PAR-04-004: INTERDISCIPLINARY BEHAVIORAL SCIENCE CENTERS FOR MENTAL HEALTH

Department of Health
and Human Services (HHS)

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INTERDISCIPLINARY BEHAVIORAL SCIENCE CENTERS FOR MENTAL HEALTH RELEASE DATE: October 3, 2003 PA NUMBER: PAR-04-004 (See Replacement PAR-07-430) (See Notice NOT-MH-06-119 Extension of and Amendments to PAR-04-004, Interdisciplinary Behavioral Science Centers for Mental Health ) (See Notice NOT-MH-06-120) EXPIRATION DATE: February 22, 2007, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) LETTER OF INTENT RECEIPT DATE: January 18, 2004, 2005, 2006, 2007 APPLICATION RECEIPT DATE: February 18, 2004; February 18, 2005; February 17, 2006; February 21, 2007 CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.242 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This PA replaces PAR-00-130. The National Institute of Mental Health (NIMH) invites applications for Interdisciplinary Behavioral Science Centers for Mental Health (IBSC). The purpose of these Centers is to support collaborative, hypothesis-driven basic research activities that will extend the most cutting-edge theories and approaches in basic behavioral science to incorporate current approaches in neuroscience. Center activities will be driven by a basic research question (or set of questions) that is framed at the behavioral level (e.g., cognition, emotion, personality, social interaction) and that is forging connection with neural-level processes. Ultimately, knowledge yielded by such connections will increase the explanatory power of behavioral science, and will enrich neuroscience by providing an ever-more-detailed understanding of behavioral and mental processes. The integration of knowledge that results will be in the service of the fullest understanding of the complex and reciprocal biobehavioral processes responsible for mental health and mental illness. In addition to support for Full-scale Center activities, support also will be available for Start-up Centers. The goal of Start-up Centers is to support a preparatory period of multidisciplinary research prior to the launching of integrative activities on a larger scale. Usually, this will be for those behavioral questions, topics, or domains for which there currently are few known links to neural processes. RESEARCH OBJECTIVES Background A broad range of substantive domains within basic behavioral science have demonstrated their critical role in elucidating fundamental mechanisms involved in mental health and mental illness. Examples are: cognitive research in attention and executive function that is fundamental to understanding deficits in both adult and childhood mental disorders; basic research in emotion that is identifying the nature and functions of both negative and positive emotion and mood; research in individual differences (including temperament) that help define both risk and protective processes; and research on interpersonal and social interaction that is demonstrating the impact of social experiences on both mental and physical health. Productive linkages of these behavioral science approaches to parallel neuroscience approaches have begun, particularly in the domains of cognition and emotion. Still, much more needs to be done in all domains to elucidate the specific paths by which behavioral processes and social experiences influence and are influenced by brain function. It is particularly important, as well, to examine the developmental course of these multi-directional influences across the lifespan. Ultimately, the full understanding of mental health and disorder will critically depend on filling these gaps in our basic knowledge of the reciprocal mechanisms linking experience, behavior, and the brain. Interdisciplinary Behavioral Science Centers (IBSCs) will support interactive collaborative research environments organized to address a cohesive, interrelated set of hypothesis-driven research questions that are stimulated by knowledge and theory in basic behavioral science and that incorporate cutting-edge methods and techniques of both behavioral science and neuroscience. In addition, Centers will be defined by diversity and cross-disciplinarity in terms of subjects (e.g., human, non-human), designs (e.g., experimental, longitudinal), settings (e.g., laboratory, field), and/or substantive domains (e.g., cognition, emotion). Centers also will offer interdisciplinary research experiences for students and junior faculty. Both Full-scale and Start-up Centers share the components and goals stated above and the characteristics listed below. In Start-up Centers, however, collaborations are expected to be less differentiated and extensive, involving a more limited range of disciplinary specialties. Research Areas Core areas of basic behavioral science that are relevant to the IBSC Program include: cognition (e.g., learning, memory, attention, language, perception, decision-making); emotion (e.g., experiential, expressive and/or physiological aspects of emotional states, emotional traits, and mood); personality processes and individual differences; motivation; social cognition (e.g., information processing, attributions, expectancies); social influences and processes; self-regulation; attitudes and persuasion; interpersonal interaction; and fundamental biobehavioral processes such as sleep, reproduction, and ingestion. Although the focus of the IBSC Program is on basic (normative) processes, the substantive relevance of the chosen topics to the understanding of mental health and mental illness must be documented and described in the application. In keeping with the integrative, multidisciplinary emphasis of the IBSC, it is encouraged that attention be given to connections across the above domains and processes, e.g., links between emotion and learning or memory, or between social experience and cognitive functioning. Developmental approaches to understanding these domains and processes also are a priority. In addition to human studies, animal models are appropriate. Also appropriate are mathematical/computational modeling approaches. In keeping with current NIH priorities related to Health Disparities, the broadest possible representation of subjects (e.g., in terms of ethnicity, sex, or age) is strongly encouraged. Where possible, power should be sufficient for testing differences within and among groups that are likely to yield information of ultimate public health importance. Neuroscience approaches relevant to the IBSC Program include examinations of neural systems, structures, circuits, or processes (e.g., development, plasticity) that are poised to inform central questions in behavioral science. Techniques may include neuroimaging (e.g., fMRI, PET, SPECT, noninvasive optical imaging), psychophysiological methods (e.g., EEG, ERP, MEG), neuroendocrine methods, and neurochemical or lesion techniques. The overriding focus of the IBSC Program is on basic principles and mechanisms in behavioral science and their links to neuroscience. In contrast, research that is primarily focused on understanding clinical disorder or applied issues such as risk/protection, treatment, prevention, or service delivery, is not appropriate for the IBSC Program. There may be specific projects or other components within an IBSC that involve mental disorder or other clinical or applied issues, but the overall emphasis and goal of the IBSC must be to advance basic science. Investigators seeking avenues for the application or translation of basic behavioral science to the understanding of mental disorders or improvements in treatment and service delivery should consider the Translational Research Centers in Behavioral Science (TRCBS), http://grants.nih.gov/grants/guide/pa-files/par-01-027.html. Basic neuroscience research that does not have an overriding emphasis on behavioral processes and research questions is not appropriate for an IBSC. Information on NIMH center mechanisms for neuroscience research is available at: http://grants.nih.gov/grants/guide/pa-files/PAR-02-121.html http://grants.nih.gov/grants/guide/pa-files/PAR-02-122.html http://grants.nih.gov/grants/guide/pa-files/PAR-02-123.html Genetics research that incorporates behavioral measures simply in order to reveal the action of specific genes is not appropriate for an IBSC. However, applications with genetic components may be considered for an IBSC if the primary goal is the understanding of experiential as well as heritable contributions to behavioral or mental function. Center Characteristics o IBSCs must address an interrelated set of hypothesis-driven research questions in basic behavioral science that are fundamental to the understanding of mental health and mental illness. o IBSCs must be conceptualized and organized according to a multidisciplinary framework that extends cutting-edge theories and approaches in basic behavioral science to incorporate current approaches in neuroscience. Expertise and technological support must be available to address the behavioral-neural linkages. o IBSCs must demonstrate synergy in their conceptualization and approach. The whole must be more than the sum of the parts. o IBSCs must address novel, innovative, and creative research questions and cross- disciplinary linkages. o The IBSC Director must be a senior scientist with substantial research and scholarly experience in basic behavioral science. S/he must have a demonstrated ability to organize, administer, and direct the Center. The Director must be the scientific leader of the Center and must also be the Principal Investigator on at least one of the individual research projects. The Director of a Full-scale Center must have a minimum time commitment of 30 percent to the Center grant (including both administrative and research efforts); for a Start-up Center, the minimum commitment is 25 percent. o Principal Investigators of individual research projects must be established scientists in basic behavioral science or neuroscience research. o An IBSC must demonstrate a high degree of collaboration and interdependence among investigators, and solid evidence of integration across the component research projects. o An IBSC must provide research apprenticeship opportunities for junior investigators to become skilled in the strategies, approaches, and techniques of cross-disciplinary behavioral science and neuroscience research. In addition, there should be close coordination between the Center and relevant predoctoral and/or postdoctoral research training programs of the institution. Special attention should be given to the recruitment and training of minority and/or disabled students and scientists. o An IBSC is conceptualized and defined by its integrative, multidisciplinary nature and need not be limited by geographical or departmental boundaries. Collaborations among different institutions are encouraged, if scientifically appropriate and feasible. o Each IBSC must have an outreach plan that makes the public aware of the importance and implications of the IBSC research for mental health and mental disorder. Activities Supported To provide a suitable structure for achieving the objectives of this program, IBSCs may request funds for the following: o Individual Research Projects: Funds should be requested to support five or more individual research projects in Full-scale Centers (three or more in Start-up Centers). Each project should have the characteristics of a traditional research grant (R01), as well as demonstrate a significant integrative contribution to the other projects in the IBSC and to the Center as a whole. If the number of projects judged to be meritorious is smaller than the specified minimum, this may preclude funding of the entire Center. o Cores: Funds may be requested for "core" support. Each Core must provide essential services to three or more approved individual research projects in Full- scale Centers (two or more in Start-up Centers). Possible Cores include those focused on administrative, subject recruitment, measurement, technological, and/or data management/analysis issues. Core support may involve salaries, research resources to be shared across projects, equipment needed to conduct the research, and incidental alteration and renovation of facilities consistent with Public Health Service policy. o Research Apprenticeships: Funds should be requested to support the supervised cross-disciplinary research activities of junior faculty, postdoctoral staff, and/or advanced graduate students. These individuals should have a high potential for a research career but require further supervised research experience. These experiences should be designed in a way that takes advantage of the cross- disciplinary, integrative character of the IBSC. Salary support, tuition, travel and research support may be provided. At least five research apprenticeships must be made available per year in Full-scale Centers (at least three in Start-up Centers). These Research Apprentice positions may not be provided to individuals receiving National Research Service Award support. o 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. Although recruitment of such scientists may take place after the award has been made, 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 such individuals may not serve as a substitute for a Project Principal Investigator after the award is made. o 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. Funds may be requested to support travel of board members for meetings in the beginning of the second and fourth years of funding. To avoid reducing the pool of potential reviewers, applicants should NOT identify prospective board members in the application or contact them before a funding decision is made. MECHANISM OF SUPPORT This PA will use the NIH Specialized Centers (P50) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. A P50 grant supporting an IBSC is not transferable to another institution. This PA uses just-in-time concepts. It does not, however, use the modular budget format; detailed budgets must be provided (see SUBMITTING AN APPLICATION below). This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. There are two levels of Center support: (1) Full-scale Centers are limited to $1.5 million direct costs in any one year. This limit applies to new grants, non-competing continuations, and any subsequent competing continuations. Support is provided for five or more individual research projects as well as for core support. Support may be requested for a project period of up to five years. Each Full-scale Center will be limited to a maximum of ten years of support in total. (2) Start-up Centers are limited to $600,000 direct costs in any one year, including non-competing continuation years. Support is provided for three or more individual research projects as well as for core support. Support may be requested for a project period of up to five years. Start-up Centers may be renewed only as Full-scale Centers, which then would be permitted a maximum of ten years of support in total. Criteria for appropriateness of Start-up Center support are noted in the PURPOSE and RESEARCH OBJECTIVES sections. 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 (R01s). Since IBSCs are defined by their multidisciplinary, integrative nature and not by departmental or geographic boundaries, projects constituting a given Center may be based at a variety of institutions. In an effort to allow for such multi- institutional involvement, for the purposes of this PA, Facilities and Administrative (F&A) Costs for such consortium and contractual arrangements will not be counted against the direct costs limits noted above. However, these costs should be delineated as instructed in Form PHS 398 (rev. 5/01). ELIGIBLE INSTITUTIONS You may submit an application 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 Foreign institutions are not eligible for an IBSC award, although foreign components are possible, e.g., via consortium arrangements. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to direct an IBSC (see criteria in Center Characteristics above) is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS In conformity with the NIH policy (http://grants.nih.gov/grants/guide/notice-files/not-od-03-032.html), applications for IBSC support must include a plan for sharing research data. The plan should be described in the Operational Plan for the IBSC (see SUBMITTING AN APPLICATION below), and the adequacy of the plan will be considered by NIMH staff in determining whether a grant should be awarded. The study section will comment on the proposed plan for sharing and the adequacy of the plan is among the review criteria. The sharing plan, as approved, after negotiation with the applicant when necessary, will be a condition of the award. 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: Mary Ellen Oliveri, Ph.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7220, MSC 9651 Bethesda, MD 20892-9651 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3942 FAX: 301-443-9876 Email: moliveri@nih.gov o Direct your questions about peer review issues to: Michael Kozak, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6138, MSC 9608 Bethesda, MD 20892-9608 Rockville, MD 20852 (for express/courier service Telephone: (301) 443-1340 FAX: (301) 594-0702 Email: kozakm@mail.nih.gov o Direct your questions about financial or grants management matters to: Ms. Carol J. Robinson Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6118, MSC 9605 Bethesda, MD 20892-9605 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3858 FAX: (301) 443-6885 Email: crobinso@mail.nih.gov LETTER OF INTENT Interested parties are strongly encouraged to contact Dr. Oliveri (listed under INQUIRIES) as early as possible in the conceptualization of a possible IBSC application in order to assess the responsiveness of the application to the mission of NIMH and to the goals of this PA. Applications judged not to be responsive or not appropriately focused on mental-health-relevant basic behavioral processes and research questions (as addressed in PURPOSE and RESEARCH OBJECTIVES) may be returned to the applicant without review. Prospective applicants are requested to submit a letter of intent that includes the following information: o Descriptive title of the proposed Center o Name, address, and telephone number of the Principal Investigator/Center Director o Names of other key personnel o Participating institutions o 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 is to be postmarked by the date listed at the beginning of this PA. It should be sent to Dr. Mary Ellen Oliveri, listed under INQUIRIES. 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 DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS 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) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this PA must be typed in Item 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS Application Format Guidelines - A major requirement for an IBSC is the conduct of collaborative, multidisciplinary research on a set of cohesive, interrelated basic science research questions that are linked in a fundamental, substantive way to mental health and mental illness. The nature of these substantive links to mental health and illness must be stated clearly in the application. The application also must describe the overall goals of the IBSC, the hypotheses to be tested, and the methods to be used. The application should clearly articulate the reasons a Center approach is needed for the proposed activities, as well as the unique benefits that will accrue from a Center. Utilizing the PHS Form 398 (rev. 5/01), 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 presented in narrative here. o Biographical Sketches of Key Personnel. These should be provided for key personnel of the entire Center, and should be arranged alphabetically based on the individual's surname. o Resources. 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; for amended applications, provide a one-page introduction describing changes from the previously submitted version). Provide an overview of the entire proposed Center, describing the Center goals and how they will be achieved. Explain the proposed contribution of each of the individual projects and cores to achieving the Center's objectives, and how these components relate to each other scientifically. 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 sharing research data as well as any research tools and 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: o Title page for the project or core. 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, 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 status of current research efforts on the topic, the limitations of these, why the particular research question lends itself to a multidisciplinary, integrative approach, and how the proposed project will be linked to and integrated with other proposed Center 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 an extra 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 skills that it will provide. Describe which projects will be supported by the Core and the manner in which that support will be rendered. o Human Subjects. For each individual project and core involving human subjects, describe the plans for protection of subjects from research risks, as well as plans for the inclusion of women, minorities, and children, as described in the PHS 398 (rev. 5/01) application instructions. o Vertebrate Animals. For each individual project and core involving vertebrate animals, provide a detailed description and justification for the use of animals as described in the PHS 398 (rev. 5/01) application instructions. Additional Information for the entire Center: o Literature Cited, compiled across all sections of the application. o Letters of Support from Collaborating Institutions, compiled across all sections of the application. Also include in this section assurances from Institutional Review Boards and/or Institutional Animal Care and Use Committees (although the former is not required for peer review). o Checklist o Personal Data on Center Director SENDING AN APPLICATION TO THE NIH: Submit a signed original of the application 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 same time, two additional copies of the application must be sent to: Jean G. 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 (express or courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this PA. If an application is received after that date, it may be returned to the applicant without review. The 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. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) and for responsiveness to this PAR by NIMH. Applications that are incomplete or unresponsive will be returned without review. Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate scientific review group convened by the NIMH in accordance with the review criteria stated below. As part of this initial merit review, all applications will: o Receive a written critique o Receive a second level review by the National Advisory Mental Health Council Although primary assessments of scientific merit will be based on the Center as a whole, one or more individual projects or cores could receive lower priority in some instances, possibly resulting in the 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, substantive relevance to mental health/illness, 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. 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; demonstration of synergy in the Center's conceptualization and approach. 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, the constituent project directors, and other investigators; 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. Thus the Director must by necessity 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 participating institutions, and plans for interactions among the participating 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 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 science and mental health and illness. o Appropriateness of the plan to share research data as well as any research tools or biological material generated by the Center. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following will be considered in the determination of scientific merit and the priority score: o 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). o 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). o 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 more than $500,000 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: January 18, 2004, 2005, 2006 Application Receipt Date: February 18, 2004; February 18, 2005; February 17, 2006 Administrative Review: February-March Scientific Review: June-July Advisory Council Review: September Earliest Start Date: September AWARD CRITERIA o Potential to advance the field o Scientific merit as determined by peer review o Responsiveness to the purposes and objectives outlined in this PA o Availability of funds REQUIRED FEDERAL CITATIONS 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 two 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: Starting with the October 1, 2003, receipt date, 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 RESEARCH WITH 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 research projects with human subjects 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 research with human subjects 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. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. 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). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). 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.health.gov/healthypeople. 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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