RFA-HD-99-012: DEVELOPMENT OF ENGLISH LITERACY IN SPANISH-SPEAKING CHILDREN

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

DEVELOPMENT OF ENGLISH LITERACY IN SPANISH-SPEAKING CHILDREN Release Date: July 20, 1999 RFA: HD-99-012 National Institute of Child Health and Human Development Office of Educational Research and Improvement Letter of Intent Receipt Date: September 1, 1999 Application Receipt Date: November 17, 1999 THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The National Institute of Child Health and Human Development (NICHD), through the Child Development and Behavior Branch (CHDB), Center for Research for Mothers and Children (CRMC), and the Department of Education, through the Office of Educational Research and Improvement (OERI), invite research grant applications to develop new knowledge relevant to the critical factors that influence the development of English-language (denoted L2) literacy (reading and writing) competencies among children whose first language is Spanish (denoted L1). Specifically, NICHD and OERI seek to stimulate systematic, programmatic, multidisciplinary research to increase understanding of the specific cognitive, sociocultural and instructional factors, and the complex interactions among these factors, that promote or impede the acquisition of English reading and writing abilities for Spanish-speaking children. It is expected that the research studies and programs stimulated by this initiative will contribute scientific data that bear directly on a number of public policy issues and instructional practices that include, but are not limited to, these overarching questions: Are there conditions under which English language literacy skills (reading and writing) are best acquired after oral language, reading and writing capabilities are first developed in Spanish? If so, when and how is the transition from Spanish to English best accomplished? On the other hand, are there conditions under which Spanish-speaking children best acquire English language literacy skills through immersion in English oral and written language? Additionally, are there specific linguistic and cultural advantages that accrue with instructional approaches that develop oral language and literacy skills in both Spanish and English simultaneously (dual language-literacy approaches)? This collaborative project is being undertaken by the Department of Education pursuant to the joint funding authority in 20 USC Section 1231. 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 priorities. This Request for Applications (RFA), English-Language Literacy Development in Spanish-Speaking Children, is related to several priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, local education agencies, and eligible agencies of the Federal government, i.e., those Federal agencies that have the express statutory authority to accept grants from another Federal agency. Foreign institutions are not eligible to apply for these grants. However, for the purposes of this RFA, applications from institutions in the United States may propose collaborations with foreign institutions/ scientists. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISMS OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01) mechanism, the NICHD Small Grant (R03) mechanism and the program project grant (P01) mechanism. A range of funding mechanisms is being made available to applicants to accommodate the complex and multivariate nature of the research to be supported. o Individual Research Project Grants (R01) The R01 mechanism is used to fund a discrete, specified, and circumscribed project that ranges in initial length from two to five years. o Small Grants (R03) The R03 mechanism typically is used to support new projects of relatively small size and length ($50,000 direct costs for each of two years, $100,000 total direct costs). The R03 cannot be used to supplement research projects already being supported or to provide interim support of projects under review, nor are simultaneous submissions of both small (R03) and regular (R01) research grant applications allowed. In the main, the R03 is used to support the development of pilot/preliminary data or to fine-tune methodological procedures to ensure that measurement and data analytic strategies and instruments are ready for application in larger scale R01 or P01 studies. In addition, the R03 mechanism is employed to provide new investigators with support to develop pilot and preliminary data for the development of a program of research in a well-defined area. For the purposes of this initiative, the R03 will be employed for these purposes as they relate to developing pilot data, measurements, and methodologies to enable investigators to pursue research questions relevant to the development of English-language literacy skills among Spanish-speaking children. Potential applicants may obtain the program announcement that describes the NICHD R03 research program at http://grants.nih.gov/grants/guide/pa-files/PAR-99-126.html. Specific application instructions for the R01 and R03 mechanisms have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. o Program Project Grants (P01) In contrast to applicants submitting an individual research project grant application (R01, R03), other applicants may be interested in conducting collaborative multidisciplinary and even multi-site studies that involve expertise in a number of disciplines, and that address research questions and hypotheses that require the integration of multiple methodologies and variables. The P01 supports a broadly based, long-term (at least three years, but typically five years), multidisciplinary research program that has a well- defined central theme and research focus. The P01 mechanism supports at least three interrelated projects and core resources that support at least three projects at all times. Inter-relationships and synergism among component research projects should result in greater scientific contributions than if each project were supported through a separate mechanism like the R01. The P01 research effort is facilitated by the sharing of ideas, data, and specialized resources, such as equipment, services, and clinical facilities. An essential requirement is a central theme toward which the total scientific effort is directed and to which each component project relates in a synergistic manner. Certainly, each of the component projects must have outstanding scientific merit individually, but they also must complement one another and support the program"s overall theme. Potential applicants may obtain a copy of the NICHD guidelines for P01 grants at http://www.nih.gov/nichd/docs/po1_guidelines_final.htm. For all mechanisms, responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for R01 and P01 applications submitted in response to this RFA may not exceed five years, R03 projects may not exceed two years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated date of award is July 1, 2000. FUNDS AVAILABLE Subject to the availability of funds, the NICHD and the OERI each intend to commit approximately $4.5 million (total costs) to fund new grants in response to this RFA in FY 2000. An applicant for the P01 may request a project period of up to five years and a budget for direct costs of up to $1 million per year. An applicant for the R01 may request a project period of up to five years and a budget for direct costs of up to $300,000 per year. An applicant for the R03 may request a project period of up to two years and a budget for direct costs of $50,000 per year. Application instructions for the Small Grant (R03), reflecting MODULAR APPLICATION AND AWARD PROCEDURES, are described below. It is anticipated that three multidisciplinary program project grants (P01) and 10 to 15 individual research grants (R01, R03) will be awarded under this program. All awards will be made by the NICHD. Although the financial plans of the NICHD and OERI provide support for this program, awards pursuant to this RFA are contingent upon receipt of a sufficient number of applications of outstanding scientific and technical merit, and the availability of funds. RESEARCH OBJECTIVES Background In October, 1998, the NICHD, in collaboration with the Office of Bilingual Education and Minority Languages Affairs (OBEMLA) and the OERI within the Department of Education, convened a conference to discuss the state of science and practice in promoting English-language literacy development for Spanish- speaking children. Within this context, a working group of distinguished scientists in bilingual education, reading development and disorders, research methodology, and educational policy met to assess the current research base in the development of English-language literacy skills among children whose first language is Spanish, identify gaps in the knowledge base, and make recommendations to the NICHD and the OERI regarding promising areas for future research. On the basis of discussions at this conference, as well as data provided in two reports from the National Research Council entitled "Improving Schooling for Language-Minority Children" and "Educating Language-Minority Children," this working group reached consensus on a number of issues and made recommendations for research to better understand the development of English reading and writing skills among Spanish-speaking children. These conclusions and recommendations are summarized as follows: First, there is a compelling rationale and need for the development of a comprehensive program of research that can identify the full range of linguistic, cognitive, cultural, familial, socioeconomic, regional, and instructional factors, and the interactions among these factors, that are directly relevant to the development of English-language reading and writing abilities in Spanish-speaking, limited English-proficient students. Becoming literate in the English language is a complex developmental process that children living in the United States must negotiate successfully in order to compete effectively in this country. The complexity of this developmental process is exacerbated when the child"s primary language differs from the oral and written language he/she encounters in school, as is the case for many youngsters whose primary language is Spanish. It is it now estimated that 59 percent of fourth grade students and 51 percent of eighth grade students whose primary language is Spanish cannot read and comprehend English-language text materials at a basic level. Indeed, Hispanic and Latino children constitute the largest group of limited-English-proficient students in the U.S. and are approximately twice as likely as non-Hispanic and Caucasian students to read significantly below average for their age. No doubt, contributing to this trend are the small number of Hispanic children enrolled in Head Start programs, the significantly low enrollment of Hispanic children in high quality, language-rich center-based child care programs, and the increasing number of very poor Hispanic families in Even Start. The complexity of understanding how language, cultural, and instructional factors influence English literacy development in Spanish-speaking children is compounded because these factors also interact in varying degrees with geographic and regional (urban vs. rural) location, immigrant status, migrant status, socioeconomic status, generation status of both children and parents, the quality of the child"s oral language development in Spanish, motivational factors, the type, quality and amount of Spanish or English spoken in the home and reinforced in the neighborhood and community, the linguistic and cultural characteristics of the teacher, the nature of previous literacy instruction, and individual differences in cognitive, linguistic, and neurobiological development. Such complexity requires the development of a collaborative multidisciplinary, multi-level, and multi-contextual program of research. More specifically, this program of research should foster the application of diverse research methodologies across varied contexts to develop models of second-language literacy acquisition and to delineate the influences, and pathways of influence, on English-language literacy development in Spanish- speaking children at the child level, the home/family level, the classroom level, and the school level. While the development of normative models of English reading and writing acquisition in Spanish speaking children is strongly encouraged, an in-depth understanding of the factors and conditions that predict and characterize atypical English-language literacy development (i.e., learning disabilities, specific language deficits, dyslexia) in this population is also critical, as is the development of instructional strategies to prevent or remediate such disabilities. Against this background, a major goal of this research initiative is to obtain converging scientific evidence that ultimately can inform the development and application of assessment and instructional approaches and strategies to develop robust literacy skills and to prevent or remediate reading and writing difficulties and disabilities among children whose first language is Spanish. In essence, research grant applications are solicited to address three major questions: 1) How do children whose first language is Spanish learn to read and write in English? Specifically, what skills and abilities are required, what types of home, preschool, child care, school, and cultural experiences and environments are most supportive of English-language literacy development at different phases of development? 2) Why do some Spanish-speaking children have difficulties acquiring English- language reading and writing skills? What specific cognitive, linguistic, environmental, sociocultural, neurobiological, and instructional factors impede the development of accurate and fluent English-language reading and writing skills, and what are the most significant risk factors that predict difficulties in the development of literacy skills? 3) For which children whose first language is Spanish are which instructional approaches and strategies most beneficial, at which stages of reading and writing development, and under what conditions? Also, what teacher knowledge, teaching skills and instructional strategies are required to ensure optimal outcomes? The complex and multivariate nature of this research goal necessitates the use of both individual-investigator research studies (e.g., R01, R03) and integrated, multidisciplinary, and multi-site approaches involving expertise in a number of disciplines (e.g., P01). Also required is access to a sufficient number of Spanish-speaking children who will be expected to acquire English-language literacy abilities. The specific mechanisms of support are discussed in a separate section of the RFA. o Research in English-language Reading Development, Disorders, and Instruction: An Overview The NICHD and the OERI have had a long-standing interest in the study of reading development, reading disorders, and reading instruction with children whose primary language is English. Over the past 30 years, studies supported by the NICHD, OERI, and other agencies and sources have obtained substantial data that converge on the following findings with children for whom English is the primary language. Good readers have developed phonemic awareness and an understanding of the alphabetic principle, and can apply this knowledge in a fluent and automatic manner when reading words and text. Given the ability to rapidly and accurately decode and recognize words, good readers bring strong vocabularies and well-developed syntactical and grammatical skills to the reading comprehension process, and actively relate what is being read to their background knowledge. Evidence has also accrued that indicates learning to read is a relatively lengthy process that begins very early in development and before children enter formal schooling. Children who are provided with stimulating oral language and literacy experiences from birth onward have an advantage in developing vocabulary, understanding the goals of reading, and acquiring an awareness of print and literacy concepts. The data also suggest that children who are read to frequently at very young ages are exposed to the sounds of the language and to vocabulary which will serve as the building blocks for the development of the alphabetic principle. As children are exposed to literacy activities at young ages, they begin to recognize and discriminate letters and begin to link the names of letters with their sounds. The data converge in demonstrating that ultimately, children"s ability to comprehend what they read is inextricably linked to their skill in reading words accurately and rapidly, to the development of vocabulary and language comprehension abilities, and to their background knowledge. In contrast, converging evidence indicates that reading failure among English-speaking children is significantly related to deficits in phoneme awareness and the development of the alphabetic principle, difficulties in the rapid application of phoneme awareness, decoding, and word recognition skills when reading connected text, a non-strategic approach to reading comprehension, and the failure to develop and maintain motivation to learn and practice reading skills. To date, there have not been comprehensive programmatic research efforts of this kind to address issues and questions relevant to (1) normative English- language reading and writing development among Spanish-speaking children, (2) difficulties/disabilities encountered by this population in learning to read and write in a second language (English), and (3) the development of effective prevention, remediation, and reading and writing instructional approaches and strategies for Spanish-speaking, English-language learners. To address this critical need, studies that contribute effectively to the research focus described below are encouraged. Research Focus The major focus of this RFA is to identify the conditions under which English- language reading and writing skills are most efficiently and productively developed in children whose first language is Spanish. Within this context, this collaborative NICHD/OERI research program seeks to increase understanding of the specific instructional, linguistic, cognitive, sociocultural and socioenvironmental factors, and the interactions among these factors, that promote or impede the acquisition of English-language reading and writing skills in Spanish-speaking children. An additional important focus of this RFA is the identification and/or development of reliable and valid measurement strategies and assessment instruments for all domains under study. Descriptive and experimental studies employing quantitative and qualitative research methodologies are encouraged, and studies that combine methodologies are particularly sought. While longitudinal designs will be critical in addressing many of the research questions, cross-sectional studies and combinations of longitudinal and cross-sectional studies are likewise encouraged. It is not expected that each application will address the entire range of issues discussed in this RFA, although multidisciplinary program projects (P01) will clearly address a combination of research targets using an integrated and synergistic design. On the other hand, individual research project grants (R01 and R03) can focus primarily on highly delineated research targets that do not necessarily require multidisciplinary expertise. As mentioned, a significant emphasis is placed on studies of the effects of different prevention, intervention, and instructional approaches and strategies at different phases of oral language and reading development in both Spanish and English. Irrespective of the type of funding mechanism (P01, R01, R03) selected by prospective investigators, each applicant should take care to ensure that the application addresses in depth the following methodological and organizational issues: o Research Population The selection of the research population should be based on the scope of the study, the methodological requirements of the study, the specific research questions posed and the nature and degree of integrated multidisciplinary effort. For both P01 and R01 funding mechanisms, applicants are encouraged to select a core research population that provides the opportunity to conduct integrated, prospective, longitudinal as well as cross-sectional investigations of reading and writing development in Spanish and English with an emphasis on the conditions under which literacy skills are best acquired and the instructional, linguistic, cognitive, sociocultural, socioenvironmental, and familial factors that influence development. It is expected that children within the research population will manifest different background characteristics and different strengths and weaknesses in skills critical for success on both Spanish and English reading and writing development. As such, applicants should consider research protocols that are capable of detecting individual differences and well-defined subgroups and subtypes that may exist within any sample. Applicants should also consider casting the sampling net wide enough to ensure a representative number of children and contrast groups for study at preschool, kindergarten, and elementary school-age levels. o Subject Selection Criteria The samples selected for study must be rigorously defined so that complete independent replication can be accomplished. Within this context, applicants should provide clearly documented and operationalized definitions for their subject selection criteria. Specifically, all participants selected for study should be defined with reference to age, grade level (if applicable), gender, ethnicity, socioeconomic status, immigrant/migrant status, generation status (of children and parents), geographic region, previous and concurrent educational placements and programs, type and severity of learning/language/academic disabilities (if known), neurophysiological/neuropsychological characteristics (if applicable), levels of academic achievement in oral language, reading, and writing, and presence of attention deficit disorder (if applicable). To the extent possible, comparison groups should be equated on these characteristics. o Measurement Criteria Standardized tests, laboratory tasks, observational measures, interview schedules, and other assessment/observational procedures (e.g., dynamic assessments, case studies, ethnographic studies) should be selected on the basis of known reliability, validity, trustworthiness, and appropriateness to 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 will be critical to much of the research solicited via this RFA since the study of the developmental course of both Spanish-language and English-language reading and writing acquisition under a variety of conditions and across a variety of settings is of significant interest. o Instructional Components and Definitions One important dimension along which reading and writing instructional approaches and strategies are distributed is the explicitness and detail with which spoken and written language structures relevant to literacy acquisition are taught. For the purposes of this RFA, the degree of implicitness- explicitness inherent in the instruction should be described in detail. For example, explicit instruction of language and literacy structures can be characterized by (1) deliberate organization of lesson format and content, (2) calibration of concept difficulty along both linguistic and developmental continua, (3) corrective feedback designed to foster linguistic insight and self-reliance in the child, (4) careful selection of textual reading material for practice, and (5) conscious interplay between spoken and written language during instruction. Another dimension along which reading instruction is distributed is the extent to which all components of a complete, integrated approach are included in each lesson, regardless of the student"s reading level. Integration is one of the most important principles of instruction to emerge from reading research, yet instructional studies frequently overemphasize one instructional component to the detriment of others. An example of this lack of integration can be found in several English-language reading instruction studies where instruction was provided to develop phonemic awareness and decoding skills without concomitant attention given to the application of these skills in text reading. Even when integrated lesson designs are used, applicants should consider designing studies to specifically demonstrate which instructional components are most pivotal in learning to read Spanish (if applicable) and English at different phases of reading development, and to explicate any interactions between response to instruction and learner characteristics, language of instruction, stage of reading development, teacher/learner activities, ecological factors, and the like. These examples of instructional dimensions are neither inclusive nor exhaustive, and applicants are encouraged to provide and define their particular frame of instructional reference in detail. The important consideration is that most instructional characteristics vary dimensionally from highly explicit to highly implicit, and applicants are encouraged to define and describe these instructional dimensions in detail. Likewise, applicants are encouraged to explicitly define and describe the types and nature of language, literacy, and learning interactions that occur in home and family settings during early childhood and preschool periods. o Research Methodologies New statistical methodologies are currently emerging to enhance the information gleaned from longitudinal studies and to bolster the interpretation of multivariate interactions that are identified in studies of behavioral/learning changes over time. This is important given that it is sometimes difficult to interpret why and how gains were achieved in instructional studies. This interpretation problem is frequently related to both instructional and non-instructional factors (social, economic, cultural, environmental, familial, etc.) that can interact to influence response to intervention. A number of methodologies are now available for studying quantitative change and for studying the manner in which a variety of determinants, including instructional and ecological factors, influence rates and patterns of change over time. Applicants are encouraged to apply methodologies that can illuminate these types of multivariate interactions. Of significant interest is also the application of qualitative research methodologies to include open-ended interviews with students, teachers, parents, and administrators, teacher logs, stimulated recalls, student"s response journals, analysis of teacher"s daily plans, and videotaping and coding of instructional interactions. When considering the use of qualitative methods, applicants must ensure the trustworthiness and credibility of the data, the transferability of the data, the adequacy of the research process for testing theory, and the empirical grounding of the research findings. Applicants are encouraged to combine quantitative and qualitative methods to optimize the validity and applicability of the findings. Research Priorities and Examples of Research Questions The NICHD and the OERI have developed a list of research priorities and examples of research questions to illuminate areas of particular interest to these agencies. These examples are illustrative but not restrictive, nor are they inclusive or exhaustive. The information on research priorities and examples of research questions may be obtained from the contact listed under INQUIRIES, below, or at: http://www.nichd.nih.gov/RFA/hd-99-012/hd-99-012.htm. SPECIAL REQUIREMENTS o Annual Meetings for Investigators Principal Investigators from projects funded though this RFA will be expected to attend an annual NICHD/OERI meeting to share findings, research approaches, and core instrumentation. The first meeting is expected to take place in January 2001. Provision for funds for travel to this annual meeting should be included in the application budget and budget justification. o Advisory Boards Because of their complexity and size, program project (P01) grants require guidance and interaction with senior members of the scientific community not directly involved in the conduct of the research operations. Applicants for P01 grants should propose and design an External Advisory Board to provide outside counsel and periodic review for the program project. 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 notifications sent to program staff at NICHD and OERI. Provision for costs of the Advisory Board are to be included in the application budget and budget justification. Following the award of grants resulting from this RFA, a multidisciplinary advisory group composed of bilingual educators, early childhood educators, reading teachers, teacher educators, researchers, school administrators, and school policy specialists will be formed by NICHD, OERI, and all Principal Investigators to provide ongoing information and advice relevant to critical issues and trends in the field at large. 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 the 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," which was published in the Federal Register of March 28, 1994 (FR 59 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/1994/94.03.18/notice-nih-guideline008.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 Peggy McCardle, Ph.D., MPH, at the address listed under INQUIRIES by September 1, 1999. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used for applying for these grants (P01, R01, R03). 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: [email protected]. Applications for the R01 grant should be prepared according to the instructions accompanying Form PHS 398 (rev. 4/98), as modified by the Modular Grant instructions, below. Applications for the R03 grant should be prepared according to the instructions accompanying Form PHS 398 (rev. 4/98), as modified by the instructions below. Applications for the P01 grant should be prepared in a manner consistent with the information presented in the NICHD Program Project Guidelines, available from the contact listed under INQUIRIES, below, and at http://www.nih.gov/nichd/docs/po1_guidelines_final.htm. Specific application instructions for the R01 and R03 have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts. The modular grant concept establishes specific budget modules in which direct costs may be requested, as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for applicants, reviewers, and NICHD staff. The following instructions are to be used in conjunction with the information accompanying application form PHS 398 (rev. 4/98), they refer only to selected items in the application form. All PHS 398 requirements should be followed, with the exception of those items affected by these instructions. Applications not conforming to the requested format will be returned to the applicant without review. Application Instructions for the R01 Modular Grant R01 applications in response to this RFA will request direct costs in $25,000 modules, up to a total direct cost request of $300,000 per year. The total direct costs must be requested in accordance with the RFA guidelines and the modifications made to the standard PHS 398 application instructions described below: FACE PAGE Items 7a and 7b: These items should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $300,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b: These items should be completed, indicating the Direct and Total Costs for the entire proposed period of support. DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. NARRATIVE BUDGET JUSTIFICATION Prepare a Modular Grant Budget Narrative page. (For sample pages, see http://grants.nih.gov/grants/funding/modular/modular.htm) At the top of the page, enter the Total Direct Costs requested for each year. This is not a Form Page. Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. BIOGRAPHICAL SKETCH The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. o Complete the educational block at the top of the Form Page. o List position(s) and any honors. o Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. o List selected peer-reviewed publications, with full citations. OTHER SUPPORT Do not complete this section. It is not required and will not be accepted with the application. CHECKLIST This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and telephone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following initial review. Application Instructions for the R03 FACE PAGE Item 6: Up to a total of two years of support may be requested. Items 7a and 7b: These items should be completed indicating Direct Costs ($50,000) and Total Costs [$50,000 plus Facilities and Administrative (F & A) costs] for the initial budget period. Items 8a and 8b: These items should be completed indicating the Direct (i.e., either $50,000 or $100,000) and Total Costs (i.e., either $50,000 or $100,000 plus F & A) for the entire proposed period of support. DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. NARRATIVE BUDGET JUSTIFICATION Prepare a Modular Grant Budget Narrative page. (For sample pages, see: http://grants.nih.gov/grants/funding/modular/modular.htm) At the top of the page, enter the total direct costs requested for each year (i.e., $50,000). This is not a Form Page. Under Personnel, list key project personnel, including their names, percent of effort, and roles on the proposed project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and role on the proposed project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested $50,000 direct cost amount. Include the Letter of Intent to establish a consortium. BIOGRAPHICAL SKETCH The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A Biographical Sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample Biographical Sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the Form Page. - List position(s) and then any honors. - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations. OTHER SUPPORT Do not complete this section. It is not required and will not be accepted with the application. RESEARCH PLAN Items a d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 10 pages. Please note that a Progress Report is not needed, competing continuation applications will be not accepted for an R03. APPENDIX Appendix material should not be submitted and will not be accepted with the application. CHECKLIST This page should be completed and submitted with the application. If the F & A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for each budget period. The applicant should provide the name and telephone number of the individual to contact concerning fiscal and administrative issues if additional information is required following initial review. 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-99-012. 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 sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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: Scott Andres, Ph.D. 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 November 17, 1999. 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 the NICHD and the OERI. 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 Council. Review Criteria for R01 and R03 Applications, and P01 Subprojects The goals of NIH-supported research are to advance our understanding of biological and behavioral 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. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the 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 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The reasonableness of the proposed budget and duration in relation to the proposed research. 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. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. Additional Review Criteria for P01 Applications All Program Project (P01) applications in response to this RFA will also be reviewed with respect to the following: Review Criteria for P01 Core Units o The qualifications, experience, and commitment of the core director and other core personnel, o The quality of services provided by the core, o The cost effectiveness and quality control of the core, o The utility of the core to the program, For the P01 Administrative Core, the following criteria also are addressed: o The core director"s experience in research administration, o The decision-making process within the proposed program project for the evaluation of research productivity, allocation of funds, and the management of resources, o The plan for program project evaluation, including the use of any internal and external advisory groups. P01 Overall Critique Program as an Integrated Effort: o The coordination, interrelationships, cohesiveness, and synergy among the meritorious research projects and core components as they related to the common theme of the program project, o The advantages of conducting the proposed research as a program rather than separate research efforts, o The mechanisms proposed for regular communication and coordination among investigators in the program, and, o The appropriateness of administrative structures and day-to-day management of the program. Overall Merit of the Program: o Significance of the program overall and its potential to advance scientific knowledge in the field, o Adequacy and quality of the experimental approaches proposed in the projects and the overall design of the program project, o Degree to which the overall program applies novel concepts and innovative approaches, represents novel collaborations, etc., o Qualifications of the Principal Investigator, the program leadership, and individual project and core directors, o Scientific, organizational/institutional, and administrative environment of the program. In addition, the overall P01 application must be evaluated with respect to Inclusion of Women, Minorities and their Subgroups, and Participation of Children. SCHEDULE Letter of Intent Receipt Date: September 1, 1999 Application Receipt Date: November 17, 1999 Peer Review Date: April 2000 Council Review: May 2000 Earliest Anticipated Start Date: July 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 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: Peggy McCardle, Ph.D., MPH Associate Chief, Child Development and Behavior Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B05, MSC 7510 Bethesda, MD 20892-7510 Phone: 301/435-6863 Fax: 301/480-7773 Email: [email protected] Daniel B. Berch, Ph.D. Senior Research Associate Office of the Assistant Secretary Office of Educational Research and Improvement U.S. Department of Education 555 New Jersey Avenue, Room 602C, NW Washington DC 20208 Phone: 202/219-2215 Fax: 202/219-1402 Email: [email protected] Direct inquiries regarding fiscal and administrative matters to: E. Douglas Shawver Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A-17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards are made under authorization of the Public Health Services Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 284 and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. 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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