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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: Disaster Mental Health Research Center (P60)

Announcement Type
New

Request For Applications (RFA) Number: RFA-MH-07-070

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release Date: December 15, 2006
Letters of Intent Receipt Date(s): March 23, 2007
Application Receipt Dates(s): April 23, 2007
Peer Review Date(s): June, 2007
Council Review Date(s): August 2007
Earliest Anticipated Start Date: September, 2007
Additional Information to Be Available Date (Url Activation Date): Not Applicable
Expiration Date: April 24, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

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
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

Although disasters are disconcertingly prevalent in modern culture, and researchers from many disciplines have focused greater attention to this area of science in recent years, there have been relatively few systematic studies capable of answering questions of import for understanding and responding to the mental health consequences of disasters.

The ability to anticipate the psychological effects of disasters based on complex interactions of individual, environmental, and contextual factors and the development of optimal ways of responding have been limited by vast differences in methodologies used, including critical items such as time frames, identification of populations, sampling, and instruments. These limitations apply to many types of research needed to sharpen our understanding of risk and recovery and to develop and evaluate practical response programs aimed at minimizing adverse outcomes and promoting community and individual recovery.

The attacks of September 11, 2001 and the catastrophic U.S. Gulf Coast storms of 2005 highlight the need for a systems orientation to planning for and responding to such emergency events at both the population/community and individual/clinical levels. It is neither possible nor desirable to treat all those touched by such disasters. The Nation's health can be better ensured with a system-wide public health infrastructure, incorporating various scientific and practice disciplines relevant to mental health. The framework for research should include biomedical, behavioral, and health systems perspectives.

There are many barriers to conducting rigorous research in the context of emergencies, including the need to establish collaborative relationships among investigators, emergency health care workers, and public health officials. The feasibility of gaining insight into preparedness, public health, and clinical response will be enhanced when opportunities to learn and validation by research are embedded in response planning. Other challenges to high quality and high impact research include hastily assembled research teams that may overlook options and important questions when making decisions about key features of the research (e.g., hypotheses, sampling methods, measures, etc). Institutional Review Boards (IRB) may be faced with urgent requests to review high and low risk protocols in areas they are not familiar with and for which they lack appropriate expertise. Funding options and strategies may be limited and force compromises, delays, and missed opportunities. These and other factors can adversely impact the quality and ultimate utility of research results.

It is clear that there is room to improve our ability to respond to large scale disaster and disruption and that a systematic method for understanding and assisting disaster exposed populations is needed. Such research can answer fundamental questions about the human (psychobiological) response to traumatic stress, including what promotes/sustains or compromises resilience, how to identify individuals at highest risk for mental disorders, and the optimal timing, intensity and focus of interventions to prevent or minimize severity of adjustment problems and mental disorders.

In the wake of major emergencies, especially those involving mass casualty and population disruption and/or displacement, and those involving human malicious intent, many public mental health challenges and questions arise. As a Nation, we have learned important lessons from prior events, including the need to assess the geographic spread and circumstances of those impacted, their exposure(s), and displacement. This type of basic information, along with the extent of injuries (physical and mental health), emergence of post-disaster health-related behaviors, the extent of pre-existing health conditions, problems with daily living, and information about the health and human service infrastructure, including its accessibility and quality is vital to assess and monitor as recovery resources are deployed and adjusted over time.

Major disasters also underscore the importance of knowledge about risk and recovery from trauma for individuals. The extant knowledge in this area, while useful and necessary for estimating needs, is not sufficient. New research is needed to isolate robust predictors of resilience to stress, post traumatic psychopathology (PTSD, Depression, SUD) and to focus on genetic and environmental interactions as well as other multi-factorial approaches to the causes and mediators of posttraumatic disorders. Similarly, we currently lack sufficient knowledge about the safety and effectiveness of existing and new interventions (pharmacological and psychosocial, clinical and non-clinical ) for minimizing chronic mental health conditions and there is a troubling lack of consensus on what constitutes a safe and effective strategy for providing assistance that does not interfere with healthy adjustment for the majority of survivors while also facilitating the identification and treatment of posttraumatic distress and psychopathology among those who do not recover in the weeks and months following trauma.

In recent years, many distinguished groups have assessed the state of the science and practice regarding mental health response to various types of disasters and mass casualty events. The following are only a few examples of these efforts.

These and related efforts together provide an assessment of the Nation’s ability to prepare for and respond to many types of emergency events and offer recommendations about what further research is needed. Cross-cutting themes emerging from these efforts are the need for new approaches to assessing population needs, monitoring recovery and illness, understanding individual risk and resilience, and evaluating various models of public health and clinical intervention.

NIMH aims to enable the research community to address at least some of these questions and needs by pre-positioning resources to engage large representative samples of trauma exposed populations as well as high and low risk cohorts for involvement in studies that can be conceived of and worked out in some amount of detail in advance of emergency events. Just as the research community has responded in many remarkable ways to prior emergencies by assembling practical research and public health activities, experienced researchers and clinicians, in collaboration with disaster authorities responsible for emergency management and evaluation, are encouraged to pre-position cutting edge science.

Objectives

Given the complex public health, political, legal, and social context brought about by major emergencies and crises, NIMH seeks to create a Disaster Mental Health Research Center (DMHRC) of interdisciplinary researchers to pre-plan epidemiological and pilot clinical research protocols in conjunction with public health authorities in advance of unforeseen emergencies.

NIMH is encouraging highly capable and experienced disaster researchers to work out complex arrangements necessary for conducting research after unforeseen events involving mass violence and/or trauma. NIMH seeks to support a research Center; a pre-positioned team to plan for various disaster scenarios, perhaps targeting predictable storm seasons, disaster prone communities, and/or major metropolitan and economic centers that may be the target of human-caused violence. The overarching goal of the DMHRC is to create a ready response multidisciplinary group to track key public health indicators and to lay the foundation for high impact clinical/services research projects.

NIMH encourages applications for a DMHRC consisting of collaborative partnerships among scientists from various disciplines, State and local health and mental health authorities as well as volunteer and other response agencies to establish the capacity for timely epidemiological, clinical and/or services research after disasters, including acts of terrorism, and to translate/disseminate findings for improved planning and response.

This RFA will use the NIH Comprehensive Research Center (P60) mechanism to support an integrated, broad-based multidisciplinary, multi-investigator, program of research and research support activities planned around a specific major research theme for the benefit of public health. The DMHRC is intended to be capable of rapid response for public mental health monitoring and scientific research activities, and ultimately to improve connections between evidence-based practice and the mental health response to disasters.

A Center should be an identifiable organizational unit within an institutional or organizational structure such as a university, medical center, or a consortium of affiliated cooperating institutions. In addition to providing support for shared resources, this type of Center allows for growth and development through pilot projects leading to new investigator-initiated studies and is intended to provide state-of-the-art leadership in the disaster mental health field.

The dual scientific purpose of this Center will be to prepare multiple strategies for deploying state-of-the-art and innovative epidemiological methods to study disaster impacted populations and build upon such methods and research resources to pursue under-studied and/or poorly understood public health and clinical issues.

Research Areas

Funding for the DMHRC can be used to support several components of research and will be implemented in two phases. Phase I will focus on preparing a viable and pre-positioned infrastructure (Epidemiological component) for rigorous epidemiological investigations after major emergency events. In this Phase, the DMHRC is expected to develop the capacity for one or more epidemiological studies in the aftermath of unforeseen events with implications for public mental health and refine plans for initiating two or more pilot clinical and/or services research projects.

Activities during Phase 1 should focus on but are not necessarily limited to organizing consortia involving multiple institutions, organizations and individuals; refining various research scenarios and options; preparing multiple epidemiological research approaches, instruments, sampling schemes, assessment methods, statistical/analytical models and methods, and study designs; preparing data collection and storage procedures, training interviewers, etc. Phase II will involve initiating one or more epidemiological studies to gather public health impact data and acquire samples for pilot research studies.

The following lists provide examples of research areas that could fit in the DMHRC program. These are not meant to be comprehensive nor exclusive of other topics.

Examples of Phase II Epidemiological Studies

Assuming adequate progress is made in the above steps (readying and initiating epidemiological studies), Phase II may continue with conducting two or more pilot clinical and/or services research studies focused on outstanding questions of import for public health response, resilience, and psychopathology.

Examples of Phase II Clinical/Services Studies:

A major priority of the NMIH is to learn what interventions work for which persons to facilitate natural recovery, reduce the severity of response to trauma, and prevent and treat potentially chronic mental disorders. Accordingly, it is strongly encouraged that the epidemiological, clinical and services research activities of the DMHRC include attention to:

Center applicants may request support for a translation/dissemination component intended to develop collaborations with outside investigators, emergency and public health authorities, disseminate findings from the Centers activities, and to provide the means to develop new research ideas and encourage new investigators.

This funding opportunity employs some aspects of research infrastructure or capacity development that are fairly straightforward (i.e., preparing instruments, sampling strategies, training interviewers, etc). NIMH is also seeking to overcome some of the limitations of research organized in the wake of emergencies by including support to develop hypothetical but high-probability pilot clinical and services research protocols in advance of various disasters or other emergency events. While it may be difficult, NIMH believes that it is not impossible to identify what types of scientific and public health questions can be pursued in the wake of several different types of emergency events.

This initiative requires investigators to resolve issues of access and cooperation with health authorities, and have potential pilot studies pre-reviewed by IRBs, at least preliminarily, in advance of emergencies. These protocols would then need to be rapidly updated and formally approved by a relevant IRB for human subjects issues and situation specific needs prior to subsequent funding.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH P60 Comprehensive Research Center grant award mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The P60 Center is intended to support an integrated, broad-based multidisciplinary, multi-investigator, program of research and research support activities planned around a specific major research theme for the benefit of public health.

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 http://grants.nih.gov/grants/funding/phs398/phs398.html). Specifically, a detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

Applicants may request support for a period of up to 5 years. The NIMH may solicit a competitive renewal application for a second 5-year period. The NIMH will not support the DMHRC Center for longer than two funding periods. Center applicants are limited to requesting $900,000 in direct costs in year one and $800,000 in any year thereafter, including all phases and components. However, the initial Phase I award cannot exceed $250,000 in direct costs for year one and $150,000 per year thereafter. Subsequent award amounts (for fielding epidemiological studies, pilot clinical and/or services research projects) will be contingent upon 1) a determination that an event of significance has occurred, 2) evidence that the epidemiological infrastructure is operational and ready, 3) rapid IRB re-review of proposed Phase II epidemiological, clinical and/or services research protocols, and 4) availability of Federal funds. NIMH recognizes that circumstances may change with the passage of time and the specifics of any particular disaster and thus may allow for additional administrative and/or competitive funding, that exceed the limits noted above, to become part of the Center.

The applicant organization should be an identifiable unit within an institutional or organizational structure such as a university, medical center, or a consortium of affiliated cooperating institutions. However, projects constituting the Center may be based at a variety of institutions and programs, representing the full continuum of relevant biomedical, behavioral and social sciences. An important goal of the Center is to transcend the barriers of disciplines, sectors, research and operational settings and organizations in order to harness a broad range of modern scientific approaches in the service of the Nation’s mental health needs in the wake of disaster and mass trauma.

While the Facilities and Administrative (F&A) costs associated with all contractual and consortium arrangements are considered as direct costs to the applicant organization, these will not count against the program direct costs cap. However, these costs should be indicated as instructed on Form PHS 398. (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html)

The Center grant provides a mechanism for fostering interdisciplinary cooperation within a group of established investigators conducting high-quality mental health research. Therefore, existence of a strong research capability is fundamental to the establishment of a new Center

2. Funds Available

The NIMH intends to initially commit approximately $250,000 in direct costs (Phase I) to fund 1 new Center in response to this RFA. However, because this Center is expected to respond to unforeseen events, and must develop a plan to do so (Phase II) , NIMH intends to make available up to an additional $250,000 in direct costs for 1 or more epidemiological surveys and up to $400,000 in additional direct costs for 2 or more pilot clinical and/or services research projects and any proposed translation/dissemination activities. The initial award will be limited to $250,000 in direct costs but the submitted budget for each year should reflect plans for Phase II projects as well. The total requested budget (Phase I and II combined) for year one may not exceed $900,000 in direct costs ($250,000 for the epidemiological platform, $250,000 for epidemiological studies, and $400,000 for clinical/services research) and $800,000 in subsequent years ($150,000 in direct costs to maintain and refine the epidemiological platform, its activities and consortia, $250,000 for epidemiological studies, and $400,000 for clinical/services research).

All funding beyond the initial award of up to $250,000 will be contingent upon 1) a determination that an event of significance has occurred, 2) evidence that the epidemiological infrastructure is operational and ready, 3) rapid IRB re-review of proposed Phase II epidemiological, clinical and/or services research protocols, and 4) availability of Federal funds. NIMH recognizes that circumstances may change with the passage of time and the specifics of any particular disaster and thus may allow for additional administrative and/or competitive funding, that exceed the limits noted above, to become part of the Center.

Although the financial plans of the NIMH provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of meritorious applications.

The NIMH notice, NOT-MH-06-120, restricting Center total budgets does not apply to this announcement or the P60 award.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

In addition, the institution must have the resources to sustain a coordinated research program. Foreign institutions are not eligible to apply. An applicant institution must demonstrate the ability to attract high-quality scientists from biomedical, behavioral, clinical and/or social science disciplines that are willing to make a commitment to the Centers research program and to dedicate the time needed for research projects if/when an emergency event occurs and the Center is activated for research. An application must also have a detailed 5-year plan for a proposed research program.

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 support. The individual named as Principal Investigator for the Center grant will serve as Center Director. This individual must demonstrate the ability to organize, administer, and direct the Center, and have sufficient authority to allocate space, personnel, and other resources essential to the Center.

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 program staff. It is not expected that existing programs necessarily include the range of expertise needed for a DMHRC (e.g., epidemiology, psychopathology, behavioral and social sciences, neuroscience, academic mental health, mental health services research, economics, disaster and trauma research, emergency management, public health). Recruitment of such individuals may take place after an award has been made; however, the expertise required, the role in Center activities, and the time to be devoted to the Center should be provided in the application. It should be emphasized, however, that after an award is made, such individuals cannot serve as a substitute for a proposed Project principal investigator.

Advisory Board

An external advisory board, while not required, is strongly encouraged to serve as a source of guidance from experts in the field who do not have a vested interest in the Center. Board members should include individuals drawn from epidemiological, clinical, and services research areas as well as those with expertise in public health preparedness and response to disaster and mass casualty events from governmental, quasi-governmental and non-governmental entities who have relevant experience and expertise. Funds may be requested to support travel of board members for meetings To avoid reducing the pool of potential reviewers, applicants should not identify, choose, or contact prospective board members before a funding decision is made.

2. Cost Sharing or Matching

Cost sharing is not required under this program. The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

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. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone 301-710-0267, 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 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.

The following paragraphs describe the Special Requirements for a Comprehensive Center application. Only applications that focus on disaster mental health related research will be considered responsive to this RFA.

Center Components and Activities Supported

The Center must have a minimum of two (2) components (administrative/scientific resource and research) and is permitted to propose a third component (translation/dissemination). The plans for the Administrative/Scientific Resource Core component and for the optional Translation/Dissemination component of the DMHC are each limited to twenty five (25) pages. The plans for the research component is limited to fifty (50) pages; 25 for the Epidemiological projects and 25 for the pilot clinical/services projects. Pages not used for one component may not be used to extend the page limit of other components. In addition to the overall budget, each component requires a separate detailed budget acknowledging that this is a best estimate and may need to be modified if/when the Center is responding after a disaster. Applicants should, to the extent possible, describe what circumstances may necessitate changes and also describe a rational process by which such adjustments will be made if necessary.

A Center must have an administrative structure and clear lines of authority which will facilitate coordination among Center personnel to assure maximum accountability and efficiency in operations. The Center Director will have responsibility for planning and coordination of the Center program, preparation of the budget and oversight of expenditures, staff appointments, space allocation, and other aspects of management and operation of the Center.

To provide a suitable structure for achieving the goals of the proposed research, the DMHRC may request funds for the following:

1). Administrative and Scientific Resource Core/Component:

The DMHRC may request support for administrative and scientific resources related to establishing, implementing and sustaining a functional framework for conducting high-impact epidemiological, clinical and/or services research projects and research translation/dissemination activities. Such core activities may include general administration, as well as functions to support subject recruitment, methodological developments, data management procedures, or statistical analysis across the Center’s activities. This core support may include salary costs, research resources shared across projects, and equipment needed to conduct the research.

Administrative resource aspects of this Core provide the organizational framework for the management, direction, and coordination of the Center; it must be managed by the Center Director. This resource should enable all proposed components and related activities to function in an optimal and synergistic manner. An important function of this resource is also the administration of the budget. This resource should be described in sufficient detail to ensure that all proposed components and related activities will function optimally. In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting should be detailed in the description of this resource.

Scientific resource aspects of this core are shared research resources that provide Center investigators with techniques, instrumentation, services, or resources that will enhance research to accomplish the common goals of the Center. Such resources can include a facility, service, or other resource that provides support for scientific research projects of the Center. Shared scientific resources should be clearly described in terms of the services and resources to be provided to investigators. The description should include a discussion of the resources contributing to the research objectives of the Center. Relevant aspects of cost effectiveness, timesaving, and increased efficiency attributable to the existence of the resource should also be addressed. A scientific resource should support the Center’s scientific research components and may also support independently funded research project grants related to the Center's theme. Each separately funded research project associated with the Center and utilizing core facilities should have a brief description that includes its research objectives and how the Center's core facility will impact those objectives. While research per se is not an essential part of a scientific resource, quality assurance activities that evaluate its operations and are directed at problem identification and improvement of functioning are appropriate.

The entire narrative for the Administrative and Scientific Resource Core/Component

may not exceed 25 pages. A budget should be submitted for each subcomponent resource (administrative and scientific) and as a whole for each year. Budget information provided for each resource should reflect best estimate costs and requested funding may not exceed $250,000 direct costs in year one and $150,000 in each subsequent year.

2). Research Components

The DMHRC is expected to contain two types of research components: a) epidemiological research components and b) clinical/services research components. Each proposed research component should provide a clear description of its major goals, objectives, and how it integrates with the other research components in relation to the overall Center program. The hypotheses to be tested should be focused and detailed to the extent possible.

The research components are scientific research projects, integrated with the overall Center program that contribute collectively to the goals of the Center program. The Research Component Director should be a qualified investigator and is responsible for the scientific direction and conduct of the individual research component. A Center Director may also serve as a Research Component Director.

The dual emphasis of these components should be: a) to track disaster aftermath and recovery periods in communities and individuals and b) to acquire the knowledge needed, including relevant basic scientific knowledge, to design and deliver highly effective public health and clinically oriented mental health interventions to disaster survivors.

NIMH is aware that the proposed studies are being planned and proposed in advance of a specific emergency event and that this poses scientific and practical challenges. However, based on the many reviews and analyses that have been conducted to identify what we know and need to know , NIMH believes that with support, investigators can develop hypothetical but high probability epidemiological and clinical/services research protocols in advance of various disasters or other emergency events. While it may be difficult, it is not impossible to identify what types of scientific and public health questions can be pursued in the wake of several different types of emergency events. Moreover, NIMH believes that it is possible to evaluate the achievability of the proposed/theoretical research projects to determine how likely it is that the proposed projects can be accomplished given that they are being planned in advance of an unforeseen event(s).

The design and procedures should describe the strategies proposed to accomplish the specific aims and innovative aspects of the approach should be highlighted. A description of the resources and working arrangements required to implement and conduct the proposed research should be fully elaborated with particular attention to a description of necessary partnerships/collaborations, resources, subjects, clinical populations, tissue resources, biological models, existing data sets, etc., which will be involved in proposed studies. If core facilities are utilized, information on their use should be provided.

Epidemiological Research Projects

Organizing principle: The ability to make rational plans for care, monitor recovery and needs, and the ability to adjust the deployment of recovery resources requires accurate data on population and clinical impact, needs, access and use of services, and ways to gauge recovery.

The DMHRC must include a component that supports epidemiological studies. Funds may be requested to establish a platform for initiating epidemiological investigations involving representative samples of impacted populations and to support one or more such studies. The description of the epidemiological research component should include how the infrastructure will be established or how existing resources will be utilized to form a viable platform for rapid research. Supported activities may include but are not necessarily limited to organizing consortia, preparing instruments, developing multiple sampling strategies, data collection and storage procedures, and training interviewers. A brief description (2 to 3 pages) of the plans and decision making process by which the Center would become activated should be included (i.e., what types of disasters/events would lead the Center Director to initiate a process (and what is the process) to launch an epidemiological study). The application must provide sufficient information to enable adequate scientific evaluation by a peer review committee, a description of the management of the component, including the process by which studies will undergo initial IRB review and just in time review subsequent to any necessary modifications. The entire narrative for Epidemiological Research Projects (combined) may not exceed 25 pages irrespective of the number of projects proposed. A budget should be submitted for the component as a whole for each year in which studies are thought to be feasible and for each individual project. Budget information provided for each project anticipated should reflect best estimate costs based on number and kind of project to be pursued. While the specific number of projects to be proposed (beyond the required 1) is at the discretion of the applicant, requested funding for studies may not exceed $250,000 for any one year. Funds requested to create and support the epidemiological platform (up to $250,000 in year 1 and $150,000 thereafter, may be used to support epidemiological studies as well)

Pilot Clinical and/or Services Research Projects

Organizing principle: Decisions regarding how to reach disaster survivors, determine who is at highest risk for adverse outcomes, who should receive what type(s) of assistance and care, when, for how long and the optimal way of organizing such assistance should be informed by data.

The DMHRC must include a component that proposes 2 or more pilot clinical and/or services research projects. It is expected that the research projects will stem from the epidemiological infrastructure and research aspects of the Center. While some of the research projects may appropriately focus on systems levels issues (organization and delivery of mental health services, work with organizations that provide mental health services), at least one research project must involve work with disaster survivor populations, that is, studies conducted with persons at high risk for or diagnosed with a mental disorder. However, multiple projects in clinical or services settings are also encouraged, for purposes of increasing the number of patient subjects, representing different aspects of clinical phenomena, including studies of resilience, and/or increasing the diversity of study populations with respect to ethnicity, gender, or age. Each project must demonstrate the capability to integrate strongly with other projects of the Center. The description of the pilot clinical/services research component should include the planned pilot studies as well as procedures for modifying projects based on emerging circumstances of any particular event. It is recognized that the relative priority or need for specific pilot projects may change over the course of time and with the emergency events that occur. The application must provide sufficient information to enable adequate scientific evaluation by a peer review committee, a description of the management of the pilot project component, including the process by which pilot studies will undergo initial IRB review and final approval subsequent to any necessary modifications.

The application should also include a description of the management of the pilot project component. Each pilot study proposed should be described to the extent possible, including its rationale, objectives, approach, investigators, and significance for the Center. Also a brief description (2 to 3 pages) of the plans to build upon pilot projects and seek independent research support for larger or follow-up studies that would become part of the Center should be included. The entire narrative for the Pilot Projects (combined) may not exceed 25 pages irrespective of the number of pilot projects proposed. A budget should be submitted for the pilot project component as a whole for each year in which pilots are thought to be feasible and for each individual project. Budget information provided for each project anticipated should reflect best estimate costs based on number and kind of pilot projects to be pursued. While the specific number of pilot projects to be proposed (beyond the required 2) is at the discretion of the applicant, requested funding for pilot studies may not exceed $400,000 for any one year.

3). Research Translation/Dissemination Component:

The DMHRC may also include a component which supports activities designed to translate research findings into health care practice, public information dissemination, or education curricula or programs for students, health professionals and community agencies. These projects shall in a meaningful way reflect the Center's research theme.

For each project in the research translation/dissemination component, a clear description of its major goals, objectives, and integration with the research components in relation to the overall center program should be provided. The plans for this optional Translation/Dissemination component may not exceed twenty five (25) pages. While the specific number of translation/dissemination projects is at the discretion of the applicant, requested funding for these optional component activities must be part of and identified in the DMHRC research budget (i.e., $250,000 for epidemiological studies and $400,000 for clinical;/services studies) and may not exceed $130,000 or 20% (whichever is larger) of the combined direct cost research budgets for any one year. A staffing plan and rationale for organization of this component should be presented. Methods, techniques, and technologies to be used for proposed activities should be defined as well as the targeted audience or participants. Issues of cultural sensitivity with regard to intended audience should be addressed. When appropriate, activities should be designed to effectively reach underserved populations and/or subgroups based on age or gender.

The scientific knowledge base and research topics or areas upon which proposed translational activities will be developed should be identified and explained. A discussion of the design, plans and procedures for development including time lines should describe strategies proposed to accomplish specific aims of the project(s). Innovative aspects of the approach to be used should be highlighted. A description of the resources, facilities, agencies, and/or institutions with working arrangements to plan, implement and conduct the proposed activities should be provided. Particular attention must be devoted to a description of necessary resources, including specialized expertise, and the target audience or participants who will derive benefit from the activity. If core facilities or services are utilized, information on their use should be provided. A description of plans to evaluate the success and/or effectiveness of educational translational activities with emphasis on their impact on knowledge, attitudes, and behaviors should be described.

The following are examples of projects that may be undertaken but are not intended to be limiting.

All translational and educational projects should have specific objectives and include a method for monitoring the effectiveness of the effort.

Other Requirements:

Facilities and Environment

Applicants must demonstrate the availability of adequate laboratory, clinical, and other office facilities needed to carry out the objectives of the proposed Center program. Relevant support services, including adequate data processing facilities, must also be readily accessible within or through the institution. Assurances of such support must be included with the application.

Summary of Center Components and Activities Supported

1) Administrative and Scientific Resource Core Component Phase I --25 pages

A budget should be submitted for each subcomponent resource as well as the overall budget. Overall budget should not exceed $250,000 direct costs in year one and $150,000 in subsequent years to establish and maintain the Epidemiological platform and support the research enterprise.

a) Administrative Resource sub-component includes organizational framework, consortia, and coordination

b) Scientific Resource sub-component includes shared research resources including techniques, instrumentation, services, or other resources to enhance research

2) Research Components Phase II

a) Epidemiological Research Project(s) (1 minimum) --25 pages

A budget should be submitted for the overall Epidemiological Project(s) as well as individual budgets for each project. The overall budget may not exceed $250,000 in any year.

b) Pilot Clinical and/or Services Research Projects (2 minimum) --25 pages

An overall budget should be submitted for the Pilot Projects as a whole for each year as well as for each individual project. The overall budget may not exceed $400,000 in any one year.

3) Research Translation/Dissemination Component (Optional) --25 pages

May include subcomponents to 1) translate research findings into health care practice; 2) public information dissemination; 3) education curricula or programs for students, health professionals and community agencies.

Each subcomponent must have a clear description of major goals objectives and integration with the research components. These will be conducted in phase 2 only. Budgets should not exceed $130,000 per year or 20% of the combined direct cost research budgets for any one year, whichever is greater. Note that funds for this optional component are counted against the overall research project budget cap.

NIMH recognizes that circumstances may change with the passage of time and the specifics of any particular disaster and thus may allow for additional administrative and/or competitive funding that exceeds the limits noted above, to become part of the Center.

Summary of Key Center Characteristics

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): March 23, 2007
Application Receipt Dates(s): April 23, 2007
Peer Review Date(s): June, 2007
Council Review Date(s): August 2007
Earliest Anticipated Start Date: September 2007

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 NIMH 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:

Farris K. Tuma, Sc.D., MHS
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7111, MSC 9632
Bethesda, MD 20892-9632
Telephone: 301-443-3648
Email: ftuma@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. 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
ATTN: RFA MH-07-070
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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Shuang-Bao Hu, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Blvd, Room 6156, MSC 9609
Bethesda, MD 20892-9609
Telephone: (301) 443-5160
FAX: (301) 480-3402
Email: shuangbaohu@mail.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). 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 the CSR and responsiveness by the NIMH. Incomplete and non-responsive applications will not be reviewed.

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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application can be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH 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.

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.

(The 2 paragraphs above apply only to Phase 1 of the award of the P60 program.)

6. Other Submission Requirements

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 expects that grant 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.
The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIMH in accordance with the stated review criteria.

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

Applications recommended by the NAMHC will be considered for funding on the basis of the overall scientific merit of the application as determined by peer review, as well as such considerations as program balance, relevance to the mission and goals of NIMH, research program priorities, and availability of funds. An Award will be made for up to 5-year project period with separate fiscal awards made annually. NAMHC recommendations will be based on the full requested budget. NIMH program staff will coordinate with NIMH Grants Management staff to ensure that the initial award is administered properly by the Center Director and that subsequent awards, to conduct individual research projects, are appropriately contingent upon successful implementation of the initial Phase/award.

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.

The initial review for scientific and technical merit will emphasize three major aspects:

(1) the review of each component: the administrative and scientific resource component, the research component, and where applicable, the translation/dissemination component

(2) consideration of practicability and flexibility of the proposed activities

(3) review of the Center as an integrated whole working together to focus on a central theme

Review will also include an assessment of the academic and physical environment and special considerations, e.g. compliance with human subjects and animal welfare requirements, and compliance with policies concerning inclusion of women, minorities and children in clinical research study populations.

The ADMINISTRATIVE AND SCIENTIFIC RESOURCE COMPONENT will be evaluated with the following criteria:

Approach for the Administrative Aspects: Are the arrangements and organizational structure, adequately developed, well integrated, well reasoned, and appropriate to the aims of the project?

Approach for the Scientific Resource Aspects: Is the justification for the need of a scientific resource clearly stated? Is the merit of the proposed resource explained?

Investigators for the Administrative Aspects: Are the investigators appropriately trained and well suited to carry out the proposed organizational interactions? Are the qualifications, experience, commitment and administrative competence of the Center Director appropriate?

Investigators for the Scientific Resource Aspects: Are the investigators appropriately trained and well suited for the resource activities? Is there a sufficient time and effort commitment made by the Director?

The RESEARCH COMPONENTS and, as applicable, the RESEARCH TRANSLATION/DISSEMINATION COMPONENT will be evaluated with the following criteria:

Significance: Do the studies address important questions/ if successful will the research results make a significant difference to the field? If the proposed aims are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project?

Innovation: Does the project employ novel concepts, approaches or methodology? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

Investigators: Are the qualifications of the epidemiological and individual pilot project leaders appropriate for the proposed research? Is the work proposed appropriate to the experience level of the component director and other researchers involved?

Environment: Is the scientific environment sufficient for the needs of the project? Does the proposed research take advantage of unique features of the environment such as: access to at risk populations, community resources or mutually-beneficial collaborative arrangements?

Practicability and Flexibility of the Proposed Activities:

CENTER AS AN INTEGRATED WHOLE will be evaluated with the following criteria:

Significance: Do the Center’s research goals address important scientific questions? 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?

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?

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

Investigators: Are the investigators appropriately trained and sufficiently experienced to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers?

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?

Coordination and Cohesiveness: Is the coordination among the administrative and scientific cores and the research components adequately explained? Is the usefulness of the scientific core components magnified by their inclusion in a Center? Is there synergistic potential among Center’s research components?

Are the management plans and arrangements feasible? Are the plans and mechanisms to evaluate the Center’s progress explained?

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.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

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. Program staff will be responsible for the administrative review of the research data sharing plan.

2.D. Sharing Research Resources

NIH policy expects that grant 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 NIMH 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

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator (PI) will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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 Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA for Phase 1 of the Center will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official. An amended NoA will need to be issued for implementing research projects once a disaster has occurred, the Center Director has indicated that they would like to initiate the research portion of the Center, and NIMH program staff have approved that the infrastructure is operationally ready and that the research projects are adequately prepared. The NIMH program official will work closely with NIMH Grants Management Officials to issue awards, via revised NOA and including any necessary and appropriate restrictions for the research projects subsequent to activating the Center after a disaster.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. 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.

The Center will be required to submit detailed annual progress reports including substantive information about research results to date, status of ongoing research, research plans for the next year, and any modifications in long-term research plans. Also required are reporting of inventions, reports of expenditures, final reports, and other reports in accordance with NIH policy. In view of the special significance of this program, the NIMH program official will have ongoing involvement with the awardees during the performance of the activities, including close coordination and communication with staff of the Center. In addition, the program official with other NIMH staff and consultants will, make on-site visits for purposes of program monitoring and exchange of information and to judge the readiness of the Center to progress with its research projects. The Center Director should keep the NIMH program official informed regarding key Center activities (e.g., establishing and making ready the Epidemiological platform; developing and refining research studies, planning for any translation/dissemination activities).

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:

Farris K. Tuma, Sc.D.., MHS
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7111, MSC 9632
Bethesda, MD 20892-9632
Telephone: 301-443-3648
Email: ftuma@nih.gov

2. Peer Review Contacts:
David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9609
Bethesda, MD 20892-9609
Telephone: (301) 443-3534
Email: armstrda@mail.nih.gov

3. Financial or Grants Management Contacts:
Rita Sisco
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-6885
Email: siscor@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.

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 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 funding opportunity 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.

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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 RFA 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, No.93.891 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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NIH Funding Opportunities and Notices


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