Full Text NR-94-001 NURSING RESEARCH CENTER CORE GRANTS NIH GUIDE, Volume 22, Number 45, December 17, 1993 RFA: NR-94-001 P.T. 04 Keywords: Nursing Clinical Medicine, General Biomedical Research, Multidiscipl National Institute of Nursing Research Letter of Intent Receipt Date: March 18, 1994 Application Receipt Date: April 21, 1994 PURPOSE The National Institute of Nursing Research (NINR) invites applications for research center core grants in important scientific areas of nursing research relevant to clinical practice and patient outcome issues. The Nursing Research Center Core grants (NRCC) will provide central resources and facilities for an active center of excellence in a specific area of inquiry that has a strong base of research funding. By developing infrastructure components, a number of established and independently funded investigators and their interdisciplinary teams will have the opportunity to enhance their collective productivity to a greater degree than would be possible from each of their separately funded projects. 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), Nursing Research Center Core Grants, is related to the priority areas of maternal and child health, acute and chronic disabling conditions, HIV infections and sexually transmitted diseases, health promotion and disease prevention topics, and women's health issues. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by colleges and schools of nursing in university settings and departments of nursing within university affiliated medical centers or hospitals. Applications from foreign institutions are ineligible for the center program mechanism. Applications from women and minority scientists are strongly encouraged. Institutions eligible for the Nursing Research Center Core Grants are those at which there are at least three Principal Investigators with Department of Health and Human Services (DHHS) funded research support grants from selective mechanisms (specifically, R01, R18, R29, R55, P01, P20, P50, U01) or comparable peer reviewed research projects (including those funded by State governments and private foundations) related to the scientific area of nursing inquiry. Each of these awards must have at least one year of committed support remaining at the time of the application receipt date. Institutions with centers grants (P50s and P20s) funded from previous NINR RFAs are eligible. Only one actively funded NINR center grant will be allowed per institution. No other NIH mechanisms of research support will be considered in determining eligibility. One of the three grants may be from a department other than nursing. A large number of NIH awards in the scientific area of inquiry for the active center of excellence would strengthen an application. Only one NRCC application will be accepted from any single applicant organization. For multi-campus institutions (e.g., the California institutions), no more than one NRCC application will be accepted from each of the separate campuses. Joint applications will not be accepted from investigators at neighboring, independent institutions, but subcontracts are allowed if their usage enhances the development of the scientific area of inquiry and stays within the dollar limits of the RFA. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research center core grant mechanism (P30). The purpose of this mechanism is to support shared resources and facilities for a specific area of scientific inquiry by a number of investigators who provide an interdisciplinary approach to a joint research effort or who focus on a common research problem. The core grant is integrated with the center's component projects or program projects, though funded independently from them. This support, by providing more accessible resources, is expected to assure a greater productivity than from the separate projects and program projects. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement (Oct 90). The total project period for applications submitted in response to the present RFA may not exceed five years. The total costs (direct and indirect costs) requested cannot exceed $300,000 for the first year. The anticipated award date is September 30, 1994. This RFA is a one-time solicitation. Support for NRCC awardees may be renewed in competing continuation applications which will compete in future NRCC RFAs. FUNDS AVAILABLE The NINR intends to fund four to five NRCC awards from this RFA in FY 1994, subject to the availability of funds and receipt of sufficiently meritorious applications. The estimated funds available for the first year of support of the centers are $1.2 million. All NRCC applications should request and provide justification for five years of support. The NINR expects to award four NRCC grants in fiscal year 1994 pending sufficiently meritorious applications and availability of funds. The total costs (direct plus indirect) for each NRCC are limited to $300,000 for the first year. The pilot and/or feasibility studies are limited to 20 percent of the total costs for each year. Cost-of-living or inflationary increases in subsequent budget years for recurring costs such as personnel and supplies may not exceed four percent escalation per year. Each budget item must be adequately justified. RESEARCH OBJECTIVES Background This initiative builds directly on a centers program initiated by House Report 100-689 accompanying the FY 1989 DHHS Appropriations Bill. The Appropriations Committee noted that the research agenda of the National Center for Nursing Research (NCNR) could benefit from a centers program. The Committee directed that $1 million be allocated to this new centers activity and asked for a multi-year plan for developing the Centers initiative. In response, NCNR funded two specialized centers (P50s) and two exploratory centers (P20s). In FY 1991, the Senate Report 101-516 accompanying the DHHS Appropriations Bill directed NCNR to support an additional exploratory center for health and behavior research. In response, NCNR collaborated with the National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH) in issuing an RFA inviting interested institutions to establish interdisciplinary exploratory centers to investigate health behavior development in children and adolescents (ages 8-18). NCNR funded three exploratory centers (P20s) and NICHD and NIMH each funded one additional exploratory center. In FY 1992, NCNR issued an RFA and funded two exploratory centers that targeted innovative clinical assessment and management strategies for symptoms commonly experienced by acutely or chronically ill patients. In FY 1994, the National Institute of Nursing Research plans to implement the research center core grant (P30) mechanism in place of the specialized center mechanism (P50). This mechanism offers support that will be advantageous to a number of schools of nursing and nursing departments in clinical settings. The research center core grant mechanism will allow the continued promotion of interdisciplinary cooperation and synergism within institutions and continue the development of infrastructure components for highly effective researchers who are building a strong center of excellence in a specific area of scientific inquiry. Content Areas Applicants should select the scientific area of inquiry based on a conceptually sound integration of their currently funded projects. The link to nursing practice issues within their center of excellence should be explicit. Examples of research areas of interest to the NINR are reflected in the following descriptions of the three branches of the Division of Extramural Programs. These examples of scientific areas of inquiry, which are making important advances relevant to clinical practice and patient outcome issues, are included only as examples and are not intended to limit the scientific area of inquiry responsive to this RFA: 1. Research in the Acute and Chronic Illness Branch deals with human responses to illness and disability throughout the life span. Research is concerned with the biological, behavioral, and psychosocial factors that contribute to these conditions and with methods to improve or alleviate the effects of the illness or condition. Research topics on nursing care of acute illness range from sleep-wake patterns of pre-term infants in the neonatal intensive care unit to the biobehavioral factors affecting recovery following a myocardial infarction. Research involving nursing care of patients with chronic illnesses addresses symptom management for conditions such as arthritis, diabetes, AIDS, and cancer. Additional research examples of patient responses being investigated include the assessment and management of pain, stress, cognitive impairment, and urinary incontinence. The Acute and Chronic Illness Branch has a special initiative to increase nursing research in structural and molecular biology, genetics, and immunology, in order to answer clinical questions and solve nursing problems. The goal of this effort is to increase the biological science interface with nursing research to validate biobehavioral knowledge underlying nursing practice. 2. Research in the Nursing Systems Branch examines the clinical practice environment in which health care is provided, factors underlying the process of nursing care, relationships among aspects of clinical practice, and the influence of that practice on outcomes of care. Also included are investigations of promising approaches to strengthening quality of care, such as studies that link nursing management and quality of care delivery. The primary focus of nursing systems research is inquiry into the delivery of health care which includes the study of the structural, organizational, and economic context of clinical practice and the processes of care delivery in relation to the assessment of clinical endpoints of appropriate care, which encompasses quality, efficacy, and effectiveness. Some examples are: investigations of the outcomes of home care, long-term care and/or hospital care; the mechanisms responsible for different clinical outcomes among different populations; the development and validation of clinical intervention strategies for rural and underserved areas; mechanisms to facilitate continuity of care; and the development of innovative approaches to the delivery of health care as linked to clinical outcomes. One special program emphasis pertains to ethical issues occurring during clinical practice that involve individual patients, their families, and practitioners. Examples include issues of advanced directives; withholding treatment; informed consent; prolongation of life; and involvement of patients, families, and care providers in clinical decision-making. 3. In the Health Promotion/Disease Prevention Branch studies on health promotion supported by the NINR are aimed at developing an understanding of the various factors involved in the advancement of well-being and the avoidance of health risks across the life span. They focus on nursing's concern with informing people about how to make good choices for themselves, and providing them with the skills, resources, and social environment needed to change and maintain healthful behaviors. Examples include, but are not limited to, studies on smoking and health, misuse of alcohol and drugs, nutrition, physical fitness and exercise, risk-related sexual behavior, family violence, self care, normal developmental processes in women, and parenting practices. Research in the HP/DP Branch also focuses on the prevention of illnesses and the promotion of health within illness. The focus of studies in this program includes the identification of biological, behavioral, and environmental risk factors and the development or refinement of methods in which nurses can intervene to enhance the abilities of at-risk individuals and their families to respond to potential health problems. Examples, include but are not limited to, studies of hypertension control, pregnancy and infant health, sexually transmitted diseases, and stress and coping through the life span. The choice of the scientific area of inquiry for the NRCC will be made by the Principal Investigator, who will be designated as the center director. The selection of a scientific area from the National Nursing Research Agenda or from other NINR initiatives will not be given preferential treatment during the review and funding process. Scientific areas of inquiries focusing primarily on psychiatric disorders, drug and alcohol usage, or pharmacological interventions will not be responsive to this RFA. However, individual research grants that focus on these topics would be acceptable as part of the funded base to meet the eligibility requirements for the proposed center. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource. Details of the interactions of the NRCC staff with the GCRC staff and research personnel may be provided in a statement describing the collaborative linkages being developed. A letter of agreement from the GCRC Program Director must be included with the application. SPECIAL REQUIREMENTS A nursing research center must be an identifiable organizational unit either within a college or school of nursing or a department of nursing within a university-affiliated medical center or hospital. Close cooperation, communication, and collaboration among all involved personnel of all disciplines is an ultimate objective of the NRCC. A Nursing Research Center Core Grant will involve the interaction of broad and diverse elements within the university or medical center. Therefore, lines of authority and sanction by the appropriate institutional officials must be clearly specified. Three mandatory research cores must be proposed. The three mandatory cores are (1) the Administrative Core to manage the overall activities of the Center and the pilot and/or feasibility studies, (2) the Research Support Core to manage the coordination of clinical and laboratory data and its appropriate data analysis, and (3) the Research Development and Dissemination Core to facilitate the research training of staff and the exchange and dissemination of information critical to the scientific area of inquiry both within the NRCC and within the broader scientific community. Additional research cores are allowed and welcomed if they are well justified, conceptually linked to the scientific area of inquiry, clearly demonstrate how the shared resources will enable investigators to conduct their independently funded research projects more efficiently and/or more effectively, and remain within the $300,000 total costs of the NRCC award and the page limitation allowed for each core. Pilot and/or feasibility studies, also described below, are another mandatory component of the NRCC application. These are intended to enable eligible investigators to explore the feasibility of a concept within the scientific area of inquiry and to amass sufficient data to pursue it through other funding mechanisms. Cores A core is a shared central laboratory or clinical research facility, service, or other resource. Each core is directed by an investigator with substantial expertise related to the core. Core facilities may be proposed which will enhance productivity or in other ways benefit a group of investigators to accomplish their stated goals. An important consideration is the degree to which core facilities will be utilized by and benefit individual ongoing-funded projects and center investigators and will assist in the development of the scientific area of inquiry. The following three cores are mandatory for all NRCCs: 1. An Administrative Core to manage the overall activities of the Center. This should include the following: a. A specified Director and Associate Director; b. A description of the administrative structure; c. A description of how the pilot and/or feasibility studies will be reviewed; d. A general description of overall facilities and institutional commitment; e. Separate budget pages detailing out the various administrative expenses and the pilot and/or feasibility studies. Each applicant institution will name an NRCC Director who will be the key figure in the administration and management of the NRCC grant. The Director will be responsible for the organization and operation of the NRCC. The Director should be experienced in conducting research and have demonstrated ability to coordinate, integrate, and provide guidance in the establishment of new programs in the scientific area of inquiry. An appropriate time commitment must be made by the Director. An Associate Director must be named who will be involved in the administrative and scientific efforts of the Center. It is expected that the NRCC administrative structure will accomplish the following: a. coordinate and integrate the NRCC components and activities; b. review the utilization of funds, including funds for pilot and feasibility studies; c. advise the NRCC Director on the activities of the Center's cores; While the final administrative structure of the NRCC will, for the most part, be left to the discretion of the applicant institution, NIH's experience has demonstrated that the effective development of Center programs requires interaction among the Director, the core leaders, the Principal Investigators of research projects using the cores, appropriate institutional administrative personnel and the staff of the awarding agency. To facilitate communication between the NRCC staffs and the NINR, the NINR requests that each NRCC application includes funds to attend an annual meeting in Bethesda, Maryland of all the NRCC Directors, Associate Directors, and their business managers. The success of the NRCC is dependent upon the involvement of scientific and professional personnel representing a variety of disciplines who must be willing to relate to and collaborate with each other in order to facilitate the development of new knowledge. An Executive Committee, consisting of the Associate Director and the heads of each of the cores, should be established to assist the Director in making the scientific and administrative decisions relating to the Center. In addition to coordination of the NRCC, the Director, with his or her Executive Committee, will be responsible for allocation of NRCC funds, the identification and selection of key personnel, and the planning and evaluation of the NRCC activities. An external Advisory Committee should be established and composed of scientists from within the institution and at least two scientists from outside the institution. This committee may also be used in evaluating the overall research programs of the NRCC, the effectiveness of communications within the NRCC, and any other activities in which problems arise for which expertise is required or desirable. The advisory committee should meet at least once annually. However, the nature of its responsibilities may require ad hoc meetings at more frequent intervals. A member of the NINR extramural program staff is to be invited to attend each meeting as an observer. The NRCC Director must describe the process that he or she will use to review the pilot and/or feasibility studies for future years of the proposed center. The review process may be carried out by the Advisory Committee, by an ad hoc Review Committee, by a mail review, or by a combination of these methods. It is recommended that the NRCC Director utilize at least two scientists with expertise relevant to the scientific area of inquiry of the NRCC from outside the institution during the review process. The research plan and the results of each pilot and/or feasibility study supported must be reported in the annual progress reports for the NRCC grants. The complex nature of administrative requirements of the NRCC will necessitate the assistance of a person with business management expertise. It is important that such an official be identified and directly involved with the fiscal aspects of the NRCC application and grant. An appropriate amount of this individual's time and effort should be committed for this purpose. The institutional business official should be a member of the executive committee. While budget formulation and planning will undoubtedly begin with the Director in collaboration with the scientific staff, the business official must be involved in the process and provide consultation in matters of fiscal administration and evaluate such issues as equipment on hand versus that requested for the core facilities. The business official should attend the annual Director's meeting and funds may be requested in the budget for this purpose. 2. A Research Support Core will support shared resources and facilities around a scientific theme. These may include functions such as patient registry, patient coordination, evaluation, clinical and laboratory data gathering, biometry or statistical data coordination. Assistance from computer experts, biostatisticians, and other individuals who can assist or collaborate with the participating investigators in conducting laboratory or applied clinical research relevant to clinical practice and patient outcomes issues may also be desirable. 3. A Research Development and Dissemination Core will facilitate the research training of staff in new skills and techniques as well as enhancing the exchange and dissemination of information critical to the scientific area of inquiry both within the NRCC and within the broader scientific community. The core will publicize the NRCC and its scientific activities (e.g., seminars, workshops, visiting scientists, and consultation opportunities in special areas of needed expertise) to foster interest within the institution and to encourage the development of a cadre of new investigators interested in the scientific area of inquiry. Clearly stated objectives and a systematic plan as to how these objectives will be met are required for this core. The NINR, through the NRCC mechanism, may support cores that seem likely to result in scientific accomplishments beyond those attainable solely through support of the mandatory cores. It is important to note that support is not allowed for cores that only replace or centralize resources supported on individual projects grants. Examples of other types of research cores that would be acceptable are: (1) provision of a technology that lends itself to automation or preparation (e.g., histology and tissue and cell cultures); (2) complex instrumentation (e.g., electron microscopy and image analysis); (3) animal preparation and care; and (4) service (e.g., molecular biology, photography, electronics shop). In a Nursing Research Center Core Grant application, it is not sufficient for the applicant merely to identify such centralized resources. Rather, it must be demonstrated exactly how each core would augment or enhance the present capabilities of the investigators and make possible new activities. In addition, after an award is made, the NINR will require documentation in annual progress reports and in renewal applications that sharing of resources has been achieved. Pilot and/or Feasibility Studies Pilot and/or feasibility studies should be included as a critical component of the NRCC application. Up to 20 percent of the total costs of the NRCC grant per year may be used for pilot and/or feasibility studies. The monies provide modest research support for a limited time (one year or two years maximum with clear justification for the time length) to enable eligible investigators to explore the feasibility of a concept within the scientific area of inquiry and to amass sufficient data to pursue it through other funding mechanisms. Eligible investigators include: 1. An established investigator in the scientific area of inquiry with a proposal for testing the feasibility of a new or innovative idea that is conceptually related but represents a clear and distinct departure from the investigator's ongoing research interest; 2. An established, supported investigator with no previous work in the scientific area of inquiry who is willing to test the applicability of his/her expertise on a conceptually related problem; and 3. A new investigator who has not been a Principal Investigator in the past, or who is not currently funded, with an NIH research project grant (e.g., R01, R29, P01). The NRCC center director and collaborating investigators are among those eligible for pilot and/or feasibility study monies. However, the pilot and/or feasibility studies monies should not be used for the next logical step in an ongoing research program for these investigators. These investigators should not be the predominately funded investigators with the pilot and/or feasibility study monies. Applications submitted in response to this RFA will not be considered for funding unless at least one pilot and/or feasibility study to be carried out during the first year has been recommended for approval. Therefore, three pilot and/or feasibility studies should be included in the application for review for the first year and they must be described in a maximum of thirty pages (which is in addition to the twenty-five pages allowed in the Research Plan, Sections 1 through 4, for describing each of the mandatory cores). The theoretical basis for the pilot and/or feasibility studies must be clearly explicated for the behavioral, psychosocial, and/or biological strategies being used. An interdisciplinary approach should be utilized to promote the collaboration of nurse scientists with scientists of other disciplines. Each pilot and/or feasibility study is limited to ten pages of description for the Research Plan, Sections 1 through 4, and should delineate the question being asked, detail the procedures to be followed, and discuss how the data will be analyzed. Both qualitative and quantitative methodologies are encouraged. Subsequent pilot and/or feasibility studies (a minimum of two ongoing each year) will be developed during the course of the award and must be discussed as part of the annual progress report. The total budget for all pilot and/or feasibility studies may be up to 20 percent of the total costs of the NRCC grant each year and should be included in the administrative core budget. Results of each pilot and/or feasibility study must be in the Center's annual progress reports to the NINR along with the plan used to solicit the new pilot and/or feasibility studies. For pilot and/or feasibility studies involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. Study populations must be described in the research design and methods section for each pilot and/or feasibility study. If women or minorities are not included in the study populations for the clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. Further information about this policy may be requested from NINR staff. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by March 18, 1994, a letter of intent that includes a descriptive title of the proposed center, 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 the RFA in response to which the application may be submitted. 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 NINR staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Ernest Marquez Office of Review National Institute of Nursing Research Westwood Building, Room 740 Bethesda, MD 20892 Telephone: (301) 594-7865 FAX: (301) 594-7894 APPLICATION PROCEDURES The application receipt date is April 21, 1994. Applications received after this date will not be considered. Form PHS 398 (rev. 9/91) is to be used to apply for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267; and from the NINR program staff listed under INQUIRIES. The pilot and/or feasibility studies and the mandatory cores have page limitations requirements. The arrangement of materials must follow both the instructions in form PHS 398 (rev. 9/91) application kit and in the NRCC guidelines which are available from the NINR program staff listed under INQUIRIES. The original and three signed exact photocopies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** In addition to mailing the application to the Division of Research Grants, send two copies of the application to: Dr. Ernest Marquez Office of Review National Institute of Nursing Research Westwood Building, Room 740 Bethesda, MD 20892** Telephone: (301) 594-7865 Applicants should keep in mind that the written application is the basis for the merit review. Site visits will not be conducted for the NRCC applications. Applications not in accordance with NRCC guidelines will be returned to the applicant. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. 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 in line 2a of the face page of the application form and the YES box must be marked. If the use of human subjects and/or vertebrate animals is proposed, appropriate institutional reviews and certifications must be obtained before the application is submitted and appropriate items on the Face Page must be completed. REVIEW CONSIDERATIONS Applications for NRCC grants will first be reviewed for completeness and responsiveness to the RFA. Applications that are incomplete or non-responsive to this RFA will be returned to the applicant. Applications that are complete and responsive may be subjected to a preliminary evaluation by a peer review group to determine their scientific merit relative to the other applications received in response to this RFA (triage); the NIH will withdraw from further consideration applications judged to be noncompetitive and promptly notify the Principal Investigator and the official signing for the applicant organization. Abbreviated summary reports will be prepared for non-competitive applications. Those applications judged to be competitive will be further evaluated for scientific merit by an ad hoc review group. This phase of peer review will be conducted by a group of expert consultants convened by the Office of Review of the NINR. Each application must be complete in itself. Site visits will not be conducted. A second level of review will be performed by the National Advisory Council for Nursing Research. Careful consideration of the information in the SPECIAL REQUIREMENTS section of the RFA and the following review criteria will be used to evaluate the NRCC grant (P30) applications: Research Base 1. Focus and depth of funded investigations that are currently in progress. 2. Presence of emerging collaborations and interactions, with common research interests, among the investigators within the research base. 3. Impact that funded investigators have made in their respective fields, as indicated by publications, and other factors. 4. The qualifications, experience, and commitment of the NRCC investigators responsible for the individual research projects, and their willingness to interact with each other. 5. The appropriateness of the investigators as participants of the center, and whether their activities warrant core support. Individual Core Projects 1. The inclusion of three mandatory cores including: (a) the Administrative Core to manage the overall activities of the Center, and the pilot and/or feasibility studies, (b) the Research Support Core to manage the coordination of clinical or laboratory data, and its appropriate data analysis, and (c) the Research Development and Dissemination Core to facilitate the research training of staff and the exchange and dissemination of information critical to the scientific area of inquiry both within the NRCC and within the broader scientific community. 2. The appropriateness and relevance of the proposed cores and the modes of operation, facilities, and potential for contribution to ongoing nursing research. Enhancement of collaborative and/or interdisciplinary research is a consideration. 3. Appropriate justification for each core component. Considerations include the duplication of existing resources or services and anticipated future use of each core. Pilot and/or Feasibility Studies 1. The scientific merit of the research proposed, how well the research fits into the focus of the overall center grant and the importance of the information sought to the goals of the NINR. 2. The feasibility and promise of the proposed methods. 3. The novelty or originality of the application. 4. The training, experience, and research competence of the investigator(s). 5. The suitability of the facilities for the proposed research, including the availability of required special resources. 6. The appropriateness and justification of the requested budget for the proposed work. 7. Provisions for the protection of human subjects and the humane care of animals. Overall Center Core Grant Application 1. The overall scientific merit and the potential of the research program for making a significant contribution to achieving the goals of the NINR. 2. The scientific gain from linking the research projects in a center grant, i.e., the degree of interrelatedness and synergism among the components of the center. 3. The qualifications of the Principal Investigator and other key investigators and the commitment of participating investigators to a common goal and to collaboration. 4. The adequacy of the available resources and the quality of the research environment. 5. The adequacy of the multiple aspects related to the administrative structure for the center, including the ability of the center director to provide the scientific and administrative leadership for the project; strategies to promote scientific planning, interaction, implementation, and evaluation; plans for succession of Principal Investigators; and arrangements for the fiscal management of the grant. 6. The institutional commitment to the center in terms of space, resources, administrative authority, and other necessary support; the extent to which the center is recognized as a major element within the organizational structure of the institution. 7. The plans for developmental activities, including recruitment and expansion, insofar as these are justified by the proposed research program. 8. The plans for outreach and collaboration with other groups doing related work. 9. Provisions for the protection of human subjects and the humane care of animals. 10. Appropriateness of the requested budget for the work proposed. INQUIRIES Prior to submission of the application, consultation with NINR staff concerning the technical aspects of preparing the application is extremely desirable. Applicants should not construe advice given by NINR staff as assurance of favorable review. The staff will not evaluate or discuss the merit of the scientific aspects of the application. Inquiries regarding programmatic/scientific issues and requests for the supplemental guidelines may be directed to: Laura A. James, Ph.D., R.N. Acute and Chronic Illness Branch National Institute of Nursing Research Westwood Building, Room 752 Bethesda, MD 20892 Telephone: (301) 594-7397 FAX: (301) 594-7603 For administrative and fiscal matters, contact: Sally A. Nichols Grants Management Officer National Institute of Nursing Research Westwood Building, Room 748 Bethesda, MD 20892 Telephone: (301) 594-7498 FAX: (301) 594-7603 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361 Nursing Research. Awards will be made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78- 410, as amended by Public Health Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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