PART THREE OF THREE FULL TEXT OF RFAs FOR ONLINE ACCESS DATA-BASED INTERVENTION RESEARCH FOR PUBLIC HEALTH AGENCIES RFA AVAILABLE: 89-CA-14 P.T. 34; K.W. 0715035, 0745027, 0795003, 0755018 National Cancer Institute Letter of Intent Receipt Date: September 1, 1989 Application Receipt Date: November 15, 1989 The Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI) invites applications for cooperative agreements in support of projects that will serve as models of data use in the planning and evaluation of statewide cancer prevention and control interventions. The RFA method of assistance solicitation is used to encourage projects of special importance to the National Cancer Program, and awards are made in accordance with the policies of the National Institutes of Health and applicable Public Health Service (PHS) policies for cooperative agreements. Application for this RFA is limited to state and territorial health departments (afterward to be called 'state health departments'). The intent of this RFA is to invite applications from those state health departments not currently funded under the grants "NCI Cancer Control Technical Development in Health Agencies" and "Data-based Interventions for Cancer Control", or the cooperative agreements "Data-based Intervention Research for Public Health Agencies". This is a one-time invitation for applications. BACKGROUND INFORMATION The Cancer Control Program of the National Cancer Institute is administered by the Division of Cancer Prevention and Control (DCPC). This program is authorized under the National Cancer Act and calls for cooperation with health agencies in the prevention and control of cancer. The overall goal of the National Cancer Program is the reduction of cancer incidence, morbidity, and mortality. The goal of a reduction of 50% in age-adjusted cancer mortality rates by the year 2000 has been announced, indicating that incidence and mortality reductions could result if state-of-the-art cancer prevention and control methods were applied fully (Greenwald P, Sondik EJ. Cancer Control Objectives for the Nation: 1985-2000. NCI Monograph No. 2, 1986). Cancer control is the application of knowledge to effect this reduction. A sequence of activities from research on interventions and their impact on defined populations to the broad, systematic application of the research results has been described (Greenwald P, Cullen JW. The new emphasis in cancer control. JNCI 1985; 74(3): 543-551). Research supported under this RFA should reflect this thinking. The importance of data collection has long been recognized in the public health arena, dating back to the first registration of births and deaths. Population-based cancer incidence registries became common in the 1960's, and today the majority of states have some level of registration activity. Risk factor surveys and hospital discharge data bases are also routine. States have access to significant amounts of relevant data, much of whose potential for use in cancer prevention and control has not been fully realized. In attempting to plan, develop, and implement cancer control interventions and to maintain a continuing evaluation of ongoing programs, data should play a major role. Many cancer incidence registries have been well utilized for etiologic studies but have been less well used for program planning, health service utilization studies, and for evaluation of intervention programs. These projects are to serve as models of data use in the planning, development, and evaluation of cancer prevention and control interventions. This use of data should allow health departments to effectively select those cancers and intervention strategies that will have the greatest effect on the public's health and to direct those interventions to specific geographic areas or target populations most in need. Priority areas for cancer control interventions based on the current state-of-the-art are: o Cessation and prevention of tobacco use o Cervical cancer detection o Breast cancer detection o Access to state-of-the-art cancer treatment o Environmental/occupational exposure reduction o Diet modification to lower fat intake, and increase intake of fiber. Cooperative agreements supported under this program should evaluate data related to at least the first three priority areas listed above for the entire state or territory. Interventions should be directed to those areas which are indicated by the evaluation of the data and are important within the priorities of the state. GOAL AND SCOPE The goal of this RFA is to stimulate the development of statewide cancer prevention and control intervention programs. This will be based on a thorough appraisal and analysis of the variety of data sources related to cancer control that exist in the state. The specific objectives are: o To stimulate more effective use of a broad spectrum of cancer-related data; o To evaluate the value of data sources used in planning, implementing, and evaluating the intervention program; o To develop a new plan or modify an existing cancer control plan for the state and, if appropriate, localities within the state; o To implement a cancer prevention and/or control program in response to the plan emphasizing selected model interventions in Phase III; o To accomplish process and outcome evaluation of the interventions; o To participate in meetings with other states and NCI staff to promote the refinement and dissemination of successful cancer control intervention strategies; o To increase the ability of the state health department to conduct cancer prevention and control intervention research. This project limits its support to the evaluation of selected data sources, the development of a subsequent intervention plan, limited support for selected interventions, and the evaluation of outcomes by health department staff. Aspects of interventions eligible for support include: training of health department staff, use of consultants, development of consortia for the interpretation and application of data to interventions, development of educational materials, support for workshops, operational costs for computers, and costs associated with the mandatory interventions related to legislatures specified below in Phase III. Funding will not be available for the actual conduct of the programs or the services required, and the applicants should demonstrate the availability of adequate support for the provision of the proposed services or specific plans for securing such support during the grant period. The project has four phases: Phase I (Appraisal and Analysis of Data) allows for the identification and appraisal of existing data sources related to the entire state population which are pertinent to the priority areas for cancer control. At a minimum, the first three priority areas (as described in part I of the RFA) must be addressed in this phase. Indicators of the quality of the data proposed to be used should be described. Epidemiologists and statisticians within the health department should work with other such experts within the state to accomplish these activities. Some applicants may have already accomplished this activity fully or in part, and, where such can be adequately demonstrated, the applicant may choose to limit the proposed time in this phase or to begin the project in a later phase. Phase I should last no more than nine months. Initial activities of the Phase II process may overlap with the end of this phase. In Phase II (Planning), the data are to be reviewed by local experts to assess its importance in the assessment of health needs of the population, and the identified needs and priorities are to be incorporated into an existing cancer control plan or used to develop a new plan. Wherever possible, this phase should combine the talents of health department planners and epidemiologists with individuals from key state organizations such as the American Cancer Society, state cancer centers, cancer councils, universities (including schools of public health and medical schools) in devising a plan toward which all organizations can work. Again, some applicants may have already accomplished this activity fully or in part, and, where such can be adequately demonstrated, the applicant may choose to limit the time in this phase or begin in a later phase. A time line of planned activity for Phases I and II is to be included in the application. A formal Verification Review, as described in Part IV of the RFA, will occur toward the end of this phase. Phase II should last no more than nine months. Phase III (Intervention) allows for the initiation of new or modification of existing selected cancer prevention and control intervention programs at the state and local levels as specified in the plan. The proposed interventions must include a program focused on informing state legislators of the nature and extent of the cancer problem in the state, the potential that exists for intervention, and the resources required to deal with the problem. This part of the intervention phase must be described in detail in the original application. In addition, one or more intervention(s) must be proposed based on the analysis of data in Phase I and importance within the priorities of the state. One aspect of this intervention might need to be further research into the scope of the problem; however, such research should be integrated into the total intervention plan. Although a detailed plan of this aspect of the intervention phase cannot be prepared until the earlier phases are well underway, a brief discussion of the capabilities, resources and potential approaches to (at a minimum) the first three priority areas should be included in the initial application. This phase will be funded for no more than three years. The first three phases combined are to be no longer than four years. Phase IV (Evaluation) is a follow-up period for three years allowing for a process and outcome evaluation of phases I through III. Changes in the quantity, quality, and type of control programs and legislative actions arising out of the first three phases will be identified and catalogued including the data used and its value to the total effort. Continued review of data sources will allow findings to be channeled into continued program planning efforts. Thus, these intervention programs, as described in their progress and evaluation reports, will serve as models to other jurisdictions. Although specific evaluation of the intervention phase cannot be detailed in the initial application, other aspects of evaluation must be described in detail. Note that Phases I, II, and IV involve all aspects of the health department's cancer control program, while Phase III will deal with only limited aspects of the total intervention effort. Applicants should consider the following as having major significance to this RFA: o Data sources: Applicants should be creative but realistic in their selection of data sources that might be evaluated. Incidence data are not required for response to this RFA, though, of course, such data should be used if quality data are available. Jurisdictions that do not have population-based incidence registries might apply incidence data from other similar populations to their population. Mortality data must be evaluated. Information on cancer control programs currently existing within the state is to be evaluated. Other examples include risk factor prevalence data, health services utilization data, and information on knowledge, attitudes and practices regarding cancer-related issues. It is the intention of this RFA to learn what data sources are most useful in cancer control planning and evaluation, and documentation of both successful and less-than-satisfactory attempts to use the data is required. This work is expected to be accomplished primarily with health department staff with outside consultants used only to fill significant gaps in health department expertise. This RFA does not support the collection of new data; however, limited funds may be used for the acquisition of already existing data. o Cancer control planning: Applicants should describe the anticipated planning process, including the development of consortia of organizations and agencies that will participate in the planning and implementation phases. The steps by which data gathered in Phase I will be evaluated to determine its importance for program and evaluation efforts must be fully outlined. o Those applicants who believe that they have completed part or all of the initial phases must provide appropriate documentation such as reports of data analysis, documentation demonstrating how the analyzed data has been used to define program needs, a copy of the current cancer plan for the state, and documentation of the involvement of other key agencies/institutions in the accomplishment of the plan. o Program for legislators: Applicants should describe the planned approach to informing the state legislators of required information. Although the content of the program will not be known until after Phases I and II, the planned approach should be well described. o Resources: Applicants should describe the support available within the state to accomplish the objectives of the statewide cancer plan. This should include information on the current structure of cancer control or other related activities, opportunities to work with other agencies, and sources of anticipated in-kind funding that may be used. The development of consortia or coalitions to achieve the objectives of this RFA is encouraged. Where this is the case, a clear delineation of roles and administrative procedures must be outlined in the application. If the budget request includes support for multiple units, policies and procedures for financial and program management should be outlined in the application. A significant aim of NCI is to improve the overall national cancer prevention and control effort by creating cohesion between cancer programs supported by NCI and the public health structure. To this end, applicants should strive to establish relationships with relevant cancer programs (e.g. facilities providing cancer care, local organizations of national cancer-related organizations, and cancer or other incidence registries) in the states where such exist. MECHANISM OF SUPPORT Support for this program will be through the cooperative agreement. The cooperative agreement is an assistance mechanism in which substantial NIH programmatic involvement with the recipient during the performance of the planned activity is anticipated. The nature of NCI staff involvement is described in Section IV. Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this Request for Applications (RFA), awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 82-50,000, revised January 1, 1987. This RFA is a one-time solicitation. Generally, future unsolicited competitive continuation applications will compete as research project applications with all other investigator-initiated applications and be reviewed by the Division of Research Grants (DRG). However, should the NCI determine that there is a sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competitive continuation cooperative agreement applications for review. Approximately $6,120,000 in total costs for seven years will be committed to specifically fund applications which are submitted in response to this RFA. It is anticipated that 8 awards will be made. Total costs (direct and indirect) per award are estimated to be $120,000 for year 1 and $170,000 for year 2 for those applicants beginning in Phase I. The total costs for the intervention phase (no longer than 3 years) are estimated as $200,000 per year and for the evaluation phase, $25,000 per year. Those applicants starting at later phases should adjust budget estimates by year for the appropriate phase. The actual level of support is dependent upon the receipt of applications of high scientific merit. The total project period for applications submitted in response to this RFA should not exceed 7 years. It is estimated that applications will be reviewed by the National Cancer Advisory Board in May of 1990 and funding will begin in August of 1990. Although this program is provided for in the financial plans of the National Cancer Institute, awards pursuant to this RFA are contingent on the availability of funds for this purpose. This RFA is primarily targeted at enhancing the capability of and information available to state health departments. Other agencies designated by, operated by, or under contract with a state or territorial government with primary cancer responsibility for the entire state or territory, or geographic subdistricts wishing to apply, must do so through the state health department. TERMS OF COOPERATION Assistance via cooperative agreement differs from the traditional research grant in that, in addition to the normal programmatic and administrative stewardship responsibilities, NCI anticipates substantial technical involvement during performance of the project. Although awarding of the cooperative agreements will be based on separately prepared and evaluated applications, awardees should demonstrate willingness to accept NCI cooperation. The role of NCI will be to facilitate and not to direct the activities. Responsibilities of program staff 1 Verification review: For those awardees who begin in Phases I and II, NCI will convene a group of non- government consultants within two months prior to the end of Phase II to evaluate the work and plans for Phase III and IV activities and to make recommendations on continuation of awards. This Verification Review will focus on the validation of stated data sources relative to the interventions specified, the relevance of the planned interventions to the NCI Year 2000 goal, and the scheduled completion of phase I as reported in the progress report due approximately three months prior to the end of Phase II. The review group will recommend to NCI whether funding should be continued, the conditions under which it may continue, and the level of continued support which may be provided. (Note: This verification step will not reduce the requirements for the applicant to prepare the customary detailed application for the RFA deadline date and should not imply that applicants may submit applications that are incomplete or inadequate.) This review may result in a recommendation to NCI staff for suspension or termination of support provided during the first two phases, the withholding of support previously recommended for future budget periods, or adjustments to recommended levels for future years. 2 Data management: The NCI Program Director will provide assistance to the awardee regarding the quality of data to be used and its potential value to the project. The Program Director will periodically review the use being made of such data providing assistance in potential further use. A document reporting results of the data evaluation will be necessary for the verification review (see #1). 3 Newly developed approaches/technologies: As information is generated by other programs and activities in state health departments or new technologies and approaches are developed, information will be provided and assistance given in their use. The NCI program director will supply new and updated information on issues related to cancer prevention and control to awardees as well as recommend specific computer hardware and software found to be most effective to accomplish particular ends. 4 NCI prior approval of intervention activities: All Phase III intervention activities as funded by the cooperative agreement must have been approved by the NCI Program Director or designee prior to implementation. Since funding will not be available for the actual conduct of the programs or the services potentially required in the intervention phase, NCI may withhold support or terminate any award if these service aspects are not funded as proposed by the applicant. 5 Reporting requirements and program monitoring: Regular reporting requirements for traditional research grants will apply. Because of the verification review, additional reporting requirements may be defined by the NCI Program Director. Awardees will provide documentation of process and outcome of efforts including those that are practical and fruitful and those found to be less so. Progress of each awardee will be monitored and technical assistance provided using periodic telephone contacts, annual reports, program monitoring site visits as needed, and the awardees' participation in meetings. Minutes of all formal meetings of awardees' advisory committees with membership from beyond the health department will be reviewed by the Program Director. 6 Personnel: The NCI Program Director retains the right to approve all key personnel changes during the project period. Key personnel are the principal investigator and others specifically identified in the Notice of Grant Award. Responsibilities of awardees: The following responsibilities are in addition to the satisfactory completion of the activities defined in the application. 1 Publications and reports: It is expected that data findings will be published and circulated through a variety of mechanisms (e.g. standard health department newsletters) to reach health professionals and the general public throughout the state. Publication of data findings and process activities (e.g., the process of involving legislators in cancer control activities) by the awardee in peer-reviewed journals is encouraged. Copies of publications and major presentations are to be provided to the Program Director. A document reporting results of the data evaluation will be necessary for the Verification Review (see TERMS OF COOPERATION, 1). 2 Participation in meetings: These activities will be fostered by NCI-coordinated meetings approximately twice a year during years 1-4. The meetings will serve as a place to exchange ideas and information on each program's progress. Appropriate project staff must attend these periodic meetings. "Appropriate" staff will be identified by the nature of the agenda of each meeting. 3 Verification review: For those awardees who begin in Phases I and II, a verification review will occur toward the end of Phase II (see TERMS OF COOPERATION, 1). Awardees will submit materials to allow reviewers to assess the satisfactory completion of Phases I and II, the relation of data findings to specified interventions, and the appropriateness of the planned interventions and their relevance to the NCI Year 2000 goal. These "TERMS OF AWARD" require that the NCI Program Director approve various steps in the performance of the cooperative agreement. Disagreements arising pursuant to these approvals will be arbitrated by a panel composed of one award recipient designee, one NCI designee, and a third designee with expertise in the relevant area chosen by the other two. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR, Part 50, Subpart D, and HHS regulations at 45 CFR, Part 16. The "Terms of Award: Nature of Participation of NCI Staff" described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR 74, and other HHS, PHS, and NIH grant administration policy statements. SPECIAL INSTRUCTIONS FOR PREPARATION OF COOPERATIVE AGREEMENT APPLICATIONS General instructions for the preparation of the cooperative agreement application are contained in the Grant Application Form PHS 398 (revised 10/88). Because the TERMS OF COOPERATION discussed above will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to those terms. Plans should describe how the applicant will comply with the NCI program staff involvement as well as how all the responsibilities of the awardees will be fulfilled. Note that it is the intention of this RFA to address both sexes and all races and ethnic groups of sufficient size in the state in Phases I and II of this program. Descriptions of how all subpopulations are to be considered must be described in the application. Data findings and the priorities defined in the planning process will define populations to be involved in Phase III. REVIEW PROCEDURES AND CRITERIA Review Procedures Upon receipt, applications will be reviewed (initially) by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NCI program staff function. Applications which are judged non-responsive will be returned by the NCI, but may be submitted by the applicant as investigator-initiated regular research grants at the next receipt date. In cases where the number of applications is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to eliminate those which are clearly not competitive. The NCI will remove from competition those applications judged to be noncompetitive for award and notify the applicant and institutional business office. Those applications judged to be both competitive and responsive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board considers the special needs of the Institute and the priorities of the National Cancer Program. Review Criteria The review will consider factors relating to the demonstration of both the data evaluation and planning aspects of the application as outlined below. o Appropriateness of initial phase. If the applicant chooses to begin in a later phase or shorten the time in any phase, is there adequate documentation to justify the approach? o Access to pertinent data. How well does the applicant demonstrate knowledge about and an ability to access and evaluate a variety of pertinent data sets? o Planning capacity. How well does the applicant demonstrate evidence of a capacity and ability to develop a statewide cancer plan and specific interventions based on data findings, and are the appropriate individuals/organizations participating in the planning process? o Approach to legislators. Does the applicant present a thoughtful and realistic approach to the educational requirements for legislators? o Support of other organizations. To what extent is there evidence of support from other key organizations and agencies both in providing data where necessary and in participating in the planning and intervention phases? o Cooperation. What relationships have been or will be developed with major cancer programs already underway in the area? Are they appropriate to the program proposed? o Skill and activity development. To what extent is it likely that the approach presented will raise the health department to a higher level of capacity and activity in the field of cancer prevention and control? o Qualifications of participants. What are the data management and public health program experience and competence of the designated health department personnel and the qualifications of any proposed institution(s) and/or consultants providing the cancer-specific technical expertise? o Commitment of resources. To what extent is there documentation of the availability of resources to conduct proposed interventions or realistic plans for securing such funds during the life of the grant? Is there evidence of strong support for the grant application within the health department and/or relevant governmental structure? o Time line. Is the time line of activities presented for Phases I and II realistic? Is there evidence that Phases I and II will be completed within the allotted time? In addition, for applicants bypassing the initial phases o Appropriateness of intervention. Is the proposed intervention scientifically sound, suggested as appropriate based on data findings, and consistent with the NCI Year 2000 goal and objectives? Subsequent to these reviews, the budget will be considered for its appropriateness. METHOD OF APPLYING State Health Departments may submit applications on either Form PHS 5161-1 or PHS 398 (revised 10/88). Application kits may be obtained from the Division of Research Grants (DRG), NIH; 9000 Rockville Pike, Westwood Building, Room 449, Bethesda, MD 20892. If the PHS 5161-1 is used, it is requested that the budget pages from PHS 398 (pages 4 and 5) be used. Because a separate budget justification for each year of support must be provided, a copy of page 5 of PHS 398 will be needed for the budget for years 6 and 7. In addition, separate budget components must be provided for consortia or subcontractors as described in PHS 398 (revised 10/88). The identifier, "88-CA-14, Data-based Intervention Research for Public Health Agencies" should be typed in bold letters in space number 2 on the face page of the application or on line 7 of the 5161-1. Investigators who are revising applications submitted under the previous RFA "Data-based Intervention Research for Public Health Agencies" should follow the instructions for revised applications (Section 2, page 19-20, Form 398, revised 10/88), identifying significant changes made and responses to criticisms in the previous summary statement. Previous applicants may choose instead to submit a totally new application. Applications must provide a statement of acceptance of NCI staff participation as outlined in "Terms of Award: Nature of Participation of NCI Staff." The completed original application and four signed, exact, single-sided photocopies should be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892-4500** Applications must be received by close of business November 15, 1989. Applications received after that date will not be considered under this RFA. The DRG will not accept any application in response to this announcement that is the same as one currently being considered by any other NIH awarding unit. Late and non-responsive applications will be returned to the applicant. The RFA label, available in the 10/88 revision of the application form 398, must be affixed to the bottom of the face page of either application 398 or 5161-1. Failure to use this label could result in delayed processing of your application such that it may not reach the review committee in time for review. In addition, the title of the application and the RFA number should be typed on line 2 of the face page of the 398 or on line 7 of the 5161-1. In order to expedite the review, two complete copies of the application should be sent under separate cover to: Referral Officer Grants Review Branch Division of Extramural Activities National Cancer Institute 5333 Westbard Avenue Bethesda, Maryland 20892-4500 Telephone conversations are invited prior to the due date for applications. LETTER OF INTENT Prospective applicants are asked to submit, by September 1, a letter of intent containing a descriptive title, name and address of the principal investigator, the names of other key personnel, the participating institutions, and the number and title of the Request for Application (RFA) in response to which the application is submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information which it contains is extremely helpful in the planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. Also NCI emphasizes the benefits to the applicant and to staff of having a principal investigator submit a letter of intent, by establishing communication between the potential applicant and the NCI Program Director who initiated the RFA. Through subsequent contact, the Program Director may be able to assist prospective applicants in several areas: scientific content and objectives of an application, size and focus of the program, organization of an application, and an appropriate use of coalitions and contractors. The letter of intent should be sent to: Dr. Leslie P. Boss Executive Plaza North, 233D National Cancer Institute 9000 Rockville Pike Bethesda, MD 20892 INQUIRIES For program information contact: Dr. Leslie P. Boss Executive Plaza North, 233D National Cancer Institute 9000 Rockville Pike Bethesda, Maryland 20892 Telephone: (301) 496-8584 For pertinent administrative matters contact: Ms. Marian Focke Grants Management Specialist Executive Plaza South, 244 National Cancer Institute 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-7800 This program is described in the Catalog of Federal Domestic Assistance, No. 13.399, Cancer Control. Awards are under the authorization of the Public Health Service Act, Section 301 (42 USC 241) and section 403 (42 USC 284) and administered under PHS grant policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 for Health Systems Agency review. GERIATRIC RESEARCH AND TRAINING CENTERS (P30) RFA AG-89-06 P.T. 04; K.W. 0710010, 0710030, 0720005 National Institute on Aging APPLICATION RECEIPT DATE: FEBRUARY 15, 1990 INTRODUCTION The National Institute on Aging (NIA) invites applications for support of centers of excellence in research in geriatrics and gerontology and training of geriatricians for leadership in academic medicine. A Geriatric Research and Training Center (GRTC) includes core activities for support of research, training, and career development. First year budgets may not exceed $800,000 direct costs. Future year budgets are limited to usual cost of living increases. BACKGROUND The health care needs of a growing population of older persons result in an increased requirement for physicians trained in clinical geriatrics as well as individuals capable of conducting research in geriatrics and training future geriatricians. At present, the number of such individuals is limited. This problem was recognized in an Institute of Medicine report which concluded that "the needed growth of academic training in geriatrics can best be accomplished in 'centers of excellence', which would focus on training physician faculty geriatricians in an environment having model teachers for educational training, vigorous basic and clinical research in multiple areas, and a variety of clinical opportunities" (Report of the Institute of Medicine: Academic Geriatrics for the Year 2000. J. Am. Geriatrics Soc. 35:773-91, 1987). In 1988, the Congress authorized the Director, NIA, to make grants for the development or expansion of centers of excellence in geriatric medicine. The goal of the GRTC program is to enhance the ability of institutions with well-developed clinical and research activities in geriatrics to provide a strong environment for the development of future academic leaders in geriatrics. Thus, institutions without a substantial amount of ongoing research in geriatrics which could benefit from core support as described below are not encouraged to apply for the GRTC Award. Institutions in which clinical and research activities are not yet sufficiently developed in geriatrics to support GRTC programs are encouraged to consider a variety of other research, training and career development support mechanisms available from NIA and other sources. SCOPE To enhance the quality of research in geriatrics and gerontology, and provide a suitable environment for fellows and junior faculty to acquire research skills and experience, three general types of activities will be supported in GRTCs: research cores, leadership/administrative cores and research development cores. A minimum of three cores must be approved by the reviewers for viability of a proposed GRTC. These may include the leadership/administrative core and the research development core, both of which are expected to be part of GRTC applications unless these functions can be demonstrated to be already available at the applicant institution. Research Cores GRTC's will provide support for personnel, equipment, and other resources which will enhance the quality of currently supported research, provide for the needs of pilot projects, and serve as a potential resource for future projects. Routine patient care costs may not be requested, but research related patient care costs are eligible for support. Core activities which focus resources from a variety of disciplines, including basic biological sciences, behavioral research, and clinical research, on important issues in geriatrics are particularly encouraged. Examples include: o A recruitment/screening/registry unit to refer potential subjects to different research protocols at the institution. o Geriatric assessment units which provide resources for testing alternative assessment strategies, development of new assessment instruments, and provision of appropriate diagnostic assessment for subjects on various research protocols. o Specialized diagnostic/pathophysiologic units focused on functional problems in geriatrics. Collaboration in these units between clinical researchers and basic scientists is especially encouraged. (Animal resources may be included where appropriate.) Examples include cores to support clinical and basic studies on urinary incontinence, autonomic dysfunction, cognitive dysfunction, gait and mobility problems, sensory deficits, and cardiovascular problems. o Resources to support testing of interventions for functional problems of older persons. Examples include facilities for the conduct of exercise protocols and/or rehabilitation techniques, nutritional units, and clinical pharmacology facilities. o Epidemiologic/biostatistical/data management units to enhance ongoing epidemiologic studies on geriatric problems, provide consultation in the design of new clinical and epidemiologic studies, and provide advice and training in methodology to research fellows and junior faculty. o Innovative geriatric health care units which provide resources to test interventions which are not feasible in conventional health care settings. Examples include outpatient geriatric rehabilitation services and various services for care and/or assessment in the home. o Enhancement of clinical research center facilities to support any of the above types of core activities. The above list is not intended to describe the full range of possible activities to be supported, nor to direct applicants towards these areas. Inclusion of cores of all these types in a single proposed GRTC is not required or even necessarily advisable. Applicant institutions are encouraged to focus on their areas of greatest strength. However, a minimum of three cores is required for a GRTC. A scientist must be named as the director of each research core unit proposed. The identification of proposed core activities should conform with needs of funded research projects at the institution. Each research core unit proposed for funding under the GRTC grant must be utilized by at least three externally funded research projects, at least one of which is NIH or ADAMHA funded. Subprojects within a program project (P01) will be considered as individual projects comparable to an R01. A detailed description of each core unit proposed as part of the center must be provided with detailed budget and budget justification. Applicants should specify the currently supported projects which will use the core facilities. The description of the core units proposed should include a rationale to show how they will support the research effort in a cost effective manner, and how they will be used in the training and career development of research fellows and junior faculty in geriatrics. Leadership/Administrative Core This core provides funds for the GRTC Director, GRTC Administrator, and support staff. Costs associated with information transfer and outreach programs may also be requested here. The GRTC Director should be a scientist who can provide effective administrative and scientific leadership. A GRTC 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. In addition, a GRTC must have an advisory panel of experts from outside the GRTC who will meet at least once a year to review and provide a written report on the progress of the GRTC. This report must be included with each year's GRTC annual progress report to NIA. Funds for salary and expenses of the Director, Administrator and appropriate administrative staff, and expenses for the advisory panel may be requested. Funds should also be requested to permit travel of three individuals from the GRTC (Director, Administrator and one other scientist) to Bethesda, Maryland, twice a year for meetings with NIA staff and staff from other GRTCs. Research Development Core This core will support pilot projects to be conducted by junior faculty members. Support for salary, equipment and other research expenses may be requested. No more than three junior faculty may receive salary support through this core at any one time and no individual may receive salary support for more than three years. The budget for each pilot project may not exceed $60,000 per year (direct cost) and the total budget for pilot projects under this core may not exceed $180,000 per year (direct cost). Junior faculty to be supported by the program must have a health professional degree in the clinical sciences (M.D., D.O., D.D.S., or equivalent) and must have either completed at least one year of fellowship training in geriatrics or geropsychiatry or obtained certification of Added Qualifications in Geriatric Medicine from the American Board of Internal Medicine/American Board of Family Practice. A minimum of two-thirds time must be devoted to research. As part of the application, the institution should present: (1) a plan for the selection of junior faculty to be supported; (2) a general plan for the career development of individuals who will be selected by the local program for these positions; and (3) a list of senior faculty who will participate in research career development (their curriculum vitae and current research support must be specified). The institution must be able to demonstrate adequate resources for the support of the research efforts of these individuals, and a plan for monitoring their progress and development toward independence. The research development core may also serve to encourage the career development of other junior faculty (in addition to those receiving salary support from this core) by coordinating the use of research core resources by those whose salary support may come from other sources such as NIA's Geriatric Academic Program Award (GAP), Geriatric Research Institutional Training Award (GRIT), Physician Scientist Award (PSA), NIA Academic Award or Clinical Investigator Award (CIA). Funds may also be requested for salary support for a director of the research development core who will be responsible for coordination of the above activities as well as the additional components of the educational program of the GRTC. MECHANISM AND SCALE OF SUPPORT Geriatric Research and Training Centers will be supported through the customary grant-in-aid mechanism. Review of applications and management of grants will be subject to applicable PHS and NIH grant policies and NIA guidelines for research center grants. Support may be requested for a period of five years. The direct costs requested for the first year may not exceed $800,000. Applications with budget requests exceeding this amount will not be accepted by NIA and will be returned to the applicant. Budget increments for subsequent years generally will be limited to no more than four percent. Plans are to make up to two awards depending upon availability of funds. METHOD OF APPLYING AND APPLICATION REQUIREMENTS Guidelines Detailed instructions for applicants are found in "NIA Geriatric Research and Training Centers Guidelines" (hereafter called GRTC Guidelines). This document may be obtained from: Geriatrics Branch, BRCM National Institute on Aging Room 5C27, Building 3l 9000 Rockville Pike Bethesda, Maryland 20892 Telephone: (30l) 496-6761 Eligibility Only U.S. organizations are eligible to apply. To be eligible for award as a GRTC, the center must provide core support to a minimum of six peer-reviewed, externally funded research projects. In the case of currently funded program projects (P01s), or similar grants, each research component will be considered as a separate project. Letter of Intent If an investigator is satisfied that his/her institution is eligible and elects to apply for a GRTC grant a letter of intent is requested (but not required) to be submitted to the Geriatrics Branch at the address given above. The letter of intent should name the director and collaborators, and should identify the core unit directors and principal investigators of the research projects that would use the core unit services. It should be submitted by November 15, 1989. The Application The applicant should submit the application using PHS 398 (revised 10/88), following the special Guidelines for GRTC applications (see above). Application kits containing this form and the necessary general instructions are available in most institutional business offices or may be obtained from the Division of Research Grants, NIH. Please note that special GRTC Guidelines mentioned above should be used to complete the application. The NIA recommends that the application be developed in consultation with program staff who will provide whatever guidance is possible and appropriate in relation to both scientific and administrative issues. RECEIPT AND REVIEW OF APPLICATIONS The original and four copies of the application are due in the Division of Research Grants on or before February 15, 1990. Applications must be sent to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 5333 Westbard Avenue Bethesda, Maryland 20892** The RFA label contained in the application kit should be affixed at the bottom of the face page of the application. Failure to use this label could delay processing of the application. Applications should be identified by checking the "yes" box in Item Number 2 on the face page of the application and typing in the words "Geriatric Research and Training Center, RFA AG-89-06." At the same time the application is submitted to the Division of Research Grants, two copies of the application, along with the six sets of appendices, should be sent to: Chief, Scientific Review Office National Institute on Aging Room 5C12, Building 3l 9000 Rockville Pike Bethesda, Maryland 20892 Failure of these copies to be received may prevent the application from being reviewed in time to be considered for an award. Review Schedule Applications received in response to this RFA will be reviewed on a nationwide competitive basis. The initial review for scientific merit will be carried out by an NIA Review Committee convened for this purpose. Depending on the magnitude of the response to this RFA, applications may undergo concurrent expedited triage review. Proposals deemed to be non-competitive will be removed from further consideration. Because a site visit is not a prerequisite for GRTC consideration, each application should be thorough and complete enough to stand on its own. The second- level review will be by the National Advisory Council on Aging in September 1990. REVIEW CRITERIA Upon receipt, applications will be reviewed by NIA staff for responsiveness to this announcement. Those applications judged not responsive, or applications with a first year budget request exceeding $800,000 in direct costs, will be returned to the applicant organization in care of the principal investigator. Applications judged responsive will be reviewed under the criteria specified in the NIA GRTC Guidelines. The primary criterion for review by the NIA review committee in evaluating each GRTC grant application will be the effectiveness of the proposed program in contributing to the development of academic leaders in geriatrics with effective research, teaching and clinical capabilities. Specific criteria related to this standard include: 1. Contribution of scientific cores to enhancement of ongoing research, and new program development projects. 2. Role of scientific cores in providing opportunities for research experience for fellows and junior faculty. 3. Role of the training/career development core (if one is proposed) in providing educational and other career development opportunities for fellows and junior faculty. 4. Strengths of existing and/or proposed fellowship and junior faculty development programs at the institution and their abilities to benefit from proposed GRTC activities. Other review criteria include: 1. Leadership ability and scientific stature of the program director and his/her ability to meet the program's demands of time and effort. 2. Qualifications, experience, and commitment of the investigators responsible for core units and their ability to devote the required time and effort to the program. 3. Presence of an administrative and organizational structure conducive to attaining the objectives of the proposed program. 4. 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. 5. Quality of proposed external review process. 6. Appropriateness of the total budget and budgetary requests for the cores and new program development projects. 7. 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 GRTCs. 8. Institutional commitment to the requirements of the program. 9. The adequacy of the means for protecting against risks to human subjects, animals and/or environment. FUNDING Although this program is included and provided for in the financial plans for fiscal year 1990, award of Geriatric Research Training Center grants is contingent upon the receipt of scientifically meritorious grants and allocation of appropriated funds for this purpose. STAFF CONTACT Potential applicants interested in obtaining further information may write or call: Stanley L. Slater, M.D. Director, Geriatrics Research and Training Program National Institute on Aging Bethesda, Maryland 20892 Telephone: (301) 496-6761 PHARMACOLOGY in GERIATRIC MEDICINE RFA AG-89-05 P.T. 34; K.W. 0710010, 0710100, 1002034, 0765025, 0765035, 1007009 NATIONAL INSTITUTE ON AGING APPLICATION RECEIPT DATE: MARCH 15, 1990 INTRODUCTION The National Institute on Aging (NIA) invites applications for investigation in the field of geriatric pharmacology. The acquisition of new knowledge which will improve the selection of medication regimens for older persons is the goal of this solicitation. Up to two million dollars in first-year costs, and additional approved expenses for up to five years, will be committed to fund applications submitted in response to this Request for Applications (RFA). This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. BACKGROUND Persons over the age of 65 comprise 12 percent of the nation's population but consume over 30 percent of the prescription drugs dispensed. Geriatric patients commonly suffer from multiple disorders for which they often take several medications whose side effects and interactions may diminish therapeutic efficacy and cause clinical problems. Several trends hold promise for improved drug prescribing for older persons. Advances in understanding of physiologic changes with age, the pathophysiology of age-related diseases, and interactions of multiple pathologies in older persons can be expected to lead to better understanding of the full range of effects of currently used drugs in older persons, and to development of new classes of agents with greater efficacy and fewer adverse reactions than those currently available. In addition, advances in information-processing systems and database technology permit improved drug utilization review, quality control, and postmarketing surveillance, as well as pharmacoepidemiologic studies to determine efficacy and side effects of drugs in older persons. However, research is needed to improve the application of these techniques to drug prescribing for older persons. SCOPE The NIA wishes to support a broad spectrum of research relevant to the use and effectiveness of medications in older people. This includes basic and clinical studies on pharmacokinetics, pharmacodynamics, receptor biochemistry and physiology, drug metabolism and excretion, toxicology, pharmacotherapy and pharmacoepidemiology, as well as studies of techniques to improve quality of prescribing and utilization review. Approaches utilizing expertise in geriatrics, epidemiology, pharmacology, pharmacy, other clinical and basic sciences, and collaborations among these disciplines are encouraged. Issues of drug efficacy and adverse drug effects, including drug toxicity, drug/drug interactions, and drug/disease interactions as applied to the complex clinical challenges posed by geriatric patients with multiple organ system pathology require further understanding. Clinical epidemiologic studies, use of large medication databases, intervention studies, and basic studies of mechanisms of drug action are examples of potentially useful approaches. Studies of the effects of drugs and drug combinations in patients with multiple disorders are especially relevant to geriatric medicine. Studies related to prescribing practices, drug utilization review and education of providers and patients are also of interest. Given the tendency of many older persons to accumulate a number of chronically used drugs, there is a need for research-based guidelines for the withdrawal of medications from older persons so that only those medications required are continued. Studies need to be carried out in carefully defined clinical populations. Specification of the health status and age of the subjects is considered crucial. For example, it is important to distinguish between age groups 65-75 and 76-90. Specific topics of interest include but are not limited to: o Testing new pharmacologic approaches for common geriatric problems, such as dizziness, urinary incontinence, osteoarthritis, and peripheral vascular disease. o Effects of age-related physiologic changes and age-related diseases on responses to medications, including basic studies of mechanisms mediating these effects. Application of advances in understanding of mechanisms of age-associated pathology to the development of more definitive therapies. Examples of the latter approach include but are not limited to: The role of growth factors in preventing or reversing atrophic or dystrophic degenerative conditions of aging such as osteoporosis, osteoarthritis, loss of muscle mass, and others. Potential for slowing or reversing the development of age- associated pathologies related to post-translational protein modifications such as glycation. Development of specific therapies for clinical problems associated with age-associated impairments in regulation of levels of specific intracellular ions, such as myocardial calcium. o Uses of computer information systems and their interfaces with pharmacists, physicians, patients, and others to improve quality of drug prescribing and drug utilization review. In particular, this research is encouraged in relation to large programs such as those required for implementing the Medicare drug benefit. Pilot studies of potential approaches for quality control and utilization review in such programs are encouraged. o Causes, prevalence, clinical consequences, and prevention of specific drug side effects and adverse reactions in older persons. Examples include but are not limited to: Anticholinergic effects of tricyclic antidepressants and other medications and their effects on lower urinary tract function, salivary function, bowel function, alertness, and other clinical consequences Hypotensive effects of calcium-channel blockers, diuretics, nitrates, other vasodilators, phenothiazines and tricyclic antidepressants CNS effects of angiotensin-converting enzyme inhibitors, H2 antagonists, methyldopa, clonidine, reserpine, benzodiazepines, calcium entry blockers, and beta blockers Effects of non-steroidal anti-inflammatory drugs (NSAIDS) on renal function, blood pressure and the medical treatment of hypertension, and gastrointestinal ulcers Exacerbation of cardiac conduction disease by calcium entry blockers, beta blockers, methyldopa, digitalis, clonidine, etc. Dietary and nutritional problems due to cardioactive drugs resulting from alterations in gastrointestinal motility Increased risk of hyperglycemia, hypercholesterolemia and hyperosmolar states associated with diuretic therapy o Role of specific medications or interactions of medications in causing, exacerbating, or ameliorating significant geriatric problems such as: Falls and gait problems Dizziness Urinary incontinence and other lower urinary tract dysfunction Confusional states and loss of alertness Depression Anorexia and/or malnutrition Impaired salivary function Hypochlorhydria and other gastric problems Constipation and other bowel dysfunction Syncope and impaired blood pressure homeostasis Tremor Impaired libido and sexual function Cardiac conduction defects Impaired glucose control Sleep apnea and other sleep disturbances o Functional effects of medications or medication interactions, such as effects on ability to perform activities of daily living or operate a motor vehicle. Both positive and negative effects are of interest. o Problems associated with complex drug regimens, drug-drug interactions, and drug-nutrient interactions in older patients, including therapeutic trials of withdrawal of chronically administered medications in older persons on complex drug regimens, and/or comparisons with nonpharmacologic therapies. o Determining efficacy and side effects in geriatric patients of newly introduced drugs, or other drugs which have not been fully evaluated in this population, including the development of methods to evaluate efficacy and side effects in complex patients with multiple coexisting diseases and/or medications. o Problems associated with anesthesia and analgesia for surgical and other procedures among older persons. MECHANISM AND SCALE OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) grant-in-aid, utilizing the RO1 grant mechanism. Applicants will be responsible for the planning, direction, and execution of the proposed project. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants policy statement, DHHS Publication No. (OASH) 82-50,000, revised January 1, 1987. This RFA is a one-time solicitation. Generally, future unsolicited competing renewal applications will compete with all investigator-initiated applications and be reviewed by the Division of Research Grants (DRG). However, should the NIA determine that there is a sufficient continuing program need, the RFA will be reissued. Up to $2 million dollars for the first year, and approved expenses for up to five years, will be committed to fund applications submitted in response to this RFA. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to this RFA should not exceed 5 years. The earliest feasible start date for the initial awards will be December 1, 1990. Although this program is provided for in the financial plans of the National Institute on Aging, the award of grants pursuant to this RFA is contingent on the availability of funds for this purpose. The NIH urges applicants for grants to include members of minority groups and women in the study populations for research. In those instances in which this is not feasible or appropriate an explanation should be provided. REVIEW PROCEDURES AND CRITERIA Applications received in response to this RFA will be reviewed on a nationwide competitive basis. The initial review for scientific merit will be carried out by a Division of Research Grants Review Committee convened for this purpose. Depending on the magnitude of the response to this RFA, applications may first undergo an expedited triage review by a subcommittee of peer-reviewers. Proposals deemed to be non-competitive will be removed from further consideration. Applications will be reviewed in accord with the usual NIH peer review procedures. The review criteria are the traditional considerations underlying scientific merit. Following study section review, second level review will be conducted by the National Advisory Council on Aging. METHOD OF APPLYING Applications should be submitted on the standard PHS 398 (Rev. 10/88) application form (available at most institutional business offices) or from the Division of Research Grants, NIH, 301-496-7870. On item 2 of the face page of the application, applicants should enter: RFA AG-89-05--Pharmacology in Geriatric Medicine. The RFA label contained in the application kit should be affixed at the bottom of the face page of the application. Failure to use this label could delay processing of the application. The completed application and five copies should be sent to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892** At the same time the application is submitted to the Division of Research grants, one copy of the application should be sent to: Geriatrics Branch National Institute on Aging Room 5C27, Building 31 9000 Rockville Pike Bethesda, Maryland 20892 STAFF CONTACT