Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Department of Veteran's Affairs (VA), (http://www.va.gov/resdev/)
Department of Defense (DOD), (http://www.defenselink.mil/)

Components of Participating Organizations
National Institute of Mental Health (NIMH/NIH), (http://www.nimh.nih.gov)
Clinical Science Research & Development Service (CSR&D/VA), (http://www1.va.gov/resdev/programs/blrd-csrd/csrd.cfm)
Military Operational Medicine Research Program (USAMRMC/DOD), (http://www.momrp.org/)

Title: Intervention and Practice Research for Combat Related Mental Disorders and Stress Reactions

Announcement Type
New

Request For Applications (RFA) Number: RFA-MH-06-004

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release Date: September 26, 2005
Letter of Intent Receipt Date: December 28, 2005
Application Receipt Date(s): January 25, 2006
Peer Review Date: May/June 2006
Council Review Date: October 2006
Earliest Anticipated Start Date: September 2006
Additional Information To Be Available Date (Url Activation Date):
Expiration Date: January 26, 2006

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
   4. Intergovernmental Review
   5. Funding Restrictions

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

 Section VI. Award Administration Information
   1. Award Notices
   2. Administrative and National Policy Requirements
   3. Reporting

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

 Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

Posttraumatic Stress Disorder (PTSD) was first brought to public attention by war veterans and there is, again, concern for and among this population. Numerous studies of war and combat trauma demonstrate a link between exposure and posttraumatic sequelae, including PTSD. Important factors for posttraumatic adjustment include individual and family history of mental health problems, the nature of combat, changes in combat experiences, other stress and trauma, physical injuries, and the social and political context to which combatants return.

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

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

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

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

Research progress linking the psychological aspects of traumatic stress reactions to neurobiological and physiological factors and processes activated under stress and the unique nature of PTSD as a disorder dependant on exposure to one or more traumatic experiences points towards the possibility of early intervention and prevention. While the precise etiological role of specific psychosocial and biological factors is unclear, environmental, psychological, and biological correlates of PTSD can be considered as potential targets for intervention research seeking to improve patient outcomes, understand risk and resilience, and to clarify causal mechanisms.

Current and Emerging Need:

Recent data from the VA reveals that approximately 244,054 veterans of active duty in Iraq and Afghanistan have become eligible for VA benefits and that 20 percent of these new veterans have received health care at a VA facility since returning home. Possible mental disorders have been reported in 26 percent and the most common diagnoses were adjustment disorders, among them PTSD. DOD sponsored research reveals significant risk for mental health problems among members of the Army and the Marine Corps involved in combat operations in Iraq and Afghanistan and suggests that there are barriers to receiving mental health services, particularly the perception of stigma among those most in need of such care. Prior research has demonstrated that mental disorders are a leading source of occupational morbidity and reason for transition out of military service for active-duty military personnel, with as many as one third of enlisted soldiers having difficulty in their first term of enlistment, most often due to mental, psychosocial, and behavioral problems.

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

With regard to returning combat duty service personnel, including National Guard and Reserve components, it has been acknowledged that the process of mental health screening, assessment, referral, treatment, tracking/follow-up and continuity of care between DOD, VA and community mental health care can be enhanced. There is a need to improve the process by which the earliest possible identification and treatment of post traumatic readjustment problems is initiated and sustained. Many individuals remain on active duty post combat while others become eligible for care in the VA as well as return to civilian health care systems in the community. Efforts to coordinate care within and between systems are needed.

Currently, only two medications (sertraline and paroxetine), both selective serotonin reuptake inhibitors (SSRIs), are recommended as first line treatment options; both have been approved by the U.S. Food and Drug Administration (FDA) for treating PTSD. Yet, research on prescribing patterns for veterans and non-veterans with posttraumatic stress disorder reveals frequent use of benzodiazepines, antipsychotics and other medications. These medications may have undesirable side effect profiles, raise safety concerns, have limited data to support their efficacy, and are generally not recommended as first-line treatment options for PTSD. The limited data available on this topic indicates that there is a gap between expert treatment guidelines and practice. This observation is particularly important in the context of treating PTSD in community-based outpatient programs where many returning combat-veterans are likely to be seen.

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

Given the current state of science and practice regarding the identification, treatment, and prevention of PTSD and related posttraumatic psychopathology, the knowledge of current treatment needs, and anticipated increases in need for services, the sponsoring agencies are encouraging applications for research along a continuum of scientific and clinical needs, including, but not limited to:

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIMH Clinical Exploratory/Developmental (R34) award mechanism. It also involves the research programs of the VA. For the purpose of initial processing, all applications must be submitted using the NIMH R34 mechanism, must include a modular budget for up to three years, and be prepared according to the PHS 398 instructions. Those selected for VA funding will be required to revise and resubmit budgets prepared on VA Merit Review budget forms 10-1313-3 and 10-1313-4. VA investigators who submit for VA funding may be selected for non-VA funding. The DOD encourages its research and clinical personnel and laboratories to submit research applications involving DOD research and clinical programs and to collaborate with governmental and non-governmental health programs. Applications are solicited from VA, DOD, academic, community-based, and other researchers and clinicians.

Applications for the R34 award may request direct costs of up to $450,000 for three years. Although variations from year to year are permissible, in no case may any year be more than $225,000 in direct costs, and total direct costs for the entire project period may not exceed $450,000. Grant applications may request 1, 2, or three years of support. This award is non-renewable. However, it is intended that grantees funded through this exploratory phase program will elect to seek continuing support for their projects through the other funding mechanisms.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This RFA uses just-in-time concepts. It also uses modular budgeting format. Given that these applications will have direct costs in each year of $250,000 or less, the modular budgeting format should be used in all applications. (see http://grants.nih.gov/grants/funding/modular/modular.htm). This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.

2. Funds Available

The NIMH intends to commit approximately $1.5 million in total costs in FY 06 to fund 4-6 new grants. NIH awards may be made to VA, DOD and other researchers. Depending upon availability of funds, VA Office of Research and Development estimates committing up to $1.5 million for this initiative. Although the DOD is not committing funds to this RFA at this time, they may elect to fund additional projects.

Investigators eligible to apply for VA funding should indicate their VA Medical Center as the academic institution and obtain the appropriate signatures. For the purpose of initial processing, the application submitted should include a modular budget for up to three years prepared according to the PHS 398 format (see above).

Although the financial plans of the participating institutions provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are also encouraged to apply. Applications are encouraged from VA, DOD, academic, community-based, and other researchers and clinicians.

This RFA is considered to be a VA special initiative and is open to all eligible VA investigators, regardless of their current VA funding. Individuals applying for VA funding must meet all VA eligibility criteria. The DOD encourages DOD clinicians and researchers to participate in this initiative.

2. Cost Sharing or Matching

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

This RFA specifically targets studies involving active-duty or recently separated military personnel, including National Guard and Reserve troops, involved in current and recent military operations (e.g., Iraq and Afghanistan). Clinicians and researchers eligible to apply include those who provide screening, assessment and/or direct care, or who otherwise have access to groups and individuals who are at-risk, combat exposed, and/or diagnosed with posttraumatic psychopathology. Investigators interested in research focusing on other populations are encouraged to apply under NIMH's program announcement PA-04-075, “Mental Health Consequences of Violence and Trauma” (http://grants.nih.gov/grants/guide/pa-files/PA-04-075.html) or VA Program announcement, Deployment Health Initiative (http://www1.va.gov/resdev/funding/solicitations/docs/ProgramAnnouncementDeploymentHealthIssues.pdf).

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) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

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

Applications selected for VA funding will be required to revise and resubmit budgets prepared on VA Merit Review budget forms 10-1313-3 and 10-1313-4 after the program has been approved. All VA requirements (e.g., no F&A costs) for budget items must be met (Reference VHA Handbook 1202.1, Merit Review Award Program, http://www1.va.gov/resdev/resources/policies/docs/1202_Merit_Review_Handbook_JIT.doc.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide a unique research opportunity not available in the U.S.

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

Letter of Intent Receipt Date: December 28, 2005
Application Receipt Date(s): January 25, 2006
Peer Review Date: May/June 2006
Council Review Date: October 2006
Earliest Anticipated Start Date: September 2006

3.A.1. Letter of Intent

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

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

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Farris Tuma, Sc.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7111, MSC 9632
Bethesda Maryland 20892-9632
Telephone: (301) 443-3648
FAX: (301) 443- 4611
Email: FTUMA@NIH.GOV

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

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

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

Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9663
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: jnoronha@mail.nih.gov

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

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the National Institute of Mental Health (NIMH). Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data

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

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

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

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

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

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute of Mental Health (NIMH) in accordance with the review criteria stated below.

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What will be the effect of these studies on the identification, treatment, or prevention of posttraumatic adjustment problems, including PTSD, and/or access, quality and outcome of mental health services for active-duty or recently separated, National Guard and Reserve troops involved in current and recent military operations (e.g., Iraq and Afghanistan).

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

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

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Have the Investigators addressed key feasibility issues, including obtaining access to active duty and other personnel.

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

2.A. Additional Review Criteria:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398). VA applicants must conform to VHA Directive 2001-028, Research Involving Children.

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

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

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

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

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

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

For NIH awardees, 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 14 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. For VA awardees, the Office of Research and Development will issue a contract to be signed by the Principal Investigator; a final approval letter will be issued to the VA Medical Center once all administrative issues are resolved.

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 Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

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

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Farris Tuma, Sc.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7111, MSC 9632
Bethesda, MD 20892-9632
Telephone: (301) 443-3648
FAX: (301) 443- 4611
Email: FTUMA@NIH.GOV

Terri Gleason, Ph.D.
Clinical/Biomedical R&D Services (121E)
Department of Veterans Affairs
810 Vermont Avenue, NW
Washington, DC 20420
Telephone: (202) 254-0498
FAX: (202) 254-0521
Email: thereas.gleason@hq.med.va.gov

Brian J. Lukey, Ph.D., D.A.B.T
Colonel, Medical Service Corps
Director, U.S. Army Military Operational Medicine Research Program
USAMRMC
Attn: MCMR_ZB_DRO
504 Scott Street
Fort Detrick, MD 21702-5012
Telephone: (301) 619-7301
Email: Brian.lukey@us.army.mil

2. Peer Review Contacts:

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD 20892-9606
Telephone: (301) 443-3534
FAX: (301) 443-4720
Email: armstrda@mail.nih.gov

3. Financial or Grants Management Contacts:

Rita Sisco
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Blvd., Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: siscor@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

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

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

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

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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