COLLABORATIVE MINORITY SERVING INSTITUTION ALCOHOL RESEARCH (CMSIAR) PROGRAM (U56) RELEASE DATE: November 1, 2002 RFA: AA-03-007 National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) LETTER OF INTENT RECEIPT DATE: January 24, 2003 APPLICATION RECEIPT DATE: February 24, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION Purpose of this RFA Objectives and Scope Mechanisms of Support Funds Available Eligible Institutions Individuals Eligible to Become Principal Investigators Special Requirements Where to Send Inquiries Letter of Intent Submitting an Application Peer Review Process Review Criteria Receipt and Review Schedule Award Criteria Required Federal Citations PURPOSE OF THIS RFA The National Institute on Alcohol Abuse and Alcoholism NIAAA) invites applications for Collaborative Minority Serving Institution Alcohol Research (CMSIAR) grants. The long range goal of the Collaborative Minority Serving Institution Alcohol Research Program is to strengthen the alcohol research capacity of Minority Serving Institutions (MSIs). The purpose of these grants is to promote and develop alcohol research expertise and infrastructure development at MSIs, and thereby ultimately to identify, characterize, and reduce alcohol-related health disparities in American ethnic and cultural populations and their subpopulations. Research development activities should address health disparities in target populations such as persons of African heritage, Hispanic/Latino culture, American Indians/Alaska Natives, Asian Americans, and Native Hawaiian and Pacific Islanders. Support for the three current Collaborative Minority Institution Alcohol Research Development Programs will expire in late 2003. Research in each of these programs is organized around a central theme to develop alcohol research capacity through collaborations with established alcohol investigators in research intensive institutions. Applications for new programs in alcohol research development infrastructure and scientific capability development in MSIs will be accepted with applications from currently funded projects seeking renewal support. The NIAAA is committed to increasing and strengthening efforts to address health disparities related to a wide range of alcohol related problems including alcohol and alcohol abuse and dependence (alcoholism). This RFA is related to priority areas found in the NIAAA "Strategic Plan to Address Health Disparities" (February 8, 2001). Potential applicants may obtain a copy of this plan at http://www.niaaa.nih.gov/about/DisparitiesIntro- text.htm. OBJECTIVES AND SCOPE Alcohol consumption is associated with a broad range of adverse health and social consequences, both acute (e.g., traffic deaths, other injuries) and chronic (e.g., alcohol dependence, liver damage, stroke, cancers of the mouth and esophagus). The scope and variety of these problems are attributable to differences in the amount, duration, and patterns of alcohol consumption; differences in genetic vulnerability to particular alcohol-related consequences; and differences in economic, social, and other environmental factors. Ethnic and cultural disparities in alcohol-related problems vary with the problem under consideration and are of pressing public health concern. Alcohol-related death rates (for all categories of alcohol- related mortality combined) are higher among Blacks than whites. Recent research indicates that cirrhosis death rates are higher among white men of Hispanic origin than among non-Hispanic black and white Americans. Alcohol-related traffic deaths are many times more frequent among American Indians or Alaska Natives than among other minority populations. The incidence of fetal alcohol syndrome (FAS) appears to be several times higher in some African American and American Indian communities than in the general population. Research also reveals that although African American teenagers typically drink less than their white or Hispanic counterparts, their mortality from cirrhosis is substantially higher as they approach middle age. Other adverse health consequences associated with alcohol consumption such as cirrhosis, alcoholic liver disease, HIV/AIDS, cardiomyopathy, pancreatitis, and alcohol-related sleep disorders are also more prevalent in some minority populations. Finally, increases in risky drinking behavior (i.e., drinking and driving) have been reported among Hispanics. Since ethnic minority groups have different genetic backgrounds, it is possible that some of the disparities in disease incidence and prevalence are due to differences in genetic predisposition. In addition, genetic and biological factors may interact with behavioral, cultural and environmental factors to manifest health disparities. MSIs conduct high quality programs for educating students from minority cultures about treating patients and providing outreach to minority communities. They represent a rich source of talent with appropriate cultural sensitivity and perspectives needed in alcohol research. However, few MSIs have developed and sustained programs in alcohol research. There is also a need to increase the number of minority scientists who are pursuing successful biomedical and behavioral alcohol research careers. Specifically, there remains a serious shortage of funded minority scientists who conduct independent alcohol research, who focus research efforts on the disproportionate incidence, mortality and morbidity rates in minority populations and who bring the cultural perspectives that are essential to the successful conduct of many forms of research involving minority patients and populations. Continued support of MSIs and minority scientists in alcohol research is essential to developing a stronger national understanding of the disparities of alcohol related incidence and mortality in minorities compared to majority populations. The potential for identifying and training minority students and faculty in areas of alcohol research have not been fully explored. A promising approach for addressing these issues is to create and sustain collaborations between scientists, clinicians, and faculty of MSIs and established alcohol investigators. The collaborators must integrate their respective expertise and experience to maximize mutually beneficial activities of the partnership. The following topics are suggested for inclusion in CMSIAR applications. The list is not in priority order nor is it exhaustive. Other research topics relevant to alcohol research may be proposed. - Studies of the patterns of alcohol consumption and alcohol related problems within specific minority populations. - Research to determine specific genetic or biological factors that may increase risk for alcohol dependence or organ damage. - Biomedical studies that examine the association between alcohol abuse or dependence and enhanced progression of AIDS-defining opportunistic infections. - Research among high-risk minority populations that develops and tests interventions to prevent maternal drinking, fetal alcohol syndrome and alcohol related neurological disorders. - Research to determine biological, genetic, and environmental risk factors that lead to disproportionately high incidence of adverse pregnancy outcomes; cirrhosis and other health consequences of alcohol abuse. - Research to identify social and cultural factors that influence motivation for alcohol treatment, adherence to treatment and treatment outcomes. - Studies to identify and characterize those aspects of minority drinking environments (problems, patterns, community norms, values, etc.) that are likely to influence the outcomes of prevention and intervention studies. - Research to evaluate the effectiveness of screening and brief interventions in high risk minority health care, education or other settings. MECHANISM OF SUPPORT This RFA will use NIH U56 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 29, 2003. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. The NIH (U56) is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award" FUNDS AVAILABLE NIAAA intends to commit up to 3.5 million dollars in FY 2003 to fund four or five awards in response to this RFA in fiscal. The specific number of awards will be contingent on the scientific and technical merit of the applications. The cost may not exceed $700,000 in direct costs per year. Although the financial plans of the NIAAA provide support for this program, awards pursuant to this RFA are contingent on the availability of funds and the receipt of a sufficient number of meritorious applications. Allowable costs for the five-year grant awards include and applicants should request: Administrative costs for managing the effort, such as salaries for key personnel, travel for key personnel and the Project Advisory Committee (PAC), equipment and supplies to support an administrative structure, and PAC- approved pilot projects as appropriate. Funds to develop: workshops, seminars, retreats, and other forms of communication to explore potential opportunities in research, training and career development or education. These costs must be used to select the areas of greatest promise for implementation as pilot projects or programs with merit and potential to result in a successful grant application. Funds for the PI and collaborator(s) to attend an annual meeting on alcohol- related health disparities research to be arranged by NIAAA. ELIGIBLE INSTITUTIONS Applications will only be accepted from Minority-Serving Institutions (MSIs) [e.g., Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions (HSIs) and Tribal Institutions (e.g., Colleges)], either in the United States or in territories under U.S. jurisdiction. You may submit (an) application(s) if your Minority Serving Institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The principal investigators must be U.S. citizens, non-citizen alien nationals, or permanent residents of the United States. The principal investigator must have his/her primary appointment at the applicant MSI institution. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. To be responsive to this RFA, eligible principal investigators must have documented plans or established collaborative relationships with established alcohol investigators. It is anticipated that in most instances the collaborating scientists will be located at one or more research-intensive institutions. THE DEFINITIONS BELOW ARE INTENDED TO CLARIFY CONCEPTS THAT ARE EXPRESSED IN THIS RFA A Minority Serving Institution (MSI) is an academic, health care or research institution with an enrollment and/or faculty predominately of ethnic minorities, or an institution that qualifies as a Historically Black College/University (HBCU), Hispanic-Serving Institution (HSI), Hispanic- Serving Health Professional (HSHPS) School, or Tribal College or University (TCU). An institution that has a significant proportion of minority enrollment and a demonstrable record of accomplishment in encouraging minority faculty, clinicians and/or students to participate in research also qualifies. Both MSIs with medical schools and MSIs with focused research and education programs (e.g., Masters and Ph.D. programs) are invited to participate in this initiative. MSIs that offer baccalaureate degrees and Tribal Institutions (e.g., Colleges) are encouraged to participate in this initiative as collaborators with another minority serving institution and collaborating research intensive institution, especially on career development and educational programs aimed at preparing students to enter careers in alcohol research. A partial list of eligible MSIs can be found at the following website address: http://www.sciencewise.com. Other institutions that meet MSI qualifications may not be listed at this website, but they are also eligible to apply. A collaborating research intensive institution is an institution with which the applicant institution has partnered. A "research intensive institution" is an academic, health care or research institution which is currently the recipient of substantial NIH research support. An established alcohol research investigator is an individual who is currently the recipient of independent research support from the NIAAA through a research grant (R01, R37, U01 or U10) or an individual who is a component director on an Alcohol Research Center (P50) or multisite consortium. The established alcohol research investigator serves as a collaborator. SPECIAL REQUIREMENTS There are a number of Special Requirements and Provisions that are required of each Collaborative Minority Serving Institution Alcohol Research grant application. Requirements bulleted here are more fully explained under the heading "Supplemental Instructions" in the SUBMITTING AN APPLICATION Section, below. Three components are required. Each collaborative alcohol research grant application must focus on 1) research AND 2) faculty and research career development and/or 3) science education and/or 4) information dissemination and outreach. a) Research The CMSIAR award is expected to support a minimum of three alcohol research projects. The projects may be of a pilot or exploratory nature. Each project will involve participation by co-investigators from the applicant minority serving institution and at least one external scientist, preferably from a research-intensive institution. The external scientist/collaborating scientist must be an established alcohol research investigator. Projects involving outreach to minority populations and science education for targeted professional and community groups are encouraged. Projects must focus on topics of significance to an alcohol related minority health issue. They must not overlap in purpose or intent with existing funded grants. b) Faculty and Research Career Development A component for research training and mentoring of faculty, clinical staff and/or students is also required. The applicant institution must demonstrate or give reasonable assurances that it has the potential for collaborative career development programs. These programs must be organized and conducted by scientists and faculty from both the MSI and the established collaborating research program but must be specifically designed for MSI scientists. Training and mentoring should focus on clinical, behavioral, and population research that pertains to health disparity issues for minority and under served populations. To promote knowledge of alcohol research and skills development, MSI staff must be actively involved in career development activities. Career development programs for minority scientists must represent true collaborations that function across the institutional boundaries of the MSI and the collaborating alcohol research program. If the applicant institution does not have or does not plan to establish a formal alcohol training programs of its own, there must be a plan for MSI faculty, clinicians, and/or students to participate in training/mentoring programs of the collaborating institution and other affiliated institutions. c) Science Education A Research-to-Education program would develop, implement and evaluate creative and innovative educational materials about scientific advances in our understanding of alcohol abuse and alcoholism. The projects can address any level of education and any of several audiences, including primary and secondary educational levels, college undergraduate education, teachers' professional development and public education. Research results and evidence- based information must be used to inform educational materials, which might also include laboratory demonstrations. National Science Education Standards should be consulted in the development of materials for schools. These standards can be found at the following website: http://www.nap.edu/readingroom/books/nses/1.html The intent of the research to education component is to provide science-based knowledge and critical thinking skills and expertise that will inform decisions to use alcohol. d) Information Dissemination and Outreach The dissemination of alcohol research findings to other scientists, alcohol treatment and intervention providers, health care professionals, and the minority community must include a comprehensive process for making the information relevant to the target audience and provide strategies for developing ongoing outreach and information services. Dissemination and outreach activities must be based on accurate, current, and culturally congruent information and must delineate methods for integrating alcohol research knowledge into minority communities. NIAAA encourages the development of coordinated outreach strategies with community and local groups including other agencies and service providers, such as prevention/treatment groups, criminal justice systems, social service agencies, youth programs, etc. All proposed outreach and dissemination proposals must include plans for ongoing evaluation. They must also describe a process for using evaluation findings to improve outreach and dissemination activities. Letters of support are needed to show that there is a collaborative partnership with an active alcohol research program. After award, an agreement between the MSI and the collaborating alcohol researchers' institution should be established. A description of the collaborative process, methods and means of communication is also required. The Principal Investigator, in consultation with the NIAAA Science Collaborator, will establish a unique Project Advisory Committee (PAC). The CMSIAR must develop a five-year plan that describes the project objectives and how project activities and processes will be used to the achieve CMSIAR program goals, for example, to develop capacity to submit competitive research grant applications. For each objective, a brief statement should describe what the MSI recipients and the collaborating alcohol scientist(s) will do to ensure that project goals will be achieved. Recipients participate in an annual meeting of CMSIAR grantees. Full support for the CMSIAR activity from senior members of the MSI (e.g., Department Chair, Dean, President, Chancellor, or Center Director) that includes institutional discretionary resources that will be made available to the Principal Investigator. When CMSIAR participants have minimal experience in alcohol research, institutional support must include release or protected time to enable faculty to participate in and focus on achievement of the objectives in the application. When the Principal investigator, faculty or clinicians are not independent investigators appropriate mentoring is developed to ensure maximum probability of success. After award, a formal agreement between the collaborating alcohol research program institution and the MSI should be established to clarify time and effort utilized by the mentors or collaborators on CMSIAR projects. Cooperative Agreement Terms and Conditions of Award: The following Terms and Conditions will be incorporated into the new award statements and will be provided to the principal investigators and to the appropriate institutional officials at the time of award. The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies. The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIAAA programmatic involvement with the awardees is anticipated during performance of the activities. Under the cooperative agreement, the NIAAA supports and stimulates the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role. The NIAAA is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole. 1. Principal Investigator Rights and Responsibilities The PI Awardee has primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their research, career development and other activities. The PI will: Create a Program Advisory Committee (PAC) in consultation with the NIAAA Scientific Collaborator. Coordinate a regular schedule of PAC meetings for review and consultation. Develop and implement the five year plan with periodic updates as needed. Coordinate project activities within their institution, with outside collaborators, and with the NIAAA Scientific Collaborator. Maintain collaboration and partnership with an established NIAAA investigator and collaborating alcohol research program. Seek and accept assistance from the NIAAA Staff Scientific Collaborator in pursuing project goals. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. 2. NIAAA Staff Rights and Responsibilities According to the terms of this cooperative agreement arrangement, the NIAAA will appoint a Program Official and a Staff Scientific Collaborator to participate in the conduct of each U56 Collaborative Minority Serving Institution Alcohol Research Program. The NIAAA Program Official provides normal program stewardship, reviews the scientific progress of individual research project components, and monitors the distribution and use of core resources in the Cooperative Agreement. The Program Official also monitors compliance with requirements described in this RFA. The NIAAA Program Official may recommend withholding support or suspension or termination of the award for lack of scientific progress or for failure to adhere to policies established by the RFA or the Notice of Grant Award statement. The NIAAA Scientific Collaborator will have substantial scientific- programmatic involvement with the awardees through providing technical assistance, advice and coordination above and beyond normal program stewardship of research grants. The NIAAA Scientific Collaborator will: a) facilitate the coordination and management of this complex project; b) participate as a voting member in the duties and responsibilities of the PAC; c) participate in monitoring progress of ongoing studies; d) participate in planning and implementing efforts to disseminate information; e) provide instruction in faculty development activities; f) participate in data interpretation and, when appropriate, in the preparation of publications and presentations. The NIAAA Scientific Collaborator is subject to the same publication/authorship policies governing all participants in the study, as well as to the official NIH Publication Policy governing extramural employees. 3. Arbitration Process Any disagreement that may arise on scientific or programmatic matters between U56 awardees and the NIAAA may be brought to arbitration before an arbitration panel. The arbitration panel will be composed of three members. One member will be chosen by the awardee. A second member will be selected by the NIAAA. The third member, having expertise in the relevant scientific area, will be chosen by the two selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. 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: Ernestine Vanderveen, Ph.D. National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 302 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2531 FAX: (301) 480-2358 Email: tvanderv@willco.niaaa.nih.gov o Direct your questions about peer review issues to: Eugene G. Hayunga, Ph.D. Chief, Extramural Project Review Branch Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Room 409, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-4375 Fax: (301) 443-6077 o Direct your questions about financial or grants management matters to: Judy Fox Chief, Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 (301) 443-4704 (telephone) (301) 443-3891 (fax) email: jsimons@willco.niaaa.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 sent by the date listed at the beginning of this document. The letter of intent should be sent to: RFA-AA-03-007 Extramural Project Review Branch Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 409-MSC 7003 Bethesda, MD 20892-7003 (courier: Rockville, MD 20814) Telephone: (301) 443-4375 FAX: (301) 443-6077 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: RFA: AA-03-007 Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard, MSC 7003 Bethesda, Maryland 20892-7003 or Rockville, Maryland 20852-7003 (for express/courier service) SUPPLEMENTAL INSTRUCTIONS This RFA requires Supplemental Instructions as follows: Each five-year alcohol research grant application must have at least three components. A research component and a faculty and research career development are required. In addition the application must include a science education and/or information dissemination and outreach component. Each component is subject to the 25-page limitations for sections a-d of the research plan. A five-year plan is required. It must describe the objectives, the activities and the processes that the MSI will use to reach the goal of developing capacity to submit competitive alcohol research grant applications in the future. For each objective, a brief statement should describe what the MSI recipients and the collaborating alcohol scientist(s) will do to ensure that project goals will be achieved. When the MSI Principal Investigator is not an independent investigator, the application must include: - a letter of support from senior members of the MSI (e.g., Department Chair, Dean, President, Chancellor, or Center Director)indicating full support for the activity including release or protected time to enable faculty to participate in and focus on achievement of the objectives in the application and institutional discretionary resources that will be made available to the Principal Investigator. - a letter of support from the prospective mentor(s) that describes mentoring activities and confirms the mentors' commitment to ensuring success of the collaborative effort. This letter is to assure appropriate mentoring and maximum probability of success. The collaborative activities must demonstrate a clear partnership between the MSI and the collaborating alcohol research program. This process must begin with collaboration in preparing the grant application for submission by the MSI. The application must describe how the MSI and the collaborating alcohol research program will complement each other in achieving clearly stated goals and common objectives. The collaborating institutions and scientists must provide evidence of commitment to the identified projects as well as plans for interactions among all parties. The requested funds must be used for totally new activities that may build on but not duplicate the purpose or intent of currently funded grants (e.g., P30, P50, P01, R01, R03, R21, R25 Research Resources, Research Infrastructure Grants, NRSA Grants, and other peer-reviewed funded programs). Recipients of these cooperative agreement awards and their collaborators will be expected to participate in an annual meeting. Travel costs for the PI to attend this meeting should be included in the grant application from the MSI. The Principal Investigator in consultation with the NIAAA Science Collaborator will establish a unique Project Advisory Committee (PAC) of four to six members. At least one PAC member should be from a relevant community group and two members should be experienced alcohol researchers. The NIAAA Scientific Collaborator will be an additional voting member of the PAC. The PAC will meet annually, and more if necessary, to review activities and make recommendations on all project functions. The role of the PAC is to advise the Principal Investigator on scientific and related issues pertinent to the operation of the CMSIAR. Among its duties, the PAC will assess interim progress of all activities within the CMSIAR, and will review and select projects proposed for future consideration and/or submission. The application should address each of the following elements: I. Administrative Core The CMSIAR must have strong and experienced central leadership to coordinate proposed activities and to keep all components informed of important activities. Critical elements of the Administrative Core include: A Principal Investigator who is a senior experienced investigator from the MSI and who will have substantial involvement in managing the CMSIAR program. A 5-year research plan developed by the CMSIAR based on areas of alcohol research interest. The selection of proposed projects must reflect the goals of the research plan and must be relevant to the research program and priorities of the NIAAA. The plan should state how the institution will build on its strengths and capabilities to conduct alcohol research and address the needs of the institution in furthering CMSIAR goals. The plan should include measurable objectives. Each CMSIAR should create a program for disseminating alcohol research information. The audiences for these activities should include health care and allied professions' students and professionals, community based organizations and researchers at the host institution as well as investigators at other institutions. Information dissemination activities may include, but are not limited to, activities such as seminars, journal clubs, training programs, short courses, telemedicine, presentations at professional meetings and publications. The content of these activities must be developed in collaboration with the NIAAA and established alcohol research scientists. The CMSIAR may wish to seek appropriate Continuing Health Education credit for participants. The information dissemination and faculty development function should work closely with the Administrative Core. The Principal Investigator will prepare a yearly progress report and a document near the conclusion of the first 5 years of CMSIAR experience. The document must contain, but is not limited to, the CMSIAR description, an assessment of the collaborative approach to project development and the enhancement of faculty expertise. Research findings and observations on the administration of the program should also be included. These reports should document progress toward implementing the CMSIAR 5-year plan. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAAA. Incomplete or unresponsive 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 Institute in accordance with the review criteria stated below. As part of the initial merit review, applications which are fully discussed will be assigned a priority score. Applications which are not discussed will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The applicant shall receive a written critique of the review. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. REVIEW CRITERIA This initiative is quite broad in scope. Under these circumstances, the review criteria are not organized under the traditional headings of Significance, Approach, Environment, Investigator and Innovation typically used for NIH research grants. Reviewers will use considerable flexibility in determining the merit of a broad range of possibilities that can expand research, training and career development opportunities for minority scientists and students. Each application must be thorough and complete enough to stand on its own. Additional materials or revisions will not be accepted after the receipt date. It is strongly recommended that Institutional Review Board (IRB) approval be secured prior to submission. I. The following criteria will be used in judging the adequacy of plans for the administrative core: - Strength of the 5-year plan of research, faculty and research career development and education or dissemination to achieve CMSIAR program goals - Evidence of experience coordinating multi-disciplinary projects and administrative core activities. - Evidence of experience with, and a commitment to, fostering working relationships with minority populations. - The degree to which the proposed collaboration presents opportunities for furthering research programs in the minority serving institution. - Evidence of the ability to disseminate information through professional and less formal mechanisms. - Appropriateness of the proposed budget. - Evidence of planned or established collaborations between faculty from the minority serving institution and external scientists from research intensive institutions. - Evidence that the proposed PAC has appropriate scientific experience, including alcohol research, and minority community membership, and that the individuals are committed to the success of the program. - The promise and potential of the pilot and exploratory studies proposed to be the basis for developing future research projects. II. The following criteria will be used to evaluate the commitment of the applicant institution to program objectives: - Strength of the evidence that the researchers and faculty of the MSI and the collaborating alcohol research program worked closely together in the preparation of the application. - The degree to which the MSI officials' letters of support address: institutional commitment to alcohol research; the need for faculty/staff/student mentoring and development; and institutional commitment to ensuring the success of the collaborations by providing release or protected time for faculty to do research and by providing other resources. - The adequacy of MSI and collaborating program staff's day-to-day oversight, coordination, and commitment to logistical support, as needed to make the collaboration successful. - The adequacy of plans proposed by the MSI and collaborating alcohol research program 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). - Clarity of the process used to identify areas for potential collaboration and/or development. - The appropriateness of all participants' academic preparation and professional experience to contribute effectively to pertinent aspects of this alcohol research project. - The potential of the proposed projects/programs to generate adequate preliminary data to become competitive for future grant support (e.g., R03, R21, R01, R25, K awards, NRSA awards for training). Renewal Applications: A comprehensive progress report is required for competing renewal applications. A statement must be included in the application regarding the progress toward achieving aims of the previously funded CMIARD during the previous period of support. In addition, for all projects in each component, supported during the previous 5-year grant period, a succinct account of its published and unpublished results must be provided. This account is required whether or not the project will be submitted for continuation in the renewal application. Other Considerations: The initial review group will also examine the appropriateness of the proposed budgets and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for scientific goals of the research and plans for recruitment and retention of subjects; the adequacy of plans for including children as appropriate for the scientific goals of the research, or the justification for exclusion; the provisions for the protection of human and animal subjects; and the safety of the research environment. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: January 24, 2003 Application Receipt Date: February 24, 2003 Peer Review: May-June 2003 NIAAA Advisory Council: September 17, 2003 Earliest Anticipated Award Date: September 29, 2003 AWARD CRITERIA The applications will compete for funds with all other proposals submitted in response to this RFA. Applications recommended by the NIAAA Advisory Council will be considered for award based on (a) scientific and technical merit as determined by peer review; (b) the program priorities of the NIAAA, and (c) availability of funds. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy is based on the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice- files/NOT-OD-00-048.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted and supported by the NIH, unless there are clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type I) 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the policy that was published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) Cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned 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 the priority area of Alcohol Research. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/ and the NIAAA "Forecast for the Future: Strategic Plan to Address Health Disparities" at http://www.niaaa.nih.gov/about/DisparitiesIntro-text.htm AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.273, Alcohol Research Program Awards are made under authorization of Sections 301, 405, and 464H of the Public Health Service Act as amended, (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR Parts 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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