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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)
United States Army (http://www.army.mil)

Components of Participating Organizations
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)

Title: Collaborative Study of Suicidality and Mental Health in the U.S. Army (U01)

Announcement Type
New

Request For Applications (RFA) Number:  RFA-MH-09-140

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release Date: January 5, 2009
Letters of Intent Receipt Date:  March 3, 2009
Application Receipt Date:  April 3, 2009
Peer Review Date:  April 2009
Council Review Date:  May 2009
Earliest Anticipated Start Date:  July 1, 2009
Expiration Date:  April 4, 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(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, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
    D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The high rates of mental health and behavioral adjustment problems among recent U.S. military combat veterans, and the increasing rates of suicide among Army soldiers, are of growing concern. This Funding Opportunity Announcement (FOA) issued by the National Institute of Mental Health (NIMH), in collaboration with the U.S. Army, solicits cooperative agreement (U01) grant applications aimed at conducting an epidemiologic study of mental health, psychological resilience, suicide risk, suicide-related behaviors, and suicide deaths in the U.S. Army. This study will evaluate selected samples of soldiers across all phases of Army service, both cross-sectionally and longitudinally, including entry-level training and service, pre-deployment training, deployment and non-combat assignments, post-deployment, and post-separation reintegration to civilian life. The intent is to identify, as rapidly as scientifically possible, modifiable risk and protective factors and moderators of suicide-related behaviors, as well as the potency of these factors and modifiers alone and in combination. Once modifiable factors are identified, investigators will identify specific intervention options for reducing suicide risk by addressing empirically-identified risk and protective factors, and develop initial research designs for subsequent research that may test practical suicide risk reduction efforts. Finalizing the design and implementation of intervention and screening trials lies outside the scope of this project.

The overall objective of this research is to generate a comprehensive research platform from which multiple determinants of suicide-related events – both positive and negative – can be evaluated, with the intent of informing the development of effective strategies for mitigating suicide risk and enhancing the resilience of Army personnel across all phases of Army service. At the same time, NIMH and the Army expect that the results of this study will shed light on a continuum of health issues, including but not limited to determinants of mental health and mental disorder across all phases of Army service, resilience to extreme stress, and processes related to emotional and behavioral readjustment following deployment to combat environments. In all aspects of this project, NIMH and the Army specifically seek to foster innovative methods to maximize the scientific and practical value of this research.

Background

In the years spanning 1994 through 2001, suicide rates among Active Duty soldiers in the U.S. Army (i.e., “the Army”) generally decreased (Allen J.P. et al. (2005). Suicide in the Army: A review of current information. Military Medicine, 170(7):580-584). Since 2001 the suicide rate for Active Duty soldiers has climbed, and in 2007 peaked at a record level (Tyson A.S. Soldiers’ suicide rate on pace to set record. Washington Post, Sep 5, 2008, page A2). Civilian and military leaders within the Army have initiated several types of internal review to understand the apparent increase in suicide deaths and nonfatal attempts among Active Duty soldiers, and to develop better methods for preventing suicidal behaviors. In this context, in collaboration with the Army, NIMH will initiate a rigorous evaluation of the mental and behavioral health of soldiers in the regular Army (RA), the United States Army Reserve (USAR), and the Army National Guard (ARNG), with an emphasis on identifying precursors of suicidal behavior, including psychological, physiological, interpersonal, and life event risk factors, as well as potential protective mechanisms, across all phases of Army service. The ultimate goal of this study is to develop data-driven methods for mitigating or preventing suicide behaviors and improving the overall mental health and behavioral functioning of Army personnel during and after their Army service.

A large literature exists on the epidemiology of suicidal behavior, with fairly consistent findings on demographic, psychiatric, psychological, and interpersonal variables that are associated with suicide risk (for recent reviews, see Nock M.K. et al. (2008). Suicide and suicidal behavior. Epidemiol Rev, Jul 24 [Epub ahead of print]; Knox K.L. and Caine E.D. (2005). Establishing priorities for reducing suicide and its antecedents in the United States. Am J Public Health, 95(11):1898-903; and Mann J.J. et al. (2005). Suicide prevention strategies: a systematic review. JAMA, 294(16):2064-74).  A complementary literature focuses on biological, cognitive-emotional, behavioral, and social factors that may protect individuals from developing stress-related adjustment and mental disorders, including suicidality (see Charney, D.S. (2004). Psychobiological mechanisms of resilience and vulnerability: Implications for successful adaptation to extreme stress. American Journal of Psychiatry, 161(2):195-216; Southwick, S.M.et al. (2005). The psychobiology of depression and resilience to stress: Implications for prevention and treatment. Annual Review of Clinical Psychology, 1:255-291; Maddi, S.R. (2002). The story of hardiness: Twenty years of theorizing, research, and practice. Consulting Psychology Journal: Practice and Research, 54(3):175-185; Borowsky, I.W. et al. (2001). Adolescent suicide attempts: risks and protectors. Pediatrics, 107(3):485-93).       

Based on findings drawn from this literature, a subcommittee of the Army Science Board (ASB) is currently studying which demographic, medical/psychiatric, military experience, relationship, and mental health treatment variables may distinguish soldiers who died by, or attempted, suicide from randomly selected peers who avoided self-injurious behavior. Although this retrospective study by the ASB may identify personal characteristics, military experiences, changes in habits, and/or triggering events that precede suicidality, it is unlikely that this approach will fully reveal how distal and proximal risk factors evolve over time and place to influence the likelihood of suicidal actions. Accordingly, the Army is interested in quantitative research to complement and extend the ASB study, particularly via prospective, longitudinal investigation to identify, measure, and mitigate suicide risk factors among soldiers. From a scientific and public health perspective, such research represents a unique opportunity to push the epidemiology of suicide beyond solely descriptive studies. NIMH envisions an analytic approach that will test theories of suicide risk, protective mechanisms, and pathways to suicidality by collecting data from population samples – including targeted samples of salient subgroups hypothesized to have elevated suicide risk based on prior research - and following them over time.  The overall intent of this initiative is to inform the development and testing of effective interventions to prevent and treat suicidality and associated mental and behavioral health problems among soldiers.

The NIH Cooperative Agreement (U01) award mechanism will be used to support this study.  A variety of factors argue for substantial Federal programmatic staff involvement in this project, including (1) the public health significance of the research topic; (2) the nature of the study population; (3) methodological and logistical challenges to surveying soldiers – including those deployed to combat theaters – both at a point in time and longitudinally; (4) the need to analyze and report interim results rapidly, to inform subsequent research activities within the current project period; and (5) the need to coordinate closely with complementary activities being conducted within other Army research institutions, particularly the U.S. Army Medical Research and Materiel Command (MRMC), the U.S. Army Center for Health Promotion and Preventive Medicine (CHPPM), and the Army G-1.

Applicants should expect substantial NIMH programmatic staff assistance in refining and conducting the study, as described in Section VI.2.A.2, NIH Responsibilities.

Aims

The objective of this research study, using epidemiologic research methods, is to identify (a) previously undetected risk factors for suicide-related events and behaviors, (b) factors that may protect individuals from becoming suicidal, c) pathways or trajectories into and out of risk for self injurious behavior, and (d) new opportunities for reducing suicide risk, with the intent of informing the development of practical strategies for optimal prevention and intervention across all phases of Army service. This study will principally utilize primary data collected from soldiers, across all phases of Army service, including entry-level training and service, pre-deployment training, deployment and non-combat assignments, post-deployment, and post-separation reintegration to civilian life, as described in further detail below. Soldiers’ spouses, partners, and/or parents may be included in the study when appropriate, for example to help assess the influence of family relationships on the mental and behavioral health of soldiers.

This study principally involves the application of epidemiologic methods. However, while efficient description is desirable, we emphasize that the project’s primary goal is not exhaustive description of suicide behaviors or risk and protective factors as an end in itself. Rather, this project is intended, as rapidly as scientifically possible, to (1) identify modifiable risk and protective factors and moderators of suicidality; (2) advance hypotheses about mediators of suicidality that can be acted upon to either reduce risk or increase protection; (3) identify specific intervention options for reducing suicide risk by addressing empirically-identified risk and protective factors; and (4) develop initial research designs for subsequent projects that may test practical suicide risk reduction efforts (e.g., screening; identification and targeting of high-risk individuals and population groups; implementation of multiple risk reduction strategies). As appropriate, intervention development options may include suggested modifications/extensions to existing Army/DoD programs in this area.

Finalizing the design and implementation of screening and intervention trials lies outside the scope of this project.  However, to ensure rapid transfer of knowledge and to avoid duplication of effort, all information obtained regarding modifiable risk and protective factors, and associated risk reduction approaches, will be shared with Army institutions that are pursuing complementary research activities, particularly the screening and surveillance efforts being led by CHPPM, the intervention research being led by MRMC, and the suicide prevention programs being led by Army G-1.  Methods for achieving cooperative oversight of these related scientific efforts are described in Section VI.2.A.3, Collaborative Responsibilities.  

This funding opportunityresponds to three objectives of the NIMH Strategic Plan (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml):  Objective 2.3, “Develop tools to better define and identify risk and protective factors for mental illness across the lifespan;” Objective 3.1, “Further develop innovative interventions and designs for intervention studies;” and Objective 4.4, “Strengthen NIMH’s relationships with other Federal agencies that address mental health issues.”

Methods

Conceptual Framework – This project is guided by the development of previous population-based epidemiological studies, such as the Framingham Heart Study [(Dawber, T.R. (1980). The Framingham Study: The Epidemiology of Atherosclerotic Disease. Cambridge, MA: Harvard University Press; Levy D. and Brink S. (2006)]. Change of Heart: Unraveling the Mysteries of Cardiovascular Disease. New York, NY: Vintage Books).  In this conceptual framework, outcomes of interest are viewed as the result of multiple, complex, and interrelated influences, many – or even most – of which may be individually weak and evolve over time and place. In the case of suicide, population-based longitudinal data are required in order to identify and target for intervention salient risk factors for potentially lethal self-destructive actions. Such data go beyond what is currently available from existing Army data sources, such as personnel, medical, and psychological autopsy records, the Army’s Mental Health Advisory Team (MHAT) assessments, and the Department of Defense Suicide Event Reports (DoDSER). To acquire suitable data on potentially modifiable risk and protective factors, one must begin with an initial cross-sectional assessment of a population sample, as was done in Framingham. Data collection at this stage can be informed by initial hypotheses and research questions about relevant risk and protective factors, based on prior theoretical and empirical work. Conceptual frameworks for considering suicide risk over the lifecourse include those described by Vaillant and Blumenthal (1990; “Suicide Over the Life Cycle – Risk Factors and Life-Span Development,” in Suicide Over the Life Cycle: Risk Factors, Assessment, and Treatment of Suicidal Patients, J. Blumenthal and D.J. Kupfer eds., Washington, DC: American Psychiatric Press) and [Joiner (2005); Why People Die by Suicide, Cambridge, MA: Harvard University Press), as well prior empirical analyses [e.g., Nock M.K. et al. (2008). Suicide and suicidal behavior, Epidemiol Rev, July 24. (Epub ahead of print)].   

Although the existing literature structures initial data collection in an epidemiologic study, much of the value of a Framingham-type approach lies in the opportunity to generate new hypotheses based on collected data, rather than to evaluate hypotheses that were specified in advance. Thus, for instance, when the Framingham study began, investigators did not specify prior hypotheses about the potential protective role of aspirin in reducing the risk of cardiac events. Rather, they formed this hypothesis mainly based on analysis of the initial data collected on the Framingham sample, and developed it further based on longitudinal follow-up of this original sample; the hypothesis was ultimately tested via a randomized control trial in a separate sample, the first Physician’s Health Study [Steering Committee of the Physicians’ Health Study Research Group (1989). Final report on the aspirin component of the ongoing Physicians’ Health Study. N Engl J Med, 321(3):129-35]. Similarly, Framingham investigators observed that women’s cardiovascular risk increased after menopause; these patterns were replicated using a new sample, the Nurse’s Health Study, which led to hypotheses about the role of estrogen in cardiovascular disease [Stampfer M.J. et al. (1991). Postmenopausal estrogen therapy and cardiovascular disease: Ten-year follow-up from the nurses’ health study. N Engl J Med, 325(11)756-62; Rossouw J.E. et al. and the Writing Group for the Women’s Health Initiative Investigators (2002). Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principle results from the Womens’ Health Initiative randomized control trial. JAMA, 288(3):321-33].   

For the present project, we are guided by a general version of this approach: collection and analysis of observational data (cross-sectional/retrospective, and longitudinal/prospective) to develop and refine hypotheses, leading to formal hypothesis-testing through a variety of subsequent research activities. In responding to this FOA, applicants must describe their plans for pursuing a Framingham-like study of suicide and suicide risk and protective factors in the Army. Specifically, applicants should (1) identify population subgroups to be included in the initial cross-sectional assessment, (2) describe primary data to be collected from these samples, justifying choices based on current conceptualizations of suicide risk, pathways to suicide, and psychological resilience, (3) outline data management procedures and biostatistical resources that will support rapid and thorough analysis of initial cross-sectional data, (4) discuss conceptual and statistical approaches that will be used to characterize the “signal strength” and potential malleability of empirically identified risk and protective factors, (5) convey the decision-making process to be used regarding immediate next steps in the research program, and (6) describe capabilities for responding quickly and flexibly to emerging scientific opportunities via suitable methods, e.g., longitudinal follow-up of initial respondents, recruitment of new cohorts, nested case-control methods, and assessment of suicide risk and protective mechanisms through laboratory-based studies. Assuming modifiable risk and protective factors are identified, applicants should describe the process to be employed for designing practical interventions for mitigating suicide among at risk individuals, including interventions that target intermediate outcomes of significance (see “Outcomes of Interest,” below).

The following issues should be considered when developing a research plan in response to this FOA:

Empirical Approach – The core activity of this project will be a comprehensive cross-sectional assessment of representative samples of the current Army population and of relevant subgroups, across all force components (i.e., RA, USAR, ARNG), and recently separated personnel. The study should include targeted oversamples of population groups that may be particularly relevant; potential examples might include those who currently serve or have recently served in a combat theater (e.g., to gauge the role of combat- and deployment-related stressors), those who have recently separated from the Army (e.g., to gauge work and other functioning as they reintegrate into civilian life), and new/recent recruits (e.g., to assess true “baseline” risk and protective factors, and because this group’s full Army experience can be tracked prospectively over time).

The initial cross-sectional data collection should include assessment of salient contemporaneous characteristics, as well as some retrospective assessment (e.g., of prior exposure to traumatic events).  Examples of potentially relevant domains for primary data are discussed below.  These cross-sectional data will provide a comprehensive “snap-shot” of current service members, including the distribution of potential risk and protective factors among e.g., new recruits and pre-deployment personnel; the distribution of mental health and functioning outcomes among e.g., post-deployment and recently separated personnel; and information about associations between potential risk and protective factors and salient outcomes. More generally, the core cross-sectional assessment should be designed specifically to enable various types of augmentation, particularly longitudinal follow-up (i.e., additional waves of data collection from the initial respondents), repeated cross-sections (i.e., additional samples, such as subsequent Army entry cohorts), and laboratory-based studies of selected subsamples to explore the mechanisms of risk and resilience in greater detail. 

NIMH expects that core data collection will be via surveys, supplemented by biomarker data (where feasible and appropriate), and linked administrative data. (Potential secondary data from administrative datasets are described further below). Issues relating to (a) composition of the initial cross-sectional sample, (b) potential high-priority extensions (e.g., additional waves/samples), and (c) potential target data domains/elements are discussed in further detail in the next section.

The overarching goal of this study is to create a platform to generate sound epidemiological data on risk and protective factors for suicide-related events and other related outcomes (e.g., psychopathology, occupational and social functioning, other external causes of death) that will inform the development, testing, and ultimately the implementation of interventions directed at potentially modifiable risk factors. The resulting scientific information is intended to be of direct practical use to the Army as a resource that complements the mental health screening and surveillance activities being led by the Army’s CHPPM, the psychological resilience and suicide prevention/counseling research being led by the Army’s MRMC, and the suicide prevention programs within the Army G1.  To the extent that it is possible, research findings generated by this project should be translated from the Army context to other military branches, and from military to civilian populations, to address the nationwide public health challenge of suicide.  

Outcomes of Interest – Investigators should describe feasible and scientifically appropriate methods for assessing empirical relationships between suicide deaths and both proximal and relatively distal risk and protective factors, as well as the interrelationships between various risk and protective factors. Investigators should consider that while suicide rates among soldiers have increased in recent years, suicide deaths are still rare in the Army (e.g., 115 confirmed suicide deaths, or 18.1/100,000 soldiers in 2007; Tyson, A.S. Soldiers’ suicide rate on pace to set record. Washington Post, Sep 5, 2008, page A2). Consequently, the research plan should present a strategy that addresses the likelihood of a low absolute number of suicide deaths during the study period, as well as methodological challenges to studying modifiable risk and protective factors for suicide under these circumstances. Investigators should discuss how potential proximate risk factors for suicide death, e.g., suicide attempts, suicidal ideation, various forms of psychopathology, the co-occurrence of multiple suicide risk factors, might be employed as outcome variables, and how such potential proximate factors represent outcomes of interest in their own right. Whatever strategy is selected, the investigator should include methods for assessing the determinants and correlates of proximal factors, keeping in mind this project’s ultimate objective of informing the development and testing of interventions directed at potentially modifiable risk and protective factors for suicidality and related outcomes.

Innovative Methods – As with other medical illnesses such as coronary artery disease, science promises to redefine mental disorders along a trajectory that moves across stages of risk from vulnerability states to early symptoms, to full symptoms or syndromes, and to remission, relapse, and recovery.  Charting the onset and course of mental disorders requires attention to genetic, neurobiological, behavioral, experiential, interpersonal, and environmental factors that may confer risk for psychopathology.  Individual characteristics, such as age, sex, race, ethnicity, culture, and socioeconomic background are additional critical considerations in this research.  Either singly or in combination, these different factors and characteristics may not only increase the likelihood that an individual will develop a mental disorder, but also affect how well that person will respond to interventions. Accordingly, the NIMH Strategic Plan encourages innovative approaches for exploring risk architecture and mechanisms in mental disorders that span genes, neurobiological systems, cognitive-emotional domains, behavior, social interactions, and environmental exposures.  In the present initiative we expect investigators to describe a similarly broad perspective for studying mental disorders, suicide risk, and suicide-related behaviors in the Army, and to illustrate how complementary research paradigms will be applied to develop innovative approaches to individual risk assessment and personalized intervention. 

Sample Selection – The intent of this project is to provide information that is relevant to the whole Army population. This broad perspective reflects available evidence on patterns of suicidality, including descriptive data suggesting that suicide risk – both distal and proximal – may be distributed across all phases of Army service. To enable the core primary data collection activities of this project, the Army has committed to provide access to data on this target population (i.e., the Army population, overall and within relevant subgroups) for purposes of sampling and contacting potential respondents. As described elsewhere in this document, access to these and other secondary data will be provided via appropriate data sharing agreements. The Army has also committed to provide written and other statements of support for this project that can accompany invitations to soldiers to participate in this project’s surveys and other research activities; to direct corresponding statements of support to personnel across the chain of command, and to relevant civilian staff, to facilitate soldiers’ participation; and, when appropriate, to have Army personnel to contact and recruit respondents and participants for this research study. Army efforts in this regard will be contributed in kind to the project, and coordinated by the NIMH Project Scientist(s).

Beyond this project’s broad focus on the overall Army population, it may be useful to consider the potential contribution of data from particular population groups towards addressing the project’s objectives. Examples of potentially relevant subgroups include:

Broadly, these groups are conceived to be both exhaustive (i.e., all soldiers fit into one of these groups) and mutually exclusive (i.e., at a given point in time, any soldier falls only into one of these groups).  It is possible however, that the latter may not hold in all cases, due to repeated deployments; applicants should consider the potential impact of different deployment histories when developing the sampling strategy (including the possibility that deployment history may not be a major independent risk factor). 

For the initial data collection, this request solicits a sample sizing and selection strategy that covers Army soldier participants across all phases of Army service, balancing interest in speed (e.g., via cross-section and retrospective assessment) and detail (e.g., via longitudinal assessment) in identifying risk and protective factors for suicidality and related impairments. Investigators responding to this FOA should address the potential composition of the initial cross-sectional sample, as well as potential high-priority extensions of it that will be pursued within the project period. For example, findings from the analysis of initial cross-sectional data may suggest that certain subgroups should be followed longitudinally (e.g., new accessions at baseline that progress to pre-deployment training or deployment; soldiers scheduled for deployment at baseline that are later deployed; soldiers deployed at baseline who return from combat theaters), that additional samples should be surveyed (e.g., subsequent cohorts of Army entrants), or that certain nested case-control analyses might be valuable. Details regarding the composition of the initial cross-section of the Army population will be finalized collaboratively with the NIMH Project Scientist(s) during the start-up phase of the study; longitudinal follow-ups and other extensions will be decided collaboratively with the NIMH Project Scientist(s) over the course of the project.

Primary Data – The major new opportunity presented by this project is to collect primary data from soldiers and, as appropriate, their family members. NIMH specifically seeks innovative approaches for identifying previously undetected risk, protective, and resilience factors, singly and in combination, by incorporating theoretical, methodological, and technological advances to the greatest extent possible. Because suicide is typically a culminating event that follows accumulation of multiple risk events and gradual reduction of protective factors, and the fact that there are likely subgroups of soldiers at elevated risk, research studies that test various models of interactions among personal, environmental, and biological factors are encouraged.

Investigators responding to this funding opportunity should identify target data domains/elements to be collected, particularly for the initial cross-sectional surveys, along with a scientific rationale for how these domains/elements have been selected, and evidence about the feasibility of assessment (or, in the absence of such evidence, plans for feasibility testing). Potentially relevant domains to be assessed include, but are not necessarily limited to:

Domains may be assessed contemporaneously, retrospectively, and prospectively via longitudinal follow-up. Details will be finalized collaboratively with the NIMH Project Scientist(s) during the initial start-up phase of the study. 

With respect to potential biomarkers, NIMH encourages investigators to propose innovative, efficient, and technically feasible methods for collecting biological information from study participants as (1) seems likely to advance this project’s scientific objectives directly; and/or (2) helps establish a credible foundation to use the present study as a basis for complementary, more basic research, which would be conducted (and funded) separately.  NIMH emphasizes that the present FOA principally involves assessment of phenotypic information using surveys and linked secondary data, but can also be envisioned as establishing a flexible platform to enable a range of biomarker research.

Given the sensitive nature of many of the issues addressed in this research, ensuring respondents’ confidentiality is particularly essential. Per agreement between the Army and NIMH, applicants should seek privacy protections for subjects through certificates of confidentiality, non-disclosure agreements, and other appropriate data management methods to ensure that individual-level data collected as part of this project are only used for the current project and other directly related research, and are not disclosed or used in identifiable form for any other purpose. All data collection from soldiers and their family members must be approved by corresponding Institutional Review Board(s) to ensure adequate standards of confidentiality protection.  

Data Collection Methods – Investigators responding to this solicitation should address optimal methods for collecting relevant primary data to best address the research aims. Factors that should be addressed include, but are not necessarily limited to:

NIMH recognizes that optimal data collection methods may vary across different groups within the overall target population. We also recognize that data collection may be unusually challenging for certain groups, perhaps most notably soldiers who are currently deployed to combat theaters. Civilian investigators will not be called upon to travel to combat areas to collect primary data from deployed soldiers. Per agreement between the Army and NIMH, the Army will provide personnel to assist with data collection during all phases or components of the study, to include data collection related to currently deployed respondents, if and how that is deemed appropriate or necessary by the investigators. Army efforts in this regard will be contributed in kind to the project, with appropriate training/supervision of Army personnel from the research project team, and coordinated by NIMH’s Project Scientist(s).

Secondary Data – In addition to data collected directly as part of this project, considerable relevant information is likely to be available on survey respondents, and the broader target population, from Army sources. Per agreement between the Army and NIMH, the Army will provide linkable individual-level information within the broad categories of demographic characteristics; medical, legal, and financial history; behavioral health at recruitment; medical readiness and deployability; conduct reports; current rank and promotion history; deployment and assignment history; psychotropic medication use; physical and psychological fitness prior to deployment; health threats or combat exposures during deployment; medical and behavioral health treatments before, during, and after deployment; medical and behavioral health status following deployment; and suicide event reports and death records. NIMH also expects to obtain relevant contextual information, such as information on the scope and quality of behavioral health services available to soldiers in different settings. Specific relevant Army data sources – including individual data elements, sources and formats – will be identified in the forthcoming Army Science Board study, and NIMH expects that any such data sources will be made available for the current project.

Investigators responding to this funding opportunity should consider priorities for primary data collection in the context of the expected availability of these types of secondary data, and how to make maximally complementary use of the combination of primary and secondary data.

Population-Based Follow-up – In the discussion to this point, this FOA has used “follow-up” mainly to refer to resurveying respondents to the initial cross-sectional assessment. However, there are additional ways to track outcomes in the study sample, which will significantly extend the informational reach of this project. To facilitate efficient tracking of outcomes in the study sample, the Army will enable ongoing linkages to data on vital status, and on suicide events where available, for each soldier in the study sample, based on administrative data from the Army’s population surveillance systems (e.g., the screening and surveillance activities being led by the Army’s CHPPM).

Sample Research Questions – As described above, this project aims to identify potentially modifiable risk factors for suicidality (including psychopathology and associated behavioral impairment), among Army personnel, and potential protective factors, as a necessary step towards developing and testing interventions to prevent and mitigate suicide behaviors and improve the mental health and associated functioning of Army personnel during and after their Army service. This section provides examples of potentially relevant research questions. These examples are not meant to be exhaustive, nor prescriptive.

Data Analysis and Reporting

Analysis – In light of the high public health importance of this project, biostatistical analyses should be conducted as rapidly as scientifically responsible for each wave of data collected. Thus, descriptive analyses and hypothesis testing relevant to cross-sectional data should be conducted as soon as the initial cross-sectional data are available. Correspondingly, hypothesis testing and other data analyses that require longitudinal follow-up, subsequent cross-sectional data, and/or laboratory-based studies should begin as soon as the necessary data are available.

Investigators responding to this solicitation should describe and budget for appropriate strategies for rapidly acquiring, cleaning, analyzing and disseminating the data, to meet these objectives.

As described above, the objectives of this project are to identify modifiable risk and protective factors and moderators of suicide-related behaviors; and, once such factors have been identified, to identify specific intervention options for reducing suicide risk by addressing empirically-identified risk and protective factors and develop initial research designs for subsequent research that may test practical suicide risk reduction efforts, as rapidly as scientifically possible. While the scope of this study does not extend to actual implementation of intervention trials, or to full-scale intervention development, the scope does extend beyond data collection and analysis. In particular, to help expedite the dissemination of the research findings and their practical application, the study team will be expected to identify and describe specific subsequent epidemiological research that would be appropriate to test hypotheses regarding potential risk/protective factors that are identified by this study. Similarly, for risk/protective factors for which enough evidence is found to warrant the development of corresponding interventions, applicants will be expected to identify specific potential real-world interventions, and to develop initial research designs capable of testing their efficacy and effectiveness.

Research Team Qualifications

The research team(s) should include outstanding scientists from diverse scientific disciplines relevant to achieving the study aims, such as psychiatric epidemiology, psychopathology research, mental illness risk factor research (including genetic and/or neurobiological approaches where appropriate), population survey research methods, public health, suicide risk and intervention research, psychological resilience/hardiness, prevention science, clinical trial design and implementation, data management and analysis, and statistics/biostatistics. Familiarity with Army policies and practices, as relevant to achieving the research aims of this study, is preferred.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH Cooperative Agreement (U01) award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI.2. Administrative Requirements - "Cooperative Agreement Terms and Conditions of Award."

2. Funds Available

The U.S. Army and NIMH have committed $10 million total costs in Fiscal Year 2009 to fund one application in response to this FOA.  The total project period for an application submitted in response to the FOA may not exceed five years or $50 million total costs.

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, 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). Each PD/PI is expected to devote a minimum of 25% effort to the project.

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs 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 PDs/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

An NIH Intramural scientist may not serve as the PD/PI of an application submitted in response to this FOA, but may participate in the study as a collaborator or consultant. To serve as a collaborator or consultant, the NIH Intramural scientist must provide justification for this involvement and description of the funds needed to support this involvement to his/her NIH Institute Scientific Director.  The Scientific Director must give written approval for the participation and for the amount of resources that may be allocated to the project; this amount must be specified in the approval letter, and may not exceed 5 percent of the resources allocated to the FOA. The requests by intramural scientists will be limited to certain  resources needed for participation.  These requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative of facilities support (equivalent to Facilities and Administrative or F&A costs).  The approval must also specify that the conduct of the project will comply with the DHHS regulations for research involving human subjects and with the PHS policy on vertebrate animal research (if applicable). The participation of an Intramural scientist on an extramural application is independent of and unrelated to the role of the NIMH Project Scientist(s) as described in the Terms and Conditions of Award. For applications that include NIH Intramural components, no funds for the support of the intramural scientist may be requested in the application.  The involvement of Intramural scientists needs to be consistent with NIH Policy. http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/ethical-conduct-toc.htm.

Applicants are not permitted to submit a resubmission application in response to this FOA.  Renewal applications are not permitted in response to this FOA.  Applicants may submit more than one application, provided each application is scientifically distinct. 

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: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5939.

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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed 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” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, 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 and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date:  March 3, 2009
Application Receipt Date:  April 3, 2009
Peer Review Date:  April 2009
Council Review Date(s):  May 2009
Earliest Anticipated Start Date:  July 1, 2009
Expiration Date:  April 4, 2009

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Robert Heinssen, Ph.D., ABPP
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7164, MSC 9635
Bethesda, MD  20892-9635
Rockville, MD  20852-9635 (for express/courier service)
Telephone:  (301) 435-0371
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the forms 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
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 five identical copies of the CDs of appendix material must be sent to:

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

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or 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 should 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 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 award if such costs: 1) are necessary to conduct the project, and 2) 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 award.

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

6. Other Submission Requirements and Information

Supplemental Instructions

The objectives and goals for the proposed study should be relevant to and compatible with the scientific priorities stated in the Research Objectives section of this funding opportunity.  Applicants should describe their plans to accommodate stated requirements, criteria, and NIMH involvement.  The research teams that respond to this FOA are expected to include outstanding scientists with diverse expertise relevant to achieving the study’s aims, such as psychiatric epidemiology, psychopathology research, mental illness risk factor research (including genetic and/or neurobiological approaches where appropriate) population survey research methods, public health, suicide risk and intervention research, psychological resilience/hardiness research, prevention science, clinical trial design and implementation, data management and analysis, and statistics/biostatistics.  Applicants should possess adequate knowledge of Army policies and practices, as relevant to achieving the research aims of the investigation.  Evidence of expertise in these areas must be documented in the research grant application.

In addition to the details described here for U01 applications, applicants also need to be aware of information described under Section III.3 - Special Eligibility Criteria.

Applicants should organize the application by initially presenting the face page, followed by the description/abstract page with key personnel and performance sites, a table of contents, a detailed budget of the initial budget period, and summary budget pages for the remaining project periods.  Next, a narrative description of research team members’ relevant expertise is required, followed by biographical sketches.  This information should be followed by (a) an overview to the research section that describes the project’s General Approach and (b) a Research Plan that identifies specific hypotheses or questions to be addressed, as well as research methods.  Other required information should be organized as follows: bibliography and references cited, protection of human subjects, inclusion of women and minorities, targeted/planned enrollment table, inclusion of children, multiple PI/PD leadership plan (if relevant), consortium/contractual arrangements, letters of support (e.g., consultants), and resource sharing plan. 

Page Limitations

In combination, the General Approach and Research Plan components of the research section must not exceed 40 pages.

Specific issues to be addressed in the General Approach and Research Plan components of the application are presented below.

General Approach

The overview of the U01 project should demonstrate the applicant’s mastery of the extant literature relating to suicide risk and resilience, intervention, and prevention, and his/her ability to apply innovative concepts from this literature to the unique cultural, organizational, and operational characteristics of the U.S. Army.  The conceptual framework for understanding suicidal thinking, suicide attempts, and suicide deaths among Soldiers should tie together concepts like fixed and variable risk factors, psychological resilience and hardiness, and environmental stressors and supports, including relevant interpersonal, organizational, and training factors.  This framework should provide a clear rationale for (a) the selection of initial samples of Soldiers across all force components (Active Duty, Reserve, National Guard) and all phases of Army service, (b) choice of dependent/outcome measures based on current theories of suicide risk and protective mechanisms, and (c) potential high-priority extensions of initial cross-sectional data collection, e.g., follow-up of initial respondents, recruitment of new cohorts, or assessment of suicide risk mechanisms through laboratory-based procedures.

1. Outcomes of interest: Investigators should describe feasible and scientifically appropriate methods for assessing empirical relationships between suicide deaths and both proximal and relatively distal risk and protective factors, as well as the interrelationships between various risk and protective factors. Investigators should consider that while suicide rates among soldiers have increased in recent years, suicide deaths are still rare in the Army (e.g., 115 confirmed suicide deaths, or 18.1/100,000 soldiers in 2007; Tyson, A.S. Soldiers’ suicide rate on pace to set record. Washington Post, Sep 5, 2008, page A2). Consequently, the research plan should present a strategy that addresses the likelihood of a low absolute number of suicide deaths during the study period, as well as methodological challenges to studying modifiable risk and protective factors for suicide under these circumstances. Investigators should discuss how potential proximate risk factors for suicide death, e.g., suicide attempts, suicidal ideation, various forms of psychopathology, the co-occurrence of multiple suicide risk factors, might be employed as outcome variables, and how such potential proximate factors represent outcomes of interest in their own right. Whatever strategy is selected, the investigator should include methods for assessing the determinants and correlates of proximal factors, keeping in mind this project’s ultimate objective of informing the development and testing of interventions directed at potentially modifiable risk and protective factors for suicidality and related outcomes.

2. Risk and protective factors:  A large literature exists on the epidemiology of suicidal behavior, with fairly consistent findings on the demographic, psychiatric, psychological, and interpersonal variables that correlate with suicide risk.  A complementary literature focuses on biological, cognitive-emotional, behavioral, and social factors that may enhance psychological resilience and protect individuals from developing stress-related adjustment and mental disorders.  To our knowledge, there has been minimal interaction between these literatures.  The applicant is encouraged to consider how concepts, measures, and interventions from the areas of psychological resilience and hardiness, as well as positive psychology, might contribute to a fuller understanding of suicide protective factors and risk reduction strategies.  In addition, investigators should discuss how genetic and neurobiological approaches could be applied in order to explore risk architecture and risk mechanisms as these relate to suicidality and associated mental disorders.

3. Epidemiologic research methods:  A major goal of this initiative is to push the epidemiologic study of suicide beyond solely descriptive studies.  Sampling and assessment plans should communicate an adequate grasp of epidemiologic research methods, as well as understanding of Army force components, phases of service, and policies and practices.  NIMH envisions an analytic approach to epidemiologic research that will test theories of suicide risk, protective mechanisms, psychological resilience, and suicidality by collecting cross-sectional and longitudinal data from population samples.  Accordingly, the applicant should discuss the general strategy envisioned for (a) pursuing rapid evaluation of initial cross-sectional data, (b) delivering data-driven recommendations for possible mitigation or prevention activities, and (c) redirecting research activities within the 5-year project period to follow-up on initial findings.  The application should describe procedures that will maximize the efficiency of data collection/entry/cleaning, and biostatistical resources that will support accelerated data analysis.  Conceptual and statistical approaches for characterizing the “signal strength” and potential malleability of newly detected risk and protective factors should be discussed.  Finally, the applicant should describe how the research team proposes to redirect efforts within the project period in order to respond quickly to emerging scientific opportunities, e.g., through longitudinal follow-up of initial respondents, recruitment of new cohorts, or intensive assessment of suicide risk and protective mechanisms through interviews or laboratory-based procedures.

4. Informing intervention development efforts: If modifiable risk or protective factors are identified, applicants are expected to propose practical interventions for mitigating suicide risk, and to describe how these interventions could be evaluated rigorously in subsequent research.  The applicant should describe expertise available to the research team for designing screening, treatment, and preventive interventions, and for designing evaluations to test their efficacy.  The actual implementation of screening, treatment, and preventive interventions lies outside the scope of this project.  Recommendations for intervention development and testing projects will be submitted to the U.S. Army Medical Research and Materiel Command, Military Operational Medicine Research Program, through the NIMH Project Scientist(s).

5. Processes for maintaining collaboration: A plan to assure the maintenance of close collaboration and effective communication among members of the research team that will include letters of commitment to this plan by all key personnel. Include plans for scheduling group meetings, notifying group members (including NIMH Project Scientists and Program Officers and Army Project Officers), and documenting and disseminating group meeting proceedings.

6. Privacy protections for subjects: Applicants should seek privacy protections for subjects through certificates of confidentiality, non-disclosure agreements, and other appropriate data management methods to ensure that individual-level data collected as part of this project can only be used for the current project and other directly related research, and will not be disclosed or used in identifiable form for any other purpose.  All data collected from soldiers and their family members must be approved by corresponding Institutional Review Board(s) to ensure adequate standards of confidentiality protection.  

Research Plan

The research plan should describe (a) the specific aims, goals, and objectives of the project, (b) background and significance, (c) the status of current research efforts, and (d) the research design and methods proposed for the investigation.  The Research Plan should describe the sample sizing and selection strategy for the initial cross-sectional survey, including any control groups, and primary data to be collected from Soldiers through survey methods.  The research design and methods section should discuss collection methods (e.g., mode, data collection intervals, reassessment strategy, methods to maximize participation), and how primary data might be augmented through linkage with administrative datasets.  When presenting the design and methods, the applicant should discuss the advantages of new methodologies or technological advances (if any), alternative approaches, the feasibility of the proposed research, and methods for assessing the success of the epidemiologic study as a whole.

Cooperative Agreement

Awardees must agree to the “Cooperative Agreement Terms and Conditions of Award” in Section VI.2.A.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html regarding the requirement that appendices be submitted on CDs.

All five copies of the Appendix CD should be submitted in the same package with the two applications sent to Jean Noronha in the NIMH Division of Extramural Activities.

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.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

For this FOA, the PD/PI, NIMH, and the Army will collaborate during the post-award period to develop a data-sharing agreement that will specify criteria for access to de-identified data, conditions for research use, and procedures for vetting requests for data access for administrative data maintained within the Department of the Army, as well as primary data collected and maintained by the PD/PI.  The applicant should propose a data sharing plan in the application that takes into account this expectation.

Timely communication/publication of major findings is expected, and is discussed further in Section VI.2.A.1d.

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIMH and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious 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 General Approach and Research Plan sections of the epidemiologic suicide risk factor study will be evaluated separately.

Review Criteria for General Approach

Significance: Does this collaborative study address important questions related to suicide, suicide risk and protective factors, psychological resilience, and practical approaches for mitigating suicide risk and preventing suicide-related behaviors in the Army?  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 the field of epidemiologic suicide research?

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?  For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?  Does the conceptual framework demonstrate the applicant’s mastery of the extant literature relating to suicide risk and resilience, intervention, and prevention, and his/her ability to apply innovative concepts from this literature to the unique cultural, organizational, and operational characteristics of the U.S. Army? Does the conceptual framework for understanding suicidal thinking, suicide attempts, and suicide deaths among Soldiers tie together concepts like fixed and variable risk factors, psychological resilience and hardiness, environmental stressors and supports, and include relevant interpersonal, organizational, and training factors?  Do sampling and assessment plans communicate an adequate grasp of epidemiologic research methods, as well as understanding of Army force components, phases of service, and policies and practices?  If the PD/PI chooses to utilize Army personnel to assist with data collection during specific phases or components of the study, are adequate methods proposed for training these individuals in data collection procedures?  Does the PD/PI present a well-developed plan that describes how Army personnel will be utilized to maximize the efficiency and effectiveness of data collection during specific phases of the project?  Is there a clear rationale for dependent measures based on current theories of suicide risk and protective mechanisms?  Is the applicant’s strategy for rapid and thorough analysis of initial cross-sectional data logical and feasible?  Is the decision-making process for specifying immediate next steps in the research program (i.e., following analysis of initial cross-sectional data) clear and well-reasoned?  Does the conceptual framework provide a clear rationale for potential high-priority extensions of initial cross-sectional data collection, e.g., follow-up of initial respondents, recruitment of new cohorts, or assessment of suicide risk mechanisms through laboratory-based procedures? How appropriate are the proposed plans for de-identifying and storing data securely?  Are the proposed conditions for research use of de-identified data and procedures for vetting data access requests adequate and appropriate? 

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms of suicide and suicide risk, or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Does the applicant propose reasonable proximate risk factors for suicide death and discuss how potential proximate risk factors represent outcomes of interest in their own right?  Will the project push the epidemiologic study of suicide beyond solely descriptive investigations?  Does the investigator propose innovative approaches for exploring risk architecture and risk mechanisms that span genes, neurobiological systems, cognitive-emotional domains, behavior, social interactions, and environmental exposures?  Does the applicant propose innovative approaches for identifying previously undetected risk, protective, and resilience factors, singly and in combination, by incorporating theoretical, methodological, and technological advances?  Has the applicant proposed innovative, efficient, and technically feasible methods for collecting biological materials from study participants?  Does the applicant describe conceptual and statistical approaches for characterizing “signal strength” and potential malleability of newly detected risk and protective factors?

Investigators: Are the investigators appropriately trained and well suited to direct or carry out an epidemiologic study of suicide, suicide risk factors, and protective mechanisms?  Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the PI/PD have previous experience or the ability to manage an integrated scientific enterprise?  Does the investigative team bring complementary and integrated expertise to the project (if applicable)?   Are the disciplines relevant to achieving the aims of such a project, i.e., psychiatric epidemiology, psychopathology research, mental illness risk factor research (including genetic and/or neurobiological approaches where appropriate), population survey research methods, public health, suicide risk and intervention research, psychological resilience/hardiness research, prevention science, clinical trial design and implementation, data management and analysis, and biostatistics adequately represented on the research team?  Do members of the research team possess adequate knowledge of Army policies and practices that are relevant to achieving the research aims of the investigation?  Is there adequate expertise for proposing practical interventions that target modifiable risk and protective factors, and to design studies that will test their efficacy in subsequent controlled research?  Does the research team demonstrate a track record for successfully recruiting subjects into population-based epidemiologic research studies and completing proposed studies within projected timelines?  Does the research team have sufficient expertise to successfully conduct research studies in military settings or with military samples?  Are the time commitments for key personnel sufficient to achieve the study’s goals?  Have collaborations been established or consultants identified to provide the appropriate depth and breadth of expertise required for the project?  Has the Principal Investigator demonstrated leadership in development, implementation, and management of comprehensive research programs?  

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? Are there adequate data management and biostatistical resources to support rapid analysis of initial cross-sectional data?  

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the priority score.

Interaction. Are there adequate plans for ensuring effective intra-Group collaboration, effective communication, and coordination among the PI/PD, Key Personnel, NIMH Project Scientists, and Army Project Officers?  Are plans included for scheduling group meetings, notifying group members, and documenting and disseminating group meeting proceedings?  Were letters of commitment to this plan supplied by all key personnel? 

Review Criteria for Research Plan

Significance:  Does this research 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 this study on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?

Approach:  Are the conceptual 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?  For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?  Does the research plan describe the sample sizing and selection strategy for the initial cross-sectional survey, including any control groups to be employed, and primary data to be collected from Soldiers through survey and other methods?  Does the applicant discuss data collection methods (e.g., mode, timing, strategies to maximize participation), and how primary data might be augmented through linkage with administrative datasets?

Innovation:  Is the project original and innovative?  For example: Does the project challenge existing paradigms of the epidemiologic study of suicide, suicide risk factors, or protective mechanisms?  Does the project challenge existing clinical practice or address an innovative hypothesis or critical barrier to progress in the field?  Does the project develop or employ novel concepts, approaches, methodologies, tools or technologies for this area?

Investigators:  Are the investigators appropriately trained and well suited to direct or carry out this work?  Is the work proposed appropriate to the experience level of the PI/PD and other researchers?  Does the investigative team bring complementary and integrated expertise to the project? 

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?

In addition to the above criteria, the following criterion will be applied to applications in the determination of scientific merit and the priority score:

Management of the Group:  Does the PI have previous experience or the ability to manage an integrated scientific enterprise?  Do other members of the Group have experience that will facilitate achieving the desired research outcomes?

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 rating:

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 on Human Subjects in the PHS 398 instructions).

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 on Human Subjects in the PHS 398 instructions).

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. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

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 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 (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.

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).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

a. The Principal Investigator will have primary authority and responsibility to define objectives and approaches and to plan and conduct the proposed research. She/he will assume responsibility and accountability to the applicant organization and to the NIMH for performance and proper conduct of all research supported in the study, including the NIH Intramural component, if applicable, in accordance with the Terms and Conditions of Award. The Principal Investigator will be a member of the Steering Committee, described further below.

b. Intramural research scientists participating as collaborators have the same rights and responsibilities as other members of the Group.

c. The Awardee Institution will retain primary custody of and rights to primary data as specified under the data and research resource sharing plans (described above). The Government, via the NIMH Project Scientist(s), will have access to primary data generated under this cooperative agreement and may periodically review the data consistent with current DHHS, PHS, and NIH policies.

d. Timely communication/publication of major findings by PD/PI is expected. However, per agreement between the Army and NIMH, before the PD/PI submits for publication any paper or abstract in which the findings of conclusions of this project are referenced, discussed, or disclosed, or undertakes to disclose publically in any other way the findings or conclusions of the study, the PD/PI shall afford the Department of the Army at least 60 days to review and comment on the proposed publication or disclosure.

e. Given the scale and scope of this project, and the likely size and diversity of the research team, the PI should establish a transparent process for proposing and developing scientific manuscripts, including appropriate mechanisms for determining authorship, in consultation with the co-investigators and the project Steering Committee.   

f. Publication or oral presentation of work done under this agreement will require appropriate acknowledgment of NIMH support, as well as the contributions of the Department of the Army, including the assigned cooperative agreement award number.

2.A.2. NIH Responsibilities

NIH Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.  The Project Scientist(s) will be a member(s) of the Steering Committee, described further below. The Project Scientist(s) interacts scientifically with the Steering Committee and may provide appropriate assistance, including assisting in research planning, suggesting studies within the scope of the study’s objectives and research activities, presenting experimental findings to the Steering Committee from published sources or from relevant contract projects, participating in the design of experiments agreed to by the Steering Committee, participating in the analysis and reporting of results, and advising in management and technical performance. In all cases, the role of NIMH Project Scientist(s) will be to assist and facilitate and not to direct activities.  The NIMH Project Scientist(s) will be named in the award notice.

a. The NIMH Project Scientist(s) will work closely with the Army Science Board to identify existing administrative datasets that could enrich primary survey data collected in the epidemiologic study.  The Army has agreed to provide individual-level information within the broad categories of demographic characteristics; medical, legal, and financial history; behavioral health at recruitment; medical readiness and deployability; conduct reports; current rank and promotion history; deployment and assignment history; psychotropic medication use; physical and psychological fitness prior to deployment; health threats or combat exposures during deployment; medical and behavioral health treatments before, during, and after deployment; medical and behavioral health status following deployment; and suicide reports and death records.  The NIMH Project Scientist(s) will work with the Army Project Officer to facilitate the PD/PI’s access to relevant administrative datasets.

b. The Army agrees to enable appropriate sampling and contacting of potential study respondents.  The NIMH Project Scientist(s) will work closely with the Army Project Officer(s) to identify potential respondents and participants for this research study.  To facilitate and encourage participation in this project by Soldiers, the Army will provide written and other statements of support for this project that could accompany invitations to soldiers to participate in this project’s surveys and other research activities.

c. The PD/PI and NIMH Project Scientist(s) will determine together the most feasible and scientifically appropriate methods for data collection.  Consistent with mission requirements, the Army will provide personnel to assist with data collection during all phases or components of the study, to include data collection related to in-theatre operations.  In the event that Army personnel assist with data collection during any phase or component of the study, such as for data collection among Soldiers currently deployed to combat theatres, the PD/PI and NIMH Project Scientist(s) will provide appropriate training and serve as a source of expert advice to such Army personnel.

d. The Army will facilitate compliance with any review(s) of research protocols and activities that may be required by Army regulations and procedures.

e. In addition to the NIMH Project Scientist(s), an Institute Program Official will be named in the award notice.  The Program Official will be responsible for the normal scientific and programmatic stewardship of the award, including monitoring implementation of the subject recruitment plan and data and research resource sharing plans.

2.A.3. Collaborative Responsibilities

A governing Steering Committee composed of the PD/PI, Research Project Leaders, NIMH Project Scientist(s), NIMH Program Official(s), and Army Project Officer(s) will be established to assist in developing the scientific content and direction of the program, and to monitor progress over time. Other personnel deemed relevant by the PD/PI, NIMH, and the Army may be added to the Steering Committee after the project’s inception.  The Steering Committee members will meet periodically to review progress, plan and design research activities, and establish priorities. The frequency of meetings, not fewer than two per year, will be determined by the PI/PD who will be responsible for scheduling the time and place, notifying group members (including NIMH Project Scientist(s), Program Official, and Army Project Officer(s), and for preparing concise proceedings or minutes (two or three pages), which will be disseminated to members of the Group within 30 days of the meeting.

This epidemiologic study of suicide risk and protective factors successfully will require close coordination and knowledge sharing with other Army efforts relating to suicidality, particularly screening and surveillance activities being led by the U.S. Army Center for Health Promotion and Preventive Medicine and intervention research being led by the U.S. Army Medical Research and Materiel Command.  This coordination of effort will be bi-directional, e.g., findings from the present study will help to inform surveillance and intervention targets; while findings from surveillance and intervention programs will guide interpretation of the epidemiologic data, associated recommendations, and subsequent data collection during the current project period.

With the exception of the NIMH Program Official, who participates on the Steering Committee as a non-voting member, each full member of the Committee will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. The three members consist of: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

For this FOA, the PD/PI and the NIMH Project Scientist(s) will provide semi-annual progress briefings to the Department of the Army and annual progress briefings to the Secretary of the Army. In these briefings the research project team will report on (a) progress towards study milestones, (b) results from each round of data analysis (summarized in data tables), and (c) any data, information, or findings that appear to identify, with a reasonable degree of certainty, an at-risk population, an effective mitigation strategy, or other information potentially of use to the Army in preventing or mitigating future incidence of suicide. At the conclusion of the study, the PD/PI and the NIMH Project Scientist(s) will provide to the Army a publication-quality report on the study’s findings and recommendations.

Prior to submission of a paper or abstract from this project for publication, or other public disclosure/presentation, the Army will have at least 60 days to review and comment on the proposed publication or disclosure. In all oral presentations or written publications concerning this project, the PD/PI will acknowledge the Department of the Army’s contribution to this research.  A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

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:

Robert Heinssen, Ph.D., ABPP
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7164, MSC 9635
Bethesda, MD  20892-9635
Rockville, MD  20852-9635 (for express/courier service)
Telephone:  (301) 435-0371
Email: [email protected]

2. Peer Review Contacts:

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Blvd, Room 6138, MSC 9606
Bethesda, MD 20892-9605
Telephone:  (301) 443-3534
Email:  [email protected]

3. Financial or Grants Management Contacts:

Rebecca Claycamp, M.S., CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-2811
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 (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.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

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 Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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 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. 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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