ALCOHOL RESEARCH CENTER GRANTS Release Date: July 17, 2002 RFA: AA-03-001 National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) Letter of Intent Receipt Date: November 12, 2002 Application Receipt Date: December 10, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION: 1. Purpose of this RFA 2. Research Objectives 3. Mechanism(s)of Support 4. Funds Available 5. Eligible Institutions 6. Individuals Eligible to Become Principal Investigators 7. Special Requirements 8. Where to Send Inquiries 9. Letter of Intent 10. Submitting an Application 11. Supplemental Instructions 12. Peer Review Process 13. Review Criteria 14. Receipt and Review Schedule 15. Award Criteria 16. Required Federal Citations 1. PURPOSE OF THIS RFA The National Institute on Alcohol Abuse and Alcoholism (NIAAA) provides grant support for Alcohol Research Centers to conduct and foster interdisciplinary research on alcoholism and alcohol abuse. The Center program is interrelated with and complementary to all other research support mechanisms and scientific activities that comprise the programs of research on the nature, causes, and consequences of alcohol abuse and alcoholism, including diagnosis, treatment, prevention, and health services research related to prevention and treatment of alcoholism. Centers are designed to stimulate and encourage application of multiple perspectives and approaches to alcohol related problems. Support for four of the current 5-year Center grant awards will expire in late 2003. Research within each of these Centers is organized around a central theme: alcohol in host defense and infection with focus on HIV and AIDS, identification of mechanisms to explain stimulus effects of alcohol on central nervous system and brain response, gene and environment interaction studies to clarify the respective influence of biological and social factors on transmission of heritability in polygenic disease, development of alcoholic liver disease and pancreatitis and the relative role of alcohol during manipulation of secondary factors known to influence ethanol induced tissue and organ damage. Applications for new Centers in these and other research areas will be accepted with applications from currently funded Centers seeking renewal support. 2. RESEARCH OBJECTIVES All proposed research to be conducted within a Center must be clearly directed toward one or more of the following goals: prevalence, etiology, diagnosis, prediction, clinical course, management or treatment of alcohol abuse, alcoholism, or alcohol-related health problems, health services research, consequences of alcoholism or alcohol abuse, and factors that relate to prevention of alcohol abuse, alcoholism, or other problems associated with alcohol consumption. Some examples are research to improve knowledge of the impact of alcohol use on related health issues, such as human development and aging, cardiovascular integrity, disease pathogenesis and progression, liver and gastrointestinal functioning, nicotine and other drug use, performance ability, neurological impairment, and mental disorders that co-occur with alcohol abuse disorders. The Alcohol Research Center grant provides a mechanism for fostering interdisciplinary cooperation in a group of established investigators conducting high-quality alcohol research. Therefore, existence of a strong research capability is fundamental to the establishment of a new Center or the continuation of an existing Center. A Center should be an identifiable organizational unit within an institutional or organizational structure such as a university, medical center, or a consortium of affiliated cooperating institutions. Unique scientific opportunities warrant collaboration with investigators in other centers and/or with scientists in institutions outside the United States. In such cases the director of the components in which collaborative activity with a foreign organization is proposed must be affiliated with a domestic institution. Center Components The following paragraphs describe the specific components of a Center application: Administrative Core Component A Center should promote synergistic interaction of broad and diverse elements that require clearly specified lines of authority and accountability by appropriate institutional officials. The purpose of the administrative core component is to provide the organizational framework for the management, direction, and coordination of the Center. The administrative core component must be managed by the Center Director or Scientific Director and may include funds for scientific enrichment activities such as special lectures, symposia, seminars, and workshops for research faculty and staff. Scientific Core Components Core components for this RFA are defined as shared research resources that enhance productivity or in other ways benefit a group of investigators working in alcohol-related research to accomplish the common goals of the Center. A core component is a laboratory, facility, service, or other resource that interacts synergistically with research projects of the Center. Cores should primarily be used to support projects which are part of the Center Grant award, but they may also be used for other support mechanisms such as Research Project Grants, Program Projects, or a combination thereof, that have relevance to the NIAAA mission. Core components should provide investigators with some technique, instrumentation, service, or resource in a way that will enhance research progress and contribute to efficiency and effectiveness. Each core component is directed by an investigator with established expertise relative to the support or service to be provided, usually a faculty-level individual. Some examples of research support that core components typically provide are: (1) technology that implements automation or large batch preparation, (2) tissue and/or cell culture facilities, (3) complex instrumentation, e.g., electron microscopy, mass spectrometry, electrophysiology, (4) animal care and preparation, (5) service and training, (6) patient coordination, and (7) information processing, data management, and statistical services. Research Components Research components are individual scientific research projects, interrelated within the overall Center program so that the components contribute collectively to the goals of the Center program to a greater extent than if each project were pursued separately. Each research component must be a highly focused project under the direction of a component director. The component director should be an established researcher of independent and scientifically recognized standing who is responsible for the scientific direction and conduct of the individual research component. A Center Director or Scientific Director may also serve as a component director. Education Component (for P60 applications) Comprehensive centers (P60) must include at least one component which supports activities designed to translate research findings into health care practice or public information dissemination. Such activities may require a substantial portion of the first year for planning and development with actual implementation beginning near the second and continuing in subsequent years. These projects shall in a meaningful way reflect the Center"s program of research. The following examples are types of projects that may be undertaken but are not limiting: Translational Research: The development of collaborative partnerships to advance the alcohol research field through translation of insights and findings from basic and pre-clinical research to test hypotheses regarding treatment and prevention of alcohol disorders, to improve interventions with alcohol affected individuals in clinical practices, health care or community settings, or the development of innovative interventions to study the effects of services for diverse populations in disparate social, cultural and environmental contexts. Dissemination of Scientific Information and Research Progress: Dissemination of scientific knowledge through educational efforts directed to the public, patient populations, professionals and para-professionals, providing information to educational institutions, the media and other appropriate organizations/groups, and educational programs for specific audiences, e.g., children, women, elderly etc. Dissemination of scientific knowledge through the establishment of research and research training collaborations for the purpose of expanding the capacity of and other institution , including minority serving institutions, in developing rigorous alcohol research programs. All translational and educational projects should have specific objectives and include a method of assuring the effectiveness of the effort. Pilot Project Component The purpose of pilot projects is to provide the Center with a flexible means to develop and explore new research activities or directions, and unique scientific opportunities that could evolve into independently funded research projects. These funds are not intended to supplement ongoing research projects. Pilot projects must be in a separate pilot project component that incorporates all of the pilot studies of the proposed Center grant. 3. MECHANISMS OF SUPPORT The Alcohol Research Centers Grant program is designed to complement the regular research project grants program of the NIAAA by providing long-term (typically for 5 years) support for interdisciplinary research programs with a distinct focus on a particular theme relating to alcoholism, alcohol abuse, and other alcohol-related problems. The program is intended to encourage outstanding scientists from biomedical, behavioral, social science, and other relevant disciplines to bring a full range of expertise, approaches, technologies and creativity to the study of problems related to alcohol abuse and alcoholism. Center grants help to provide a stable environment for investigators to engage in alcohol research in a coordinated, integrated and synergistic effort. Centers are expected to be sources of scientific excellence, provide leadership to the field, and, through sustained excellence, to become significant regional or national research resources. In addition, they are expected to attract promising and established investigators and to provide training, career development and mentoring opportunities to persons from various disciplines and professions. A specialized center (P50) is an integrated, broad-based multidisciplinary, multi-investigator, long-term program of combined research and research support activity planned around a specific major research objective or research theme. In addition to providing support for shared resources, this type of Center supports a full range of basic, developmental, clinical, and/or applied research components, allows for growth and development through pilot projects, and is intended to provide state-of-the-art leadership in the alcohol field. A comprehensive center (P60) expands the specialized center program of research and research training by inclusion of additional components or elements developed in conjunction with available community based agencies, institutions, facilities and resources. Projects could include community education and alcohol information dissemination to the public and education for medical and allied health care professionals concerning the problems of detection, diagnosis, treatment and prevention of alcohol dependence and alcohol abuse. While not all of these areas must be represented in one center, the community education or information dissemination project proposed should be a comprehensive approach and have a clear relationship to the research theme of the center. 4. FUNDS AVAILABLE It is estimated that approximately 7.0 million dollars will be available in FY2004 to fund four or five Centers. The total cost (direct plus Facilities and Administrative (F&A) costs) for a Center may not exceed $1.8 million per year for a P50 and $2.0 million per year for a P60. Continuation support in future years is anticipated. 5. ELIGIBILITY INSTITUTIONS 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, 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 organizations In addition, the proposed Center must be affiliated with an institution, such as a university, medical center, or research center that has the resources to sustain a long-term, coordinated research program. An applicant institution must demonstrate the ability to attract high-quality scientists from biomedical, behavioral, clinical and/or social science disciplines who are willing to make a long-term commitment to research, and must assure that research-training opportunities will be available. An application must also have a detailed 5-year plan for a proposed research program. 6. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The individual named as principal investigator for the Center grant will also serve as Director of the Center. This individual must demonstrate the ability to organize, administer, and direct the Center, and have sufficient authority to allocate space, personnel, and other resources essential to the Center. 7. SPECIAL REQUIREMENTS The following paragraphs describe the Special Requirements for a Center application. Details for preparing the application are provided in the Supplemental Instructions (see Item 11.) It is essential that applicants carefully adhere to the Supplemental Instructions. Center grant applications should be organized into discrete components that comprise a proposed program of research. Each component is either a research component or a core component for which a separate detailed budget is included in the application. The application must include an administrative core and at least three research components, it may also include shared scientific resource cores, education on translational research component for P60s, and/or a pilot project component. The minimum acceptable combined number of research components and core components is four (an administrative core and three research components). The maximum combined number of research components and core components, including a pilot project component, is 10. An education component does not count toward this total. More than a total of 10 components is not acceptable even if some components are in operation for less than the 5-year period. All proposed research components need not be ongoing at any one time, but may be phased in at different time points during the life of the proposed Center grant. At least three research components must be ongoing at all times, and no more than 10 research and/or core components may be proposed over the entire project period. Education components do not count toward the required three research components. This aspect should receive careful attention in the application and individual component preparation. The research plan for each core component, each research component, and each education component is limited to 25 pages. Pages not used for one component may not be used to extend the page limit of other components/cores. These page limits do not apply to pilot projects. For pilot project requirements, see section entitled "Pilot Project Component," (below). Administrative Core Component The administrative core component plays a key role in the coordination and operation of the Center. This core should be described in sufficient detail to assure that all proposed components and related activities will function optimally and in an interactive synergistic manner. An important function of this core is the administration of the budget. Through this component, the Center Director provides substantive leadership and manages the administrative core component. This component may also include the costs of scientific enrichment and education activities for faculty and staff. Scientific Core Components Each shared scientific resource component should be clearly described in terms of the services/resources to be provided to investigators. The description should include a discussion of the core"s contributions to the research objectives of the Center. Relevant aspects of cost effectiveness, timesaving, and increased efficiency attributable to the existence of the cores should also be addressed. A core component should support Center grant research components and may also support separately funded research project grants that are related to the Center"s theme. Each separately funded research project associated with the Center and utilizing core facilities should have a brief description that includes its research objectives and how the Center"s core facility will impact upon it. The minimum number of research components/projects supported by a core component is two. A core component director who has documented experience and scientific expertise relative to the purpose of the core must be designated for each core. This person should be an established scientist in his or her field. The description of the organization and mode of operation of the shared resource core should include discussion of quality control for the service or resource, and the procedures for evaluating and selecting projects eligible for use of the core facility. Training in complex techniques and methods should be described if they are functions in proposed cores. Core components are intended to enhance opportunities for investigators at the Center to include new technologies that broaden their research initiatives. While, research per se is not conducted as part of the scientific core, quality assurance activities that evaluate the operation, resources, quality and utilization of the core and that are directed at problem identification and improvement of core functioning are appropriate. In renewal applications, ongoing or completed core activity that has enhanced or facilitated alcohol research should be described. Past performance and accomplishments of cores should be described, as should the effect of services provided by cores on investigators" productivity. Research Components For each proposed research component, a clear description of the major goals, objectives, and its integration with the other components in relation to the overall Center program should be provided. o The question(s) to be addressed and the hypotheses to be tested by the proposed research should be highly focused and fully explained. o A discussion of the design and procedures should describe the strategies proposed to accomplish the specific aims of the project and highlight innovative aspects of the approach. o A description of the resources and working arrangements required to implement and conduct the proposed research should be fully elaborated with particular attention devoted to a description of necessary resources, subjects, clinical populations, tissue resources, etc., which will be involved in proposed studies. If core facilities are utilized, information on their use should be provided. Education Component (for P60 applications) For each education/translation component, a clear description of the major goals, objectives, and its integration with the research components in relation to the overall center program should be provided. Specific projects for translational education/information dissemination activities should be described. While the specific number of education projects is at the discretion of the applicant, requested funding for education component activities may not exceed $100,000 or 10 percent (whichever is larger) of the direct cost budget proposed for any one year. A staffing plan and rationale for organization of this component should be presented. Methods, techniques and technologies to be used for proposed activities should be defined as well as the targeted audience or participants. Issues of cultural sensitivity with regard to intended audience should be addressed. When appropriate, activities should be designed to effectively reach minority populations and/or subgroups based on age or gender. o The scientific knowledge base and research topics or areas upon which proposed translational activities will be developed should be identified and explained. o A discussion of the design, plans and procedures for development including time lines should describe strategies proposed to accomplish specific aims of the project(s). Innovative aspects of the approach to be used should be highlighted. o A description of the resources, facilities, agencies, and/or institutions with working arrangements to plan, implement and conduct the proposed activities should be fully elaborated. Particular attention must be devoted to a description of necessary resources, including specialized expertise, and the target audience, or participants who will derive benefit from the activity. If core facilities or services are utilized, information on their use should be provided. o A description of plans to evaluate the success and/or effectiveness of educational translational activities with emphasis on their impact on knowledge, attitudes, and behaviors. Pilot Project Component The process for selecting pilot projects should be fully, though concisely described. For the first 2 years that funds are requested for pilot projects, the application must provide descriptions of the projects to be supported. For years 03-05, the application must provide the specific number of pilots planned in each year and a brief description of the anticipated direction of these pilots. While the specific number of pilot projects to be proposed is at the discretion of the applicant, requested funding for pilot studies may not exceed $100,000 or 10 percent (whichever is larger) of the direct cost budget proposed for any 1 year. All proposed pilot projects need not be ongoing at any one time, but may be phased in at different points during the life of the proposed Center grant. It is recognized that the relative priority or need for specific pilot projects may change over the course of time. While the Center"s framework for management of pilot funds and the mechanism for operating the program are left to the discretion of the Center, the application must provide specific information to enable adequate scientific evaluation by a peer review committee. The application should include: o A full description of the management of the pilot project component, including a description of the process to be followed by the Center Director in selecting new pilot projects and replacing projects proposed in the application, should it become necessary. o A full description of each pilot study proposed in the first 2 years, including its rationale, objectives, approach, investigators, and significance for the Center. A description of the number and anticipated direction of pilot projects in the 03-05 years, including their significance to the Center. The research description of any individual pilot project may not exceed five pages, the entire narrative for this Pilot Project Component may not exceed 25 pages irrespective of the number of pilot projects proposed. o For competing renewal applications, information should be provided in the pilot project component description on the past experience of the Center in utilizing pilot funds to further the goals. The narrative should include an assessment of the overall benefits derived from the availability of pilot resources. A budget should be submitted for the pilot project component as a whole for each year in which pilots are proposed. For years 01 and 02, this budget will reflect costs of pilots proposed in the application. For years 03-05, the budget will estimate cost based on the number and kind of work to be pursued. In addition, budget information should be provided for each individual pilot project including those for the 03- 05 years. Supplemental Instructions provide further information on pilot project description requirements. Renewal Applications A comprehensive progress report is required for competing continuation (renewal) applications. A statement must be included in the application regarding the progress made by the Center as a whole in its development as a national or regional research resource. In addition, for each research component of the existing Center grant, a succinct account of its published and unpublished results must be provided, indicating progress toward achieving aims regardless of whether the component has been submitted for renewal. More specific details are provided in the Supplemental Instructions. Facilities and Environment Applicants must demonstrate the availability of adequate laboratory, clinical, and other office facilities needed to carry out the objectives of the proposed Center program. Although not required, it is desirable for all Centers to have a commitment for sufficient contiguous space so that the Center has a high degree of cohesion and visibility. Reference facilities affording access to relevant literature must be readily available. It is expected that such reference facilities will be the primary repository of additional reference materials that may be obtained through Center funding. Relevant support services, including adequate data processing facilities, must also be readily accessible within or through the institution. Assurances of such support must be included with the proposal. Organization and Administration A Center must be an identifiable organizational unit with an administrative structure and clear lines of authority which will facilitate coordination among Center personnel to assure maximum accountability and efficiency in Center operations. The Director of the Center will have responsibility for planning and coordination of the Center program, preparation of the budget and oversight of expenditures, staff appointments, space allocation, and other aspects of management and operation of the Center. Overall program management, coordination, communication, progress assessment, and quality control are typically responsibilities of the Director and are facilitated through the administrative core. The administrative core should be described in sufficient detail to assure that all proposed components and related activities will function optimally. In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting should be detailed in the description of this core. The applicant may also designate a Scientific Director who will be responsible to the Center Director and provide direct supervision of the scientific and operational aspects of the research program. Such a person should be an individual who has established scientific credentials and who is capable of providing the leadership essential to the success of the center program. The Scientific Director will be responsible for assuring interaction and collaboration among scientists conducting research within the Center to facilitate a concerted approach to the research goals of the Center. The Scientific Director also will be responsible for the direct monitoring of ongoing research and for identifying (with the assistance of colleagues) research and educational activities to be expanded or decreased and needs for additional resources or reallocation of resources. If the Center Director also serves as the Scientific Director, his or her functions as Scientific Director should also be described. Key professional staff, such as directors of individual research components and core components of the Center, should have the necessary training/experience to assure that the objectives and goals of the proposed studies will be achieved. Such persons must be independent investigators with scientifically recognized standing. A Program Advisory Committee shall be established and chaired by the Center Director. Its membership, selected by the Center Director from individuals outside the Center, should be composed of at least five members. These members should be persons of recognized scientific standing who are generally familiar with the Center"s activities and represent a cross-section of disciplines that are relevant to the work of the proposed Center. It shall be the responsibility of this Committee to review and make recommendations to the Center Director on the conduct of all activities of the Center, including the management of pilot projects. If committees other than the Program Advisory Committee are included, specific plans regarding committee selection and function should be provided in the application. Training While the primary function of each Center is the conduct of high- quality interdisciplinary research, an important component related to the Center and its research efforts is the training of research and clinical personnel. The applicant institution must therefore demonstrate or give reasonable assurances that it has: (a) the capacity to train predoctoral and/or postdoctoral students for careers in alcohol research, and (b) the capacity to conduct programs of continuing education in the Center"s designated research theme in the medical, behavioral, epidemiological, or health service fields. While the Center need not necessarily have formal training programs of its own, there must be specific provision for coordination between the Center and the training programs of the applicant institution and/or affiliated institutions. Center grant funds may not be used to pay stipends or other trainee costs, however, Center staff may participate in the development of training programs, and Center resources may be made available for use of trainees. 8. WHERE TO SEND INQUIRIES Written and telephone inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ernestine Vanderveen, Ph.D. Centers Program 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 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 Boulevard MSC 7003 Bethesda, MD 20892-7003 (Rockville, Maryland 20852 for express/courier service) Telephone: (301) 443-2434 Email: jsimons@willco.niaaa.nih.gov 9. 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: Ernestine Vanderveen, Ph.D. Centers Program 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 10. 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. 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) Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included in the application materials. At the time of submission, two additional copies of the application plus appendices must also be sent to: RFA: AA-03-001 Extramural Project Review Branch Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) FAX: (301) 443-6077 Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. 11. SUPPLEMENTAL INSTRUCTIONS Supplemental instructions for preparing your application may be found on the NIAAA website at: http://www.niaaa.nih.gov/extramural/supplemental.htm 12. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the appropriate IC. 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 IC 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 or NCCAM National Advisory Council. 13. REVIEW CRITERIA The initial review for scientific and technical merit of applications will emphasize two major aspects: (1) review of the Center as an integrated research effort focused on a central theme, including the administrative core, and (2) the review of each research component, education component, all other core components, and the pilot component as applicable. This review will also include an assessment of the academic and physical environment and special considerations, e.g., compliance with human subject and animal welfare requirements, and compliance with policies concerning inclusion of women, minorities and children in clinical research study populations. A) ADMINISTRATIVE CORE 1) Key Staff o Qualifications, experience, commitment and administrative competence of the Center Director o Ability of the Center Director to devote substantial time and effort to the Center o Scientific ability of the Scientific Director and his or her professional experience and leadership o Ability of the Scientific Director to devote substantial time and effort to the Center o Scientific qualifications and ability of the directors of the research components, education components, and core components and their commitment to the center 2) Arrangements and Organizational Structure o Processes to facilitate and monitor attainment of Center objectives o Plans for communication and cooperation among investigators involved in the Center o Quality control and oversight mechanisms for ongoing projects o Day-to-day management o Long-term management and periodic evaluation of goal attainment o Contractual and consortium arrangements (as applicable) o Procedures for replacement of key personnel, if necessary B) SCIENTIFIC CORE COMPONENTS o Need/justification for the core service/resource o Scientific and technical merit of the service/resource provided o Plans for resource allocation o Quality control procedures o Qualifications, experience, and commitment of the component director o Adequacy of component director"s time and effort o Adequacy of the resources and environment C) RESEARCH COMPONENTS o Significance: Does this study address an important problem? If the proposed aims are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? o Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the investigator acknowledge potential problem areas and consider alternative tactics? o Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o Investigators: Is each investigator appropriately trained and well- suited to carry out this work? Is the work proposed appropriate to the experience level of the component director and other researchers (if any)? o Environment: Does the scientific environment in which the work will be done contribute to the probability of success of the project? Does the proposed research take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? D) EDUCATION/TRANSLATIONAL COMPONENTS (for P60 applications) o Significance: Does this project address an important topic? If the proposed aims are achieved, how will the level of science based knowledge be enhanced? What will be the effect of these projects on knowledge, attitudes and behaviors? o Approach: Are the conceptual framework, design, methods, and evaluations adequately developed, well-integrated, and appropriate to the aims of the project? Does the project director acknowledge potential problem areas and consider alternative tactics? o Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o Investigators: Is each investigator appropriately trained and well- suited to carry out this work? Is the work proposed appropriate to the experience level of the component director and other professional staff (if any)? o Environment: Does the environment in which the work will be done contribute to the probability of success of the project? Does the proposed project take advantage of unique features of the academic and community resources and employ useful collaborative arrangements? Is there evidence of institutional support? E) PILOT PROJECT COMPONENT 1) Pilot Project Component o Adequacy of the selection process for new and replacement pilot projects o Monitoring and oversight procedures and continuation decisions o Adequacy of the resources and environment for all projects 2) Individual Pilot Projects o Importance of topic o Grounding in the literature or empirical findings o Reasonableness of the approach o Potential to develop into full-scale independent project o Qualifications of the project director F) CENTER AS AN INTEGRATED WHOLE 1) Significance o Significance of the overall research goals o Development of a well-defined central theme o Multidisciplinary scope 2) Coordination and Cohesiveness o Interrelatedness of administrative core, scientific cores, research components and education components with each other o Usefulness of scientific core components to research components and to independently supported investigators who use them o Synergistic potential among Center components and core units o Justification for each research component in terms of the central theme and the overall research goals of the Center o Justification for each scientific core component in terms of accomplishing center objectives 3) Resources and Environment o Institutional strength, stability, commitment to research, and support of the Center, including fiscal responsibility and management capability to assist the Center Director and staff in complying with DHHS, PHS, and NIH policies o Opportunities for research training and education for persons from various disciplines and professions o Potential for interaction with scientists from other departments and institutions o Academic and physical environment in which the research will be conducted, including availability of space, equipment, research subjects, and materials 4) Potential as a Resource o Potential of the Center to become or maintain itself as a regional and national resource o Capacity to provide quality research training, opportunities for independent research career development o Plans for research information dissemination and educational activities 5) Renewal Applications o Degree to which the Center achieved stated goals with special attention to: - scientific merit of completed research - recruitment of new scientists into alcohol research - development of a multidisciplinary team - coalescence of Center staff into an effective team OTHER CONSIDERATION For the Center as a whole and all components/cores. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the research proposed in the application. o The adequacy of the proposed plan to share data, if appropriate. 14. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 12, 2002 Application Receipt Date: December 10, 2002 Peer Review Date: Spring 2003 Council Review: September 18, 2003 Earliest Anticipated Start Date: December 1, 2003 15. AWARD CRITERIA Center grant funds may be requested for support of core components, individual research components and education components associated with the Center program. Administrative core resources may include, for example, salaries of personnel responsible for management of the Center, program enrichment activities for investigators and staff such as special lectures, visiting scientists, symposia, seminars, workshops, etc., and costs related to dissemination of research information to the scientific community and lay public. Funds may be requested for costs associated with individual components that are part of the Center program. Examples of such costs include: research staff salaries, supplies, travel, special consultation, research patient costs, publication costs, and the like. Funds also may be requested for the allowable indirect costs of the applicant organization. In addition, costs of advisory committees and consultants may be included in the administrative core. Consultants for specific components should be included in the budgets for those components. Alcohol Research Center grant funds may be used only for costs that are necessary to carry out the research, research support and education activities of the Center program, and must be in conformance with HHS cost principles (encompassed in 45 CFR Part 74) and the NIH Grants Policy Statement (effective 10/98). This publication should be available from your office of sponsored research. Funds provided under this program may not be used for the purchase of land, nor for the purchase, construction, preservation, or repair of any building. However, costs of alteration and renovation of existing facilities necessary to accomplish the objectives of the grant may be allowed subject to PHS grants policy limitations. Funds provided through Center grants may not be used for support of trainee stipends, fees, or other expenses directly relating to training activities. Research, research information dissemination and training activities associated with the Center may receive additional funding from Federal sources as well as from State and local sources. The NIAAA expects and encourages the institution and scientists attracted to such Centers to seek and compete actively for such funding. Research staff in funded Centers may submit applications for independent research project grants for support of research projects that do not overlap with their Center project(s). Centers will be required to submit detailed annual progress reports including substantive information about research results to date, status of ongoing research, research plans for the next year, and any modifications in long-term research plans. Also required are reporting of inventions, reports of expenditures, final reports, and other reports in accordance with NIH policy. In view of the special significance of this program, close coordination and communication between the NIAAA staff and staff of the Alcohol Research Centers is intended. The NIAAA program official will have responsibility for maintaining liaison with appropriate Center leadership, serving as resource consultant to the Center program, and keeping NIAAA staff informed on progress and accomplishments of the Centers. In addition, the program official with other NIAAA staff and consultants will, from time to time, make on-site visits for purposes of program coordination and exchange of information. Applications recommended by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific merit of the application as determined by peer review, as well as such considerations as program balance, relevance to the mission and goals of NIAAA, research program priorities, equitable geographic distribution, continuity of support, and availability of funds. Awards will be made for up to 5-year project periods with separate fiscal awards made annually. 16. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. 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. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.891. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464J, and administered under the Federal Regulations at Title 42 CFR Part 549, "Grants for National Alcohol Research Centers" and NIH grants policies and Federal Regulations 42 CFR 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 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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