CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS Release Date: February 10, 2000 RFA: AG-00-001 National Institute on Aging (http://www.nih.gov/nia/) Letter of Intent Date: June 15, 2000 Application Receipt Date: August 23, 2000 PURPOSE The National Institute on Aging (NIA) invites applications for support of Claude D. Pepper Older Americans Independence Centers (OAICs). These centers are for the purpose of increasing independence in older Americans. OAICs will provide support for research to develop and test clinical interventions, and for core laboratories in the basic sciences. OAICs also will train individuals in research approaches to develop and test methods of maintaining and increasing independence, and to enhance expertise in aging research through the provision of training in the relevant fundamental scientific disciplines. They will conduct demonstration projects and information dissemination concerning the applications of such research. Centers should promote linkages between mechanistic and outcome research and thereby foster the development by new investigators of better clinical treatments and preventive approaches. It is recognized that the balance between support devoted to intervention studies and fundamental science will differ among Centers to take advantage of areas of strength in geriatric and gerontologic research available at different institutions. In those instances where applications request significant core resources to enhance ongoing projects, the number and quality of externally funded peer-reviewed studies will be of special importance. OAICs may support a broad range of geriatric and aging research. However, applications with a predominant focus in neuroscience (with the exception of stroke rehabilitation in older persons) or the behavioral and social sciences are more appropriate for other NIA centers' programs with a primary focus in these disciplines. 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 Request for Applications (RFA), Claude D. Pepper Older Americans Independence Centers, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Only U.S. organizations are eligible to apply. Applications may be submitted by 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. MECHANISM OF SUPPORT Older Americans Independence Centers will be supported through the comprehensive center grant (P60) mechanism. The awarding of funds pursuant to this RFA is contingent on availability of funds. FUNDS AVAILABLE First year budgets may not exceed $1.6 million (direct plus facilities and administrative (F&A) costs). Budget increments for subsequent years generally will be limited to no more than one percent. Awards are made initially for five years and may be renewed competitively for five-year periods. Although it is anticipated that up to $6.4 million will be directed to the support of competing OAICs in Fiscal Year 2001, and that four awards will be made from the applications received in response to this RFA, issuance of an Older Americans Independence Center award is contingent upon the receipt of scientifically meritorious applications and allocation of appropriated funds for this purpose. RESEARCH OBJECTIVES Background and Goals Millions of older Americans suffer from loss of abilities needed to live fully independently. Loss of independence imposes enormous personal and financial burdens on older persons and their families. The annual cost to the Nation for care of dependent older persons totals billions of dollars. Dependence is not inevitable in old age. It results from disabling conditions which are potentially, if not currently, preventable or reversible. The development and testing of interventions to reduce disability and increase independence thus offers immense benefits and potential savings in health care costs. To date efforts to develop such interventions and test their efficacy in maintaining and increasing independence have been modest, and the number of researchers with the abilities to conduct such research has been small. There is a need for more researchers and research teams with the ability to: 1) Conduct controlled clinical trials of promising interventions against disabling conditions of older persons. 2) Fill gaps in knowledge of the pathophysiology of disabling conditions, and of the mechanisms affecting their responses to treatment, and develop and test improved treatments based on this knowledge. 3) Develop and test ways of applying independence-enhancing advances in treatment within the American health care system. The combination of these three abilities would allow the conduct of concerted research programs to increase independence for older Americans. The Claude D. Pepper OAIC program is designed to expand this research and the number of researchers capable of conducting it. Specifically, as authorized under amendments to Section 445A of the Public Health Service Act, each OAIC will conduct: "research into the aging processes and into the diagnosis and treatment of diseases, disorders and complications related to aging, including menopause, which research includes research on such treatments, and on medical devices and other medical interventions regarding such diseases, disorders and complications, that can assist individuals in avoiding institutionalization and prolonged hospitalization and in otherwise increasing the independence of the individuals and programs to develop individuals capable of conducting research in these areas." As defined by Section 445A of the Public Health Service Act, "the term independence, with respect to diseases, disorders, and complications of aging, means the functional ability of individuals to perform activities of daily living or instrumental activities of daily living without assistance or supervision." The overall goals of the OAIC program are: 1) To facilitate the development and testing of interventions to increase or maintain abilities needed for independence of older persons. 2) To use knowledge gained in these intervention studies in developing and testing improved interventions. 3) To strengthen core laboratories in the basic sciences as they relate to aging research and to train researchers in the techniques of fundamental research relevant to studies in aging and geriatric medicine. 4) To train researchers capable of leading and conducting research programs as described in 1), 2), and (3) above. OAIC research projects should provide opportunities for the training of such researchers. 5) To translate OAIC research findings into improvements in health care practice through demonstration and dissemination projects. The components of OAICs derive from these goals. OAICs will support intervention studies (IS) and intervention development studies (ID, Research Resources Cores (RRC), Research Development Cores (RDC), Demonstration and Information Dissemination Projects (DIDP) and Leadership/Administrative Cores. These components are described below. Intervention Studies and Intervention Development Studies At least one Intervention Study or Intervention Development Study which utilizes human subjects must be eligible for funding following peer review to qualify as an OAIC. Intervention Studies. Proposed intervention studies must test the efficacy of interventions to prevent or ameliorate functional impairments contributing to loss of independence. Studies may be of effects on long-term disability and/or temporary disability following illness or injury. In studies of prevention interventions, a focus on subgroups at high risk for disability is encouraged where appropriate. All Intervention Studies should measure direct effects on functional status and have adequate statistical power to determine important intervention effects on functional abilities. Central in the evaluation of these studies will be the adequacy and appropriateness of the plans for measurements of changes in functional status. Measures of related medical and physiologic endpoints are encouraged wherever pertinent. Because older persons with multiple health problems are at especially high risk for disability, determinations of the efficacy of interventions in such persons, and analyses of the effects of different health problems on treatment efficacy, are encouraged where feasible. Tests of interventions specifically designed against disabilities resulting from the interaction of two or more comorbid conditions are also encouraged. Besides measurements of intervention effects on the above outcomes, each proposed intervention study must also include planned investigations of: o Mechanisms underlying the interventions' effects on functional status, to provide a basis for further improvements in interventions. Intervention interactions with intermediary response variables such as underlying disease mechanisms, symptoms, and behavioral factors should be measured and analyzed as needed for this purpose. o Factors affecting recruitment into the study and participants' compliance, to provide data for potential wider applications of the interventions are considered pertinent and must be included. o Cost-effectiveness and effects on health care utilization (e.g. hospitalizations, nursing home admissions and stays, use of home care services) of the intervention(s) tested. Proposals for intervention studies which do not contain the above elements will be returned to applicants. Examples of types of interventions for study include: o Interventions to prevent or reduce frailty and increase physical performance abilities. Exercise, nutritional, pharmacologic, rehabilitative, surgical, and other interventions against disorders such as osteoarthritis, congestive heart failure, chronic pulmonary disease, pathologic loss of muscle mass and/or strength, protein-calorie malnutrition, dizziness, nausea, and gait and balance problems are encouraged. o Interventions to reduce risk of disabling events such as hip fractures and strokes, and to reduce impairments following these events. Studies of interventions against osteoporosis and to prevent hip fracture, and studies of techniques to improve functional status after hip fracture and strokes are encouraged. o Interventions to prevent or reduce disabling side effects from medication use. Examples include drug withdrawal studies and testing of non-pharmacologic therapeutic alternatives, as well as testing improved pharmacologic agents or regimens. o Interventions to prevent, lessen, or shorten temporary disability from exacerbation or complications of chronic diseases of older persons. Examples include transient disability associated with exacerbations of chronic pulmonary disease, deconditioning during hospitalization, and acute confusional states. o Interventions to prevent or reduce disabling sequelae of menopause and associated estrogen deficiency. Examples include osteoporotic fractures and urge incontinence. o Combined intervention strategies to prevent or ameliorate disabilities in older persons with multiple impairments. The above list is not exhaustive and its order is not intended to reflect NIA priorities. All studies of promising interventions to enhance independence in older persons are encouraged. No priority is placed on having a diversity of intervention topics associated with a single OAIC. Applicants may find it advantageous to concentrate on one or a few topics in which their strengths are greatest. Subjects for these studies may include older persons living at home, recipients of home care, nursing home residents, hospitalized patients, and those in other pertinent clinical settings, as appropriate to each intervention study. Organizational liaisons involving one or more medical centers, nursing homes, home care services, and other care organizations are encouraged wherever appropriate for the conduct of OAIC activities. All activities to be performed by proposed cores as part of Intervention Studies should be clearly described in the plans for the Intervention Study itself. Examples include functional assessment, biostatistical support, etc. Intervention Development Studies. The OAIC center grant may support other studies to identify, develop, or refine potential interventions to preserve or increase independence. Each proposed Intervention Development Study should present a complete plan for conduct of the proposed research, analogous in the level of detail to an individual research project grant proposal. It should be presented in sufficient detail to allow for full scientific review. Types of such studies include: o Tests of therapies on physiologic factors known to affect functional status. Both beneficial and adverse effects may be studied. o Studies to identify or confirm reversible or preventable risk factors for disability and/or disabling events. Examples include diseases, and previously unidentified pathophysiologic changes leading to functional impairment and/or disabling events. Large-scale epidemiologic studies are outside the scope of this RFA. o Studies of experimental therapeutics directed at the prevention or treatment of morbid conditions associated with aging. Research utilizing animal and/or human subjects is appropriate. (If a study utilizing animal subjects is proposed, another study utilizing human subjects must be included in the IS/IDS section.) All activities to be performed by proposed cores as part of Intervention Development Studies should be clearly described in the plans for the Intervention Development Study itself. Examples include functional assessment, biostatistical support, etc. Research Resources Cores Applicants may request core resource support to enhance the quality of OAIC research projects, i.e., Intervention Studies, Intervention Development Studies and Pilot Research Projects. RRCs for the support of laboratories in the fundamental sciences as they relate to aging research or geriatric medical subspecialties may be requested as well. RRCs may also provide support for research projects relevant to the mission of OAICs whose support is independent of the OAIC. (e.g. R01, P01, foundation Grant). Opportunities to participate in the scientific activities of RRCs should serve to enhance the development of research skills of new investigators and where appropriate should encourage linkages between fundamental science and clinical intervention research. Applicants should not propose a core unless it supports at least two projects (otherwise the core could simply be included in the one project it supports). The justification for proposed cores (including the merit and number of projects they would support) will be evaluated by peer reviewers. Routine patient care costs may not be requested, but research-related patient care costs are eligible for support. Examples of possible RRCs include: o Recruitment/screening/assessment/registry units for subjects for different OAIC intervention study research protocols. o Functional assessment units to monitor functional status of subjects in OAIC studies. o Diagnostic and pathophysiologic units for studies of mechanisms of treatment response and interactions with disease. o Basic science laboratories providing state of the art technologies and training to center investigators. o Biostatistical/data management units. o Cost-effectiveness analysis units. o Veterinary Units for the support of laboratory animals used in aging research and the development of animal models of age-associated diseases. The above list is not intended to describe the full range of activities to be supported, nor to direct applicants towards these areas. Inclusion of research resources cores of any or all these types in a single proposed OAIC is neither required nor necessarily advisable. Innovative organizational approaches are encouraged. Institutions which are recipients of NIH General Clinical Research Center awards who wish to apply for an (OAIC) award are encouraged to use core resources from these Centers for support of OAIC projects where appropriate. For each Research Resources Core proposed, a core leader should be named, and plans for the scientific and administrative functioning must be presented. The method for prioritizing access to core resources requested by multiple projects should be described. Research Development Core The Research Development Core is a required component of all OAICS. The RDC will provide salary and other support for junior faculty and research associates to acquire abilities in research to enhance the independence of older persons. This includes all phases of research to develop interventions to enhance independence, including clinical trials, studies of mechanisms of treatment response, and cost- effectiveness/health care utilization studies. The development of persons who will have the necessary breadth and depth of experience needed to lead teams spanning this range of research is of high priority. The career development of individuals acquiring skills in fundamental aging research related to the mission of OAICs may also be supported here. The research development core should promote linkages between mechanistic and outcome research. This will enhance the capacity of young scientists to develop better clinical treatments and preventive approaches. This goal may be achieved in a variety of ways including periodic meetings of center staff and other scientists and most importantly through the provision of suitable training opportunities. While the creation of these linkages is an important overall function of the RDC, it is recognized that this will not in all cases be feasible. However, the plan for the educational program of the RDC as a whole should describe the approach to be followed and the training plan for at least one (preferably more) of the individuals receiving support under the RDC should document how training opportunities will be utilized to achieve the goal of creating these linkages. The components of the Research Development Core are: Junior Faculty Development Support. Support may be requested for salary and fringe benefits for junior faculty participating in OAIC Intervention Studies and other OAIC research. The Research Development Core should present a plan for achieving development of junior faculty supported under this component, including a mechanism for monitoring their scientific progress and development toward independent research. Applicants should clearly specify the role of senior mentors in training and supervising junior faculty and research associates. A biographical sketch (two pages maximum), a list of active research support, and a brief description of the mentor's role in proposed OAIC activities should be provided for all proposed mentors. Though applicants are not required to identify individual junior faculty, research associates, and their specific roles in advance, they are encouraged to do so if possible, since this information is useful to peer reviewers. If support is requested for "to-be-named" junior faculty or research associates, applicants should present their plans for recruiting, training, and supervising these persons. The Research Development Core may also serve to encourage the research career development of other junior faculty and research associates (in addition to those receiving salary support from this core) by coordinating the participation in OAIC research projects of other junior faculty and research associates whose salary support may come from other sources. The overall contribution of the OAIC to the development of researchers throughout the grantee institution who can contribute to the development of independence-enhancing interventions will be considered in the evaluation of OAIC proposals. Didactic Training. Support may be requested for didactic training in such topics as clinical trials methodology, biostatistics, pertinent topics in disease mechanisms and related basic sciences, behavioral sciences, health services research, etc. Such support is not restricted to individuals receiving salary support from the core, but may be provided to other personnel on OAIC research projects or OAIC Intervention Development Studies. Pilot and Feasibility Studies. Pilot and feasibility studies may be proposed. New initiatives or pilot and feasibility studies for biomedical, epidemiological, or behavioral research may be supported by the RDC funding. These funds may be used for new investigators, investigators from other fields willing to bring their research expertise to geriatrics research, and for investigators whose proposed research would constitute feasibility testing. This funding mechanism is intended to provide modest support which will allow an investigator the opportunity to develop preliminary data sufficient to provide the basis for an application for independent research support through conventional granting mechanisms. New initiatives, or pilot and feasibility studies, are typically limited to a one- time nonrenewable award for a maximum of one year of support. In very special circumstances, which must be described and well justified, two years of support may be requested. Any one investigator is eligible only once for pilot support, unless the additional proposed pilot and feasibility study constitutes a real departure from his or her ongoing research. Pilot and feasibility study support is not intended for large undertakings of established investigators for which it would be appropriate to submit separate research grant applications. Pilot and feasibility funds are not intended to support or supplement ongoing-supported research of an investigator. The proposals for the pilot or feasibility studies should present a testable hypothesis and clearly delineate the question being asked, detail the procedures to be followed, and discuss how the data will be analyzed. Each pilot project is limited to no more than $50,000 direct costs. If the pilot project is requested and justified for two years, the direct costs are limited to $50,000 per year. A maximum of $150,000 (direct costs) may be spent on Pilot and Feasibility Projects. Research Development Core Leader. Support may be requested for a core leader who will be responsible for coordination of the above activities and must report annually on the progress of all individuals supported thorough this core, and other core activities. A maximum of $300,000 in total (direct plus facilities and administrative (F&A) costs) first-year costs may be requested for the Research Development Core. Budget increments in future years will generally be limited to one percent. Demonstration and Information Dissemination Projects OAICS must include a DIDP which supports activities to translate findings from their research into health care practice. These activities would normally be expected to be conducted beginning in the second year of the project, with the first year devoted to planning. A maximum of $50,000 first-year total (direct plus F&A) costs and $80,000 annual total (direct plus F&A) costs for project years two through five may be requested for these activities. (This sum is a ceiling, not a floor; if less is requested in this core, more may be requested in other parts of the application.) Specific projects for demonstration/information dissemination activities should be described. The staffing plan and a rationale for the organization of this core should be presented. The methods and techniques to be employed for information dissemination and the audience targeted and size should be defined. Attention should be directed to issues of cultural sensitivity with regard to the target audience. Where appropriate, the information should be structured so that it can effectively reach minority populations, including non- English-speaking older people. Examples of projects that may be supported include dissemination of research results to the public, professionals, and paraprofessionals, through symposia and in-service training. Planning and pilot activities for larger scale demonstration projects to evaluate the practicability of interventions tested in OAICs within various health care settings are also appropriate. Leadership/Administrative Core Applicants may include a Leadership/Administrative Core which requests funds for the OAIC director, OAIC administrator, and support staff. The OAIC director should be a scientist who can provide effective administrative and scientific leadership and coordination with OAIC Intervention Studies. An OAIC administrator who will assist the director in managing the Center, addressing issues of fiscal management and compliance with institutional, PHS, NIH and NIA policies, should be identified. A maximum of $120,000 (direct plus F&A costs) per year for this core, for salary, travel, and other expenses of the director, administrator and appropriate administrative staff may be requested. Future year annual increases will generally be limited to no more than one percent. OAIC Advisory Panel. OAIC applications, regardless of whether a Leadership/Administrative Core is requested, must describe a plan and budget for the selection of experts from outside the OAIC who will meet yearly to review the progress of the OAIC and provide a written report to the OAIC Director. Potential outside experts should not be selected or named. The outside experts' review will be included in the annual OAIC Progress Report to the NIA. (A member of the NIA extramural staff assigned to each Center will routinely attend the Advisory Panel meetings. It will be the OAIC Director's responsibility to notify NIA Staff well in advance of the date scheduled). Coordination Among OAICs. OAICs are expected to meet together yearly to compare research results and to explore possibilities for collaborative efforts. Funds should be requested to permit travel of the OAIC director, administrator and PIs on all OAIC Intervention Studies, and Intervention Development Studies for meetings with NIA staff and staff from other OAICs. Responsibility for organizing these meetings will rotate among OAIC sites. Required Components of an OAIC. The minimum required components which must be determined to be eligible for funding by the peer reviewers in order to qualify for an OAIC Award are 1) at least one Intervention Study or Intervention Development Study 2) a Research Development Core and 3) a Demonstration and Information Dissemination Project. All required components must be recommended for the full 5 years in order for the application to be eligible for funding. The total first year budget may not exceed $1,600,000 (direct plus F&A costs) and the total first year budget for the sum of the Research Resources Cores, Research Development Core, Demonstration and Information Dissemination Project and the Leadership/Administrative Core may not exceed $1,275,000. Thus, a center application requesting the full $1,600,000 will have an Intervention Study/Intervention Development Study first year total budget request of at least $325,000. SPECIAL REQUIREMENTS SPECIAL NOTE: Required Components of an OAIC. The minimum required components which must be determined to be eligible for funding by the peer reviewers in order to qualify for an OAIC Award are 1) at least one Intervention Study or Intervention Development study utilizing human subjects. 2) a Research Development Core and; 3) a Demonstration and Information Dissemination Project. All required components must be recommended for the full five years in order for the applications to be considered for funding. 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 is provided 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 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 reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, https://grants.nih.gov/grants/guide/notice-files/not94-100.html CLINICAL RESEARCH All proposed clinical research must adhere to "Implementation of Policies for Human Intervention Studies", originally published in the NIH Guide, Volume 25, Number 33, October 4, 1996, and now revised and available from https://grants.nih.gov/grants/guide/notice-files/not98-084.html. NIA further requires adherence to its own clinical research policy statement to be found at http://www.nih.gov/nia/resfund/humint.htm. LETTER OF INTENT Prospective applicants are asked to submit, by the letter of intent receipt date listed in the heading of this RFA, a letter that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the 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 subsequent applications, the information that it contains allows NIA staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to the program staff listed under INQUIRIES by the letter of intent receipt date listed in the heading of this RFA. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, MSC, 7910, Bethesda, MD 20892-7910, telephone 301/710-0267. The application should be prepared using the OAIC (P60) Guidelines available from the program administrator listed under INQUIRIES. Page Limitation Applications may not exceed a total of twenty-five (25) pages for parts a-d of the Research Plan for each project and (10) pages for each core section, with the exception of The Research Development Core which may include an additional (10) pages for the Research Plan of each pilot project. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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 sample RFA label available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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, At the time of submission, two additional copies of the application must be sent to: Mary Nekola, Ph.D., Chief, SRO National Institute on Aging Gateway Building - Room 2C212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the program staff of 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 NIA in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the relevant institute advisory 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. The reviewers will comment on the following aspects of the application in their written critiques 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. The five criteria to be used in the evaluation of grant applications are listed below. 1. Significance. o Will the program be effective in contributing to increasing independence for older Americans through the conduct of research, demonstration, and dissemination projects; and developing academic leaders in geriatrics who have effective research, teaching and clinical capabilities? o Will the research provide foundations or infrastructure for other research and outstanding opportunities for career development of researchers in geriatrics and gerontology? o Will the research advance human health directly or indirectly? o Will the OAIC have a significant effect on the concepts or methods that drive efforts to enhance independence for older persons? 2. Approach. o Is the conceptual, organizational and operational framework reasonable and appropriate to the aims of the project? o Do the Research Resources Cores, where included, enhance the quality of research, training and pilot projects. Where major resources are requested for the RRCs, the number and quality of externally-funded peer-reviewed studies will be of considerable importance. o Does the Research Development Core provide educational and other career development opportunities for fellows, junior faculty and other professional and paraprofessional personnel associated with the Center? The quality of the plans to promote linkages between mechanistic and applied research are an important aspect in the evaluation of the RDC. For competing renewal applications, the subsequent career activities of junior faculty and other professionals supported in the prior funding cycle(s) will be of importance. o Are there adequate arrangements for internal quality control of ongoing research, the allocation of funds, day-to-day management, contractual agreements, the internal communication and cooperation among investigators in the program? o Does the program incorporate both fundamental discovery and the development of applied research? o Does the RDC provide a viable strategy for career development and a menu of education opportunities, ranging from formal programs to courses and seminars, visiting scientist programs, etc? o Is there a viable strategy to develop a plan for making tangible, useful output available to the research community? o Is there a clear plan for defining sharing of responsibilities among investigators and between institutions (if more than one institution is involved)? o Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. o Does the OAIC employ novel approaches or methods for facilitating scientific interaction? o Are the proposed projects original and innovative? o Does the OAIC group challenge existing paradigms or develop new methodologies or technologies? 4. Investigators. o Are the OAIC PI, and lead investigators appropriately trained and well suited to the organizational and scientific responsibilities associated with this project? o If there are plans to recruit investigator(s), are those plans reasonable and necessary and can those efforts be completed in a timely manner, such that the recruited investigator(s) can make meaningful contributions to the OAIC? 5. Environment. o Is there evidence of significant commitment of the institution to fulfilling the objectives of the OAIC? o What is the quality of the academic and physical environment as it bears on patients, space and equipment and on the potential for interaction among scientists within the center and with scientists from other departments, institutions and Claude D. Pepper Centers? o If collaborative arrangements are proposed, is there a convincing demonstration that these interactions will be consistent enough to meet the needs of the OAIC? o Is the proposed external review process adequate? The initial review group will also examine: 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 adequacy of plans for the provisions for the protection of human and animal subjects; and the safety of the research environment. For competing renewal applications, an assessment of achievements during the prior award period is an important aspect for evaluation. AWARD CRITERIA The award criteria are: o priority score o availability of funds o programmatic priorities OAIC awards will be based primarily on the basis of scientific merit as determined by peer review, availability of funds, and programmatic priorities. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Stanley L. Slater, M.D. Geriatrics Program National Institute on Aging Gateway Building, 3E-327 Bethesda, Maryland 20892-9205 Telephone: (301) 496-6761 Fax: (301) 402-1784 Email: Slaters@exmur.nia.nih.gov Direct inquiries regarding fiscal matters to: David Reiter Grants Management Office National Institute on Aging Gateway Building, Room 2N_212 Bethesda, Maryland 20892-9205 Telephone (301) 496_1472 Email: ReiterD@exmur.nia.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. Awards are 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 Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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