Program Announcement

U.S. Army Medical Research and Materiel Command

Military Operational Medicine Research Program

Suicide Prevention and Counseling Research (SPCR)

Funding Opportunity Number: W81XWH-08-MOMRP-SPCR

TABLE OF CONTENTS

I.Helpful Information

A.Contacts

B.National Technical Information Service

C.Commonly Made Mistakes

II.Funding Opportunity Description

A.Program History and Objectives

B.MOMRP-SPCR Award Description

C.Funding

D.Award Administration

III.Timeline For Submission And Review

IV.Submission Process AND application INSTRUCTIONS

A.Step 1: Letter of Intent Submission

B.Step 2: Full Proposal Components and Submission

C.Formatting Guidelines

D.Compliance Guidelines

V.Information For Proposal Review

A.Proposal Review and Selection Overview

B.Review Criteria:

VI.GRANTS.GOV INFORMATION

A.Public Law 106-107

B.Grants.gov

VII.Administrative Information

A.Excluded Parties List

B.Administrative Requirements

C.J-1 VISA Waiver

D.Disclosure of Information outside the Government

E.Government Obligation

F.Integrity of Review Process

G.Disclosure of Proprietary Information Included in a Proposal

H.Award Negotiation

I.Title to Inventions and Patents

J.Contracted Fundamental Research

viiI.Instructions and Guidelines For Regulatory Requirements

A.Certificate of Environmental Compliance

B.Safety Program Documents

C.Research Involving Human Subjects or Human Data

IX. INSTRUCTIONS FOR REPORTS

A.Research Progress Reports

B.Fiscal Reports

I.Helpful Information

  1. Contacts

To view all funding opportunities offered by the USAMRMC, perform a Grants.gov basic search using the CFDA Number 12.420. Submit questions as early as possible. Response times will vary depending upon the volume of inquiries. Every effort will be made to answer questions within 5 working days.

Questions related to the submission process for this announcement should be directed to

Fay Peiffer at the U.S. Army Medical Research Acquisition Activity at 301-619-4055 or

Questions related to the research area for this announcement ONLY should be directed to

Dr. Joan Hall at 301-619-6641 or .

Grants.gov contacts: Questions related to submitting applications through the Grants.gov ( portal should be directed to Grants.gov help desk.

Phone: 800-518-4726, Monday to Friday, 7:00 a.m. to 9:00 p.m. Eastern Time

Email:

Deadline for full proposal submission is 11:59 p.m. Eastern time. Therefore, there are approximate 3-hours during which the Grants.gov help desk will NOT be available. Proposals should be submitted at least 48-72 hours before the deadline so that Grants.gov can provide notification of errors and allow for resubmission of application package prior to the deadline. Proposals received after the deadline will not be evaluated.

Grants.gov will notify Principal Investigators (PIs) of changes made to this Funding Opportunity and/or Application Package ONLY if the PI clicks on the “send me change notification emails” link and subscribes to the mailing list on the Opportunity Synopsis Page for this announcement. If the PI does not subscribe and the Application Package is updated or changed, the original version of the Application Package may not be accepted.

  1. National Technical Information Service

The technical reference facilities of the National Technical Information Service ( are available for the purpose of surveying existing knowledge and avoiding needless duplication of scientific and engineering effort and the expenditure thereby represented. All other sources also should be consulted to the extent practical for the same purpose.

  1. Commonly Made Mistakes
  2. Not obtaining or confirming the organization’s DUNS number ( well before the proposal submission deadline.
  3. Not obtaining or confirming the organization’s registration with the Central Contractor Registry (CCR)( well before the proposal submission deadline.
  4. Failing to request “send me change notification emails” from Grants.gov (
  5. Not contacting help desks until just before or after deadlines.
  6. Not completing the Letter of Intent submission before the mandatory deadline.
  7. Using an incorrect Grants.gov application package to submit a proposal through Grants.gov. Each Funding Opportunity requires a specific application package.
  8. Uploading attachments into incorrect Grants.gov forms.
  9. Attaching files in the wrong location on Grants.gov forms.
  10. Submitting attachments that are not PDF documents, except for the R&R Subaward Budget Attachment(s) Form.
  11. Exceeding page limitations.
  12. Failing to submit a proposal 48-72 hours before the deadline so that Grants.gov can provide notification of errors and allow for resubmission of application package.
  13. Failing to submit full proposal by submission deadline.

II.Funding Opportunity Description

A.Program History and Objectives

The SUPPLEMENTAL APPROPRIATIONS FOR FISCAL YEAR 2008 in the Defense Health Program appropriations provided $273.8 M under “BATTLE CASUALTY AND PSYCHOLOGICAL HEALTHRESEARCH”to address prevention, diagnosis,treatment, and mitigation of deployment-related injuries and psychologicalhealth concerns. Of these funds, approximately $8.5M has been allocated to the Military Operational Medicine Research Program to manage efforts directed toward Suicide Prevention and Counseling Research.

The mission of Military Operational Medicine Research Program is to develop effective medical countermeasures against combat and operational stressors to maximize Warrior health, performance, and well-being. The research program consists of four overarching areas of focus: injury prevention, psychological health and resilience, mission reset and recovery, and environmental health and well-being. The research focus is on multistressor interactions involving human tolerances, metabolic physiology, psychological processes, and brain functionthat span the Warfighter Deployment Lifecycle.

The MOMRP Psychological Health Research and Resilience Research Program area is dedicated to developing effective strategies and interventions that build psychological resilience and optimize psychological health and emotional well-being among Soldiers and Families.

The MOMRP anticipates the award ofup to $8.5 million (M) of the full $273.8M FY08 Supplemental appropriation. The research projects must be tailored for use within a military milieu across levels of clinical care. Strategies that promote and sustain healthy adaptation to, and recovery from prolonged and/or adverse military operations across the deployment lifecycle are sought.

The proposals must contribute to our understanding of suicide, suicide prevention and counseling, and align with the MOMRP intramural core research program mission and objectives stated in this funding opportunity.

The aims of this funding opportunity are to: 1) facilitate development of a comprehensive approach to preventing suicide among Military Service members, 2) establish effective interventions to support first responders and loved ones of persons who completed suicide, and 3) develop effective counseling interventions to prevent suicide (including reducing nurse stress and fatigue at military treatment facilities). These efforts will assist in providing an evidence base for policy development and interventions to prevent suicide and manage Service members who present with intentional self-harming behavior, facilitate reset among providers of persons who care for those Service members and their loved ones, and assist loved ones personal recovery from their loss.

The ultimate goal of this research program is to expand our knowledge, understanding, and capacity to prevent, detect, diagnose, treat, and enhance the quality of life of persons in military communities and general public who are affected by suicide related problems.

The MOMRP research program seeks to:

  • Encourage investigators to explore approaches and directions in suicide research among military populations
  • Encourage development and validation of universal prevention programs that show promise in preventing suicidal behavior among military populations
  • Support studies that increase understanding of causal factors of suicide and factors associated with suicide risk among military populations
  • Test treatments and other interventions to prevent suicide
  • Support research on the effects of suicide on loved ones and first responders
  • Encourage development and validation of counseling practices to prevent suicide
  • Effective interventions to reducing nurse stress and fatigue in military treatment facilities

The MOMRP is seeking proposals for military suicide prevention and counseling research across four categories: Prevention, Screening, Treatment, and Quality of Life and 10 topic areas (see the Research Proposal Topicson the next page for details). If the research is not relevant to the currently advertised MOMRP topic areas, the Government reserves the right to administratively withdraw the proposal. The Government also reserves the right to reassign the proposal’s topic area if submitted under an incorrect topic area.

B.MOMRP-SPCR Award Description

1.Overview

The MOMRP will execute this extramural research program through the award of assistance agreements (grants and cooperative agreements). The type of instrument used to reflect the business relationship between the recipient and the Government will be a matter of negotiation prior to award.The MOMRP supporting contracting office, USAMRAA, will negotiate and award proposals selected for funding.

This funding opportunity supports rapid implementation of studies with the potential to have a significant impact on suicide prevention and counseling addressed in one of the FY08 MOMRP-SPCR topic areas. All proposed research must be responsive to the prevention, detection, diagnosis, treatment, and/or quality of life of persons affected by suicide related behavior. The study may be designed to evaluate promising products, pharmacologic agents (drugs or biologics), psychotherapeutic interventions, clinical guidance, and/or telehealth technology.

Any pharmacological agent used must be FDA approved for the intended disease/condition. This funding opportunity will not consider: (a) Proposals that suggest off-label use of pharmacological agents; (b) Research involvingthe use of animals;(c)Preclinical researchstudies; or (d) Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications.

2.Research Proposal Topics: MOMRP is seeking proposals for military suicide prevention and counseling research across four categories (Prevention, Screening, Treatment, and Quality of Life) and 10 topic areas:

Prevention

  1. Effective suicide prevention strategies that focus on tactical suicide prevention across the operational spectrum and DoD that use a broad based approach designed to, but not limited to:
  1. Reduce risk factors and enhancing protective factors
  2. Change social norms to eliminate stigma about seeking help
  3. Improve understanding of mental health
  4. improve buddy-aid
  1. Evidence based counseling to prevent and/or reduce nurse stress and fatigue at military treatment facilities
  2. Effective peer, leader, and first responder risk assessment and management training tools and products to detect and prevent suicide

Screening

  1. Test ways to effectively detect and assess the psychological impact of first responders who work on the scene with suicide completers and their survived loved ones
  2. Test ways to detect the antecedents, associations (to include, but not limited to family adversities, prescribed medications, other therapies, substance misuse, and mental disorders), and other risk factors effective at predicting suicidal behavior in field and clinical environments (i.e., primary care, behavioral health) across the military operational spectrum
  3. Test ways to effectively detect the psychological impact, coping mechanisms, and psychological risks from loss to suicide among loved ones of the deceased
  4. Evidence based suicide assessment scales effective at predicting suicidal behavior and evidence-based suicide assessment interventions for tactical (i.e., peer, leader, first responder) and clinical environments (i.e., primary care, behavioral health) across DoD and VA health care systems

Treatment

  1. Evidence based treatment, crisis intervention, clinical post-intervention and case management for Service members identified with suicidality
  2. Evidenced-based treatment of patients with co-occurring suicidality and mental and/or physical illness

Quality of Life

  1. Investigations into the reactions, grief, and needs of loved ones and peers of suicide completers which lead to evidence based bereavement interventions to facilitate support and recovery from loss.

The research projects must be tailored for use within a military milieu across field, garrison, shipboard, primary care, behavioral health care, or combat settings. Other contextual factors such as, but not limited to, individual, peer, family, community, culture, and social that may affect the selection, implementation, and outcomes of empirically validated research should be addressed. Studies that focus on gender, ethnicity, individual military augmentees (IMAs), randomized controlled trials, and comparisons between Active Duty, National Guard, and Reserve service members are invited.

It is expected that research projects submitted demonstrate a) a thorough review and knowledge of the scientific literature relevant to the nature of the proposed study, b) a theoretically and hypotheses driven approach, and c) translation into clinically and operationally relevant military applications.

It is the responsibility of the PI to clearly and explicitly articulate the project’s impact on Military Suicide Prevention and Counseling Research.

3.Military Populations

Military Relevance is a key feature of this award. Therefore, PIs are strongly encouraged to collaborate and integrate their projects with DoD and/or Veterans Affairs (VA) research laboratories and programs. Each PI must provide a transition plan (including funding and resources) showing how the research product will progress to the next phase and/or delivery to the military community after successful completion of this award.

PIs must describe the military population(s) to be used for the proposed study and/or the relationship of nonmilitary research participants to a military population. PIs should identify the specific research population in the research proposal and attach Letters of Support as applicable. The research projects must be tailored for use within a military milieu across levels of clinical care.

Research conducted using military populations in Iraq is conducted solely by select elements of the Multi-National Corps-Iraq (MNC-I). PIs who are outside of this system and submit a research proposal designed to recruit patients within MNC-I must be working in collaboration with an in theater military investigator, undergo an in theater review, and be approved by the MNC-I Command and the MNC-I designated Institutional Review Board. Given the constraints of wartime operations, investigators without an ongoing collaboration with an appropriate military investigator should strongly consider alternatives to conducting in theater research. DOD-supported human subjects research can only be conducted by institutions (including those in theater) with approved Federal Assurances for the protection of human research subjects.

There is no ability to conduct research using military populations in Afghanistan at present.

Department of Veterans Affairs (VA) Medical Centers' patient populations: Access to patient populations from the Department of Veterans Affairs (VA) Medical Centers or use of information from VA data systems must be coordinated by the PI. PIs who submit a research proposal designed to recruit patients from a VA Medical Center or use information from VA data systems, and those who do not have an appointment at one of the VA Medical Centers, mustinclude a collaborator with a VA appointment. This collaborator must be willing to assume the role of PI for the VA component of the research.

Multi-institutional Studies: If the proposed study is multi-institutional, plans for communication and data transfer between the collaborating institutions, as well as how data obtained during the study will be handled, should be included in the appropriate sections of the proposal. A separate intellectual and material property plan agreed upon by all participating institutions is also required for multi-institutional studies.

Research Involving Human Subjects.Use of human subjects and human biological substances: All DOD-funded research involving human subjects and human biological substances must be reviewed and approved by the USAMRMC Office of Research Protections, Human Research Protection Office (HRPO) in addition to local Institutional Review Boards (IRBs). The HRPO is mandated to comply with specific laws and directives governing all research involving human subjects that is conducted or supported by the DOD. These laws and directives are rigorous and detailed, and will require information in addition to thatsupplied to the local IRB.The PI must address pertinent issues relating to the use of human participants in the proposed research. Include the required approvals, forms and information as specified on the Human Research Protection Office (HRPO) website:

4.Eligibility

To protect the public interest, the Federal Government ensures the integrity of Federal programs by only conducting business with responsible recipients. The US Army Medical Research and Materiel Command (USAMRMC) will use the Excluded Parties List System (EPLS) to exclude recipients ineligible to receive Federal awards. The EPLS is online at (Reference Department of Defense Grant and Agreement Regulations [DODGAR] 25.110.)

All individuals, regardless of ethnicity, nationality, or citizenship status, may apply as long as they are employed by, or affiliated with, an eligible institution. PIs must be independent investigators at any academic level.

Eligible Institutions include nonprofit, public, and private organizations, such as universities, colleges, hospitals, laboratories, and commercial firms. Historically Black Colleges and Universities/Minority Institutions (HBCU/MI)are encouraged to submit proposals for review and funding consideration under this announcement.

C.Funding

It is anticipated that up to $8.5 million will be awarded. It is anticipated that no individual award will be more than $2 million inclusive of direct and indirect costs, with a maximum period of performance of 3 years. Reasonableness of budget for the proposed research is a component of the peer review evaluation process. Strong justification must be provided to support the requested budget.

Within the guidelines provided in the Application Instructions, funds can cover:

Salary

Research supplies

Equipment

Clinical costs

Research-related subject costs

Travel to scientific/technical meetings

Travel between collaborating institutions

Travel to MOMRP required meetings (i.e. Programmatic Line Review (PLR) & Integrating Integrated Product Team (IIPT) Meetings)

Indirect Costs

Other direct costs

The MOMRP expects to allot approximately $8.5M of the $273.8M FY08 War supplemental appropriation to fund approximately 5-10 research proposals, depending on the quality and number of proposals received. Funding of proposals receivedin response to this Funding Opportunity is contingent upon the availability of Federal funds for this program. If the funding appropriation is either increased or decreased in order to execute the program, the Government reserves the right to adjust the funding levels and number of awards accordingly.