NIA PILOT RESEARCH GRANT PROGRAM Release Date: February 2, 2000 PA NUMBER: PA-00-053 National Institute on Aging Application Receipt Dates: March 17, 2000; July 17, 2000; November 17, 2000 THIS PA USES MODULAR GRANT AND JUST-IN-TIME APPLICATION PROCEDURES. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The National Institute on Aging (NIA) is seeking small grant (R03) applications in specific areas to: (1) stimulate and facilitate the entry of promising new investigators into aging research, and (2) encourage established investigators to enter new targeted, high priority areas in this research field. This Small Grant (R03) Program provides support for pilot research that is likely to lead to a subsequent individual research project grant (R01) that is focused on aging and/or a significant advancement of aging research. HEALTHY PEOPLE 2000 Each NIH PA addresses one or more of 22 Health Promotion and Disease Prevention priority areas identified. These areas can be found via the WWW at http://odphp.osophs.dhhs.gov/pubs/hp2000 ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign organizations and institutions are not eligible. Participation in the program by investigators at minority institutions is strongly encouraged. New or established investigators are eligible to apply for this award. (1) Investigators are considered new when they are neither current nor former principal investigators on NIH research project (R01), FIRST Awards (R29), sub-projects of program project (P01) or center grants (P50), and the equivalent. If the applicant is in the final stages of training it is permissible to apply for an R03 but no award will be made to individuals who are still in training or fellowship status at the time of award (see reference to Biosketch under Application Procedures). (2) For an established investigator to be eligible the individual must propose research that is unrelated to any federally-funded research project in which the investigator participates. MECHANISM OF SUPPORT Applicants may request either $25,000 or $50,000 in direct costs for one year through the small grant (R03) mechanism. These awards are not renewable. Before completion of the R03, investigators are encouraged to seek continuing support for research through a research project grant (R01). Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by NIH. Complete and detailed instructions and information on Modular Grant applications can be found at: https://grants.nih.gov/grants/funding/modular/modular.htm. Replacement of the Principal Investigator on this award is not permitted. Revisions of applications previously reviewed under this initiative but unfunded are not permitted. A new application must be substantially different from one previously reviewed and have a different title in order to be accepted for review. It must be responsive to the announcement that is active at the time the new application is submitted. All applications will be reviewed as new applications. RESEARCH OBJECTIVES Investigators may apply for a small grant in one of the following areas. Applications for support in other areas will be returned to the proposed Principal Investigator without review. Investigators should follow the instructions described under APPLICATION PROCEDURES to identify the topic on which the application is focused. 1. HIV/AIDS and Aging: Behavioral, social, clinical, neuroscientific, and/or biological research on older people infected by, and affected by, HIV/AIDS. Prevention sciences research is encouraged, and both basic and applied research are welcomed. 2. Medication and Aging: Research on the epidemiological, social, economic, behavioral, and biological aspects of medication use in the elderly. Research is encouraged on the multiple factors that affect medication use and its outcomes in the elderly, with special emphasis on factors affecting misuse and strategies for improving drug taking and drug prescribing behaviors. Research leading to reduction of medication errors as noted in the recent IOM Report To Err Is Human: Building a Safer Health System is strongly encouraged. 3. Racial/Ethnic Differences: (1) Research leading to identification of underlying mechanisms, including cellular and molecular mechanisms, linked to racial/ethnic differences in late life function or disease e.g. cognition, Alzheimer's disease, cardiovascular disease, cancer, infectious diseases, and diabetes. (2) Research on clinical, and social factors contributing to racial/ethnic differences and changing patterns of difference in late life diseases and disability. 4. Cardiovascular and Cerebrovascular aging: Behavioral, social, cellular, and molecular studies of cardiovascular and cerebrovascular aging. N.B. Applications for clinical studies, exclusively on the aging cardiovascular system, will not be accepted in response to this announcement. 5. Stems Cells, Tissue Repair, and Cell Replacement in Aging: Studies on the biology of stem cells as a function of aging and disease; genetic and environmental effects on tissue stem cells; development of cell markers and imaging techniques to identify and monitor stem cells in vivo; and transplantation of stem cells to effect tissue repair. Investigators are advised to consult the NIA staff listed under INQUIRIES to determine the status of NIH guidelines for stem cell research. These guidelines are under development at the time of publication of this announcement. 6. Neural Modeling: Studies to develop computational neural-network models of neural changes with age that impact behavioral outcomes of memory, learning, sensory function, and motor function as well as plasticity. 7. Sensory and Motor Processing: Mechanisms underlying age-related changes in sensory and motor processing in the nervous system and in sensory receptors. 8. Alzheimer's Disease Drug Discovery: Studies for preclinical research in the discovery, design, development and testing of novel compounds aimed at slowing, halting, or, if possible, reversing the progressive decline in cognitive function and modifying the behavioral symptoms in Alzheimer's disease victims as well as delaying the onset of or preventing Alzheimer's disease. 9. Sleep and Circadian Processes: Mechanisms underlying changes in sleep and circadian processes in older organisms. Studies at the molecular and cellular level are encouraged. 10. Extracellular Matrix and Cytoskeleton: Studies on age-related changes in the structure, content, or function of the extracellular matrix and cytoskeleton, including regulation of cell signaling cascades, intracellular transport mechanisms, cell motility and morphology, and cell death. 11. Functional Senescence: Genetic, cellular and biochemical basis of functional senescence: (including phenotypic characterization of age-related changes.). 12. Psychoneuroimmunology: The interactions of neural and neuroendocrine mechanisms with immune pathways modulating the aging immune system response to psychologic and pathologic challenges, and understanding the mechanisms underlying "placebo" effects with age. 13. Vaccine Development: Preliminary basic and clinical studies, and therapeutic trials of vaccines for use in elderly populations. Vaccines may be prophylactic or therapeutic in nature. These may include studies of methods to enhance the immune response in older persons including alternative administration schedules with existing vaccines, the use of adjuvants, and/or new vaccines. 14. Health-related Consequences of Female Reproductive Aging: Basic molecular and cellular research to elucidate underlying neuroendocrine, endocrine and physiologic mechanisms of the female reproductive aging process, especially changes across the hypothalamic-pituitary-ovarian axis leading to menopause in women, and the association of hormonal and other changes in that process with increased risk for health problems associated with the peri- and postmenopause, e.g., cardiovascular disease, osteoporosis, brain pathology, cognitive impairment, sleep disturbances, hot flashes, urinary incontinence, excessive uterine bleeding, vulvovaginal dysfunction, etc. 15. Biology of Age-related Prostate Growth: Basic molecular and cellular research to explore underlying mechanisms responsible for prostate growth in men leading to benign prostatic hyperplasia and prostate cancer. 16. Nutrient Modulation: Mechanisms that underlie nutrient modulation of cellular, tissue and organ integrity during the aging process. This might include but is not limited to nutrient requirements, nutrient modulation/control of cell homeostasis, repair and regeneration, cell-cell signaling, and transport mechanisms at the molecular level. 17. Basic Underlying Mechanisms of Musculoskeletal Aging (muscle, bone, cartilage, neuromuscular junction, peripheral nerve, and motorneuron). Applications for clinical studies on the aging musculoskeletal system will be considered non-responsive to this research bullet. Investigators interested in submitting exploratory/pilot clinical studies of the aging musculoskeletal system are encouraged to contact the Geriatrics Program (E-mail: Gpquery@exmur.nia.nih.gov) to explore other options. 18. Animal Models of Aging: Development of new and informative mammalian models for aging research, including genetically defined and/or genetically altered animals. 19. Tools for Research on the Genetics of Aging: Development of tools such as cDNA full length libraries, single nucleotide polymorphism (SNP) analysis, and conditional gene expression systems for studying the genetic basis of aging. High priority will be given to proposals to demonstrate proof of principle using high throughput technology, e.g. microarrays, to obtain data on age-related changes in gene expression or DNA sequence in addressing questions of gerontological significance. To encourage such applications NIA has set aside funds specifically for meritorious applications submitted in response to this bullet. 20. Genetic Epidemiology: Preliminary studies (including analyses of existing datasets and/or research on subjects in ongoing studies) to evaluate prospects for subsequent studies to determine genetic influences on outcomes such as longevity, active life expectancy, and/or rates of change of age- related pathologies. Examples include analyses of existing population-based and/or family studies data for feasibility and power calculations; pilot testing of proband- identification and recruitment strategies; identifying families with high frequencies of these traits; determining the frequency of known polymorphisms, and/or estimating their contribution to the phenotype of interest. Pilot studies for linkage of two or more data sets to facilitate larger sampling frames by combining familial and medical information are also of interest. 21. Data Collection in Population Aging: New pilot data collection leading to large scale new or enhanced surveys and studies on topics such as retirement, health disparities, trends in disability, biodemography, and early determinants of late life health (including birth to death studies). Feasibility studies are frequently needed to determine whether or not the studies can actually be done and to establish appropriate methodologies. International comparative studies are permitted. 22. Personality and Experimental Social Psychology: Applications are solicited for personality and genetics, personality in social context, personality trait- structure-process interactions, personality stability and change, personality theory, personality and health, interpersonal relationships, life-course transitions, social cognition, attribution, and decision making. 23. Care for Older People: (1) Studies on self-management for older people with chronic illnesses and disabilities, family care, and doctor-patient encounters. (2) Studies on how the organization and delivery of care for older people influence health-related behaviors and outcomes. (3) Research on the determinants and outcomes of new ways of organizing care in nursing home settings and assisted living facilities. 24. Work and Older Workers: Research on the demographic, economic, social, psychological, and human factors aspects of older workers in the workplace. The National Institute on Aging will modify the selected topic areas annually by reissuing the program announcement. Information on other initiatives supported by NIA may be found at the following internet address: http://www.nih.gov/nia. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. These may be accessed at: https://grants.nih.gov/grants/guide/notice-files/not94-100.html Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and prepared according to the directions in the application packet, with the exceptions noted below. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892- 7910, telephone (301) 710-0267, FAX (301) 480-0525, Email: grantsinfo@nih.gov. On the face page of the application: Item 2 Type "NIA: PILOT RESEARCH GRANT PROGRAM" and the number of the program announcement. Check the "YES" box. Abstract: The first line of the abstract must list the number and title of the particular research topic (see RESEARCH OBJECTIVES) being responded to. Biosketch (also see below under modular procedures): Applicants who remain in training or in fellowship status at the time of application should list in their biosketch the position they will occupy at the time of award with the expected start date in that position. If the position is contingent on receipt of the award then it should be described as "contingent on award". Research plan: Do not exceed a total of ten pages for the following parts (a- d): Specific Aims, Background and Significance, Progress Report/Preliminary Studies, and Experimental Design and Methods. Tables and figures are included in the ten page limitation. Applications that exceed the page limitation or PHS requirements for type size and margins (Refer to PHS 398 application for details) will be returned to the investigator. The ten page limitation does not include parts e through i. (Human Subjects, Vertebrate Animals, Literature Cited, Consortium Arrangements, Consultants). Appendix: The only items that may be included in an appendix are original glossy photographs or color images of gels, micrographs, etc., provided that a photocopy (that may be reduced in size) is also included within the 10 page limit of items a-d in the research plan. No photographs or color images may be included in the appendix that are not also represented in the Research Plan. Do not include publications or preprints. Materials submitted after the receipt date. No additional materials pertaining to a particular application will be accepted after the receipt date for which the application is submitted except for certifications of Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) approval. As specified in the PHS 398 form, certifications of IRB or IACUC approval must be received within 60 days after the receipt date for which the application is submitted. The NIA pilot grant program will follow modular procedures (See https://grants.nih.gov/grants/funding/modular/modular.htm) for application and award. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. MODULAR BUDGET INSTRUCTIONS Applications in response to this announcement should request either $25,000 in total direct costs or $50,000 in total direct costs. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (either $25,000 or $50,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. As these are one year applications items 8a and 8b should show the same amounts as items 7a and 7b. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) rounded to the nearest $1,000. List the individuals/ organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: https://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the form page; - List position(s) and any honors; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years; - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Submit a signed, original of the application, and three exact photocopies, including the checklist, 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) In addition, to prepare for review of the application, submit two additional exact photocopies of the application directly to: Dr. Mary Nekola Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Bethesda, MD 20892-9205 It is important that applicants submit two additional copies to the Scientific Review Office as requested. Amended applications will not be accepted. The submission, review, and award schedule for the Pilot Research Grant Program for 2000 is: Application Receipt Dates: 03/17/2000 07/17/2000 11/17/2000 Institute Committee Review: Jun-Jul Oct-Nov Feb-Mar Earliest Funding: Sep 2000 Jan 2001 May 2001 Only one Small Grant application may be submitted by a Principal Investigator per receipt date in response to this program announcement. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR. Applications for this PA must focus on one of the 24 topics identified. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete 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 receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, and assigned a priority score. 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 review, comments on the following aspects of the application will be made in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of a pilot project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the likelihood that the pilot project will lead to the development of an R01 application, or significant advancement of aging research; the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review o availability of funds o program priority INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. For applications with primary emphasis on the biology of aging contact: Dr. David B. Finkelstein Biology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 2C231, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: BAPquery@exmur.nia.nih.gov For applications with primary emphasis on behavioral or social research on aging contact: Ms. Angie Chon-Lee Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Avenue, Suite 5C533, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 594-5943 FAX: (301) 402-0051 Email: BSRquery@exmur.nia.nih.gov For applications with primary emphasis on the neuroscience or neuropsychology of aging contact: Dr. Judy Finkelstein Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3C307, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: NNAquery@exmur.nia.nih.gov For applications with primary emphasis on geriatrics research contact: Ms. Wanda Solomon Geriatrics Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3E327 MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 435-3046 FAX: (301) 402-1784 Email: GPquery@exmur.nia.nih.gov Direct inquiries regarding fiscal matters to: Mr. Joe Ellis 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: ellisJ@exmur.nia.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.866. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410), as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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