POPULATION RESEARCH INFRASTRUCTURE PROGRAM RELEASE DATE: July 1, 2002 RFA: HD-02-021 National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) LETTER OF INTENT RECEIPT DATE: October 20, 2002 APPLICATION RECEIPT DATE: November 20, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Child Health and Human Development (NICHD), through the Demographic and Behavioral Sciences Branch (DBSB), Center for Population Research (CPR), invites applications for infrastructure grants in support of population research relevant to the DBSB mission. Applicants may request funds to support infrastructure development and/or research designed to: (1) enhance the quality and quantity of population research conducted at an institution, and (2) develop new research capabilities to advance population research through innovative approaches. A central goal of this program is to facilitate interdisciplinary collaboration and innovation in population research while providing essential and cost-effective core services in support of the development, conduct, and translation of population research based in centers or comparable administrative units. This announcement invites applications for two types of award: for full- fledged Research Infrastructure Awards and for Developmental Awards. Developmental Awards are intended to support the development and demonstrate the feasibility of programs that have high potential for advancing population research, but have not yet fully developed the necessary resources and mechanisms to qualify for a Research Infrastructure Award. RESEARCH OBJECTIVES Background The Demographic and Behavioral Sciences Branch (DBSB) is one of three programs in the Center for Population Research of the NICHD. The mission of the Branch is to foster research on the processes that determine population size, growth, composition, and distribution, and on the determinants and consequences of those processes. This mission translates into a research portfolio that looks intensively at the demographic processes of fertility, mortality, and migration and at their broad interrelationships with larger social, economic, and cultural processes. Areas of supported research include fertility and family planning, sexually transmitted disease, family and household demography, mortality and health, population movement, population and environment, and population composition and change. Research supported by the Branch uses a broad spectrum of scientific approaches in the clinical, behavioral, and social sciences. During the years 1972-2000, NICHD provided infrastructure support for population research through the Center Core Grant (P30) and Specialized Research Center Grant (P50) mechanisms. In 1999, DBSB undertook a comprehensive review of this program to determine whether its structure and guidelines best served the future needs of population research. A report summarizing the results of this review is available at http://www.nichd.nih.gov/about/cpr/dbs/pubs/report.pdf and from the program contact named under WHERE TO SEND INQUIRIES, below. As a result of the review, DBSB is phasing out the P30 and P50 mechanisms in favor of the R24 and R21 mechanisms. Objectives and Scope The primary purposes of the Population Research Infrastructure Program are to provide resources to support and advance research that will improve understanding of the antecedents and consequences of population structure and change, facilitate interdisciplinary collaboration among investigators conducting population-related research, and promote innovative approaches to population research questions. An additional goal is to facilitate interaction among scientists in locations throughout the United States that contributes to the integration and coordination of population research. The Infrastructure Grant will retain some of the characteristics of traditional P30 and P50 grants. It will continue to fund infrastructure to support a portfolio of population research housed in or coordinated by a center or other research unit (hereafter, "research unit" or "unit") at an institution. However, it is designed to move beyond the traditional center grant mechanism to allow institutions to aggressively pursue scientific opportunities appearing at the boundaries between traditional population research and allied fields, and to facilitate partnerships among diverse scientists and institutions. The Infrastructure Grant will permit a streamlined format that allows more flexible use of funds to address not only the core support needs of existing projects, but also the development of new directions and approaches to population research and the translation and dissemination of research findings and resources. It asks applicants to design and propose infrastructure programs that will serve to advance the interdisciplinary reach, innovation, and impact of their research programs, in addition to serving the existing needs of researchers. It also allows and encourages the development of infrastructure that broadly serves the field of population research. Institutions that have not held a P30, P50, or R24 grant related to population research in the 10 years prior to the application date may, at their option, request to be considered for a R21 Developmental Award. This award is intended to support the development of research units that have high potential for advancing population research. The award provides such units the opportunity to further develop the mechanisms and resources required to support and facilitate significant new contributions to the field, continue to build a substantial interdisciplinary portfolio of population research, and demonstrate their feasibility as full-fledged population research units. Applicants responding to this RFA must articulate a clear vision for their research unit and its current and future contributions to population research. Applicants must identify the central scientific objectives and signature population-related themes of the unit and these must be relevant to the DBSB mission. A description of the DBSB mission is available at http://www.nichd.nih.gov/about/cpr/dbs/dbs.htm. Illustrative examples of population research topics that fall within the DBSB mission are listed below. Applicants are encouraged to consult with program staff listed under WHERE TO SEND INQUIRIES to determine the relevance of other topics to the DBSB mission. 1. Antecedents and consequences of changes in population size, structure, and composition, including the relationship of economic development to population change, population modeling and the projection and/or prediction of human population change, and the interrelationship between population and the physical environment. 2. Family and household dynamics, including issues related to intergenerational relationships. 3. Fertility and family planning, including issues related to union formation and dissolution, births and birth spacing, family size, gender in relation to fertility, and social acceptability of measures for the biological regulation of human fertility. 4. Spatial distribution of human population groups, causes and consequences of migration, including issues related to international and internal migration, residential mobility, and interrelationships between population and the environment. 5. Demographic aspects of health, morbidity, disability, and mortality, including issues related to the influence of early life on later life development and outcomes, status of children, the interrelationship between health and socioeconomic status. 6. Social, demographic, and behavioral studies of sexual behavior, sexually transmitted diseases, and contraception. Infrastructure Support – R24 Research Infrastructure Awards R24 applicants may request support in the following categories: (1) Research Support Cores, (2) Developmental Infrastructure, (3) Research Projects, and (4) Public Infrastructure. Applicants are not expected to request support in all or even most of the categories, rather, they should request types and levels of support that best suit their needs and objectives. The NICHD expects that the amount and allocation of infrastructure support that applicants request will vary substantially. The first three categories of infrastructure support are intended to advance the scientific program of the applicant research unit. For these categories, applicants must justify the types and amounts of support requested in terms of: (1) the scope, objectives, and current and potential impact of the applicant"s research program, (2) the potential contribution of requested infrastructure to advancing the research program, and (3) the cost- effectiveness of the requested support. Applicants are expected to define guidelines for determining the eligibility of researchers and research projects to access resources provided under this program, and guidelines and procedures for allocating such resources. No restrictions on access (e.g., by students, investigators lacking research support, investigators in fields other than population research) are imposed under this announcement. However, applicants must demonstrate that their proposed guidelines and procedures for controlling access to core resources are consistent with the scientific objectives of their research program and the goals of this RFA. Definitions of Infrastructure Support Categories: 1. Research Support Cores provide shared resources that support the applicant"s research program. Examples include: o Administrative Core, providing for coordination of research, editorial services, and/or assistance with grant application development and fiscal management of grants. o Computing Core, providing equipment and/or services supporting shared computing needs. o Information Core, providing support for retrieving information, materials, and data commonly used in population research. o Methodology Support Cores, providing support for specific methodologies employed in population research (e.g., GIS, statistical methods, biomarkers, survey methodologies). Research Support cores should be designed to advance the central scientific objectives and signature population-related themes of the applicant"s research program while providing essential, cost-effective services to support on-going research activities. Cores should be designed to facilitate and promote innovation in the science conducted by program researchers in addition to responding to researcher needs. Equipment and support services that are specific to individual research projects or researchers are not allowable, except in the context of individual research projects that may be proposed in response to this RFA. 2. Developmental Infrastructure refers to activities that promote the development of new research capabilities. Examples include: o Seed grant programs, providing funds for the development of new research projects. Institutions proposing seed grant programs must develop guidelines and eligibility requirements appropriate to the goals of this RFA, and procedures and policies for administration of the program. Issues that may be addressed include (but need not be limited to): (1) priorities for allocating funds (e.g., junior researchers, specified areas of research, interdisciplinary work, etc.), (2) procedures for reviewing applications, (3) requirements for leveraging funds or preparing research proposals to continue or expand the research project, (4) size of awards, (5) length of award periods, (6) number of awards permitted to an individual researcher, (7) mentoring arrangements, and (8) support for the program from the parent institution or other funding sources. o Faculty development, providing for partial salary support or other support for the recruitment of new faculty in scientific areas critical to the development of innovative and/or interdisciplinary research directions. Support for any one individual may not exceed three years in duration. o Activities that foster the development of new core services. For example, applicants may propose to hire consultants to assist with the design of GIS services, or conduct pilot studies to evaluate the cost-effectiveness of alternative modes of core service delivery. o Workshops, conferences, seminar series, and visiting scholar programs that lay the groundwork for new substantive work or foster new research collaborations. 3. Research Projects proposed for R24 support must be of R01 quality, must directly address and advance the program"s central scientific objectives and signature population-related themes, and should emphasize innovative, interdisciplinary, and/or cross-cutting elements. Institutions are encouraged to consider R01 and other research grant mechanisms for the support of research projects that do not explicitly meet these criteria. 4. Public Infrastructure activities differ from the first three categories of infrastructure support in that they are not solely intended to advance the research program at the applicant institution, but are primarily directed instead at external audiences. These audiences may include (but are not limited to) the broad community of population researchers or communities concerned with public policy or health or social programs. o Illustrative examples of activities benefiting the broader scientific community include: supporting and disseminating databases of high relevance to population research, developing and disseminating multidisciplinary bibliographic databases, and providing general resources for data sharing. Applicants must justify public infrastructure activities aimed at the scientific community by demonstrating: (1) that these activities will significantly advance the field of population research, (2) that the proposed activity does not duplicate existing resources or services, and (3) that the proposed activity is cost-effective. Applicants must present their plans for sharing their resource(s) or service(s) with the scientific community. They should also address the time frame during which the resource(s) or service(s) will be needed, and the short- and long-term plan for supporting them. This plan should address, as applicable, expectations for NICHD support, support from the institution and other sources of support, and plans for charging users and managing program income. o Illustrative examples of activities benefiting policy or program audiences include the development of tools for effectively communicating population research findings to relevant audiences and innovative strategies for translating basic research findings for application to programs designed to improve health and well-being. Applicants must present their plans for ensuring effective dissemination of the resources, tools or services developed by the activity. They should also address the time frame during which the resource(s) or service(s) will be needed, and the short- and long- term plan for supporting them. This plan should address, as applicable, expectations for NICHD support, support from the institution and other sources of support, and plans for charging users and managing program income. Applicants may propose to cooperate with other institutions in undertaking any of the above-mentioned infrastructure activities. Cooperative activities may include the development of research partnerships involving scientists in the applicant"s program and colleagues in other institutions, and/or joint ventures with other institutions to provide research, developmental, or public infrastructure services. Proposed research partnerships must be justified in terms of the scientific advances to be gained through collaborations across institutions relative to those likely to emerge from within-institution partnerships. Examples of allowable activities include travel for project development and coordination and use of research support core, seed project, and research project funds. Applicants also may propose cooperative research support, developmental, or public infrastructure services in which the applicant and a Population Center or similar unit in another institution participate in joint funding and administration of a common service or resource. Examples might include a shared library, data archive or outreach effort. Partners in a cooperative venture need not be another funded applicant or Center. Applicants must clearly describe the rights and responsibilities of each proposed partner in the funding, administration, and use of shared resources. Infrastructure Support - R21 Developmental Awards R21 applicants may request support in only two categories: (1) Research Support Cores and (2) Developmental Infrastructure. Although applicants may not request support for R01-like research projects, they may request support for developmental activities, using a seed grant or similar mechanism (see description under Developmental Infrastructure, above). Specific guidelines for these categories are provided above under "Infrastructure Support - R24 Research Infrastructure Awards." Applicants must justify the types and amounts of support requested in terms of: (1) the scope, objectives, and current and potential impact of the applicant"s research program, (2) the potential of the requested infrastructure to develop the resources and mechanisms required to build a substantial interdisciplinary portfolio of population research and facilitate significant new contributions to the field, and (3) the cost-effectiveness of the requested support. All other guidelines pertaining to infrastructure requests for R24 Research Infrastructure Awards apply also to R21 awards. MECHANISMS OF SUPPORT This RFA will use the NIH Resource-related Research Project Grant (R24) award mechanism for Research Infrastructure Awards and the Exploratory/Developmental Grant (R21) award mechanism for Developmental Awards. A table summarizing the differences between the R21 and R24 mechanisms as applied to this RFA is available at: http://www.nichd.nih.gov/RFA/HD-02-021/HD-02-021.htm. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. NICHD expects to issue an RFA annually to solicit applications for this program, applications may be submitted only in response to an RFA. The anticipated award date is July 1, 2003. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting a Developmental Infrastructure (R21) application, use the modular format. If you are submitting a Research Infrastructure Award (R24) application, follow the instructions for non-modular research grant applications. FUNDS AVAILABLE NICHD intends to commit approximately $907,000 in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2003 to fund one to three new and/or competitive continuation grants in response to this RFA. An applicant for an R21 Developmental Award may request a project period of up to three years and a budget for direct costs of up to $150,000 per year. An applicant for an R24 Research Infrastructure Award should request a project period of five years and should request support appropriate to the size and impact of their scientific portfolio and to the goals of their infrastructure program. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the NICHD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. As a general rule, NICHD expects direct cost budget requests for R24 applications to average approximately $15,000 for each researcher in the program who can provide evidence of research activity directly relevant to the DBSB mission in two or more of the following categories: (1) externally funded research grants or contracts in the past three years, (2) publications in peer-reviewed journals during the past three years, and (3) papers in preparation and future plans for research. See ELIGIBLE INSTITUTIONS, below, for further information on these categories of research activity. Requests may vary from the guideline provided above as justified by evidence of exceptionally high impact or productivity or special features of the proposed infrastructure program. Applicants may request additional funds beyond those suggested by the guideline for Public Infrastructure activities (see RESEARCH OBJECTIVES, above). Applicants are encouraged to discuss budget requests with program staff listed under WHERE TO SEND INQUIRIES, below, prior to submission. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign Applicant institutions must have an established research center or other administrative unit (referred to as the "research unit" or "unit") that serves as a focal point for or coordinates population research across the institution. This unit must have a defined governance structure. The research conducted at the unit should reflect scientific benefits and cost-efficiencies resulting from cooperation and interaction among a pool of scientists with shared interests in population research. Applicants should have in place (or propose in their applications) effective mechanisms for fostering the development of an intellectual community that bridges investigators from different disciplines and different projects and promotes innovation in population research. To be eligible to apply, the unit must have at least three researchers who can present evidence of research activity related to the mission of DBSB in all three of the following categories: (1) externally funded research grants or contracts in the past three years, (2) publications in peer-reviewed journals during the past three years, (3) papers in preparation and future plans for research. The "past three years" refers to the 36-month period preceding the application submission date for this RFA. "Externally funded" means funding is received from sources outside the institution, it may include funding from NIH, NSF, other federal agencies, state and local governments, and private foundations. Include only projects on which the individual has served as Principal Investigator or had substantial involvement, comparable to that indicated by identification of an investigator as "key personnel" on an NIH-funded grant. Note that the criterion used for unit eligibility above (at least three researchers with evidence of research activity in all three categories) differs from the criteria used to define guidelines for requested budgets under FUNDS AVAILABLE and to define page limitations under the Application Guidelines at http://www.nichd.nih.gov/RFA/HD-02-021/HD-02-021.htm. In each of the latter two cases, the criterion of an "active researcher" is evidence of research activity in at least two of the three categories defined above. If your institution has held a P30, P50, or R24 grant related to population research in the 10 years prior to the application date, you may not apply for an R21 Developmental Award. Developmental awards are nonrenewable and institutions may not simultaneously hold a Developmental Award and a Research Infrastructure Award. Potential applicants are strongly encouraged to contact staff listed under WHERE TO SEND INQUIRIES, below, to discuss eligibility prior to submission of an application. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The Principal Investigator should be a scientist or science administrator who can provide effective administrative and scientific leadership. SPECIAL REQUIREMENTS Because the Infrastructure Program is expected to enhance the unit"s competitiveness for NIH funding, the institution and pertinent departments are expected to show a strong commitment to the unit and to match the requested infrastructure support at a level appropriate to the resources of the institution and the scope of the proposed program activities. Such commitment may be demonstrated by the provision of dedicated space, faculty appointments in subject areas relevant to the goals of the unit"s research program, salary support for investigators or core staff, dedicated equipment, or other financial support for the proposed program. Applicants are encouraged to consult with program staff listed under WHERE TO SEND INQUIRIES to discuss this requirement. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Christine Bachrach Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-9485 FAX: (301) 496-0962 Email: cbachrach@nih.gov (email communication preferred) o Direct your questions about peer review issues to: Dr. Robert Stretch Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 Fax: (301) 402-4104 Email: stretchr@mail.nih.gov o Direct your questions about financial or grants management matters to: Ms. Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17G, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 Fax: (301) 480-4782 Email: kh47d@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Dr. Christine Bachrach Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-9485 FAX: (301) 496-0962 Email: cbachrach@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: Applications for Research Infrastructure Awards (R24) and Developmental Awards (R21) should be prepared according to the Application Guidelines available at http://www.nichd.nih.gov/RFA/HD-02- 021/HD-02-021.htm and from program staff listed under WHERE TO SEND INQUIRIES. All instructions and guidelines accompanying the PHS 398 are to be followed, with the exception of the sections modified by these guidelines. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: All applications for Developmental Awards (R21) must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. All applications for Research Infrastructure Awards (R24) should be submitted using the non-modular format, even if they request less than $250,000 in direct cost in all years. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Dr. Robert Stretch Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by 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: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Child Health and Human Development Council. Applicants should anticipate that no site visit will be conducted and ensure that their applications are complete at the time of submission. REVIEW CRITERIA Overall Program – R24 Research Infrastructure Awards: Two primary criteria will be used to evaluate the overall scientific merit of an application for a Research Infrastructure Award: 1) Quality of the research program and its impact on the field: Reviewers will consider the significance, innovation, and quality of current and recent contributions of program scientists. Have these contributions produced new knowledge and/or new approaches to research that have significantly expanded, improved or altered the content, methods, and direction of population research? In order to create a level playing field for smaller and larger programs on this criterion, reviewers will be asked to take size of the program into account in assessing impact. In other words, while both larger and smaller programs will be expected to demonstrate research activity of high quality, programs with fewer researchers would not be expected to demonstrate the same quantity of research productivity and program impact as programs with a greater number of researchers. 2) The potential future contributions of the applicant program to population research: Reviewers will base their assessment of potential on such factors as the current trajectory of research productivity, innovation, and accomplishments, the significance of the applicant"s central scientific objectives and signature population-related themes and the plan for advancing them, the program"s plan for encouraging synergy and interaction among population researchers, and the applicant"s success in contributing to the development of junior investigators. Applicants proposing only Public Infrastructure activities will be judged on the basis of the secondary criteria below and the detailed review criteria listed below under "Public Infrastructure." Three secondary criteria will also be used to assess the overall scientific merit of applications: 1) Quality and potential impact of proposed infrastructure program: Reviewers will examine the overall quality, scientific merit, and innovation of the activities to be supported. Reviewers will consider the likelihood, based on existing capabilities and proposed activities, that the proposed program will enhance population research, promote new research directions, facilitate interactions across disciplines and substantive areas of study, or advance theoretical or technical approaches. For infrastructure components benefiting audiences outside the population research community, reviewers will assess potential impact in terms of improving the accessibility of population research to significant audiences and enhancing the appropriate application of research findings to activities that improve health and well- being. 2) Research competence of key personnel: Reviewers will consider the capability and scientific credentials of the Principal Investigator to direct the Program and maintain high standards of research collaboration, the specific technical qualifications of core directors, and the scientific accomplishments of all participating investigators. 3) Institutional commitment and environment: Reviewers will assess the nature and level of resource commitment from the institution in which the center is housed and any cooperating institutions, taking into account the institutional context. Reviewers also will consider the academic and physical environment as it bears on research opportunities, space, equipment, and the potential for interaction with scientists from various departments, institutions or disciplines. Overall Program – R21 Developmental Award: One primary criterion will be used to evaluate the overall scientific merit of an application for a Developmental Award: The potential future contributions of the applicant program to population research. Reviewers will base their assessment of potential on such factors as the current level and trajectory of research productivity, innovation, quality and significance, the significance of the applicant"s central scientific objectives and signature population-related themes and the plan for advancing them, the program"s plan for encouraging synergy and interaction among population researchers, and the applicant"s success in contributing to the development of junior investigators. Three secondary criteria will also be used to assess the overall scientific merit of applications: 1) Quality and potential impact of proposed infrastructure program: Reviewers will examine the overall quality, scientific merit, and innovation of the activities to be supported. Reviewers will consider the likelihood, based on existing capabilities and proposed activities, that the proposed program will develop the resources and mechanisms required to build a substantial interdisciplinary portfolio of population research and facilitate significant new contributions to the field. 2) Research competence of key personnel: Reviewers will consider the capability and scientific credentials of the Principal Investigator to direct the program and maintain high standards of research collaboration, the specific technical qualifications of core directors, and the scientific accomplishments of all participating investigators. 3) Institutional commitment and environment: Reviewers will assess the nature and level of resource commitment from the institution in which the center is housed and any cooperating institutions, taking into account the institutional context. Reviewers also will consider the academic and physical environment as it bears on research opportunities, space, equipment, and the potential for interaction with scientists from various departments, institutions or disciplines. Infrastructure Support Components: For both R21 and R24 applications, each individual element of the proposed infrastructure program will be evaluated separately based on the criteria below. Research Support Cores o Potential or actual contribution of the proposed core to advancing research within the applicant unit, by: enhancing the productivity of the existing scientific program, fostering new scientific advances, facilitating interactions across disciplines and substantive areas of study, and/or advancing theoretical or technical approaches. o Appropriateness to the size and characteristics of the applicant"s existing research program and the central scientific objectives and signature population-related themes of the program, o Qualifications, experience, and commitment to the program of the investigators responsible for the cores or activities and their ability to devote the required time and effort to the program, and o Cost-effectiveness of services or activities and appropriateness of cost- sharing arrangements with the institution, relevant departments, and other external infrastructure support programs. Developmental Infrastructure o Potential of the proposed activity to advance research within the applicant unit by stimulating innovation in population research and/or fostering the development of junior scientists. o Appropriateness to the size and characteristics of the applicant"s existing research program and the central scientific objectives and signature population-related themes of the program, o Qualifications, experience, and commitment to the program of the investigators responsible for the activities and their ability to devote the required time and effort to the program, and o Cost-effectiveness of services or activities and appropriateness of cost- sharing arrangements with the institution, relevant departments, and other external infrastructure support programs. o For seed grant programs proposed under "Developmental Infrastructure," the appropriateness and quality of procedures and policies for administering the program, such as guidelines for reviewing applications, priorities for allocating funds, requirements for leveraging funds, and size and length of awards, and other program guidelines. Upon renewal, seed grant programs will be reviewed for their success in developing funded research projects relevant to the mission of DBSB. Research Projects (R24 only): 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. Each proposed research project will also be evaluated with respect to: o The contribution of the project to advancing the unit"s central scientific objectives and signature population-related themes and the extent to which it embodies innovative, collaborative, and/or cross-cutting elements of the unit. Public Infrastructure (R24 only): Public infrastructure components will be evaluated according to the following criteria: o For activities intended to benefit the research community, the value and significance of the proposed activity for population researchers and its potential for promoting interdisciplinary and/or innovative population research. o For activities directed to policy, program, or other audiences, the significance of the proposed activity and its potential for improving the accessibility of population research to significant audiences and enhancing the appropriate application of research findings to activities that improve health and well-being. o Appropriateness of the targeted audiences and the adequacy of the plans for disseminating the proposed activities, resources, or services to these audiences. o Cost-effectiveness of services or activities and appropriateness of the short- and long-term plans for supporting them (including cost-sharing arrangements). o Qualifications, experience, and commitment to the program of the investigators responsible for the cores or activities and their ability to devote the required time and effort to the program. Applications proposing to undertake any infrastructure activity in cooperation with another institution will be evaluated for the value added by the involvement of other institutions and the appropriateness and adequacy of plans for the sharing of rights and responsibilities among proposed partners with respect to the funding, administration, and use of shared resources. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 20, 2002 Application Receipt Date: November 20, 2002 Peer Review Date: March 2003 Council Review: June 2003 Earliest Anticipated Start Date: July 1, 2003 AWARD CRITERIA Criteria that will be used to make award decisions (selection of applications for award and the level of support provided) include: o Scientific merit (as determined by peer review) o Availability of funds o Relevance of the applicant"s research program to the DBSB mission o Programmatic priorities. Within applications recommended for funding, specific infrastructure components may be funded selectively. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at 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. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.864 (Population Research) and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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