension, written expression, and unidirectional and bidirectional relationships among and between these oral and written language domains; and (c) identify basic neurobiological, genetic, cognitive/behavioral, and environmental mechanisms that influence the expression of LDs at different phases of development. These three primary aims are not mutually exclusive. Indeed, they are inextricably linked. Applicants are encouraged to use multiple designs and methods to integrate studies across these domains. While each is necessary to better understand and to prevent or remediate LDs, none are sufficient in their own right.

The research needs identified below are examples of research topics that applicants should consider when developing their response to this solicitation. The examples provided are not an exhaustive list but are offered as illustrations.

The Classification, Definition, and Identification of LDs in Basic Reading Skills, Reading Fluency, Reading Comprehension (to include vocabulary development) and Written Expression.

Background

The field of LD continues to be beset by persistent difficulties in developing a valid classification system and operational definitions for the range of LDs (and their comorbidities) currently included in federal legislation. The most frequently employed definition is an exclusionary model (LDs are defined by what they are not) that typically uses an IQ-achievement discrepancy as a criterion for diagnosis. These definition and identification practices are problematic for several reasons, including: (a) IQ is not a robust measure of one's potential to learn specific academic skills; (b) discrepancy scores are unreliable; (c) a focus on discrepancies hinders an emphasis on instruction and learning; (d) a reliance on discrepancies in the identification of LDs typically prevents individuals from receiving the specialized instruction they need until after nine years of age; (e) individuals are both over and under identified as manifesting LDs when IQ-achievement discrepancy is employed as a criterion for identification; (f) IQ-achievement discrepancies have little utility in distinguishing between LDs and other diagnostic and clinical entities; and (g) factors that would exclude individuals from a diagnosis of LDs may actually influence the expression of LDs (e.g., environmental disadvantage).

The development of a comprehensive classification and definition model for LDs has been constrained by insufficient examination of the basic neurobiological, genetic, instructional, and environmental factors that influence the expression and severity of LDs in reading fluency, reading comprehension, oral language (particularly vocabulary), and written expression. Studies to improve classification and definition models of LDs must include these sub-categories of LDs in the process.

Taken together, existing data relevant to the classification and definition of LDs point to the significant need for improvement in the definitional coverage and the internal and external validity of this broad diagnostic category. Suggestions for developing, evaluating and implementing viable alternatives are provided below.

Examination of Response to Instruction (RTI) as a Viable Candidate for Classification and Identification of LDs

Recent data obtained by a number of developmental scientists suggest the potential of employing a response to instruction (RTI) model in the classification and definition of LDs, and in the development and implementation of psychometrically and ecologically valid assessment and identification procedures. The implementation of an RTI model in clinical and classroom settings typically requires the application of evidence-based early instructional strategies that are specifically linked to the diagnosed academic needs of individual students. Students' progress is closely monitored through the use of criterion-referenced assessment embedded in progress monitoring strategies. Based on this process of continuous assessment, instruction is modified to ensure academic growth.

Within an RTI model, the identification of LDs is based on a "risk" perspective. Specifically, children at risk for significant academic problems are provided early intervention. Children who fail to respond or respond minimally to the instruction following data-based teaching adjustments based on continuous assessments of student need in combination with other factors (e.g., exclusion factors) are identified as manifesting LDs. The RTI model is typically implemented using a multi-level or multi-tiered approach where the intensity of instruction increases over designated periods of time when the desired response is not observed.

The advantages of using RTI as at least one of the criteria include: (a) it provides supplemental instruction to a large number of at-risk children; (b) it requires continuous monitoring of student progress; and (c) it reduces the biases inherent in traditional referral systems that depend upon subjective criteria (e.g., teacher perceptions).

While initial data indicate that RTI models show promise and should be pursued as a viable procedure contributing to the identification of individuals with LDs, a number of conceptual, methodological, measurement, and implementation issues require intensive scrutiny and investigation to ensure appropriate implementation. For example, it is not yet clear what child and program characteristics best predict RTI in the areas of word level reading skills and reading-related skills, reading fluency, reading comprehension (to include vocabulary development), and written expression. A number of these issues are delineated below. These examples of gaps in the knowledge base and the types of research needed to close the gaps are illustrative rather than exhaustive.

•  Determination of at-risk status in all domains of LDs, including word level deficits, and difficulties in reading fluency, vocabulary, reading comprehension, and/or written expression

While substantial progress has been made in the development of reliable and valid screening and early identification protocols to identify children at risk for failure in beginning reading skills, there remains a critical need to develop similar strategies to determine at-risk status in reading fluency, vocabulary, reading comprehension, and written expression. Although beginning reading clearly involves screening as early as possible, consideration of the best age/grade for screening for other types of LDs should be considered. For all types of LDs, including deficits in word level reading skills, it is essential that an operational definition of at-risk status be developed. Different RTI studies have employed different at-risk criteria. For example, different cut points from a variety of screening and early identification measures have been employed. Some studies employ normative data in establishing the cut points, while others use curriculum-based measures with performance compared to local district or school norms. Some studies employ combinations of data. In any case, the reliability and predictive validity of any approach or combination of approaches to determine at-risk status must be established a priori .

•  Determination of RTI criteria to identify LDs

While the development of reliable and valid screening and early identification protocols is essential to implementing an RTI model, it is not yet known which specific RTI criteria are most valid for the identification of LDs. Without these criteria, it will be difficult, if not impossible, to determine which children do or do not respond adequately to instruction. For example, is a lack of response to instruction sufficient as a sole marker for LDs or is a combination of findings/observations necessary for a valid identification of LDs? If a combination of features is required, what is the optimal combination? For instance, should students be identified as LDs on the basis of growth models that indicate a suboptimal level of response and a discrepancy from grade-level performance (dual discrepancy models)? Is the accuracy of identification improved when other factors (e.g., exclusion of other disorders) included in the process? What types of measurement and assessment metrics are most reliable and valid in making these determinations?

•  Definition of "responder" and "non-responder" status

Whether unitary or combined criteria are employed, it is essential that definitions of "responders" and "non-responders" be established a priori and validated against external criteria. For example, what constitutes adequate progress? Specifically, what magnitude of response within what period of time (number of weeks, months, etc.) is required for assignment to more intensive instruction and eventually to responder or non-responder status? How is non-responsiveness defined and within which instructional contexts and mode of service delivery (general education classroom, special education setting, multi-level context)? Moreover, what types of measurement strategies and metrics are reliable and valid to assess RTI and how often are data collected? What is the reliability of the decision points (e.g., cut points) used in the determination of responsiveness or non-responsiveness? In addressing these and similar questions, studies that examine differences between responders and non-responders on neurobiological, genetic, cognitive, academic, perceptual, linguistic, social, emotional, motivational, and environmental variables are of significant interest. Note that although examination of differences on all of these external validation variables is not mandatory, it is encouraged.

•  Instruction

It is critical in examining the utility of RTI models that specific characteristics of the instruction be sufficiently defined and described to permit independent replication. Details regarding instructional content, scope, and sequence, explicitness of presentation, whether the approach is standardized or individualized, intensity and duration of the intervention(s), and descriptions of instructional interactions within each level of multi-level approaches should be provided. Evidence of effectiveness of approaches/programs considered for implementation in RTI studies should be provided if available. It is imperative that comparisons of different instructional approaches embedded in RTI models use research designs and methods capable of inferring cause and effect (randomized control trials, quasi-experimental designs). Combinations of quantitative and qualitative designs and methods that provide a comprehensive analysis of the effects of RTI are encouraged.

•  The role of the teacher and the instructional setting

Because the magnitude of RTI is substantially mediated by teacher knowledge and experience, relationships between teacher characteristics (content expertise, knowledge of assessment and instructional tactics, general or special education background, etc.) and student response should be addressed. In addition, the instructional setting (classroom, small-group, individual tutorial, etc., and combinations of these) and teacher-pupil ratios must be specified and incorporated into any analysis of the effects of RTI models.

•  Assessment of implementation fidelity

The benefits of RTI can be seriously undermined if the instructional program is not implemented as required. Studies should incorporate measures of treatment fidelity to identify potential mediating or confounding variables in their analyses. For longitudinal studies, these measures must be sensitive to program effects and include measures of teacher consistency and experience with the program, curriculum, and instructional approach. For studies using multiple comparison and/or control groups, measures describing the instruction must be included in the study design and/or data analysis plan to ensure that any differences in child outcomes between experimental groups and control groups are attributable to the instruction, and take into consideration the possibility of unintended spill-over effects across study groups.

•  Longitudinal studies of RTI

Recent studies have demonstrated that the implementation of RTI models can prevent reading failure and have suggested that RTI is a legitimate candidate for continued study to determine diagnostic utility. At the same time, there are no converging data that indicate whether initial positive responses to instruction are maintained over time. It is critical that RTI studies be cast within a longitudinal framework to identify individual differences in long term outcomes of the treatment and to identify the child, program, and fidelity characteristics that best predict which children will require subsequent supplemental instruction to maintain gains.

Basic and Applied Research in the Development of Proficiency in Reading Fluency, Reading Comprehension (to include vocabulary develoment), and Written Expression

Background

From a basic science perspective there continues to be a lack of converging evidence and consensus on the genetic, neurobiological, cognitive, and environmental factors related to the phenotypic expression of different types of LDs. While significant progress has been made in identifying some etiological factors related to deficits in basic (alphabetic) reading skills (e.g., phonemic awareness, phonics), additional questions remain. For example, what specific unidirectional and/or bidirectional relationships exist between word level skills and other critical componential reading skills? This is primarily because little is known about the etiologies, developmental courses, and diagnostic characteristics of children with LD who display primary deficits in reading fluency, vocabulary, reading comprehension, and written expression.

Therefore, there is a significant need to initiate studies to (a) identify critical etiological factors (neurobiological, genetic, cognitive, linguistic, social, emotional behavioral, environmental) that alone, or in combination, influence the development of reading fluency, vocabulary, reading comprehension, and written expression, (b) map the developmental course of skill and concept acquisition in these domains, (c) determine how proficiency or deficiency in each component reading skill (e.g., basic reading skills, reading fluency, vocabulary, reading comprehension, written expression) is influenced by or influences development in all other domains, and (d) identify relationships among etiological characteristics and comorbidities among reading and writing deficits, as well as other disorders, that mediate response to treatment.

In order to address these research needs, studies beginning at various phases of development of reading fluency, vocabulary, reading comprehension, and written expression are appropriate. Longitudinal and cross-sectional investigations beginning in the preschool period, the early grades, or middle school grades and/or the use of multiple cohorts to examine development in one or more of these age ranges are encouraged. The bi-directional role of component abilities in the development of alphabetic skills, reading fluency, reading comprehension, and written expression, and how these are best learned, must be more clearly understood in order to design, implement, and test the effectiveness of treatment protocols.

The research needs identified below are examples of research directions and topics that applicants should consider when developing their responses to this solicitation. The examples provided are not exhaustive but are offered as illustrations.

•  Prevalence of LDs in reading fluency, reading comprehension, and written expression

Prospective longitudinal epidemiological studies are needed to estimate the true prevalence of LDs in reading fluency, vocabulary and other oral language abilities, reading comprehension, and written expression, whether alone or in combination with other LDs and developmental disorders (disorders of attention, genetic disorders, neurodevelopmental disorders, etc.). Studies should identify linkages between LDs in reading fluency, vocabulary, reading comprehension, and written expression, and sociocultural, economic, and demographic factors, as well as in basic reading skills. Of particular importance are the effects of disadvantage/poverty on the failure to develop proficiency in reading and written language domains, and the identification of risk and protective factors within these contexts. The proportion of females to males affected has not been sufficiently examined. It is not clear whether there is a gender-based difference in the prevalence of LDs in reading fluency, reading comprehension, and/or written expression. With respect to severity of expression of deficits in these domains, comorbidities, behavior in the home and/or classroom, and parent and/or teacher expectations should be addressed explicitly.

•  Neurobiology (neuroanatomy, neurophysiology, neuroimagin)

Basic research on the neurobiological underpinnings of reading fluency, vocabulary development, reading comprehension, and written expression are critically needed. Likewise, additional neurobiological studies of word level reading processes as they relate to the development of reading fluency, vocabulary, reading comprehension, and written expression are important. Given substantial advances in neuroimaging capabilities, the timing is excellent to use imaging modalities to clarify the relationships between brain structure/function and the acquisition of reading fluency, vocabulary, reading comprehension, and written expression strategies and skills. Recent advances in the application of functional neuroimaging modalities (e.g., fMRI, MEG) have indicated that neural activation patterns differ significantly between children with word level reading disabilities and normal readers. Additionally, data now exist demonstrating that both improvements in alphabetic reading behaviors and neural activation are linked to the effectiveness of well-defined instructional protocols. The degree to which these neuroimaging capabilities and combined neuroimaging-instruction designs can adduce new knowledge relevant to brain-behavior relationships in reading fluency, vocabulary, reading comprehension, and written expression should be studied. Imaging studies that use a variety of imaging modalities (e.g., MRI, fMRI, MEG, MRS, Diffusion Tensor Imaging) to develop convergent evidence are encouraged.

•  Genetics of alphabetic reading skills, reading fluency, vocabulary, reading comprehension, and written expression

While there is extremely limited evidence regarding the genetic substrates of reading fluency, vocabulary, reading comprehension, and written expression, future research efforts in these areas can build on lessons learned and methods developed in the study of word level reading skills. For example, 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 selected language and word level reading abilities. 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 on the development of reading fluency, vocabulary, reading comprehension, and written expression.

Some molecular genetic studies have provided preliminary evidence that selected word level reading skills can be linked to specific chromosomal regions. Because these findings have not been sufficiently replicated, there is a significant need to continue these and additional molecular genetic studies, and to continue to develop new techniques and strategies to identify specific relationships between genotype and phenotypic expression of different types of LDs. For the purpose of this RFA, studies that combine both behavior genetic and molecular studies of oral language components related to reading and writing, reading and reading-related skills, and written expression skills are encouraged. It is noted that studies involving reading fluency, vocabulary, and reading comprehension are of highest priority.

Section II. Award Information


1. Mechanism(s) of Support


This funding opportunity will use the NIH Specialized Research Center (P50) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project .

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions. A detailed categorical budget for the “Initial Budget Period “ and the “Entire Proposed Period of Support” is to be submitted with the application.

2. Funds Available

The NICHD intends to commit approximately $6.2 million dollars in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2005 to fund four to five new and/or competing continuation grants in response to this RFA. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html . An applicant may request a project period of up to five years and budget for direct cost of up to $1.2 million dollars per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NICHD provides 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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

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

2. Cost Sharing
There are no requirements for cost sharing, matching, or cost participation for eligibility

3. Other-Special Eligibility Criteria

Annual Meetings for Investigators

Principal Investigators (PIs) of the Centers funded through this RFA will be expected to attend one meeting per year to share common concerns, common research opportunities, measurement and research design strategies, as well as methods and approaches to data collection and analysis. PIs will be encouraged to establish, where possible, common measurement protocols to maximize the systematic collection of converging data across Centers. PIs from currently funded research projects within the NICHD Reading Research Network will also attend these meetings to build collaborative relationships across a wide range of scientists and scientific interests. The first meeting is expected to take place in June 2006 to identify common concerns and to discuss core instrumentation and replication strategies. Provision for funds for travel to these meetings, which will be held in the Washington, D.C. area, should be included in the application budget request.

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 activities and operations. For the purpose of this RFA, applicants should propose an External Advisory Board to provide objective outside counsel and periodic review of the Research Center's activities and progress. Applicants are not to contact or select 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 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. Provisions for costs of the Advisory Board are to be included in the application budget request and justification.

Section IV. Application Submission Instructions


1. Address to Request Application Information


The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov .

Telecommunications for the hearing impaired: TTY 301-451-5936.


2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/ . The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See Subsection VI.2 Administrative Requirements for additional information.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates

Applications must be mailed on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates

Letters Of Intent Receipt Date(s): February 11, 2005
Application Receipt Dates(s): March 11, 2005
Peer Review Date(s): June/July 2005
Council Review Date(s) : September 2005
Earliest Anticipated Start Date: December 1, 2005


3.A.1. Letter of Intent

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

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:


G. Reid Lyon, 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
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-9849
FAX: (301) 480-0230
Email: rl60a@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

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

Using the RFA Label: The RFA label available in the PHS 398 application instructions 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 .

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.


4. Intergovernmental Review

This initiative is not subject to intergovernmental review .

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3. Award Criteria).

6. Other Submission Requirements

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing . All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131 . Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the data sharing plan and the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.


Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NICHD . Incomplete and/or nonresponsive applications will not be reviewed.

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 NICHD in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

3. Merit Review Criteria

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5 . Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Individual Cores

(a) qualifications, experience, and commitment of the core director and other core personnel;

(b) the quality of services to be provided, (c) the cost effectiveness and quality control of the core, and (d) the utility of the core(s) to the research center.

Administrative Core

(a) the core director's experience in research administration;

(b) the decision-making process within the proposed center for the evaluation of research productivity, allocation of funds, and management of resources;

(c) the plan for center evaluation, including the use of any internal and external advisory boards.

Research Center as an Integrated Effort and the Overall Merit of the Center

(a) the coordination, interrelationships, cohesiveness, and synergy among the research projects and core components as they relate to the common theme of the center;

(b) the multidisciplinary scope of the center's research program;

(c) the advantages of conducting the proposed research as a program rather than through separate research efforts;

(d) the mechanisms proposed for regular communication and coordination among investigators and the center; and

(e) the appropriateness of the administrative structures and day-to-day management of the center, including arrangements for internal quality control of ongoing research.     

Protection of Human Subjects from Research Risk : The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

3.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

3.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing

3.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps and http://www.ott.nih.gov/policy/rt_guide_final.html . Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

Section VI. Award Administration Information


1. Award Notices


After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a summary statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm

A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via e-mail notification from the awarding component, NICHD, to the grantee business official (designated in Item 14 on the Application Face Page). If a grantee is not e-mail enabled, a hard copy of the Notice of Grant Award will be mailed to the business official.      

2. Administrative Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm .

3. Award Criteria

The following will be considered in making funding decisions:

4. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually:
http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts



1. Scientific/Research Contacts:

G. Reid Lyon, 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
Rockville, MD 20852 (for express/courier service)
FAX: (301) 402-0230
Email: rl60a@nih.gov


2. Peer Review Contacts:

Robert Stretch, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: stretchr@mail.nih.gov


3. Financial or Grants Management Contacts:

Angelos Bacas
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435- 6976
FAX: (301) 451-5510
Email: ab329b@nih.gov


Section VIII. Other Information

Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm .

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity, and dose-finding studies (phase I); efficacy studies (Phase II) efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html ).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing ).

Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html ); a complete copy of the updated Guidelines is 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

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 applications for research involving human subjects and individuals designated as key personnel. The policy is available 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.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/ ) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html .

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 PA 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm .

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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