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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: Mental Health Consequences Of Violence And Trauma (R34)

Announcement Type
This is a reissue of PA-04-075, which was previously issued on March 12, 2004.

Update: The following update relating to this announcement has been issued:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-07-315

Catalog of Federal Domestic Assistance Number(s):
93.242

Key Dates
Release/Posted Date: January 19, 2007
Opening Date: January 19, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable.
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Submission/Receipt Date(s): Not applicable.
Peer Review Date(s):See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s):See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s0: See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date: November 17, 2009

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 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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission Review and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically 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

Through this Funding Opportunity Announcement (FOA), the National Institute of Mental Health (NIMH) seeks to encourage investigator-initiated research on the etiology of psychopathology related to violence and trauma, as well as research to advance diagnostics, treatments, services, and prevention strategies in this area. NIMH is vitally concerned with the psychological impact of violence and trauma from both the perspective of resilience and psychopathology.

In the last several years, various programs of the NIH and NIMH have organized and participated in scientific meetings concerning, acute reactions to trauma and risk and resilience for psychopathology; psychobiology of posttraumatic psychopathology; prevention and early intervention research; and disaster mental health. This FOA reaffirms the NIMH’s long-standing interest concerning mental health research on trauma and violence and reflects suggestions that have emerged from the above-mentioned scientific meetings.

Emerging areas of particular interest to the NIMH include. interdisciplinary approaches combining multiple levels of inquiry (e.g., psychological, neurobiological, genetic) and scientific tools (e.g., ecological assessment, neuroimaging, microarrays) for psychopathology risk modeling; identification of highly predictive markers of psychopathology and improved diagnostics; translation of basic behavioral and neuroscience findings on resiliency and risk for intervention development and testing; and strategies for effective service provision, particularly where non-specialty systems (i.e., primary care) may be required to provide mental health services. These areas incorporate research needs regarding the consequences of interpersonal violence (e.g., child abuse and neglect, violence against women, hate crimes); exposure to mass violence/major traumatic events (e.g., terrorism, major accidents, combat and war, refugee trauma and relocation, torture, natural and technological disaster); exposure to family, school, and community violence; violence in the media; and other types of trauma and violence. Populations of concern include children, youth, adults, the elderly, men and women, and all racial and ethnic groups.

A great deal has been learned and applied to improve the mental health of traumatically stressed persons. Despite the growth of research on traumatic stress, the field lacks a clinically meaningful marker of psychopathology; predicting which traumatized individuals will go on to develop mental disorders and serious functional impairment remains a challenge. Other challenges include understanding how to maintain and enhance resilience; finding and refining effective treatments for all who suffer from often debilitating disorders; and achieving a better understanding of the most effective means of organizing, implementing, financing, and delivering mental health services, including quality and outcomes of care. The need for focused, systematic research in these areas provides the impetus for this FOA.

Although not participating in this FOA, the National Institute of Child Health and Human Development (NICHD) shares an interest in this area of research. For specific information on NICHD interests, see http://www.nichd.nih.gov/crmc/cdb/p_cog.htm.

Significance/Background

The effects of experiencing traumatic stress, either as a witness or direct victim, are a major public health problem in the United States, with consequences of potentially severe psychological, behavioral, medical, and social dysfunction, including Post Traumatic Stress Disorder (PTSD) and other anxiety disorders, depression, and psychotic conditions, as well as injury and death. There is also a growing awareness that posttraumatic psychopathology is linked to other serious health conditions (e.g., hypertension, smoking, heart disease, substance use and abuse).

Trauma affects a large number of people. Self-report surveys suggest that millions of children are physically abused each year, and hundreds of thousands are victims of sexual abuse (National Clearinghouse on Child Abuse and Neglect Information) (http://www.childwelfare.gov/).

While lethal violence in the U.S. has actually been decreasing over the last decade, levels of non-lethal violence have not been decreasing and are of concern. Each year many children and adolescents sustain injuries from violence, they lose friends or family members, or they are adversely affected by witnessing a violent or catastrophic event. Annually, approximately 500,000 persons report rapes and sexual assaults. Other forms of physical assault are widespread (Department of Justice http://www.usdoj.gov/). Data from the National Comorbidity Survey (Kessler et al. 1995) indicate that many Americans will experience one or more major traumatic events (e.g., physical attack, house fire, rape, witness to death) in their lifetime.

A recent review of disaster studies highlights that natural disasters, technological disasters, and mass violence, including terrorism in the U.S., other developed countries, and in developing countries, can have severe impacts on those affected (Norris et al, , 2001). Mental health outcome data regarding the U.S. terrorist attacks of September 2001 are becoming available and findings from studies conducted in the most directly impacted communities underscore the capacity of man-made disasters to cause clinically significant, enduring and episodic psychobiological disorders, emotional distress, and impairment. Data emerging from studies initiated after the 2005 U.S. Gulf Coast Hurricanes indicate that a substantial percentage of survivors are struggling with new and exacerbated disorders.

Data from the U.S. Departments of Defense (DOD) and Veterans Affairs (VA) reveals that hundreds of thousands of veterans and active duty personnel involved in recent and on-going wars report extreme and intense traumatic experiences and have been identified as in need of mental health services.

The World Health Organization report on Violence and Health (2000) highlights the heavy cost of violence and trauma in health effects, in both financial losses from injury and decreased productivity as well as psychological and behavioral problems that may extend to permanent physical and mental disability.

Post-Traumatic Stress Disorder (PTSD)

The mental health sequelae of exposure to traumatically stressful events, including Posttraumatic Stress Disorder (PTSD), have been the focus of research for several decades. PTSD, recognized as a leading organizing construct for many posttraumatic adjustment difficulties, is a psychiatric disorder that can occur following the experience or witnessing of life-threatening events such as military combat, natural disasters, terrorist incidents, serious accidents, or violent personal assaults. People who suffer from PTSD often relive the experience through nightmares and flashbacks, have difficulty sleeping, and feel detached or estranged. PTSD is often associated with impairment in social, educational, occupational and family functioning and when symptoms are severe, the disorder can significantly impair the person's daily life. Problems with posttraumatic adjustment are frequently complicated by the fact that they are accompanied by disorders such as depression, substance abuse, problems of memory and cognition, and other problems of physical and mental health.

The past decade has witnessed considerable progress in expanding our knowledge of the neurobiological underpinnings of PTSD and in refining effective clinical interventions for PTSD. At the same time, it must be recognized that the diagnosis of PTSD, as currently conceptualized, does not fully capture the full range of symptoms associated with extreme stress and environmentally toxic experiences. In addition, current treatments while effective for many, are not effective for all persons with PTSD and do not adequately address all domains of dysfunction associated with this condition.

Among the most promising new approaches for understanding PTSD and, in turn, improving clinical treatments, lies in research that is mapping the neural circuitry involved in response to danger. Extreme environmental forces are clearly capable of changing the function and structure of the brain and these changes can now be quantified using imaging techniques with high resolution. An exciting area receiving renewed attention focuses on fear conditioning models of PTSD. These compelling models implicate the central importance of fear conditioning and the role of extinction learning in the etiology and maintenance of PTSD and emerging data from animal and human studies are pointing toward improved, more precise fear extinction paradigms. The ability to target specific brain regions implicated in acquiring conditioned responses and extinction-learning that is thought to challenge the conditioned fear response can improve various forms of therapy for PTSD. Genetics, an emerging area of interest in PTSD research, is another focal area that holds great promise for understanding individual differences in vulnerability to enduring psychopathology following extreme trauma. A major issue is that risk of PTSD along with other mental disorders is genetically complex, meaning that multiple genes as well as non-genetic factors contribute to individual risk. The identification of risk genes will provide great benefit in trying to understand the pathogenesis of PTSD, for identifying individuals for indicated prevention efforts, and for identifying targets for new forms of therapy.

The benefits of such research can only be realized if socio-environmental forces, conveying and buffering against risk and disorder, are ascertained and understood in concert with genetic and neurobiological forces and in the context of dynamic developmental influences.

Accumulating knowledge about basic brain processes and complex gene and environmental interactions offer the promise for predictive, personalized, and preventative approaches to intervention and rehabilitation. While pursuing these leads, NIMH recognizes the needs of those who are suffering today and appreciates the need for efficacy and effectiveness trials of established and new therapeutic approaches, as well as health services research to transform mental health service programs to be optimally responsive to the needs of current victims and survivors of trauma.

Research Goals and Topics

There is a growing literature of empirically-derived information to support integrative models for understanding and addressing posttraumatic psychopathology. Certain aspects of etiology, course, and treatment of PTSD and other sequelae of violence and trauma can be understood with models emphasizing learning theory, information processing, social support/resources, development, and learned helplessness. It is also known that multiple neurobiologic systems become activated when an organism is threatened. While these processes generally serve a protective role in the short run, it appears that acute maladaptive responses to stress fail to resolve for some trauma survivors. Applications in response to this FOA are strongly encouraged to build on and strengthen this empirical foundation by integrating what is known, for example, about psychosocial and neurobiological aspects of posttraumatic psychopathology.

Several areas stand out as priorities for future research on the mental health consequences of violence and trauma. Broadly stated, needs include: basic, clinical, and genomic studies of the mental health consequences of traumatic stress, the development and testing of interventions to assist victims and survivors, and models for delivering care effectively and efficiently.

Gaps exist in the fundamental knowledge of psychobiological implications of traumatic stress, particularly with regard to the development of children and adolescents. It is clear that simple models about the direct effects of early exposure to trauma and adversity are incomplete. Early trauma does not equate simply and consistently to complex psychopathology and co-morbid conditions. A variety of research approaches can provide needed insights into the nature, cause, and pathogenesis of posttraumatic psychopathology including: assessment and measurement research on violence exposure and its consequences, theory-guided research on risk and protective factors, studies of mediators and moderators of exposure to various and multiple forms of violence and their consequences, and basic research on cognitive processing, arousal, and memory, as well as neurobiological and functional consequences of exposure to traumatic stress. This information in turn can inform the further development of theoretically driven interventions and services.

Much can be learned from research involving various types of trauma (e.g., interpersonal violence and crime, child abuse and neglect, mass violence and disasters.) and from basic, pre-clinical, and clinical research (e.g., animal models of stress, as well as human studies of molecular and cellular brain function in the context of trauma). Research assessing acute responses to trauma, risk for long-term adjustment problems, translational research to better understand early experiences, emotion regulation, and the development of stress-sensitive neurobiological systems and their relevance as targets for preventive interventions also emerge as important topics. Similarly, research to develop and refine interventions and effective ways to deliver care in multiple contexts, including stepped care and triage approaches are needed.

Examples of developmental areas that require additional exploration include defining critical aspects of exposure, taking into account cognitive, emotional, and neurobiological limitations in young children. The examination of potentially modifiable factors and processes involved in reactions to trauma, which are indicative of risk and resiliency, are also of interest to the NIMH.

There is strong evidence demonstrating that various forms of Cognitive Behavioral Therapy, pharmacotherapy and combined therapies are effective for reducing core symptoms of PTSD and related role impairment for many people with this disorder. Yet, it is equally well documented that not everyone treated with these evidence-based therapeutic techniques improves. Moreover, evidenced-based treatments for PTSD often require relatively intensive efforts on behalf of clinicians and patients and may not be widely available. The limited availability of evidence-based treatments for posttraumatic psychopathology, their often resource intensive nature, and emerging empirical knowledge regarding risk and resilience highlight the need for innovative approaches to risk reduction, treatment and the delivery of mental health services.

Currently, only two medications (sertraline and paroxetine), both selective serotonin reuptake inhibitors (SSRIs), are recommended as first line treatment options; both have been approved by the U.S. Food and Drug Administration (FDA) for treating PTSD. Yet, research on prescribing patterns for patients with PTSD reveals frequent use of benzodiazepines, antipsychotics and other medications. These medications may have undesirable side effect profiles, raise safety concerns, have limited data to support their efficacy, and are generally not recommended as first-line treatment options for PTSD. The limited data available on this topic indicates that there is a gap between expert treatment guidelines and practice; closing this gap is a major research priority.

The increasing reliance on community-based mental health services and the relatively large role that primary care providers play in addressing common mental disorders highlights the need to transfer and probably adapt existing evidence-based approaches to treatment. Such efforts might focus on utilizing a variety of health professionals (e.g., MSWs, psychiatric nurses) as well as approaches to care (e.g., individual, group, family - psychotherapy, pharmacotherapy, combination therapy).

Research on the psychobiology of PTSD suggests that prevention is a realistic and important goal. Changes in various indices of biologic functions observed in close proximity to trauma and those that emerge over time indicate that some biologic variables may predate trauma exposure and increase the risk for the development of PTSD while others appear to emerge weeks after trauma exposure. This type of information is ripe for exploratory translational research to advance interventions. Understanding how stress impacts brain structures and functions involved in cognitive processing, arousal, memory, and behavior should be driving intervention research seeking to understand pathophysiology, minimize symptoms, improve outcomes and correct or prevent alterations from becoming fixed.

Research on psychosocial and socio-environmental factors present prior to, during, and after trauma exposure has led to compelling theories about the mediation of risk for adverse outcome. For example, depressed unit/group/family atmosphere, availability of social support, loss of other resources, as well as individual factors such as developmental competencies, temperament, self-esteem, locus of control, skills to manage psychological and physiological symptoms are likely to have an effect on risk for developing PTSD, its course and individual outcomes.

While the precise etiological role of specific psychosocial and biological factors is unclear, environmental, psychological, and biological correlates of PTSD can be considered as potential targets for intervention research seeking to improve patient outcomes, understand risk and resilience, and to clarify causal mechanisms.

Given the current state of science and practice regarding the identification, treatment, and prevention of PTSD and related posttraumatic psychopathology and knowledge of current treatment needs, NIMH is encouraging applications for research along a continuum of scientific and clinical needs.

This mechanism provides resources for evaluating the feasibility, tolerability, acceptability and safety of novel approaches to improving mental health and modifying health risk behavior, and for obtaining the preliminary data needed as a pre-requisite to a larger-scale (efficacy or effectiveness) intervention or services study. NIMH intervention and services research is aimed at preventing or ameliorating mental disorders, emotional or behavioral problems, the co-occurrence of mental, physical and substance abuse problems, HIV infections, and the functional consequences of these problems across the life span. This funding opportunity addresses several recommendations of the National Advisory Mental Health Council: Bridging Science and Service); Translating Behavioral Science into Action); and Priorities for Prevention Research at NIMH).

Exploratory Grants for MH Intervention and Services Research are designed to support the early phases of intervention development or adaptation, protocol development and preliminary pilot testing to support a full-scale (e.g., R01) efficacy or effectiveness study, and innovative services research. For the purpose of intervention development or pilot testing, "intervention" is broadly defined to include psychosocial, pharmacologic, somatic or combination approaches to prevent disorder; efforts to treat disorder in the acute and later phases, such as continuation and maintenance; efforts to prevent relapse, side effects, or co-morbid symptoms and disorders; rehabilitative efforts to reduce residual symptoms and/or enhance functioning; efforts to target provider behavior change; or system organizational efforts to improve care quality, coordination or delivery. In terms of innovative services research, pilot studies might include explorations of the use of approaches and concepts new to a particular substantive area, research and development of new techniques, or initial research to develop a body of data upon which significant future research may be built (i.e., potential for high impact).

Integrated preventive, rehabilitative, treatment and services strategies should consider the timing and sequencing of these strategies, as well as the development of incremental outcome measures that could reflect cumulative effects of multiple interventions. Outcomes may be defined at the individual, group, system, or population levels, or any of these in combination.

1. Development and Pilot Testing of New or Adapted Interventions

Intervention development can be considered to have three stages: 1) conceptualizing an intervention based on theory and empirical research, 2) developing and standardizing the intervention, and 3) pilot testing.

(Stage 1) Applicants should explicate a clear conceptual link between relevant psychological or behavioral factors, various intervention components being proposed (including a description of the mechanisms of action by which these components are hypothesized to have an effect), and their relationship to the particular aspects of outcome that are being targeted. It is also appropriate to present data from prior research describing characteristics of client subgroups, settings, care providers or other relevant variables that were associated with non-response, partial response or relapse. New interventions should be designed or adapted to address factors (such as participant personality variables, expectancies or preferences, behavioral and interpersonal skills deficits, training/supervision of care providers, organizational characteristics, insufficient medication dosing, etc.) that have previously been identified as predictors of positive or negative client outcomes. High priority will be given to applications that demonstrate the systematic translation of basic behavioral and neurobiological processes (e.g., cognition, memory, attention, emotion, personality) into applied interventions. Attention should also be given to the effects of these interventions with underserved populations in disparate social, economic, cultural and environmental contexts.

(Stage 2) Standardization of an intervention includes procedures such as the following: development of a treatment protocol (e.g., psychotherapy manual, medication dosing schedule, quality improvement effort) including iterations to this protocol based on information such as feedback from patients, care providers and other investigators; development or adaptation of relevant measures including diagnostic, cost and outcome assessments; formulation of measures of provider competency, acceptance and adherence to the protocol, implementation fidelity, and participant acceptance and/or behavior change related to the treatment. Components of the intervention should be operationalized in as much detail as appropriate commensurate with its present stage of development.

(Stage 3) Pilot and feasibility studies involve testing and further refining the intervention manual and measures developed during Stage 2. Typically, data are gathered to estimate intervention parameters (e.g., effect size, attrition rates, response rates) and to perform preliminary power analyses. In some instances pilot tests take the form of small, tightly controlled efficacy trials designed to hold constant or eliminate any factors that could reduce the treatment effect, including patient heterogeneity. However, under other circumstances an alternative design might be more appropriate depending upon the nature of the research question, the number of participants included in the study, the characteristics of the disorder or population being studied, the risks and benefits of providing (or withholding) an intervention from the target population, subject recruitment concerns (especially for rare diseases), or the availability of other effective interventions to patients in their communities. Therefore, under certain circumstances, investigators might need to consider alternative methodologies, including quasi-experimental or even uncontrolled single case designs, if necessary. It is the responsibility of the investigator to provide a justification for the type of experimental design chosen. In summary, the goal of this phase of research is for the investigator to propose the most rigorous means of collecting data (in light of ethical or other limitations) that will prepare him or her to conduct a larger, more definitive test of the intervention in the future.

For exploratory/development grants, the goals of the study should be clearly outlined and related to specific aims and procedures pertinent to whichever stage(s)of development will be pursued. It is acknowledged that boundaries between the stages above are non-discrete and therefore, investigators may propose ideas or methods including subsets of one or more categories. Importantly, however, the proposal should include a clearly operationalized description of each component step, with decision points indicating when each has been successfully completed and when to move onto subsequent components. Furthermore, investigators are not expected to necessarily complete all phases of development during the 3-year duration of the award. They should propose feasible and systematic goals that can be accomplished within the time and funding constraints of this award while considering the aim of accomplishing the prerequisites for conducting a larger (e.g., R01) study.

2. Adaptation and Pilot Testing for Effectiveness

The principal aim of effectiveness (or public health-oriented) research is to determine whether interventions with demonstrated efficacy under tightly controlled conditions can have a measurable beneficial effect when implemented in less precisely controlled circumstances with more heterogeneous populations, providers and settings. These studies have broad inclusion and relatively few exclusion criteria. Exclusion criteria are based more on concerns for participants' safety than on achieving tight control over extraneous sources of variation that may complicate causal interpretations of intervention effects. Age, gender, ethnic minority status, and comorbidity are seen as important dimensions on which to ensure sample representativeness and generalizability, rather than as bases for participant exclusion. Potential outcomes are broad and often include variables such as performance (school, work, etc.), relationship functioning (family, interpersonal, etc.), HIV risk reduction, disability, quality of life, mortality, institutionalization, and health care resource use in addition to measures of psychiatric morbidity. When conducting effectiveness research on an intervention with previously demonstrated efficacy, information regarding its initial degree of "fit" within an applied setting (e.g., specialty or primary care, school or work site) and the iterative process that is expected to occur when altering the intervention for successful implementation within this setting should be articulated.

3. Innovative Services Research

This FOA is also intended to encourage applications to facilitate innovative services research directions that require preliminary testing or development. Such pilot studies might include service delivery model development, explorations of the use of approaches and concepts new to a particular substantive area, research and development of new techniques, or initial research to develop a body of data upon which significant future research may be built (i.e., potential for high impact). Studies designed to develop and/or test novel service delivery models should reflect one or more of the 3 stages of intervention development described in the "Development and Pilot Testing of New or Adapted Interventions" section of this Program Announcement. Additional examples of relevant services research areas might include "practice research," studies of dissemination and implementation and/or organizational processes, and/or the analysis of complex, multi-dimensional mental health care delivery systems. Research in these areas may require novel or mixed methodologies and/or innovative statistical approaches.

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

Section II. Award Information

1. Mechanism of Support

This FOA will use the R34 award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses the modular as well as the non-moduluar budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

R34 grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. However, it is intended that grantees funded through this exploratory phase program will elect to seek continuing support for their projects through the R01 grant mechanism.

Up to two resubmissions (formerly revisions/amendments ) of a previously reviewed R34 may be submitted.

2. Funds Available

Under this FOA, applicants for an R34 award may request direct costs of up to $450,000 for three years. Although variations from year to year are permissible, in no case may any year be more than $225,000 in direct costs, and total direct costs for the entire project period may not exceed $450,000. Grant applications may request one, two, or three years of support. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization 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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., Special Instructions, regarding appropriate required budget component.)
Research & Related Budget (required for foreign applications)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan (section 14 of the PHS398 Research Plan component), must be included. The governance and organizational structure of the research project should be described, including communication plans, process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs, including responsibilities for human subjects or animal studies as appropriate.

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are note required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: January 19, 2007 (Earliest date an application may be submitted to Grants.gov)
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit 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 an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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.

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 renewal (formerly 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 renewal 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 the NIH Grants Policy Statement.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

The R34 is not renewable. Up to two resubmissions (formerly (revisions/amendments ) of a previously reviewed R34 may be submitted.

All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R34 applications:

Appendix Materials

R34 appendix materials should be limited, as is consistent with the exploratory nature of the R34 mechanism. The following materials may be included in the appendix:

Stop SignIMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Foreign Applications (Non-domestic (non-U.S.) Entity)

Plan for Sharing Research Data

Not Applicable.

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_2003/NIHGPS_Part7.htm#_Toc54600131). 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 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). See Section VI.3., Reporting.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

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

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

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The R34 clinical exploratory/developmental grant is a mechanism for supporting the development and/or pilot testing of new or adapted interventions; pilot testing interventions with demonstrated efficacy in broader scale effectiveness trials; or innovative services research directions that require preliminary testing or development. Because this is a clinical exploratory/developmental grant application, it need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R34 applications; however, they may be included if available.

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.

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?

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: 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 or methodologies, tools, or technologies for this area?

Investigators: Are the PD/PIs and key personnel 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)?

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:

Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

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 item 6 of the Research Plan component of the SF424 (R&R).

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 item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) 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 appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.

2.C. Sharing Research Data

Not Applicable.
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_2003/NIHGPS_Part7.htm#_Toc54600131). 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.

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

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), See Section VI.3., Reporting.

Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations. For the R34 mechanism, the presence or adequacy of a plan should not enter into the scoring of the application.

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 PD/PI will be able to access his or her Summary Statement (written critique) via the NIH 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.

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 will be generated via email notification from the awarding component to the grantee business official.

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 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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually 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:

A listing NIMH Scientific/Research Contacts are available at: http://www.nimh.nih.gov/grant/Violence_Trauma.cfm

Direct your questions about adult psychopathology and disaster mental health research to:

Farris 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: [email protected]

Direct your questions about child psychopathology research to:

Christopher Sarampote, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6182, MSC 9617
Bethesda, MD 20892-9617
Telephone: (301) 443-1959
FAX: (301) 480-4415
[email protected]

Direct your questions about services research to:

Denise Juliano-Bult, M.S.W.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room, 7137 MSC 9631
Bethesda, MD 20892-9632
Telephone: 301-443-3364
Email: [email protected]

Direct your questions about stigma and health disparities research to:

Emeline Otey, Ph.D.
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6227, MSC 9615
Bethesda, MD 20892 (express mail, Rockville, MD 20852)
Telephone: 301-443-9284
Email: [email protected]

2. Peer Review Contact(s):

Not applicable.

3. Financial/Grants Management Contact(s):

Rebecca Claycamp
Division of Extramural Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: 301-443-2811
FAX: 301-443-6885
Email: [email protected]

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 (45 CFR 46) 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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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 SF424 (R&R) application; 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.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS 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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 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 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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