PA-99-049: NIA PILOT RESEARCH GRANT PROGRAM

Department of Health
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NIA PILOT RESEARCH GRANT PROGRAM Release Date: January 22, 1999 PA NUMBER: PA-99-049 P.T. National Institute on Aging Application Receipt Dates: March 17, 1999, July 16, 1999, November 17, 1999 THIS PROGRAM ANNOUNCEMENT USES MODULAR GRANT PROCEDURES. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. (SEE APPLICATION PROCEDURES. ALSO SEE MODULAR GRANT APPLICATION AND AWARD NOTICE http://www.nih.gov/grants/guide/notice-files/not98-178.html) 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) and/or a significant advancement of aging research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), National Institute on Aging: Pilot Research Grant Program, is related to several priority areas applicable to aging. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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) For a new investigator to be eligible the individual should be in the first five years of his or her independent research career. 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. (2) For an established investigator to be eligible the individual must propose research that is unrelated to a currently 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). Replacement of the Principal Investigator on this award is 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 program 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, 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. 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. Investigations should control for known educational and economic differences. 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. Glial Cells in Aging and Neurodegeneration: Studies on the function and plasticity of neuroglia/non-neuronal cells that examine cellular and molecular factors controlling cell activation, death, regionally-specific responses, and receptor and transport activities, including changes in the blood brain barrier, with age and age-related disorders. 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. Amyloid Precursor Protein: Studies on the functions and interactions of the amyloid precursor protein and its homologs, especially in the nervous system, in aging and disease, in both human and animal model systems. Investigations centering on the amyloid beta-peptide, per se, are excluded. 9. 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. 10. Vaccines and immune response: Preliminary clinical studies designed to contribute to the improvement of vaccines for use in elderly populations. These may include studies of methods to improve the immune response in older persons including alternate immunization schedules with existing vaccines or the use of new vaccines. Human clinical studies designed to characterize age-related immune dysfunction are also appropriate as they may contribute to the identification of potentially correctable deficiencies. 11. Sleep and Circadian Processes: Mechanisms underlying changes in sleep and circadian processes in older organisms. Studies at the molecular and cellular level are encouraged. 12. 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. 13. Genetic, cellular and biochemical basis of functional senescence: (including phenotypic characterization of age-related changes.) 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 middle-aged 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: - to develop 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. 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, and attribution. 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 changes in the organization and delivery of care for older people (e.g., closing of Medicare HMOs) 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. Elder Abuse and Neglect: Studies that determine the ability of various methodological techniques to measure abuse and neglect in the elderly. Studies are needed to compare techniques such as face-to-face surveys, telephone interviews, undercounts, sentinel tracking, etc., as means to determine the prevalence of this socially stigmatized phenomenon. 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: http://www.nih.gov/grants/guide/notice-files/not94-105.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. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. However, the scientific goals of this program announcement are focused on aging. In describing the plan to recruit human subjects, investigators may cite a focus on aging or on aging-related aspects of disease as the justification for why children will be excluded. In this regard applicants may use Justification 1, the research topic to be studied is irrelevant to children, from the policy announcement. 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 - PA-99-049." Check the "YES" box. 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 for application and award. The following changes to the instructions in the PHS 398 form pertain to the use of the modular application and award process. Use these instructions to complete the application. FACE PAGE: Item 7a should be completed, indicating Total Direct Costs for the first year requested either as $25,000 or $50,000 annual direct costs. Item 7b should reflect Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs]. As this program provides funds for one year only, Items 8a and 8b should show the same costs as items 7a and 7b DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. NARRATIVE BUDGET JUSTIFICATION Use a Modular Grant Budget Narrative page. (See http://www.nih.gov/grants/funding/modular/modular.htm ) At the top of the page enter the total direct costs requested. Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. For Consortium/Contractual, costs provide an estimate of total costs (direct and F&A) 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. BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://www.nih.gov/grants/funding/modular/modular.htm . -Complete the educational block at the top of the form page, -List current position(s) and then previous positions, -List selected peer-reviewed publications, with full citations, -Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. 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. It is important to identify all exclusions that were used in the calculation of the F&A costs for the proposed budget period. 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 expedite the 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 In order not to delay review, it is important that applicants comply with this request. The submission, review, and award schedule for the Pilot Research Grant Program for 1999 is: Application Receipt Dates: 03/17/99 07/16/99 11/17/99 Institute Committee Review: Jun/Jul Oct-Nov Feb-Mar Earliest Funding: Sep 1999 Jan 2000 May 2000 Applicants may not submit other research project grant applications on the same topic concurrent (to be considered at the same review cycle) with the submission of a Small Grant application. REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and 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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