Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

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

Title: Suicide Prevention in Emergency Medicine Departments (U01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-MH-09-150

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release Date: February 9, 2009
Letters of Intent Receipt Date:  March 20, 2009
Application Receipt Date:  April 14 2009
Peer Review Date(s):  June/July 2009
Council Review Date:  August 2009
Earliest Anticipated Start Date:  September 30, 2009
Expiration Date:  April 15, 2009

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
   A. Purpose 
   B. Background
   C. Objectives and Knowledge to be Achieved
   D. Research Approaches
   E. Examples of Research Topics
   F. Research Team

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
7. Special Instructions/Research Plan Page Limitations

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

Emergency medicine department (ED) practitioners are responsible for conducting appropriate identification, triage, risk assessment and referral of high-risk suicidal individuals who present to the ED, yet no evidence-based standards exist for these practices.  This is a growing public health concern due to the increasing number of individuals who seek care in EDs for suicidality.  This Funding Opportunity Announcement (FOA) intends to fund one application that will support the development and testing of improved suicidality screening and one or more post-screening interventions, which together would form a “chain of care” in order to improve outcomes for patients presenting in EDs who are at high risk for suicidal behavior.  To optimize the generalizability of improved ED care to reduce suicidality, applicants should propose to test screening and intervention methods across multiple general medical ED settings; the settings should be diverse with regard to geographic location (e.g., urban, rural), ED staffing and referral resources, and patient characteristics (e.g., Veteran status, insurance status, patient income level).

This FOA solicits a research project with multiple components.  At minimum, the effort should include (1) the development and testing of a standardized mechanism to screen ED patients for high risk of suicidal behavior, ideally adapted from one or more existing screening tools; and (2) the development and testing of one or more ED-based post-screening interventions to reduce suicidal behavior and associated morbidity and mortality, delivered in the ED and/or following ED discharge.  Possibilities include, but are not limited to:  practical approaches to further evaluate those who self- identify as well as those patients identified through screening; safety assessments and/or safety plans that can be used by ED staff and community based providers who receive referrals post ED-discharge to help patients decrease their risk; brief ED-based interventions aimed at improving referral uptake and safety; and improved patient risk assessment, patient safety and monitoring skills among community-based providers who receive ED referrals. All developed components should be suitable for systematic use in EDs or the relevant non-ED settings, ideally without necessitating major adaptation across local settings to be feasible.

Applicants should consider various control conditions to test the range of interventions, including approaches to characterizing ‘usual care’ (UC) in the ED as well as post ED discharge. Screening and post-screening intervention(s) could be tested in sequence or in parallel.  Because improved identification of suicidality may be an effective intervention in its own right, applications under this FOA must be able to evaluate the independent effects of screening on outcomes.

Regardless of the screening and intervention approaches proposed, the overall goal is to improve care in the ED and following ED presentation, in order to reduce suicidal behavior and associated morbidity and mortality. Primary outcomes of interest include the reduction of various types of suicidal behavior (suicide ideation, first and repeated suicide attempts, suicide deaths) and rates of other types of injury, improvement in individual functioning and reduction in overall mortality, over at least a one-year time frame. Data on intervention and other health care costs should be collected.  Additional outcomes to be assessed could include cost-effectiveness from various perspectives (e.g., society, ED/health system, payer, patient), ED compliance with regulatory suicide risk screening requirements, quality of care in ED settings, and patient and family satisfaction with ED care.

Applications responding to this FOA must include research to:

Beyond these core elements, applications responding to this FOA could include, but are not limited to, research to:

The ultimate intent of this FOA is to yield research findings that are robust and generalizable across multiple and diverse ED settings, and that are practical and feasible to implement widely within existing delivery and financing systems.  In particular, in order to most closely replicate naturalistic practice conditions, NIMH encourages applicants to rely whenever possible on real-world payment mechanisms (e.g., private health insurance, Medicaid, Medicare) for delivering the proposed screening and intervention services, instead of relying on research–based financing.

The Substance Abuse Mental Health Services Administration (SAMHSA) may be able to provide resources for patient, family and provider education materials and training on suicide prevention.

Background

Suicide prevention continues to be a research priority area for NIMH, due to its obvious public health importance.  The present effort is directly intended to improve public health outcomes.  This FOA is consistent with Objective 3 of the NIMH Strategic Plan, Develop new and better interventions that incorporate the diverse needs and circumstances of people with mental illness: and with Objective 4: Strengthen the public health impact of NIMH-supported research (http://www.nimh.nih.gov/about/strategic-planning-reports/).  As evidenced by responses to a recent NIMH Request for Information (RFI; http://grants.nih.gov/grants/guide/notice-files/NOT-MH-08-013.html ) previous research supported by NIH and others indicates that there are multiple existing approaches for screening, assessing and implementing practical suicide prevention interventions in the ED and post ED discharge.  What remains to be addressed is whether these efforts are effective and can form a convincing evidence base to identify “best practices” for suicide prevention that can be initiated in the ED setting.

Objective 7.1 of the National Strategy for Suicide Prevention (DHHS, 2001) identified the ED setting as a site of opportunity for suicide prevention:  “Increase the proportion of patients treated for self-destructive behavior in hospital emergency departments that pursue the proposed mental health follow-up plan.”  The ED is a viable location for this type of strategy due to the large numbers of individuals who present with suicidal ideation and/or attempts.  U.S. based EDs are treating growing numbers of individuals who have attempted suicide, with an estimated 47% increase of people presenting to EDs with self-harming behavior from 1992 to 2001.  In 2005, there were 32,637 suicide deaths in the US, and at least 10-times more known suicide attempts compared to suicide deaths, with a CDC estimate of over 372,000 attempts documented through ED visits.  Serious suicide ideation is even more frequent than suicide attempts or suicide death, and many serious ideators also present at EDs, prior to acting on plans.  Given that prior suicide attempts are one of the most significant predictors of suicide death, and that serious ideation has been found to be a precursor to suicidal actions, capitalizing on intervention opportunities for this high-risk group is of paramount importance.  Moreover, while improving services delivered directly in the ED at the time of initial presentation is one important objective, risk for suicide death among attempters seen in EDs is highest in the days and weeks immediately after discharge.  Thus, it is also essential to improve referral mechanisms for post-discharge suicide prevention services, and the effectiveness of those services.  A South Carolina study of 2004 mortality and service use data reported that 10% of suicide decedents had been seen in an ED in the two months prior to death.

Importantly, suicidal ideation is also prevalent among patients who present to EDs for reasons and symptoms that are ostensibly neither suicide- nor mental health-related.  One screening study found that 13% of ED patients presenting for health problems other than mental health or substance use, endorsed either suicidal ideation or behavior, with 2% of this subgroup attempting suicide within 45 days of the screen.  Despite this substantial prevalence, few EDs implement routine, systematic screening of patients for suicidality.  More generally, there are no evidence-based practices for systematic assessment of suicide risk among ED patients, or for intervening.  When ED staffs provide referrals as part of their triage duties, estimates of 50 to 70% of suicidal at-risk individuals do not attend appointments for follow-up care.

In this context, focus groups of ED providers have reported frustration with the lack of valid screening measures as well as the absence of evidence-based guidance on how to assess and refer suicidal patients.  The existence of a subgroup of patients who repeatedly are seen in the ED with suicidality reflects the inability of the ED and referral providers to adequately reduce the distress and risk of a particular subset of ED patients.  There are two other concerns that may stem from the absence of routine, validated screening:  One is that many patients with real elevated risk do not receive needed care, and the second is that EDs expend substantial resources providing services to ED patients who are not actually at elevated and/or acute risk of suicide.

Two regulatory efforts have also highlighted the need for improved suicide risk detection, assessment and risk reduction.  Since 2007 the Joint Commission has promoted suicide risk assessment of individuals seen in behavior health settings, among its patient safety goals; this includes risk after discharge.  (See Goal 15 http://www.jointcommission.org/NR/rdonlyres/DA83B449-FFB0-40B7-9516-080C2504F02D/0/BHC_NPSG.pdf)  This goal is likely to expand to all health care settings, making EDs and their parent hospitals inherently interested in the most effective screening assessment approaches to determining and mitigating suicide risk.  Similarly, in 2006 the Centers for Medicare and Medicaid Services listed suicide deaths and attempts among its “never events.” These are events that are considered serious and costly errors in the provision of health care services and “should never happen” (see http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=1863).

Objectives and Knowledge to be Gained

Current understanding of suicide prevention efforts in U.S.-based EDs is limited.  The recent edition of Evidence-based Emergency Medicine (BH Rowe et al., Eds., 2009.  See:  http://www.wiley.com/WileyCDA/WileyTitle/productCd-1405161434.html) contains no specific information regarding the identification or management of suicidal patients.  National surveys provide information on the numbers of individuals seen in EDs for self-inflicted injuries, along with basic demographic information on these individuals (e.g., geographic region, age, gender, treatment disposition).  However, due to variability in suicidal behavior definitions, information on ED ascertained suicidal behaviors and related risk and protective factors are not easily compared across studies.  Similarly, little or no information is available about ED providers’ ‘usual care’ with regard to their approaches to detecting, assessing or triaging and referring suicidal individuals for follow-up care.  A number of studies assume the key problems in ED-based care that results in continued suicide risk for patients are breaks in the “chain of care,” and a lack of maintained contact with patients (see Research Approaches below).  These studies then focus on maintaining periodic contact with patients, and improving attendance at outpatient referrals.  However, few studies have provided adequate information on patient case definition, or have been powered sufficiently to adequately test these approaches or to provide a persuasive evidence base for establishing ED based practices.

Through this FOA, it is the intent of NIMH to support research that better defines and characterizes suicidal individuals seen in the ED, and assesses the degree to which improvements in case identification and initial and follow-up care are beneficial. These improvements may include:  implementing practical ED-based screening for more accurate detection, improving risk assessment and evaluation of suicidal individuals, and enhancing the referral and follow-up care of these individuals.  Evidence will be based primarily on patient outcomes (morbidity and mortality), as well as satisfaction with ED care, improved show rates for referrals provided by EDs, and possible mediating outcomes such as gains in patients’ suicide risk reduction-related coping strategies.  ED-based outcomes, such as reduced recidivism, improved compliance with Joint Commission suicide risk assessment, cost effectiveness, provider-perceived competency in suicide risk assessment and management, and patient and family satisfaction, are also of interest.

Although research on dissemination of evidence-based practices is beyond the scope of this FOA, applicants are strongly encouraged to consider input from and collaboration with institutions/stakeholders that are likely to influence- and could promote or inhibit- eventual uptake and dissemination of effective interventions.  Potentially relevant institutions include, but are not limited to the Substance Abuse and Mental Health Services Administration (SAMHSA); the Veterans Administration (VA); the Joint Commission and other licensing and credentialing bodies; and public and private purchasers and health care plans.

Research Approaches

There are a number of research challenges that may need to be addressed in applications to this FOA.  One problem that has confronted the suicide prevention field is the varied approaches to defining suicidal behavior. The Joint Commission’s patient safety goal of assessing patients for suicide risk has led a number of EDs to work on ways to measure suicide risk, but the reliability and validity of these approaches are not yet known.  Some have argued that it is particularly important to distinguish self-harming behavior without intent to die, from behaviors that include intent to die, as appropriate treatment approaches might differ for these behaviors.  The CDC has convened a series of meetings with scientific experts to develop a surveillance definition for self-directed violence that distinguishes self-directed injury with and without the intent to die—the former defining suicidal behavior. The resulting document is scheduled to be published in the Spring of 2009.

A challenge related to the definition of suicidality is the relatively low base rate of suicide deaths, regardless of definition used.  This FOA requires that interventions include as their outcome suicidal behavior and associated morbidity and mortality over at least a 12 month period.  Investigators should describe feasible and scientifically appropriate methods for defining outcomes, anticipating a likelihood of a low absolute number of suicide deaths during the study period.  Investigators should discuss how outcomes related to suicide death, e.g., suicide attempts, injury and death by accidents, or crisis rescue efforts, may represent outcomes of interest in their own right.  Whatever strategy is selected, the applicant should include appropriate methods for their assessment.

Based on responses to the recent NIMH RFI (http://grants.nih.gov/grants/guide/notice-files/NOT-MH-08-013.html), various specific ED-based brief interventions have been tested and found to improve patient outcomes, although currently none seems to be generally accepted nor widely used.  One approach has been to modify the “screening, brief intervention and referral to treatment (SBIRT)” model used successfully to reduce substance use problems associated with injuries. This model uses reliable and valid screens of the target problem, and assumes that the patient’s time in the ED is a “teachable moment” to assess risk, and encourages individuals to seek substance use treatment in order to reduce future injury and death.  The effectiveness of this approach has been demonstrated with regard to reduction of re-injury and related ED costs, and financing of SBIRT efforts has been negotiated and implemented (see http://sbirt.samhsa.gov/documents/SBIRT_guide_Sep07.pdf).  Other efforts that have been used to improve patient outcomes for suicidal individuals seen in the ED include: providing patients and families educational and referral materials; ED providers following patients through telephone contacts, home visits and/or mailed post cards; implementing peer support contact (in person, by phone, by web-based contact) programs, systematic follow-up of all suicidal patients by a designated ED staff member; and a medical-record based tracking approach.

Many suicidal individuals are helped through in- and out-patient mental health and substance use treatment, yet a substantial number of individuals remain at risk for suicide despite such engagement with the health care system.  The National Strategy for Suicide Prevention has pointed to the limited degree of suicide assessment and management training among health care providers (see http://mentalhealth.samhsa.gov/publications/allpubs/SMA01-3518/default.asp, Objective 7).  To address that gap, SAMHSA has supported an expert consensus approach to train clinicians to improve their assessment and management of patient suicide risk (available through the SAMHSA funded Suicide Prevention Resource Center, see  http://www.sprc.org/traininginstitute/amsr/clincomp.asp).  The Veterans Administration (VA) has been implementing training for mental health providers in patient suicide safety assessments and safety planning. Other programs have been used to train lay individuals as well as providers, such as the LivingWorks’ Applied Suicide Intervention Skills Training (ASIST; see  http://www.livingworks.net/) and QPR (Question Persuade Refer; see http://www.qprinstitute.com/).  ASIST and QPR have some empirical basis for enhanced knowledge about and attitudes towards suicide prevention, as well as improved detection and referral of suicidal individuals.  Such training programs have been used to improve the quality of care among hospital- and ED-based providers, along with community providers.

While enhancements to care components could incrementally improve the quality of care for suicidal individuals, a number of regional suicide prevention strategies have argued for a comprehensive “chain of care” approach that requires improvements across the different service sectors that a suicidal individual is likely to encounter.  The “chain of care” is intended to provide competent, ongoing contact and care with at-risk individuals to keep them safe until they are past a crisis point.  Research on “collaborative care” interventions to improve care for common disorders such as depression indicate that multiple changes in care systems (e.g., patient and provider education; care coordination, including ongoing symptom monitoring; consultation/communication between providers) are necessary for improving clinical and functioning outcomes. A collaborative care model was found by the NIH PROSPECT and Hartford Foundation IMPACT studies to reduce suicidal ideation in depressed older adults in primary care, and found to be relatively cost-effective overall.  Similarly, the “Perfect Depression Care Program,” a demonstration program with no control/comparison condition, used multi-component changes to seek “zero suicides” within depression care of a behavioral health service.  Changes in the program included improved patient and family education, improved psychotherapy quality (both in- and out-patient settings), more rapid and easier access to care, and wider provider access to patient treatment progress information, including suicide risk.  Since implementation of the program, the suicide rate of depressed patients served was reported to have dropped 75% over a four-year period and the program is viewed as cost effective. 

Given the absence of widely used evidence-based ED practices for the assessment and treatment of suicidality, this FOA seeks to fund one applicant capable of incorporating, at a minimum, several core elements in his/her research approach.  These elements include: representative samples of general medicine ED patients; a well-defined approach to characterizing suicidal patients; and the ability to follow patients over at least a 12 month period after the “index” visit to the ED (i.e., the ED visit in which high suicide risk is first identified).  With regard to research questions addressed, there should be a project to develop and test a standardized instrument/method to screen ED patients for high risk of suicidal behavior, ideally adapted from one or more existing screening tools, that is suitable for ED use.  This measure should be evaluated with regard to its possible reduction in suicide risk and associated outcomes. Post-screening interventions should address one or more aspects of the ‘chain of care’ provided within the ED and/or post-discharge to improve patient outcomes. Screening and post-screening intervention(s) can be tested in sequence or in parallel, as long as it is possible to evaluate the independent effects of modified/enhanced screening on outcomes.

The NIH Cooperative Agreements (U01) award mechanism will be used to support a comprehensive, conceptually-driven approach to reducing suicidal morbidity and mortality in the ED setting.  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 multidisciplinary and applied nature of the research setting;  (3) the scope of the project with regard to the number of ED sites and patients to follow; and (4) the need to analyze and report interim results rapidly, and then to refine designs and implement subsequent research activities within the 5-year project period.  Applicants should expect substantial NIMH programmatic staff assistance in refining and conducting the study, as described in Section VI.2.A.2 -  NIH Responsibilities.

Examples of Research Topics

The overall focus of this FOA is to solicit research to develop and evaluate a ‘chain of care’ intervention for individuals who are at-risk for suicide and present to ED settings.  Thus, research submitted in response to this FOA should include, at a minimum, the test of a measure to screen/identify individuals at-risk for suicide and one or more interventions.  These additional interventions may be at the individual, provider, system and/or community level.  Interventions should be practical in terms of their likely uptake in the ED setting and lack of future dependence on research infrastructure.  In addition to achieving the primary aims of the work, there are many important ancillary questions that can be addressed for each ED related suicide prevention component being tested.  In addition to questions derived from the aims already described, further questions could include, but are not limited to, the following:

Research Team

By their nature, EDs are a multidisciplinary practice setting, and the involvement of the various disciplines working in EDs is expected.  A range of ED staff should be considered for inclusion in the research team, such as nurses, emergency medicine physicians, trauma surgeons, emergency medical technicians, VA clinicians, physician assistants, social workers, psychologists, and psychiatrists.  In order to meet the research objectives of this FOA, collaboration among researchers with the following expertise will be needed: suicide assessment and intervention, ED-based clinical epidemiology, services research in quality improvement and practice implementation, practical clinical trials design, data base management (electronic assessment and patient tracking expertise), biostatistics and economics.

As noted in the Background in this section, EDs and their parent hospitals may be working toward becoming compliant with Joint Commission safety goals to routinely assess and reduce suicide risk.  For this reason, appropriate collaborations with hospital administrators who can facilitate quality improvement and patient follow-up over time to determine patient outcomes, are expected.  The input of additional stakeholders is also likely to enhance the applicability of the study findings.  These stakeholders could include, but not be limited to: referring institutions (e.g., law enforcement, educational settings, Veterans Healthcare settings); referring providers (community therapists, primary care providers); providers receiving referrals (e.g., inpatient as well as outpatient providers; case workers; substance use counselors); family members or close associates of the patient; as well as recovered patients, patient advocates, and suicide prevention advocacy groups. 

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 announcement (FOA) will use the NIH Cooperative Agreement (U01) award mechanism.  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).

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 NIMH has committed $3 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 this funding opportunity may not exceed 5 years.  Although award amounts may vary to reflect the scope and work load of the study, direct costs should not exceed $2 million in any one year.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of the award will also vary. Although the financial plan of the NIMH provides support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds. 

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

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 U.S.-based 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 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

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

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

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

SPECIAL INSTRUCTIONS

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 such as SO or IAR 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

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date:  March 20, 2009
Application Receipt Date:  April 14, 2009
Peer Review Date:  June/July 2009
Council Review Date:  August 2009
Earliest Anticipated Start Date:  September 30, 2009
Expiration Date:  April 15, 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. Applicants are strongly encouraged to submit a letter of intent.

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:

Jane Pearson, Ph.D.

Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC 9635
Bethesda, MD  20892-9635
Rockville, MD  20852-9635 (for express/courier service)
Telephone:  (301) 443-3598
Email:  jpearson@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application 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 materials 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:  jnoronha@mail.nih.gov

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, it 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 merit 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.

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 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

The study objectives and goals should be relevant to and compatible with the NIMH priorities stated in Section I.1. Applicants should describe their plans to accommodate the stated requirements, criteria, and NIMH involvement.

It is anticipated that the research teams will include outstanding scientists from diverse scientific disciplines relevant to achieving the study’s aims, such as suicide assessment and intervention, ED-based clinical epidemiology, services research in quality improvement and practice implementation, practical clinical trials design, data base management (electronic assessment and patient tracking expertise), biostatistics and economics. The teams should also demonstrate familiarity with ED and hospital organizations and practices as relevant to achieving the research aims of the investigation.

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

Applicants are encouraged to organize the application by initially presenting the face page, the abstract page with key personnel, a table of contents, summary budget pages for the entire proposal, and other documentation pertaining to the entire project (i.e., the Special Requirements). This should be followed by an introductory section of no more than 7 pages that provides a General Description of the project. The content requirements of this section are described below.

After the General Description, the applicant should detail the proposed research that includes the screening/evaluation effort, and the intervention effort (which may include multiple components).  It is up to the discretion of the applicant to determine how to appropriately stage the research efforts. With regard to research questions addressed, the project to refine and validate an existing screening measure for suicide risk that is suitable for ED use should be evaluated independently with regard to its possible effects on reducing suicide risk and improving associated outcomes. Post-screening interventions should address one or more aspects of the ‘chain of care’ provided within the ED and/or post-discharge to improve patient outcomes. Screening and post-screening intervention(s) could be tested in sequence or in parallel, as long as it is possible to evaluate the independent effects of modified/enhanced screening on outcomes.

For the purpose of the application and review, it is suggested that each component (screening, and additional intervention components) be described as its own Research Project, though each individual project is, ultimately, one part of a larger whole.  The applicant will have an opportunity in the General Description to outline how the research will be staged.  Thus, the application should include a General Description, a Research Project section that includes the screening/evaluation tool project, and then an unspecified number of additional Research Project sections to describe the fielding and testing of additional intervention efforts to be included in the ‘chain of care.’

Page Limitations:  The General Description (no more than 7 pages) together with the Research Project sections should be no longer that 30 pages total.

A.  General Description of the Overall U01 Project

This section must not exceed 7 pages, and should provide the following details

B. Specific Instructions for Individual U01 Research Projects.  For each Research Project there should be a research plan (i.e., specific aims, background and significance, preliminary studies, and research design and methods), as indicated in the form PHS 398.  For each individual Research Project, the research plan needs to address:

Cooperative Agreement

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

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 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.  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,. 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.htm.

(b)  (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)  (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/.

A data sharing plan is required for this FOA, and must specifically state when and how the data will be shared.  It is expected that there will be rapid sharing of data.

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 this FOA will be evaluated for scientific and technical merit by an appropriate scientific review group convened by the NIMH, 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:

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

The 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, and weighted 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.

Review Criteria for the Overall Project and Individual Research Projects (U01) 

The review criteria outlined below are intended to be applied to assess individual research projects in combination with the overall project. 

Significance: Does this study address important questions related to suicide prevention efforts that can be fielded in the ED? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of the projects on the concepts, methods, technologies, interventions, or services that drive the field of suicide prevention research?  What is the potential public health significance of the study findings on suicide morbidity and mortality?

Approach:  Are the conceptual or clinical and services 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?  Do the proposed intervention models make maximum use of real-world payment mechanisms (e.g., private health insurance, Medicaid, Medicare) for delivering screening and intervention services, instead of relying on research–based financing?

Do the sampling, assessment and intervention plans communicate an adequate understanding of ED settings, more specifically ED and hospital policies, practices, institutions and organizations?  Is the decision-making process for specifying stages and necessary alterations in research plans clear and well-reasoned?  Are the scientific disciplines represented in Research Projects adequate to achieve the objectives of specific research projects, as well as the overall aims of the study (including adequate capacity to assess relevant outcomes of interest)?

Innovation:  Are the research projects proposed original and innovative?  Do the projects address innovative hypotheses or critical barriers to progress in the field?  Do the projects develop or employ novel concepts, approaches, control groups, methodologies, tools, or technologies for this area?  Do the projects challenge existing practice and consider real-world approaches to improvements in suicide prevention? 

Investigators:  Are the Investigators and other key personnel (including Research Project Leaders and relevant stakeholders) appropriately positioned, trained, and well suited to direct or carry out the overall study aims as well as the individual projects proposed Is the work proposed appropriate to the experience level of the key personnel and other researchers?  ?  Is expertise in practical clinical trial design and implementation, services research, data analysis, and statistics/biostatistics and economics adequately represented on the research team? Are appropriate members of the ED staff adequately integrated in the research team?  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?  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 related large, multi-faceted studies?

Environment:  Does the technical and scientific environment where the work will be done contribute to the probability of success?  Does the proposed work benefit from the unique features of the technical and scientific environment, or employ effective collaborations?  Is there evidence of institutional support and competence of the applying Institution to administrative serve and support the research team(s)?  Does the research team demonstrate a track record in successfully recruiting participants from EDs into research studies and completing proposed studies within projected timelines?  Has the research team successfully coordinated data collection and analyses across multiple sites? Are there adequate data management and biostatistical resources to support rapid analyses of ongoing follow-up of participants?

In addition to the above review criteria, the following criterion will be addressed and considered in the determination of scientific merit and the rating.

Interaction:  Are there adequate plans for ensuring effective intra-Group communication, interaction, cohesiveness, and coordination among the PI, Research Project Leaders, and NIMH Project Scientists?  Do the investigators state their willingness to collaborate extensively and share information fully?  Do the investigators state their willingness to abide by the policies stated in the Terms and Conditions of the Cooperative Agreement?

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. Efforts should be made to clarify what research costs are above and beyond usual ED costs and referral services (in- and out-patient treatment).  The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plan(s)

Reviewers will be instructed to comment on the reasonableness of the Data Sharing Plans. 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).

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 an 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 Research Project Leaders or collaborators have the same rights and responsibilities as other members of the Group.

c. Awardees will retain custody of and have primary rights to the data developed under these awards subject to Government rights of access consistent with current HHS, PHS, and NIH policies. A data sharing plan is required for this FOA, and must specifically state when and how the data will be shared.  It is expected that there will be rapid sharing of data.  Timely publication of major findings by the Group members is encouraged.  Publication or oral presentation of work done under this agreement will require appropriate acknowledgment of NIMH support, including the assigned cooperative agreement award number.

2.A.2. NIH Responsibilities

During performance of the award, the role of the NIMH Project Scientist is one of substantial involvement above and beyond the normal program stewardship role of a Program Official. The Project Scientist will be an active member of the Steering Committee and will have voting rights as a committee member. The participation of the NIMH staff Project Scientist is intended to assist the project Steering Committee in its efforts to ensure that the broad scientific goals of NIMH are reflected in the final design, implementation, and reporting of results from the study.  Specifically, the NIMH Project Scientist will participate in decisions about the study design, instrumentation, and clinical assessment.  The NIMH Project Scientist will participate in all major project meetings and may cooperate with the awardee as author or co-author of resulting publications in accordance with publication policies developed by the Steering Committee of the awarded project.  Publications involving NIMH staff must follow NIH and NIMH publication policies. 

Additionally, an Institute Program Official will be responsible for the normal scientific and programmatic stewardship of the award, including programmatic monitoring and assistance in the coordination of the overall project, including implementation of the data and research resource sharing plans and will be named in the award notice.  The Program Official will not be a voting member of the project Steering Committee.

2.A.3. Collaborative Responsibilities

A governing Steering Committee composed of the PI, Research Project Leaders, and NIMH Project Scientist(s) will be established to assist in developing the scientific content and direction of the program, and to monitor progress over time. 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 (generally at one of the performance sites) and for preparing concise proceedings or minutes (two or three pages), which will be delivered to the members of the Group within 30 days of the meeting.  Adequate budgeting of these meetings should be detailed in the application budget.

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. It will have three members: 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 required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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:

Jane Pearson, Ph.D.
Division of Services and Intervention Research

National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC 9635
Bethesda, MD  20892-9635
Rockville, MD  20852-9635 (for express/courier service)
Telephone:  (301) 443-3598
Email:  jpearson@mail.nih.gov

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:  armstrda@mail.nih.gov

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: rclaycam@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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.


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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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