COOPERATIVE AGREEMENT FOR EXPLORATORY/DEVELOPMENTAL GRANTS FOR MINORITY INSTITUTIONS ALCOHOL RESEARCH PLANNING (U01) RELEASE DATE: May 2, 2002 RFA: RFA-AA-02-013 National Institute on Alcohol Abuse and Alcoholism (http://www.niaaa.nih.gov/) LETTER OF INTENT RECEIPT DATE: July 1, 2002 APPLICATION RECEIPT DATE: July 30, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of This RFA o Research Objectives o Mechanism 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 OF THIS RFA The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks applications for cooperative agreement grants (U01 mechanisms) to support research planning and research development at Minority Serving Institutions (MSIs). The purpose of these grants is to promote 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. Grant planning activities should address health disparities in the following target populations but are not limited to persons of African heritage, Hispanic/Latino culture, American Indians/Alaskan Natives, Asian Americans, and Native Hawaiian and Pacific Island populations. An essential characteristic of the programs funded in response to this RFA is that it will require long-term committed partnerships between the recipient MSI and one or more established alcohol research investigators at research intensive institution(s). The NIAAA encourages a multidisciplinary approach to research, and it is expected that at least one project will address questions related to alcohol-related health disparities. It is also expected that these grants will develop and sustain preliminary research studies that will lead to the submission of competitive grant applications from MSIs. 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 one or more of the priority areas found in the strategic plan. Potential applicants may obtain a copy of "Strategic Plan to Address Health Disparities" (February 8, 2001) at http://www.niaaa.nih.gov/about/DisparitiesIntro-text.htm. OBJECTIVES AND SCOPE OF THE PLANNING GRANT Background: Alcohol consumption is associated with a wide 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 and women of Hispanic origin than among non-Hispanic black and white Americans. Alcohol- related traffic deaths are many times more frequent (per 100,000 population) 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 differing 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 for 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, and there is a need to increase the number of minority scientists who are pursuing successful biomedical and behavioral alcohol research careers. More 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. One piloted and potentially powerful approach for addressing these issues is to create and sustain collaborations between scientists and faculty of MSIs and established alcohol investigators in ways that integrate and take maximum advantage of their respective expertise and experience into mutually beneficial activities. TOPICS AND AREAS FOR CONSIDERATION Development in at least three of the following four broad areas is required and must include activities linked to achieving NIAAA objectives through focused planning and implementation of pilot studies. The four planning grant areas include: 1) Alcohol Research Training and Career Development: While the primary purpose of each planning grant is preparation for the conduct of alcohol research, an important component related to planning for research is the training of research and clinical personnel. The applicant institution should demonstrate or give reasonable assurances that it has: - the potential for collaborative career development programs jointly organized and conducted by scientists and faculty of both MSI and the established collaborating research program specifically designed for training and mentoring minority scientists. Focus should be on training minority scientists in clinical, behavioral, and population research that can address health disparity issues among minority and under served populations. Career development programs for minority scientists must represent true collaborations that function across institutional boundaries of the MSI and the collaborating alcohol research program; or - the potential to develop programs designed to train predoctoral and/or postdoctoral students for careers in alcohol research; or - the capacity to establish and conduct programs of continuing education in the medical, behavioral, epidemiological, or other health service fields relevant to alcohol abuse and alcoholism. While the applicant institution need not necessarily have formal training programs of its own, there must be specific provision for coordination between the MSI and the training programs of the collaborating institution and/or other affiliated institutions. Planning grant funds may not be used to pay stipends or other training related costs. However, grant resources may be made available for payment for services rendered, such as research assistance, teaching, or laboratory support. MSI staff should be actively involved in the development of training programs. 2) Research Collaborative alcohol research projects, including pilot studies, must build and stabilize the collaborative alcohol research capabilities of minority institutions to address the impact of alcohol on populations experiencing negative alcohol-related consequences. Projects should enhance development of collaboration of partner investigators, scientists, and clinicians in minority serving institutions with established alcohol investigators. These grants will support the planning, partnership development, and implementation of mutually beneficial collaborations between applicant institutions and collaborating research intensive institutions that support productive alcohol research programs. Approaches to planning are encouraged to address essential elements including: a focus on interdisciplinary alcohol and health disparities research; institutional commitment; administrative capabilities and facilities; and interdisciplinary coordination and collaboration. Single or multi-site pilot or feasibility research projects that address health disparities are appropriate. Topics listed below are examples of some research areas that might be considered for planning and piloting. They are not comprehensive, restrictive nor in priority order. - 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. - 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. 3) Science Education Education programs can include activities augmenting existing curriculum or creating new curricula in the MSI and/or the collaborating alcohol research program. NIAAA encourages the development of educational programs designed to motivate minority students to pursue careers in research at earlier stages of their educational experience (e.g., high school, undergraduate). A successful planning effort in this area is expected to result in the submission of a competitive R25 application. All educational programs and activities must include plans for ongoing assessment and evaluation and demonstrate processes for linking evaluation results to improving training curriculum and related educational tools. 4) Outreach and Research Dissemination The dissemination of alcohol research results to health care professionals, and the minority community must include a comprehensive process for linking information to the target audience and provide strategies for developing ongoing outreach and research services. The MSI and collaborating alcohol research program are required to develop an outreach strategic plan. Dissemination and outreach activities must be based on accurate, current, and culturally competent information and detail methods for translating alcohol research knowledge to minority communities. NIAAA encourages the development of coordinated outreach strategies with community and local groups. All outreach and dissemination activities must include plans for ongoing assessment and evaluation and demonstrate processes for linking evaluation results to improving outreach and dissemination activities. The expectation is that these U01 alcohol planning grants will become the basis for generating competitive research grant applications including: research project grant (R01); exploratory /development grant (R21); educational project grant (R25); training grant applications (T32, F31, F32); and career development grant applications (K awards) for submission to NIAAA. MECHANISM OF SUPPORT This RFA will use a Cooperative Agreement (U01) mechanism. The NIH U01 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". At present, the plans for extending the cooperative agreement projects beyond the initial award period are indefinite. Future plans will be based on evaluation of scientific progress achieved by awardees during the initial funding period. FUNDS AVAILABLE The NIAAA anticipates making up to six three-year (U01) awards and plan to set aside a total of $2.0 million for first year funding. The maximum total annual direct cost budgets for these cooperative planning grants is $250,000 annually. Applications exceeding this limit will be considered unresponsive to this RFA and will be returned without further consideration. Although the financial plans of the NIAAA 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. Applicants should request funds to attend an annual meeting on alcohol- related health disparities research to be arranged by NIAAA. Allowable costs for the three-year U01 alcohol research-planning grants include: - Administrative costs for managing the effort, such as salaries for key personnel, travel for key personnel, equipment and supplies to support an administrative structure. - Developmental costs for: for workshops, seminars, retreats and other forms of communication to explore potential opportunities in research, training and career development or education. These costs must be for the purpose of selecting the areas of greatest promise for implementation as specific types of pilot projects or programs based on merit and potential to result in a successful grant application. - Costs related to implementing pilot research projects or pilot programs in training and career development or education for the explicit purpose of obtaining preliminary data for the submission of a specific grant application(s). 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, and from institutions or organizations that can demonstrate organized, integrated research efforts focused on alcohol. You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, hospitals and health maintenance organizations o Domestic Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. To be responsive to this RFA, eligible institutions must have documented collaborative agreements 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. - 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), a Hispanic-Serving Institutions (HSI), a Tribal College or University (TCU), or a Hispanic-Serving Health Professional Institution (HSHPI), comprise a significant proportion of the enrollment s and that have a track record of commitment to the special encouragement of minority faculty, students and investigators. Both MSIs with medical schools and MSIs with more focused research and education programs (e.g., Masters and Ph.D. programs) are invited to participate in this initiative. MSIs that offer only baccalaureate degrees and Tribal Institutions (e.g., Colleges) are encouraged to participate in this initiative as full collaborators, especially in the development of educational programs aimed at motivating 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. - The collaborating research intensive institution is the 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 one or more of the following mechanisms: regular research grant (R01, R37, U01 or U10) or a component director within an Alcohol Research Center. 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. SPECIAL REQUIREMENTS AND PROVISIONS There are a number of Special Requirements and Provisions that are required of each alcohol research planning grant application. Requirements bulleted here are more fully explained under the heading "Supplemental Instructions" in the SUBMITTING AN APPLICATION Section, below. - Each planning grant application must be focused on three of the four of the following targeted areas: a) alcohol research training and career development; b) research; c) science education; and d) dissemination and outreach. - Appropriate letters of support. - Demonstration of a collaborating partnership with an active alcohol research program. - Description of the collaborative process, methods and means of communication. - Pilot projects and pilot programs must not overlap in purpose or intent with existing funded grants. - Recipients to participate in an annual meeting. - The Principal Investigator with consultation of the NIAAA Science Collaborator will establish a unique Project Advisory Committee (PAC) 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. - Implement the approved three year plan for the planning effort, 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. - 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 As per the terms of the cooperative agreement arrangement, the NIAAA will appoint a Program Official and a Staff Scientific Collaborator to participate in the conduct of each of U01 Planning Cooperative Program. - The NIAAA Program Official provides normal program stewardship and reviews the scientific progress of individual research project components, and the use of the core resource facilities among the research projects within each Cooperative Agreement. The Program Official also monitors compliance by the Cooperative Agreement with the operating policies of this RFA. The NIAAA Program Official may recommend withholding of support, suspension, or termination of an award for lack of scientific progress or failure to adhere to policies established by the RFA or the 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 necessary to manage this complex project; b) participate as a non-voting member 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 U01 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. INQUIRIES Written, telephone, fax and e-mail inquiries concerning this RFA are strongly encouraged, especially during the planning phase of these applications. Below is a listing of program (i.e., scientific management), grants administration (i.e. fiscal management) and review (i.e., management of peer review process) staff of the NIAAA who are available for inquiries: Direct inquiries regarding programmatic issues to: Ernestine Vanderveen, Ph.D. National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 301 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 (Rockville, Maryland 20852 for express/courier service) Telephone: (301) 443-2531 FAX: (301) 480-2358 Email: tvander@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Judy Fox Simons Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 505 6000 executive Blvd. (MSC-7003) Bethesda, MD 20892-7003 (Rockville, Maryland 20852 for express/courier service) Telephone: (301) 443-2434 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 NIAAA 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-AA02-013 Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 409-MSC 7003 Bethesda, MD 20892-7003 (Rockville, Maryland 20852 for express/courier service) Telephone: (301) 443-4375 FAX: (301) 443-6077 SUBMITTING AN APPLICATION The following procedures apply to submitted applications: Applications are to be submitted using the Form PHS 398 (rev. 4/01) using the SUPPLEMENTAL INSTRUCTIONS provided below. 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; FAX: (301) 480-0525; Email: grantsinfo@nih.gov. NOTE: The RFA label available in the PHS 398 application form (or at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf) must be affixed to the bottom of the face page of the application and the RFA number AA02-013 written on the label. Failure to do so could result in delayed processing of the application such that it may not reach the review committee in time for the review. On Line 2 of the Face page the YES box must be checked and the number and title of the RFA typed in. Submit the complete signed application with the checklist, and three photocopies without the checklist to: Center for Scientific Review Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7910 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-02-013 Extramural Project Review Branch National Institute on alcohol Abuse and alcoholism Willco Building, Room 409 6000 Executive Boulevard, MSC 7003 Bethesda, Maryland 20892-7003 (Rockville, Maryland 20852 for express/courier service) Supplemental Instructions This RFA requires Supplemental Instructions as follows: - Each three-year alcohol research planning grant application must be focused on three of the four of the following targeted areas: a) alcohol research training and career development b) research c) science education and d) dissemination and outreach. A three-year plan, jointly proposed by the MSI and the collaborating alcohol research scientists, must be presented. The plan must describe the activities and the process through which the MSI will reach the goal of developing competitive projects and preliminary research results in support of applications for further grant support. The plan, must include a chronological table of collaboration development listing the specific first year and second year objectives. For each objective, a brief statement should be made about the separate contributions of the MSI and the collaborating alcohol research scientist or program in order to achieve success. The final objective must be the submission of a grant application to NIAAA-. - When the Principal Investigator from the MSI is not an independent investigator, the application must include: 1) a letter of support from senior members of the MSI (e.g., Department Chair, Dean, President, Chancellor, or Center Director) to indicate full support for the activity. 2) a letter of support from the prospective mentor(s) to assure appropriate mentoring and maximum probability of success. The letter of support should describe mentoring activities and support to ensure success of the collaborative effort. The support must include release or protected time to enable faculty to participate in and focus on achievement of the objectives in application and institutional discretionary resources that will be made available to the Principal Investigator. Evidence of significant institutional commitment is required of applications that propose PIs with minimal experience in alcohol research (e.g., a training program or an education program that provides commitment from appropriate institutional officials of the MSI (Dean or President) and the collaborating alcohol research program institution. - The collaborative activities must demonstrate a clear partnership between the MSI and the collaborating alcohol research program. This must be done through collaboration in preparing the planning 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 institution and scientist must provide evidence of commitment to the project and expectations for interactions and performance by each partner should be clearly presented. - For interactions and progress in planning, the application must clearly describe a collaborative process outlining: methods for appropriate means of communicating and identifying areas of potential collaborations; areas of focused collaboration and strategies selected for implementation; and pilot projects/programs through which preliminary data is acquired to be as basis for submitting a specific competitive grant application in one or two of the target areas referenced or specified above to the NIAAA. - The use of funds to support pilot projects and pilot programs must be for totally new activities that do not overlap in purpose or intent with existing 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 planning awards and their collaborators will be expected to participate in an annual meeting. Travel costs for this purpose should be included in the grant application from the MSI. - The Principal Investigator with consultation of 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 non-voting member of the PAC. The PAC will meet at least annually to review activities and make recommendations on all project functions. The role of the PAC is provide advice to the Principal Investigator on scientific and related issues pertinent to the operation of the CMIARD. Among its duties, the PAC will assess interim progress of all projects within the CMIARD, and review projects proposed for future implementation. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 NIAAA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique 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 second level review by the NIAAA National Advisory Council on Alcohol Abuse and Alcoholism. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 NIAAA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique 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 second level review by the NIAAA National Advisory Council on Alcohol Abuse and Alcoholism. REVIEW CRITERIA This initiative is quite broad in scope and includes alcohol research, alcohol research training and career development and alcohol research education objectives. 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 have to 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. Applicants can apply for three years of support and should include information on their experience, interactions and planning history, consequently reviewers must evaluate the following: 1. 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. 2. As applicable, the degree to which the letters of support from senior faculty and/or institutional/center leaders address the need for mentoring of inexperienced Principal Investigators or for specific institutional/center commitments to ensure the success of the collaboration. 3. As applicable, the adequacy of provisions made for day-to-day oversight, coordination, support and logistical services needed to make the collaboration successful. 4. Planning Activities: a. The adequacy of the different planning methods 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). b. The adequacy and duration of the initial planning stage needed to identify areas of potential collaboration. c. The quality and merit of the documented planning process used for identifying areas ready for prioritization and/or for pilot testing. d. The appropriateness and adequacy of the specific faculty and scientists identified from the MSI and the collaborating alcohol research program to contribute effectively to each aspect of this planning effort. 5. Pilot Projects/Programs a. The qualifications of the Co-leaders to implement a pilot project/program. b. The merit of the project/program and its feasibility to acquire the necessary preliminary data to become competitive for specific grant support (e.g., R03, R01, P01, P50, K12, T32, R25). 6. Applicants must choose three of the four planning grant areas. Review criteria for each of the four areas follow the objectives described in the Topics and Areas for Consideration section. In addition, reviewers should take into account the planning grant level of these objectives. Briefly, the criteria for each area include: a. Alcohol Research Training and Career Development: - The potential for collaborative career development programs jointly organized and conducted by scientists and faculty of both MSI and the established collaborating research program. - The potential to develop programs designed to train predoctoral and/or postdoctoral students for careers in alcohol research. - The capacity to establish and conduct programs of continuing education in the medical, behavioral, epidemiological, or other health service fields relevant to alcohol abuse and alcoholism. b. Research - Feasibility of establishing collaborative alcohol research projects based on the research capabilities of the MSI. - Likelihood of the research to address health disparities related to the impact of alcohol on minority populations. - Expectation that pilot research projects will enhance the development of collaborations between MSI investigators, scientists, and clinicians and their counterparts among established alcohol investigators. - Evaluation of opportunities to encourage additional desirable elements such as interdisciplinary coordination; institutional commitment; and the development of administrative capabilities and facilities. c. Science Education - Feasibility of education programs to augment existing curriculum or create new curricula at the MSI. - Feasibility of strategies to motivate minority students to pursue careers in research. - Likelihood that a successful planning effort in this area may result in the submission of a competitive R25 application. d. Outreach and Research Dissemination - Feasibility of creating a plan for the dissemination of alcohol research information to health care professionals and the minority community. - Feasibility of a process for linking alcohol information to the target audience and providing strategies for developing ongoing outreach and research services. - Feasibility of developing a strategic plan for dissemination and outreach activities based on accurate, current, and culturally competent information and effective methods for information transfer to minority communities. - Possibilities for the development of coordinated outreach strategies with community and local groups. - Inclusion of plans to develop strategies for ongoing assessment and evaluation of all outreach and disseminating activities. 7. 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: July 1, 2002 Application Receipt Date: July 30, 2002 Peer Review: August-September 2002 Review by NIAAA Council: September 2002 Earliest Anticipated Award Date: September 28, 2002 AWARD CRITERIA Applications recommended by the NIAAA Advisory Board will be considered for award based upon (a) scientific and technical merit as determined by peer reviewers; (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/ AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.398, Alcohol Research Manpower Awards are made under authorization of Sections 301 and 405 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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