Part I Overview Information

Department of Health and Human Services

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/)

Title: Mental Health Centers for Intervention Development and Applied Research (CIDAR)

Announcement Type
New

Update: The following updates relating to this announcement have been issued:

Program Announcement ( PA) Number: PAR-05-039 (See addendum, NOT-MH-05-012)

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release Date: January 21, 2005
Letters of Intent Receipt Date(s): May 13, 2005, 2006, 2007
Application Receipt Dates(s): June 14, 2005, 2006, 2007
Peer Review Date(s): Oct/Nov 2005, 2006, 2007
Council Review Date(s): January 2006, 2007, 2008
Earliest Anticipated Start Date: April 1, 2006, 2007, 2008
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: June 15, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

This PA invites investigator-initiated grant applications for Mental Health Centers for Intervention Development and Applied Research (CIDAR). The primary purpose of each CIDAR is to support a team of leading basic, applied and clinical investigators engaged in a focused research program targeting a specific problem in clinical medicine. Center applications responsive to this PA may focus on research to: 1) define predictors and understand the mechanism of treatment response in major mental disorders; 2) create and refine biomarkers to assess the presence and/or extent of mental illness; and/or 3) hasten the development of novel treatments for mental disorders. The primary goal of this initiative is to support the translation of basic and clinical research into innovations in clinical assessment and therapeutics. Applicants may request support for a period of up to five years, followed by a competitive renewal application for a second five-year period. Direct costs are limited to 1.5 million in any one year. This limit applies to new grants, their non-competitive continuations, and any subsequent competitive renewals. This PA uses the NIH specialized center (P50) award mechanism. Eligible organization include: Domestic institutions, for-profit organizations, non-profit organizations, public or private institutions, such as universities, colleges, hospitals, and laboratories, units of State and local government, eligible agencies of the Federal government. 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. The number of different applications each applicant may submit is unrestricted. The application form is available at http://grants.nih.gov/grants/funding/phs398/phs398.html.

Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

  Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2.Cost Sharing or Matching
    3. Other - Special Eligibility Criteria

  Section IV. Application and Submission Information
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

  Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

  Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  3. Reporting

  Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

Background

Mental disorders of sufficient severity to impair functioning affect approximately 5-9 percent of the U.S. population annually. Examples of these illnesses include schizophrenia, mood disorders, anxiety disorders, childhood and adolescent mental disorders, sleep disorders, eating disorders, and dementias. The staggering cost of treating these disorders is surpassed only by the cost in human suffering endured by these patients and their families through extended and recurring periods of illness and distress.

Advances in neuroscience, genetics, and basic behavioral science, together with technological developments, have yielded a rich knowledge base relevant to understanding the biological, behavioral, and environmental bases of major mental illnesses, clarifying the mechanism of action of current treatments, and identifying predictors of therapeutic response and side effects of psychotherapeutic agents. In addition, studies aimed at elucidating the pathophysiology of major mental disorders have generated hypotheses about both new molecular targets for pharmacological therapies, and new clinical targets for treatment that are important determinants of disease burden but are currently beyond the reach of extant therapeutics (e.g., cognition or suicidality in schizophrenia, anhedonia in depression). The primary goal of many of these scientific efforts is the development of individualized assessment technologies and individualized treatments to reduce the burden of mental illness and address important clinical problems in mental health.

As highlighted in a recent FDA report (Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Therapeutics, http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html) the diagnostic and therapeutic technology development process has yet to fully benefit from tremendous advances in the basic sciences. By FDA's assessment, both translational research (which aims to carry ideas from basic science into new hypotheses about the diagnosis or treatment of disease) and development science or critical path research (that focuses on providing new tools and concepts for the medical product development process) are required to fuel further innovation in diagnostics and therapeutics. Examples of advances in development science with the potential to accelerate the efficiency of treatment development, include new and more accurate assessment methods and clinical trial endpoints, predictive markers to reduce patient heterogeneity, and biomarkers of the presence or extent of disease that might be used to follow disease progression and the impact of therapeutic interventions. Surrogate markers of other disease (such as CD4 count as a marker for HIV progression) have greatly enhanced the development of therapeutics in these areas of medicine. The care and treatment of individuals with mental illness would be similarly enhanced by the development of robust predictive models capable of defining with greater specificity which individuals are likely to respond to particular therapeutic interventions. Likewise, the development of biological tests to accurately and reliably define the presence and/or extent of mental illness would enhance both treatment development and clinical treatment decisions.

This Program Announcement (PA) invites investigator-initiated grant applications for support of Mental Health Centers for Intervention Development and Applied Research (CIDAR). Center applications responsive to this PA may focus on discovery-oriented and/or hypothesis-driven research to: 1) define predictors and understand the mechanism of treatment response in major mental disorders; 2) create and refine biomarkers to assess the presence and/or extent of mental illness and/or 3) hasten the development of novel treatments for mental disorders. The primary goal of this initiative is to support the translation of basic and clinical research into innovations in clinical medicine.

Objectives and Scope

The primary purpose of each CIDAR is to support a multidisciplinary team of leading basic, applied and clinical researchers engaged in a focused program targeting a specific problem in the diagnosis or treatment of mental illness. Because Centers must be thematically organized to focus on an important clinical problem, the capacity to recruit, study and retain a population of patients with mental illness is expected. A primary research project addressing the central problem that is the Center's organizing theme must be proposed, along with at least two additional projects with specific aims related to treatment development, understanding the mechanism of treatment response, predicting treatment response, reducing heterogeneity and/or elucidating the pathophysiology of the disorder in the clinical population under study. These studies may employ animal or human models of disease, studies of post-mortem tissue, genomic or proteomic strategies, neuroimaging or other approaches appropriate to the specific aims of the additional project. The application must explicitly address, however, how the proposed projects taken as a whole will yield meaningful progress in addressing the central clinical problem that is the centers organizing theme. The multidisciplinary team of investigators comprising the center may include investigators of any basic, clinical, or applied discipline relevant to addressing the problem that represents the Center's central theme. A CIDAR should clearly demonstrate a high level of interdependence of projects and investigators, and solid evidence of integration between basic science and clinical components.

Organization of Centers

A CIDAR may be organized in a variety of ways and may include one or more institutions. There is no single model for a Center; the structure will depend upon the research theme, questions and approaches selected. One type of Center may conduct multi-disciplinary research at a single institution. Another might adopt a decentralized, multi-site focus in which specialized activities are supported at different sites. A conceptual and theoretical rationale for the organizational structure should be discussed in the application. Centers must, however, include 2 required cores and at least 1 primary and 2 secondary research projects addressing the central problem that is the Center's organizing theme. The following are examples of broad research areas within the NIMH research mission that might serve as a focus for a CIDAR. This list is not meant to be comprehensive, nor are the examples meant to be exclusive of other topics.

Research Topics

In recognition of the fact that the development of therapeutic, predictive models and diagnostic procedures can be significantly enhanced by the collaboration of scientists in federal, academic and industry laboratories, academic-industry partnerships (e.g., pharma, biotech, imaging manufacturers) are encouraged in one of more CIDAR projects. Collaborations between academic and NIH intramural investigators may also be proposed.

Program Specifications

Principal Investigator Specifications

The CIDAR Director should have overall responsibility for leadership of the center as a major national scientific resource and be recognized as a leader in the research area chosen for the center. This individual must have demonstrated capability to organize, administer, and direct the center, and have a minimum time commitment of 30 percent as the center director.

Cores

Each CIDAR must have the following two cores: 1) Operations and Clinical Assessment Core and 2) Research Methods Core. A third Optional Special Scientific Procedures Core may be added (see below).

Operations and Clinical Assessment Core

Each center must have a clearly articulated Operations and Clinical Assessment Core that should integrate the scientific and infrastructure aims. This core includes administrative functions, data management and statistical analysis, clinical population recruitment and assessment, and specialized interdisciplinary components.

Applicants should describe under the Operations and Clinical Assessment Core section how the CIDAR will: 1) foster an environment of research excellence through multidisciplinary teams operating at a high level of methodological sophistication; 2) support innovation by integrating productive partnerships with academic disciplines that may be relative newcomers to these areas of research; and if applicable 3) actively engage and maintain collaborations with industry and or other research partners concerned with developing new therapeutic and/or diagnostic approaches to mental illness.

The CIDAR may consist of several collaborating sites that are not all located in a single institution or geographic region. The collaboration among multiple institutions and settings to create a “virtual center”, or “virtual cores” must be specified and explained in the Operations and Clinical Assessment Core of the lead institution receiving the funding so the feasibility of such arrangements can be evaluated.

The Operations and Clinical Assessment Core section of the application should outline the administrative and scientific leadership for all anticipated research. It should describe an administrative structure that maximizes efficiency through program planning and monitoring, an infrastructure development and maintenance plan, opportunities for investigators to do integrative work, and plans for accountability. The Operations and Clinical Assessment Core should also address knowledge and technology transfer, and enhance the availability of center accomplishments (e.g., data, methods, networks) within and beyond the center. Centers are encouraged to consider support for scientific meetings through the NIH R13 mechanism (see http://grants.nih.gov/grants/guide/pa-files/PAR-03-176.html).

The Operations and Clinical Assessment Core must include a data management and statistical analysis unit. This unit may be located at a single institution or across multiple institutions.

Since each CIDAR is thematically organized around a central problem in mental illness, a clinical assessment unit within the Operations and Clinical Assessment Core is required to recruit patients for study, ensure all aspects of protection of human research subjects, and ensure reliable and valid standardized assessment procedures. Applicants should describe efforts for recruitment of research participants, including assuring appropriate representation of women and minorities, and data collection activities within this Core.

Applications should address how the CIDAR will facilitate innovative and interdisciplinary training, education, career development, and research apprenticeships. Although direct support of research training efforts (e.g., stipends) and short-term education programs should be sought through NIH research training and career development mechanisms, description of how junior investigators will be involved in the CIDAR should be included. Applicants must include plans for attracting and retaining physicians and other clinically trained individuals into patient-oriented research careers. In addition, applicants should address the ways in which training opportunities will seek to reduce disparities in the mental health of traditionally underserved populations

If collaborations between federally-supported academic and industry scientists or laboratories are proposed, the management of these collaborations, including Intellectual Property issues, must be described within the Operations and Clinical Assessment Core.

Research Methods Core

Each CIDAR must include a Research Methods Core. New technology, research designs and innovative analytic approaches are needed to develop predictive models, biomarkers and new interventions for mental illness. Centers are expected to develop, enhance and provide state-of-the-art, sophisticated methodological expertise to all CIDAR supported research projects. This function includes, but is not limited to: methods and instrument development, cross-site standardization of biological assessments, research design, novel data base management techniques, new biostatistical analytic methods, and use of mixed methodologies.

Conducting the kinds of research called for in this PA will require the development and adaptation of sophisticated methods from areas such as genomics, neuroimaging, and psychophysiology. Thus, this Core should seek to encourage collaboration of methodologists from diverse academic backgrounds representing expertise in areas appropriate to the applied research program proposed. As part of this core, centers may develop plans to stimulate technological innovation through collaboration with small businesses using either the Small Business Technology Transfer (STTR) program or the Small Business Innovation Research (SBIR) program. Information on the SBIR and STTR programs may be obtained at: http://grants.nih.gov/grants/funding/sbir.htm.

Optional Special Scientific Procedures Core

Based on the central problem addressed by the Center, an optional Special Scientific Procedures Core may be proposed. If, for example, animal models will be employed in parallel with human studies to evaluate the efficacy and/or study the mechanism of a novel pharmacological or somatic treatment, a Pre-Clinical Studies Core might be proposed. Alternatively, if highly specialized clinical, psychophysiological, or neuroimaging procedures will be developed and/or employed as potential predictors of markers of treatment response a Specialized Assessment Core may be proposed. If required by discovery-oriented activities (e.g., hypothesis-generating gene array studies, proteomic studies, exploratory imaging-based activation paradigms), an appropriate Discovery-based Scientific Procedures Cores may be proposed. The application must specifically address how the activities conducted in a Special Scientific Procedures Core will support and enhance the overall aim of the CIDAR's central thematic focus and promote the application of novel methodologies.

Other Center Mechanisms

Applicants interested in a Center to test interventions (treatment, rehabilitative, and preventive) through studies in multiple settings and to improve the utilization of research-based prevention, treatment and service interventions in community and practice settings should see PAR-01-089, ADVANCED CENTERS FOR INTERVENTIONS AND SERVICES RESEARCH (ACISR) (http://grants.nih.gov/grants/guide/pa-files/PAR-01-089.html) or PAR-01-090 (Developing Centers for Interventions and Services Research (http://grants.nih.gov/grants/guide/pa-files/PAR-01-090.html).

Applicants interested in funding a center for basic neuroscience research relevant to mental illnesses should see PAR-02-121, Silvio Conte Centers for Neuroscience Research (http://grants.nih.gov/grants/guide/pa-files/PAR-02-121.html) and those interested in a center for translational research between basic and clinical neuroscience research on severe mental illnesses should consider PAR-02-122, Silvio Conte Centers for the Neuroscience of Mental Disorders (http://grants.nih.gov/grants/guide/pa-files/PAR-02-122.html). Applicants interested in funding for a center for research at the interface between basic behavioral research and neuroscience should see PAR-04-004, Interdisciplinary Behavioral Science Centers for Mental Health (http://grants.nih.gov/grants/guide/pa-files/PAR-04-004.html). Applicants interested in a center that would foster research projects on the translation of basic behavioral research to mental disorders and public health applications should consider PAR-04-151, Translational Research Centers in Behavioral Science (http://grants.nih.gov/grants/guide/pa-files/PAR-04-151.html). Those interested in a center with a focus on HIV/AIDS should apply for funding through PAR-03-142, Core Support Program for Mental Health/AIDS Research (http://grants.nih.gov/grants/guide/pa-files/PAR-03-142.html)

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH specialized center (P50) award mechanism, which provides funding 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 five years, followed by a competitive renewal application for a second five-year period. NIMH will not support individual Centers for longer than two consecutive funding periods.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

Direct costs are limited to $1.5 million in any one year. This limit applies to new grants, their non-competitive continuations, and any subsequent competitive renewals. Since the best scientific talent and resources are expected to be brought to bear on questions posed in each Center, and since these may not all be available at any single institution, projects constituting a given Center may be based at multiple institutions. In an effort to allow for such multi-institutional involvement Facility and Administrative (F&A) costs for consortium activity at collaborating institutions will not be counted against the $1.5 million limit to direct costs (but these costs should be delineated as instructed in form PHS 398 (see NOT-OD-05-004).

It is anticipated that individual projects that are developed as outgrowths of a Center grant will seek independent funding through research project grant mechanisms (e.g.,R01s). The Center mechanism may not be used as a substitute for individual grant support. It is, therefore, expected that investigators participating in Centers will have independent, peer reviewed research support. A Center must be viewed as a unique scientific opportunity to investigate leading edge research questions not currently being addressed in optimal ways.

Allowable Costs

CIDAR funds are intended to support both infrastructure and specific research projects. If appropriate, based on the thematic focus of the CIDAR, infrastructure funds may be used to support research participant recruitment and outreach activities to ensure appropriate participation by all populations, especially women, children and adolescents, elderly populations and traditionally underserved populations such as racial and ethnic minorities and people in rural areas. For those centers that will support multi-site clinical trials, funds may be used to set up a Data and Safety Monitoring Board for these trials. Funds may be requested to initiate specific pilot studies in the scientific areas chosen as the focus of the center and to support data bases and/or maintain tracking of research participants while new grants are developed to address follow-up questions raised by early studies. Funds may also be used for travel, salaries, meeting expenses, subcontracts and to pay consultants. Applicants are referred to the General Clinical Research Center program at the NIH/National Center for Research Resources (http://www.ncrr.nih.gov/clinical/cr_gcrc.asp) as a potential resource for inpatient and outpatient facility costs.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Fiscal and administrative costs are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

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.

2. Cost Sharing or Matching
Not applicable

3. Other-Special Eligibility Criteria

Principal Investigator Specifications

The CIDAR Director should have overall responsibility for leadership of the center as a major national scientific resource and be recognized as a leader in the research area chosen for the center. This individual must have demonstrated capability to organize, administer, and direct the center, and have a minimum time commitment of 30 percent as the center director.

Cores

Each CIDAR must have the following two cores: 1) Operations and Clinical Assessment Core and 2) Research Methods Core. A third Optional Special Scientific Procedures Core may be added (see below).

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are 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.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. 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.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times
Applications must be mailed on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): May 13, 2005, 2006, 2007
Application Receipt Dates(s): June 14, 2005, 2006, 2007
Peer Review Date(s): Oct/Nov 2005, 2006, 2007
Council Review Date(s): January 2006, 2007, 2008
Earliest Anticipated Start Date: April 1, 2006, 2007, 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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:

Deborah Babcock, M.D., Ph.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7178, MSC 9621
Bethesda, MD 20892-9621
Telephone: (301) 443-1692
Email: dbabcock@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application must be sent to:

Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service]
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: jnoronha@mail.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by CSR and responsiveness by the NIMH.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH 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 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 eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Application Format Guidelines

A major requirement for each Center is the conduct of multidisciplinary problem-oriented research targeting a central specific problem in diagnosis or treatment of mental illness. The application must describe the clinical problem to be addressed, as well as the goals of, and approaches used in the Center.

In addition, the application should clearly articulate the reasons a Center approach is needed for the proposed work as well as 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. It should be emphasized that this center mechanism is not meant to be a substitute for individual grant support. Therefore, the reasons that constituent cores and projects require Center support should be fully justified.

The application should utilize PHS Form 398 and include the following components in the specified order:

Information for the Entire Center:

Provide an overview of the entire proposed Center describing the central clinical problem to be addressed and the research and development goals to be achieved. Describe how the overall Center will achieve its major objectives. Explain the proposed contribution of each of the projects and cores in achieving the objectives of the Center and how these components, especially the projects, relate to each other scientifically.

Present evidence that the research team will be able to work together to accomplish the research proposed in the projects, present preliminary results, present evidence of competence in the areas proposed, etc.

If previously supported by an NIMH R01 or other support mechanisms in areas directly related to the central theme of the Center, indicate the outcome of that specific activity as it relates to the application for the proposed Center support.

Describe the results of each of the projects supported in the previous CIDAR grant and the manner in which those results and projects relate to the currently proposed Center application. Describe the manner in which the Center mechanism provided synergy to the previously funded Center.

The working administrative and logistical arrangements, as well as the resource support necessary to implement the research, should be fully elaborated in the application. Particular attention should be devoted to a description of the clinical populations, tissue resources, etc., which will be involved as part of the Center's clinical component. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included (documentation of these arrangements should be included in the "Letters of Support" section).

Also included in this section is the manner in which an external advisory board will advise the Center. Prospective board members should not be chosen or contacted prior to a funding decision and therefore should not be named.

The plan for sharing data, biological material resources, and tools generated by the Center should also be included in this section.

A description of the manner in which Center activities will provide opportunities for new investigators and how the proposed CIDAR relates to existing training programs of participating institutions should be given. Also, plans for disseminating information to the public regarding the activities of the Center should be given.

Information for Each Project or Core:

For each project or core, the information should be arranged in the following order:

The research plan for each project should describe the specific aims, background and significance. In these sections, the research question to be addressed and the hypothesis to be tested by the proposed research project should be highly focused and fully explained. A review is required of: the status of current research efforts addressing the issue (both within the Center and elsewhere), the limitations of existing research strategies, why the particular research question lends itself to a multidisciplinary, integrative approach, and how the proposed project is to be linked and integrated with other proposed Center projects. As applicable, the relationship between basic and clinical science aspects of the research as well as discovery-oriented and hypothesis testing research components should be made explicit.

The research plan for each project should also include a description of the research design and methods. This will not require extensive details for individual experiments. Description of the experimental design should outline the strategies proposed to accomplish the specific aims of the project and should include a discussion of the innovative aspects of the approach. Experimental procedures need not be spelled out in great detail if those procedures have already been extensively published and widely accepted by the scientific community, the methods to be used should be cited and referenced. Any new methodology, however, and its advantage over existing methodologies, should be well described. Further, the feasibility of the proposed experiments, potential pitfalls, alternative approaches, if necessary, and relevance to Center goals should be discussed, as should plans for data sharing.

Describe how the core will contribute to the overall goals of the Center as well as which projects will be supported by the core and the manner in which that support will be rendered by the core. The description of each core should clearly indicate the facilities, resources, services, and professional skills that the facility will provide to the proposed Center.

Other Information:

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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 the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm ). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria
Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the NIMH on the basis of established PHS referral guidelines. Appropriate scientific review groups convened by the NIMH in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

As part of the initial merit review, all applications will:

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an 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.

Overall Criteria for scientific review of CIDAR applications will include the following:

Criteria for Review of Cores

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 Cores progress.

Criteria for Review of Projects

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators. Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 Form 398 research grant application instructions will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: 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 the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

The NGA will be sent via email to the administrative official whose name is listed in Block 12 on the Face Page of the Form PHS 398.

2. Administrative Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity 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:

1. Scientific/Research Contacts: Program contact has changed, see NOT-MH-05-020

Wayne S. Fenton, M.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard , Room 6216, MSC 9621
Bethesda , MD 20892-9621
Telephone: (301) 443-9700
Email: wfenton@mail.nih.gov

2. Peer Review Contacts:
Not applicable

3. Financial or Grants Management Contacts:

Brian Albertini
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-0004
FAX: (301) 443-6885
Email: albertib2@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
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). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, 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 and 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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical 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 (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available 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 (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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


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