TRANSLATIONAL RESEARCH CENTERS IN BEHAVIORAL SCIENCE (TRCBS) Release Date: December 5, 2000 PA NUMBER: PAR-01-027 (see replacement PAR-04-151) National Institute of Mental Health (http://www.nimh.nih.gov/) Letter of Intent Receipt Dates: February 12 and September 22, 2001 September 22, 2002 September 22, 2003 Application Receipt Dates: March 12 and October 22, 2001 October 22, 2002 October 22, 2003 PURPOSE The National Institute of Mental Health (NIMH) invites research grant applications for Translational Research Centers in Behavioral Science (TRCBS). The purpose of these centers is to support the translation of work from basic behavioral science research, and relevant integrative neuroscience research, to pressing issues regarding all aspects of mental disorders. Such clinical issues include an understanding of the etiology and assessment of disorders, the assessment of functioning, development of innovative and culturally appropriate preventive, treatment and rehabilitation interventions, and improvement of methods for the effective delivery of mental health services. The centers are also intended to encourage basic behavioral scientists to seek a further understanding of behavioral processes through an exploration of how those processes are altered by mental and behavioral disorders. These Centers are intended to support integrated research teams drawn from the fields of basic behavioral and social sciences, neuroscience, epidemiology, prevention, academic mental health, and mental health services delivery. Centers are to develop hypothesis-driven approaches to an important research question, or a focused set of research questions, using innovative designs and cutting-edge approaches to methodological and statistical issues. An important goal of the centers is to transcend the barriers of disciplines, research settings, and institutions in order to harness the full range of modern behavioral science to the service of the nation’s critical mental health needs. (See the recent Institute of Medicine report, Bridging Disciplines in the Brain, Behavioral, and Clinical Sciences, available at http://books.nap.edu/catalog/9942.html.) This Program Announcement (PA) is one of two announcements developed in response to a report written by the National Advisory Mental Health Council’s Behavioral Science Workgroup, entitled Translating Behavioral Science into Action (http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm). The other announcement describes a range of collaborative arrangements designed to foster smaller-scale and developmental activities in translational research in the behavioral sciences (see RFA-MH-01-005 at http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-01-005.html). This PA expires 3 years from the Release Date shown above. 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 PA, Translational Research Centers in Behavioral Science, is related to the priority area of Mental Health and Mental Disorders. 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 center grants (P50). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT A TRCBS will use the Center Grant mechanism (P50), which provides support for multidisciplinary and multi-investigator approaches to the investigation of specific and complex research problems requiring the application of diverse expertise and methodologies. Applicants may request support for a period of up to 5 years, followed by a competitive renewal application for a second 5-year period. The NIMH will not support individual Centers for longer than two funding periods. Centers are limited to $1.5 million in direct costs in any single year, including non- competing continuation years. Competitive supplements will not be considered for these Center grants. It is anticipated that individual projects that are outgrowths of Center activity will seek independent funding through mechanisms such as research project grants (R01). Since TRCBSs are defined by their integrative nature and not by departmental or geographic boundaries, projects constituting a given Center may be based at a variety of institutions, representing both basic and clinical or services research. While 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 program direct costs cap of $1.5 million per year. (However, these costs should be indicated as instructed on Form 398, rev. 4/98.) RESEARCH OBJECTIVES Background As enumerated in the recent Surgeon General’s report on mental health (available at http://www.nimh.nih.gov), mental disorders affect approximately 15-20 percent of the U.S. population, annually. These disorders represent a major cause of disability: In a recent study of developed nations, mental disorders comprised four of the ten most severe causes of disability (depression, schizophrenia, bipolar disorder, and obsessive-compulsive disorder). In the most recent estimate, the costs of treating mental illness were nearly $70 billion per year, with billions of dollars more in lost wages and other indirect costs. In view of these pressing needs, all available resources must be applied toward efforts to improve the prevention, treatment options, and delivery of services for mental disorders. The field of behavioral science represents a major potential resource to address these urgent problems. Accordingly, NIMH has for many decades been a primary source of support for research in the basic behavioral sciences. This long-term investment in behavioral research has resulted in the development of a large literature of data, theories, and methods regarding various aspects of human behavior. A number of investigators have applied this body of knowledge to issues in mental disorders. However, to a surprising extent, considerable areas of relevant and potentially valuable basic behavioral research have remained largely separated from academic clinical departments, schools of public health, or mental health services settings. A number of problems can be identified which impede such translation. These include: growing disciplinary fragmentation, the fact that basic, clinical, and services researchers typically work in different venues, a disjunction in training between basic and clinical researchers, the incentive system in academic research, which typically rewards quantitative productivity in narrow areas, and, the frequent unavailability of clinical populations to basic researchers. In 1999, the NIMH Director and the National Advisory Mental Health Council convened the Behavioral Science Workgroup to explore ways to increase the impact of behavioral science research on public mental health issues. The Workgroup was comprised of experts in social, cognitive, developmental, and clinical psychology, psychophysiology, anthropology, sociology, public health, and biostatistics. In their report, "Translating Behavioral Science into Action," they highlighted three priority areas of translational behavioral science research. These included: (1) Basic behavioral processes in mental illness, (2) Functional abilities in mental illness, and (3) Contextual influences on mental illness and its care. Regarding these three areas, the Workgroup wrote: "These priority research areas are critical starting points for progress in translational science because they are at the interface of what end-users have identified as important and what behavioral science researchers regard as areas of opportunity. They offer the prospect of conducting exciting research, advancing scientific understanding of behavior in health and in illness, and improving the mental health of our Nation." This announcement represents a major NIMH effort to implement the Workgroup’s report, by providing for large-scale research centers with the scale and resources to overcome the barriers to effective translational research. It is expected that Centers will include sites with multiple components drawn from basic research in behavioral science and relevant neuroscience, and other components comprising high-risk populations, clinical populations, and/or settings where mental health services are provided. In addition to these fundamental components, Centers are intended to provide for the development of innovative advances in appropriate methodological and statistical techniques, and support the training of a new generation of research scientists schooled in the integration of basic and clinical science. Center Characteristics o TRCBSs are expected to be organized around a specific and focused set of hypotheses, in which one or more areas of basic behavioral science are applied to clinical issues in mental disorders or mental health services delivery. Centers will involve a multidisciplinary team of basic and clinical or services researchers organized to communicate across boundaries or disciplines, institutions, and settings. Collaborations among different institutions are encouraged in view of the frequent distinctions between basic science and clinical/services settings. However, the TRCBS must indicate how communication will occur across institutional and geographic boundaries so that fully developed collaborative research partnerships can occur. o TRCBSs are expected to include components from both basic behavioral science and clinical or services research settings. Each TRCBS must demonstrate the integration of basic and clinical work, with an organization conceived to promote sharing of information in both directions between the basic and clinical or services components. Thus, research programs in the basic behavioral sciences should serve as a source of concepts and methods for clinical work, data gathered from clinical or high-risk populations may prompt additional research questions to be tested with non-clinical samples, or new methodological questions to be addressed. o The inclusion of investigators and research programs from relevant areas of biological science and neuroscience (e.g., psychophysiology, neuroimaging, neurohormonal measurements) is strongly encouraged, but not required. The focus of neurobiological measures should be on their integration with concepts and data drawn from behavioral science. o A TRCBS is intended to promote innovative translational research. A Center should not duplicate ongoing research, and should demonstrate how the proposed Center activities represent a novel synthesis of basic and clinical science. o The director of a TRCBS should be a distinguished senior scientist, with a strong record of prior research and scholarly activities. The director should also demonstrate the capability to organize, lead, and administer the Center. In addition to serving as the scientific head of the Center, this individual should also direct at least one of the individual projects, and allot a minimum time commitment of 30 percent effort to the Center. o Principal investigators of individual projects within the Center should be established investigators in their respective fields, with a strong record of basic, clinical, or services research. Principal investigators of the projects are not required to have independent funding, but must demonstrate the experience and qualifications to provide scientific leadership of the project. o The clinical and/or services components of the proposed Center may include any aspect of relevant work. These components are to include research with patient populations, that is, studies conducted with persons at high risk for mental disorders, diagnosed with a disorder, or with organizations that provide mental health services. The TRCBS must outline clearly the ways in which the contributions of basic behavioral science (concepts, principles, extant literatures, paradigms, measures, statistical approaches, etc.) are to be applied to the research questions in a clinical or services setting. o It is expected that the basic behavioral science components of a Center will include active programs of experimentation, methodological or statistical development, or other scientific work that serves to advance the knowledge base being applied to the clinical applications. That is, basic behavioral scientists should not serve only in a consultative role to clinical/services projects. The basic research components could also address basic research questions arising from results with samples drawn from high- risk/clinical/services settings. o A TRCBS must include research apprenticeships. These should include opportunities for young investigators to gain experience with the concepts, methods, and techniques in one or more areas of specialization. Research apprenticeship opportunities should specifically address the application of basic research principles to clinical or services issues. Centers should coordinate closely with other pre- and post-doctoral training programs at the institutions involved. Special attention should be given to the recruitment and training of minority and/or disabled students and scientists. o Each TRCBS should include a program of outreach to facilitate public awareness of the issues involved in the research, the integration of basic and clinical or mental health services research, and the advances that are achieved by the Center’s activities. Research Areas The goal of the TRCBS program is to support the translation of basic behavioral science research to significant issues in mental disorders and mental health services. Relevant areas of basic behavioral research include: cognition, including learning, memory, perception, etc., affective processes, including emotion, mood, and motivation, temperament and personality, social cognition, social and cultural influences and processes, attitudes and persuasion, interpersonal relationships, and fundamental biobehavioral processes such as sleep and eating (http://www.nimh.nih.gov/publist/953682.htm). Basic research may include animal models as well as studies with human populations, and may also involve theoretical and/or mathematical modeling approaches. Relevant domains of neurobiological measurement could include psychophysiology (both peripheral and central nervous system measures), neuroimaging, and neurohormonal activity. It is anticipated that activities of a TRCBS might well include work drawn from a number of these fields, e.g., the mutual interactions of cognitive and affective processes in mental disorders and their effect on responsiveness to treatment. Clinical issues are expected to involve significant issues in the etiology, assessment, prevention, treatment, or rehabilitation of mental disorders or the delivery of mental health services with respect to children or adults. Applied research can include the use of both qualitative and quantitative methods. A major priority of the NIH is to study disparities in health across different ethnic and minority groups. Accordingly, it is strongly encouraged that both basic and clinical studies include a broad representation of subjects with respect to gender, ethnicity, age, etc., wherever possible, groups should be large enough to provide sufficient power for meaningful statistical tests of these group differences. The TRCBS program is designed to foster the integration of basic behavioral research with mental health prevention, clinical, and services research. In contrast, research that is focused only on fundamental psychological and neural processes likely to be involved in mental health and mental illness is not appropriate for the TRCBS program. For information regarding interdisciplinary basic behavioral science centers, investigators should consult the following announcement: (http://grants.nih.gov/grants/guide/pa-files/PAR-00-130.html). Research that is primarily directed toward the pathophysiology of mental disorders, as opposed to integrative behavioral and physiological investigations, is also not appropriate for a TRCBS. Investigators interested in these topics should consult the NIMH web site for information on the Silvio Conte Centers for the Neuroscience of Mental Disorders (http://grants.nih.gov/grants/guide/pa-files/PAR-98-058.html). The following list provides some examples of broad research areas that could fit in the Centers program. This list is not meant to be comprehensive, nor are the examples meant to be exclusive of other topics. o Studies of temperament, mood, emotion (including emotion dysregulation), and cognition, as they are mutually involved in the etiology and course of mood and anxiety disorders o Research pertaining to factors that support the behavior of patients with serious mental illness in their daily functioning and therapeutic regimens (e.g., mechanisms of learning and memory in patients with serious mental illnesses, mechanisms of emotional response and emotional control in these patient groups, optimal characteristics of service providers, and the organization of mental health services in these populations) o Studies of processes that affect the risk, course, severity, prevention, and treatments for attention-deficit/hyperactivity disorder (ADHD) (e.g., models of normal temperament development, relation between temperament and cognitive development, age-appropriate models of ADHD, advances in appropriate measurement and diagnosis, measurement of cognitive and emotional processes in ADHD, and the relationship of central nervous system activity to behavioral measures across developmental age) o Research using concept and methods of basic behavioral science to identify specific functional deficits in mental disorders, development of targeted interventions for rehabilitation, and ways to organize the delivery of mental health services in the current health care context to provide optimal rehabilitation services o Research on new methods of conceptualizing and classifying mental disorders, as considered from multi-disciplinary perspectives (e.g., utility of dimensional approaches to such areas of psychopathology as mood disorders) o Research on the prevention of mental disorders, integrating basic research on biological, psychological, and social risk and protective processes in order to develop new models of preventive interventions. Prevention may include interventions to (a) reduce the risk of onset, or delay onset, of mental disorders and behavioral dysfunction, (b) reduce the severity and course of disorder, (c) prevent comorbid conditions, and (d) prevent relapse, excess disability, and inappropriate service use. o Research regarding the interaction of behavioral and neurophysiological processes in schizophrenia such as studies of the interaction of cognitive and emotional processes (as measured behaviorally and neurophysiologically) involved with functional deficits in psychotic disorders, combined behavioral and CNS measures to develop an enhanced understanding of the various symptom patterns and their interrelationships (e.g., positive and negative symptoms, cognitive disorganization) in psychotic disorders, and development of behavioral techniques that may act through brain plasticity to ameliorate functional deficits in patients with schizophrenia) o Research programs to study the factors involved in improving mental health services in primary care settings (e.g., factors influencing the decision to seek treatment, methods of improving provider behavior to recognize, diagnose, and treat mental disorders, development of valid and reliable screening and other assessment techniques for use in primary care settings, studies of alternative providers, procedures, and technologies to facilitate mental health services in primary care settings o Research to develop an understanding of the behavioral and neurobiological deficits in autism (e.g., aspects of social and cognitive behavior as related to activity in specific brain regions, and development of behavioral and pharmacologic interventions for improvement of autistic symptoms) Activities Supported To provide a suitable structure for achieving the goals of the research program, a TRCBS may request funds for the following: Individual Research Projects Funds must be requested to support a number of research projects. It is expected that 2 or more of the research projects will involve the basic behavioral sciences and/or relevant neuroscience. (Investigators contemplating a project with only 1 or 2 basic science components should consider a single R01 application or a set of Interactive Research Project Grant applications.) At least 1 of the research projects must involve work with patient populations, that is, studies conducted with persons diagnosed with a mental disorder, or with organizations that provide mental health services. However, multiple projects in clinical or services settings are also encouraged, for purposes of increasing the number of patient subjects, representing different aspects of clinical phenomena, or increasing the diversity of patient populations with respect to ethnicity, gender, or age. Each project must demonstrate the capability to integrate strongly with other projects of the Center. It is anticipated that TRCBSs will request support for 1 or more core activities. These could include such functions as administration, subject recruitment, methodological developments (e.g., diagnosis, assessment instruments), data management procedures, or statistical analysis (including innovation in statistical methodologies as well as conducting actual statistical tests). The TRCBS should clearly indicate how the cores will support the integrative, translational mission of the Center. Core support may include salary costs, research resources shared across projects, equipment needed to conduct the research, and incidental alteration and renovation of facilities needed as consistent with Public Health Service policy. Essential Scientific Expertise To provide the most effective combination of scientific knowledge and skills, applicants may request funds to support scientists to augment or strengthen the skills, expertise, and capabilities of existing Center staff. Recruitment of such individuals may take place after an award has been made, however, the expertise required, the role in Center activities, and the time to be devoted to the Center should be provided in the application. It should be emphasized, however, that after an award is made, such individuals cannot serve as a substitute for a Project principal investigator. Advisory Board An external advisory board should serve as an important source of guidance from experts in the field who do not have a vested interest in the Center or in the research to be conducted by the Center. Board members should include individuals drawn from both basic science areas and from clinical or services areas who have relevant experience and expertise. Funds may be requested to support travel of board members for meetings in the beginning of the second year of funding, and for one or two additional meetings across the project period. To avoid reducing the pool of potential reviewers, applicants should not identify, choose, or contact prospective board members before a funding decision is made. 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report 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. 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. LETTER OF INTENT Prospective applicants are asked to submit, by the dates indicated in the heading of this PA, a letter of intent that includes: a descriptive title of the proposed Center, 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 this PA. 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 NIMH staff to estimate the potential review workload and to plan the review. The letter of intent should be sent to Dr. Bruce Cuthbert, at the address listed under INQUIRIES, below. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program contacts listed under INQUIRIES with any questions regarding the responsiveness of their proposed project to the goals of this PA. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted on March 12 and 22, 2001, October 22, 2002, and October 22, 2003. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: GrantsInfo@nih.gov. Applications are also available on the World Wide Web at http://grants.nih.gov/grants/forms.htm. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the applicant must obtain agreement from the Institute staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html. Any application subject to this policy that does not contain the required information in a cover letter sent with the application will be returned to the applicant without review. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. A major requirement for a TRCBS is the conduct of multidisciplinary research focused on the integration of multiple areas of basic behavioral and neuroscience, as they converge to address an important set of issues regarding mental disorders and/or the delivery of mental health services. The application must describe the hypotheses to be tested and the goals of the TRCBS. In addition, the application should clearly articulate the reasons a Center approach is needed for this work and the unique benefits that will accrue from having a Center in this research area, rather than addressing the research issues through other modes of support. Using the PHS Form 398, the application should include the following components in the designated order. Information for the entire Center: o Face Page, pertaining to the entire Center o Description, performance sites, and Key Personnel (Form Page 2), pertaining to the entire Center o Table of Contents (Form Page 3) for the entire application o Budget (Form Pages 4 and 5). Categorical figures should be provided to describe the budget of the overall Center. Since detailed budget justification will be provided separately for each project and core (as described below), only items for which justification is not provided elsewhere should be included in narrative here. o Biographical sketches of Key Personnel (Form Page 6). These should be provided for key personnel of the entire Center, and should be arranged alphabetically based on the individual’s surname. o Other Support (Form Page 7) of key personnel for the entire Center, presented alphabetically by surname. o Resources (Form Page 8). These should be restricted to those not described separately for the individual projects and cores. o General description of the overall Center (not to exceed 10 pages, amended applications should include a one-page introduction to the revision). Provide an overview of the entire proposed Center, describing the Center goals and how they will be achieved. Explain the contribution of each of the individual projects and cores to achieving the Center’s objectives, and how these components relate to each other. o Evidence of Feasibility and Preliminary Findings (for new--Type 1-- applications and amended Type 1 applications only, not to exceed 10 pages, for amended applications, provide a one-page introduction describing changes from the previously submitted version). Present evidence that the research team will be able to work together to achieve the research goals of the Center, preliminary results, evidence of competence in the areas proposed, and any other information that speaks to feasibility. o Progress Report (for competing continuation--Type 2--applications and amended Type 2 applications only, not to exceed 3 pages for each project supported in the previous Center grant, for amended applications, provide a one-page introduction to the entire Progress Report describing changes from the previously submitted version). Describe the research progress of the previously supported Center and the manner in which the results relate to the current application. Describe the manner in which the Center mechanism provided synergy to the previously funded Center. o Operational Plan for the Overall Center (not to exceed 10 pages, for amended applications, provide a one-page introduction describing changes from the previously submitted version). Describe the working administrative and logistical arrangements, as well as resource support necessary to implement the research. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included (and documented in the Letters of Support section). Also include in this section a description of the manner in which an external advisory board will relate to the Center. Prospective board members should not be chosen or contacted prior to a funding decision and, therefore, should not be named in the application. Finally, describe the plan for providing access to data, research tools, and any biological material generated by the Center. o Research Career Development and Outreach Plans (not to exceed 2 pages). Describe how the Center will provide opportunities for junior investigators, including the Research Apprentice positions as well as relationships with training programs of participating institutions. Also, describe plans for disseminating information to the public regarding the activities of the Center. Information for each Project or Core: Provide, in the order indicated: o Description, Performance Sites, and Key Personnel (Form Page 2), referring specifically to the project or core. o Budget (Form Pages 4 and 5). Detailed budgetary information for each project or core, including narrative justification. o Resources (Form Page 8), referring specifically to the project or core. o Research Plan for Individual Projects (not to exceed 10 pages for any one project, for amended applications, provide a one-page introduction describing changes from the previously submitted version). Describe the specific aims, background, and significance, the research questions to be addressed, and the hypotheses to be tested. Address the ways in which the particular research question lends itself to a translational approach. Projects should describe the bi-directional flows of data and research questions that are anticipated between basic and clinical or services research projects. Describe the research design and methods in as much detail as possible, and address issues of feasibility, potential pitfalls, alternative approaches, and relevance to Center goals. o Descriptions of Individual Cores (not to exceed 8 pages for any one Core, for amended applications, provide a one-page introduction describing changes from the previously submitted version). Describe how the core will contribute to the overall goals of the Center, including the facilities, resources, services, and professional expertise that it will provide. Describe which projects will be supported by the Core and the manner in which that support will be rendered. o Literature Cited, compiled across all sections of the application o Letters of Support from Collaborating Institutions o Checklist o Personal Data on Center Director Submit a signed, typewritten original of the application, including the Checklist, and four 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, one additional copy of the application must be sent to: Jean Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Blvd., Room 6154, MSC 9609 Bethesda, MD 20892-9609 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by CSR for completeness and by NIMH program staff to determine if they satisfy the objectives and requirements of a TRCBS as outlined in this PA (excluding scientific or technical merit). Applications that are incomplete or that do not meet these objectives and requirements will not be accepted and will be returned to the applicant. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NIMH in accordance with the standard NIH peer review procedures. 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 applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Mental Health Council. Although primary assessments of scientific priority will be based on the Center as a whole, one or more individual projects or cores could receive lower priority in some instances, resulting in funding of a Center smaller than proposed. Review Criteria Criteria for review of scientific and technical merit will include the following: o Intrinsic Merit: The overall quality, scientific merit, and innovation of the research to be conducted, the likelihood that the Center will lead to fundamental advances, to new discoveries, and/or to new technological developments. In addition, the research must center around a highly focused and well defined set of research questions. o Appropriateness of the Center Approach: The need for and suitability of a Center approach, whether a Center approach will add significantly to what could be accomplished through other modes of research support. In this respect, the integration and interdependence of component projects and cores is of utmost significance and should be described explicitly. o Research Competence: The qualifications and scientific credentials of the Center Director and constituent project directors, these individuals should be regarded by their peers as leaders in, and at the forefront of, their respective fields. o Center Director Credentials: Demonstrated ability of the Center Director to organize, direct, and administer the Center and, in addition, be the Principal Investigator on at least one of the individual projects. It is expected that this individual will devote a minimum of 30 percent time to the Center grant. The Director must be the scientific leader of the Center. o Institutional Commitment: The nature and level of resource commitments and resources available from the home institution and from other participant institutions, and plans for interactions with the rest of the sponsoring institutions. o Appropriateness of Management Plans and Arrangements: The feasibility and adequacy of the organizational and administrative plans, the appropriateness of the budget, and the mechanisms to evaluate the Center’s progress. o Quality of Plans for Research Apprenticeships: The effectiveness of approaches used to attract and involve junior investigators and students who show potential for significant contributions to translational research and independent research careers. o Quality of linkages between the proposed Center and ongoing training programs in the institutional environment. o Outreach: Quality of approaches used to disseminate information regarding the Center’s activities as they relate to public understanding of the ways in which basic behavioral and neurobiological sciences are harnessed to address important issues with regard to our understanding of the nature of mental disorders, and the delivery of mental health care services. 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 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. AWARD CRITERIA Applications will compete for available funds with all other recommended applications assigned to NIMH. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. The P50 grant supporting a TRCBS is not transferable to another institution. RECEIPT AND REVIEW SCHEDULE To ensure a uniform review quality, all applications will be reviewed by a single review group, which will meet once per year. In accordance with this objective, there will be one receipt date each year. Applications received after this date will be returned to the applicant without review. RECEIPT AND REVIEW SCHEDULE Letter of Application Initial Review Council Earliest Intent Receipt Date Group Meeting Meeting Start Date Feb. 12, 2001 March 12, 2001 June 2001 Sept. 2001 Sept. 30, 2001 Sept. 22, 2001 Oct. 22, 2001 Feb. 2002 May 2002 June 30, 2002 Sept. 22, 2002 Oct. 22, 2002 Feb. 2003 May 2003 June 30, 2003 Sept. 22, 2003 Oct. 22, 2003 Feb. 2004 May 2004 June 30, 2004 INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Bruce N. Cuthbert, Ph.D. Adult Psychopathology and Prevention Research Branch Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6184, MSC 9625 Bethesda, MD 20892-9625 Telephone: (301) 443-3728 FAX: (301) 443-4611 Email: bcuthber@mail.nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@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 the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. 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 and contract 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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