RESEARCH ON ADULT AND FAMILY LITERACY Release Date: October 26, 2001 RFA: RFA-HD-02-004 National Institute of Child Health and Human Development (http://www.nichd.nih.gov/) National Institute on Aging (http://www.nia.nih.gov/) National Institute for Literacy (http://www.nifl.gov/) Letter of Intent Receipt Date: April 15, 2002 Application Receipt Date: May 15, 2002 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute of Child Health and Human Development (NICHD), National Institute on Aging (NIA), and National Institute for Literacy (NIFL), in partnership with the Department of Education, Offices of Vocational and Adult Education (OVAE), Special Education and Rehabilitation Services (OSERS), Elementary and Secondary Education (OESE), and Office of Educational Research and Improvement (OERI), invite research grant applications to develop new knowledge on adult literacy learning and new knowledge relevant to the critical factors that influence the instruction and development of literacy (reading and writing) competencies in adults and in young children (birth through kindergarten entrance) through adult and family literacy program activities, to identify or design the most effective program structures and models of service delivery. This RFA seeks to stimulate systematic, programmatic, multidisciplinary research to determine the most effective instructional methods and program organizational approaches for both adult literacy programs and family literacy programs. Specifically, the co-sponsoring agencies seek 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 within adult and family literacy programs and activities. 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. 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 Request for Applications (RFA) is related to one or more of the priority areas. Potential applicants may obtain "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Research Project Grant (R01) and Small Grant (R03) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years for the R01 and may not exceed two years for the R03. The Small Grant (R03) mechanism should be used when a full-scale study is premature, for example, when there is a need for feasibility or pilot data. Further information on R03 application procedures is available at http://grants.nih.gov/grants/guide/pa-files/PAR-99-126.html. 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 award date is September 2002. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE The NICHD intends to commit approximately $1 million and the other cosponsors intend to commit approximately $2.3 for a total of $3.3 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2002 to fund eight to ten new grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $500,000 per year for the R01 and up to two years and $50,000 per year for the R03. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the co-sponsors 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. RESEARCH OBJECTIVES Background In November 2000, the National Institute for Literacy and the National Center for the Study of Adult Literacy and Learning co-sponsored a meeting in Cambridge, MA, to review the current state of research and instruction in adult literacy, and to identify gaps and research needs in the field. This was followed by a practitioners meeting on adult literacy, held by NIFL and the NICHD in Rockville, MD, to review and discuss the draft document that was the outcome of the earlier Cambridge meeting. The research priorities presented in this RFA and related documents draw in part from the draft document summarizing those two meetings. In addition, NICHD, NIFL, OVAE, OESE, and OERI brought together leading researchers and practitioners from various fields to forge a joint research agenda in adult and family literacy. This meeting was held August 21-22, 2001, in Rockville, MD, and a summary document is available from the individual program representatives listed under INQUIRIES, below, and at http://www.nichd.nih.gov/crmc/cdb/reading.htm. The combined conclusions and recommendations of these meetings are summarized as follows: Literacy, and specifically English language literacy, is a complex learning process that everyone living in the United States must negotiate successfully in order to compete effectively in this country. There are 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 reading and writing abilities in adults. In addition, the unique value of family literacy programs, as compared to adult programs that encourage parent-child interactions around literacy and as compared to preschool programs that include emergent literacy activities and a focus on parent involvement, has yet to be clearly elucidated. Therefore, there is a need to document the effectiveness of adult and family literacy programs in terms of specific literacy outcomes for adults and young children and to develop and test new innovative interventions. The complexity of understanding how language, cultural, and instructional factors influence literacy development in adults and in their children is compounded because these factors also interact in varying degrees with geographic and regional (urban vs. rural) location and, in many cases, immigrant status, migrant status, socioeconomic status, generation status of both young children and parents, the quality of the child’s oral language development, motivational factors, and for those whose native language is not English, the type, quality, and amount of each language spoken in the home and reinforced in the neighborhood and community, the linguistic and cultural characteristics of the instructor, 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 adult and family literacy programs and instructional methods and to delineate the influences, and pathways of influence, on English- language literacy development in both adults and their children at the individual level, the home/family level, and the classroom level. In addition, while many adults who are not literate may simply not have learned or not have been adequately taught to read and write, or may be literate in another language but in need of literacy instruction in English, there are also many adults who are not literate in any language due to learning difficulties. There is very little high quality, well-controlled research on the optimal methods of teaching and supporting the development of first or second language literacy in adults. An in-depth understanding of the factors and conditions that hinder this learning process is also crucially important, and the development and testing of interventions to identify and remediate reading difficulties in adults is strongly encouraged. Research in Adult and Family Literacy: An Overview: The NICHD and the Department of Education have had a long-standing interest in the study of reading development, reading disorders, and reading instruction. 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, 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. 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 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) the learning of literacy in adulthood, including literacy learning by individuals for whom English is not their native language, (2) difficulties/disabilities encountered by this population in learning to read and write, and (3) the development of effective prevention, remediation, and reading and writing programs and instructional approaches and strategies for low-literate adults, (4) the value added by the integrative approach that underlies family literacy programs, both for adults and their young children, in terms of specific literacy outcomes, as compared to high quality adult literacy and child intervention programs. To address these critical research needs, studies that contribute effectively to the research focus described below are encouraged. Research Scope 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 adults who, for whatever reason, have reached adulthood without these vital skills. Another major goal is to determine the effectiveness of family literacy programs in providing unique services to families where adults have limited literacy skills that impede their providing nurturance and support of literacy skills in their young children. Within family literacy, there is a specific need to address the more fundamental issue of whether rigorous evidence can be obtained in support of the primary assumption, as yet untested, that underlies the family literacy approach namely, that greater benefits to both adult and child learners will be attained by taking an integrated family literacy approach than by independently addressing adult and child needs through separate high quality adult literacy and child intervention programs. Through this initiative, the funding partner agencies hope to gain convergent evidence with which to address these overarching questions: o What are the most effective instructional methods and program organizations/structures for which groups/subgroups of adults and under what conditions are these most efficiently implemented? That is, what are the optimal instructional content, instructor qualifications and preparation, and timing, duration, and methods of delivery of instruction, for specific groups/subgroups of participants in adult literacy and family literacy programs in terms of specific literacy (reading and writing) outcomes, and which approaches, methods, and types of programs are most cost-effective for which participants? o What are the optimal instructional methods, contexts, and instructor characteristics that ensure the development of literacy in adults who are native speakers of English and adults who are not native speakers of English? What differences in these approaches may be required at different stages of adult development (i.e., young adulthood, midlife, and old age)? How should instructional approaches differ for adults who are literate at some level in their own language but seeking to develop literacy in English and adults whose native language does not have a written form? o What are the most effective methods for identifying and remediating adults with literacy (reading and writing) difficulties? That is, what factors and measures are most useful in identifying adults with reading disabilities, and what instructional methods, types of instructors, and types of programs (in terms of structure, organization, and other characteristics) are most effective in achieving useful literacy outcomes for which participants? In addition, what factors and measures are most useful in assessing and planning intervention for adults whose first language is not English? To adequately address these questions, it will be important to indicate what are the most important literacy outcomes for specific participants, and how these might be measured. o What are the best remedial procedures for circumventing the cognitive limitations of older adults that may otherwise interfere with the acquisition of literacy skills? That is, what methods can be used for enhancing reading and writing skills that either avoid or compensate for the text- processing problems typically experienced by older adults? For example, what compensatory strategies would aid these individuals in overcoming potential difficulties with reading comprehension that may occur as a result of declines in working memory capacity or decreased speed of information processing? o To what extent can interventions for enhancing literacy skills in older adults yield improvements in cognitively-demanding, instrumental activities of daily living? That is, what kinds of instructional methods may be required for ensuring the transfer of literacy competencies to the management of everyday problem-solving activities that are highly dependent on adequate reading and writing skills, such as grocery shopping, meal preparation, financial management, medication adherence, and health care management? o Are greater benefits to both adult and child learners attained by taking an integrated family literacy approach than by independently addressing adult and child needs through separate high quality adult literacy and parenting education/child intervention programs? That is, can it be demonstrated that there is "value added" (in literacy gains, in reduced costs, or in recruitment/retention levels) from bundling services to families in which both adults and young children require intervention and, if so, why? This will require addressing the issue of measurement of adult-child interaction, as well as careful measurement of other constructs and outcomes. o What are the optimal conditions under which family literacy programs can facilitate the development of literacy in adults and/or young children? What factors should be considered in selecting the language of first literacy in cases where the home language of a family is not English, and whether there are specific linguistic and cultural advantages that accrue with instructional approaches that develop oral language and literacy skills in two languages simultaneously (dual language-literacy approaches) for parents and/or young children within family literacy programs. What are the most effective intervention methods for parents with reading or other disabilities that impede their own literacy development and the most effective methods of helping these parents foster literacy development in their children? o To the extent that it is not already known, who are the adults/families in this country requiring literacy instruction, and how can they be best identified, recruited, and served? That is, what specific groups or subgroups of adults/families (in terms of racial/ethnic, cultural, linguistic, socioeconomic and geographic characteristics, as well as age and educational attainment) in the US are currently found in the various programs providing literacy instruction and, specifically, how can these populations be characterized to enable service providers to best identify them, to recruit and retain them, and to tailor the organization and structure of programs and specific instructional methods to optimally achieve defined literacy outcomes? Are there adults/families who can be identified who are not being served but would potentially benefit from such services? Research Focus The major focus of this RFA is to identify the conditions under which reading and writing skills are most efficiently and productively developed in low- literate adults, including adults with learning disabilities and adults who are English language learners, and to address the fundamental issue of the value added by the integrative approach used in family literacy programs in contributing to both adult and child literacy. Within this context, this collaborative, inter-agency research program seeks to increase understanding of the specific learner, instructional, linguistic, cognitive, sociocultural and socioenvironmental factors, and the interactions among these factors, that promote or impede the acquisition of literacy (reading and writing) skills of adults participating in adult education programs and/or family literacy programs. 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. However, applications must address issues that will contribute to the ultimate goal of answering the overarching questions under Research Scope, above, which place significant emphasis on the effects of different prevention, intervention, and instructional approaches and strategies, and of program models and organizational structures. Application Considerations 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. Especially for the R01 funding mechanism, 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 with an emphasis on the conditions under which literacy skills are best acquired and on the instructional, linguistic, cognitive, sociocultural, socioenvironmental, and familial factors that influence learning. It is expected that individuals within the research population will manifest different background characteristics and different strengths and weaknesses in skills critical for success in attaining reading and writing abilities. 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 individuals or programs and contrast groups for study. It is anticipated that the populations studied will include large numbers of individuals who are from minorities and/or who are from lower socio-economic levels, so that the research findings gained from this initiative will be useful in addressing the educational disparities that exist for these groups. o 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 or program 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 known learning or attention problems (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 change over time and the documentation of specific literacy outcomes (reading and writing) under a variety of conditions and across a variety of settings are 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 educational level continua, (3) corrective feedback designed to foster linguistic insight and self-reliance in the student, (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 demonstrate specifically which instructional components are most pivotal in learning to read 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. 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. Also of significant interest is 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, NIFL, OVAE, OSERS, OESE and 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/crmc/cdb/reading.htm. In addition, we encourage potential applicants to examine a Program Announcement that supports research complementary to this solicitation, entitled Age-Related Changes in Reading and Oral Language Comprehension (PA-01-002), available at http://grants.nih.gov/grants/guide/pa-files/PA-01-002.html. Applicants are encouraged to respond to whichever of these two notices that most closely fits their area of research interest. SPECIAL REQUIREMENTS Semi-Annual Meetings for Investigators Because of the importance of cross-project communication and collaboration in this research effort, Principal Investigators from projects funded though this RFA will be expected to attend semi-annual meetings to be organized and managed by the funding partners, for investigators to share findings, research approaches, and core instrumentation. The first meeting is expected to take place in November 2002. Requests for funds for travel to these two meetings for the Principal Investigator and one research team member (for example, the team’s research methodologist) should be included in the application budget and budget justification. Data Archives Investigators who will collecting data on large numbers of subjects are encouraged to include in the application plans to archive data or to prepare public use files at the end of the project so that data can be shared with other investigators. While this is not a requirement of this RFA, it is strongly encouraged. 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 sub-populations 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 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH-defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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, published in the NIH Guide for Grants and Contracts, March 6, 1998, and available at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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 plan the review. The letter of intent is to be sent to Peggy McCardle, Ph.D., MPH, at the address listed under INQUIRIES, below, by April 15, 2002. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. Application Instructions Application instructions for the NICHD Small Grant (R03) mechanism must be followed in preparing applications for the R03 in response to this RFA. These are available at http://grants.nih.gov/grants/guide/pa-files/PAR-99-126.html. Appendices for R01 applications should accompany the grant application. Note that the R03 application does not allow appendices. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific 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 the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Submission Instructions The RFA label available in the PHS 398 (rev. 5/2001) application form must be stapled to the bottom of the face page of the application and must display the RFA number HD-02-004. A sample RFA label is available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in the pdf format. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application should be sent to: Director Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E-03, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Applications must be received by May 15, 2002. 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NICHD. 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 receive a written critique and may 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, assigned a priority score, and receive a second level review by the National Advisory Child Health and Human Development Council and the National Advisory Council on Aging. Review Criteria 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. 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: o 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. o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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 The adequacy of the proposed plan to share data, if appropriate. SCHEDULE Letter of Intent Receipt Date: April 15, 2002 Application Receipt Date: May 15, 2002 Peer Review Date: July 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 2002 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. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Peggy McCardle, Ph.D., MPH Child Development and Behavior Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6863 FAX: (301) 480-7773 Email: pm43q@nih.gov Daniel B. Berch, Ph.D. Chief, Section on Cognitive Aging Individual Behavioral Processes Branch Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Avenue, Suite 533 Bethesda, MD 20892-9205 Telephone: (301) 594-5942 FAX: (301) 402-0051 Email: Daniel_Berch@nih.gov Sandra Baxter, Ed.D. National Institute for Literacy 1775 I Street, NW Suite 730 Washington, DC 20006 Telephone: (202) 233-2054 FAX: (202) 233-2050 Email: sbaxter@nifl.gov Direct inquiries regarding review issues to: Robert Stretch, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: rs365f@nih.gov Direct inquiries regarding fiscal matters to: Mary Daley Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1305 FAX: (301) 402-0915 Email: md74u@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.865 (NICHD), 93.866 (NIA), and 84.257 (NIFL). 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant 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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