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.

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