COOPERATIVE AGREEMENT FOR EXPLORATORY/DEVELOPMENTAL GRANTS FOR MINORITY INSTITUTIONS ALCOHOL RESEARCH PLANNING (U01) RELEASE DATE: April 7, 2003 RFA: AA-03-010 National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.273 LETTER OF INTENT RECEIPT DATE: May 16, 2003 APPLICATION RECEIPT DATE: June 17, 2003 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 agreements (U01s) to support research planning and research development at Minority Serving Institutions (MSIs), hereafter called "alcohol research planning grants" or "planning grants". The purpose of these grants is to support development of alcohol research expertise and infrastructure development at MSIs to conduct research to identify, characterize, and reduce alcohol-related health disparities in American ethnic and cultural populations and their subpopulations. At least one of the topics for planning activities should address health disparities in the following target populations: the rural poor, 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 they will require long-term committed partnerships between the MSI participants, the Mentor and collaborators from one or more established collaborating alcohol research programs. The NIAAA encourages a multidisciplinary approach to research. At least one project must address questions directly related to alcohol and health disparities. These planning grants should also develop preliminary research studies that will lead to the preparation and submission of competitive grant applications from MSIs. The NIAAA is committed to increasing and strengthening efforts to address health disparities and alcohol related problems that ensue from alcohol abuse and alcohol dependence (alcoholism). This RFA specifically addresses priority areas found in the NIAAA strategic plan for minority health and health disparities. The award is restricted to Minority Serving Institutions (MSIs). Research topics must include a scientific area related to minority health, and the career development and research training is addressed toward MSI faculty and staff. 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. RESEARCH OBJECTIVES Background Alcohol consumption is associated with a broad range of adverse health and social consequences, both acute (e.g., violence, traffic deaths, injuries) and chronic (e.g., alcohol dependence, liver damage, stroke, and 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 and differences in vulnerability to alcohol-related consequences that may be either biological or environmental, including economic or social factors. Hispanic, Native Americans and African Americans are less likely to drink than Whites of European heritage but those who do drink consume more on days they do drink and have a higher frequency of heavy drinking. Being of Caribbean ancestry is associated with more moderate drinking for both Hispanics and Blacks (Dawson, J Subst Abuse, 10: 321-339, 1996). 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 (Natl Vital Stat Reports 50 #15, 2002). A large NIAAA-directed epidemiological study indicates that cirrhosis death rates are highest among white men of Hispanic origin, intermediate among non-Hispanic black and white Americans and lower among black Hispanics (Stinson, Grant & Dufour, Alcohol Clin Exp Res 25: 1181-1187, 2001). The percentage of fatal automobile crashes that are alcohol-related is greater among Hispanic, American Indian and Alaska Native men than among men of other populations (NHTSA Tech Transfer Ser # 239, 2001). The prevalence rates of fetal alcohol syndrome (FAS) appears to be several times higher in some African American and American Indian communities than in the general population (Centers for Disease Control, 2002). Research also reveals that although fewer African Americans drink than their white counterparts, they exhibit greater vulnerability to many of the adverse effects of alcohol. 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 many minority populations. Finally, comparison of national probability samples drawn in 1984 and 1995 shows that, while rates of frequent heavy drinking have declined significantly among white men, the rates remain high among Black and Hispanic men in parallel to reports of alcohol related problems (Caetano & Clark, J Stud Alcohol 59: 659-668, 1998). Thus while disparities in alcohol-related outcomes remain significant the reasons for these disparities remain incompletely known, largely because they are the consequence complex interactions of a variety of risk factors that represent the range of biomedical and psychosocial research. MSIs educate students from minority cultures and provide outreach to and a voice for minority communities. Thus, they represent a rich source of talent with appropriate cultural sensitivity and perspectives needed in alcohol research. However, few MSIs have programs in alcohol research and there is a serious shortage of minority scientists actively pursuing biomedical or behavioral alcohol research careers. Thus the purpose of this RFA is to address these issues by supporting MSIs and minority scientists in alcohol research through collaborations between scientists and faculty of MSIs and established alcohol investigators. The MSI staff lead by the Principal Investigator, and the outside collaborators including the Mentor, would work together to take advantage of their respective expertise and experience to undertake mutually beneficial collaborative research, research training and information dissemination activities. Structure of Alcohol Research Planning Grants Each alcohol research planning grant must include three components, one focused on each of these areas: Pilot research projects; Investigator career development or student research training; and Science education or outreach and research dissemination. 1. Pilot Research Projects Each Planning Grant must have two or more pilot research projects in progress at all times. At least one project must address an alcohol-related issue of importance to the local minority community. Project proposals should be written in coordination with the outside Mentor and collaborators. Since this is a planning grant it is assumed that specifics of research design and IRB approval of clinical studies, will be finalized after the award has been made. However, the application must provide the following elements: o A sound rationale for the proposed studies from a point of view of the needs of the MSI and the clinical populations they serve. o A link between these needs and the research expertise and facilities available within the MSI and those provided by the outside Mentor and collaborators and the collaborating institutions. o Evidence that the plan will enhance the collaboration between these advisors and the scientists and research clinicians in the MSI. o The proposed research must be interdisciplinary to build a range of competencies needed in the conduct of rigorous alcohol research. o Documentation of appropriate institutional commitment to providing administrative support, release time and facilities to the project. Topics listed below are examples of some research areas that might be considered for planning and piloting. o Studies of patterns of alcohol consumption and alcohol-related problems in specific minority populations. o Research to identify biological, environmental and socio-cultural factors that may increase risk for alcohol dependence or vulnerability to the effects of alcohol. o Studies of the role of alcohol in the prevention and treatment of HIV/AIDS among minority and other underserved populations. o Research to develop and test interventions to prevent maternal drinking, fetal alcohol syndrome and alcohol-related neurological disorders among high-risk minority populations o Research to determine biological, environmental and socio-cultural factors risk factors that lead to disproportionately high incidence of adverse pregnancy outcomes. o Research to identify social and cultural factors that influence motivation to seek treatment, access to treatment, adherence to treatment and treatment outcomes. o Studies to identify and characterize those aspects of minority drinking environments (problems, patterns, community norms, values, economics, etc.) that are likely to influence the outcomes of prevention and intervention strategies. o Research to evaluate the effectiveness of screening and brief interventions in high-risk minority health care, social service, education or other settings. The grants will support planning, partnership development, and mutually beneficial collaborations between the applicant MSI staff and students, and scientists at collaborating alcohol research program(s). The grants will support onsite training, research assistance, subject recruitment and other research costs. 2. Research Career Development or Research Training The purpose of the planning grant is to prepare the MSI staff to make a significant contribution to alcohol research and complete successfully for subsequent NIH funding. An essential and complementary activity to the research, is the opportunity for career development, mentoring and training for faculty, research personnel and students. Therefore, the applicant institution must demonstrate or give reasonable assurances that it can: o Design programs to meet the specific training experience and mentoring needs of minority scientists, research clinicians, and students in their institutions. o Implement and sustain collaborative career development programs jointly organized and conducted by scientists and faculty from both the MSI and the established collaborating alcohol research program(s). o Focus on topics that prepare participants to conduct clinical, behavioral, and population research that addresses health disparity issues among minority and under-served populations. o Create career development programs for minority scientists that foster true collaborations. o Establish collaborations that function across the institutional boundaries of the MSI and collaborating alcohol research program(s); o Develop programs to train predoctoral and/or postdoctoral students for careers in alcohol research. MSI staff must be actively involved in outlining career development activities and MSI participants' individual career development plans. If the applicant institution does not have or plan to establish a formal training program of its own, the application must document explicit arrangements for MSI participants to be involved in programs that develop research expertise. Such programs may be in the established collaborating alcohol research program or in other research- intensive institutions. Planning grant resources may pay trainees for services rendered, such as research assistance, teaching, or laboratory research activities. However, grant funds may not be used to pay stipends or other trainee costs. 3. Either Science Education or Outreach and Research Dissemination The Science education programs can include activities that augment existing or create new curricula in the MSI and/or the collaborating alcohol research program. NIAAA encourages the development of educational programs designed to motivate and empower minority students to pursue careers in research at early stages of their educational experience (e.g., high school, undergraduate). All educational programs and activities must include plans for ongoing assessment and evaluation and demonstrate processes for linking evaluation results to improving the training curriculum and related educational tools. The Outreach and Research Dissemination option requires the MSI and collaborating alcohol research program develop an outreach strategic plan to disseminate alcohol research results to health care professionals and the minority community that they serve. This may take the form of continuing education in the epidemiological, medical, behavioral, or other health service fields as they pertain to alcohol abuse and alcoholism. Dissemination and outreach activities must be based on scientifically accurate, current, and culturally relevant information. NIAAA encourages the development of coordinated outreach strategies with community and local groups. All proposed outreach and dissemination activities must discuss plans for concurrent assessment and evaluation. The expectation is that these alcohol research planning grants will generate data, develop the appropriate experience and institutional infrastructure to prepare for subsequent NIAAA competitive applications including: Alcohol-related research projects (R01), Exploratory/developmental grants (R21), Collaborative Minority Serving Institution Alcohol Research (CMSIAR) Program (U56); Educational grants (R25); Fellowships (F series); Career development awards (K series) or Institutional training grants (T32). MECHANISM OF SUPPORT This RFA will use NIH U01 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 15, 2003. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. 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". FUNDS AVAILABLE The NIAAA intends to commit approximately $1.5 million in FY 2003 to fund up to four cooperative agreement alcohol research planning grants in response to this RFA. An applicant may request a project period of up to three years and a budget for direct costs of up to $250,000 per year. Applications exceeding this limit will be considered unresponsive to this RFA and will be returned without further consideration. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of 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. ELIGIBLE INSTITUTIONS Applications will only be accepted from Minority-Serving Institutions (MSIs) in the United States or in territories under U.S. jurisdiction. Collaborating alcohol research programs need not be in institutions that are minority serving but must be able to demonstrate organized, integrated research efforts focused on alcohol. Qualifying minority-serving institutions may be from any one of the following categories. o For profit or non-profit organizations. o Public or private institutions, such as a universities, colleges, hospitals or laboratories o Units of State and local government o Eligible agencies of the Federal government o Faith-based or community-based organizations Foreign institutions are not eligible to apply. Explanation of terms used in this section A Minority Serving Institution (MSI) is an academic, health care or research institution with an enrollment and/or faculty predominately of ethnic minorities, or an institution that qualifies as a Historically Black College/ University (HBCU), a Hispanic-Serving Institution (HSI), a Hispanic-Serving Health Professional School (HSHPS) or a Tribal College or University (TCU). Other institutions that meet MSI criteria are also eligible to apply. An institution that has a significant proportion of minority enrollment and a demonstrable record of accomplishment in encouraging minority faculty, clinician/scientists, and students to participate in research also qualifies. Inquiries regarding MSI status should be directed to Dr. R. Thomas Gentry (telephone: 301-443-6009). Minority serving medical schools and institutions with research or education programs (e.g., Masters and doctoral programs) are invited to participate in this initiative. A "collaborating alcohol research program" is a program that is establishing or has a partnership with the applicant MSI institution or program. The collaborating alcohol research program must be in an academic, health care or research institution that is currently the recipient of substantial NIH research support. Evidence that the institution of the collaborating alcohol research program supports this project must be included in the application. The Mentor's institution will be a collaborating alcohol research program. Other collaborators' institutions are also "collaborating alcohol research programs." 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 principal investigator must have his or her primary appointment at the applicant MSI institution. SPECIAL REQUIREMENTS There are a number of Special Requirements and Provisions that are required of each alcohol research planning grant. 1. Each alcohol research planning program should be presented in such as way as to demonstrate the likelihood for an effective and mutually beneficial collaboration between the PI, the Mentor and the other partners both within the MSI and at the collaborating alcohol research program(s). 2. Each alcohol research planning grant application must include three components: a pilot research project component, a career development or research training component, and either science education or an outreach and research dissemination component. For each component the application should identify the component leader and the other key personnel including outside collaborators. 3. The description of each proposed component must demonstrate a clear partnership between the MSI and the collaborating alcohol research program(s). This must start with 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 collaborative alcohol research program and individual scientist(s) must provide evidence of commitment to the project. Expectations for interactions and performance by each partner should be clearly presented. 4. Letters of support must be exchanged between the MSI and collaborating alcohol program(s). These letters should reflect institutional acknowledgement that collaborators are committed to working on the alcohol research planning grant projects and culminate in a letter of agreement signed by a high level institutional official. These letters should describe proposed activities, methods and means of communication and support for the collaborative effort. 5. Funds for pilot research projects must be used for totally new activities that do not overlap in purpose or intent with NIAAA grant supported projects or other peer-reviewed funded programs. After an award has been made, the Principal Investigator will coordinate the continued planning for each of the three components, and for the program as a whole working in partnership with the Mentor and the other collaborators. In addition: 1. The PI in consultation with the NIAAA Scientific 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 member of the PAC. The PAC will meet annually, and more often if necessary, to review activities and to advise the principal investigator on scientific and other aspects of the program. Among its duties, the PAC will assess progress of active projects, review proposed projects and approve meritorious projects for future implementation. 2. During the first three months of the program, a refined plan for each year of the project and for each component must be developed and approved by the PAC and Program officer. In a chronological table, the plan must describe; objectives, milestones, activities and processes that the MSI will use to develop capacity to submit competitive alcohol research grant applications in the future. For each objective, a brief statement should describe what the MSI participants, the Mentor, and collaborators will do to ensure that project goals will be achieved. The plan should be examined annually to assess progress in achieving objectives and may be revised to ensure that the partnership aspects of the collaboration are still balanced and working well. The ultimate objective must be the submission of a grant application to NIAAA. 3. The principal investigator will establish and chair an internal executive committee comprised of research project and component leaders, institution administrators, representatives from collaborating departments within the MSI, and one or more representatives from the community. The executive committee will meet monthly to plan activities that involve the MSI at-large and to promote coordination among the projects. 4. Recipients of these cooperative agreements and their collaborators will be expected to participate in an annual meeting. Travel costs for personnel from both the MSI and the collaborating alcohol research program(s) for this purpose should be included in the grant application. Explanation of terms 1. The "Mentor" must be an individual who is currently the recipient of independent research support from the NIAAA through a research grant or an individual who is a component director on an Alcohol Research Center or a multisited consortium. In most instances, the Mentor will be affiliated with the primary collaborating alcohol research program. The Mentor is expected to have active involvement in preparing the application and in the development of the project through all phases. The Mentor's role in coordinating administrative, research and training activities between the MSI and the collaborative alcohol research program should be described explicitly in the application. 2. A "collaborator" must be an individual who is currently the recipient of independent research support from NIH, and preferably from NIAAA. The Mentor may also be a collaborator but other researchers will also serve as collaborators on individual projects. Collaborators work as partners on specific research projects and should be involved in developing the application but may not be identified until plans are refined. 3. A "consultant" is a scientist who advises MSI participants and helps them obtain information, knowledge and expertise in specific areas needed to implement the project. (e.g. epidemiologist, biomedical, socio-behavioral investigator, statistician). Some consultants may be identified in the application while others may not be identified or needed until project plans are more concrete. Cooperative Agreement Terms and Conditions of Award The following Terms and Conditions will be incorporated into the notice of grant award 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 for the project as a whole resides with the awardee. 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: o Create a Program Advisory Committee (PAC) in consultation with the NIAAA staff and coordinate a regular schedule of PAC meetings for review and consultation. o Develop and implement all components and phases of the approved plan, and provide periodic updates as needed. o Recruit and convene an internal executive committee o Coordinate activities between all MSI participants and the Mentor, outside collaborators and with the NIAAA staff. o Seek and accept assistance from the NIAAA Staff Scientific Collaborator in pursuing project goals. o Coordinate activities and maintain effective communications between the academic, scientific, administrative and financial staff in their institutions. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. 2. NIAAA Staff Rights and Responsibilities According to the terms of the cooperative agreement arrangement, the NIAAA will appoint a Program Official and a Staff Scientific Collaborator for each cooperative agreement alcohol research planning grant. o The NIAAA Program Official will provide normal program stewardship by reviewing the scientific progress of individual research project components and monitoring the distribution and use of resources in the Cooperative Agreement. The Program Official will also monitor the grantee's compliance with the requirements described in this RFA. The NIAAA Program Official may recommend withholding of support or suspension, or termination of the award for lack of progress or failure to adhere to policies established by the RFA or the Notice of Grant Award. o The NIAAA Staff Scientific Collaborator will have substantial scientific and programmatic involvement with the awardee by providing technical assistance, advice and coordination beyond normal program stewardship of research grants. The NIAAA Staff Scientific Collaborator will: a) facilitate the coordination and management of this complex project; b) participate as a non-voting member in the duties and responsibilities of the PAC; c) participate in monitoring progress of ongoing studies; d) participate in planning and implementing efforts to disseminate information; e) provide advice in faculty development activities; f) participate in data interpretation and, when appropriate, in the preparation of publications and presentations. The NIAAA Staff Scientific Collaborator is subject to the same publication and 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 cooperative agreement 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. A third member with expertise in the relevant scientific area will be chosen by the two selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: R. Thomas Gentry, Ph.D. National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 302 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-6009 FAX: (301) 480-2358 Email: tgentry@mail.nih.gov o Direct your questions about financial or grants management matters to: Judy Fox (formerly, Simons) Chief, Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 (express/courier use Rockville, MD 20852) Telephone: (301) 443-4704 Fax: (301) 443-3891 e-mail: 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 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-AA-03-010 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Room 409, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) FAX: (301) 443-6077 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS Each alcohol research planning grant must include three components, one focused on each of these areas: Pilot research projects; Investigator career development or student research training; and Science education or outreach and research dissemination. 1. The application must clearly describe a preliminary plan for each year and for each component of the program. The plan must be developed jointly and proposed by MSI participants and the Mentor. The plan must describe initial activities and the process through which the MSI will reach the goal of developing competitive research projects capable of producing preliminary results to be used in support of future grant applications. 2. The plan must include a chronological table to describe the activities and objectives for each component and each year. For each objective, a brief statement should describe what the MSI participants and the collaborators will do to ensure that project goals will be achieved. The ultimate objective must be the submission of a grant application to NIAAA. 3. The application must clearly describe the collaborative process by outlining methods for identifying and selecting areas of potential collaboration. The application also must indicate how focused collaborative strategies will be implemented to ensure that pilot projects will produce preliminary data that can be the basis for subsequent independent grant proposals to the NIAAA in the target areas described above. 4. The application must clearly describe a collaborative process. It must outline how participants will communicate, how they will identify areas for potential collaboration, how collaborations might be implemented, and potential topics that might be pursued as a basis for future projects in one or two target areas (i.e., research AND career development and research training, AND science education or dissemination and outreach.) 5. Activities described in the application must demonstrate the potential for a productive partnership between the MSI and the collaborating alcohol programs, and indicate the expected benefits to each. The process must begin with collaboration in preparing the grant application for submission by the MSI. The application must describe how the MSI and the collaborating alcohol research program(s) will complement each other in achieving clearly stated goals and common objectives. Each of the partners must provide evidence of commitment to the project and a clear summary of their individual performance goals, and their expectations for interactions with the other parties. 6. The application must include letters of support from: o Senior MSI administrators (e.g., Department Chairs, Dean, President, Chancellor, or Center Director) who need to indicate the nature and the level of institutional support for the alcohol research planning grant. Specifically, the letters should identify space, administrative, and other discretionary institutional resources that will be made available for the principal investigator to implement project objectives. Release time to enable participants to work on achieving the objectives in the application must be identified. Clear evidence of significant institutional commitment is required when starting a new program. Also, the applicant is encouraged to identify and obtain supporting letters from other institutional resources (e.g. colleagues with research experience and technical expertise in other departments of the MSI) that could be tapped to achieve the goals of the planning grant. o The Mentor and the collaborators, who need to specify the projects on which each individual will collaborate, their particular areas of expertise and the facilities they will be able to contribute to the project. Letters should also describe the means of communication and support as well as mentoring and potential collaborative activities that will be applied to ensure success of the collaborative effort and the probability of success. Allowable costs for the cooperative agreement alcohol research planning grants include: 1. Administrative costs for managing the effort, such as salaries and travel for key personnel, travel for the Project Advisory Committee, and services, equipment and supplies to support an administrative structure and shared resources for PAC-approved projects, as appropriate. 2. Costs for developmental activities such as: workshops, seminars, retreats and other forms of communication to explore potential opportunities in research, career development and training or education. 3. Funds to conduct pilot research projects or pilot programs in training and career development or education for the explicit purpose of obtaining preliminary data upon which to base future research. These costs must be used for the areas of greatest promise based on merit and potential to result in a successful grant application. 4. Grantees and their Mentors will be expected to participate in an annual meeting. Travel costs for this purpose should be included in the grant application from the MSI. 5. The requested funds must be used for totally new activities that may build on but cannot duplicate the purpose or intent of currently funded grants. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: RFA: AA-03-010 Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard, MSC 7003 Bethesda, Maryland 20892-7003 or Rockville, Maryland 20852-7003 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. 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, career development and research training 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 approaches to expanding research, training and career development opportunities for minority scientists and students. Applicants can apply for up to three years of support and should include information on their experience, interactions and planning history as well as institutional resources that could assist in achieving the goals of the planning grant. 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 preparing the application. 2. The degree to which letters of support from the MSI senior administrators address the project needs, including support for the principal investigator and specific institutional commitments to ensure the success of the program. 3. Evidence that the collaborating alcohol research program(s) and institution(s) support the proposed collaboration with the MSI. 4. As applicable, the adequacy of provisions described for day-to-day oversight, coordination, support and logistical services needed to make the collaboration successful. 5. General Planning Activities: o 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). o The appropriateness of the proposed areas of potential collaboration with respect to participants' expertise, past experience and institutional and community resources. o The adequacy and merit of the planning process that will be used to identify and prioritize areas ready for pilot testing. o The appropriateness of expertise and congruence of interests of the faculty and scientists identified from the MSI and the collaborating alcohol research program to contribute effectively to each aspect of this planning effort. 6. Pilot Research Projects Component o Feasibility of establishing collaborative alcohol research projects based on the current research capabilities of the MSI o Likelihood that the research will add to our knowledge of alcohol problems and health disparities in minority populations. o Expectation that pilot research projects will enhance the development of collaborations between MSI participants and their counterparts among established alcohol investigators. o Evaluation of opportunities to encourage additional desirable outcomes for the MSI and collaborating alcohol research programs, such as, interdisciplinary coordination; greater institutional commitment; and the enhancement of administrative capabilities and facilities to do alcohol research. 7. Career Development and Alcohol Research Training Component o The evidence of potential for collaborative career development programs jointly organized and conducted by scientists and faculty of both MSI and the collaborating alcohol research program o The evidence of potential to develop programs designed to train predoctoral and/or postdoctoral students for careers in alcohol research. o The evidence of 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. 8. Science Education or Outreach and Dissemination Component Science Education Option o Feasibility of education programs to augment existing or create new curricula at the MSI. o Feasibility of strategies to motivate minority students to pursue careers in research. o Inclusion of plans to develop strategies for ongoing assessment and evaluation of Science Education activities. Or Outreach and Research Dissemination Option o Feasibility of creating a plan for the dissemination of alcohol research information to health care professionals and the minority community. o Feasibility of a process for linking alcohol information to the target audience and providing strategies for developing ongoing outreach and research services. o Feasibility of developing a strategic plan for dissemination and outreach activities based on accurate, current, and culturally appropriate information and effective methods for information transfer to minority communities. o Inclusion of plans to develop strategies for ongoing assessment and evaluation of outreach and dissemination activities. 9. The overall likelihood that the alcohol research planning program will generate the appropriate preliminary data and develop the required experience and infrastructure to permit the MSI to prepare competitive alcohol-related NIH applications. These could be for example, Research projects (R01), Exploratory/Developmental grants (R21), Collaborative Minority Serving Institution Alcohol Research (CMSIAR) Program (U56); Educational grants (R25); Fellowships (F series); Career development awards (K series) or Institutional training grants (T32). ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: If appropriate, the adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: May 16, 2003 Application Receipt Date: June 17, 2003 Peer Review: July-August, 2003 Review by NIAAA Council: September, 2003 Earliest Anticipated Award Date: September, 2003 AWARD CRITERIA The applications will compete for funds with all other applications submitted in response to this RFA. Applications recommended by the NIAAA National Advisory Council on Alcohol Abuse and Alcoholism will be considered for award based on: o Scientific and technical merit as determined by peer review o Program priorities of the NIAAA, and o The availability of funds. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. MONITORING PLAN AND DATA AND SAFETY 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 and Safety 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 "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): If applicable, 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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