CHILD AND ADOLESCENT INTERDISCIPLINARY RESEARCH NETWORKS Release Date: November 26, 2001 RFA: RFA-MH-02-011 National Institute of Mental Health (http://www.nimh.nih.gov) Letter of Intent Receipt Date: March 4, 2002 Application Receipt Date: April 10, 2002 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute of Mental Health (NIMH) seeks to encourage collaborative partnerships among scientists from various disciplines to facilitate interdisciplinary approaches to significant public health questions in child and adolescent mental health. To this end, this Request for Applications (RFA) is designed to create interdisciplinary networks for fostering innovative approaches to research in child and adolescent mental health. This RFA is in response to a report by the National Advisory Mental Health Council"s Workgroup on Child and Adolescent Mental Health Intervention Development and Deployment entitled "Blueprint for Change: Research on Child and Adolescent Mental Health" (http://www.nimh.nih.gov/childhp/councildesc.cfm). To develop effective solutions to problems in a field as complex as children"s mental health, coordinated research efforts that integrate scientific advances from a range of specialty areas are required. Interdisciplinary studies could be brought to bear on issues of etiology, risk processes, intervention development and implementation. While advances have been made in understanding some of the basic psychological processes related to attention, cognition, motivation, and stress, for example, their application to public health questions about risk processes, the etiology of disorders, and clinical interventions has yet to be realized, in part due to the challenges unique to children"s mental health. Similarly, a growing research base on effective treatments, preventive interventions, and services for youth with mental disorders exists, but unresolved and important questions still remain about those core processes that are related to outcomes and about the feasibility of implementing the evidence-base in different service contexts. This initiative serves as a catalyst for the Institute"s long-term commitment to strengthening the research base on child and adolescent mental health. Critical to these efforts is the recognition of the importance of linking basic science and clinical intervention development, of accelerating the pace of intervention development by repositioning such work within real-world settings, and of realigning the evidence base with clinical and service practice. 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, Child and Adolescent Interdisciplinary Research Networks, 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 Applicants are strongly advised to contact NIMH staff listed below, prior to submission, to discuss the eligibility of a proposed application. Applicants are strongly encouraged to submit a letter of intent by March 4, 2002. Applications may be submitted by domestic and foreign, 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use two mechanisms to support two types of interdisciplinary research partnerships: the R21 Exploratory Network grant award mechanism and the R24 Developmental Network grant award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. Future unsolicited competing applications that stem from this network will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The earliest anticipated award date is September 30, 2002. The R21 mechanism is designed to encourage new research directions and exploration of approaches and concepts that are innovative to a particular area. As such, it encourages newcomers to a field and also high-risk, high- impact hypotheses, with fewer expectations regarding preliminary data than other funding mechanisms. The R24 mechanism is designed for groups of currently funded investigators working on a common problem. The goal is to bring together investigators at different institutions and to provide resources for collaborative and interactive activities that will further the shared research goals and significantly enhance what could be accomplished within the individual investigator"s grant support. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at: http://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE The NIMH intends to commit approximately $2,000,000 in FY 2002 to fund new and/or competitive continuation grants in response to this RFA. For the R21 grants, an applicant may request a project period of up to 3 years and a budget for direct costs of up to $125,000 per year, this award is not renewable. For the R24 grants, an applicant may request a project period of up to 4 years and a budget for direct costs of up to $250,000 per year, this award is also not renewable, and is not transferable to another institution. Although the facilities and administrative (F&A) costs associated with all contractual and consortium arrangements are considered as direct costs to the applicant organization, for the purposes of this announcement only, these will not count against the direct cost limits. RESEARCH OBJECTIVES Background The National Advisory Mental Health Council convened its first workgroup focused exclusively on child and adolescent mental health in January 1999. This workgroup was comprised of an interdisciplinary group of scientists, providers and consumers with shared expertise in youth mental health. This workgroup assessed the status of the NIMH portfolio and identified research opportunities in the development, testing, and deployment of treatment, service, and preventive interventions for children and adolescents in the context of families and communities. Their findings and recommendations are reported in the "Blueprint for Change: Research on Child and Adolescent Mental Health Research" (http://www.nimh.nih.gov/childhp/councildesc.cfm). The key recommendation by the workgroup relates to the need for inter- disciplinary integration of knowledge in a range of scientific areas to address some of the more vexing problems in children"s mental health, including unresolved questions about etiology, risk processes, intervention development and the implementation of effective interventions into practice settings. The workgroup further recognized that if the form and function of research are to be transformed to meet public health needs, partnerships must be forged with groups sometimes considered outside the scientific arena, including families, youth, providers, and other key stakeholders. The complexity of the problems within children"s mental health, the impressive research advances from the basic sciences, and the pressing need for effective solutions for children with mental disorders, led the workgroup to suggest several actions steps: 1. Linkages must be made among neuroscience, genetics, epidemiology, behavioral science, and social sciences, and the resulting interdisciplinary knowledge must be translated into effective new interventions. 2. Scientifically proven interventions must be disseminated to the clinics, schools, and other places where children, adolescents, and their families can easily access them. This requires an interdisciplinary science base that can be translated, used and sustained in the community. This RFA is designed to encourage unique partnerships with the goal of fostering new approaches to diagnosis, functioning, assessments of risk, development of new preventive strategies, treatments, and services, and the implementation of interventions in real-world settings. The workgroup recognized that different areas in the field of children"s mental health are at varying stages of readiness for such collaboration. Consequently, this RFA offers two types of interdisciplinary network arrangements. For investigators who are just beginning to explore interdisciplinary research questions, there is the Exploratory Network grant. For investigators who have already initiated some collaborative partnerships and want to increase interdisciplinary capability, there is the Developmental Network grant. Each grant will be discussed below. General Characteristics All applications to this RFA must provide a cogent rationale as to why an interdisciplinary approach is needed to address the chosen problem area. The description of the topic(s) should include a compelling justification for the interdisciplinary potential of the research collaboration, including the relevance for clinical or practical utility, the theoretical progress that will be accomplished through the cross-disciplinary networking, and the reasons why an interdisciplinary approach will advance the field or answer previously intractable questions. In all cases, a strong knowledge base should already be available that is germane to the interdisciplinary effort. Relevant areas of the basic sciences for an interdisciplinary focus may include: animal models of human behavior, decision-making models, or behavior change theories. Proposed candidate circuits and brain mechanisms that can be directly tested through animal models, human neuroimaging, or genetic comparisons could be appropriate. Relevant areas of the clinical or services science appropriate for an interdisciplinary network might include: methodology development (e.g., for assessing core mediational processes or intervention effectiveness), models of assessment, specific paradigms for collaborative partnerships to facilitate the uptake and sustainability of scientifically-supported interventions. These areas should not be considered exclusive and experts from any of them might be brought together to form a network. The center of gravity for the network should revolve around the core research questions for which interdisciplinary approaches are likely to yield significant progress. Applications must demonstrate that research partnerships among basic scientists (e.g., developmental, behavioral, neuroscience, genetics), clinical and/or services researchers, key stakeholders or others with relevant expertise (e.g., from anthropology, social marketing, educational or school psychology, history, organizational/industrial psychology, information theory, health economy, etc.) exist or will be developed and nurtured. The minimum collaborative arrangement would thus involve at least 3 investigators from different scientific disciplines, although larger groups of actual and potential collaborators are encouraged. Where appropriate, the involvement of mental health stakeholders outside the scientific community is strongly recommended. Networks are to be conceptualized by the nature of the research goals and are expected to extend beyond geographical and departmental boundaries. Collaborations among different institutions are strongly encouraged. In all cases, applications should be clear about how communication will occur across these boundaries so that the feasibility of achieving a fully-developed collaborative research partnership is apparent. Note that the Research Plan is limited to 15 pages for the R21 grants and to 25 pages for the R24 grants. R21 Exploratory Network Grants for Interdisciplinary Research R21 Exploratory Network grants provide an avenue for investigators to initiate and explore potential research collaborations. These networks are defined by the following characteristics: o Initial development of collaborative work: Investigators need not demonstrate any history of prior collaboration. However, those factors in the investigators" background and/or institutional circumstances that would facilitate success in collaboration should be clearly delineated. o Clear plan for the development of the collaboration: Such efforts could include travel among sites for informal meetings, workshops and small conferences, consultants, and analyses of extant data sets, using new methodologies or approaches. The purpose of these activities will be to shape or refine conceptual frameworks for organizing additional interdisciplinary research and to identify which specific research questions show greatest promise for advancement. o Pilot studies may be included (although not required) to demonstrate feasibility of certain aspects of the research approaches and develop further interdisciplinary research projects. o Salary support for faculty, research assistants, and other professional staff may be provided. o Description of the anticipated longer-term goals or outcomes of the collaboration and an anticipated timetable: Such goals might variously include an application for a R24 developmental network grant or an R01-based research collaboration. R24 Developmental Network Grants for Interdisciplinary Research R24 Developmental Network grants provide support for the development and enhancement of interdisciplinary research capabilities and pilot projects. As such, it is expected that the primary components of these projects will involve activities designed to foster interdisciplinary approaches to defined research questions. These networks are characterized by the following: o Demonstrated ability to organize, administer, and direct the network: The principal investigator should have a demonstrated history of organizing, administering and directing collaborative, interdisciplinary research activities. Further, the PI should propose a clear and feasible organizational scheme, and show a minimum time commitment of 15 percent. Other investigators must also allot a percentage of effort that is commensurate with their role in the project. Prior research collaborations among investigators under this network would be beneficial. o Integration of ideas from diverse scientific and disciplinary realms: This network should comprise a group of investigators who are interested in integrating ideas from diverse scientific and disciplinary realms. Participating researchers on this network should have external, peer-reviewed research grant support from either an NIH institute or another source. Although it is not necessary that all members of the project have independent research funding, investigators (with the exception of non-scientist mental health stake holders) are expected to demonstrate a strong record of scientific productivity and innovation. o Development of a specific set of hypotheses: The goals of the network should define the interdisciplinary mission of the study, addressing relevant theoretical and empirical literature from the scientific areas to be studied. The potential for developing significant and innovative interdisciplinary research should be demonstrated. Accordingly, the study should clearly describe the scope and goals of intended future work, including scientific goals and how this network will serve as a critical stepping stone for future anticipated mechanisms of support (e.g., Collaborative R01 submissions) that are expected to emerge from the developmental process. o Seed money and start-up funds may be requested to support new, innovative pilot projects that reflect: (1) research that is needed to facilitate the translation of basic science findings to applied research issues, and (2) research on clinical or services issues that incorporate the theories or methods of basic science, or vice versa. o Access to specialized resources and equipment: Funds may be used to facilitate access to resources such as those for genomics, brain imaging, electronic communication media, bioinformatics and computational services to facilitate collaborative capabilities. o Plans for interdisciplinary research apprenticeships to facilitate cross- fertilization of knowledge: These networks should include opportunities for at least two young investigators to be mentored in one or more areas of specialization, and specifically address the application of basic research principles to clinical or services issues. Project leaders are expected to make maximum use of the variety of funding mechanisms available to foster the development of junior scientists with expertise in interdisciplinary research (e.g., minority supplements, mentored K awards). Specialized training of personnel in cross-disciplinary concepts and approaches is strongly encouraged. Research Themes The following are examples of broad research themes that might be the focus of interdisciplinary efforts. They are not meant to be exhaustive or restrictive, but to highlight areas of particular interest for advancing the Institute"s research agenda on children"s mental health. Core Components, Processes, and Mechanisms of Action of Therapeutic Interventions The past 25 years of clinical trials in child and adolescent mental health interventions have yielded evidence for the efficacy and effectiveness of certain interventions. Further, research indicates that processes of implementation such as fidelity and family engagement are linked to outcomes of interventions. Thus, intervention-related changes may be due to key processes or components of an intervention or factors related to the manner and context of the intervention"s delivery. Yet, the active components and processes by which such change occurs are not well understood. Conceptual models or specific theories about how interventions achieve therapeutic change are needed. Further it is important to identify the active ingredients or processes of interventions and the causal mechanisms that mediate effective and sustained benefits. Identifying core processes of interventions that potentiate the outcomes of interests is important if consumers of research and buyers of services are to make informed choices about how to improve the efficiency of services. This network could focus on: o Identifying key components or active ingredients that represent specific components of an identified intervention that mediate change. The mechanism of change may occur at multiple levels (e.g., decreased deviant peer association (active ingredient) mediated by increased parental monitoring of child activities (change in family interaction), leading to decrease in aggression and change in neurochemical activity) o Identifying key processes that mediate therapeutic change, maintenance of gains, and relapse. Such key processes may be non-specific, and may or may not draw directly upon knowledge about the disorder itself (e.g., therapeutic alliance, client motivation, changes in expectations, attributional changes) o Understanding how the implementation process (e.g., family engagement, intervention x client fit, provider characteristics, organizational factors) and service delivery context (e.g., home vs. school or primary care vs. specialty clinic) may influence outcomes. Functional Impairments in childhood mental disorders Assessment of functioning has lagged behind the assessment of clinical symptoms in children"s mental health research. The definition of what constitutes functional impairments varies greatly across professional disciplines and service systems involved in providing mental health care (e.g., education, welfare, juvenile justice, primary care, substance abuse, specialty mental health). In addition, the serious economic and societal burden of childhood mental illness requires developmentally-appropriate tools to help researchers, policymakers and other mental health stakeholders to (1) assess the form, frequency, and severity of functional impairments, (2) account for the relative importance of these impairments vis- -vis the particular sociocultural contexts in which a child lives, and (3) project future needs for mental health treatment and support. Limited conceptual models and tools have been developed with which to examine issues related to functioning. Both animal models and basic behavioral studies can contribute to the assessment of functioning. There is a need for detailed empirical study of specific social, cognitive, emotional, and behavioral processes that are impaired in childhood disorders and their relationship to broader areas of functioning (e.g., social and academic functioning). For example, o Identifying critical deficits in memory, attention, language, emotional processing and regulation, social cognitive capacities, and dimensions of child temperament. Specifying the nature of deficits in these domains to identify genetic, biologic and experiential risk processes involved in the etiology of these deficits o Developing new assessment tools by taking advantage of knowledge in basic and behavioral sciences. For example, animal models, biological measures, measurement theory (i.e., Item Response Theory), and computerized adaptive testing may be applied in developing new tools. Of particular interest are psychometrically sound measures that are sensitive to intervention related changes and usable in clinical settings o Developing targeted interventions where researchers have already documented specific cognitive and psychophysiological deficits and fMRI differences associated with childhood mental disorders, understanding how those deficits are related to specific functional problems and how such problems may be addressed by interventions and rehabilitation. Disorders of Mood Regulation Mood disorders are among the most prevalent, recurrent, and disabling of all illnesses. Childhood unipolar and bipolar mood disorders, while rare, can be chronic and recurrent conditions. Adults often report onset of their depressive disorder in late adolescence or earlier. Recent studies of children and adolescents confirm that serious symptoms of mood disorders are detectable. Further, these disorders are often associated with adverse and chronic illnesses or disabilities and tend to be familial. While many risk factors for mood disorders have been identified, these are correlates rather than causal. The etiologic processes that give rise to unipolar and bipolar disorders remain elusive, despite significant knowledge growth in the basic sciences. Integrated models are needed to understand the interplay among genetic, biologic and environmental risk processes involved in mood disorders and their relationship to commonly comorbid conditions. Interdisciplinary networks that can draw from the substantial knowledge and tools from diverse fields such as epidemiology, genetics, developmental neuroscience, developmental psychology, cognitive, behavioral and clinical science are encouraged. Such networks might focus on: o Understanding the mechanisms behind the well-documented sex disparity in the prevalence of unipolar depression from puberty onward, including the role of biologic changes (e.g., hormonal, morphological), social changes or their interactions, the impact of early adverse experiences on the developing stress-response system, and the neuropathophysiology of depression in the developing brain to improve targets of intervention o Developing interventions or service delivery models that are sensitive to differences in the neuropathophysiology of depressed pre-pubertal children, with attention to factors such as cognitive capacity, familial culture, environmental adversity, comorbid conditions, or other factors that may influence treatment course and outcome o Clarifying the development of bipolar disorder through studies examining the genetic and neurobiologic determinants of extreme mood lability in childhood and environmental contributions to course, outcomes, and cormorbidity with other mental disorders. Dissemination and Implementation for Treatment and Prevention Efficacious interventions for child emotional or behavior problems exist (e.g., psychopharmacologic, psychosocial, integrated interventions), however, these interventions are not commonly implemented into practice. Efforts to disseminate knowledge to stakeholder groups or implement "evidence-based" interventions have often failed partly due to their poor fit with the target audience or setting context. "Dissemination" involves the targeted distribution of information to a specific audience. "Implementation" is the use of strategies to introduce or change practices within communities. Current conceptual models, methods, and strategies have largely failed to facilitate dissemination or implementation efforts to translate research to practice. Interdisciplinary networks are needed to explore the complex nature of such dissemination or implementation processes. Community-based child mental health preventive or treatment services are often provided outside of traditional mental health specialty care, however, relevant stakeholders from these settings are often not involved in intervention development or testing. These stakeholders (i.e., state/county health administrators, family members, pediatricians, teachers, social workers) will be critical to both the dissemination and implementation process. Interdisciplinary networks on either dissemination or implementation processes could draw from the substantial knowledge and tools of the stakeholders listed above as well as more traditional research disciplines (e.g., clinical scientists, social scientists, methodologists, economists, anthropologists, public policy, information theory, marketing). Such interdisciplinary networks could focus upon, but are not limited to, the following: o Understanding how messages about mental health treatments and prevention can be created, packaged, delivered, and evaluated within a dissemination study. Since dissemination is concerned with the transmission and reception of messages, networks might draw upon the fields of information theory, marketing, organizational theory, or learning. o Understanding the specific contexts in which information on interventions is disseminated or in which interventions are being implemented. Various service providers (teachers, administration, social workers) and delivery contexts (e.g. primary care) likely require unique information or intervention delivery strategies. o Understanding the process of implementing evidence-based interventions, involving factors such as provider behavior change, decision-making, consumer help-seeking and motivation, management and financing. The outcome of implementation studies is the use of the intervention in real world settings. o Clarifying factors that influence the sustainability of treatment or preventive interventions. Networks might examine the impact of past dissemination and implementation trials, as well as design pilot studies to assess the sustainability of messages, treatments, and programs. 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 (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 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: http://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. 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: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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 to Dr. Serene Olin by the letter of intent receipt date listed in the heading of the RFA. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must 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. The title and number of the RFA must be typed on line 2 of the face page of the application form and the YES box must be marked. For the R24 mechanism, the background section must include a description of already funded component projects that is sufficient to enable an assessment of the degree to which the R24 grant would facilitate collaborative approaches to the research problem. This section also should contain a rationale for why this group of components and investigators was selected, and why the requested consortium support is likely to significantly enhance progress on the research problem, beyond what could be accomplished with the individual research grant support. If some of the participating investigators are at the same institution, a rationale must be provided explaining how this R24 mechanism will enhance integration and collaboration amongst those participants, beyond what would normally be expected of a group of investigators with shared interests at the same institution. The Research Plan should contain a description of the approaches and how they will be accomplished to further the research goals. The principal investigator should describe how the activities will be coordinated and made accessible to all participating components. Applicants should also include specific plans for sharing data and materials that may be generated through the consortium grant. The Resource section should address existing intellectual and other resources. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. 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. 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: Jean Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9609 Bethesda, MD 20817 (for express/courier service) 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 the CSR and responsiveness by the NIMH. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIMH in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and 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, assigned a priority score, and receive a second level review by the National Advisory Mental Health 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. In the written comments reviewers will be asked to discuss the following aspects of the application 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 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 major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Will the collaborative activities supported by this application further research on 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? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project and to the type of application, i.e., R21 or R24? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the basic research components and research questions suitably chosen to represent a feasible and potentially valuable interdisciplinary project? (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 principal investigator appropriately trained and well suited to carry out this work? Does the interdisciplinary network involve basic and clinical/services expertise, other mental health stakeholders and experts as appropriate? Is the work proposed appropriate to the experience level of the principal investigator and collaborative researchers? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Additional Review Criteria for the R24 grant mechanism: o Will the proposed collaborative activities and/or resources significantly enhance the ability of the investigators to address the goals of the component projects? o Do the component projects address a common problem and are they suitable for a collaborative and integrative approach? o Have the team members been assembled with respect to employing the expertise needed to address the shared research problem, regardless of their location? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. o The adequacy of the proposed plan to share data, if appropriate. Schedule Letter of Intent Receipt Date: March 4, 2002 Application Receipt Date: April 10, 2002 Peer Review Date: June/July 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 30, 2002 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 INQUIRIES Inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to the individuals listed on the following website: http://www.nimh.nih.gov/grants/MH02011rfacontacts.cfm Direct inquiries regarding fiscal matters to: Joy Knipple Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-8811 FAX: (301) 443-6885 Email: jk173r@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. 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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