Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Mental Health (NIMH)

Funding Opportunity Title

Pilot Effectiveness Studies and Services Research Grants (R34)

Activity Code

R34 Planning Grant

Announcement Type

New

Related Notices

  • September 25, 2014 - See Notice NOT-MH-14-033. Notice of Information on High-Priority Research Areas to Understand and Reduce Mental Health Disparities.
  • July 8, 2014 - NIMH Focus for Intervention Studies Submitted Under the Stigma and Health Literacy Announcements. See Notice NOT-MH-14-016.
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 14, 2014 - See Companion RFA-MH-15-340, R01 Research Project Grant .
  • June 12, 2014 - See Notice NOT-MH-14-015, Data Sharing Expectations for NIMH-funded Clinical Trials.

Funding Opportunity Announcement (FOA) Number

RFA-MH-15-330

Companion Funding Opportunity

RFA-MH-15-320, R01 Research Project
RFA-MH-15-325, Collaborative R01 Research Project Grant
RFA-MH-15-300, R21/R33 Phased Innovation Award
RFA-MH-15-310, R33 Exploratory/Developmental Grants Phase II
PAR-14-107, U01 Research Project – Cooperative Agreements

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.242

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage pilot research consistent with NIMH’s priorities for: 1) effectiveness research on interventions with previously demonstrated efficacy, for use with broader target populations or for use in community practice settings, and 2) innovative services research directions that require preliminary testing or development. Applications should provide resources for evaluating the feasibility, tolerability, acceptability and safety of approaches to improve mental health and modify risk factors, and for obtaining the preliminary data needed as a pre-requisite to a larger-scale intervention trial (e.g., comparative effectiveness study, practical trial) or large-scale services study.

In this pilot phase of intervention and services research, NIMH places highest priority on approaches that can be justified in terms of their potential to substantially impact practice and public health and approaches that are empirically grounded.  Specifically:  1) Applications should justify the potential impact of the proposed intervention/services models on practice and public health in terms of the magnitude of likely improvements in effect size, safety/tolerability profile, value and efficiency, or dissemination potential, as compared to existing approaches;  2) Adaptations or augmentations of efficacious interventions should only be undertaken if there is an empirical rationale for the adaptation target and for the corresponding mechanism by which the adapted intervention or augmentation is expected to substantially enhance outcomes; and  3) For pilot tests of intervention effectiveness or service delivery approaches, the study should be designed to explicitly address whether the intervention engages the mechanism that is presumed to underlie the intervention effects.     

Key Dates
Posted Date

February 24, 2014

Open Date (Earliest Submission Date)

May 17, 2014

Letter of Intent Due Date(s)

30 days before the application due date

Application Due Date(s)

June 17, 2014, October 17, 2014, and February 17, 2015, 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)

Not Applicable

Scientific Merit Review

October, 2014; March 2015; June 2015

Advisory Council Review

January 2015; May 2015; October 2015

Earliest Start Date

February, 2015; June  2015; September 2015

Expiration Date

February 18, 2015

Due Dates for E.O. 12372

Not Applicable

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.


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Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

Purpose

The purpose of this Funding Opportunity Announcement (FOA)is to encourage pilot research consistent with NIMH’s priorities for: 1) effectiveness research on interventions with previously demonstrated efficacy, for use with broader target populations or for use in community practice settings, and 2) innovative services research directions that require preliminary testing or development. Applications should provide resources for evaluating the feasibility, tolerability, acceptability and safety of approaches to improving mental health and modifying risk factors, and for obtaining the preliminary data needed as a pre-requisite to a larger-scale effectiveness trial (e.g., pragmatic trial) or large-scale services study.  In this pilot phase of intervention and services research, NIMH places highest priority on approaches that can be justified in terms of their potential to substantially impact practice and public health and are empirically grounded. 

Specifically, applications should justify the potential impact of the proposed intervention/services models on practice and public health in terms of the magnitude of likely improvements in effect size, safety/tolerability profile, value and efficiency, or dissemination potential, as compared to existing approaches. Adaptations or augmentations of efficacious preventive, therapeutic, or services interventions should only be undertaken if there is (a) an empirical rationale for the adaptation/augmentation  target (i.e., a clear association of the adaptation/augmentation with non-response, partial response, patient non-engagement, or relapse), (b) a clear hypothesis and plan to address the mechanism by which the adapted intervention or augmentation will enhance outcomes, and (c) evidence to suggest that the adapted intervention will result in a substantial improvement in response rate, speed of response, an aspect of care, or uptake in community/practice settings.

For pilot tests of intervention effectiveness or service delivery approaches, the study should be designed to explicitly address whether the intervention engages the mechanism that is presumed to underlie the intervention effects (the mechanism that account for changes in clinical/ functional outcomes, changes in provider behavior, etc.) in order to re-confirm whether the intervention targets and associated change mechanisms previously identified under more controlled, efficacy conditions are operative in the effectiveness context.  In this manner, the results of the pilot effectiveness trial will advance knowledge regarding therapeutic change mechanisms and inform decisions about whether further effectiveness testing is warranted (see NIMH web page on Clinical Trials).

Depending on the nature of the intervention, the intervention “targets” and change mechanisms might involve specific neurobiological entities (e.g. brain circuits) or a psychological or behavioral processes (e.g., attention bias, cognitive control, stress regulation); in the case of services interventions, targets might involve consumer or provider behaviors that result in better access, engagement, quality or outcomes.  Applications should justify the plan for assessment of targeted mechanisms using valid measures that are as objective and direct as is feasible (e.g., using  neurophysiological and/or behavioral measures or laboratory tasks that have been previously validated as reflecting underlying behavioral, psychological or neural targets/mechanisms, as appropriate and feasible in the effectiveness context).

This R34 FOA supports pilot effectiveness studies focused on refining and optimizing interventions with previously demonstrated efficacy for use with broader target populations or for use in community practice settings in anticipation of fully-powered trials (e.g., practical trials).  With appropriate justification, there could be an exception to the requirement for efficacy evidence before an intervention is tested in an effectiveness context.  For example, to reduce the alarming fall-off in effect sizes from efficacy to effectiveness studies, and to expedite translation from intervention development to practice-ready interventions, this FOA can be used to conduct pilot trials in community settings as early as possible following a demonstration of efficacy.  Researchers interested in novel intervention development that is explicitly focused on the initial translation of neurobiological, basic cognitive and behavioral science findings into novel interventions are referred to the NIMH web page on Clinical Trials.

This FOA is also intended to support innovative pilot services research, including research to identify mutable factors that impact access, utilization, quality, and outcomes of mental health services and to inform patient-, provider-, organizational-, or systems- level services interventions to improve care quality, coordination, or delivery.  Pilot studies leading to services research other than clinical trials (eg.: testing the feasibility of integrating existing data sets to understand factors affecting access, quality or outcomes of care) will also be supported under this announcement.

Potential applicants are encouraged to contact Scientific/Research staff as far in advance as possible to discuss the potential clinical practice/public health impact of the proposed pilot investigation, as well as concordance with current NIMH priorities.

Information about the mission, strategic plan and research interests of the NIMH can be found at the NIMH website (http://www.nimh.nih.gov) including http://www.nimh.nih.gov/research-priorities/strategic-objectives/index.shtml.  Applicants are also strongly encouraged to review the information on the NIMH website focused on clinical trials http://www.nimh.nih.gov/funding/clinical-trials-for-researchers/index.shtml.Please note, per NOT-MH-14-007 NIMH will not accept R01, R21, or R03  applications that include clinical trials of potential therapies for mental disorders, under the NIH parent R01 Funding Opportunity Announcement (FOA) PA-13-302, NIH parent R21 FOA PA-13-303, and NIH Parent R03 FOA PA-13-304, and subsequent reissuances of these FOAs

Scope of Pilot Research

Pilot effectiveness studies in response to this announcement should propose the developmental work that would justify and inform the design of a subsequent randomized controlled trial (RCT).  Pilot trials  should be explicitly designed to enhance the probability of obtaining meaningful results in well-powered RCTs by including measures of action (i.e., assessment of presumed mechanisms, such as specific neurobiological entities (e.g. brain circuits) or psychological or behavioral processes (e.g., attention bias, cognitive control, stress regulation) that are presumed to underlie the intervention effects and account for changes in clinical/functional outcomes, changes in provider behavior, etc.), as appropriate and feasible in the effectiveness context. For studies that involve preventive or therapeutic interventions, as appropriate, the study should take into account RDoC or RDoC-like constructs when defining the subject eligibility (inclusion), intervention targets or mechanisms, and outcomes (see the RDoC webpage http://www.nimh.nih.gov/research-funding/rdoc/nimh-research-domain-criteria-rdoc.shtml for more details).  In this manner, pilot study results – whether positive or negative – will provide information of high utility to the field by informing decisions about whether further testing is warranted and by advancing knowledge regarding therapeutic change mechanisms.

This pilot FOA also affords an opportunity to refine and pilot test the experimental protocols, including the assessment protocol, the experimental intervention protocol (e.g., the manual for a psychosocial intervention, the dosing schedule for a pharmacological approach), and the comparison intervention protocol and randomization procedures (if appropriate); to examine the feasibility of recruiting and retaining participants into the study conditions (including the experimental condition and the comparison condition, if relevant); and to explore the feasibility of delivering the intervention with the target population (e.g., a case series in a community practice setting). 

Accordingly, collection of preliminary data regarding feasibility, acceptability, safety, tolerability, and target outcomes is appropriate.  Given the intended pilot nature of the R34 mechanism, conducting formal tests of clinical outcomes or attempting to obtain an estimate of an effect size is often not justified.  Given the limited sample sizes typically supportable under this pilot study mechanism, the variability in the effect sizes obtained is often so large as to be unreliable. Thus, using these potentially unstable effect size estimates in power calculations for larger studies, without regard to clinical meaningfulness, is not advisable.

Likewise, pilot services studies that do not involve development or testing of interventions do not need to be a reduced scope version of the anticipated larger study, but should instead attempt to develop and refine the research strategies to be utilized in the subsequent definitive study.

1.  Pilot Effectiveness Studies

NIMH supports intervention research to examine effectiveness (i.e., the utility of research-based approaches in community practice settings) and research to optimize, sequence, and personalize intervention approaches for improved response rates, more complete and rapid remission, improved functional outcomes, and more efficient clinical practice.  Such studies might focus on empirically justified new, adapted, or augmented interventions designed to significantly improve outcomes or facilitate their uptake; strategies that employ predictors or moderators of treatment response (e.g., clinical/socio-demographic information, measures of neuropsychological functioning, biomarkers, surrogate markers of early response) to construct and test algorithms for more personalized treatment selection, sequencing, or step-wise approaches to care; and more efficient, scalable strategies for implementing interventions (e.g., technology-assisted approaches) that can improve the value and facilitate the dissemination of evidence-based care (see Strategic Research Priorities for Strategic Objectives 3.3 and 4.1).  

The primary goal of effectiveness research and other public health-oriented practical trials is to determine whether interventions with demonstrated efficacy under tightly controlled conditions can have a measurable beneficial effect when implemented in less precisely controlled circumstances with more heterogeneous populations, providers and settings.  Typically, these studies have broader inclusion (i.e., relatively few exclusion criteria) and outcomes, including functioning (school, work, interpersonal, etc.), quality of life, mortality, institutionalization, and health care resource use, in addition to measures of psychiatric morbidity, and are principally aimed at informing practice and programmatic decision making. 

Pilot effectiveness research can be considered to involve a series of steps including: (step 1) an initial step where characteristics of typical patients, providers, and the community/practice settings in which the intervention will be transported are systematically studied; (step 2) a step in which empirically suggested adaptations to improve the fit of the intervention are operationalized and incorporated in intervention manuals and materials; and (step 3) a step in which the intervention is pilot tested. 

Step 1.  A systematic assessment of the degree of fit between the un-adapted intervention and the target population/setting typically precedes that refinement of interventions with demonstrated efficacy for use with new target populations or for use in community practice settings. At this step, relevant characteristics of the target population/setting are specified and needed refinements to the intervention (e.g., adaptation to intervention content or format) are identified.  In some cases, the information regarding the characteristics of the target population or setting that have implications for informing the adaptation may already be known from previous research, and additional step 1 activities may not be needed prior to steps 2 and 3, below.  Regardless of whether the information to inform the intervention adaptation is based on extant studies or based on step 1 activities, as described above, the justification for a refined or adapted intervention should be based on data describing characteristics of client subgroups, settings, care providers or other relevant variables that are associated with non-response, partial response, relapse, or poor uptake. 

Adaptation or augmentations of efficacious interventions should only be undertaken if there is a compelling rationale, supported by empirical evidence, that justifies the adaptation in terms of: (a) theoretical and empirical support for the adaptation target (e.g., a prognostic variable such as a neurocognitive functioning variable, that has been associated with non-response, partial response, patient non-engagement, or relapse); (b) a theoretical/empirical explanation of how the prognostic variable interferes with the response to the un-adapted intervention (i.e., a clear hypothesis regarding the mechanism by which a the prognostic variable moderates response to the un-adapted intervention or functions to disadvantage a subgroup);  and (c) evidence to suggest that the adapted intervention will result in a substantial improvement in response rate, speed of response, an aspect of care, or uptake in community/practice settings when compared to the un-adapted interventions or existing intervention approaches (see the NAMHC Workgroup Report, "From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses", see Recommendation 2.4.1, page 19, for additional guidance regarding the empirical justification for intervention adaptations and augmentations). 

Applications that propose adaptations or augmentations of currently available treatments for new subpopulations or settings without strong empirical justification will be considered low priority. The application should articulate the process for determining the intervention’s initial degree of "fit" and the iterative process that will be used to adapt/refine the intervention for successful implementation with the target population or within the target setting.    

Step 2.  Standardization of an intervention primarily involves further development or adaptation of the intervention protocol (e.g., psychotherapy manual, medication dosing schedule), including iterative refinements based on extant research and feedback from patients, care providers, and other investigators.  NIMH encourages a deployment-focused approach in which end-user feedback is systematically incorporated to refine the intervention and research protocols.  Accordingly, this step might also involve refinements to assessment strategies (e.g., measures to determine inclusion/exclusion; measures and assessment schedules to assess change mechanisms as well as psychiatric and other outcomes, including functioning, and value and efficiency; and measures to assess acceptability of the intervention protocol, fidelity of provider implementation, and client/patient engagement and adherence).

Step 3.  The pilot effectiveness stage involves feasibility testing of the intervention protocol and assessment strategies developed in earlier stages of intervention development/refinement.  Typically, data are gathered to examine the feasibility of:  identifying, enrolling, and retaining participants; implementing the experimental intervention (and comparison condition, as relevant); and implementing the assessment protocols, including examining feasibility of measures for assessing inclusion/exclusion, fidelity of intervention delivery, mediators/moderators of response, and outcomes.  Depending on the characteristics of the disorder or target population, the nature of the intervention, the nature of intended providers or settings, and the stage of research program, pilot testing may take various forms.  Pilot testing might involve systematic study of an uncontrolled case series, a small randomized pilot trial to explore feasibility of both the experimental intervention and the control condition that will be used in the subsequent definitive trial, or alternative designs (e.g., quasi-experimental designs, multiple-baseline, single-case designs).  The application should provide a clear justification for the type of experimental design chosen; the goal of this phase of research is to propose the most rigorous means of collecting data (in light of ethical or other limitations) that will inform a larger, more definitive test of the intervention.

The boundaries between these three steps are not discrete.  It is expected that most applications will propose research activities or methods that span all of the above-noted steps and all projects will include step 3 activities that will provide the prerequisite information needed for conducting a larger (e.g., R01) study.

Intervention research that addresses objectives outlined in the NIMH Strategic Plan and NIMH Strategic Research Priorities is strongly encouraged.  Additional priorities for intervention research are detailed in the NAMHC Workgroup Report "From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses."  Updated priorities for NIMH clinical trials research are also detailed on the NIMH website focused on clinical trials http://www.nimh.nih.gov/funding/clinical-trials-for-researchers/index.shtml.

NIMH emphasizes the potential for impact on practice and public health in new/adapted interventions and in effectiveness studies and practical trials.  Applications should justify the potential impact on public health of the proposed intervention, compared to existing approaches, in terms of the magnitude of likely improvements in effect size, safety/tolerability profile, value and efficiency or dissemination potential.

Consistent with recommendations of the NAMHC Workgroup on interventions research (noted above), NIMH encourages clinical trials research that will foster personalized mental health care, including studies aimed at identifying predictor/moderator variables (e.g., clinical/socio-demographic information, biomarkers, surrogate markers of early response) that can be used to characterize patients more likely to benefit from a specific treatment and, when appropriate, encourages the use of more advanced research designs that can be used to examine prescriptive approaches for matching individuals to optimal care (e.g., adaptive designs, stepped-care approaches).  Studies that involve randomization of large samples in pursuit of incremental gains in effect sizes, especially without attention to modifiers of response that have implications for personalizing care, will be considered lower priority.  Accordingly, pilot studies in anticipation of trials to examine more personalized approaches are encouraged.

Applications are expected to maximize efficiencies in effectiveness research and should explicitly address how efficiencies are incorporated.  Accordingly, NIMH encourages pilot effectiveness studies that examine the feasibility of utilizing existing infrastructure (e.g., practice-based research networks, electronic medical records, administrative data bases, patient registries) to increase the efficiency of participant recruitment (e.g., more rapid identification and enrollment) and to facilitate the collection of moderator data (e.g., clinical characteristics, biomarkers), longer-term follow-up data, and broader, stakeholder-relevant outcomes (e.g., mental health and general health care utilization). 

Examples of possible NIMH-relevant effectiveness research questions include, but are not limited to:

Examples of studies that are not responsive to this FOA and will not be reviewed include the following:

2.  Innovative Services Research

This funding opportunity is also intended to encourage applications to facilitate innovative services research directions that require preliminary testing or development.  Services Research pilot studies might include research on mutable factors that impact access, utilization/engagement, quality, and outcomes of mental health services, or inform or pilot test patient-, provider-, organizational-, or systems- level services interventions to improve care quality, coordination, or delivery. 

Research in these areas may require novel or mixed methodologies and/or innovative statistical approaches, including but not limited to  clinical trials approaches for  developing and/or pilot testing novel service interventions or service delivery models (e.g., interventions targeting provider behavior to increase concordance with research-based practices, or system-level interventions targeting MH services organization/delivery).  Research on novel service interventions might reflect one or more of the three steps of intervention development described in the "Pilot Effectiveness Studies" section of this FOA. Alternatively, practice-based research approaches may be proposed.  NIMH encourages research on services interventions that explicitly address whether the intervention engages the mechanism that is presumed to underlie the intervention effects (e.g., the mechanisms that account for changes in client, family, provider, etc. behavior or in health services accessibility/organization/delivery).  The feasibility of proposed service interventions and their potential for widespread uptake and sustainability should be carefully considered at the outset to maximize public health impact.  Applicants should demonstrate that, to the maximum extent possible, the study design reflects real-world service delivery circumstances.  For example, the subject sample should reflect patients typically seen in the selected service setting with minimal exclusion criteria so as to enhance generalizability; interventionists should be those typically found in the targeted setting or community rather than research staff; and existing financing mechanisms should be used to cover the cost of the proposed intervention(s) to the extent possible.  Likewise, observation of factors influencing implementation and dissemination should be addressed in the pilot work, wherever possible.

Services research that addresses research objectives outlined in Objective 4 of the NIMH Strategic Plan and NIMH Strategic Research Priorities is expected.   Additional Priorities for services research are addressed in the NAMHC Workgroup Report “The Road Ahead: Partnerships to Transform Services."

Examples of NIMH-relevant services research applications in this area include, but are not limited to:

Examples of studies that are not responsive to this FOA and will not be reviewed include the following:

Support for fully-powered effectiveness studies is provided via separate FOAs, including a single R01 grant mechanism (RFA-MH-15-320 "Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01)") and a collaborate R01 grant mechanism for multi-site trials (RFA-MH-15-325 "Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01)").  Investigators are strongly encouraged to visit the NIMH Clinical Trial web page and consult with Program Staff regarding grant activities that are appropriately matched to the stage of intervention research and study scope.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New  
Resubmission
Revision

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 to commit approximately $3 million dollars across FY 2015 and FY 2016 to fund 10 new awards in response to this FOA and the companion announcements.  

Award Budget

Direct costs are limited to $450,000 over the R34 project period, with no more than $225,000 in direct costs allowed in any single year.

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed three 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.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

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

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

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:

Section IV. Application and Submission Information


1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

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:

NIMHClinicalTrials@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

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.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities and Other Resources: The description of the resources and environment should address how the study utilizes existing infrastructure (e.g., CTSAs, practice-based research networks, electronic medical records, administrative data bases, patient registries) or utilizes other available resources to increase the efficiency of participant recruitment and data collection or provide a justification in the event that such efficiencies cannot be incorporated. 

Other Attachments:  Applicants should upload a single attachment that includes the following information relevant to the proposed clinical trial.  It is recommended that this attachment include no more than 4 pages.  Applicants should use the headers below in their description.

I.  Participant Recruitment and Retention Procedures:  Applications must provide a clear description of:

II. Milestones and Timeline:  Applications must provide a clear description of:

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

As appropriate, Senior/Key Personnel should demonstrate their experience and expertise at collaborating with community practice partners/providers, consumers, and relevant policy makers to conduct effectiveness studies. 

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: The Research Strategy should include the following information.

Significance

Approach:

Protections of Human Subjects: Describe key features of a safety monitoring plan including plans for efficient IRB review and approval including the use of centralized IRB models when multiple clinical sites are planned.

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 modification:

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.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

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.

Important reminders:
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. 

Use of Common Data Elements in NIH-funded Research

NIH encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies.  CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.  Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.  NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository).  NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection.  The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.  Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

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.

For this particular announcement, note the following:

The NIMH R34 FOA supports the development and/or pilot testing of new or adapted interventions, pilot testing of interventions with demonstrated efficacy in broader scale effectiveness trials, or conducting pilot innovative services research that requires preliminary testing or development.  Because this FOA supports clinical exploratory/developmental research, applications need not have extensive background material or preliminary information as one might normally expect in an R01 application.  Preliminary data are not required for R34 applications, but may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.  

Overall Impact

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).

Scored Review Criteria

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.

Significance

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?

Does the application justify the potential impact of the proposed intervention/service delivery approach on practice and on public health in terms of a substantial improvement in effect size, safety/tolerability profile, value/efficiency, and scalability or dissemination potential, as compared to existing approaches?

If the approach is successful, is it scalable and could it be disseminated into practice given typically available resources (e.g., trained, skilled providers), typical service structures (including MH financing), and typical service use patterns?

How likely is it that the proposed research will generate data that will lead to a firm conclusion about the feasibility of a regular research project grant or full scale clinical trial? 

Is information provided about the scope and goals of intended future work? 

Investigator(s)    

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? 

As appropriate, does the trial involve collaborations and/or input from community practice partners/providers, consumers, and relevant policy makers in a manner that informs the research and helps to ensure the results will have utility?

Innovation

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?   

Approach

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?

For pilot effectiveness trials of therapeutic, preventive and services interventions:

Is the study designed to explicitly address whether the intervention engages the mechanism that is presumed to underlie the intervention effects (the mechanism that account for changes in clinical/ functional outcomes, changes in provider behavior, etc.), so that the results will inform understanding of change mechanisms and inform decisions about whether further effectiveness testing is warranted? Does the application provide justification for the plan for assessing intervention mechanisms using valid measures that are as objective and direct as is feasible in the effectiveness context?

When appropriate, for studies that involve preventive or therapeutic interventions, does the study take into account RDoC or RDoC-like constructs when defining the subject eligibility (inclusion), intervention targets or mechanisms, and outcomes, as feasible in the effectiveness setting?

Does the application include provisions for the assessment and monitoring of the fidelity of intervention delivery via procedures that are feasible and valid for use in community practice settings, as appropriate?

Are proposed outcome measures validated and generally accepted by the field; are stakeholder-relevant outcomes included, as appropriate (e.g., functioning, health services use)?

Does the study explore the feasibility of collecting data on potential moderators such as clinical and biological variables (e.g., blood for genetic analysis, other potential biomarkers), as appropriate, that might be used to inform or test algorithms for more prescriptive approaches?

Does the application provide justification for the sample size in terms of feasibility goals?

Is there preliminary evidence or data to support the proposed work and for hypotheses that are proposed?

Are proposed milestones and timelines clearly described and feasible?

Are the data and biospecimens collected in a manner that could ultimately facilitate appropriate data sharing and integration into larger databases (e.g., use of common data elements)? 

For studies proposing adaptations of existing interventions for broader use, is the justification for the proposed adaptation based on data describing characteristics of client subgroups, settings, care providers or other relevant variables that are associated with non-response, partial response, relapse, or poor uptake? (see page 19 of council report on Interventions)

For applications that propose to develop or adapt an intervention or service delivery approach, is there an adequate description of the steps for intervention development/refinement and a clear rationale for the choice of methods proposed?  For example, is there an appropriate rationale for the decision regarding whether or not to include a control group at this stage of pilot research?  Is there appropriate caution regarding plans to interpret observed outcomes given sample size limitations?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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? 

Does the study utilize existing infrastructure (e.g., CTSA, practice-based research networks, electronic medical records, administrative data bases, patient registries) or utilize other available resources to increase the efficiency of participant recruitment and data collection or provide a justification in the event that such efficiencies cannot be incorporated?

If the study involves data collection at more than one site, are the investigators able to arrange a single IRB?

As appropriate to the intervention proposed, is there evidence that the intervention or device will be available in sufficient quantities to conduct the study?

Additional Review Criteria

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.

Milestones and Timeline

Are appropriate, evaluative milestones clearly defined for the aims associated? Are the milestones feasible and quantifiable with regard to the specific aims and timeline?  Is there a back-up plan for failing to reach the milestones?

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NMH, 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:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information


1. Award Notices

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. Given the resources necessary to launch and conduct trials in community/practice settings, the award and continuation of funding are subject to milestones to be specified in the notice of grant award according to NIMH policies regarding recruitment and retention of research participants.  The Terms and Conditions for the award for such clinical trials will include overall recruitment milestones expected to be met by the study at specific time periods, accrual goals for women and minorities (as appropriate), and any other identified requirements for completion of the approved research.  As with any award, continuation, even during the period recommended for support, is conditional upon satisfactory progress. If, at any time, recruitment falls significantly below the projected milestones for recruitment, the NIMH will consider ending support and negotiating a phase-out of the award. The NIMH retains the option to obtain periodic external peer review of progress.

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  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

Not Applicable

3. Reporting

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. 

Recruitment Reporting and Trial Registration

NIMH requires reporting of recruitment milestones for participants in clinical trials as noted at http://grants.nih.gov/grants/guide/notice-files/NOT-MH-05-013.html.  While trials in response to this FOA may not seek 150 subjects or more (the level at which this reporting has been required), we expect reporting for all trials, even those with less than 150 subjects.  

The NIMH expects the registration and results reporting for all NIMH-supported clinical trials in ClinicalTrials.gov, regardless of whether or not they are subject to FDAAA (see http://grants.nih.gov/ClinicalTrials_fdaaa/at-a-glance.htm).  We plan to include language regarding this expectation in the notice of grant award.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

For Studies involving therapeutic and preventive interventions:

Joel Sherrill, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-2477
Email: jsherril@mail.nih.gov

For Studies involving services interventions:

David Chambers, D.Phil.
National Institute of Mental Health (NIMH)
Telephone:  301-443-3747
Email:  dchamber@mail.nih.gov

Peer Review Contact(s)

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  301-443-3534
Email: armstrda@mail.nih.gov

Financial/Grants Management Contact(s)

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone:  301-443-8811
Email: tkees@mail.nih.gov  

Section VIII. Other Information

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.

Authority and Regulations

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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