Full Text PAR-96-004 RESEARCH INFRASTRUCTURE IN MINORITY INSTITUTIONS NIH GUIDE, Volume 24, Number 37, October 20, 1995 PA NUMBER: PAR-96-004 P.T. 34, FF Keywords: Biomedical Research, Multidiscipl Behavioral/Social Studies/Service National Center for Research Resources Office of Research on Minority Health Letter of Intent Receipt Date: January 2, 1996 Application Receipt Date: February 1, 1996 PURPOSE The National Center for Research Resources (NCRR) and the Office of Research on Minority Health (ORMH) encourage the submission of grant applications from eligible institutions for the development of their biomedical research infrastructure. The purpose of these Phase II exploratory grants, which will use the P20 mechanism, is to enable minority baccalaureate and masters degree granting institutions to implement their plans to significantly enhance their capacity and competitiveness for the conduct of biomedical and/or behavioral research. The NCRR/ORMH announced the availability of planning grants (Phase I of this initiative) in the NIH Guide for Grants and Contracts, Vol. 24, No. 12, March 31, 1995. Applications were due June 1, 1995, with Phase I awards scheduled for September 30, 1995. Receipt of a Phase I Planning Grant is not a requirement for participation in Phase II (implementation). It is a requirement of Phase II applications that the eligible minority institutions have, at the time of application submission, formal collaborative agreements with research-intensive doctoral degree-granting institutions. The major objectives of the Phase II Research Infrastructure in Minority Institutions (RIMI) Initiative are to: (1) establish a RIMI activity that will enhance the institution's biomedical research infrastructure, and (2) utilize collaborative agreements with institutions granting doctoral degrees in the health sciences to encourage and facilitate research and mentoring interactions between the biomedical research faculty in grantee and collaborating institutions. Increased participation of students from the grantee institution in these doctoral programs is expected to be an additional benefit of these collaborations. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Research Infrastructure in Minority Institutions (RIMI), is related to all priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0 or Summary Report: Stock No.017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Domestic academic institutions with more than 50 percent minority enrollment that offer one or more baccalaureate and/or master's degrees in the sciences related to health are eligible to compete for support under this initiative. Minority institutions that award an M.D., D.D.S., Pharm.D., D.V.M. or other doctoral degree in the health professions, and/or a Ph.D. in the sciences related to health are not eligible. However, they may serve as the collaborating research-intensive institutions. Eligible institutions must have formal collaborative agreements, by February 1, 1996, with one or more research-intensive universities offering doctoral degrees in the health-related sciences. These collaborations must encourage and facilitate research between faculty in the participating institutions. They also should facilitate the participation of students from the undergraduate institution in the doctoral degree programs. Applicants must provide evidence of the existence and nature of the collaborative agreement(s) in the application. The receipt of a Phase I planning grant is not a prerequisite for submission of an application for a Phase II award. MECHANISM OF SUPPORT Awards under this PA will use the exploratory grant (P20) mechanism. The applicant will be solely responsible for the planning, direction, and execution of the grant. The total requested project period may not exceed five years. Requested direct costs may not exceed $600,000 for each 12 month period. Indirect costs will be provided. The anticipated award date is September 30, 1996. This PA is a one-time solicitation. Allowable Costs Requested allowable costs of activities should focus primarily on the establishment of biomedical research infrastructure at the applicant institution. Requests for a maximum of three relevant developmental/collaborative research projects may be included but may not exceed 50 percent of the budget. All requested items must be related to the needs of the institution's RIMI implementation plan, and must be specifically and thoroughly justified. Research related costs at the collaborating institutions are allowable and must be listed in the budget as contractual costs. These costs must be related to the collaborative research, and should augment existing resources. Costs related to student training are not allowable. FUNDS AVAILABLE If a sufficient number of highly meritorious applications are received, it is anticipated that up to five to seven Phase II grant awards may be made. Award of grants pursuant to this PA is contingent upon the number of highly meritorious applications received and the availability of funds. RESEARCH OBJECTIVES Background The ORMH strongly supports the establishment of institutional partnerships as an essential approach toward reaching its goals of (1) extending healthy life and reducing the burden of illness among minorities through targeted research and (2) increasing the participation of minorities in all phases of biomedical research. There is enormous potential for mutual growth as an outcome of interaction between, on the one hand, Historically Black Colleges and Universities, Hispanic Serving Institutions, and other institutions serving primarily minority populations; and, on the other hand, research-intensive institutions that award doctoral degrees in the health sciences or sciences related to health. The ORMH Fact-Finding Team (FFT) was convened in May 1991 to recommend ways in which the ORMH could reach its goals. Thirteen recommendations resulted, of which four advocated directly or indirectly the development of the institutional partnership concept. Precedents for this partnership model have been set by several programs within the NIH and many collaborative efforts are now in place between minority and majority institutions. To the minority institutions, benefits derived from these partnerships have accrued in the areas of faculty recruitment and retention, student development, enhanced research capacity, and administrative acumen. Majority institutions have broadened the scope of their missions, heightened the diversity of their activities, and reshaped their vision for the future of their institutions. The Research Infrastructure in Minority Institutions (RIMI) Initiative, which will assist in the development of the biomedical research infrastructure at eligible minority institutions, is responsive to mutual and synergistic goals of the NCRR and the ORMH, and is in response to the FFT's recommendations. It will be a merger of the ORMH institutional partnership concept and the extensive experience of NCRR in developing the research infrastructure of minority doctoral degree-granting institutions. This initiative will also address the problem of diversity in the biomedical sciences, a major NIH concern. Program Characteristics The Principal Investigator (PI) should be the President of the applicant institution or his/her designated representative for implementation of the RIMI Program. In addition, the governance structure must include a Program Director (PD), and a RIMI Advisory Committee. The PD is nominated by and responsible to the PI; the PD must be willing and able to devote the time and effort necessary for effective management and implementation of the RIMI program. He/she should be a knowledgeable and experienced biomedical scientist, and an effective administrator. A RIMI Advisory Committee that is advisory to the PI and PD must be established. It should consist of eight to twelve members and must include a cross-section of qualified faculty and appropriate members external to the institution. One or more of the external members must be from the collaborating institution(s). It is essential that the Committee be knowledgeable about the institution's strengths and weaknesses in biomedical research, capabilities and needs, and overall goals. It should possess, among its members, the experience and knowledge to provide appropriate guidance for the program and identify and recommend expert consultation from others, including leaders in relevant scientific disciplines and other fields as needed, to provide the critical input necessary to develop and maintain a competitive RIMI Program. The Committee will oversee the implementation of the plans for infrastructure development and for collaborative relationships among institutions, faculty and students, and will make recommendations throughout the process. Therefore, competing or conflicting interests must be carefully considered when developing Committee operating procedures. Program plans for enhancement of biomedical research capacity must be consistent with the long-range goals of the applicant institution. It is recognized that the nature and scope of a RIMI application may vary widely in different institutional settings. Each applicant must assess and address its own needs. The applicant must describe and justify how existing and requested resources will be utilized to implement the institutional plan and collaborative agreements to create and maintain an environment and framework suitable to achieve the objectives of the RIMI program. Some examples of items that may be appropriate for support are a Program Director and staff, research support personnel, a core laboratory with multi-user research equipment, and up to three collaborative/developmental research projects. Resources that facilitate networking, consultation and collaboration between the applicant's faculty and faculty at the other participating institution(s) are appropriate and encouraged. Renovation of research space and recruitment of faculty scientists are other possibilities. For the application to be complete, an evaluation plan must be developed to determine the extent to which the program goals are being achieved. This plan may include, but should not be limited to, the evaluation of both the short-term and long-term goals and how the RIMI goals match and/or affect the goals of the applicant institution. The evaluation plan should address such issues as availability of expertise, time allocation, and resource allocation. The implementation of appropriate Memoranda of Understanding and Agreements (MUAs) with one or more institutions that award doctoral degrees in the biomedical sciences is required in Phase II. There must be reasonable opportunities for the faculty at the grantee institution to serve on doctoral thesis advisory committees and to have other faculty privileges as appropriate. Additionally, effective mechanisms for the participation of students from the applicant institution in these doctoral programs should be included in the MUAs. The establishment of biomedical research collaborations among the faculty at these institutions is expected. Applicant institutions must have these MUAs in place at the time of application. Signed copies must be included in the application. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by January 2, 1996, a letter of intent that includes a descriptive title of the proposed RIMI Program; 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 PA 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 is helpful in planning for the review of applications. It allows NCRR 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: Director, Office of Review National Center for Research Resources 6705 Rockledge Drive, Suite 6018, MSC 7965 Bethesda, MD 20892-7965 FAX: (301) 480-3660 APPLICATION PROCEDURES Prospective applicants are advised to communicate with program and grants management staff of the NCRR as early as possible in the planning phase of application development. NCRR staff available to assist applicants are listed under INQUIRIES. A workshop will be held in the Washington, DC area in early to mid-November to provide technical assistance in the preparation of applications and to assist in the development and implementation of such plans. Additional information may be obtained from the program contact listed under INQUIRIES. The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3034, MSC 7762, Bethesda, MD 20892-7762, telephone 301/710-0267, Email: girg@drgpo.drg.nih.gov. Applicants should thoroughly review and follow the instructions accompanying form PHS 398 and the following: Face Page Item 1. Title of Project. The title should reflect the overall research emphasis of the RIMI Program. Item 2. Response to Specific Program Announcement. Check "YES" and type in the number and title of this program announcement. Items 6. Dates of Proposed Period of Support. Up to five years of support may be requested. The start date should be September 30, 1996. Page 2 (Description, Performance Site(s) and Key Personnel) Description of Proposed Program. In describing the RIMI program, outline the overall objectives and the implementation plan, indicating how each component will contribute to the achievement of these objectives and the goals of the RIMI Program. Performance Sites. Include all locations, whether at the applicant or the collaborating institution(s). Key Personnel. Under key personnel, include the Principal Investigator, the Program Director, and any other individuals with a significant role in implementing the RIMI program. This should include personnel at the collaborating institutions. Form Page 3 (Table of Contents) Modify the table of contents to reflect the content and sequence outlined in the modified instructions in this PA. Form Page 4 (Detailed Budget for Initial Budget Period) and Form Page 5 (Budget for Entire Period) Use these forms to provide a Summary budget for the RIMI program (not to exceed $600,000 direct costs per year). Salary support for employees of the applicant institution must be listed as personnel. Support for all other personnel should be listed under consultants (including consulting fees and travel expenses), or under consortium/contractual costs. Also use both forms to provide an Administrative budget. Include the Principal Investigator, the Program Director, administrative support personnel and other budgetary items needed for central coordination of the program. The need for each budget item requested and its cost must be thoroughly documented in the "Justification" section. Form Page 6 (Biographical Sketch) Include for the Principal Investigator and the Program Director in this section. (Biographical sketches for other key personnel, including specific activity or project leaders, should be included in the section describing that activity). I. Institutional Setting and General Plan (Limit narrative to 10 pages) Research Plan Do not follow the outline in form PHS 398; Develop as follows: Description of Applicant Institution Provide a brief history of the institution and its mission, including developmental milestones over the last 10 years. Describe the institution's current status by providing: o a self-analysis of organizational, educational and scientific strengths and weaknesses; and o a summary of major resources (physical, human, and financial) for biomedical research. Include numbers of faculty involved and numbers of students in the health-related sciences. Description of Collaborating Institution Provide a brief summary of the principal resources (researchers, core labs and other research facilities) at the collaborating institution that will be used to facilitate the achievement of the RIMI objectives. General Plan for Expanding Biomedical Research Capacity Briefly describe the process used to select the plan, addressing the areas of: o concept development, including the identification of institutional goals, formulation of organizational/advisory structures, and prioritization of research development area(s); and o application development, including the role of the Advisory Committee and the involvement of peer reviewers. Describe the institutional plan developed by this process in terms of: o specific aims and goals for the project period, o brief description of specific component activities, o implementation timetable, and o plan for institutionalization of RIMI-supported resources and maintenance of enhanced biomedical research capacity after RIMI support ends. Organizational Structure and Administration Outline the organizational structure of the institution, showing how the RIMI PD will interface with the administrative structure. Describe the lines of authority and indicate how the proposed structure will allow the PD to best accomplish the goals identified for the RIMI program. RIMI PD Describe the qualifications of the faculty member selected for this role, including his/her scientific training, biomedical research experience, administrative leadership skills, and commitment to the RIMI initiative. RIMI Advisory Committee Describe the composition and function of the Committee. List the names and titles of the members, including their institutional affiliations. Identify the expertise that each member contributes to this Committee. The PI and PD are non-voting members. Provide a description of how the committee functions, its roles and responsibilities, resources available to it, frequency of meetings, and reporting requirements. Institutional Commitment Provide evidence of the applicant institution's commitment to biomedical research and to enhancing its biomedical research environment. Examples might include the availability of research space, cost sharing, promotion and tenure policies emphasizing the importance of research, an institutional strategic plan that complements the RIMI initiative, ongoing collaborations with research-intensive institutions, participation in PHS research and training activities, and any other activity that encourages faculty and student involvement in biomedical research. Evaluation plan Describe the plan for evaluation of the RIMI Program. Collaborative Agreement(s) Describe the essential elements of the collaborative agreements between the applicant institution and research-intensive doctoral degree-granting institutions, that address the goals of this initiative. If modifications, improvements, or expansion of these agreements are planned, describe these in detail. Address any anticipated or potential problems and describe proposed alternative plans to resolve them. Include a copy of the current MUA(s) in this section of the application. II. Baseline Data on Biomedical Research Capacity (Limit narrative to 10 pages) This section should be used to describe a) current institutional resources and activities related to biomedical research, b) ongoing biomedical research programs of faculty, and c) the pre and post award management process. Also describe, for the past five years, a) the number of student majors and degrees awarded in the sciences related to health, b) faculty awards, honors and involvement in professional societies, and e) research publications, and grants and contracts awarded. The above information should be limited to those departments/research areas which would be impacted by the RIMI program. III. Detailed Plan for Each RIMI Activity or Project The RIMI application may include several activities. A separate plan must be developed for each research infrastructure and collaborative research activity. Include pages 2 and 4 through 8 from PHS 398. Follow the PHS 398 instructions (pp 15-19) for the Research Plan for each activity. In addition, emphasize the important aspects noted below in describing: Infrastructure Components Tailor the narrative to clearly describe the objectives, needs, rationale for the approach selected, and implementation timetable in the context of current resources, alternatives considered, and overall program goals. Describe the planning process, explain the management structure, and outline the corporate plan to institutionalize support over time. Identify the user community, explaining in detail the nature and extent of utilization by each investigator (current and/or proposed). Collaborative Research Projects Clearly describe the importance and relevance of the proposed collaborative projects to the institution's RIMI program goals. IV. Appendix List in the Table of Contents any items included in the Appendix. The Appendix should be limited to letters of commitment from consultants, collaborators, and institutional officials from the applicant and collaborating institutions, and no more than three relevant research publications. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, and one copy of the Appendix, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 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, and four copies of the appendices, are to be sent to: OFFICE OF REVIEW NATIONAL CENTER FOR RESEARCH RESOURCES 6705 ROCKLEDGE DRIVE, SUITE 6018, MSC 7965 BETHESDA, MD 20892-7965 BETHESDA, MD 20817 (for express/courier service) Applications must be received by February 1, 1996. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Applications that are incomplete or nonresponsive to this PA will be returned to the applicant. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Research Resources Council, NCRR. Major factors to be considered in the overall evaluation of the applications include: o Adequacy of the planning process, including self-assessment of current biomedical research capabilities, concept development and involvement of advisory resources. o Appropriateness of the organizational and administrative structure established to accomplish RIMI program goals. o Qualifications, experience and commitment of the PD, and his/her ability to provide effective leadership in implementing the institutional RIMI plan. o Appropriateness of the RIMI Advisory Committee and other consultative resources for guiding the implementation of Phase II. o Adequacy of institutional commitment to biomedical research. o Appropriateness of the collaborative arrangements with doctoral degree-granting institutions for achieving RIMI program goals. o Appropriateness and adequacy of the institution's evaluation plan, including availability of expertise, and time and resource allocation. o Appropriateness of requested budget and proposed project period. In addition, major factors to be considered in specific activity areas include: Infrastructure Components: Assessments of infrastructure requests are not based primarily on specific evaluations of individual scientific protocols, but rather on a broader perception of the feasibility of achieving what is proposed with the resources requested. The criteria for review of these components include: o Adequacy of mechanisms to enhance proficiency of grants and contracts management. o Rationale and need for these resources to achieve institutional RIMI goals, including the potential for developing high quality research programs. The availability of a user community is critical. o Adequacy and appropriateness of administrative and scientific leadership for implementing and managing the resources, including collaborative and consultative arrangements. o Appropriateness of the plan for the resource,including objectives, implementation strategy and timetable, and involvement of the advisory committee. o Reasonableness of plans to institutionalize support for this resource over time. Developmental and Collaborative Research Projects: Review of developmental research projects is based not only on the traditional considerations necessary for peer evaluation of scientific merit, but also takes into account the preliminary nature of the proposed studies and, in a broader sense, the extent to which the research activity will contribute to the goals of the RIMI Program. The criteria for review of these developmental research projects include: o Significance and relevance of proposed research problem. o Appropriateness of research plan, including specific aims, experimental design, methodology, consideration of alternatives, data analysis, scope and timetable. o Adequacy of resources, including background and training of the activity leader and other personnel, appropriateness of consultants and collaborators, and availability and suitability of specialized facilities and equipment. o Relevance of proposed project to the institutional plan for expansion of biomedical research capacity and enhanced opportunities for collaboration. AWARD CRITERIA Award decisions will be based on the technical merit of the application as determined by peer review, availability of funds, and other programmatic priorities to ensure a balance among the various types of programs, populations served, and/or geographic distribution. INQUIRIES Written and telephone inquiries concerning the PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Robert F. Hendrickson National Center for Research Resources 6705 Rockledge Drive, Suite 6030, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0760 Email: roberth@ep.ncrr.nih.gov Direct inquiries concerning fiscal matters to: Mr. Paul Karadbil Office of Grants and Contracts Management National Center for Research Resources 6705 Rockledge Drive, Suite 6086, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0844 Email: paulk@ep.ncrr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.389. Awards will be made under authorization of the Public Health Service Act, Title III, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR, Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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