TRANSDISCIPLINARY PREVENTION RESEARCH CENTERS RELEASE DATE: December 19, 2002 RFA NUMBER: DA-03-008 National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) Letter of Intent Receipt Date: March 28, 2003 Application Receipt Date: April 28, 2003 THIS REQUEST FOR APPLICAIONS (RFA) CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms 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 Drug Abuse (NIDA) invites exploratory center grant applications (P20) to support the development of transdisciplinary prevention research centers (TPRCs). These centers will extend the work of NIDA's National Prevention Research Initiative (NNPRI: Community Multi-site Prevention at http://www.nida.nih.gov/researchtraining/traininghome.html) by creating environments in which scientists from the basic and applied/clinical disciplines can come together to develop a coherent program of transdisciplinary research. The ultimate goal of these centers is to overcome the barriers inherent in integrating cross-disciplinary concepts, methods, and findings that hold promise for the development of innovative prevention intervention questions and approaches. Thus, it is expected that a transdisciplinary approach will explore and catalyze new ways of conceptualizing prevention research. These centers are intended to maximize creativity through establishing environments for ongoing interactions and collaborations focused on theory-driven research. RESEARCH OBJECTIVES Background Previous research has identified significant risk and protective factors that influence drug abuse. Discoveries from the basic biological (e.g. neurobiological), psychological (e.g. emotional, behavioral, cognitive, and developmental) and social (e.g. social learning, peer network, and communications) sciences have elucidated individual and group vulnerabilities to drug use initiation and escalation from occasional use to abuse. Based on these findings and their underlying theoretical frameworks, over two decades of prevention research have produced prevention programs with proven efficacy and effectiveness, from which a general set of science-based prevention principles has emerged. However, much existing research on biological, psychological, and social processes and mechanisms has not been fully utilized for purposes of developing and testing innovative, potentially efficacious, drug abuse prevention interventions. Research Goals and Scope NIDA recognizes the need to maximize the use of existing underutilized approaches and research findings from biological, psychological and behavioral sciences for the development of innovative preventive interventions targeted to the initiation and escalation of drug abuse. Thus, transdisciplinary collaborations in these exploratory research centers should: (1) stimulate the translation of basic science discoveries to the design of innovative preventive intervention components, and (2) capitalize on prior drug abuse prevention research to inform basic science hypotheses that have implications for the development of new intervention paradigms or refinement/improvement of existing programs. To stimulate the development and testing of new prevention paradigms, a number of research directions could be taken. For example, existing findings from the basic sciences could facilitate: (1) identification of malleable biological and social mediators as targets for intervention; (2) development of interventions targeted to specific patterns of interactions between environmental, neurobiological or genetic factors that produce vulnerability to drug abuse; and/or (3) integration of knowledge about patterns of abuse and context-specific factors into the development of tailored interventions. Findings from these studies could then inform the development of new intervention components. In developing and testing research hypotheses derived from science-based intervention findings, the underlying biological, psychological, and social processes that contribute to outcome success could be explicated. For example, a more complete understanding of critical biological, psychological, and social processes and mechanisms targeted by interventions would allow for: (1) the identification, modification, or elaboration of critical underlying features responsible for successful program results or impact at the group and/or individual level; (2) the development and pilot testing of new paradigms based on what is learned about sustained behavior change or alteration of developmental trajectories; and (3) ultimately the testing of new or evolved features of prevention approaches in laboratory or small-scale efficacy trials. Inherent in these lines of research is the challenge to better characterize individuals and subgroups in regard to traits or characteristics (e.g., endo- phenotyping using neurobiological assessments, sensation-seeking, impulse control, arousal level, stress reactivity, environmental deprivation or enrichment, social cohesion) that may influence their responsivity to interventions, and can subsequently inform targeted intervention strategies. It is the intent of this RFA to support transdisciplinary collaborations along a continuum of prevention-related research ranging from basic science in the interest of program component development, to pilot testing, and feasibility studies. Three types of studies, laboratory, pilot, and efficacy, are appropriate for inclusion in project areas. The following are examples of these study types: (a) Laboratory studies: Basic biological, psychological, and social research studies, with imminent application to the development and testing of theory- based or hypothesis-driven innovative prevention intervention components or programs in human laboratory settings; (b) Pilot studies: Research that integrates discoveries from basic biological, psychological, or social research into the development, refinement and testing of prevention intervention strategies in small, highly controlled pilot studies with particular attention to moderators and mediators of effects; (c) Efficacy studies: Feasibility testing of novel intervention strategies that show promise in laboratory or pilot studies through the use of small- scale efficacy studies with random assignment to control or intervention condition conducted in highly structured real world settings. NOTE: Investigations supported through this RFA must simultaneously or sequentially address drug abuse prevention questions at two or all of these levels. Centers must focus thematically on areas of research for which: (1) there are significant gaps in the integration of knowledge from several disciplines; (2) there is imminent potential for contributing to the development of new approaches to drug abuse prevention; and (3) there is evidence that the thematic focus can benefit from transdisciplinary collaboration. Applicants are encouraged to include the study of developmental, gender, racial/ethnic, cultural, sexual orientation, geographic, and socioeconomic differences when possible and appropriate. The following examples of scientific themes that might benefit from transdisciplinary collaborations are not intended to be inclusive; many other topics may be significant and appropriate: o Examination of drug use decision-making processes of adolescents, with emphasis on the identification of modifiable elements (e.g., presumed risk, predicted outcomes and expectancies, interactions between cognitive processes and emotional states) that can be used to develop potential intervention components; o Studies that develop and test intervention components based on established basic science findings on malleable psychological and social factors (e.g., selective disinhibition, negative attributional biases, and poor affect management); o Integration of new methodologies or techniques into existing science-based prevention intervention components to develop more precise targeting (e.g., examination of the relation between brain development, drug using behaviors and other domains of behavioral functioning; patterns of activation in cortical and subcortical circuits underlying emotional and cognitive responsivity to prevention messages); Characterization of underlying biological, psychological or social processes resulting in positive changes among drug abuse prevention intervention participants (e.g., identification and modulation of markers or indicators of stress reactivity or impulsivity, role of socialization and other social factors); o Exploration and adaptation of models of behavioral change used in prevention interventions for diseases, disorders, or risk behaviors outside of the area of drug abuse; o Studies that incorporate findings on the processes and mechanisms by which family interactions, peer dynamics, social networks and other contextual variables confer vulnerability or resiliency for drug abuse (e.g., sibling drug use, subtle reinforcement of antisocial attitudes and behaviors) into the development of novel targeted interventions. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) exploratory center grant award (P20) mechanism (see http://www.nida.nih.gov/Funding/GrantGuidelines.html). The P20 mechanism provides the opportunity for a transdisciplinary group of investigators to focus on a common problem through facilitation of coordinated communication and research across disciplinary and geographic boundaries. For the purposes of this RFA, transdisciplinary research is defined as a cooperative effort by a team of investigators from diverse disciplines including meaningful representation of basic sciences as well clinical or applied sciences. Normally, a transdisciplinary team of investigators will include persons from different departments but the key issue is that the team will include members who bring markedly diverse methods and concepts to bear on the scientific theme. Thus, the TPRCs are expected to foster transdisciplinary integration of knowledge and collaborations relevant to the development of novel and innovative drug abuse prevention interventions. The P20 centers called for in this RFA must demonstrate the following characteristics: (1) thematic synergy and interrelationship of the constituent core(s) and project areas; (2) commitment and ability to capitalize on concepts, approaches and findings from various scientific areas in the conduct of transdisciplinary research; (3) ability to conduct transdisciplinary research using laboratory, pilot and/or feasibility designs; (4) explication of how each project area and core enhances the overall research goals and synergy of the center; (5) mechanisms for ensuring information sharing within and across project teams and sites on a frequent and ongoing basis, which may include a scientific advisory board comprised of outside scientists and prevention practitioners if this will foster the research aims of the center; and (6) a research training and career development component designed to ensure the meaningful development of transdisciplinary collaborations. Participation of key center personnel in the NNPRI Network will help to foster the national presence of each TPRC. 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 30, 2003. FUNDS AVAILABLE NIDA intends to commit approximately $2,500,000 in FY 2003 to fund two to three P20 awards in response to this RFA. Additional awards will be considered based on availability of funds. Funding in response to this RFA is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of NIDA, the award of grants pursuant to this RFA is contingent upon the anticipated availability of funds for this purpose. This RFA is a one- time solicitation; subsequent applications will be expected to compete under NIDA's ongoing Centers PA or through other available mechanisms. Under this RFA, exploratory research center applications (P20) may request budgets up to a maximum annual of $1.2 million in total costs (including direct and indirect costs). The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award date is September 30, 2003. ELIGIBLE 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 o Faith-based and community-based organizations 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. SPECIAL REQUIREMENTS OF TPRCs 1. TPRC Core(s) Each center will consist, at a minimum, of an administrative core responsible for developing and maintaining an infrastructure that supports reciprocal transdisciplinary communication and interaction among researchers and scientific projects areas (outlined below). To facilitate this interaction, each center must propose a coherent plan for developing interactions among center scientific staff that is reflected in the organizational structure of the center and in the conceptualization, planning and implementation of scientific project areas of the center. The administrative core will also facilitate participation of key center personnel in the NNPRI Network for the purposes of fostering expanded collaborations and ideas to support the development of transdisciplinary research. Thus, the annual Network meeting will provide a forum for sharing emerging findings, assessing scientific progress in the field, mapping new directions for research, and promoting cross-project and cross-center collaborations. The administrative core is expected to facilitate cross-site and cross-project area of collaborations to accelerate the pace of discovery by providing a means for rapid assembly of research teams and scientific advisory board members, independent of geographic location. The administrative core must document procedures for adequate supervision and development of project areas. Finally, the TPRCs are expected to be ideal settings for training future generations of transdisciplinary prevention researchers and providing cross-disciplinary training for their own researchers. Thus, objectives for training and career development must be addressed in the application. Awardees will be encouraged to augment training and career development capacity through the use of National Institutes of Health training and career development mechanisms (see http://www.nida.nih.gov/researchtraining/traininghome.html.) An additional core or cores may be included as deemed necessary to provide shared resources in other critical areas (e.g., subject, data, and statistical management, laboratory equipment and management). 2. Project Areas The TPRC must include a minimum of 3, and not more than 5, project areas with justifiable or demonstrated transdisciplinary potential. Each project area must, at a minimum, provide: a clear review of the empirical and theoretical literature that points to the potential of the project area for development of innovative prevention components; a description of the significance, importance, and potential impact of the proposed research for drug abuse prevention; a well-specified plan for integration of concepts and methodologies from the basic and clinical/applied sciences; preliminary aims and hypotheses that are clearly related to both the center theme and the project area; a complete discussion of procedures, data analytic strategies and expected outcomes of the proposed line of research; at a minimum, one fully developed laboratory or pilot study; and a conceptual mapping that anticipates and justifies future studies for the support period requested. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Susan E. Martin, Ph.D. Division of Epidemiology and Prevention Services National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Telephone: (301) 443-1514 FAX: (301) 443-2636 Email: sm458s@nih.gov o Direct your questions about peer review issues to: Teresa Levitin, Ph.D. Office of Extramural Program Review National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDA 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: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for courier or express delivery) Telephone: (301) 443-2755 Fax: (301) 443-0538 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: (Center applications must clearly articulate the following features:) 1. General Description of the Overall Project (Not to exceed 10 pages): The applicant must provide an overview of the proposed exploratory research center including its theme, the background from the included scientific areas that point to the need for their integration, the current empirical and theoretical knowledge supporting the theme, the general objectives of the center, and the scientific integration and contribution of each project area and core to the overall project. Specifically, centers must provide strong evidence of thematic integration, synergy and the potential for transdisciplinary collaborations and interactions between basic and clinical or applied researchers; an overall scientific theme with clear potential for informing innovative drug abuse prevention efforts; evidence of interdependency of the proposed center theme, project areas, and core(s); potential for basic science to inform the design of innovative drug abuse prevention interventions and/or for prevention research studies to generate testable hypotheses at the basic science level that will subsequently "feedback" to inform prevention intervention development; and explanation of how a transdisciplinary approach will accelerate research on innovative prevention intervention approaches. 2. Cores (Not to exceed 10 pages for the administrative core and 5 pages for any one other core): The applicant must describe how each core will contribute to the goals of the overall project as well as how each project area will utilize resources provided by the core(s). The description of a core must clearly indicate the facilities, resources, services, and professional skills and expertise that the core will provide to the project areas. The center may include other core structures as deemed necessary to provide shared resources in critical areas (e.g., subject, clinical, data, equipment, statistical management, or laboratory facilities). If more than one core is included, a clear description of how the cores will collectively operate to produce a coherent center must be provided. At a minimum, one administrative core is required to ensure effective and synergistic functioning among project area teams; to promote the conduct of innovative, transdisciplinary research by supporting interactions and collaborations between constituent investigative teams; to provide for effective administration and organization of the center, effective long-range planning, evaluation of center activities, quality control, and effective budget management; to provide administrative structure for the development of transdisciplinary training and career development; and to facilitate interactions with other components of the NNPRI. The administrative core will be directed by a scientifically and administratively qualified principal investigator with overall responsibility for scientific, administrative, budgetary and operational aspects of the center; the principal investigator must demonstrate ability to provide direction and ensure the development of a transdisciplinary research program and team; the application's principal investigator (as noted on the face page of the application) must commit 25 percent effort to the activities of the core, in addition to other effort proposed for the center; and there must be support sufficient for the effective administration of the center including a minimum of the equivalent of one full-time support staff to the principal investigator. The processes must be described through which the TPRC scientists will supervise and develop the specific project areas over the full period of the TPRC. A full budget justification must be included. Evidence of institutional commitment, such as adequacy of facilities, equipment, and space, to promote the transdisciplinary research objectives must be documented. 3. Project Areas (Not to exceed 15 pages for any one project area): Applications should include descriptions of a minimum of 3 proposed research project areas that focus on different aspects of a common significant and innovative scientific theme or problem with applicability to drug abuse prevention. Discussion of the current state of the science and limitations of existing approaches in the thematic area is required. The major aims and hypotheses of the project area and their relation to the center and the constituent cores and project areas must be documented. Descriptions of the transdisciplinary nature and expected contributions of the project area to the development of transdisciplinary themes of the center are required. The stated aims and hypotheses of the project area must either fully explicate a line of research or provide a conceptual map and justification for additional studies. Detailed plans for at least one laboratory or pilot study must be developed and included. Proposed project areas should incorporate the following into the application: A clear description of the project areas with examples of how theoretical or empirical evidence from existing preclinical, human laboratory or field research can be immediately integrated into the design of innovative preventive interventions and/or examples of findings from drug abuse prevention research that will be used to inform the design of basic science studies with feedback potential for intervention development, or modification or elaboration of existing prevention programs; justification for how the proposed project areas and core(s) address research questions or problems integral to the scientific theme of the center; a description of the project areas' contribution to the overall synergy of the TPRC; and a detailed budget for all proposed and planned work. A data safety and monitoring (DSM) plan may be required. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health/DHHS 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: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for courier or express delivery) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA 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 National Advisory Council on Drug Abuse REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Overall Application: In reviewing the overall scientific merit of the center, reviewers will be asked to address: The likelihood of a significant impact on the field of drug abuse prevention; the innovation and transdisciplinary potential of the center's proposed research activities; the quality of the integration of the center components in relation to the center theme, including the scientific compatibility of all center components with the theme; relevance of the planned research activities to fulfilling the stated goals of the center; mechanisms for facilitating relationships between center components; involvement of a variety of scientific disciplines in the planning and conduct of the science; the appropriateness and adequacy of plans for development of transdisciplinary competencies among team members; the appropriateness and adequacy of facilities to the conduct of the science proposed; the appropriateness and quality of the proposed shared (core) facilities to the proposed work; the quality of the available supportive analytic, methodological and technical expertise; ability of the center Principal Investigator to direct and integrate the center science; the quality of the investigative team; and evidence in the budget requested that use of this center mechanism adds to the cost-efficiency of conducting the research. 2. Administrative Core: In reviewing the administrative core, reviewers will be asked to address: The ability of the administrative core to coordinate and foster the synergy of project areas around an overarching transdisciplinary theme or topic related to drug abuse prevention; the adequacy of plans for effective implementation of research objectives; the ability to promote and facilitate collaboration and interaction between basic and applied/clinical researchers; the ability of the administrative and organizational structure to facilitate innovative and scientifically rigorous transdisciplinary research studies; the quality of the plans for development and maintenance of shared resources; the scientific qualifications, including demonstrated scientific and administrative leadership capabilities of the Center Principal Investigator and other key scientific personnel; the adequacy of the plan for submission, review, and oversight of additional project area research projects; the adequacy of plans for intra-center and NNPRI network interaction, communication and collaborations; evidence of the institution's commitment to the proposed center; the adequacy of internal processes that allow for program area priority setting; and adequacy of the plans and objectives for providing cross-disciplinary training and career development. 3. Optional Core(s): In reviewing optional cores, reviewers will be asked to address: The ability of the core to support the synergy of project areas around an overarching transdisciplinary theme or topic related to drug abuse prevention; the ability of the core to promote and facilitate collaboration and interaction between basic and applied/clinical researchers; the ability of the core activities to facilitate innovative and scientifically rigorous transdisciplinary research studies; the quality of the plans for development and maintenance of shared resources; the scientific qualifications, including demonstrated scientific and administrative leadership capabilities of core investigators other key scientific personnel. 4. Project Areas. In reviewing individual project areas, reviewers will be asked to address: SIGNIFICANCE. Is there empirical and theoretical literature support for the potential of the project area for development of innovative prevention components? Does the project area address issues of substantive importance for either informing prevention development efforts or formulating novel questions in basic science that can shape prevention directions? Does the application provide a well-specified plan for integration of concepts and methodologies from the basic and clinical/applied sciences? Are the preliminary aims and hypotheses clearly related to both the center theme and the project area and is there adequate a complete discussion of procedures, data analytic strategies and expected outcomes of the proposed line of research. APPROACH. Are the conceptual framework, research aims, hypotheses, design, methods, and analyses adequately developed, well integrated and appropriate to the project area? Does the application present a conceptual map of how the work is expected to proceed given confirmation or disconfirmation of hypotheses? Does the applicant acknowledge potential problem areas and consider alternative approaches? Are transdisciplinary links apparent in the description of the project area and associated studies? Does the application describe specific processes through which reciprocal interactions among basic and applied/clinical researchers will be facilitated? INNOVATION. Does the project area utilize or develop methodologies or technologies in the basic sciences that have the potential to inform the development of prevention intervention components, or utilize findings from drug abuse prevention research that provide new hypotheses for investigation in the basic sciences with feedback potential for the development, significant modification or elaboration of interventions? Does the proposed project area reflect sufficient originality, novelty, and innovation to make it highly relevant to the overall transdisciplinary theme of the center? INVESTIGATORS. Are the investigators appropriately qualified with demonstrated competence to conduct research in the proposed project area? Is the proposed work appropriate to the experience level of the principal investigator and project researchers? Are the proposed time commitments for key laboratory and clinical researchers reasonable and adequately reflected in the proposal? ENVIRONMENT. Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed project area take advantage of the unique, transdisciplinary features of the scientific environment and specify scientifically useful collaborative arrangements? Is there evidence of adequate institutional support? Is the project area interactive and integrative with other components of the TPRC, thematically, conceptually, and experimentally? To what extent is this project area an essential part of, and contributor to the realization of the overall thematic goals of the center? LABORATORY/PILOT STUDY. (Each of the project areas must include, at a minimum, one fully developed laboratory or pilot study, which should demonstrate the operationalization of the project area's direction, and reflect on the internal review process used by the Administrative Core to implement submission, review, and oversight of additional research projects that may be started in future years.) (1) Significance: Does this study address an important problem? If the aims of the application 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 and the project area within the Center? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do they reflect the transdisciplinary goals of the Center? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application, including a DSM plan. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 28, 2003 Application Receipt Date: April 28, 2003 Peer Review Date: June/July 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 30, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phases 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. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS: The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html 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. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.279, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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