PAR-98-021: NATIONAL INSTITUTE ON AGING: PILOT RESEARCH GRANT PROGRAM

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NATIONAL INSTITUTE ON AGING: PILOT RESEARCH GRANT PROGRAM Release Date: January 9, 1998 PA NUMBER: PAR-98-021 P.T. National Institute on Aging Application Receipt Dates: March 17, 1998, July 17, 1998, November 17, 1998 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, or (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 up to $50,000 (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. Revisions of applications previously reviewed under this initiative but unfunded are not permitted. 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. Racial and ethnic differences: Studies on causes of differences among ethnic and racial groups in susceptibility to age-related disease and dysfunction. 3. Cartilage aging/Osteoarthritis (OA): Studies of the basic underlying mechanisms of cartilage aging, including changes in cartilage turnover, signal transduction and regulation of cartilage gene expression, and pilot studies of new clinical diagnostic tools for OA (e.g., novel imaging techniques, new or improved methods to quantitate data from radiographs or MRI scans, and identification of potential biochemical markers for OA). 4. Cardiovascular and cerebrovascular aging: Behavioral, social, clinical, and biological studies of cardiovascular and cerebrovascular aging. Clinical studies include systems physiology and integrative approaches to defining age-associated changes in the cardiovascular, cerebrovascular, pulmonary or renal systems and how these changes increase the risk of developing cardiovascular and cerebrovascular disease. 5. Alternatives to estrogen therapy: Preliminary clinical studies to explore potential therapeutic benefits, feasibility, and/or risks of administering selective estrogen receptor modulators (SERMs) to middle-aged and older women and men to prevent, retard or treat a variety of age-related disorders such as osteoporosis, cardiovascular disease and Alzheimer’s disease. Potential therapeutics may include pharmaceuticals or naturally occurring substances, such as phytoestrogens. 6. Reproductive aging: Molecular and cellular mechanisms of reproductive aging: areas include prostate growth in middle-aged and older subjects (see PA-93-052, Prostate Growth in Older Men: Age-dependent Mechanisms), biology of the menopausal process (see PA-95-006, Biology of the Menopause: Change of Ovarian Function) including molecular and cellular mechanisms underlying development of cardiovascular and brain pathology, and neuroendocrine mechanisms underlying reproductive senescence. 7. 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 modulation/control of cell repair and regeneration, cell-cell signaling, and transport mechanisms at the molecular level. 8. DNA polymorphisms: Studies to identify DNA polymorphisms in candidate genes that may affect age-related pathologies and/or lifespan in either human or animal models. 9. Gene expression vectors: Development and/or use of conditional gene expression vectors for the regulation of aging- and cell-specific gene expression. 10. Enhancing self care and management: How older people recognize and act upon new illness symptoms and/or manage everyday chronic conditions and how they interact with their health care providers. Three types of research are solicited: 1) basic research exploring the patterns, dynamics and processes of self care behaviors practiced by older adults, 2) the design, implementation, and evaluation of theoretically based self-care interventions, and 3) either basic or intervention studies examining the nature and outcomes of older-patient/health provider medical encounters and interactions. 11. Social and structural factors in health care: Interactions between changing health care systems and the needs of aging persons in an aging society:1) impact of the type of health care organization on clinical outcomes, patient satisfaction, and/or provider satisfaction, 2) health and social consequences of a change in the usual source, quality, and quantity of health care at the time of Medicare enrollment, 3) effect of managed care"s prevention model on clinical and behavioral outcomes in an aging patient base, and 4) the dynamic interplay between changing needs of aging persons and changing health care delivery system characteristics. 12. Death and dying: Research on understanding the role of family, care providers, and relevant social institutions upon decreasing the trauma and difficulty of end-of-life decisions. Research on the dying process as a normal life transition within a social context is also solicited. 13. Social psychology of aging: Interplay among psychological processes and personal relationships in the immediate social environment as people age in regard to: 1) close interpersonal relationships (friends and family) in midlife and old age, and 2) social cognition (e.g., knowledge schemas, collaborative cognition, emotion and motivation, self regulation, self evaluation, and attitudes and beliefs including stereotypes and automaticity, (see PA-97-065, Social Cognition and Aging, NIH Guide, Vol. 26, No. 19, June 6, 1997). 14. Personality in adulthood and old age: Studies of stability and change in personality with age, personality, health and disease, personality and environment, personality and genetics, and age-related differences in personality by socioeconomic class, gender, and racial/ethnic groups. 15. Behavior genetics and aging: Suggested areas for behavior genetics and aging research in both humans and animals include attention, processing speed, memory, intelligence, training, emotionality, sense of control, motivation, and temporal organization. 16. Sensory and motor processing: Mechanisms underlying changes in sensory and motor processing in the aging nervous system and in sensory receptors. 17. Attention and frontal lobe function: Studies of neural mechanisms of age- related changes in attention and frontal lobe executive processes. Development of specific behavioral tasks of attention and other areas of cognition for use in evaluation of animal models generated through genetic and molecular manipulations. 18. Neuronal tissue RNA metabolism: Regulation of RNA metabolism in cells of the nervous system during aging and in age-related neurological disorders. 19. Sleep and circadian processes: Mechanisms underlying changes in sleep and circadian processes in older organisms. Studies at the molecular and cellular level are encouraged. 20. Blood-brain barrier: Research on changes that occur at the molecular level in the blood brain barrier, especially its transport mechanisms, with age and age-related diseases. 21. Amyloid precursor protein: Studies of the normal function of the CNS amyloid precursor protein. Studies of the amyloid beta protein are excluded. 22. Pathogenic organisms: Susceptibility of the aging nervous system to pathogenic organisms, and neural, neuroendocrine and immune system mechanisms and pathways modulating the aging immune system in response to such challenges. 23. Non-neuronal cells in the nervous system: Studies on the function and plasticity of neuroglial/non-neuronal cells in aging that examine cellular and molecular factors controlling cell activation, death, regional specificity, receptor and transport activities, and mitochondrial alterations. 24. Genetic epidemiology: Preliminary genetic epidemiologic research on longevity, active life expectancy, or slow rate of progression of age-related pathologies. Examples include analyses of existing familial, demographic, and/or epidemiologic 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. (See also program announcement on Secondary Analysis in Demography and Economics of Aging.) 25. 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. 26. Cancer and aging: Studies on the current and future magnitude of the cancer problem for persons aged 80 years and older regarding incidence, survival, and clinical impact. Topics include: Approaches to overcoming the practical problems of acquiring data on this age segment of cancer patients, tumor-related tissue studies, autopsy investigations, characterization of cancer as it interfaces with other chronic diseases prominent in the elderly. Development of clinical assessment tools(i.e., prognostic indicators for patient evaluation and work-up) that can be used by physicians to determine the patient’s overall physical and physiologic health status may be included in this solicitation. 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. 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. 5/95) 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) 435-0714, FAX (301) 480-0525, Email: ASKNIH@OD.NIH.GOV. On the face page of the application: Item 2 Type "NATIONAL INSTITUTE ON AGING: PILOT RESEARCH GRANT PROGRAM - PAR-98-021." 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 and whether the principal investigator is a new or established investigator. 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. 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 courier/overnight 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. Amended applications will not be accepted. The submission, review, and award schedule for the Small Grant Program for 1998 is: Application Receipt Dates: 03/17/98 07/17/98 11/17/98 Institute Committee Review: June-July Oct-Nov Feb-March Earliest Funding: Sep 1998 Jan 1999 May 1999 Only one Small Grant application may be submitted by a principal investigator per receipt date. 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 will be assigned on the basis of established PHS referral guidelines. 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, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. 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 in the assignment of the overall score. 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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