NIDA NATIONAL PREVENTION RESEARCH INITIATIVE (NNPRI): TRANSDISCIPLINARY PREVENTION RESEARCH CENTERS Release Date: December 31, 2001 RFA: RFA-DA-02-005 National Institute on Drug Abuse (http://www.nida.nih.gov) Letter of Intent Receipt Date: March 26, 2002 Application Receipt Date: April 26, 2002 PURPOSE The National Institute on Drug Abuse (NIDA) is accepting applications under a new National Drug Abuse Prevention Research Initiative (NNPRI) for (1) expanding the knowledge base of basic research with strong translational potential for informing the design of drug abuse prevention interventions; (2) accelerating the development of new prevention interventions arising from transdisciplinary research interactions; and (3) testing research-based interventions in large-scale field trials. The NNPRI is formulated on a conceptual model that encourages translational research along a continuum of basic research, to preliminary prevention intervention development, effectiveness testing and large-scale program implementation. The model also recognizes the potential contributions of service delivery providers, even in very early stages of basic research, for facilitating the ultimate translation of research to practice. This Request for Applications (RFA) invites grant applications (P50) to support the creation of transdisciplinary prevention research centers (TPRCs) that will accelerate the development of new and innovative preventive interventions for drug abuse. For purposes of the present RFA, transdisciplinary research is defined as a cooperative effort by a team of investigators, each expert in different methods and concepts, collaborating in an organized research endeavor to address a specific scientific problem. It is expected that a transdisciplinary approach will bring diverse and multiple scientific perspectives to catalyze new thinking about prevention research questions. The scientific interactions and collaborations supported by this center model are intended to maximize scientific creativity and stimulate new developments in the field of drug abuse prevention research more rapidly than would be possible by depending on individual investigators working in relative isolation. It is the intent of this RFA to support centers that can demonstrate reciprocal interactions between basic and applied research components to enhance creative and innovative research along this continuum of prevention research. 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, NIDA National Prevention Research Initiative (NNPRI): Transdisciplinary Prevention Research Centers 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/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for P50 grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Competitive continuation applications will not be accepted under this solicitation. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) center grant award (P50) mechanism (see http://www.nida.nih.gov/Funding/GrantGuidelines.html#Purpose). NIDA provides support for research center grants to foster a synergistic approach to drug abuse and addiction research and to enable studies that would not occur without the climate, facilities and research resources that a research center can uniquely provide. Research supported at a NIDA research center must be thematically focused and must reflect in clear ways interdependence of components of the research program that would not occur simply from the mere collection of the individual components. Taken as a whole, then, a NIDA center is expected to enable a level of achievement which exceeds that expected on the basis of "the sum of its parts." In addition, NIDA research centers are expected to serve as national research resources. They are expected to attract established and promising investigators into drug abuse research and to provide opportunities for research training, career development, and mentoring. The present RFA will support the integration of basic and prevention research, along a continuum ranging from basic research studies with potential application to the development of innovative prevention interventions, through efficacy testing and small scale effectiveness trials of promising interventions. PIs will be responsible for the planning, direction, and execution of the proposed TPRC program. Awards will be administered under NIH grants policy as stated in the new NIH Grants Policy Statement (http://www.nih.gov/grants/policy/policy.htm). Under this RFA, requested budgets will be subject to the following limits: A new P50 application may request a maximum annual direct cost of $1.0 million and maximum annual total cost of $1.5 million. Future year budgets may include annual increases up to three percent, but cannot exceed the annual cap of $1.5 million in total costs. In complying with the direct cost cap of $1.0 million, the indirect costs related to subcontracts to other institutions or organizations will not apply toward the direct cost cap, but the total dollar request may not exceed $1.5 million. 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, 2002. FUNDS AVAILABLE NIDA intends to commit approximately $4,000,000 in FY 2002 to fund up to four P50 awards in response to this RFA. Additional awards will be considered based on availability of funds. An applicant may request up to five years of support. 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. RESEARCH OBJECTIVES Background Previous research has identified significant risk and protective factors that influence the development of drug abuse and addiction. Discoveries from the behavioral and social sciences, and from neuroscience, cellular, genetic and molecular biology, have elucidated individual vulnerabilities to initiate drug use, and to some extent, the changes associated with progression from occasional use to chronic, uncontrollable patterns of abuse. Over two decades of prevention research have produced drug abuse prevention programs with proven efficacy and effectiveness, based on a general set of science-based prevention principles. However, there are many important research questions and opportunities remaining for drug abuse prevention research. For example, findings from research on the underlying biological, cognitive, psychological, social and behavioral processes involved in drug abuse and addiction have not been fully exploited for purposes of developing innovative prevention interventions. Research Goals and Scope The NIDA recognizes the need to encourage the development of new, innovative preventive interventions targeting both the initiation and escalation of drug abuse. Preventing escalation of abuse, and the transition to compulsive, uncontrollable use (e.g., an integration of prevention and early intervention models) is of particular interest in this initiative. The overall goal for this RFA is to stimulate the development and testing of prevention interventions that can ultimately be demonstrated to produce long-lasting and broad-based reductions in the initiation and progression of drug abuse behaviors. NIDA is especially interested in the development of new prevention paradigms (e.g., peer-to-peer interventions, brief motivational interventions, internet delivery systems, etc.) and in novel research on the delivery, receipt, processing and outcome of drug abuse messages and communications. In addition, the underlying mechanisms that contribute to the effectiveness of existing interventions need to be more fully elucidated so that these approaches can be strengthened, and new programs developed to target critical mechanisms of behavioral change or to re-direct developmental trajectories. As it is recognized that even the most effective interventions have not benefited all who have been exposed to those interventions, remaining challenges in drug abuse prevention research include better characterization of subgroups or individuals who are refractory to existing interventions, and the development of new paradigms for targeting resistant populations. Finally, given growing evidence that (a) risk and resiliency factors and the basic mechanisms of drug abuse may differ for males and females, and that (b) cognitive, social, and developmental processes are often gender-sensitive, researchers are strongly urged to incorporate a gender-based approach in their research design. It is the intent of this RFA to support transdisciplinary collaborations along a continuum of research, ranging from basic science that can inform or guide the development of novel prevention interventions, through preliminary program development, efficacy testing, and small-scale effectiveness trials of promising new interventions. Studies at the following levels along a continuum of basic science to prevention research are appropriate and centers should incorporate more than one level in the transdisciplinary proposal: (a) Theory-based or model-driven basic research studies, with potential application to the development of innovative prevention interventions;(b) Research on the development, refinement and pilot testing of new interventions, including studies aimed at translating discoveries from basic behavioral, cognitive, social or neuroscientific research into novel or improved interventions; (c) Efficacy testing of interventions that show promise; including research on the hypothesized mechanisms through which these interventions produce their effects; (d) Small scale effectiveness trials of prevention interventions. A transdisciplinary approach is best suited for developing a research environment conducive to a reciprocal exchange of scientific information and ideas between projects and between prevention centers. Transdisciplinary collaborations in these TPRCs should: (1) stimulate the translation of basic science discoveries (from both preclinical and human laboratory-based or field investigation) into the design of novel preventive interventions, and (2) capitalize on opportunities from drug abuse prevention research to inform the design of basic science investigations on vulnerability to drug abuse and addiction. For example, collaborative interactions between neuroscientists and prevention specialists may facilitate the identification of biological mediators or moderators as targets for intervention. Behavioral scientists studying individual differences can develop models of how environmental and neurobiological or genetic risk factors interact and can be manipulated to reverse or attenuate vulnerability to acquire drug abuse behaviors. Cognitive scientists can contribute through model-driven research aimed at processes that guide decision-making under different parameters of risk and consequences. Epidemiologists working with drug abuse prevention researchers can investigate clusters of trajectories, patterns of abuse or changes in patterns of abuse, and population-, community-, or context-specific factors that may be amenable to tailored interventions. Developmental specialists may characterize maturation factors and processes that can be targets for intervention activities, such as changing profiles of cognitive, emotional and behavioral capabilities or strategies (e.g., information processing). The focus on different aspects of drug abuse prevention research will vary from center to center, but each center must focus thematically on an area of research in which (1) there are significant gaps in our knowledge; (2) there is potential for contributing to the development of new approaches to drug abuse prevention or the prevention of escalation; and (3) there is evidence that the thematic focus can benefit from transdisciplinary collaborations among scientists from diverse methodological and theoretical disciplines. Applicants are encouraged to include the study of racial, ethnic minority group membership, sexual orientation, and effects of gender and culture. Following are examples of scientific themes in drug abuse prevention research that might benefit from transdisciplinary collaborations within the context of a P50 center. However, the list is not intended to be all-inclusive, and many other significant topics of scientific inquiry may be appropriate: o Processes and mechanisms in adolescent decision making about drug abuse, and research aimed at modifying these processes and their behavioral outcomes; e.g., calculation of presumed risk; influence of predicted outcomes and consequences on decisions; impact of short- and long-term consequences; context variables as proximal mediators in decision making; interactions between cognitive processes and emotional states. o Developmental trajectories in cognitive functioning and studies addressing how such trajectories might be influenced or altered; development of dis- inhibition, attributional biases, expectancies and impulsivity; as well as developmental transitions as periods of plasticity and vulnerability that may provide targets for intervention. o Cognitive, affective and behavioral characteristics of target populations that may be addressed as malleable targets for intervention; for example, individual factors that influence the impact of prevention messages and materials. o Biological, genetic, behavioral, environmental, cognitive and emotional variables that contribute to, or are modified as a result of, dynamic processes in the escalation to uncontrollable drug use; research to identify interventions that can re-direct behavioral outcomes resulting from the influence of these variables. O Characterization of changes in neurobiological, psychological or social processes resulting from efficacious drug abuse prevention interventions, including study of the processes through which these changes occur; e.g., identification of markers or indicators in stress reactivity, neuronal activation, affect, or information processing that correlate with or predict positive outcomes of drug abuse prevention interventions. o Neurobiological development during adolescence and young adulthood; research to examine how neurobiological indices are related to the impact of interventions at critical or transition periods; e.g., examinations of changing patterns of activation in cortical and subcortical circuits underlying emotional and cognitive processes in the reaction to prevention messages, or recruited in the context of making drug abuse decisions. o Exploration and development of behavioral change models from arenas of prevention research outside of the area of drug abuse; processes involved in the impact of changing attitudes and values, or influence of contextual variables, on behavioral choice, as exemplified by interventions from other fields of health and behavioral medicine. O Studies to examine processes and mechanisms by which family interactions, peer dynamics, social networks and other contextual variables confer vulnerability or resiliency for drug abuse; (e.g., identifying features of peer interactions that account for their influence on drug abuse in adolescents); including the development of interventions to modify these processes and mechanisms. o Self-regulation and regulation failure in modulating drug abuse behavior; the role of conscious (controlled) and unconscious (automatic) mental processes in self-regulation and research aimed at strengthening self- monitoring and self-regulation in intervention paradigms. o Social interaction, affiliative and antagonistic behaviors; bonding and attachment; research on neurobiological substrates of these processes as moderators or mediators of behavioral consequences that may provide targets for intervention strategies. SPECIAL REQUIREMENTS 1. TPRC Requirements Each center must develop an infrastructure that ensures transdisciplinary communication and reciprocal interaction between basic and applied prevention researchers. The Center's infrastructure will consist of core elements, including at minimum an administrative core, with other core elements to provide shared resources as deemed necessary such as, for example, a statistical/data management core, or a recruitment core, etc. In addition, each TPRC must initiate a minimum of 3 projects with demonstrated translational potential; thus applicants must describe the potential contributions of three of more interacting projects, for leading to promising new drug abuse prevention approaches. Because it is intended that the these prevention research centers will provide ideal settings for training future generations of drug abuse prevention researchers in transdisciplinary sciences and translational perspectives, TPRC applications must have strong career development objectives. TPRCs supported by this initiative must have input from local and state prevention practitioners in the design of the proposed investigations. Centers also will be expected to develop plans for rapid implementation of future pilot projects to capitalize on especially promising discoveries, and to respond to emerging trends from epidemiological data. Lastly, it is expected that each center will participate in a national drug abuse prevention network to share information, assess scientific progress in the field, identify new research opportunities, and promote inter-center collaborations. The center application must clearly articulate: (a) Center integrity that provides for thematic integration, synergy and ensures transdisciplinary interactions between basic and applied prevention researchers; an overall scientific theme with clear potential for informing innovative drug abuse prevention efforts; evidence for interdependency of proposed projects; translational potential of the projects for informing the subsequent design of novel drug abuse prevention research, or for prevention research studies to generate testable hypotheses at the basic science level; explanation of how a transdisciplinary approach will accelerate the pace in this area of investigation (i.e., to bring new prevention interventions to be subsequently tested in field and systems trials); and plans for ensuring that translation is facilitated (when appropriate) in a logical progression of research projects; (b) An administrative core structure to ensure effective and synergistic functioning among projects; to promote the conduct of innovative, transdisciplinary research by supporting interactions and collaborations between co-investigators and 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; (c) Other core structures as deemed necessary, such as shared statistical, clinical, data sharing, equipment or recruitment resources; (d) A scientifically and administratively qualified principal investigator who has responsibility for scientific, administrative, budgetary and operational aspects of the center; who can provide direction to the TPRC, ensure a transdisciplinary research emphasis, and build a career development program; the principal investigator should demonstrate an adequate commitment of time and effort (35% effort at the minimum); (e) A cadre of experienced and productive investigators that represent a breadth of transdisciplinary expertise; and administrative support sufficient for the effective administration of the center including a minimum of one full-time administrative assistant to the principal investigator; (f) Evidence of institutional commitment, such as adequacy of facilities, equipment and space to promote transdisciplinary research objectives; (g) Evidence that an advisory board representing local and state drug abuse prevention practitioners is in place and has provided input to the design of the proposed research, for purposes of ultimately facilitating the translation of research to practice; also, plans for this board to continue to provide guidance on issues of practical applicability, and make recommendations for future research priorities; the board must be comprised of at least three drug abuse prevention practitioners who represent programs at the state and local level, selected on the basis of their expertise in the thematic scientific area of the TPRC; other local and/or state practitioners may be included as needed; each board must also have representation from two researchers from outside of the TPRC, representing areas of basic science and/or drug abuse prevention, with appropriate expertise for the projects proposed in the application; budget should include bi-annual meetings of the full board to evaluate progress from the projects and advise on future directions; (h) A strong commitment to career development in transdisciplinary and translational research perspectives, especially at the level of the early career investigator, with a plan included as part of the application; plan may also include a provision for established investigators who wish to cross- train in a new discipline; recruitment must include qualified women and minorities; there must be a clear policy and plan for recruitment of career development candidates; the application should state the number of trainee positions proposed, the criteria for eligibility and for selection of candidates, and describe the selection process; the application should indicate potential mentors who are already in place at the proposed TPRC, briefly describe their research programs, and describe complementary activities that contribute to the transdisciplinary environment for career development (e.g., existing training grants, other career development mechanisms, established collaborators within and outside of the center, and relevant programs); (i) A budget for supporting future pilot studies to capitalize on opportunities arising from new scientific discoveries, or to rapidly respond to shifting or emerging drug abuse trends from epidemiologic data; applications should propose an institutional review process that selects pilot projects for funding which represent the most innovative ideas and which are likely to have the greatest impact on the development of new and innovative drug abuse prevention programs; (j) Plans to foster intra- and inter-center collaborations including interactions among TPRCs; may be in the form of research collaborations, exchange of scientists on a visiting basis, exchange of resources and materials, and other innovative mechanisms; budget must accommodate travel for all TPRC PIs and co-investigators to participate in two meetings per year as part of the National Drug Abuse Prevention Research Initiative; and (k) A budget justification for all core elements and projects. In addition applications should include description of a minimum of three proposed research projects that focus on different aspects of a common scientific theme or problem in the area of drug abuse prevention, (along the continuum of basic research to prevention intervention development, through efficacy testing and small-scale effectiveness trials); evidence must be presented for transdisciplinary interaction and collaboration across projects. Included in these project proposals should be: - a clear description of the project's translational potential; that is, evidence provided that basic science discoveries (from both preclinical and human laboratory-based or field investigation) can be incorporated into the design of novel preventive interventions, and/or that findings from drug abuse prevention research will be used to inform the design of basic science investigations on vulnerability to drug abuse and addiction; - evidence that the project addresses a research question or problem that is appropriate for the scientific theme of the center; - a description of the project's contribution to the overall synergy of the TPRC; - evidence that these projects are exemplary in scientific innovation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. DATA AND SAFETY MONITORING PLAN As of the October 2000 receipt date, applicants must supply a general description of the Data and Safety Monitoring Plan for ALL clinical trials; this must be included in the application https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. For purposes of reviewing applications submitted to the NIH, a clinical trial is operationally defined as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). The degree of monitoring should be commensurate with risk. NIH Policy for Data and Safety Monitoring requires establishment of formal Data and Safety Monitoring Boards for multi- site clinical trials involving interventions that entail potential risk to the participants. The absence of this information will negatively affect the priority score. 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 services. Persons at risk for HIV infection include injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see https://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html. 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 http://www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the letter of intent receipt date listed to: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for courier or express delivery) Telephone: (301) 443-2755 APPLICATION PROCEDURES PHS 398 research grant application instructions and forms (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. Applicants submitted under this solicitation must conform to the SPECIAL REQUIREMENTS described above. Because of the multi-project nature of a TPRC grant and the special requirements in this RFA, additional instructions regarding format are listed below: Applicants are encouraged to organize their application by initially presenting the face page, the abstract page with key personnel, a table of contents, summary budget pages for the entire TPRC, and other documentation pertaining to the entire TPRC. This should be followed by an Introductory Section of no more than three pages. It should be written for the proposed TPRC application describing it as a whole with respect to the overall theme, goals, objectives, and overall research plan. The Introductory Section should contain information on i) the overall research theme, ii) timelines and milestones for each projects in a graphic outline to clearly lay out the sequence of research events and how each project of the TPRC relates to each other, iii) the capacity of the TPRC to conduct the research as proposed iv) the capability of the proposed Principal Investigator and his/her institution to carry out the scientific and administrative duties required in this RFA. After the introductory section, each core and research project should be presented with its accompanying individual budget, budget justification, biographical sketches, and other support information and research plan. For each core and research project component, there is a 25 page limit for the sections of the research plan (i.e., specific aims, background and significance, preliminary studies/progress report, and research design and methods) as indicated in the form PHS 398. Appendix material limits apply to each component separately; each component's appendix may include up to 10 publications, manuscripts, abstracts, patents, or other printed material directly related to the project. Surveys, questionnaires, data collection instruments, and clinical protocols may also be submitted in the appendix. Original glossy photographs or color images may be included, provided that a photocopy (that may be reduced in size) is included within the 25 pages of the research plan. Applications exceeding page limits, font limits, or appendix limits will be returned to the applicant without review. Appendices should not be placed within the body of the application when submitting, but should be bundled separately, component by component. 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: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for courier or express delivery) Telephone: (301) 443-2755 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by 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 the NIDA in accordance with the review criteria stated below. Applications receive a written critique as part of the initial merit review. They may 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 be assigned a priority score, and receive a second level review by the National Advisory Drug Abuse Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact, and thus, have high scientific merit. In reviewing Core Components, reviewers will be asked to address: o synergy of the projects around an overarching theme or topic and its relationship to drug abuse prevention; innovativeness and transdisciplinary nature of the proposed research activities; demonstration of collaborations and communication between basic and applied prevention researchers; likelihood of a significant impact on the field; and plans to effectively pursue translational research objectives; o administrative and organizational structure and support conducive to successful research coordination; an organizational structure that allows for efficient and cost-effective management and allocation of funds; o plans for the development and maintenance of shared resources that promote the highest quality of research; o scientific qualifications and demonstrated scientific and administrative leadership capabilities of the Principal Investigator; o quality of the cadre of investigators and evidence of research productivity; breadth of expertise represented among investigators; quality of interactions and nature of collaborations; o evidence of the institution's substantial commitment to the center; o plans for the establishment of an outside advisory structure that includes scientific expertise relative to both the thematic area, and the proposed research projects, and community and state level prevention provider input on research design and priorities; o appropriate plans for cross-disciplinary training of new and established investigators, including adequacy of facilities for workshops, seminars and other educational activities; capacity to train predoctoral and/or postdoctoral students in transdisciplinary drug abuse research; career development plans for current drug abuse researchers; demonstrated success in mentoring and career development activities; o internal process that allows for priority setting; including an internal process for the assessment and approval of future pilot projects; o evidence of plans to interact with other TPRCs and members of the NNPRI, including participation in two meetings per year with other TPRC directors and co-Investigators; adequate planning for intra-center interaction, communication and collaborations; o appropriateness of the proposed budget and duration in relation to the proposed research; In reviewing individual projects, reviewers will be asked to address: Significance. Does this study address an important research problem related to the theme of the TPRC? Does the scientific merit and experimental design of the project adequately address issues of substantive importance for either informing prevention development efforts or formulating novel questions in basic science that can shape prevention directions? Approach. Are the conceptual research framework, design, methods, and analyses adequately developed, well integrated and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative approaches? Are translational linkages between sequences of investigations apparent where appropriate? Innovation. Does the project develop new methodologies or technologies in the area of basic science that have the potential of informing the development of prevention programs, or from the area of drug abuse prevention research that provide new hypotheses for basic science investigations? Does the experimental design reflect sufficient originality, novelty, and innovation to make it highly relevant to the overall translational goals and objectives of the TPRC? Investigators. Are the investigators appropriately qualified with demonstrated competence to conduct the proposed research? Is the proposed work appropriate to the experience level of the principal investigator and project researchers? Are the proposed time commitments for all key laboratory and clinical researchers reasonable and adequately associated with the project? Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed projects take advantage of unique and multidisciplinary features in the scientific environment and reach out to useful collaborative arrangements? Is there evidence of adequate institutional support? Is the project interactive with other components of the TPRC, conceptually, experimentally, and translationally? Context. How well does this project contribute to/or benefit from other projects in the center. How is the scientific merit enhanced by being part of a center? To what extent does this project seem to be an essential part of the center's goals? Other aspects of individual pilot projects include: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Awards will be based upon scientific and technical merit reflected in the priority score or percentile, which will be used to make award decisions. Staff may consider other criteria such as the geographical location of the applicant organization as well. The most common award criteria are scientific merit as determined by peer review, availability of funds and programmatic priorities. Schedule Letter of Intent Receipt Date: March 26, 2002 Application Receipt Date: April 26, 2002 Peer Review Date: June/July 2002 Review by NIDA Advisory Board: September 2002 Anticipated Award Date: September 30,2002 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issue or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Minda Lynch, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Boulevard Bethesda, MD 20892-9547 Telephone: (301) 443-1887 FAX: (301) 594-6043 Email: mlynch@nida.nih.gov Direct inquiries regarding review matters to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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