National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Funding Opportunity Title
Pediatric Suicide Prevention in Emergency Departments (U01)
U01 Research Project – Cooperative Agreements Research Project Grant
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
This Funding Opportunity Announcement (FOA) encourages cooperative research project grant (U01) applications aimed at developing and determining, prospectively, the sensitivity and specificity of approaches to screening and stratifying youth (under age 18) who are at risk for suicide in order to improve the overall care of these individuals in the Emergency Department (ED) setting. To optimize the generalizability of improved ED care to reduce suicidality, applications should develop screening and risk stratification approaches that can be tested across multiple general medical emergency department settings. Improved screening would inform subgroup-by-intervention pairing to increase impact and future intervention development to target modifiable risk factors within specific high risk groups.
April 15, 2013
Open Date (Earliest Submission Date)
September 18, 2013
Letter of Intent Due Date(s)
September 18, 2013
Application Due Date(s)
(Extended to November 1, 2013 per NOT-OD-14-003), Originally October 18, 2013, by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)
Scientific Merit Review
Advisory Council Review
Earliest Start Date
(Extended to November 2, 2013 per NOT-OD-14-003), Originally October 19, 2013
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
This Funding Opportunity Announcement (FOA) encourages cooperative research project grant (U01) applications aimed at developing and determining, prospectively, the sensitivity and specificity of approaches to screening and stratifying youth (under age 18) who are at risk for suicide in order to improve the overall care of these individuals in the Emergency Department (ED) setting. To optimize the generalizability of improved ED care to reduce suicidality, applications should develop screening and risk stratification approaches that can be tested across multiple general medical emergency department settings. Improved screening would inform subgroup-by-intervention pairing to increase impact and future intervention development to target modifiable risk factors within specific high risk groups. Research funded through this FOA should be consistent with the National Action Alliance for Suicide Prevention priorities, one of which is to transform health care systems to significantly reduce suicide (http://actionallianceforsuicideprevention.org/about-us/priorities).
In 2010, suicide was the third leading cause of death for both 10-14 year olds (267 deaths) and 15-24 year olds (4,600 deaths) (CDC, http://www.cdc.gov/injury/wisqars/fatal.html). Among 10-17 year olds, there are approximately 1,000 deaths by suicide each year, but nonfatal suicide attempts are more frequent. According to the 2011 Youth Risk Behavior Surveillance System, in the 12 months prior to the survey, 2.4% of students nationwide had made a suicide attempt that resulted in an injury, poisoning, or overdose that had to be treated by a doctor or nurse, 7.8% of students had attempted suicide one or more times, and 12.8% of students had made a plan about how they would attempt suicide. Given that the strongest predictor of suicidal death is a prior attempt, it is possible that intervening with adolescents who attempt suicide and those thinking about self-harm (ideators) may result in a reduction in the national suicide rate, reduced health care burden (hospitalizations) and, because of developmental stage, a significant number of life-years saved.
An ED visit represents a prime opportunity for suicide prevention efforts. According to Agency for Healthcare Research and Quality's Healthcare Cost and Utilization Project (HCUP) Nationwide Emergency Department Sample (NEDS) (http://www.hcup-us.ahrq.gov/nedsoverview.jsp), in 2009 there were 9,834,267 ED visits for youth ages 10-17. 700,755 visits involved a psychiatric concern, and 128,456 visits were for intentional self-harm. These figures are likely an underestimate of the potential impact of screening, as they do not account for ‘occult’ cases – i.e., those whose risk status may be identified if directly asked about suicide, but not presenting for suicide or psychiatric related reasons. While ED practitioners are responsible for conducting appropriate identification, triage, risk assessment, and referral, no evidence-based standards exist for these practices. Many ED sites are seeking guidance for how to conduct this type of assessment as they anticipate compliance with the Joint Commission National Patient Safety Goal 15.01.01, requiring behavioral health care organizations, psychiatric hospitals, and general hospitals treating individuals for emotional or behavioral disorders, to identify individuals at risk for suicide.
Past research has identified the population risk factors for suicide/suicidal behavior, but it remains a challenge to predict individual risk. Once an individual screens positive for suicide risk, there are few, if any, strategies to inform 'matching' of individuals to the appropriate intervention (type/intensity) given their level of risk. Current practice is to provide all individuals who screen positive for suicide risk to the same level of intervention, which is often of high intensity (e.g., inpatient hospitalization). High intensity interventions are not always necessary, or clinically indicated, and may represent a poor allocation of limited resources as well as treatment regimen that may be less effective as it is not matched to individual need.
In 2009, the NIMH funded the Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) Study (U01 MH088278), a cooperative agreement to evaluate an approach to universal screening and intervention for adults at-risk for suicide and presenting to the ED. While addressing several important priority areas with respect to advancing suicide prevention efforts, ED-SAFE was not designed to address the unique factors associated with children and adolescents at risk for suicide. In 2012, the NIMH, along with the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse issued a Request for Information (RFI) (NOT-MH-12-035) to obtain input on strategies to enhance suicide prevention efforts targeted at children and adolescents within emergency medicine department (ED) settings. This FOA is an outgrowth of some of the feedback NIH received in response to this RFI.
This FOA intends to support research project(s) that address two objectives:
Responsive applications are expected to address both core objectives. Studies should be adequately powered to conduct a psychometric analysis that would provide data with respect to the reliability, sensitivity, specificity and predictive validity of the screening tool and algorithms developed. The goal is to develop and evaluate tools that are practical and feasible to implement widely within existing delivery and financing systems. Responsive applications should consider an economic analysis of the costs and potential cost-savings associated with implementing the screening/risk stratification tools.
Applications submitted to this FOA are expected to develop or refine a screening instrument. While several brief suicide screening measures exist, unanswered questions remain. Despite research demonstrating the validity of several instruments, few have been studied extensively for use in the ED setting, or have demonstrated utility for the purpose of risk prediction, stratification, or matching to intervention. The goal of the current initiative is to improve the specificity of prediction of suicidal behavior, while maintaining the sensitivity of screening instruments. If appropriate, responsive applications may choose to use existing, empirically-supported instruments. It is up to the investigative team to determine if existing instruments sufficiently capture those factors that may be most predictive of future suicide attempts in youth, or if a new instrument is needed. For example, an unanswered question is whether assessment of suicide risk should focus simply on suicidal ideation and behavior, or should more generally assess for other potential risk factors (e.g., impulsivity, past attempts, mental health diagnoses, substance use, non-suicidal self-injurious behavior, etc.). Related, research is also needed to determine whether assessment of youth suicide risk could rely only on child/adolescent self-report, or whether adequate screening necessitates parent/guardian report of youth behavior. If the latter, strategies for combining reports from multiple informants would be needed in the service of risk prediction.
As this FOA is focused on prospective validation of screening and risk stratification, youth enrolled should be followed for a minimum of six months. Youth who screen positive and negative for suicidality are expected to be included in the ongoing assessments. Risk stratification algorithms developed from the screening should be practical and easy to implement in ED settings. Although the algorithms may result in referral to treatment/mental health services, studies submitted as part of this initiative are not expected to develop or test interventions to treat youth identified as at-risk or who are actively demonstrating suicidal behavior; treatment as usual (TAU) is an acceptable intervention. Responsive applications should, however, provide detailed plans for ensuring patient safety and strategies for linking youth identified as high risk to appropriate services.
Because the ultimate intent of this FOA is to yield research findings that are robust and generalizable across multiple and diverse ED settings, it is expected that the study will be conducted at several sites. The research should occur in general medical, as opposed to psychiatric, emergency settings to enhance generalizability. Priority will be given to applications that take advantage of existing research networks with an established infrastructure to track patients and support multi-site investigations (e.g., the Mental Health Research Network (MHRN), the Pediatric Emergency Care Applied Research Network (PECARN), the Emergency Medicine Network (EMNet), Clinical and Translational Science Awards (CTSAs)).
There are a number of research challenges that may need to be addressed in applications submitted in response to this FOA. One problem that has confronted the suicide prevention field is the varied approaches to defining suicidal behavior. 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 developed consensus surveillance definition for self-directed violence that distinguishes self-directed injury with and without the intent to die—the former defining suicidal behavior (http://www.cdc.gov/violenceprevention/pdf/Self-Directed-Violence-a.pdf). Although self-directed injury without intent to die is a concern, for the purpose of this initiative it should be considered as a potential risk factor for future suicide attempts, as opposed to a primary outcome.
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 applications include as their outcome suicidal behavior and associated morbidity and mortality over at least a 6 month period; ideation alone as a proxy for suicidal behavior would not be considered sufficient or responsive to this FOA. Investigators should describe feasible and scientifically appropriate methods for defining outcomes, anticipating the 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 for defining outcomes, the applicant should include appropriate methods for their assessment, and be adequately powered to detect events.
Issues pertaining to human subjects’ protections - both for treatment and research - are also an important consideration. Responsive applications should provide plans for addressing questions of consent (with consideration of participant ages, maturity and psychological state) – for clinical care and research – in the event that a child/adolescent presents to the ED alone/without a parent or legal guardian. Responsive applications should also address issues for consenting youth who are wards of the state, or have been legally emancipated. The presence or absence of a legal guardian may not impact emergency clinical services, but can impact the research study, particularly since an open research question is whether it is sufficient to only assess the child, or if adequate risk assessment involves the report of a parent or other legal guardian. Related, there could be key clinical differences between youth who present alone or with a parent/guardian. Responsive applications should consider strategies to include high risk youth who may present without a parent (e.g., foster care youth, youth involved in the juvenile justice system).
Epidemiologic data suggest that certain populations (e.g., lesbian, gay, bisexual, transgender (LGBT), Latino/a youth, American Indian/Alaska Native) are at higher risk for suicidal ideation and death. Responsive applications should address the cultural appropriateness of screening instruments and risk prediction algorithms, and may include strategies specifically targeted towards high risk groups.
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, 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 risk factors and assessment, instrument development/psychometrics, ED-based clinical epidemiology, services research in quality improvement and practice implementation, data base management (electronic assessment and patient tracking expertise), statistics and economics. As described in the Cooperative Agreement Terms and Conditions of Award, responsive applications will include a leadership structure (e.g., Steering Committee) responsible for overall project administration and provisions of cross-site coordination and quality control.
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; 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.
It is expected that an NIMH Data and Safety Monitoring Board (DSMB) will provide oversight of the study. The nature of this study is such that there will be high volume of Adverse Events (AEs) and Serious Adverse Events (SAEs) that will require reporting to the DSMB in a timely manner. As a result, it is expected that the research team will include a full time Safety Monitor, whose primary responsibility will be the tracking and reporting of AEs and SAEs, and following-up on any individual subject safety concerns.
Both the multi-site nature of the project, and the expected volume and frequency of safety monitoring and reporting will require that the research team be supported by an identified Data Coordinating Center (DCC) that has the requisite experience and knowledge in customizing and implementing robust scalable electronic data capture systems and in supporting multi-site, multi-disciplinary clinical research programs. It is expected that the data center will provide ongoing management support and consultation in the design, execution, and analysis for the proposed study and ensure that the proposed study is of the highest scientific integrity. Details regarding expectations for the DCC are outlined in Section IV.2, PHS 398 Research Plan.
The NIH Cooperative Agreement (U01) award mechanism will be used to support a comprehensive, conceptually-driven approach to youth suicide screening and risk stratification 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 amount and frequency of safety monitoring due to the anticipated number of adverse events. Applicants should expect substantial NIMH programmatic staff assistance in refining and conducting the study, as described under in NIH Staff Responsibilities.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
|NIMH intends commit approximately $12,000,000 for this initiative with $2,4000,000 in FY 2014 to fund 1 award.|
Budgets may not exceed $2,400,000 (total costs) in any one year.
Award Project Period
The total project period for an application submitted in response to this FOA may not exceed five years.
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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
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.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Amy B. Goldstein, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7133, MSC 9633
Bethesda, MD 20892-9633
Rockville, MD 20852 (for express/courier service)
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: Organize the Research Strategy in the specified order and using the additional instructions provided. Start each section with the appropriate section heading.
Background and Overview: This section should include a general introduction to the study topic area, including relevant literature reviews to support the subsequent design strategies. Additionally, this section should be used to describe:
Innovation and Approach: This section should describe both the screening and risk validation studies. Although it is up to the investigative team to determine exactly how to structure the project, it is suggested that these two core objectives be considered separate research projects; i.e., one research project focused on screening, followed by a second study to develop/validate risk stratification approaches. Additionally, this section should be used to describe:
Study Leadership, Management, and Operations:
Study Leadership and Management: While this is expected to be a multi-site project, it is not a collaborative U01. As a result, there will be one grant awarded, with the expectation of multi-subcontracts to study sites. This may be either a single or multiple PD/PI project. With regard to Study Leadership and Management, this section should include:
Study Operations, including Safety Monitoring: In addition to the oversight provided by the study PD/PI(s), it is expected that the study will have an identified Data Coordinating Center. It is expected the Data Coordinating Center (DCC) will include a multi-disciplinary staff, consisting of appropriate statistical leadership and data management expertise. The DCC will work with the Steering Committee and serve as a technical support organization to the investigative team by implementing the decisions of the Steering Committee regarding protocol development, protocol execution, data processing, and analysis. Prior to the initiation of a study, it is expected that the DCC will collaborate with the study investigators in the development of the data collection forms and will take the lead on the development of detailed manual of operation and training manuals.
Adverse Event/Safety Monitoring: This type of research project is unique in that the primary outcomes of interest (suicidal ideation and behavior) are considered Adverse Events, and reportable to the study DSMB. As a result, careful attention should be paid to how Safety Monitoring will occur in a timely and efficient matter. It is expected that the aforementioned DCC will take primary responsibility for the timely reporting of AEs/SAEs.
Human Subjects Concerns
Issues of informed consent should be discussed in light of the context of the research (the ED setting) and the potential for individuals who may be eligible for the research study to present to the ED without a legal guardian. The presence or absence of a legal guardian may not impact emergency clinical services, but can impact the research study, particularly since an open research question is whether it is sufficient to only assess the child, or if adequate risk assessment involves the report of a parent or other legal guardian. Related, there could be key clinical differences between youth who present alone or with a parent/guardian. The discussion of Human Subjects should include:
Note that some of the above information (e.g., strategies for informed consent) may be appropriately placed in the Human Subjects section of the application, while other topics (e.g., rationale for included/excluded certain subgroups) should be placed within the Research Strategy.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:
Consistent with NIH efforts to establish and promote the use of common standardized measures and methods, the harmonization of data across sites, and the sharing of data with the wider research community, responsive applications are expected to include a Data Sharing Plan that addresses:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
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 only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at NIMHReferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? If the aims of the project are advanced, will there be practical, tangible products (i.e., screening instruments, prediction algorithms) that could be used in ED settings? What will be the effect of the project on the concepts, methods, technologies, interventions or services that drive the field of suicide prevention research?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is expertise in: suicide risk factors and assessment, instrument development/psychometrics, ED-based clinical epidemiology, services research in quality improvement and practice implementation, data base management (electronic assessment and patient tracking expertise), statistics and economics adequately represented on the research team in order to accomplish the study aims as specified in the application? Are appropriate members of the ED staff adequately integrated in the research team? Have collaborations been established or consultants identified to provide the appropriate depth and breadth of expertise required for the project? Has the PD/PI demonstrated leadership in development, implementation, and management of related large, multi-faceted studies? Has the study team identified an appropriate individual to serve as a study Safety Monitor, and is the effort allocation that individual will devote to the project sufficient to meet the need of timely AE and SAE reporting? Is the Data Coordinating Center adequate to meet the study demands? Did the applicants provide evidence of experience in quality assurance, reporting data to monitoring boards, and developing de-identified limited access datasets?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Do the screening methods and decision making tools include innovations that take advantage of health technologies? Are the approaches practical and efficient - easily implemented in real world settings?
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed? Is the project designed in such a way that a psychometric analysis of the screening
instrument - including an analysis of sensitivity, specificity, and predictive
value will be possible? Does the project move beyond concurrent validity and
include a prospective study of the instrument's characteristics? Are the
screening and risk stratification procedures proposed feasible in real world
settings? Does the approach take into account the commonly available resources
and competing demands in the ED setting? Does the approach include strategies
to address the needs of specific cultural groups, as appropriate?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Does the project clearly detail a plan for the appropriate clinical management of youth identified as at-risk? Is there a strategy proposed for linking youth to services and/or providing treatment as usual?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Do the study environments reflect a range of ED settings? Are the environments such that findings will be generalizable beyond the specific EDs in which the study is being conducted? Does the application propose to take advantage of an existing research network/established infrastructure?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Are there adequate plans for ensuring effective intra-group/Steering Committee communication, interaction, cohesiveness, and coordination among the PD(s)/PI(s), Research Project Leaders, and NIMH Project Scientist?
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Do the investigators state their willingness to collaborate and share data? With respect to data sharing, does the application include a plan that states which data will be shared and at what time? Does the project budget reflect the resources needed to prepare, store and distribute an appropriately de-identified database, with associated dictionaries, for public access use? Will the final dataset be hosted on the NIMH Limited Access Dataset website?
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIMH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:
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.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.
Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
following special terms of award are in addition to, and not in lieu of,
otherwise applicable U.S. Office of Management and Budget (OMB) administrative
guidelines, U.S. Department of Health and Human Services (DHHS) 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.
The PD(s)/PI(s) will have the primary responsibility for:
NIMH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
A governing Steering Committee composed of the PD(s)/PI(s), Research Project Leaders, and NIMH Project Scientist 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 study progress, plan and design research activities, and establish priorities, policies and procedures. Adoption of study policies and procedures will require a majority vote. Each member will have one vote in any decision to be made by the Steering Committee with respect to study policies and procedures. The NIMH Project Scientist will be a voting member of the Steering Committee but may not serve as the Chair of the Steering Committee. The frequency of meetings, not fewer than two per year, will be determined by the PD(s)/PI(s) who will be responsible for scheduling the time and place and for preparing concise proceedings or minutes (two or three pages), which will be delivered to the members of the Steering Committee within 30 days of the meeting. Adequate budgeting of these meetings should be detailed in the application budget.
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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
Contact Center Phone: 800-518-4726
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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