MATHEMATICS COGNITION AND SPECIFIC LEARNING DISABILITIES RELEASE DATE: December 12, 2002 RFA: HD-02-031 (Reissued as RFA-HD-07-005) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) Department of Education (DoED) (http://www.ed.gov/) LETTER OF INTENT RECEIPT DATE: February 28, 2003 APPLICATION RECEIPT DATE: March 28, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Child Health and Human Development (NICHD), in partnership with the Office of Special Education and Rehabilitation Services (OSERS), U.S. Department of Education, invites innovative research grant applications designed to contribute new knowledge in the area of mathematical cognition and learning, with a focus on: (1) normal development of mathematical proficiency (e.g., in basic calculation skills, mathematical conceptual understanding, comprehension, reasoning, procedural fluency, and strategic competence); (2) individual differences that moderate the development of mathematical proficiency (e.g., gender, ethnic or cultural factors, socio-economic status, personality, cognitive style); (3) specific learning disabilities in mathematics, including definitional elements, classification, epidemiology, preventive strategies, early intervention, etiology, diagnosis, and treatment; and (4) combinations and relationships among these. The topical domains of interest under the rubric of mathematical learning include, but are not limited to, basic calculation skills, mathematical conceptual understanding, comprehension, reasoning, procedural fluency, and strategic competence. Of particular importance for this RFA is the discovery of cognitive, perceptual, behavioral, genetic, hormonal, and neurobiological mechanisms that are influential in the expression of learning abilities, individual difference factors, and specific learning disabilities in mathematics, as well as predictors of success and failure, along with the development of preventive and treatment approaches to ameliorate specific learning disabilities in mathematics. This RFA will result in grants supporting multidisciplinary, integrated, coordinated programs of research (P01) and individual, possibly multi-site, multidisciplinary research project grants (R01). The funded investigators will become part of a Mathematics Learning and Specific Learning Disabilities Research Network. RESEARCH OBJECTIVES Background The National Institute of Child Health and Human Development (NICHD), NIH, has had a long-standing interest in the study of individual differences in learning and specific learning disabilities. Several recent national and international reports have called attention to the poor achievement record of our nation's children in the area of mathematics. The 1996 National Assessment of Educational Progress (NAEP) revealed that approximately 35 percent of U.S. children in grades 4, 8, and 12 scored below the basic level in mathematics, and only about 45 percent scored at the basic level; the basic level is taken as indicating partial mastery of the knowledge and skills considered fundamental to mathematics proficiency. The NAEP proficiency level indicates that students have the capability of completing challenging subject matter and are well prepared for the next level of schooling; only 21 percent of fourth graders and 24 percent of eighth graders scored at the proficient level. Students whose math achievement is low are disproportionately African American, Hispanic, Native American, and those in urban or rural school districts. While NAEP long-term trend data do indicate progress in the overall proficiency of U.S. students over the past three decades, the gap between African American and Caucasian students has widened in the 1990s, and this disparity does not appear to be wholly attributable to poverty or disadvantage. In the Third International Mathematics and Science Study (TIMSS) (http://nces.ed.gov/timss/), conducted by the National Center for Educational Statistics in cooperation with the National Science Foundation and international partners in 1994-1995 and published in 1995, there were some troublesome findings. U.S. students scored above the international average in both mathematics and science at the fourth-grade level. However, at the eighth-grade level, U.S. students performed below the international average, and in 12th grade, U.S. performance was among the lowest. The TIMSS-R (Repeat) conducted in 1999-2000 assessed only eighth graders. The results showed that U.S. children had moved from being similar to the international average in fourth grade in 1995 to being significantly below it in eighth grade in 1999. Although educational research has provided some important insights into student learning, teacher development, and teaching strategies and technologies that enhance achievement in mathematics, the research has lacked a convergent knowledge base that can support systemic reform. The limited use of educational research and development (R & D) for improving practice can be attributed in large part to under-investment in R & D and the consequent fragmentation of the current research effort in reading, mathematics, and science (see the 1999 National Research Council Report, "How People Learn: Bridging Research and Practice," http://www.nap.edu). Two recent national reports call for heightened research attention to the area of mathematics learning and learning difficulties. In 2001, the National Research Council (NRC) of the National Academy of Sciences published "Adding It Up: Helping Children Learn Mathematics." Comparing remediation in mathematics to that in reading, the NRC committee pointed out that there are few supplementary interventions and there is little targeted enrichment in mathematics that can help students overcome specific difficulties. The committee also emphasized the crucial importance of school-based instruction for math, given that children are likely to spend little voluntary time exercising math skills outside the classroom. In March 2002, the Rand Mathematics Study Panel, supported by the Office of Educational Research and Improvement (OERI), U.S. Department of Education, distributed a draft report for comment. This report, "Mathematical Proficiency for All Students: Toward a Strategic Research and Development Program in Mathematics Education," also emphasized the need for substantial research to develop an empirical base of evidence upon which new interventions can be based, and for research on their effectiveness once new interventions are designed and implemented. The Rand report cites previous research efforts in mathematics as fragmented, disconnected from problems of practice, and non-cumulative. In a call for well-conceived interventions, the report states that efforts at improving math education often proceed without adequate evidence and independent of theory about promising courses of action. Both the NRC and Rand reports emphasize the importance of a more comprehensive view of mathematics learning. Specific learning disabilities now account for more than half of all students enrolled in special education, an increase of 22 percent over the past 25 years. In the past decade, the number of students ages six to 21 years identified with specific learning disabilities has increased by 38 percent. At the same time, efforts at remediation are not effective for most children. There appear to be several reasons for this dramatic increase in students placed in, and remaining in, special education: the identification of students with specific learning disabilities is a highly subjective process that differs from state to state or school district to school district, and there are no uniform assessment procedures to determine what constitutes a specific learning disability or a specific learning disability in mathematics. Students are generally identified only after a period of two to three years of school failure, although we know that the remediation of most learning difficulties is more challenging at later ages; and many teachers are not prepared to address the individual needs of students with specific learning disabilities. Further, we do not have the assessment tools or procedures in place for early identification of children at risk for or suffering from specific learning disabilities, nor do we have the necessary information about specific learning capabilities and disabilities in mathematics, to design and tailor interventions for children who are experiencing learning difficulties. Much of current controversy over math instruction revolves around the timing and sequence of instruction on basic arithmetic operations and more complex, abstract mathematical and algebraic concepts. Algebra is fundamental to math learning, enabling one to represent quantities and relationships, model situations, solve problems, and state and prove generalizations. Algebra offers procedures and terminology for use in learning other areas of math. U.S. school children learn to count, add, subtract, multiply, and divide, first with whole numbers and then with decimals and fractions. They use numbers to measure length, area, and volume of geometric shapes. Algebraic concepts and procedures help them understand the systematicity within number systems, yet we often do not begin to teach children algebraic concepts until quite late in their schooling, and this knowledge is often not linked to or integrated with other areas of mathematics. While there is insufficient research to fully characterize how children learn in all areas of mathematics, the complex, abstract aspects of conceptualization of mathematical relationships have been even more neglected than the learning and teaching of basic numerical skills and arithmetic calculations. There is a clear need for both basic and intervention research on the normal development of mathematical proficiency, individual differences in learning, and specific learning disabilities in mathematics. Research is needed to elucidate how students learn mathematics, that is, how they develop proficiency with the central concepts of arithmetic and algebra, measurement, geometry, descriptive statistics, and probability; why some children have difficulty mastering these concepts and their fluent use in solving mathematical problems both in the classroom and in daily life; and how we can identify and remediate those who have or are likely to have learning difficulties in developing mathematical proficiency. Research Scope Current knowledge related to how children develop mathematical proficiency, from the early preschool years through grade school and high school, is insufficient. Gaps in the extant knowledge base on how children develop mathematical proficiency require systematic research that must address various domains of math learning. Studies are needed that will map the developmental course of skill and concept acquisition in these domains, and will identify the optimal timing and sequence or integration of instruction in these domains. At the same time, there is a need to initiate studies of specific learning disabilities in mathematics, particularly as they relate to: (1) establishing reliable and valid definitions and classification systems that can differentiate specific learning disabilities in mathematics from other factors and conditions leading to underachievement in mathematics development; (2) designing reliable and valid measurement strategies and instruments to identify critical etiological factors (cognitive, linguistic, genetic, neurobiological, experiential) associated with impairments in mathematics; and (3) developing well-defined, evidence-based treatment interventions. 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. Likewise, neuroanatomical, neurophysiological, neuropsychological, and educational studies of development and disorders in executive function and social, nonverbal communication are critically needed in regard to the development of mathematical abilities, as well as the diagnosis, prevention, and remediation of specific learning disabilities in mathematics. Research Focus The research needs identified below are examples of research topics that applicants should consider when developing their responses to this solicitation. The examples provided are not an exhaustive list but are offered as illustrations. Basic Research in the Development of Mathematical Proficiency It is not clear how the learning of numerical concepts, the development of higher level problem-solving abilities, and language and memory abilities are interrelated in the development of mathematical proficiency. Longitudinal studies must be carried out to examine the differences in the growth trajectories of children with specific learning disabilities in math, low- achieving children, and normally achieving children. In addition, it would be useful to study the instructional and cultural practices that give rise to the identification and remediation of specific learning disabilities in math. Longitudinal studies of the development of mathematical proficiency are especially encouraged, beginning either in the preschool period or in the early grades. The roles of various component abilities in mathematical proficiency, and how these are best learned, must be understood in order to design, implement, and test the effectiveness of instructional approaches, both for instruction as part of a math curriculum and for intervention for specific learning disabilities in math. The Definition and Classification of Specific Learning Disabilities in Math Under the Regulations for the Individuals with Disabilities Education Act (IDEA, P.L. 105-17) a specific learning disability is defined as a disorder in one or more of the basic psychological processes involved in understanding or in using language, spoken or written, that may manifest itself in an imperfect ability to listen, think, speak, read, write, spell, or to do mathematical calculations, including conditions such as perceptual disabilities, brain injury, minimal brain dysfunction, dyslexia, and developmental aphasia. The term does not include learning problems that are primarily the result of visual, hearing, or motor disabilities, of mental retardation, of emotional disturbance, or of environmental, cultural, or economic disadvantage. A major prerequisite for studies concerning the definition and/or classification of specific learning disabilities in math pursuant to the present RFA is that they be carried out within a longitudinal developmental framework. It should also be noted that such studies do not need to adhere to a priori assumptions reflected in current definitions of specific learning disabilities. Additionally, the development of valid definitions requires that studies be conducted with representative groups of children over time and that they document, with robust measurements and measurement models, how individual differences among children emerge, change, respond to treatment, and influence further development. In the process of forming definitions, a critical emphasis should be placed on the identification of valid inclusion criteria. Moreover, any classification effort must be informed by a well- developed model that incorporates behavioral, environmental, neurobiological, genetic, and hormonal influences and their relationships. Finally, such efforts should be designed to identify and describe co-morbidities of specific learning disabilities in math with attentional problems, specific learning disabilities in reading, and specific genetic disorders affecting social, emotional, linguistic, and behavioral development. o Current exclusionary definitions and assessment techniques may be invalid if discrepancy criteria are used. For example, research has demonstrated that children with specific learning disabilities in reading, with and without a discrepancy between IQ and reading achievement, do not differ in information processing sub-skills (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 children with specific learning disabilities in reading, with and without IQ-achievement discrepancies, and recent intervention studies indicate that the presence and magnitude of the discrepancy between IQ and reading achievement does not predict response to treatment. Researchers have not yet explored whether discrepancies between IQ and achievement constitute valid markers in the area of mathematics, or whether discrepancies are worthwhile predictors of response to treatment/interventions in math domains. o Given the lack of success in remediation to date, it appears that specific learning disabilities in math may reflect a persistent deficit rather than a developmental lag in basic arithmetic skills, but the nature of this deficit is not yet understood. Studies are needed to determine whether there are definable subcategories of specific learning disabilities in math and, if so, what the most effective interventions might be for each. o Another important question is whether there are common cognitive/ neuropsychological origins for the difficulties with fact retrieval experienced by children who exhibit a co-morbidity of specific learning disabilities in math and reading. It is important to be able to distinguish between children with true disability in math and other low-achieving children who are delayed but do not have a core neuropsychological deficit. Prevalence of Specific Learning Disabilities in Math Longitudinal, epidemiological studies are needed to estimate the true prevalence of specific learning disabilities in math, whether alone or as a comorbid condition with other specific learning disabilities. Such studies should identify linkages between specific learning disability in math, and sociocultural, economic, and demographic factors. Of particular import are the effects of poverty on the failure to develop mathematical proficiency, and the identification of risk and protective factors within these contexts. The proportion of females to males affected has not been well investigated. It is not clear whether there is a gender-based difference in the prevalence of math difficulties and, if so, what the basis for such a difference might be. While there is some suggestion that specific learning disabilities, most specifically those in reading, follow family lines, there is less specific evidence of a genetic component of specific learning disabilities in math. Questions related to severity, classroom behavior, teacher expectations and perceptions, and the influence of co-morbidities need to be addressed explicitly. Genetics of Specific Learning Disabilities in Math o While there is currently a paucity of evidence regarding the genetic substrates of specific learning disabilities in math, future research efforts in this area can build on lessons learned and methods developed in the study of specific learning disabilities in reading. 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 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 specific learning disabilities in mathematics is strongly encouraged. o Some data suggest that at least one type of a specific learning disability in reading 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, and 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. Neurobiology (Neuroanatomy, Neurophysiology, Neuroimaging) Basic research on the neurobiological underpinnings of math cognition is needed. Given advances in neuroimaging technology, the timing is excellent to use these tools to clarify the relationships between brain structure/function and the acquisition of mathematical strategies and skills. Just as it has in the area of reading, the combination of functional neuroimaging and behavioral studies can help us examine the neural substrates of specific learning disabilities in math. Recent advances in the application of functional neuroimaging modalities (e.g., fMRI) have indicated that neural activation patterns differ significantly between children with specific learning disabilities in reading and normal readers. Ideally, convergent evidence will be gathered using any of a number of neuroimaging modalities (e.g., MRI, fMRI, MEG, MRS, Diffusion Tensor Imaging) and dependent measures to assess the neural organization of cognitive and linguistic skills critical to mathematics. In addition, studies designed to delineate the neural substrates and changes necessary for the development of automaticity, procedural fluency, and mathematical proficiency/expertise are critically needed. Given the findings of "neural signatures" for skilled reading and for specific learning disabilities in reading, it will be important to determine whether such neural signatures for mathematical abilities and disabilities can be found. 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 for the area of mathematics 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. MECHANISM OF SUPPORT This RFA will use the NIH Research Project Grant (R01) and Program Project Grant (P01) award mechanisms. The R01 mechanism supports a focused research project conducted by one Principal Investigator, with or without collaborators. If an application proposes a single, albeit large, multi-site project, it should be submitted as an R01. In contrast, the P01 mechanism supports a broadly based, coordinated, collaborative, multi-disciplinary research program that has a well-defined central theme, research focus, or objective. A P01 application must include at least three separate, but interrelated projects and usually at least one core resource. Synergy among the component research projects comprising the P01 should result in greater scientific contributions than if each project were supported through separate R01 grants. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 2003. For R01 applications, this RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an R01 application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. For P01 applications, you must follow the instructions available in the NICHD Program Project (P01) Guidelines at: http://www.nichd.nih.gov/funding/mechanism/p01_guide.cfm. Any applicant considering applying for a program project grant is strongly encouraged to communicate with the program contact listed below under WHERE TO SEND INQUIRIES prior to submitting an application. FUNDS AVAILABLE The participating ICs and agencies intend to commit approximately $4 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2003 to fund three to five new grants in response to this RFA: NICHD, $3 million; and ED, up to $1 million. An applicant may request a project period of up to five years and a budget for direct costs of up to $500,000 for the R01 or up to $1 million for the P01. Although the financial plans of the NICHD and Department of Education provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any established researcher with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Meeting for Investigators Principal Investigators of projects funded through this RFA will be expected to attend one meeting to share research designs and proposed measurement strategies, as well as methods and approaches to data collection and analysis, and to establish, where possible, core instrumentation intended to maximize the systematic collection of converging data across projects. Requests 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. Application Considerations 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 specific learning disabilities in mathematics, alone or in combination with one or more of several domains to include oral language, basic reading skills, reading comprehension, and written expression, 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 children with specific learning disabilities of different ages, ranging across the elementary and middle school age-spans, also should be considered, but such studies must be related meaningfully to the questions being asked within the longitudinal studies. Children selected for study likely will vary across cultural, familial, ethnic, racial, economic, and other demographic characteristics that could influence development. There likely will be subgroups and subtypes of children with significantly different patterns of demographic characteristics, academic deficits, different patterns of co-morbidity, 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 children with specific learning disabilities of varying demographic characteristics, intellectual abilities, with primary deficits in mathematics 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" children with specific learning disabilities is clearly discouraged unless the demographic and diagnostic characteristics in these cases also 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 specific 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, and appropriateness for the samples under study. If reliability and validity 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 of sufficient data prior to, during, and following the instructional/treatment study to allow for estimation of change over time. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Daniel B. Berch, Ph.D. Child Development and Behavior Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-0699 Fax: (301) 480-0230 Email: firstname.lastname@example.org Tom V. Hanley, Ed.D. Office of Special Education and Rehabilitation Services U.S. Department of Education Switzer Building, Room 3526 330 C Street, SW Washington, DC 20202-2461 Telephone: (202) 205-8110 Fax: (202) 205-8105 Email: Tom.Hanley@ed.gov o Direct your questions about peer review issues 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 Telephone: (301) 496-1485 Fax: (301) 402-4104 Email: email@example.com o Direct your questions about financial or grants management matters to: Dianna Bailey Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6978 Fax: (301) 402-0915 Email: firstname.lastname@example.org LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Daniel B. Berch, Ph.D. Child Development and Behavior Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-0699 Fax: (301) 480-0230 Email: email@example.com SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, E-mail: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at https://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NICHD and the Department of Education. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score. o Receive a second level review by the National Advisory Child Health and Human Development Council. REVIEW CRITERIA FOR R01 APPLICATIONS The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator 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 (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. REVIEW CRITERIA FOR PROGRAM PROJECTS (P01) Peer review of scientific and technical merit focuses on three areas: (1) review of the individual component projects; (2) review of the individual cores; and (3) review of the program as an integrated effort and the overall merit of the program. P01 applications submitted in response to this RFA will be evaluated according to the review criteria described in the NICHD P01 Guidelines, available from the contacts listed under WHERE TO SEND INQUIRIES, above, and at http://www.nichd.nih.gov/funding/mechanism/p01_guide.cfm. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 28, 2003 Application Receipt Date: March 28, 2003 Peer Review Date: July 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 2003 AWARD CRITERIA Criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at https://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance Nos. 93.865 and 84.324 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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