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

Optimizing Fidelity of Empirically-Supported Behavioral Treatments for Mental Disorders (R21/R33)

Activity Code

R21/R33 Phased Innovation Award

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-MH-12-050

Companion FOA

NoneNone

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.242

FOA Purpose

This Funding Opportunity Announcement (FOA) seeks research applications designed to develop and test methods for improving the fidelity, and ultimately the effectiveness, of empirically supported behavioral treatments (ESBTs) implemented by front-line therapists in community practice settings.

Because achieving this aim presumes valid and reliable assessment of fidelity, the FOA uses the sequential R21/R33 funding mechanisms to encourage research designed to develop and test (a) methods for assessing theory-derived ESBT fidelity components (R21 phase), and (b) interventions that enhance and maintain the fidelity with which clinicians implement an ESBT in community practice settings (R33 phase).

Key Dates
Posted Date

March 31, 2011

Open Date (Earliest Submission Date)

May 9, 2011

Letter of Intent Due Date

May 20, 2011

Application Due Date(s)

June 20, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)
Scientific Merit Review

October 2011

Advisory Council Review

January 2012

Earliest Start Date(s)

April, 2012

Expiration Date

June 21, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.

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 and Objectives

The NIMH Strategic Plan calls for improving interventions for people with mental disorders and increasing their effective application in community-based practice. Similarly, the recent National Advisory Mental Health Council’s workgroup report, From Discover to Cure:  Accelerating the Development of New and Personalized Interventions for Mental Illnesses, recognizes the need for optimizing current treatments.

This Funding Opportunity Announcement (FOA) seeks research applications that aim to study methods for improving the fidelity, and ultimately the effectiveness, of empirically supported behavioral treatments (ESBTs) as implemented by front-line therapists in community settings.

Because achieving this aim presumes valid and reliable assessment of fidelity, the FOA uses sequential R21/R33 funding mechanisms to encourage research designed to develop and test (a) methods for assessing theory-derived ESBT fidelity components (up to two years of R21 funding), and (b) interventions that enhance and maintain the fidelity with which clinicians implement an ESBT in community settings (up to three years of R33 funding). There are many factors that are relevant to all ESBTs (e.g., therapist level of training, quality of supervision, therapist motivation); however, the intent of this FOA is that investigators should select a particular ESBT for study, and focus on its particular therapeutic components.

Because valid assessment will ideally link theory-derived fidelity components to clinical outcomes, a by-product of the FOA may be increased knowledge about how ESBTs work (i.e., their mechanisms of action). This would guide further research and subsequently facilitate paring these treatments down to their most essential elements.

Background and Rationale

Although efficacious behavioral treatments for many mental disorders exist, research suggests that people with mental disorders who seek treatment in community settings rarely receive them.  A major factor in this widely acknowledged science-to-service gap is treatment fidelity (also known as treatment integrity), which refers to the implementation of an intervention in a manner consistent with principles outlined in an established manual.

Only a small fraction of clinicians who routinely provide an ESBT such as cognitive-behavior therapy are able to do so with adequate fidelity (e.g., one study found 5% based on direct observation, Santa Ana et al., 2008; Journal of Substance Abuse Treatment, 35, 369-379). This may reflect the insufficiency of commonly used ESBT training and dissemination methods such as workshops and lectures, which by themselves effect little substantive change in clinician behavior. Moreover, even documented acquisition of fidelity skills under close supervision does not guarantee continued fidelity maintenance.

The fidelity of an ESBT is important for several reasons. First, the integrity of a psychosocial intervention is highly dependent on clinician behavior: what the clinician does and does not do (based on an ESBT manual) defines a multi-component independent variable – the treatment itself – encompassing domains such as adherence, competence, and differentiation from other treatments.

Second, if ESBT fidelity predicts outcome, fidelity failures may explain some of the fairly dramatic reduction in effect sizes associated with transporting ESBTs from university-based efficacy trials to effectiveness studies in community settings (e.g., Henggeler, 2004; Journal of Family Psychology, 18, 420-423). Unfortunately, while successful fidelity acquisition and maintenance are feasible in randomized efficacy trials, surprisingly little is known about how to extend effective methods of ESBT training and fidelity maintenance used in controlled studies to community practice (e.g., how much and what kind of direct observation and feedback are sufficient?).

Third, a sharpened focus on fidelity has the potential to increase knowledge about specific targets for behavior change, which could make ESBTs more efficient and attractive for broader adoption. For example, the complex, multi-component nature of some ESBT treatment packages may itself pose a barrier to successful community implementation.  In the absence of specific knowledge about how these treatments work (i.e., which components are active and which are inert), a common practice is to train therapists in all elements of the package, emphasizing active and inert components equally. Findings from the assessment-development phase (R21 phase) could begin to illuminate which fidelity components of an ESBT are most and least crucial to immediate (e.g., session) or longer-term (e.g., end-point, follow-up) patient outcomes. Although discarding components on the basis of how well they relate to outcome would be premature, the intervention-development (R33 phase) presents opportunities to experiment in a more focused manner with methods for enhancing and maintaining fidelity components that do correlate with outcomes, which could lead to subsequent refinement of an ESBT.

Specific Areas of Research Interest

By “fidelity component,” this FOA refers to definable elements or clusters of therapist behavior presumed to activate theory-relevant mechanisms of change, which in turn lead to positive patient outcomes such as symptom alleviation or improved quality of life. The optimal number and molarity of components should depend not only on conceptual considerations specific to a given ESBT, but also on psychometric (e.g., factor analytic) and validity results, such as how the measure of a component relates to concurrent expert judgments and/or to independent markers of session or intermediate outcomes.

Responsive applications must establish, first, that a given ESBT is in fact “empirically supported” for a given mental disorder according to accepted standards of scientific evidence. Investigators should explain the criteria on which they base this determination and cite supporting research. Eligible ESBTs encompass a wide range of behavioral and psychosocial treatments for mental disorders of children and adults.

A second prerequisite is that the ESBT (and the manual(s) defining it) reflects a coherent theory of change, specifying the psychosocial processes or change mechanisms through which the intervention presumably has its beneficial effects. This theory of change guides what the therapist does to implement the ESBT and ultimately grounds the definition of fidelity components.

Third, when operationalizing the components of ESBT fidelity, responsive applications will account for at least the following core dimensions or domains: (a) how well the intervention components are delivered (i.e., quality), in addition to their frequency or quantity as captured by adherence check-lists; (b) proscribed as well as prescribed therapist behavior (what the therapist should and should not do); (c) components that are unique and essential to the ESBT, as well as those that are essential but not unique; and (d) expected pacing and sequencing of intervention components, given that some might precede or build upon others.

Applications should aim to demonstrate reliable and valid measurement of treatment fidelity and its active components. Essential aspects of reliability include consistency of the items or rating elements within each fidelity component construct, as well as consistency between the judgments of different raters (the latter indicating that different people who use the measure would come to similar conclusions regarding therapist fidelity). Demonstrating the validity of fidelity measurement can take several forms, including concurrent validity (e.g., relating a measure to judgments of the same behavior sample by unimpeachable experts, such as ESBT developers); predictive validity (e.g., relating a measure to markers of a relevant change mechanism in the same session or later sessions); and construct validity (e.g., demonstrating that a measure of one fidelity component is distinct from measures of other components). Closely related to validity is the question of how fidelity components, alone or in combination, correlate with intermediate and ultimate outcome, with relevant criteria ranging from session outcome to markers of theory-relevant change mechanisms and longer-term symptom alleviation.

The following examples, while far from exhaustive, illustrate possible fidelity components and their relationships to theory-derived change mechanisms:

Needless to say, measurement in this area presents formidable challenges, not the least of which is the inherently interactional nature of many fidelity components, where intervention quality reflects not only what the therapist does but also how the client responds, and how the therapist takes this response into account while staying faithful to the ESBT’s theory of change. On the therapist side, fidelity measures will need to include clearly defined behavioral anchors for each point on a given scale; and on the patient/response side, investigators will need to consider whether to emphasize intermediate outcomes, longer-term outcomes, or both, as this will influence the possibility of detecting putative mediators or mechanisms of change. Finally, given the ultimate goal of assessing fidelity in a variety of community practice settings, selection and/or refinement of fidelity tools should consider efficiency and respondent burden.

To summarize, responsive applications in the assessment-development (R21) phase should assess the quality of ESBT delivery in addition to the mere adherence to a treatment manual; go beyond an overall fidelity scale to examine the fidelity of specific, theory-derived components of an ESBT; validate measures of specific fidelity components, e.g., by correlating these component measures with intermediate and/or longer-term markers of mechanisms or outcomes. Ideally, scales that capture variability in therapist fidelity also predict clinical outcomes, either alone or in combination with other variables.

Although the R33 phase should entail new data collected from interventions in community settings, the R21 phase might utilize archival data from either efficacy or effectiveness trials, especially if these data sets entail sufficient variability in fidelity to identify meaningful fidelity-outcome correlations.  An advantage of archival data for the R21 phase of this FOA is having large enough sample sizes to examine measurement models.

Research questions relevant in the R21 phase include, but are not limited to, the following:

Applications in the R33 phase should establish access to community therapists with caseloads that would support the application’s aims. Priority will be given to applications that include community-based consultants advising on the feasibility and practicality of the research plans. Relevant aspects of fidelity enhancement or maintenance include: (a) therapist training, (b) ongoing supervision, and (c) ongoing monitoring and feedback. While an application may address one of these aspects more than others, it is important to consider how approaches to enhancing all three will contribute to knowledge. In addition, investigators should use fidelity measures developed in the R21 phase to evaluate the success of interventions designed to enhance and maintain fidelity in the R33 phase.

The intervention-development (R33) phase is intended to yield valuable knowledge about how to help community therapists maintain high-fidelity intervention over time in ways that are relatively cost effective. The goal of this work is to inform strategies for enhancing ESBT fidelity in community settings (e.g., via peer- and supervisor-based assistance models, ongoing collaborative learning networks). At the conclusion of the R33 phase, investigators should be able to show preliminary evidence regarding the effectiveness of procedures for enhancing and maintaining ESBT fidelity in community settings. Tangible byproducts of this effort might include empirically-supported training and supervision manuals, and, if applicable, other implementation products such as demonstration videos and technology aids. In addition, investigators should be able to provide information on the feasibility of developing an R01 application that would implement fidelity enhancement strategies on a larger scale and assess the impact of such interventions on provider behavior (i.e., increased fidelity) and patient outcomes. Partnering with organizations that already train clinicians and monitor intervention quality may be useful in these endeavors.

Research questions relevant in the R33 phase include, but are not limited to, the following:

Finally, this FOA does not address other factors that may play an important role in improving the effectiveness of ESBTs (e.g., interventions aiming to change organizational climate and attitudes towards ESBT adoption).  Investigators interested in these areas should refer to PAR-10-038 - Dissemination and Implementation Research in Health (R01). 

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NIMH intends to commit approximately $1,500,000 in FY 2012 to fund up to 7 grants in response to this FOA.

Award Budget

Direct Costs, across all years are limited to $900,000, excluding consortium F&A costs, if applicable.

The R21 phase may not exceed two years or $300,000 in direct costs over the two year period, with no more than $225,000 in direct costs in any single year.

The R33 phase may not exceed three years with no more than $225,000 in direct costs per year.

Award Project Period

The total project period for an application submitted in response to this FOA may not exceed five years. The R21 phase may not exceed two years and the R33 phase 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 (non-U.S.) components of U.S. Organizations are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

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/Principal Investigator (PD/PI) 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 SF 424 (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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

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.

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:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Varda Shoham, Ph.D.
Division of Adult Translational Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7126, MSC 9632
Bethesda, MD 20892-9632
Email: varda.shoham@nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

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.

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.

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations 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 in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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 SF 424 (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/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.

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 Central Contractor Registration (CCR). 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.

Specific Instructions for Preparing a Combined R21/R33 Phased Innovation Award Application

For the R21/R33 Phased Innovation Award application, the initial review group will evaluate the specific goals for each phase and the investigator-generated expected milestones that would justify expansion to the R33 phase.  A single impact/priority score will be assigned to each discussed application.  For the R21/R33 application the initial review group may recommend that only the R21 phase be supported, based on concerns related to the application’s specific goals and the feasibility of achieving the milestones that justify the expansion to the R33 phase.  The recommendation to delete the R33 phase by the review panel or presentation of inadequate milestones in the application may affect the merit rating of the application.

The milestones proposed in the application should be well described, quantifiable, and scientifically justified to allow program staff to assess progress in the R21 phase and readiness for the R33 phase.  The milestones should provide data on the reliable and valid assessment of the ESBT’s fidelity and its components, as described in Section 1 of Part 2, of this FOA. The milestones will be considered in evaluating the approach proposed by the investigator.  A discussion of the milestones relative to the progress of the R21 phase and the implications of successful completion of the milestones for the R33 phase should be included.  Applications lacking this information, as determined by NIH staff, will not be reviewed.  The clarity and completeness of the R21/R33 application with regard to specific goals and feasibility milestones are critical. 

The R33 phase, investigating interventions to enhance and maintain ESBT fidelity, is open to a wide range of experimental and naturalistic research designs.  However, applicants must make clear how they will use assessment methods developed in the R21 phase to evaluate the success of these interventions.  At the conclusion of the R33 phase investigators should be able to show preliminary evidence regarding the effectiveness of procedures for enhancing and maintaining ESBT fidelity in community settings. Tangible byproducts of this effort include empirically-supported training and supervision manuals, and if applicable, other materials such as demonstration videos, and technology aids.  In addition, investigators should be able to provide evidence of an active partnership with community clinics developed during the grant period and information on the feasibility of developing an R01 application that would (a) implement fidelity enhancement strategies on a larger scale (i.e., across a variety of clinical populations and community settings), and (b) assess the impact of such interventions on provider behavior (i.e., increased fidelity) and patient outcomes.

Prior to award, the Program Officer will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel as indicated in the Summary Statement.  The Program Officer and the applicant will negotiate and agree on a final set of R21 milestones.  These will be the basis for judging the success of the R21 work.  For funded applications, the Project Director/Principal Investigator (PD/PI) will submit a progress report to the Program Officer upon completion of the R21 milestones.  Receipt of this progress report will trigger an administrative program review that will determine whether or not the R33 should be awarded.  The release of R33 funds will be based on successful completion of negotiated scientific milestones, on program priorities, and on the availability of funds.

The R21 and R33 cannot be funded in the same fiscal year.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

The R21/R33 phased innovation grant support exploratory/developmental investigation of novel ideas and strategies that have the potential for significant improvements in prevention or treatment of mental disorders.  The R21/R33 grant application need not have extensive background material or preliminary information (although the availability of archival source data would allow investigators to conduct a more efficient R21 phase, especially if these data sets entail sufficient variability in fidelity to afford meaningful fidelity-outcome correlations).  Accordingly, reviewers will be asked to focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly impact the outcomes and functioning of individuals with mental disorders, or those at high risk for mental disorders.  Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  Preliminary data are not required for R21/R33 applications; however, they may be included if available.

Overall Impact

Reviewers will provide an overall impact/priority 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? Is the project likely to advance knowledge of how to best assess theory-derived fidelity components of a specific EBST, and are the methods for enhancing and maintaining fidelity likely to be effective and transportable to community practice settings?

Investigator(s)    

Are the PD/PIs, 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?  Do the investigators have documented expertise relevant to treatment fidelity and the specific ESBT under investigation, and more generally to developing behavioral measures and evaluating behavioral interventions? Does the investigative team include community-based consultant(s) to advise on the feasibility and practicality of the project? 

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?  Does the application entail innovative approaches to assessing treatment fidelity (R21 phase) and to enhancing and maintaining fidelity in community settings (R33 phase)?

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? 

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?  Specifically, in the assessment-development (R21) phase, does the application (a) go beyond an overall fidelity scale to examine specific, theory-derived fidelity components? (b) propose to assess the quality ESBT delivery in addition to mere adherence? (c) attempt to validate measures of specific fidelity components? and (d) plan to correlate these components with intermediate and/or longer-term markers of mechanisms or outcomes? Are the investigators likely to establish a reliable, valid, and practical approach to ESBT fidelity measurement applicable in community settings? 

In the intervention (R33) phase, is the application likely to (a) yield valuable preliminary knowledge about ESBT training and methods for helping therapists maintain high-fidelity intervention over time in community settings? (b) produce treatment-specific implementation products such as ESBT training and supervision manuals, and, if applicable, demonstration videos, and technology aids? and (c) produce compelling feasibility data for developing an R01 application aimed at enhancing ESBT fidelity and thus improving provider behavior (i.e., improved fidelity) and patient outcomes across community settings and patient populations?

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?  Specifically, can the investigators obtain data appropriate to the aims listed in the R21 phase, and to community therapists and caseloads as required for the R33 phase?      

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/priority score, but will not give separate scores for these items.

Milestones

Given the critical nature of the milestones for the transition from the R21 to the R33 phase, are the proposed milestones well-defined with quantifiable measures that are appropriate for assessing the success of the R21 phase of the application? Do the investigators make clear how they will use the assessment methods developed in the R21 phase to evaluate the success of the fidelity-enhancing interventions they plan to develop in the R33 phase? Is it clear how the R33 phase will develop once the R21 milestones are achieved?

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.

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

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

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/priority 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 NIMH , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

See Section IV.6 - Specific Instructions for Preparing a Combined R21/R33 Phased Innovation Award Application, for additional reporting requirements related to the R21/R33 mechanism.

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. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
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

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Varda Shoham, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  301-443-8694
Email: varda.shoham@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)

Joy Knipple
National Institute of Mental Health (NIMH)
Telephone: (301)443-8811
Email: knipplej@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 Regu78lations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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