RESEARCH INFRASTRUCTURE IN MINORITY INSTITUTIONS (RIMI) RELEASE DATE: February 9, 2004 RFA Number: RFA-MD-04-003 (This RFA has been modified, see RFA-MD-05-004) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENT OF PARTICIPATING ORGANIZATION: 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: March 22, 2004 APPLICATION RECEIPT DATE: April 19, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o 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 Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA 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 academic institutions with the ultimate aims of: 1) developing sustainable research programs, and 2) enhancing the overall quality of the educational experience for students in the life sciences and related areas. The intent of this RIMI research infrastructure grant program is to strengthen the research environment of predominantly minority-serving academic institutions through grant support to develop and/or expand existing capacities for institutional and/or individual faculty initiated basic, biomedical, social, and/or behavioral research programs. Applicants have the flexibility to consider for example, research efforts that address areas of disparities in healthcare among racial and ethnic minorities and the medically underserved that reside in the Southwest Border States; rural communities, such as the Appalachia Region, Mississippi Delta, and Frontier States; and urban centers of the Nation. More specifically, this RFA MD-04- 003 is intended to help non-research intensive minority-serving institutions, solidify and strengthen their infrastructure and capacity to conduct biomedical and behavioral science research. Thus, the overarching objectives for this RFA are to: o Establish a research program, with special emphasis on eliminating health disparities, that will strengthen an institution's basic science, biomedical, social, or behavioral research infrastructure and capabilities; o Enhance individual faculty members research training so that they can successfully compete for independent research funding, especially funding in areas that address health disparities; and o Encourage and facilitate research and mentoring interactions between the biomedical research faculty of grantee and mentoring institutions by establishing a partnership, using a mentoring/collaborative agreement model, with an institution(s) that grants doctoral degrees in public health, clinical services and the biomedical and/or behavioral sciences. It is expected that the use of a mentoring/collaborative agreement model will contribute to an increased enrollment of graduate students from the grantee institution into doctoral programs at the mentoring institution. When employing this type of research infrastructure strengthening approach, such collaborations must be clearly described, with measurable objectives and expected outcomes, and documented in the application. RESEARCH OBJECTIVES Background Historically, the RIMI Grant 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), February 1992. This meeting produced the Minority Programs Fact-Finding Teams Recommendations publication. These recommendations gave guidance for future development of policies on the support for minority programs and initiatives at the NIH. One of the overall recommendations stated that NIH must continue and, where possible, expand programs at institutions with significant or predominant enrollment of minorities . The fact-finding team further concluded that this enhancement will allow some of these institutions to become research intensive institutions that could provide quality research training in the health sciences field and conduct innovative faculty research. Public Law 106-525 also gave notice of a national need for minority scientists in the fields of biomedical, clinical, behavioral, and health services research. The statute recognized that the inclusion of underrepresented minorities and women in the scientific, technological and engineering workforce will enable society to better address its diverse needs. In addition, the NCMHD acknowledges that RIMI-eligible and other predominantly minority-serving academic institutions play an important role in the early training of minority scientists. Thus, continued support for the development of sustainable research programs at non-research intensive institutions of higher education, is expected to have a three-fold impact on the discovery of new knowledge in science and technology, possible refinement and greater understanding of the nature of health disparities; and the development of a knowledge infrastructure that contributes to the intellectual development of researchers and health professionals that are trained at such institutions. History has shown also that many of healthcare researchers and future professionals who graduate from minority institutions are likely to devote their careers providing biomedical and behavioral services in minority communities. (Public Law 106- 525; Allocating Federal Funds for Science and Technology, Supplement 4, http://bob.nap.edu/html/fedfunds/). Under this RFA, the NCMHD will support programs that facilitate two types of primary activities:(1) institutional research development to strengthen institutional infrastructure and enhance the capacity of individual faculty members to undertake basic science, biomedical, social and/or behavioral research; and (2) individual faculty investigator research project support in order to develop research scientists to conduct small grant research activities that can lead to successful applications for future funding under more traditional research grant mechanisms. Therefore, this grant program will establish building blocks that support the NIH-NCMHD long-term strategy to create a cadre of biomedical, clinical, behavioral and social science researchers that possess the understanding and the competency necessary to engage in leading innovative research that will contribute to reducing and eliminating health disparities in the United States. In order to achieve this goal, however, there are clearly defined capacity gaps and shortfalls that must be closed and/or removed. Many of these areas of concerns have resulted from the lack of research training capacity and/or strong infrastructure at many of the nation’s non-research intensive academic training institutions, especially predominantly minority-serving academic institutions. Accordingly, the RIMI Program encourages the participation of predominantly minority-serving institutions in the research enterprise through the support of activities that build and/or expand research infrastructure, and expand the range of research expertise at such institutions, as well as contribute to strengthening the research skills of individual faculty members. The areas of concentration for this RFA are captured in three major program areas: 1) capacity-building, 2) research, and 3) career development. The programmatic objectives for these areas are the following: o To encourage the use of enterprising methods in building research infrastructure, including but 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; providing technical assistance in research, and decreasing the digital divide with respect to computer technology. o To identify/address barriers to effective research administration. o To encourage the creation of supportive research environments by emulating institutions that have demonstrated successful approaches to procurement processes, development/use/support of core resources, innovative offices of sponsored research, research grants administration, etc. o To foster basic and applied biomedical/behavioral research, as well as clinical and social research investigations. o To promote health research, including but not limited to: o Health Promotion and Disease Prevention Research o Translational Research o Epidemiological Studies o Research that advances knowledge of the biological mechanisms by which the broader environment contributes to disease and disease progression. o To develop the capacity for identifying appropriate use of research methodologies and their applications. o To enhance research related skills, including the development of grant applications, writing peer-reviewed research papers for publication, management of 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. 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. They are: 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. Renovations: 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. Requested research equipment/instrumentation for laboratories 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. 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. 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 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. MECHANISM OF SUPPORT This RFA will use the NIH Exploratory Grant (P20) award mechanism. Applicants will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is September 30, 2004. This RFA will not use the just-in-time concepts. In addition, 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 (see http://grants.nih.gov/grants/funding/modular/modular.htm). 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 commit approximately $2 million in FY 2004 to fund two to three new and/or competitive continuation grants 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. 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. 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. F&A costs will be provided. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o Domestic predominantly minority-serving academic institutions 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. o Public or private predominantly minority-serving institutions, such as universities and colleges. o Foreign institutions are not eligible to apply for a RIMI Grant. An institution may no longer apply for and/or receive two RIMI Grant awards. An applicant institution can be awarded only one RIMI Grant. Existing RIMI grantees are not eligible to apply for a new RIMI grant. An applicant institution can submit only one grant application in response to this announcement. 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, bio-behavioral, 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. 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. If applicable, 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. 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. When appropriate, the applicant should 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, such as health disparities research activities. 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 measurable objectives, measures of success with specific milestones and expected outcome(s). Sub-project Investigators Prospective subproject investigators must have a full-time faculty appointment at the applicant institution. The proposed research plan for each subproject should include the following: o The name of the candidate o Career development plan, including plans for developing a sustainable research program o Comprehensive Description of Proposed Research plan o Name and brief background description of the Mentor/collaborator o Description of the Research environment o Statement of Institutional commitment o Description of Needed 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, electro-physiology; 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. 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: DeLoris L-James Hunter, Ph.D. Director, Division of Research and Training Activities 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: Hunterd1@mail.nih.gov o Direct your questions about peer review issues to: Lorrita Watson, Ph.D. Review Branch 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: WatsonL@ncmhd.nih.gov o Direct your questions about financial or grants management matters to: Bryan S. Clark, MBA Chief, Grants Management Office 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: ClarkB@ncmhd.nih.gov LETTER OF INTENT Each prospective applicant is 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 the letter provides will allow staff to estimate the potential review workload and plan the review. The letter of intent is to be received by the date listed at the beginning of this document. The letter of intent should be sent to: Lorrita Watson, Ph.D. Review Branch National Center on Minority Health and Health Disparities National Institutes of Health 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 Bethesda, MD 20817 (for express/courier service) Telephone: (301) 402-1366 FAX: (301) 480-4049 Email: WatsonL@ncmhd.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS Applicants should thoroughly review and follow the instructions accompanying the PHS 398 Form and the following: o 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, 2004. o 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 site 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, if applicable. o Form Page 3, Table of Contents. o Modify the table of contents to reflect the content and sequence outlined in the modified instructions in the RFA. o Form Page 4, Detailed Budget for Initial Budget Period, and o 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. o 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. 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. 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. Description of the Collaborating Institution. 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. 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 percentage of your overall budget that will be allocated to achieving the objectives in the indicated goal area (area of emphasis). 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. 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. Although the RIMI program provides no direct support for student participation in research, the RIMI program may sponsor mentoring activities such as: graduate school workshops, GRE preparation training, and counseling activities. Such activities should be designed to facilitate the minority students' pursuit of enrollment in doctoral programs. One question the applicant may want to address is: Are there an identifiable linkages between the availability of RIMI support and the number of students who pursue doctoral programs, in particular at mentoring institutions or 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 applications for research and related support? Has the institution's overall funding success rate for grant applications changed since the onset of funding support through the RIMI program? Can such increases, if any, be directly linked to activities supported by the RIMI program? 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 research at the institution has impacted the academic experience of its students, in particular those in the RIMI supported departments. Proposed RIMI Program -- Maximum of 20 pages. 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 of 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. 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. 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/labels.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the appendices, checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Lorrita Watson, Ph.D. Review Branch 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 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 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 from the previous unfunded version of the application. 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 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 written critique o Receive a second level review by the NCMHD National Advisory Council. 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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 work that by its nature is not innovative, but important and is essential to advance the science in the specific field of study, such as areas related to the elimination of health disparities. SIGNIFICANCE: Does the proposed project address current areas of emphasis in the relevant field, such as health disparities research? If the proposed aims of the proposed study are achieved, how will this scientific knowledge be advanced? 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? 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? INVESTIGATORS: Is the investigator appropriately trained, well suited and/or mentored to carry out the proposed scientific investigation? 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? 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. Accordingly, the following are additional considerations for each of the proposed research projects. 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 proposed individual research projects in the Developmental/Collaborative Research" area of emphasis will not be based entirely on the traditional considerations for peer evaluation of scientific merit. But, reviewers will also take into consideration the preliminary nature of the proposed studies and, in a broader sense, the extent to which the proposed research activity will contribute to the goals of the RIMI program. 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 REVIEW CONSIDERATIONS 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: March 22, 2004 Application Receipt Date: April 19, 2004 Peer Review Date: July-August 2004 Council Review: September 2004 Earliest Anticipated Start Date: September 30, 2004 AWARD CRITERIA Award decisions will be based on: o Scientific Merit of the Application (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. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing. Guidelines and additional information on this requirement can be found at the following web location http://grants.nih.gov/grants/policy/data_sharing. Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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 at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html; a complete copy of the updated Guidelines is 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 the 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://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application as appropriate, 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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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