EXCELLENCE IN PARTNERSHIPS FOR COMMUNITY OUTREACH, RESEARCH ON HEALTH DISPARITIES AND TRAINING (CENTERS OF EXCELLENCE RESOURCE-RELATED RESEARCH GRANTS) RELEASE DATE: February 6, 2004 RFA Number: RFA-MD-04-002 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): 93.307 LETTER OF INTENT RECEIPT DATE: March 19, 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 Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE The National Center on Minority Health and Health Disparities (NCMHD) invites applications for establishing Resource-Related Research Grants (R24) under a continuing program for Project EXPORT: Centers of Excellence, Excellence in Partnerships for Community Outreach and Research on Disparities in Health and Training. This Centers of Excellence Program was authorized by the Minority Health and Health Disparities Research and Education Act of 2000 and is in support of the Department of Health and Human Services initiatives to address and ultimately eliminate health disparities. These R24 grant applications will focus on the development of resources and infrastructure at some institutions as a prelude to initiating full-scale health disparities research, community outreach, and training. The purpose of a resource-related research grant (R24) under Project EXPORT is to augment and strengthen the institutional infrastructure and capacity to conduct research (basic, clinical, behavioral, and/or social sciences) aimed at addressing and ultimately eliminating health disparities. The expectation is that following the 3 years of support for the developmental/planning phase the recipients of R24 awards will be positioned to compete for a P20 or P60 application. Thus, an application for an R24 must describe a 3-year plan that will allow the applicant institution to compete successfully for a P20. Partnering with an institution with on-going Health Disparities research is encouraged during this developmental/planning phase. Accordingly, the objectives of an R24 application initiative are to 1) build research capacity for health disparities research in minority- serving and other designated institutions; 2) promote the participation of health disparity groups in biomedical and behavioral research and prevention and intervention activities; and, 3) promote planning for the conduct of minority health and/or other health disparities research. The range of activities that may be supported by this Project EXPORT activity includes: the acquisition of data and analyses necessary to clarify/refine research questions; the identification and development of collaborative resources; recruiting research expertise; development of testable hypotheses and theories and/or the framework to which the research will contribute. RESEARCH OBJECTIVES Background The mission of the National Center on Minority Health and Health Disparities (NCMHD) is to promote minority health and to lead, coordinate, support, and assess the NIH effort to reduce and ultimately eliminate health disparities. In this effort, the NCMHD supports basic, clinical, and behavioral research; promotes research infrastructure and training; fosters emerging programs; disseminates information; and reaches out to minority and other health disparity communities. Although the diversity of the population in contemporary America is one of its greatest assets, the richness of this feature is overshadowed by the reality of the disproportionate burden of disease and illness that is borne by racial and ethnic minority populations and the rural and urban poor. Compelling evidence of the disparate health status of America's racial and ethnic minority populations and the economically disadvantaged is documented in the form of shorter life expectancies and higher rates of cancer, birth defects, infant mortality, asthma, diabetes, cardiovascular disease, and stroke. Other areas in which racial and ethnic minorities and the medically underserved suffer a disproportionate burden of morbidity and mortality include: HIV Infection/AIDS, autoimmune diseases such as lupus and scleroderma, oral health, sexually transmitted diseases, disease burden associated with mental disorders, drug use associated mortality, and viral borne diseases such as hepatitis C. While studies cannot delineate with certainty why health disparities exist, data suggests that differential incidences of disease and health outcomes result from the interaction of a plethora of factors in complex and unsuspecting ways. Observations and anecdotes provide clues about the etiology of the disproportionate burden of disease and illness, but it has only been through rigorous population and epidemiologic research that the medical community has been able to reasonably discern the extent of the healthcare crisis. We are now poised to more completely define the scope of the problem and begin the process of identifying and evaluating new approaches to mitigating disparities in health. Clearly, the soundest investment that can be made for the present and immediate future is a strengthened commitment to research, research training, and enhanced community involvement aimed at elucidating the etiology of health disparities, developing new diagnostics and treatment and prevention strategies, and the full implementation of such. Project EXPORT is central to NCMHD's investment strategy for addressing disparities in health status. Consistent with the goals of the trans- NIH Strategic Plan, EXPORT Centers will focus on research aimed at reducing and eliminating health disparities, improving research capacity, and providing outreach and education. In the first year of Project EXPORT Centers of Excellence Program, NCMHD supported the establishment of six Resource-Related Research Projects, (R-24), ten Exploratory Center Grants, (P-20), and 11 Comprehensive Center Grants, (P-60). In the second year of Project EXPORT Centers of Excellence Program, NCMHD supported the establishment of ten Resource-Related Research Projects, (R-24), 11 Exploratory Center Grants, (P-20), and 12 Comprehensive Center Grants, (P-60). This announcement is intended to expand the Centers of Excellence Program, in order to ultimately include all geographic regions of the US and its territories and to ensure the establishment of centers that focus on disparities in health status for all health disparity populations, including African Americans, American Indians and Alaska Natives, Asian Americans, Hispanic Americans, Native Hawaiians, Pacific Islanders and other medically underserved populations (i.e., socio- economically disadvantaged individuals in rural and urban areas). Research Topics for Consideration In developing the research question(s) to be considered, possible topics responsive to this RFA include, but are not limited to: o Interdisciplinary minority health and other health disparities research, including basic, clinical, behavioral and social sciences research to advance understanding of disease/disability development and progression. o Research that improves approaches for diagnosis, prevention, and treatment. o Potential pathways to disparities in health outcomes, environmental exposures, genetic variations and/or other underlying biological factors, ethnic and familial factors. o Developmental influences across the life span, specific health behaviors, and discrimination in health processes, psychosocial and socio-cultural influences, and socioeconomic (SES) related factors such as differential access to health care. Health processes include the technical and interpersonal activities pertaining to disease prevention, diagnosis, and treatment that go on between patient and practitioner. The research topics listed above are neither comprehensive, restrictive, nor in priority order. Project EXPORT Developmental/Planning Activities. Note that the planning phase for this R24 application requires detailed information on the functioning and proposed activities of the Administrative Core and the Advisory Committee. In order that external reviewers and NCMHD staff understand the proposed future research areas, be sure to provide substantial detail(s) in the following components: o Administrative Core o Research questions, feasibility studies, pilot research directions o Community Outreach and Information Dissemination Core o Training / Mentoring activities o Administrative Core - Mandatory -- 15-page maximum The administrative core component plays a key role in the coordination and operation of the proposed EXPORT Center. Through this core, the Center director provides substantive leadership as well as manages the administration of the budget. This core should be described in sufficient detail to assure that all proposed components and related activities would function optimally and in an interactive, synergistic manner. o Research Questions/Feasibility Studies/Pilot Research Component -- Mandatory -- 10-page maximum The research questions/feasibility studies/pilot research component may include several proposed investigations under the direction of a component director. And overall, the projects within the component must be interrelated so that they collectively contribute to the goals of Project EXPORT to a greater extent than if the projects were undertaken separately. The component should be thematic, highly focused, and interrelated areas of investigation. The descriptions of all proposed feasibility studies or pilot projects must be limited to 1 page each. This is in addition to the recommended 10-page maximum. o Community Outreach and Information Dissemination component -- Mandatory -- 15-page maximum The mission of the Community Outreach and Information Dissemination Component is to integrate the EXPORT Centers into the local communities as a disease prevention and health and science education resource. Accordingly, there is a three-fold focus: 1) development and dissemination of culturally sensitive health information directly related to the research of the Center or general health information presented in a culturally sensitive manner; 2) encouraging and equipping the community for potential participation in clinical studies and for partnering in the conduct of evidence based disease prevention and intervention activities; and 3) sponsorship of science education outreach activities (e.g., K-12 science programs with area middle schools and/or high schools). Project EXPORT developmental grant applicants may create programs for disseminating evidence based minority health and health disparities research information as well as sponsor activities that encourage community participation in research either as study participants or equipping community based organizations for partnering in and/or conducting disease prevention and/or intervention activities. In particular for information dissemination purposes, the audiences should include health care students and professionals, community based organizations and researchers at the host institution as well as investigators at other institutions. Information transfer activities may include, but are not limited to activities such as training programs, short courses, telemedicine, presentations at professional meetings and publications. Information transfer refers specifically to activities that involve interactive exchanges between Project EXPORT staff and the community. With respect to equipping health disparity communities to develop and manage culturally sensitive programs for educating their populations and/or participating in prevention and intervention activities, the focus could be on addressing risk factors for disease, chronic disease management, screening, prevention, and decision making with respect to available therapeutics. Such activities may require a substantial portion of the first year for planning and development with actual implementation beginning near the second year and continuing in subsequent years. The application should provide a clear description of the major goals and objectives and the methodology for accomplishing community outreach and information dissemination activities, which include health information dissemination and prevention and intervention activities. Issues of cultural sensitivity with regard to the intended audience should be addressed. The items below reiterate and/or expand the issues that must be addressed in the community outreach/information dissemination component. o The design, plans and procedures for developing the component, including time lines and a description of strategies proposed to accomplish specific aims of the project(s) should be described. Innovative aspects of the approach to be used should be highlighted. o The resources, facilities, agencies, and/or institutions with which the Center would work to plan, implement and conduct the proposed activities should be fully addressed. Particular attention must be devoted to a description of necessary resources, including specialized expertise, and the target audience, or participants who will derive benefit from the activity. If core facilities or services are utilized, information on their use should be provided. o Plans to evaluate the success and/or effectiveness of the proposed community outreach/information dissemination activity should be described, with emphasis on the impact of the proposed activities on knowledge, attitudes, and/or behaviors. o Training / Mentoring Activities - Mandatory - 15-page maximum Project EXPORT developmental activities are expected to provide mentoring for junior investigators by experienced researchers. New and established mentoring and training initiatives should represent true collaborations that function across institutional boundaries. o Minority Health and Health Disparity Education -- Optional -- 15- page maximum. An educational component could focus on efforts to augment existing or create new curricula among partner institutions that would apprize and culturally sensitize undergraduates and post baccalaureate trainees in research, medicine, or public health of the need to reduce and eliminate disparities in health status among the nation's ethnic and racial minority groups and the medically underserved. It is anticipated, however, that such efforts will later lead to institutional commitments to make these curricula an inherent component of their educational systems. The educational component must identify a proposed director and describe all planned educational and/or developmental minority health and health disparity related curriculum activities. The description should include strategies and timelines, and innovative aspects of the approach to be used should be highlighted. The direct cost of the educational activity must be well justified. A description of the strategies to evaluate the planned curriculum development activities should be provided with emphasis on its anticipated impact on knowledge and attitudes. MECHANISM OF SUPPORT This RFA will use the NIH Resource-Related Research project (R24) 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 NIH peer review procedures. The anticipated award date is September 30, 2004. Allowable Costs Funds may be requested for personnel, such as faculty release time and support for a program director and staff; and consultant services, including external advisors and collaborators. Requests for office equipment, office supplies, travel, and other expenses should be limited to those necessary for program development and should be carefully and specifically justified. Support will be provided for pilot research projects, research infrastructure, or students. All requested items must be related to needs for a 36-month planning activity. FUNDS AVAILABLE The NCMHD intends to commit approximately $1.0 million in FY2004 to fund 3 to 4 new grants in response to this RFA. An applicant may request a project period of up to three years and a budget for direct costs of up to $275,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of 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 You may submit an application if your institution has any of the following characteristics: o Public or private degree granting institution (i.e. universities and colleges) o Do not have a Comprehensive (P-60) or Exploratory Center(P-20) grant funded by other NIH Institutes and Centers. o Do not have an existing NCMHD Resource-Related Grant (R-24) o Foreign institutions are not eligible to apply This is an institutional award. Therefore, only one application per institution will be accepted for review and only one award will be made to an institution based on the merit of its application and the availability of funds. Non-degree granting institutions, for-profit or non-profit state, local and faith-based organizations, and Tribal governments must partner with eligible institutions in order to participate in this RFA. Additional requirements pursuant to the statute that authorized this program can be found in the SPECIAL REQUIREMENTS section. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Definitions The definitions below are intended to clarify concepts that are expressed in this RFA. APPLICANT INSTITUTION: The applicant institution is the entity at which the EXPORT Center will be physically and/or integrated into its administrative structure. The Center Director must have his/her primary appointment at the applicant institution. COLLABORATING INSTITUTION: The collaborating institution is the institution with which the applicant institution has partnered. PREDOMINANTLY MINORITY SERVING INSTITUTION: A predominantly minority serving institution is an academic, health care or research institution with an enrollment and/or faculty that consists predominantly of racial and ethnic minorities. DESIGNATED INSTITUTION: Pursuant to Public Law 106-525, a designated institution is an institution of higher learning that has a history of enrolling and graduating racial and ethnic minority and socio-economically disadvantaged students from their degree programs. The recruitment of racial and ethnic minority faculty and staff is also a priority at such institutions. The recruitment of racial and ethnic minority faculty and staff is also a priority at such institutions. Operationally, a Designated Institution is one that has: o Been effective in assisting racial and ethnic minority and other health disparity student groups to complete a program of study or training and receive the advanced degree involved. o Made significant efforts to recruit racial and ethnic minority and other health disparity student groups to enroll in and graduate from the institution, which may include providing means-tested scholarships and other financial assistance as appropriate. o Made significant recruitment efforts to increase the number of minority or other members of health disparity populations serving in faculty or administrative positions at the institutions. o NON-DESIGNATED INSTITUTION: A non-designated institution is considered as any institution of higher learning that does not have a record of recruiting racial and ethnic minority students nor graduating such students from its degree programs. o HEALTH DISPARITY POPULATIONS: African Americans, Alaskan Natives, American Indians, Asian Americans, Hispanic Americans, Native Hawaiians, Pacific Islanders, and other medically underserved populations, which includes socio-economically disadvantaged individuals in rural and urban areas (P.L. 106-525). o PARTNERSHIP AND CONSORTIUM ARRANGEMENTS: When a grant application includes research activities that involve more than one institution it is considered a partnership or consortium effort, depending on the number of institutions involved. Such activities are encouraged in Project EXPORT, but it is imperative that such applications be prepared so that the programmatic, fiscal and administrative considerations are explained fully. In addition, the Project EXPORT thematic science focus must be evident in the application. Applicants should exercise care in preserving the interactions of the participants and the integration of the partnership or consortium project(s) with those of the primary applicant institution, because synergism and cohesiveness can be diminished when projects are located outside of the group where the administration of Project EXPORT is carried out. Applicants are encouraged to review the NIH policy and procedures to consortium agreements, which are published as part of the NIH Grants Policy Statement, Part III, available on the NIH homepage at: http://grants.nih.gov/grants/policy/nihgps_2001/index.htm. Note that while partnerships among designated institutions are strongly encouraged, involvement in a partnership is not an absolute requirement for participation in Project EXPORT. Also note that pursuant to Public Law 106-525 designated institutions are institutions of higher learning that have a history of enrolling and graduating racial and ethnic minority and other socio-economically disadvantaged students from their degree programs. The recruitment of racial and ethnic minority faculty and staff is also a priority at such institutions. Questions may be directed to the fiscal contact below. Examples of Allowable Costs for Developmental Activities o Planning, evaluation, and community analysis activities o Costs for travel for key personnel, start-up packages for newly recruited investigators in areas for development and stabilization as well as costs to merge existing programs to identify new areas of opportunity. o Emerging partnerships, which includes support for workshops, seminars, retreats and other forums to strengthen, stabilize and consolidate interactions and cooperation between partnering institutions for the purpose of identifying new areas of opportunity and high priorities as the partnership evolves. o Feasibility studies, development of research questions, pilot research projects. Other Special Requirements Each Project EXPORT developmental activity application must include the following: o Letters of commitment from the leadership of each partnering institution. The letters should indicate full support for this activity and specify what efforts will be made to ensure the success of these planning activities. Such efforts might include protected faculty time, provision to recruit new faculty, space and facilities for the proposed new projects/programs, capital improvements, etc. Projects/Cores/Components The minimum acceptable combined number of mandatory cores and components is four, and the maximum acceptable number of cores and projects is five. Each application must include: o Administrative core o Research questions/feasibility studies/Pilot Research component o Training / Mentoring component o Community Outreach and Information Dissemination component o Organization/Administration and Administrative Core. A Project EXPORT developmental activity must be an identifiable organizational unit with an administrative structure and clear lines of authority that will facilitate coordination among Center personnel to assure maximum accountability and efficiency in Center operations. OTHER SPECIAL REQUIREMENTS Each exploratory EXPORT Center application must include and/or address the following: o Program Advisory Committee, comprised of at least three to five scientists, with national scientific reputations in their field; their expertise must be directly relevant to the scientific theme of the Project EXPORT activity. The advisory committee responsibilities include concept development, program planning, encouraging faculty development and mentoring, identifying resources, and evaluating progress toward stated goals. The committee will also review and approve candidates for replacement/substitute projects and investigators as required, before such requests are forwarded to NCMHD. The committee must meet at least twice per year and minutes are to be recorded and made available for review by NCMHD program staff responsible for Project EXPORT. If a committee other than the Program Advisory Committee such as a proposed Program Executive Committee is included, specific plans regarding committee selection and function should be provided in the application. An Executive Committee usually consists of the heads of all cores, representatives from the partnering institution (if applicable), and appropriate business officials. The function of such a committee would be to assist the Director and Co-director with decisions with respect to the allocation of funds, the identification and selection of key personnel, and the planning and execution of the center activities o Planning/Evaluation. There must be a common planning and evaluation core shared between the partnering institutions. This core will be responsible for planning and implementing internal processes (e.g., workshops and other forums to identify areas of new opportunity as well as for strengthening, establishing and merging existing projects/programs). Internal processes must also have an evaluation and prioritization process in place for reviewing internal proposals for Pilot and full projects/programs, recruitment of research associates, new investigators and establishment of resources and infrastructure on the basis of their merit and potential to contribute effectively to achieving high priority goals and objectives. In cases where a single institution is the applicant, such a planning mechanism is also required. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: Direct inquiries regarding programmatic issues to: Mireille Kanda, M.D., M.P.H. Deputy Director NCMHD/NIH 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 TEL: 301-402-1366 FAX: 301-480-4049 EMAIL: Kandam@mail.nih.gov Direct your questions about peer review issues to: Lorrita Watson, Ph.D. NCMHD/NIH 6707 Democracy Blvd., Suite 800, MSC 5465 Bethesda, MD 20892-5465 Telephone: (301) 402-1366 Fax: (301) 480-4049 Email: WatsonL@ncmhd.nih.gov Direct your questions about financial or grants management matters to: Bryan S. Clark, MBA Chief Grants Management Officer, NCMHD/NIH 6707 Democracy Blvd., Suite 800, MSC 5465 Bethesda, MD 20892-5465 Telephone: (301) 402-1366 Fax: (301) 480-4049 Email: Clarkb@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 research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC 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: Project EXPORT Lorrita Watson, Ph.D. NCMHD/NIH 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 TEL: 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. 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 sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in PDF format. 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 and two copies of any appendix material must be sent to: Lorrtia Watson, Ph.D. NCMHD/NIH 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 TEL: 301-402-1366 FAX: 301-480-4049 EMAIL: WatsonL@ncmhd.nih.gov APPLICATION PROCESSING: Applications must be received by 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. 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction section that addresses the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by 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 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 discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Are you appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: 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 included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o Feasibility and timeliness of the proposed plan, based on the mission, recent development history and current biomedical research capability of the applicant institution. o Adequacy of the planning process, including concept development and involvement of advisory resources. o Appropriateness of the organizational and administrative structure established to accomplish planning grant goals. o Qualifications, experience and commitment of the Program Director, and his/her ability to provide effective leadership in developing the institutional plan. o Appropriateness of the Advisory Committee and its role. o Adequacy of institutional commitment to the proposed activities and the pursuit of biomedical research in terms of P60 or P20 application after the development/planning grant ends. o Merit of the applicant's institutional plan for developing an enhanced biomedical research infrastructure. o For non-degree granting institutions or organizations, appropriateness and feasibility of plans to establish, enhance and/or maintain collaborative agreements with doctoral degree-granting institutions. o Strength of the evidence that the researchers and faculty of the partnering institutions worked closely together in the preparation of the application. o The degree to which the letters of support from senior faculty and/or institutional leaders were supportive of the planning activities. o As applicable, the adequacy of provisions made for day-to-day oversight, coordination, support and logistical services needed to make the collaboration successful. Planning o The adequacy of the different planning methods proposed by the institutions to fully explore areas of opportunity and to ensure highly interactive and integrated efforts between individual scientists (e.g., research project) and/or between faculty and scientists (e.g., training program, education program). o The appropriateness and adequacy of the specific faculty and scientists identified to contribute effectively to each aspect of this planning effort. OTHER CONSIDERATIONS Administrative Core (Mandatory) o Adequacy of the administrative core to manage the overall planning activities. o Appropriate justification for the core, including the duplication of existing resources or services and anticipated future use of the core. o Qualifications of the Director of the Administrative core (if applicable), including the ability of the center director to provide the scientific and administrative leadership for the planning activities, strategies to promote scientific planning, interaction, implementation, and evaluation; and arrangement for the fiscal management of the grant. o Proposed composition and function of the Executive Committee to support the proposed activities. o The proposed composition and function of the external Advisory committee to support a proposed EXPORT Center. Research Questions/Feasibility Studies/Pilot Projects Component (Mandatory) o The scientific merit of the concepts for the proposed research and the importance of the information sought to the mission of the NCMHD. o The process for selecting the pilot/feasibility studies to be included in the planning activities. o How well the proposed research areas address a minority health or health disparities topic. o The innovativeness and promise of the proposed methods to be used in the conduct of research. o The novelty or originality of the proposed research concepts. o The appropriateness and justification of the requested budget for the proposed planning activities. o The qualifications of the investigator that will lead the initiative to develop the research questions and/or plan feasibility studies. If required, areas in which investigators will be recruited. o Adequacy of plans to identify and address ethical concerns related to conducting health disparities research. Training / Mentoring Activities (Mandatory) o Evidence of a strong commitment to and plans to help foster and facilitate the research career development of junior faculty. o The plans to facilitate and monitor the research career trajectory and productivity of participants at both members of the partner institution and where applicable at all members of a consortia. o Qualifications of the investigator that will lead the planning activities for research mentoring component. Community Outreach/Information Dissemination Component (Mandatory) o Adequacy of plans for establishing, sustaining, and evaluating research-based prevention and intervention studies with targeted communities, if applicable. o Adequacy of plans for K-12 science education outreach, if applicable. o A plan for disseminating health disparities research findings to participants, community groups, and lay and professional audiences. o The qualifications of the leadership of the planning activities for research outreach and dissemination. Overall Research Resource-Related Developmental Activity o Evidence of collaborative and/or interdisciplinary research, and interdisciplinary approach of the Project EXPORT activity. o Adequacy of the available resources and the quality of the research or training environment. o The institutional commitment to the Project EXPORT planning activity in terms of space, resources, administrative authority, and other necessary support, e.g., donated faculty time, and the extent to which a proposed EXPORT Center would be recognized as a major element within the organizational structure of the institution. o The plans for developmental activities, including recruitment and expansion, insofar as the proposed research and/or training program justifies these. o The plans for the provision of protection of human subjects and the humane care of animals. o Appropriateness of the requested budget for the work proposed. o The adequacy of plans to include both genders, and if applicable, other health disparity groups, and children as appropriate for the scientific goals of the proposed research. Plans for the recruitment and retention of subjects will also be evaluated. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 19, 2004 Application Receipt Date: April 19, 2004 Peer Review Date: June July 2004 Council Review: September 2004 Earliest Anticipated Start Date: September 30, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities o Demographic goals 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 DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 or state why this is not possible. 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 (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://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. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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