RESEARCH INFRASTRUCTURE IN MINORITY INSTITUTIONS (RIMI) RELEASE DATE: March 14, 2003 RFA: MD-03-005 National Center on Minority Health and Health Disparities (NCMHD) (http://www.ncmhd.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER (S): 93.389 LETTER OF INTENT RECEIPT DATE: May 9, 2003 APPLICATION RECEIPT DATE: June 11, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Capacity Building and Research Objectives o Mechanism(s) 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 Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA Predominately minority-serving colleges and universities, institutions with a racial and ethnic minority student enrollment of 50 percent or greater, play an important role in the early training of minority scientists. Accordingly, the current RFA represents a National Center on Minority Health and Health Disparities (NCMHD) effort to enable such institutions to continue their participation in the training of underrepresented racial/ethnic minority scientists in the 21st century. The mission of NCMHD is to promote minority health and to support programs that aim to reduce and ultimately eliminate health disparities. In this effort NCMHD supports basic, clinical, social, and behavioral research, promote research infrastructure and training, foster emerging programs, disseminate information, and reach out to minority and other health disparity communities. The Research Infrastructure in Minority Institutions (RIMI) Program focuses on building research capacity in predominantly minority-serving academic institutions that offer one or more baccalaureate and/or master's degrees in the life sciences and other areas related to health. The RIMI program seeks to facilitate the integration of teaching and research at predominantly minority-serving institutions with the ultimate aims of: 1) developing sustainable research programs and 2) enhancing the overall quality of the educational experience for the students in the life sciences and related areas. The application receipt date is May 16, 2003. This announcement (RFA-MD-03-005) solicits only Phase II RIMI applications; solicitations for Phase I applications have been discontinued. The overarching objectives of the Phase II RIMI initiative are to: 1) establish an 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. Such collaborations must be clearly described and documented in the application. CAPACITY BUILDING AND RESEARCH OBJECTIVES Background Historically, the RIMI Program was developed and implemented in response to recommendations resulting from the proceedings of three regional conferences that were convened by the former NIH Office of Research on Minority Health (ORMH). The need for RIMI and similar programs that focus on building and/or enhancing research infrastructure at predominantly minority institutions was reiterated in Public Law 106-525. The statute recognized that the inclusion of underrepresented minorities and women in the scientific, technological and engineering workforce enabled society to better address its diverse needs. The law also gave notice of a national need for minority scientists in the fields of biomedical, clinical, behavioral, and health services research. RIMI-eligible and other predominantly minority-serving institutions play an important role in the early training of minority scientists. The development of sustainable research programs at predominantly minority institutions is expected to have a two-fold impact--the discovery of new knowledge in science and technology and the development of a knowledge infrastructure that contributes to the intellectual underpinnings of racial and ethnic minority researchers and health professionals that are trained at such institutions, many of which often live and serve in minority communities. (Public Law 106- 525; Allocating Federal Funds for Science and Technology, Supplement 4, http://bob.nap.edu/html/fedfunds/) Accordingly, the RIMI Program encourages and facilitates the participation of predominately minority serving institutions in the research enterprise through the support of activities that build and/or expand research infrastructure, expand the range of research expertise at such institutions, as well as contribute to the competitiveness of individual faculty members. Capacity Building Objectives o To encourage the use of entrepreneurial methods in building research infrastructure, including but is not limited to: developing and implementing innovations for increasing time commitment to research related activities, developing thematic approaches to or building marketable institutional niches in research; developing innovations in addressing shortfalls in Research Infrastructure in Minority Institutions; technical assistance in research programs, and decreasing the digital divide with respect to computer technology; o To identify/address barriers to effective research administration; and o To encourage the creation of supportive research environments by modeling institutions that have demonstrated successful approaches to procurement processes, development/use/support of core resources, innovative offices of sponsored research, research grants administration, etc. Research Objectives o Basic and applied biomedical/biobehavioral research o Health disparities research, including but not limited to: - Health promotion and prevention research - Health services research - Translational research- How to successfully incorporate research into health promotion, and disease prevention - Epidemiologic studies- Assess and understand health disparities in local communities - Communications research-How to reach racial/ethnic minority, and other medically underserved populations with messages that will lead to positive behavioral and health changes - Research that advances knowledge of the biological mechanisms by which the broader environment (social capital, access, risk factors, etc.), coping styles, micronutrient/gene interactions, experiences across the life span, etc. contribute to the differential susceptibility to disease and disease progression. Career Development Objectives o To learn state of the art research methodologies and their application o To enhance research related skills, including the development of grant proposals, writing peer reviewed research papers for publication, management research programs, etc. o To facilitate investigator networking through research interest or working groups aimed at facilitating collaborative research project development and raising awareness of emerging technologies and areas of emphasis in research. MECHANISM OF SUPPORT This RFA will use the NIH Exploratory Grant (P20) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. Awards will be made prior to September 30, 2003. This RFA uses just-in-time concepts. However, because it is anticipated that direct costs for each year will exceed $250,000, applicants are advised to follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The NCMHD intends to make four to five new awards in FY 2003 in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $650,000 per year. Because the nature and scope of the proposed research and related capacity building activities will vary from application to application, it is anticipated that the size and duration of each award will also vary. In the first year of support for the new 5-year project period a one-time allocation of $150,000 for renovations may be added to the $650,000 maximum. Indirect costs will be provided. Although the financial plans of the NCMHD 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. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS Domestic academic institutions with a greater than 50 percent minority enrollment that offer one or more baccalaureate and/or master's degrees in the life and related sciences are eligible to compete for support under this initiative. Health professions schools that award the M.D., D.D.S., Pharm. D., D.V.M. or equivalent degrees and other institutions or programs that award the Ph.D. or other equivalent degrees are ineligible to apply. However, such institutions may serve as collaborating research institutions. An institution may apply for and receive a maximum of two RIMI awards, providing the following conditions are met: o Only one application is submitted in response to this announcement o At least one of the RIMI programs has a health disparities focus o Infrastructure initiatives supported by the RIMI awards are synergistic and not duplicative Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The President of the applicant institution or a designated representative with the skills and knowledge to provide leadership and authority to make high-level decisions regarding faculty time commitment and research administration related decisions must serve as the Principal Investigator. This is a special requirement of the RIMI program. Such a policy is intended to ensure that the capacity building activities proposed in the application are consistent with the vision and mission of the applicant institution. SPECIAL REQUIREMENTS Program Governance The governance structure must include a Principal Investigator (PI), Program Director (PD), and a RIMI Advisory Committee. Program Director The PD must be nominated by and be responsible to the PI. Moreover, the PD must be willing and able to devote the time and effort necessary for effective implementation and management of the RIMI program. He/she should be a knowledgeable and experienced biomedical, biobehavioral, or social scientist and an effective administrator. RIMI Advisory Committee The Advisory Committee should consist of eight to twelve members and must include a cross-section of qualified faculty and appropriate members external to the institution; its role is to advise the PI and PD. One or more of the external members should represent the collaborating institution(s). It is essential that the Committee be knowledgeable about the applicant institution's strengths and weaknesses in biomedical and related research, capabilities and needs, and overall goals. The Committee should possess, among its members, the experience and knowledge to provide appropriate guidance for the program and identify and recommend expert consultation from other sources, including the Research Infrastructure in Minority Institutions leaders in relevant scientific disciplines and other fields as needed. Guidance from such a group ensures the critical input necessary to develop and maintain a competitive RIMI program. The Committee should oversee progress toward the full implementation of the institution's plan for developing research infrastructure and for developing and enhancing collaborative relationships among institutions and faculty members. Competing or conflicting interests must be carefully considered when developing the operational procedures for the Committee. The Committee should meet at least twice annually. Institutional Research Infrastructure The plans for enhancing research infrastructure must be consistent with the long-range goals of the applicant institution. The application must describe how requested resources will be used to implement the institutional plan as well as discuss what role the collaborative partnerships will play in creating and maintaining an environment and framework suitable to achieve the objectives of the RIMI program. The NCMHD recognizes that the nature and scope of applications from the various institutions will vary widely, depending on individual institutional settings. Note that funds may be used for faculty expansion (i.e., recruitment of additional faculty who complement the scope of the proposed program) -- up to $100,000 per year for each position. Such funds may be used for salary, supplies, and equipment costs. Developmental/Collaborative Research The purpose of the research core is to facilitate the development of independent investigators and/or sustainable research programs. Institutions may provide up to 50 percent release time for subproject investigators, thus permitting a significant time commitment to the research enterprise. The requested support for a developmental/ collaborative research core must not exceed 50 percent of the total direct costs of the RIMI grant award. A plan describing the long-term goals for transitioning RIMI research support to competitive grant support through applications submitted by faculty members to relevant NIH Institutes and Centers is strongly encouraged. The plan should include measures of success with specific milestones. Sub-project Investigators Prospective subproject investigators must have a full-time faculty appointment at the applicant institution; and, the proposed research plan for each subproject should address the following: o The candidate o Career development plan, including plans for developing a sustainable research program o Research plan o Mentor/collaborator o Research environment o Institutional commitment o Technical Support o Budget Shared Resources A shared resource core activity or facility is intended to enhance opportunities for investigators at the applicant institution to take advantage of new technologies that could enhance and broaden their research initiatives. While, research per se is not conducted as part of the shared resource core, quality assurance activities that evaluate the operation, resources, quality and utilization of the core and that are directed at problem identification and improvement of core functioning are appropriate. Some examples of support that shared resource cores typically provide are: a) technology that implements automation of large batch preparations; b) tissue and/or cell culture facilities; c) complex instrumentation, e.g., electron microscopy, mass spectrometry, electrophysiology; d) animal care and preparation; e) information processing, data management, and statistical services, networking activities such as the establishment of scientific working groups, etc. The rationale for the establishment of shared resource cores is projected use by RIMI and/or non-RIMI investigators (e.g., MBRS Score (Support of Continuous Research Excellence)) at the grantee institution. Accordingly, the minimum requirement for establishing a shared resource core is significant usage by two or more investigators with RIMI and/or independently supported, peer-reviewed projects. New Opportunities A number of recommendations for consideration were provided in the Mid- Term Evaluation of previously established RIMI Programs. The activities described below represent efforts to convert those recommendations to potential RIMI program components for consideration. 1. Institutional Role Modeling: One possible approach to alleviating barriers to success in key areas is to identify a role model institution to emulate, particularly as related to best practices for addressing such barriers (i.e. release time for research, procurement challenges, grants administration and enhancing and developing effective offices of sponsored research, etc.). In particular, RIMI institutions may benefit from developing a mentoring relationship between its Office of Sponsored Program and such an entity at a collaborating institution. Support for institutional role modeling and related training activities are allowable costs. 2. Renovations: The Mid-Term Evaluation noted that the quality of research facilities was linked to the ability to recruit new faculty members and to the ability to carry out good research. Accordingly, this RFA will provide up to $150,000 in year one of the award as a one- time cost expenditure for renovations and alterations, providing the alterations and renovation projects are relevant to the scope of the proposed research and at the applicant institution. Research equipment/ instrumentation for laboratories may be requested but must be justified on the basis of the proposed scientific projects. This RFA will not provide support for the completion of shell space, or for equipment intended for teaching or non-research related purposes. Additional opportunities for the renovation and modernization of facilities will likely be made available through competitive supplements to funded RIMI programs. 3. Entrepreneurial Opportunities: One of the objectives of the RIMI Program is to increase the capacity of undergraduate institutions to compete successfully for research and related support from public and private agencies. One model for facilitating such activities is to provide incentives for granting writing activities and/or encourage collaborations among programs. Further, to maximize collaborations and minimize duplication of effort among NIH sponsored program, the NCMHD encourages RIMI Programs to use a combination of initiatives to support the development of research infrastructure at their institutions. Programs may select to pilot a variety new opportunities that are designed to enhance research infrastructure. Keep in mind, however, that an institution is encouraged to pursue only those approaches that best suit its vision and needs. Below are examples of activities that can strengthen research and related infrastructure programs at RIMI institutions. a. Scientific Working Group(s): The concept of a scientific working group as a shared resource is taken from the Mid-Term Evaluation of established RIMI Programs. Such a resource could address two areas highlighted in the Mid-Term Evaluation: 1) the need for increased interactions with other research scientists and 2) keeping abreast of emerging opportunities for research support. There was concern that the research topics/fields at teaching institutions tend not to be current. The purpose of Working Groups is to increase interactions of RIMI investigators with other investigators with similar or complementary research interests. Such groups can explore opportunities for collaborative research in related areas as well as serve as a forum for obtaining research perspectives from key individuals in the researchers' field(s) of interest. Planned annual or biannual meetings could focus on the status of the field in the participant's area of interest, new research methodologies that can enhance the participant's research, NIH guide announcements as areas for proposed collaborations between members of the group, etc. b. Student Mentoring Activities: RIMI programs are encouraged to develop mentoring activities designed to increase the number and quality of graduate program applications submitted by students in the life and related sciences. Such activities could include sponsorship of graduate school workshops and networking activities, career counseling, oversight for GRE training, sponsorship of tutoring activities for "gateway" courses, etc. Gateway courses include those such as organic chemistry and others that are essential for ensuring competitiveness for consideration for acceptance in graduate degree programs. c. Student Support for Participation in RIMI-Supported Research Projects: The Mid-Term Evaluation addressed the issue of inadequate laboratory support and the lack of significant student involvement in RIMI related activities. These concerns may be addressed by finding innovative means of garnering student support for limited technical assistance. For example, RIMI Programs are encouraged to work collaboratively with programs such as the Minority Biomedical Research Support (MBRS) RISE Program that provides support for student participation research projects: http://grants.nih.gov/grants/guide/pa-files/PAR-99-151.html. For example, institutions that already have MBRS RISE grant awards, may conceivable submit supplemental applications during the first 18-month period of these four-year awards for the purpose of expanding the program to include student support for RIMI projects. Institutions that do not have MBRS RISE awards may consider applying for such support. The advantage of such a strategy is that it lessens duplications among the programs sponsored by the NIH Centers and Institutes and it encourages collaborative synergy between the various programs at RIMI institutions. d. Collaborative Intra- and Inter-Departmental Activities: Allowable costs for technical support on research subprojects can be used to encourage intra- and/or inter-departmental collaborations. In such cases, the total level of faculty support on a project may not exceed 75 percent effort. For example, if the PI of a project requests 50 percent effort, a co-investigator on the project may request up to 25 percent effort. In such cases, no technical support may be provided beyond that obtained through the potential use of shared resources or through student assistance on the project. e. An Institutional Research Advocate: The concept of an institutional research advocate was introduced in the Mid-Term Evaluation of established RIMI Programs. Such an individual may be recruited or appointed by the PI to serve as a research leader for the institution. The research advocate's primary responsibilities would include developing a strategic plan for the institution's biomedical and related research, including health disparities research, as well as identifying areas for intra- and inter-departmental collaborations. Identifying the range of research expertise among the faculty might present opportunities for developing niches for institutional research. An institutional niche is an area of research in which a significant number of faculty members have the requisite expertise to develop synergistic and productive collaborations. Support for this activity, if applicable, may be included in the administrative core of a RIMI Program. f. Support for Proposal Development: The Mid-Term Evaluation also addressed the issue editorial assistance for manuscript preparation. One model for securing editorial assistance is to develop an inter- departmental collaborative arrangement with the English Department at RIMI institutions. Teachers and advanced students may be an invaluable asset in such an activity. Such a model would also encourage cross- institutional participation in the research enterprise. The NCMHD encourages the use of the latter or any other pilot innovative models for providing editorial assistance in developing research proposals and the preparation of manuscripts. Support for this activity, if applicable, may be included as an area of emphasis. g. Productivity Incentives: Pending the availability of funds, RIMI supported faculty members that publish papers in a peer reviewed journal (or minimally have manuscripts approved for publication in peer-reviewed journals) during a given budget period may request support for travel to a scientific meeting in the annual non-competing renewal application. If there is more than one author, support may be requested for at least two authors on the publication. For each new peer-reviewed research project funded by a public or private agency, the RIMI program may request support for attendance at a domestic scientific meeting for the PI and Co-PI. 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: Jean Flagg-Newton, Ph.D. Chief, Office of Research National Center on Minority Health and Health Disparities National Institutes of Health 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 Telephone: (301) 402-1366 FAX: (301) 480-4049 Email: flaggnej@ncmhd.nih.gov o Direct your questions about peer review issues to: Tommy Broadwater, Ph.D. Chief of Review National Center on Minority Health and Health Disparities National Institutes of Health 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 Telephone: (301) 594-8950 FAX: (301) 451-4049 Email: BroadwaT@ncmhd.gov o Direct your questions about financial or grants management matters to: Bryan Clark, MBA Grants Management Officer National Center on Minority Health and Health Disparities National Institutes of Health 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 Telephone: 301.402.1366 Email: ClarkB1@ncmhd.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 capacity building/research activities 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 IC 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: Tommy Broadwater, Ph.D. Chief of Review National Center on Minority Health and Health Disparities National Institutes of Health 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 Telephone: (301) 594-8950 FAX: (301) 451-4049 Email: BroadwaT@ncmhd.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. SUPPLEMENTAL INSTRUCTIONS 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 a Specific RFA. Check "YES" and type in the number and title of this announcement. Item 6. Dates of Proposed Period of Support. Up to five years of support may be requested. The start date should be September 30, 2003. Form Page 2 -- Description, Performance Site(s) and Key Personnel. Program Overview. Provide an overview of your proposed program, including the objectives and specific aims and areas of emphasis. Summarize your approach for enhancing the proposed areas of emphasis. 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 carrying out the RIMI action plan. This should also include personnel at the collaborating institution. Form Page 3 -- Table of Contents. Modify the table of contents to reflect the content and sequence outlined in the modified instructions in the RFA. Form Page 4 -- Detailed Budget for Initial Budget Period, and Form Page 5 -- Budget for Entire Period. Consolidated RIMI Budget. The consolidated budget should consist of a compilation of the individual budgets for the administrative core and each area of emphasis. Except in the first year of the project, direct costs may not exceed $650,000 per year. (See the section on Renovations -- Use form pages 4 and 5). Budgets for Areas of Emphasis. Use form pages 4 and 5 to develop separate budgets for the administrative core and each area of emphasis. For each area of emphasis (e.g., facility improvement, developmental/collaborative research, etc.), include the salary support for its director as well as the costs of the activities (i.e., laboratory renovation, research subprojects, etc.) that support that area of emphasis. Support for staff from the applicant institution, if applicable, should be listed as personnel and support for other personnel should be listed under consultants (including consulting fees and travel expenses, or under consortium/contractual costs). Include in the following in the administrative budget: 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 section labeled: Justification. 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. The biographical sketch should list the most recent or significant publications, and overall, must not exceed four pages per person. Page Limitations. DO NOT EXCEED 35 PAGES FOR ITEMS 1-3 OF THE CAPACITY BUILDING PLAN. All tables, graphs, charts, figures and diagrams must be included in the 35-page limit. Applicants are encouraged to be succinct and are reminded that there is no requirement to use the 35 pages allotted to items 1-3 of the Capacity Building Plan. In addition to the 35-page limit, applicants may use up to 10 pages (excluding the biographical sketches, budget pages, and references) to describe EACH of the research sub-projects under item 3, Research Infrastructure in Minority Institutions. Institutional Setting and Overview of General Plan -- Limit the narrative for items 1 and 2 to a total of 15 pages. 1. Capacity Building Plan -- Do not follow the outline in Form PHS 398. Develop according to the following format. Maximum of eight pages for items 1a-1c. a. Description of Applicant Institution: o Provide a brief history of the institution and its mission, including developmental milestones over the last 10 years. o Summarize the major resources (physical, human and financial) for biomedical and related research. Include the number of faculty involved and number of students in the health and related sciences. o Discuss the role that research is intended to play in enabling your institution to accomplish its mission. o Describe your institution's long-term objectives and specific aims in enhancing its research infrastructure; and indicate any changes in such that may be different in the current RIMI program cycle. b. Description of the Collaborating Institution: o Provide a brief summary of the resources of the collaborating institution (research, core laboratories, and other research facilities) and discuss how the proposed partnership facilitates the achievement of your institution's research agenda. In particular, indicate the area of emphasis to which the partnership contributes most significantly. c. Plan for Expanding the Capacity for Biomedical and Related Research. Discuss briefly EACH area of emphasis for the current project period (e.g., faculty development, physical plant improvement, research administration, procurement, student entry into graduate programs, etc.), indicate the specific objectives associated with each goal area (area of emphasis), and describe briefly the action plan for accomplishing these objectives. For example, for EACH area of emphasis identified, provide the following: o Description of the area of emphasis o Objectives under the area of emphasis o Action plan(s) for accomplishing the objectives (i.e., describe the proposed activities or program components for achieving the indicated objectives) and a timetable for implementing the proposed activities. o Measures of success for tracking progress toward accomplishing your institution's objectives in the relevant area of emphasis. o The percent of your overall budget that will be allocated to achieving the objectives in the indicated goal area (area of emphasis). 2. Progress From the Previous Project Period —- Maximum of Seven Pages (COMPETITIVE RENEWAL APPLICATIONS ONLY) Describe the accomplishments during the previous project period within the context indicated below. Where appropriate, information may be presented in tabular format. o Areas of Emphasis. For each area of emphasis supported (e.g., faculty recruitment, developmental/collaborative research, etc.) describe the objectives and the action plans for accomplishing the objectives. Indicate measures of success and describe the progress made in accomplishing the objectives in terms of the measures of success. For example, an important measure of success for an institution's research capacity is the amount of research dollars garnered by the institution during a given period. An important measure of faculty productivity may include the number of publications in peer-reviewed journals, presentations at scientific meetings, and/or the overall number of student contact hours per semester during a given period. Note that if "student pursuit of doctoral programs" was considered as an area of emphasis, the following section also applies. 2a. Although the RIMI program provides no direct support for student participation in research, the RIMI program may have sponsored mentoring activities (e.g., graduate school workshops, GRE training, counseling activities, networking, etc.) designed to facilitate the minority students' pursuit of doctoral programs. Is there an identifiable linkage between the availability of RIMI support and the number of students that pursue doctoral programs, in particular in the departments that are directly supported by RIMI funding? o Effectiveness of your partnership in terms of its impact on your research agenda. Be sure to discuss its strengths and indicate areas where improvements can be made. o Impact of RIMI support on the institution's capacity to compete successfully for research support. How many of the RIMI supported investigators have submitted grant proposals for research and related support? Has the institution's overall success rate for numbers of applications funded changed since the onset of funding support through the RIMI program? Can such increases, if any, be directly linked to activities supported through RIMI support? o Barriers to success and needed program adjustments. Please identify any barriers to the successful implementation of the institution's plan for enhancing research infrastructure. Also identify areas of concern that the institution plans to address in the competitive renewal application. o Institutional incentives for research that may have been developed and implemented during the previous RIMI project period. And how has research at the institution impacted the academic experience of its students, in particular those in the RIMI supported departments. 3. Proposed RIMI Program -- Maximum of 20 pages. a. Organizational Structure and Administrative Core Activities. (Limit narrative to 5 pages.) o Outline the organizational structure of the institution, showing how the RIMI PD interfaces with the administrative structure. Describe the lines of authority and indicate how the proposed structure will allow the PD to best accomplish the goals and objectives identified for the RIMI program. o Describe the qualifications of the faculty member selected for this PD, including his/her scientific training, biomedical research experience, administrative leadership skills, and commitment to the RIMI initiative. o Describe how the Advisory Committee functions, in particular its roles and responsibilities, available resources, its frequency of meetings and reporting requirements. Also describe the composition the Committee. In a tabular format, list the names and titles of the members, including their institutional affiliations. Identify the expertise that each member contributes to this commit. o Institutional Commitment. Provide evidence of the applicant institution's commitment to biomedical and related research and to enhancing its 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, sponsorship of an office of sponsored programs, 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. o Evaluation Plan. Describe the plan for evaluation of the RIMI Program. One way of evaluating the program is to develop a performance plan based on the strategic plan for the RIMI Program. Describe the measures of success that would be key in your performance plan. o Collaborative Agreement(s). Describe the essential elements of the collaborative agreements between the applicant institution and its partner(s). When there is only one partner, the collaborator MUST be a doctoral degree-granting institution. In cases where there is more than one partner, only one of the collaborators must meet the aforementioned criterion. 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 your application. b. Areas of Emphasis —- Limit narrative to 15 pages. Provide a separate detailed plan for EACH AREA OF EMPHASIS. In describing each area of emphasis, follow the PHS 398 instructions (pp. 17 -20) for the Research Plan and use form page 2 and forms 4 through 8. Be sure to address the important items noted below: o Narrative. Clearly describe the objectives, needs, and rationale for the approach selected, implementation timetable in the context of available resources, alternatives considered, and overall program goals. Explain the management structure, and outline the corporate plan to achieve non-RIMI institutionalize support over time. o Shared resources/facilities. Shared resources/facilities may comprise an independent area of emphasis or activity component within an area of emphasis. Identify the user community and explain in detail the nature and extent of utilization by each participant, current and proposed. o Developmental/Collaborative Research. Whether an independent area of emphasis or an activity component within an area of emphasis, IN ADDITION TO THE ABOVE, clearly describe the importance and relevance of the proposed collaborative projects to the institution's RIMI program goals. Also for each research subproject supported, address the following: - Candidate - Career development plan - Research plan - Mentor/collaborator - Environment - Institutional commitment - Technical Support (up to 50% support for a technician) - Budget (up to 50% effort for the PI and support for supplies, small instrumentation, etc.) Limit the description of EACH research project to be supported to 10 pages, excluding the biographical sketches, references, and budget pages. This is in addition to the 20-page maximum allotted to describing the plans for and management of the Areas of Emphasis. 4. Appendix. List in the Table of Contents any items included in the Appendix. 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: Tommy Broadwater, Ph.D. Chief of Review National Center on Minority Health and Health Disparities National Institutes of Health 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 Telephone: (301) 594-8950 FAX: (301) 451-4049 Email: BroadwaT@ncmhd.gov 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 for responsiveness by the NCMHD. 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 NCMHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Receive a second level review by the NCMHD National Advisory Council. REVIEW CRITERIA Areas of Emphasis: Assessments of EACH AREA OF EMPHASIS will be based the specific evaluations of the proposed core action plans (i.e., planned core activities) for that area and the feasibility of Research Infrastructure in Minority Institutions achieving what is proposed for the overall area with the resources requested. Accordingly, the criteria for review of the proposed plan for each area of emphasis include: o Appropriateness of the plan for developing the area of emphasis, including objectives, proposed core activities or action plan, implementation strategy and timetable, and involvement of the advisory committee in the planning process. o Adequacy of proposed mechanisms or activities proposed for addressing the expressed needs in the area of emphasis. o Adequacy and appropriateness of administrative and/or scientific leadership for implementing and managing the resources, including collaborative and consultative arrangements. Note that the above assessments should be made for each area of emphasis in the proposed continuing RIMI Program. Also if applicable, the review of the individual research projects proposed in the "Developmental/ Collaborative Research" area of emphasis will not be based entirely on the traditional considerations for peer evaluation of scientific merit, but will also take into consideration 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. Accordingly, the following are additional considerations for each of the research projects proposed. o Significance: Does the proposed project address current areas of emphasis in the relevant field? If the proposed aims are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? o Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of each of the research components? Does the PI acknowledge potential problem areas and consider alternative approaches? o Innovation: Does the research employ novel concepts, approaches or methods? Are the aims original and innovative? Do the concepts challenge existing paradigms or propose to develop new methodologies or technologies? o Investigators: Is the investigator appropriately trained and well suited to carry out this work? o Environment: Does the scientific environment in which the work will be done contribute to the probability of success of the project? Does the proposed research take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Note that a research project does not need to be strong in all categories to be judged likely to have a major scientific impact. 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. o The appropriateness of the proposed budget and duration, including the justification for requested items in terms of the aims and methods of the proposed research studies will be evaluated. Overall RIMI Program Major factors to be considered in the overall assessment of the plans for the proposed continuing RIMI Programs include: o Adequacy of the planning process, including the assessment of current biomedical research capabilities, concept development and involvement of advisory resources in the planning process. o Appropriateness of the organization 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 the institutional research infrastructure development plan o Adequacy of institutional commitment to biomedical research 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. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: 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. (If Applicable) 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: May 9, 2003 Application Receipt Date: June 11, 2003 Peer Review Date: July/August 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 30, 2003 AWARD CRITERIA Award decisions will be based on the scientific merit of the application as determined by peer review and availability of funds. 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. 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: (if applicable) 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. 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 the Public Health Service act, Title III, Part A (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. 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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