TRANSLATIONAL RESEARCH CENTERS IN BEHAVIORAL SCIENCE (TRCBS) RELEASE DATE: August 25, 2004 PA NUMBER: PAR-04-151 Update: The following update relating to this announcement has been issued: August 26, 2009 - See Notice NOT-MH-09-017 Second Amendment to the Notice to Discontinue this PAR as of September 26, 2009. (See Notice NOT-MH-09-014 Notice to Discontinue this PAR, NIMH will no longer accept renewal (competing continuation) applications of center grants from this program ) (See Notice NOT-MH-06-121 Notice of Discontinuation and New Total Costs Limits) EXPIRATION DATE: October 23, 2006, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) LETTER OF INTENT RECEIPT DATE: September 22, 2004, September 22, 2005, September 22, 2006 APPLICATION RECEIPT DATES: November 15, 2004, October 19, 2005, October 22, 2006 CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THE PA This PAR replaces PAR-01-027. 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 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/publicat/nimhtranslating.pdf). 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). 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 PA 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. 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 PA: (http://grants.nih.gov/grants/guide/pa-files/PAR-04-004.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-02-122.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 and 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 with subcontracts.) 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. MECHANISM OF SUPPORT This PA will use the NIH Specialized Centers (P50) award mechanism, 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. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. 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 PA 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 PHS 398. (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html) ELIGIBLE INSTITUTIONS You may submit an application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic institutions/organizations o Foreign institutions are not eligible to apply INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Bruce N. Cuthbert, Ph.D. 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: email@example.com Ann A. Hohmann, Ph.D., MPH Division of Services and Interventions Research National Institute of Mental Health 6001 Executive Boulevard, Room 7135, MSC 9631 Bethesda, MD 20892-9631 Telephone: (301) 443-4235 FAX: (301) 443-4045 Email: firstname.lastname@example.org Direct your questions about peer review issues to: Michael Kozak, Ph.D. Divisions of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6138, MSC 9606 Bethesda, MD 20892-9608 Telephone: (301) 443-1340 FAX: 301) 443-4720 Email: email@example.com o Direct inquiries regarding fiscal matters to: Rebecca D. Claycamp, CRA Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6122, MSC 9605 Bethesda, MD 20892-9605 Rockville, MD 20852 (overnight) Telephone: (301) 443-2811 FAX: (301) 443-6885 Email: firstname.lastname@example.org LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Bruce N. Cuthbert, Ph.D. 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: email@example.com SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS 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 revised Type 1 applications only; not to exceed 10 pages; for revised 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 revised Type 2 applications only; not to exceed 3 pages for each project supported in the previous Center grant; for revised 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 APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the application deadlines listed in the heading of this PA. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting $500,000 or more must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material 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 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3367 FAX: (301) 443-4720 Email: firstname.lastname@example.org APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this PAR. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The correct standard language from the PA template should be used here. KFS The Center for Scientific Review (CSR) will not accept any application in response to this PA 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 a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIMH in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o 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 and assigned a priority score o Receive a written critique o 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual 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 tactics? 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? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 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: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: 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 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. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting $500,000 or more in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. 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. REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible http://grants.nih.gov/grants/policy/data_sharing. Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the “Standards for Privacy of Individually Identifiable Health Information”, the “Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on “Am I a covered entity?” Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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