CENTERS ON THE DEMOGRAPHY OF AGING RELEASE DATE: June 17, 2003 (see corrections NOT-AG-03-003 and NOT-AG-03-005) RFA: AG-04-001 (Reissued as RFA-AG-09-005) National Institute on Aging (NIA) (http://www.nia.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.866 LETTER OF INTENT RECEIPT DATE: September 22, 2003 APPLICATION RECEIPT DATE: October 22, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators 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 on Aging (NIA) invites applications for Research and Development Center Grants (P30) in the areas of demography and economics of health and aging. NIA invites both new teams of investigators and continuing centers (funded under RFA AG-99-001) to apply. The purpose of these center grants is to support: the infrastructure and pilot data necessary for research and program development in selected areas (described under RESEARCH OBJECTIVES); research projects in selected areas (described under RESEARCH OBJECTIVES); the development of innovative national and international networks of researchers; the recruitment of new researchers into the field; the development and enhanced sharing of specialized databases and the rapid application of research results from these databases; and the development of statistical data enclaves for the analysis of large-scale, often- longitudinal, databases with linked administrative data. RESEARCH OBJECTIVES Background Scientific initiatives in the demography and economics of health and aging increasingly require integration and collaboration with each other and also with allied scientific fields such as genetics, biology, clinical medicine, and epidemiology. Collaboration across institutions and with international organizations is often required. Advances in computing technology have made new methodologies such as macro and microsimulation and the multivariate analysis of complex longitudinal data more practical and efficient, while raising the obligation to protect confidentiality. In addition, the ability to link datasets or to combine raw data from different data collections can lead to innovative research designs. Progress in research on population aging can be accelerated and significantly enhanced by the widespread collaboration of investigators at multiple institutions and by the creation of innovative networks of researchers. The NIA has supported the development of major data collection efforts in areas such as long term care, retirement and economic status, and the dynamics of health and functional change in the very old. However, use of these and other datasets requires considerable investment prior to conducting any sophisticated research. Efficiency is increased, and costs of individual research projects can be reduced, when several researchers at the same institution can make use of centralized data files staffed by knowledgeable data managers. Also, there is a growing demand from the federal government and the policy community for timely and appropriately synthesized research findings from these datasets. Finally, in February 2003 NIH reaffirmed its support for the concept of data sharing and stated that data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data (http://grants.nih.gov/grants/policy/data_sharing/index.htm). Applicants may address several of the topic areas below. They are not intended to be prescriptive; applicants may redefine these areas, merging and combining topics according to their own perspectives of the future course of the population sciences related to aging. Comparative international research is encouraged. Wherever possible, special attention should be given to the demographic and economic aspects of the health and well-being of special older populations such as the oldest old, Blacks and Hispanics, and older women. Objectives and Scope A. Biodemography of Aging Demographic aspects of heritability and familial aggregation of disease and longevity; incorporation of genetic, biological, and disease variables into demographic models and age-specific mortality rates; the social roles of the elderly in nature; and biological mediators of the relationship between socio-economic status and health. B. Trends in Chronic Disease and Disability Investigation of the factors underlying the recent trend in declining disability in the older population. Determination and quantification of causal factors underlying the trend (e.g. medical technological interventions, health care access and use, early life experiences, education, biomedical and social research advances, healthy lifestyle behaviors, public health measures). Interventions to maintain and accelerate the trend. International comparative analyses of declining disability in countries with different institutional and family structures are encouraged. Forecasting life and active life (health) expectancy, medical services and long term care usage. Quantification of the impact of medical interventions on future lifetime health care economic costs. Modeling risk factor trajectories and trends in non-communicable disease disability and mortality in developed and developing countries, with emphasis on aging populations. Analyses and projections of the epidemiological transition in developing countries. Improved measures of adaptation to chronic and acute illnesses and associated disability, including the costs of adaptation and coping on well-being. Innovative methods to reconcile changes in objective and subjective measures of well-being over the natural history of aging-related diseases. Summary measures of health and the burden of illness. Cross-national studies to harmonize and validate measures. Innovative methods for melding laboratory, clinical or ethnographic approaches with large-scale population studies. C. Health Systems Studies to document how middle-aged and older adults are affected by trends in how health systems are organized and financed, and by consequent health system inefficiencies and under-utilization of resources. Translation of research results about the strengths and weaknesses of various health financing schemes to practical programs for the delivery of health care services for the older population. Improved analysis and projections of the global burden of disease (e.g., incorporating microdata on risk factors to model the impact of interventions), and critical analyses of emerging methodologies for resource allocation in the health sector. Development of national income and product accounts that accurately reflect the level and changes in output produced in the health sector of the US economy. D. Living Arrangements Analysis of the factors that trigger movement of the elderly through various living arrangements, from independent living through the various forms of long-term care, and the functional and health-related outcomes associated with residential options available to older persons. E. Race, Ethnicity and Socioeconomic Status Interactions between health and socio-economic status (and their cumulative relationship) over time and across generations. Relationship among health, wealth and education. Improved measures of socioeconomic position for aging populations; economic determinants of health promotion and disease prevention behaviors. Improved understanding of the mechanisms underlying associations between socio-economic status and health. Role of social cohesion as a mediating factor. Elucidation of the causal pathways and mechanisms that may underlie the association between education and health. Research to disentangle the effects of socio-economic status, social and environmental factors, health behaviors, and race and ethnicity on health. Studies of the health of diverse racial and ethnic older populations and the health of small geographic areas. Variables of interest include the effects of lifelong poverty, birth weight, access to and utilization of employer- provided health insurance, recency and circumstances of immigration; the strain of physically demanding work; occupation; wealth, income and early- life health status; and experiences of discrimination. Studies of the changing composition and conceptualization of race and ethnicity in the US and the effects on the U.S. socially, economically, and demographically, including how increasing racial and ethnic diversity are affecting population health and health disparities; issues related to the development of racial and ethnic identity and to interactions between racial/ethnic identification and demographic, health, and other outcomes; and issues related to the measurement of race and ethnicity, including racial and ethnic self-identification. F. Policy Simulations Evaluations and simulations of the impact of changes in DHHS and SSA policies (e.g. changing the age of eligibility for Medicare and Social Security benefits, and expanding coverage to include prescription drugs) on the health, labor supply and functioning of the older population. Stochastic forecasting and simulations of the Social Security program and of changes in Social Security policy. Macroeconomic simulations of changes in Social Security policy on, e.g., national saving, investment and economic growth. Interactions of Social Security with other public and private programs. International comparisons are encouraged. G. Work and Retirement Implications of population aging for public and private retirement programs (national and international) and for income security of future retirees; implications of women's life history (e.g., temporary exits from the labor force for child rearing and caregiving of older parents) on retirement income and savings adequacy; implications for late-life health and financial security of the timing of demographic events such as marriage, child-rearing, widowhood, etc.; allocation of family resources across generations; determinants of retirement, family labor supply, and saving; consequences of retirement for health and functioning; comparative studies of labor force activity; effects of psychological factors (e.g. expectations, risk taking, personality, altruism, time preferences, etc.) and mental health characteristics (e.g. depression) on economic behaviors (e.g. savings and transfers); and economic and demographic analyses of employer- and organizational-level determinants of labor force participation at older ages. Translation of research results in these areas to improved interventions for older persons. H. Disease-Specific Demography and economics of dementia and Alzheimer's Disease. Studies examining the impact of social relationships (e.g., social network structures, types, levels and quality of social support) on cognitive decline and dementia. Demography and economics of HIV/AIDS in older populations. Studies of the demographic consequences of HIV/AIDS, especially in developing countries where the age structure of the disease is unique and where individual and aggregate-level processes affect modeling efforts. Also, studies of the social, economic, comorbid and other health risks and consequences of HIV/AIDS for older persons as parents and relatives of HIV infected adults, in both developed and developing countries, are welcome. Estimation of the impact of health (including links with geography and demography) on economic development, especially in developing countries. I. General Demography Cohort analyses of aging, including the baby boom cohort; implications of changing family structures on caregiving needs; historical demographic and epidemiological research on the aging process and on the determinants of health and mortality in older populations; migration and immigration; the impact of state and small area characteristics on health; improved descriptive analyses of centenarian populations; macro and micro dynamics of intergenerational exchanges; use of public and private resources in the period before death; and comparative international analyses of population aging using Census and other data. Description of a Center The center grant for this RFA minimally consists of two required cores: (A) an administrative and research support core, which will provide coordination, research planning, logistical, and centralized data and technical support, and (B) a program development core providing for small scale pilot studies related to program development or methodological innovation. In addition, an application may request funding for (C) an external innovative national or international network core, (D) an external research support and dissemination core, (E) a statistical data enclave core, and (F) a coordinating center function. Each proposed Center should focus on one or more scientific themes or areas directly relevant to population aging. The dollar limit for each core is set in terms of average annual DIRECT COSTS over the life of the requested center rather than simple annual DIRECT COSTS. The following limitations apply to the maximum amount that may be requested for average annual DIRECT COSTS over five years, excluding the indirect costs associated with consortia: core A, up to $360,000; core B, up to $180,000; core C, up to $113,000, core D, up to $225,000, core E, up to $225,000; and core F up to $113,000. For the Center as a whole, the maximum TOTAL COST requested may not exceed $788,000 in the first year, for cores A, B, C, D and E. A 3% per annum inflation increase is allowable in subsequent years. Funds of up to $113,000 in direct costs (plus indirect costs) may be requested per year for the coordinating center function (core F) above the $788,000 total costs limit. Given these constraints plus the limitation on total annual costs, no institution will be able to submit an application for all four optional cores for the full amounts. Therefore, each institution should decide on an optimal mix of topical foci and cores, and within cores, of specific core functions and levels of effort. A. Administrative and Research Support Core (MANDATORY) The Administrative and Research Support core manages the activities of the Center and provides shared resources such as datasets. The application must name a Center Director who will provide the overall scientific management and coordination of the Center. The Center Director must be an experienced researcher with appropriate experience in research on population aging. The objective of this core is to accomplish the following: 1. Plan, coordinate, review and manage the Center's activities. 2. Develop, review, fund and monitor pilot projects. 3. Purchase and provide facilities or services such as centralized data libraries, including the purchase of hardware such as workstations, high capacity storage devices (hardware or equipment purchases may not exceed 15 percent of requested funding), and data files; development of user-friendly data files; salary for data managers; and cost effective data processing for the Institution's research and training on population aging. Facilities and services should have the potential for general use at the institution, and must not be for the sole use of any single project. Any overlap with activities funded or proposed through NICHD center grants must be clearly specified. Salary support may be requested for the scientific director, core technical staff, consultants, and advisors. Travel funds may be requested for researchers to attend scientific meetings, for training of technical and scientific staff, for new program development, and for travel related to outreach and network functions. 4. Manage the Advisory Committee (see SPECIAL REQUIREMENTS). B. Program Development Core (MANDATORY) The objective of this support is to allow the institution to develop sufficient preliminary information to permit the submission of applications for peer-reviewed research or career development projects. To this end, the Center application must request funds to initiate small-scale (in the range of $15,000 to $75,000 direct costs) pilot research that is consistent with the theme of the Center grant and that will lead to new program development. Such pilots could be implemented by both junior and established investigators at the Center institution or at outside institutions or in association with academic partners. Funds may be requested for: 1. Small-scale projects, which may include pilot or feasibility projects. These small-scale projects (in the range of $15,000 to $75,000 direct costs) are ordinarily limited to two years but may be extended with appropriate justification. The application must describe the proposed use of program development funds for two, and only two, pilot projects in each of the first two years of the proposed center. Adequate detail should be provided in order to allow for the evaluation of the scientific value and significance of the proposed activities. Provision should be made in the Administrative and Research Support Core for the institutional review of new projects (including human subjects review). The description of all pilot projects, and any results must be reported in the Center's annual progress report to the NIA. 2. Optional salary support for (a) new faculty development in demography of aging; (b) increasing the critical mass of the scientific research staff; and (c) the development of new program areas and methodologies. Salary support is limited to tenure track faculty (or equivalent in research organizations), and five years per individual. The total annual salary support cannot exceed $84,000 in direct costs (salary and fringe benefits) from the Center grant, and the institution is expected to supplement any such salary costs with funds from other sources. As a target, it is expected that scientists supported through this mechanism will either compete successfully for grant support or receive substantial support from the institution by the end of the third year. C. External Innovative Network Core (OPTIONAL) This optional core differs from the new program development core in that it explicitly is for the development of networks beyond the applicant institution's boundaries, including internationally; hence the designation, external. Any overlap with activities funded or proposed through NICHD center grants must be clearly specified. Funds may be requested for: 1. The development of innovative research networks on the topics listed in the RESEARCH OBJECTIVES section, and consistent with the Center's goals, that will serve to enhance research not only at the institution, but more generally within the field, as well as in relation to other relevant disciplines. Such networks might include electronic bulletin boards, workshops, collaboration on pilot projects, and the development of common research resources. 2. Outreach activities that will encourage and nurture the development of minority researchers. Such activities may include, e.g., sponsoring workshops on minority populations and issues, developing networks of minority researchers, and providing mentorship opportunities. 3. Technical assistance activities intended to support users of large NIA funded databases who are outside the NIA Demography Centers, including the development of a "virtual" Center for those at other institutions. D. External Research Resources Support and Dissemination Core (OPTIONAL) This optional core differs from Core A in that its objective is the communication and dissemination of research resources, findings and new concepts and techniques within and beyond the institution. Applicants are encouraged to propose innovative and creative methods of dissemination. Any overlap with activities funded or proposed through NICHD center grants must be clearly specified. Funds may be requested for, but are not limited to: 1. The dissemination of new methodologies and important databases to the larger scientific community. Encouragement is given for the development, support, and sharing of user-friendly databases and specific analytic methodologies resulting from grants, contracts, and cooperative agreements, both within the institution, and nationally to appropriate researchers. Such dissemination might include, e.g., research and training workshops, development of user-friendly extract files with imputed variables, newsletters, and electronic bulletin boards providing technical support. Development of innovative approaches to dissemination is also encouraged. The value-added components to any on-going activities should be clearly specified. 2. The timely dissemination of well-synthesized research results to the Federal government, scientific community, and policy making community. Strong encouragement is given for the dissemination of research results from NIA sponsored databases on the topics listed above under RESEARCH OBJECTIVES. Such dissemination might include briefings, training seminars, working paper series, and research briefs, and newsletters. Encouragement is also given to translating basic demographic and economic research into research briefs that are easily accessible. E. Statistical Data Enclave Core (OPTIONAL) Demographic and economic aging research depends heavily on large-scale, often-longitudinal, databases with linked administrative (e.g., CMS and SSA) data, geocoding, and, potentially, genetic data. The advent of cheap and powerful computers plus the internet, coupled with increased public and legislative sensitivity and the enactment of the HIPAA Privacy Rule, has created a new environment for this type of research. Increased emphases on cross-national research must deal with international laws on confidentiality and transmission of health data across borders. Any overlap with activities funded or proposed through NICHD center grants must be clearly specified. Funds may be requested for, but are not limited to: 1. Development of leading-edge analytic methods; development of new statistical techniques to mask individual identities in microdata while maintaining the maximum research value of the data. Development of methodology for linking administrative data with longitudinal data sources and distributing the linked files. 2. Statistical analyses of risk disclosure for public use files. 3. Methodological research on the merits and drawbacks of various identity masking strategies. 4. Establishing a secure data enclave for analysis of longitudinal data with sensitive linked administrative records. F. Coordinating Center Function (OPTIONAL) Applicants are encouraged to apply for the coordinating center function in order to promote collaboration and networking among the NIA Demography Centers. Funds of up to $113,000 in direct costs (plus indirect costs) may be requested for these functions above the $788,000 total costs limit. Funds may be used to arrange annual meetings, sponsor multi-center activities or workshops, or produce bibliographic or other special reports that would be of benefit to all NIA Demography Centers. Any overlap with activities funded or proposed through NICHD center grants must be clearly specified. Coordinating Center functions may include, but are not limited to, establishing a multi- center website, coordinating conferences, preparing annual reports and research briefs of center research findings, and funding multi-center activities, including travel to workshops. Although NIA will fund only one Coordinating Center, other centers may propose coordinating functions that would exist independently from the Coordinating Center, such as the development of a series of research briefs which highlight research findings from all the NIA Demography Centers. MECHANISM OF SUPPORT This RFA will use the NIH Research and Development Core Center Grant (P30) mechanism. P30 grants support shared resources and facilities for a multidisciplinary research team or group of investigators focusing on a common research topic. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one- time solicitation. The anticipated award date is July 1, 2004. FUNDS AVAILABLE The NIA intends to commit approximately $4,000,000 in FY 2004 to fund 5 to 10 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for TOTAL COSTS of up to $788,000 per year for Cores A, B, C, D, and E. A 3% per annum inflation increase is allowable in subsequent years. Funds of up to $113,000 per year in direct costs (plus indirect costs) may be requested for the coordinating center function (Core F) above the $788,000 total costs limit. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) 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. The NIA appreciates the value of complementary funding from other public and private sources, including foundations and commercial and industrial concerns, for activities that will complement and expand those supported by the NIA. ELIGIBLE INSTITUTIONS You may submit (an) application(s) 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 Note that foreign organizations are not eligible to apply for P30 grants. A Center on Demography (P30) grant requires substantial pre-existing research activity on population aging at the institution. A minimum of at least two peer-reviewed and externally funded, currently active research projects directly and centrally within the area of demography or economics of health and aging is required. Ideally, applicant institutions will have a substantial base. Sub-projects on NIA P01 grants may be counted as individual projects. Although two peer-reviewed and externally funded, currently active grants is the minimum requirement, considerable weight will be given to significant research activity in demography and economics of health and aging. 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. SPECIAL REQUIREMENTS Advisory Committee The Administrative and Research Support Core should include an Advisory Committee that oversees the functioning of the Center and assists the Director in making the scientific and administrative decisions relating to the Center, including the allocation of funds for pilot studies. Members of the Advisory Committee should NOT be named in the application; instead areas of expertise should be listed. The Advisory Committee should consist of at least five members drawn from diverse expertise. The PI of the Center should be the chair of the Advisory Committee. During the first year of the Center, the Advisory Committee should meet at least twice (one of these meetings may be a conference call, but at least one meeting must be in person) to review the research plans and status of current projects. During the out-years of the Center, the Advisory Committee should meet at least once per year, either in person or by conference call. Minutes of these meetings should be prepared and provided to the NIA Program Official. The Administrative Core budget should reflect the costs associated with communicating with and convening the Advisory Committee. Annual Meeting Demography Center (P30) Principal Investigators and Core leaders will be required to attend an annual meeting held at the Population Association of America, or at another site agreed to by the PIs and the NIA. The travel budget of the Administrative and Research Support core should therefore reflect appropriate allocation for this activity. Funds should be requested for the PI and one additional key personnel (e.g., the co-director, a Core leader, the Center Administrator, etc.) Approval of Pilot Projects NIA policy requires that the specific aims of any pilot project, in addition to the pilot project budget and Curriculum Vitae of the pilot investigator, must be submitted to the NIA Program Official for approval before funds may be expended. Institutional Support The institution and pertinent departments must show a strong commitment to the Center's support. Such commitment may be provided as dedicated space, salary support for investigators, release time, new staff positions, dedicated equipment, clerical support, or other financial support for the proposed Center. 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: Georgeanne E. Patmios Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Avenue, Suite 533, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-3138 FAX: (301) 402-0051 Email: PatmiosG@nia.nih.gov (e-mail correspondence is preferred) o Direct your questions about peer review issues to: Mary Nekola, Ph.D., Chief Scientific Review Office Gateway Building, Room 2C212 Bethesda, MD 20892-9205 Telephone: (301) 496-9666 FAX: (301) 402-0066 E-mail: NekolaM@nia.nih.gov o Direct your questions about financial or grants management matters to: Traci Lafferty Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: laffertt@mail.nih.gov (e-mail correspondence is preferred) 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 IC 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, by fax, to: Dr. Mary Nekola Chief, Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9666 FAX: (301) 402-0066 NekolaM@nia.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: Center applications must follow the application format and page limitations described in the NIA Program Project Guidelines available on the NIA Webpage at http://www.nia.nih.gov/GrantsAndTraining/Policies/ProgramProjectPoliciesandGuidelines.htm. The following exceptions to these guidelines apply: no pre-application permission is required; the eligibility requirements do not apply; the submission date is October 22, 2003; the instructions for amended and supplemental applications do not apply; and the applicable review criteria are listed in the RFA. The Center application must follow the organization format described in the Guidelines. To summarize: Cores are limited to 20 pages for sections a-d and there should be up to a ten-page introduction of the Center as a whole. Regarding the Pilot Core, examples must be given of two pilot projects, and each example should not exceed 2 pages; these descriptions must be included within the 20 pages allotted for the Pilot Core. The 10 page introduction should provide an overview of the Center as a whole and describe how currently available resources will be used to support Center activities. For competing continuations (i.e., Centers supported under AG-99-001) this section should also be used to report progress made under the funded Center grant. The progress report should 1) list the Specific Aims as actually funded and 2) describe studies and activities directed toward the Specific Aims over the last project period. If the specific aims were modified by NIA prior to award (for example because of budget reductions), give the revised aims. This information will be used by reviewers to assess the degree to which original aims have been met and the potential of the competing continuation application to result in significant continuing progress. New applicants should also use this section to describe preliminary studies and ongoing work relevant to the Center application. 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 and all five copies of the appendix must be sent to: Dr. Mary Nekola Chief, Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9666 FAX: (301) 402-0066 Email: NekolaM@nia.nih.gov APPLICATION PROCESSING: Complete applications must be received on or before 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. No additional application materials will be accepted after the receipt date. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIA. 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 NIA 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 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: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. 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. 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? 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? 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? 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)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: For competing continuation applications: o Reviewers will assess the degree to which original aims have been met and the potential that the competing continuation application will result in significant continuing progress. For all applications: o The potential for significant scientific progress in the specific areas or themes addressed by the application, and the overall strategy for developing research in the demography and economics of health and aging generally and specifically within the areas or themes; o The level and extent of funded research directly relevant to the demography and economics of health and aging; o Successful training activity in the area of population aging including the recruitment and training of junior investigators; o The scientific merit of the proposed pilot or new program development projects and the adequacy of the review procedures to assess the scientific merit of future studies; o The value to the institution's researchers of the support and maintenance functions for e.g., databases and methodologies; o Evidence of concrete commitment of the institution's administration to develop and support research and training on population aging; provision of new resources (e.g., co-funding or new positions); and o The scientific value and public good that might result from any proposed external outreach and network building activities. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH: The adequacy of plans to include subjects from both genders and all racial and ethnic groups (and subgroups), as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: September 22, 2003 Application Receipt Date: October 22, 2003 Peer Review Date: February/March 2004 Council Review: May 2004 Earliest Anticipated Start Date: July 1, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm MONITORING PLAN AND DATA AND SAFETY 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 and Safety 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 "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 are 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. 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm 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. REFERENCES Behavioral and Social Research Program, National Institute on Aging, National Institutes of Health. Website: http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/ National Research Council, 2001. Cells and Surveys: Should Biological Measures Be Included in Social Science Research? Finch CE, Vaupel JW and Kinsella K, Editors. Committee on Population. Washington, DC: National Academy Press. (available at http://www.nap.edu.) National Research Council, 2001. New Horizons in Health: An Integrated Approach. Committee on Future Directions for Behavioral and Social Sciences Research at the National Institutes of Health. Burton H. Singer and Carol D. Ryff, editors. Commission on Behavioral and Social Sciences and Education. Washington, DC: National Academy Press. (available at http://www.nap.edu.) National Research Council, 2001. Preparing for an Aging World: The Case for Cross-National Research. Committee on Population and Committee on National Statistics. Washington, DC: National Academy Press. (available at http://www.nap.edu.) National Research Council, 1997. Between Zeus and the Salmon: The Biodemography of Longevity. Wachter KW and Finch CE, Editors. Committee on Population. Washington, DC: National Academy Press. (available at http://www.nap.edu.) National Research Council, 1997. Racial and Ethnic Differences in the Health of Older Americans. Martin LG and Soldo BJ, Editors. Committee on Population. Washington, DC: National Academy Press. (available at http://www.nap.edu.) World Health Organization (2002). The World Health Report: 2002. Reducing risks, promoting healthy life. Geneva: WHO (Available at http://www.who.int/whr.) World Health Organization (2000). The World Health Report: 2000. Health Systems: Improving Performance. Geneva: WHO. (Available at http://www.who.int/whr.) World Health Organization (1999). The World Health Report 1999. Making a Difference. Geneva: WHO. (Available at http://www.who.int/whr.)


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