NURSING RESEARCH DEVELOPMENTAL CENTER GRANTS (P20) RELEASE DATE: March 17, 2003 RFA: NR-04-001 National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.361 LETTER OF INTENT RECEIPT DATE: July 15, 2003 APPLICATION RECEIPT DATE: August 15, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplemental Instructions o Peer Review Process o Review Criteria o Additional Considerations o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Nursing Research (NINR) invites applications for Developmental Center grants (P20s) in key clinical and basic areas of nursing research that establish a scientific basis for the care of individuals across the life span. NINR seeks to increase the numbers of research-intensive schools of nursing through the Nursing Research Developmental Center grants (P20s). The Developmental Center grant, targeted to schools, colleges, or departments of nursing that are developing research programs, will augment the research resources in schools of nursing by facilitating the growth of infrastructure to centralize resources and facilities in a specific area of inquiry that has a beginning base of research funding. By increasing infrastructure components, Center investigators will have the opportunity to enhance their research productivity. RESEARCH OBJECTIVES The National Institute of Nursing Research (NINR) has historically supported the development of research infrastructure in schools of nursing by funding Centers. NINR's current Centers program includes Research Core Center (P30) grants and Exploratory Center (P20) grants. The Nursing Research Center Core grants provide the infrastructure to centralize resources and facilities to support an active center of excellence in a specific area of inquiry that has a strong base of research funding. The Nursing Research Exploratory/Developmental Center grants provide resources to develop research infrastructure and to facilitate the establishment of nursing research programs. The Nursing Research Developmental Centers RFA is designed to assist departments, schools, or colleges of nursing that are not research intensive in developing research programs and needed infrastructure by augmenting the research resources. Funds will support planning for new research programs to facilitate growth and development, expansion or modification of existing research resources, pilot or feasibility studies, and interdisciplinary collaboration. Applicants should select a scientific area of inquiry based on a conceptually sound integration of currently funded projects that comprise the research base. The link to nursing practice issues within the Center should be explicit. Applications should contain innovative ideas consistent with NINR's mission. Applicants are encouraged to review the Strategic Planning for the 21st Century document on the NINR website that includes the following examples of areas of scientific opportunity at NINR: o Chronic illness experiences, such as managing symptoms, avoiding complications of disease and disability, supporting family caregivers, promoting adherence and self-management activities, and promoting healthy behaviors within the context of the chronic condition. o Cultural and ethnic considerations in health and illness, including culturally sensitive interventions to decrease health disparities among groups by focusing upon health promotion activities and chronic illness management strategies. o End of life/palliative care research. NINR is currently the lead institute at NIH for this area of research and is focusing on clinical management of physical and psychological symptom management, communication, ethics and clinical decision-making, caregiver support, and care delivery issues. o Health promotion and disease prevention research, particularly as it relates to lifestyle changes and health behavior maintenance across the lifespan. o Implications of genetic advances, including reducing factors that increase risk of disease, issues related to genetic screening, and subsequent gene therapy techniques. o Quality of life and quality of care, to include cost savings for the patient, health care system, and society. o Symptom management of illness and treatment, such as pain, cognitive impairment, fatigue, nausea and vomiting, and sleep problems. o Telehealth interventions and monitoring or other emerging technologies to promote patient education and treatment. Proposed scientific areas for this RFA are not limited to these specified categories. In addition to these areas, applicants should note the research program categories that describe NINR broad areas of interest. The categories are listed at (http://www.ninr.nih.gov/ResearchAndFunding/DEA/OEP/AreasofscienceFile.htm). MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Exploratory/Developmental Center (P20) grant award mechanism. The purpose of this mechanism is to support planning for new programs, expansion or modification of existing resources, and feasibility studies to explore various approaches to developing research programs that address areas consistent with the mission of NINR. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The earliest anticipated award date is April 1, 2004. This RFA uses just-in-time concepts. FUNDS AVAILABLE NINR intends to commit approximately $2.5 to 3.0 million in FY2004 to fund 8 to 10 new and/or competitive continuation grants in response to this RFA. In this RFA, a change has been instituted. New, first-time P20 Centers will be awarded for up to 5 years, nonrenewable. Institutions with existing P20 Centers are being offered two options: 1) applying for a P30 award (see RFA- NR-04-002 at http://grants.nih.gov/grants/guide/rfa-files/RFA-NR-04-002.html), or 2) applying for a one-time competing continuation of up to 3 years. A budget for direct costs of up to $200,000 is allowable for the first year. Three (3) percent escalation is permitted for the outyears. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award may also vary. Although the financial plans of the NINR provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic Foreign institutions are not eligible for the Center program grants. Institutions eligible for the Nursing Research Developmental Center grants are those that are developing research programs and have not been major recipients of NIH support. The institution must have at least two (2) research projects funded by the Department of Health and Human Services (DHHS) grants from selected mechanisms (such as, R01, R03, R15, R21) or comparable peer reviewed research projects, including those funded by State governments and private foundations. These research projects should be directly related to the scientific area of the proposed Center. Each of these projects in the research base must have at least one (1) year of committed support remaining at the anticipated time of the Center award, i.e., funding must continue through March 31, 2005 at a minimum. A project that is in a no- cost extension phase does not meet this requirement. The PIs of at least two of the projects in the research base must be in the school of nursing. A larger number of NIH awards in the scientific area of inquiry would strengthen an application. Institutions with Exploratory Centers currently funded by NINR may apply for a competing continuation of up to 3 years. See COMPETING CONTINUATION APPLICATIONS section below. Institutions may not apply if they are: (1) current applicants for or recipients of an NINR Core Center grant (P30), and/or (2) ineligible for NIH Academic Research Enhancement Award (AREA) grants. (http://grants.nih.gov/grants/funding/area.htm) An institution may not concurrently apply for a P30 Core Center grant and a P20 Developmental Center grant. If eligible under the above criteria, an institution with a currently funded NINR P20 Partnership Center may submit an application for a P20 Developmental Center. An applicant organization may submit only one (1) P20 application. 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. Collaboration activities with other institutions, including P30 Center grant recipients, are encouraged. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS The Center must be an identifiable organizational unit within a department, school, or college of nursing. A Nursing Research Developmental Center grant benefits from an interdisciplinary approach. When multiple organizations within an institution are represented in the application, clear lines of authority and sanction by the appropriate institutional officials must be specified. Each applicant institution must name a Center Director who will be the key figure in the administration and management of the Center grant. The Director will be responsible for the organization and operation of the Center. 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. The Director must make an appropriate time commitment. Funding is intended to support shared resources and facilities (core units) that will enhance and extend the effectiveness of research at the applicant institution. CORES A core is a shared central resource, designed to enhance productivity or in other ways benefit a group of investigators in accomplishing their stated goals. The Developmental Center grant must consist of (1) an Administrative Core providing administrative, coordinating, planning, logistical, and/or methodological (e.g., research design, data analysis) support, and (2) a Pilot/Feasibility Studies Core. Each core should be directed by an investigator with substantial expertise related to the core. An important consideration is the degree to which core facilities will be utilized by, and benefit, individual ongoing and/or proposed projects and Center investigators, and will assist in the development of the scientific area of inquiry. It is not sufficient for the applicant merely to identify such shared resources. Rather, the applicant must demonstrate exactly how each core would augment or enhance the present capabilities of the investigators and make possible new activities. Administrative Core (Mandatory) An Administrative Core is mandatory for all Centers, and should manage the overall activities of the Center. Its description should include the following: 1. A specified Director; 2. A description of the administrative structure; 3. A general description of overall facilities and institutional commitment. It is expected that the Center administrative structure will accomplish the following: 1. manage, coordinate, and integrate the components and activities of the Center; 2. review utilization of funds, including funds for pilot and feasibility studies; 3. manage the shared resources of the Center, such as data sets, community or clinical research facilities, or provide research design and data analysis/statistical service; 4. provide information to the Center Director on the activities of the Center. While the final administrative structure of the Center 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, appropriate institutional administrative personnel and the staff of the awarding agency. To facilitate communication between the Center staffs and the NINR, the NINR expects that each Center application will include funds for the Center Director to travel to meetings in Bethesda, Maryland in the second and fourth years of the award period. An Executive Committee, consisting of the heads of both cores and the business official, should be established to assist the Director in making the scientific and administrative decisions relating to the Center. In addition to coordination of the Center, the Director, with his or her Executive Committee, will be responsible for allocation of Center funds, the identification and selection of key personnel, and the planning and evaluation of the Center activities. The complex nature of the administrative requirements of the Center will necessitate the assistance of a person with business management expertise. It is important that such a person be identified and directly involved with the fiscal aspects of the Center 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 should 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. An Advisory Committee should be established and composed of scientists, administrators, and others with expertise or experience relevant to the scientific program of the Center. The Advisory Committee will comprise individuals from within the institution and at least two (2) scientists from outside the institution. This committee may also be used in evaluating the overall research programs of the Center, the effectiveness of communications within the Center, and any other activities in which problems arise for which independent expertise is required or desirable. The Advisory Committee should meet at least once annually. The nature of responsibilities, however, may require ad hoc meetings at more frequent intervals. A member of the NINR extramural program staff may request to attend a meeting as an observer. Pilot/Feasibility Studies Core (Mandatory) Pilot/feasibility studies are a mandatory component of the Center 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. The budgets provide modest research support for a limited time (one year or two years maximum with clear justification for the time length). Eligible investigators include: o An established investigator with no previous work in the scientific area of the Center who will test the applicability of his/her expertise on a conceptually related problem; o A previously funded, beginning or mid-career investigator who would benefit from additional pilot work to prepare for an R01-type study; o A new investigator who has never been a Principal Investigator funded with a DHHS research project grant (e.g., R01, R03, R15, R21, or P01). Applications must propose a minimum of three (3) and a maximum of five (5) pilot/feasibility studies to be carried out during the first year. A minimum of three pilot/feasibility studies must be determined acceptable by the reviewers. The application should describe the review and selection process for the proposed pilot/feasibility studies. The theoretical or conceptual basis for the pilot/feasibility studies must be clearly explicated. An interdisciplinary approach is encouraged to promote the collaboration of nurse scientists with scientists of other disciplines as appropriate. Each pilot/feasibility study is limited to 10 pages of description for the PHS-398 Research Plan, Sections a. through d., and should delineate the question(s) being asked, detail the procedures to be followed, and discuss how the data will be analyzed. The application must indicate how the proposed pilot/feasibility study fits within the scientific area of nursing inquiry selected for the Center, and how the investigator satisfies the eligibility criteria listed above. Subsequent pilot/feasibility studies (a minimum of two (2) ongoing each year) must be developed during the course of the award. A description of how the pilot and/or feasibility studies were selected for this application and will be reviewed and selected in the future must be provided. 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 Center Director utilize at least two (2) scientists with expertise relevant to the scientific area of inquiry of the Center from outside the institution during the review process. Evaluation Plan A plan for evaluating progress toward aims and/or goals of both cores and the overall Center is required. This plan should include the specific measurement criteria and the methods that will be used for the evaluation. The plan should specify the types of evaluation information that will be submitted in the Center's annual progress reports. Competing Continuation Applications—Additional Requirements (P20s) In addition to all of the requirements noted above for the new P20 Center application, the competing continuation application must include the areas listed below. The content for these areas may be integrated in the narrative, but a summary of the rationale for a continuation must also be included. Justification of the need for an additional 3-year period for the Centers who choose to apply should address, but are not limited to, the following points: o Rationale for requesting continuation of the Center, including goals not fully achieved in the initial Center grant funding period and how continuing and new goals will be accomplished in the continuation Center grant. o Evidence of increased research intensity in the school of nursing directly attributable to the current Center. o Specific accomplishments of the overall Center and the individual cores, including results of the Center evaluation plan proposed in the initial application. o Center research program accomplishments, such as, but not limited to, 1) applications submitted and/or awarded and funding source, 2) publications, 3) significant contributions of the Center pilot studies, and 4) investigator accomplishments. o Advances in the development of the science focus of the Center. o Evidence of collaborative activities within and across institutional departments and disciplines as well as any external collaboration activities. o The goals and plans of the Center at the conclusion of the Developmental Center award. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Nell Armstrong Office of Extramural Programs National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-5973 FAX: (301) 480-8260 Email: armstrongn@nih.gov o Direct your questions about peer review issues to: Dr. John E. Richters Office of Review National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-5971 FAX: (301) 451-5645 Email: john_richters@nih.gov o Direct your questions about financial or grants management matters to: Ms. Cindy McDermott Chief Grants Management Officer National Institute of Nursing Research 6701 Democracy Boulevard, Room 710 One Democracy Plaza Bethesda, MD 20892-4870 Telephone: (301) 594-6869 FAX: (301) 402-4502 Email: cindy_mcdermott@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NINR staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Dr. John E. Richters Office of Review National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-5971 FAX: (301) 451-5645 Email: john_richters@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. The instructions for the Form PHS 398 do not entirely apply to the submission of these P20 grant applications. Accordingly, applicants are strongly encouraged to follow the SUPPLEMENTAL INSTRUCTIONS below, which have been adapted to accommodate the PHS 398 and the special requirements of this RFA. These instructions include all of the information that will be needed by the peer reviewers of these applications. SUPPLEMENTAL INSTRUCTIONS 1. Face Page: Use Form Page 1 as instructed in the PHS 398. On line 2, enter the number and title of this RFA. Remember to affix the RFA label that comes with the PHS 398 to the bottom of the Face Page. 2. Description, Performance Site(s) and Key Personnel: Use Form Page 2 of the PHS 398 and follow the instructions provided in the PHS 398. 3. Table of Contents: Provide a detailed Table of Contents organized as described below. This differs from Form Page 3 of the PHS 398. Content Page Number o Face Page o Description, Performance Sites and Key Personnel o Table of Contents, including List of all Tables and Figures o Detailed Budget for Initial Budget Period (Cores and Pilot/Feasibility Studies) o Budget for Entire Proposed Project Period (Cores and Pilot/Feasibility Studies) o Budgets Pertaining to Consortium/Contractual Arrangements (if applicable) o Budget Justification Pertaining to Consortium/Contractual Arrangements (if applicable) o Biographical Sketch of the Principal Investigator (Center Director) o Biographical Sketches of All Professional Personnel and Pilot Investigators o List of participating faculty/members of the Center o Resources o Overview of Center and Description of Research Base o Administrative Core, Budget, and Budget Justification o Pilot/Feasibility Studies Core, Budget, and Budget Justification o References o Letters of Support o Pilot/Feasibility Study #1 o Pilot/Feasibility Study #2 o Pilot/Feasibility Study #3 o Pilot/Feasibility Study #4 (optional) o Pilot/Feasibility Study #5 (optional) o Consortium/Contractual Arrangements o Checklist o Appendix Material 4. Detailed Budget for Initial Budget Period: Use Form Page 4 of the PHS 398 application kit. This budget should include total direct costs of the Cores and Pilot/Feasibility Studies. 5. Budget for Entire Proposed Project Period: Use Form Page 5 of the PHS 398 application kit. This budget should include total direct costs of the Cores and Pilot/Feasibility Studies for all years requested. Future pilot/feasibility studies to be identified should be budgeted as a block under "Other Expenses" in the Pilot/Feasibility Studies Core. 6. Budgets Pertaining to Consortium/Contractual Arrangements: Use Form Pages 4 and 5. These budgets are included if consortium/contractual arrangements are needed. 7. Budget Justification Pertaining to Consortium/Contractual Arrangements: if applicable. 8. Biographical Sketch of Principal Investigator (Center Director): Use the Biographical Sketch Format Page of the PHS 398 and follow the instructions in the application kit. 9. Biographical Sketches of All Professional Personnel and Pilot Investigators: Use the Biographical Sketch Format Page of the PHS 398 as above. This section should include all professional personnel who are listed with a percent effort, including consultants and members of the External Advisory Committee. Biographical sketches are also required for those who are listed in the research base. Arrange the biographical sketches alphabetically. These pages should not be duplicated in the individual component cores or pilots. 10. Complete List (or Table) of Participating Faculty/Members of the Center and the External Advisory Committee: List members alphabetically by name and include for each individual his/her degree, institution and department affiliation or equivalent, and research or other interest (e.g., research area, training, or education). 11. Resources: Using the Resources Format Page in the PHS 398 application kit, describe the relevant resources. 12. Overview of the Center and Description of the Research Base: This section is limited to 25 pages. The Specific Aims should state concisely the scientific area of inquiry that will serve as the focus for the Center, and the overall objectives of the Center. The Background and Significance section should include a critical review and synthesis of relevant research, theory, and methods to establish the scientific and public health significance of the proposed Center's objectives as described under Specific Aims. It should also provide a detailed rationale and justification for the proposed scientific area of inquiry with emphasis on how the institution will benefit from the proposed Center. Plans to develop productive collaborations among Center investigators should be highlighted, and criteria for designating an investigator as a Center participant (investigator) should be defined in terms of the responsibilities and privileges associated with a Center investigator. The justification for continuation of an existing Center should also be included in this section. The Preliminary Studies section should provide a detailed description and discussion of funded research projects that constitute the proposed Center's Research Base, and indicate how these studies support the selected scientific theme. It is helpful to present the Research Base studies in table format, specifying for each funded study (a) the title and grant number, (b) funding organization, (c) period of committed support, (d) direct costs for the project period, (e) current year annual direct costs, (f) names and institutional affiliations of the principal investigator and co- investigators, and (g) principal investigator's percent of committed effort. The Research Base studies and related resources should be described and discussed in sufficient detail to support an evaluation of their (a) relevance to the scientific area of inquiry, and (b) strengths and limitations as a scientific foundation for pursuing the Specific Aims of the proposed Center. Applicants may want to provide similar tables depicting pending support for research projects related to the scientific area of inquiry and current support for research projects unrelated to this theme. The focus and interrelationships of ongoing research and research interests for Center investigators should be documented. The Overview should also include a description of the qualifications of the Center Director. 13. Administrative Core: Provide a Detailed Budget, a Budget for Entire Proposed Project Period, and Budget Justification for the Administrative Core: Use Form Pages 4 and 5 of the PHS 398 application kit. The narrative section is limited to 25 pages. Provide a detailed description and discussion of the objectives, functions, organizational infrastructure, administrative procedures, key personnel (including the Core Director), and resources of the Administrative Core within the context of the overall Center. The description should depict the relationships and lines of authority by appropriate officials; committee structures and membership; and plans for assistance of a business official for fiscal matters. A diagram of the interactions to be fostered by the Center is useful in depicting proposed interrelationships and collaborations among institutional resources. Provide a general overall description of facilities and institutional commitment, including letter(s) of institutional commitment, and if applicable, a letter from the General Clinical Research Center Director. The composition and functions of the External Advisory Committee should be delineated. Also describe the criteria, methods, and other components of the comprehensive evaluation plan for the Center. 14. Pilot/Feasibility Studies Core: Provide a Detailed Budget, a Budget for Entire Proposed Project Period, and Budget Justification for the Pilot/Feasibility Studies Core: Use Form Pages 4 and 5 of the PHS 398 application kit. Future pilot/feasibility studies to be identified should be budgeted for as a block under "Other Expenses" (on Form page 5). The narrative section is limited to 25 pages. Provide a detailed description and discussion of the objectives, functions, organizational infrastructure, administrative procedures, key personnel (including the Core Director), and resources of the Pilot/Feasibility Studies Core within the context of the overall Center. The description should portray the relationships and lines of authority and any committee structures and membership. A detailed description of Core activities designed to facilitate the development and completion of pilot/feasibility studies should be provided, including the process used for selecting pilot studies included in this application, and for selecting future pilot studies. 15. References: Follow the directions and instructions provided in the PHS 398 application kit. 16. Letters of Support: Provide letters of support. 17. Pilot/Feasibility Studies: For each proposed pilot/feasibility study, provide the information below. o Description, Performance Site(s), and Key Personnel: Use PHS 398 Form Page 2. o Detailed Budget for the Pilot/Feasibility Study for the Initial Budget Period: Use Form Page 4 of the PHS 398 application kit. If the pilot/feasibility study is longer than one year in duration, also include Form Page 5 of the PHS 398 application kit, Budget for Entire Proposed Project Period. o Budget Justification: Use PHS 398 Form Page 5. If the pilot/feasibility study is longer than one year in duration, provide the requested direct costs under Budget for Entire Proposed Project Period as well as Budget Justification information. o Justification of eligibility of the principal investigator according to the stated criteria. o Justification of the study as a pilot study (including where the project could lead) and how the study fits into the Center's scientific area of inquiry. o Scientific proposal as outlined in PHS 398 (including justification for core use if applicable): (10 pages maximum) See PHS 398 application kit, Research Plan, sections a. through d. o Information regarding human subjects or vertebrate animals as applicable. o Literature cited. 18. Consortium/Contractual Arrangements: Follow the directions and instructions provided in the PHS 398 application kit. 19. Checklist: Use Checklist Form Page in the PHS 398 application kit. 20. Appendix Material: Follow the directions and instructions provided in the PHS 398 application kit. 21. Personal Data on Principal Investigator/Program Director: Use Personal Data Form Page in the PHS 398 application kit. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Dr. John E. Richters Office of Review National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NINR. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NINR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Council for Nursing Research. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to give careful consideration of the information in the SPECIAL REQUIREMENTS section of the RFA and the review criteria listed below in order to judge the likelihood that the proposed Center will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Overall Center Grant Application 1. The overall scientific merit and the potential of the Center for making a significant contribution to achieving the goals of 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 Center co-Directors and other key investigators and the commitment of participating investigators to a common goal, to the science focus, and to collaboration. 4. The adequacy of the available resources and the quality of and potential for the research environment. 5. The commitment of the institution to the Center in terms of space, resources, administrative authority, and other necessary support, e.g., donated faculty time, use of equipment, and the extent to which the Center is recognized as a major element within the organizational structure of the institution. 6. The plans for developmental activities, including recruitment and expansion, insofar as these are justified by the proposed research program. 7. Evidence of the extent to which the planning, organization, structure, and design of the proposed Center and activities reflect a genuine collaboration within and across disciplines. 8. Appropriateness of the requested budget for the work proposed. Research Base 1. Focus and depth of funded investigations that are currently in progress. 2. Presence of current and emerging collaborations and interactions among investigators with common research interests within the area of scientific inquiry, and 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 Center investigators responsible for the individual research projects, and their willingness to collaborate with each other. 5. The appropriateness of the investigators as participants of the Center. Administrative Core 1. The adequacy of the Administrative Core to manage the overall activities of the Center. 2. The appropriateness and relevance of the proposed Core and the modes of operation, facilities, and potential for contribution to ongoing nursing research. 3. Appropriate justification for the Core, including avoiding duplication of existing resources or services and anticipated future use of the Core. 4. The qualifications of the Director of the Administrative Core. 5. The adequacy of the multiple aspects related to the administrative structure for the Center, including the provision of scientific and administrative leadership for the Center; strategies to promote scientific planning, interaction, implementation, and evaluation; and arrangements for the fiscal management of the grant. 6. The proposed composition and functions of the Executive Committee to support the proposed activities of the Center. 7. The proposed composition and function of the Advisory Committee to support the proposed activities of the Center. 8. The appropriateness of the plan to evaluate Center activities and outcomes. Pilot/Feasibility Studies Core 1. The process for selecting the pilot/feasibility studies included in the application. 2. The proposed process for reviewing and selecting future pilot/feasibility studies. 3. The qualifications of the Director of the Pilot/Feasibility Studies Core. 4. The appropriateness and relevance of proposed Core activities to facilitate successful pilot/feasibility studies. 5. Evidence of a strong commitment to, and plans to support, pilot investigators in successful completion of their studies. Pilot/Feasibility Studies 1. The scientific merit of the research proposed and the importance of the information sought to the mission of the NINR. 2. How well the pilot/feasibility study fits into the area of scientific inquiry selected for the Center. 3. The justification for eligibility of the investigator(s) according to criteria listed in the RFA. 4. The feasibility and promise of the proposed methods. 5. The novelty or originality of the proposed study. 6. The training, experience, and research competence of the investigator(s). 7. The suitability of the facilities for the proposed research, including the availability of required special resources. 8. The appropriateness and justification of the requested budget for the proposed work. 9. Provisions for the protection of human subjects and the humane care of animals, and the appropriate inclusion of women, minorities, and children in clinical research. 10. Adequacy of the Data and Safety Monitoring Plan for clinical trial pilot studies. Competing Continuations—Additional Review Criteria 1. The adequacy of the justification for the competing continuation. 2. The innovativeness and/or originality of the proposed competing continuation. 3. The extent of the Center's accomplishments based on its goals. 4. The extent to which the new and continuing Center goals are likely to be met. 5. The extent to which increased research intensity has resulted from the current Exploratory Center, and the potential for further development. 6. The potential for sustainability of the Center activities. 7. The progress of current Center investigators toward a program of research. 8. The appropriateness and adequacy of existing collaborations in furthering the goals and activities of the Center. 9. The extent to which advances have occurred in the development of the science focus. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: July 15, 2003 Application Receipt Date: August 15, 2003 Peer Review Date: October/November 2003 Council Review: January 2004 Earliest Anticipated Start Date: April 1, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/ guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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