Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Purpose and Objectives

The 2008 NIMH Strategic Plan called for the clarification of the underlying causes of mental disorders across the life span, with efforts towards integrating genetic, neurobiological, imaging, behavioral, and clinical data.  This FOA reflects Strategy 1.4 of that plan: Develop, for research purposes, new ways of classifying mental disorders based on dimensions of observable behavior and neurobiological measures. NIMH pursued Strategy 1.4 via the Research Domain Criteria (RDoC) project.  This project, developed by an internal NIMH working group in conjunction with a small group of external consultants, created a template for formulating research questions and experimental designs. The goal of the RDoC initiative is to identify organizing dimensions that cut across multiple disorders as traditionally defined, and to promote research designed to interrogate these dimensions rather than to validate traditional diagnostic categories. The 2015 NIMH Strategic Plan assumes the continuation of the RDoC initiative, so that the results of RDoC-oriented research might inform the development of new diagnostic methods and treatment targets. Applications that focus primarily on validating a DSM diagnostic category will NOT be considered responsive to this funding opportunity. Rather, this FOA encourages projects that are consistent with the organizing dimensions identified by the RDoC project.  The RDoC project aims to support development of an integrative scientific literature that can inform future diagnostic systems which will be based on genetics, neuroscience, and psychology.  Five organizing domains have been identified in the draft specification.  These include Negative Valence Systems (i.e., aversive motivational dimensions), Positive Valence Systems, Cognitive Systems, Social Process Systems, and Arousal/Regulatory Systems. Consensus workshops on these five domains have been completed, and applications must focus on at least one of the constructs that have been identified in the completed RDoC workshops, as indicated in the workshop proceedings.  Interested applicants are encouraged to consult the NIMH RDoC web site (http://www.nimh.nih.gov/research-priorities/rdoc/index.shtml) for information regarding these domains.

This FOA invites submission of research project grant applications that focus on explicating and validating the domains and their subsidiary constructs that have resulted from RDoC consensus workshops.  The initiative encourages the evaluation of relevant constructs via convergent measurement across multiple units of analysis, and the elaboration of aspects of the constructs that are underdeveloped. See the Specific Areas of Research Interest section, below, for illustrations.

Background and Rationale

Currently, the diagnosis of mental disorders is based on clinical observations and reports by patients, caregivers, parents, and teachers. This approach, formalized in the Diagnostic and Statistical Manual-III (DSM-III) in 1980 and refined in subsequent DSM versions, has served to improve diagnostic reliability in clinical practice and research. The diagnostic categories represented in the DSM-5 and the International Classification of Diseases-10 (ICD-10), containing virtually identical disorder codes, remain the consensus standard for diagnosis of mental disorders, and are employed for insurance billing, U.S. Food and Drug Administration requirements, and other institutional uses. By default, DSM diagnoses have also become standard for characterizing research participants in grant applications and publications.

Its dominance notwithstanding, the DSM diagnostic scheme has not assimilated recent breakthroughs in genetics and neuroscience. Most genetic and neural circuit anomalies appear to link either with multiple DSM diagnostic categories or with narrow subgroups within diagnoses.  A questionable assumption that the clusters of self-reported symptoms codified in the DSM define unique and homogeneous disorders could be constraining advances in the biology of mental illness.  Consequently inadequate understanding of pathophysiology would in turn hamper the development of better treatments.  Notwithstanding these difficulties, there is general consensus at this time that the biology of mental illness is insufficiently developed to support a classification scheme based on the integration of genetics, neuroscience, and psychopathology.  The purpose of the RDoC project is to promote such integrative science so that advances in genomics, pathophysiology, and psychology can substantially inform diagnosis.

The purpose of the initial phase of the RDoC project is to promote research employing clinical subjects from multiple diagnostic groups appropriate to the research question, in order to establish construct validity for some proposed organizing dimensions of psychopathology. A goal is to explain, via RDoC constructs, important individual psychiatric symptoms or highly coherent clusters of important psychiatric clinical phenomena, independent of conventional diagnostic categories. This is to be done through research on brain-behavior relationships that integrates findings from multiple scientific disciplines.  It is hoped that in later stages of development, measures of the integrated constructs can be developed for practical clinical use.

Specific Areas of Research Interest

Potential applicants are encouraged to read the material at the RDoC website (http://www.nimh.nih.gov/research-priorities/rdoc/index.shtml). This site contains a detailed description of the background, rationale, draft matrix of domains and units of analysis, examples of potential research applications, and results of workshops convened to generate consensus specifications. In accord with the focus on integrative science, each RDoC construct will map onto seven units of analysis:  behavior, cells, circuits, genes, molecules, physiology, and self-reports. Note that independent variables may be selected from any of the units of analysis and would typically include subjects from multiple diagnostic groups. Research plans should incorporate dependent variables from at least two units of analysis to converge upon the construct to be studied.  Applications that do not include at least two dependent units of analysis will be considered NOT responsive to this funding opportunity.

The RDoC project involved a series of consensus workshops, one for each of the organizing domains listed above. The purpose of each workshop was to identify promising constructs within the domain, define each construct (and its overlaps and differences from other constructs), and specify elements at each of the units of analysis that converge on the construct. The draft matrix entries represent elements (genes, molecules, circuit measures, behavioral tasks, questionnaires, etc.) that have been vetted by the workshop process and appear especially promising for inclusion in research plans.  Applicants may opt for other relevant measures where a strong justification can be made.

This FOA invites applications to study constructs only that have been addressed by RDoC workshops, and thereby have a definition and list of pertinent elements at each unit of analysis. The FOA also invites evaluation of the continuity of adult RDoC constructs in child and adolescent populations, and the adaptation or development of relevant measures for children. Workshops have been completed for Negative Valence Systems, Working Memory, Positive Valence systems, Cognitive Systems, Social Processes, and Arousal/Regulatory systems.  The relevant materials can be found at the RDoC website under the heading Workshop Proceedings http://www.nimh.nih.gov/research-priorities/rdoc/detailed-description-of-the-rdoc-project.shtml ."  Applications may study constructs that are essentially related to the constructs and circuits delineated in the RDoC matrix.  For example, emotion regulation is a construct that refers to dynamic regulation of threat-related amygdala activity by the ventromedial prefrontal cortex, and so could be reasonably related to the RDoC threat construct.  Because projects that focus on the social processes and arousal/regulatory mechanism domains are underrepresented in the NIMH's current RDoC portfolio, applications to study these areas are particularly encouraged.

Examples of research projects that might be submitted under this FOA include, but are not limited to:

• Evaluate the efficacy of one or more treatments for anxiety symptoms in individuals along a distribution of hypo- to hyper-reactive amygdalar responses to threat stimuli
• Evaluate the relationship among measures of social agency, and those regarding affiliation and attachment, to auditory hallucinations
• Evaluate neural processes by which aberrant perception/processing of facial communication information is related to various types of disrupted social cognition or behavior
• Evaluate the relationship of subgenual cingulate activity and serotonergic function along a dimension of emotional dysregulation
• Evaluate the relationships among social affiliation and attachment ratings, social performance in dyadic interactions, and neural activity during a social reward task
• Evaluate developmental delays in prefrontal cortical thickness and/or neural reactivity along a dimension of performance on a series of working memory tasks
• Evaluate the relationships between various types of dysregulation in HPA axis activity and the formation of emotional memories for pleasant and unpleasant material
• Examine the extent to which sleep duration and architecture predict reactivity and performance during tasks involving emotional stimuli or challenges
• Explicate the dimension of reactivity in arousal systems to motivationally relevant stimuli, and the extent to which differential reactivity to positive and negative-valence stimuli relates to clinical symptoms

Priority will be given to applications that have a well-justified plan to include patients from multiple diagnostic groups (including Not Otherwise Specified and forme fruste diagnoses) as appropriate for explicating the dimensions and constructs of interest in the study design. Studies that include patients from a single diagnostic group may also be considered if there is a particularly strong justification for examining constructs of interest within one diagnostic category.  A defensible approach might be to screen all patients presenting themselves at a specialty clinic, e.g., mood disorders clinic, anxiety clinic, or psychotic disorders clinic, regardless of whether they meet criteria for a particular DSM diagnosis, in order to identify a sample with a broad range of scores along the clinical and explanatory dimensions to be studied. 

The intent of this funding opportunity is to stimulate human-only work that is appropriate to the RDoC domains and to constructs that have been identified through the RDoC workshop process.  An application concerning a dimensional construct that has NOT been defined in one of the RDoC workshops would NOT be considered responsive to this FOA, but may be submitted independently as a standard investigator-initiated application to PA-13-302. The constructs identified in the RDoC workshops for each domain are: a. Negative Valence Systems Domain: acute threat, potential threat, sustained threat, loss, frustrative non-reward; b. Positive Valence Systems Domain: reward valuation, effort valuation, expectancy/reward prediction error, action selection/preference-based decision making, initial responsiveness to reward, sustained responsiveness to reward, reward learning, habit; c. Cognitive Systems Domain: attention, visual perception, auditory perception, olfactory somatosensory multimodal perception, declarative memory, language behavior, goal selection, updating, representation and maintenance, response selection/inhibition/suppression, performance monitoring, active memory maintenance, flexible memory updating, limited memory capacity, memory interference control; d. Social Process Systems Domain: attachment formation and maintenance, reception of facial communication, production of facial communication, reception of non-facial communication, production of non-facial communication, agency, self-knowledge, animacy perception, action perception, understanding mental states; e. Arousal and Regulatory Systems Domain: arousal, circadian rhythms, sleep and wakefulness. Additional descriptions of each of these constructs can be found in the workshop proceedings at the RDoC website: http://www.nimh.nih.gov/research-priorities/rdoc/detailed-description-of-the-rdoc-project.shtml.  Similarly, applications that propose both animal and human studies relevant to RDoC dimensions would NOT be considered responsive to this FOA but may be submitted independently as standard investigator-initiated applications.  Although it would be permissible to include multiple RDoC constructs in one research plan, constructs that are the focus of study for this FOA must have been identified by the RDoC workshops. Applications that propose to study a mix of RDoC-vetted constructs and others that have not been articulated in an RDoC workshop (even if the non-vetted constructs are listed in the draft RDoC matrix but have not been addressed by a workshop) will NOT be considered responsive to this FOA, but may be submitted independently as standard investigator-initiated applications.  For more detailed background, investigators should refer to the proceedings of the RDoC workshops posted at http://www.nimh.nih.gov/research-priorities/rdoc/detailed-description-of-the-rdoc-project.shtml.

Consistent with its continuing interest in the mental health of diverse populations, the NIMH encourages submission of applications that conform to the RDoC requirements of this FOA and that are designed to test well justified hypotheses about differences in the mechanisms of psychopathology in diverse groups.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (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.

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.

•  Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent should be sent to:

Email: [email protected]

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

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.

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

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

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

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

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

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

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

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

Research Strategy: The application should propose to investigate some psychiatric symptom or coherent cluster of psychiatric symptoms, independently of traditional diagnostic boundaries, via one or more of the previously vetted RDoC constructs that are listed in the RDoC matrix. The application should describe clearly how the psychiatric symptom (or cluster of symptoms) to be studied especially merit NIMH investment toward improving the public health.

The application should indicate potential of the project to inform future diagnostics that are based on the integration of biology and psychology. The application should propose to evaluate previously vetted RDoC constructs that have been addressed by RDoC consensus workshops, i.e., Negative Valence Systems, Positive Valence Systems, Cognitive Systems, Working Memory (subsidiary of Cognitive Systems), Social Processes, and/or Arousal/Regulatory Systems via convergent measurement across at least two units of analysis. Sample composition should be justified in terms of how the proposed design would cut across traditional diagnostic categories and employ dimensional measurement to examine the hypothesized explanatory constructs. If the sample would encompass only a single traditional diagnostic category, the application should explain how this approach would be better suited to addressing the symptoms to be studied than would a cross-cutting sampling design.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Sharing Human Data via the RDoC database (RDoC db): In order to advance the goal of widespread data sharing among NIMH researchers, investigators funded under this FOA who are collecting data from humans are strongly encouraged to share those data via the Research Domain Criteria database (RDoC db).  Established by the NIMH, RDoC db is a secure bioinformatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation.  RDoC db links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. RDoCdb will do the same. (Refer to NOT-MH-15-012 )

Investigators funded under this FOA are encouraged to use these technologies to submit data to RDoC db. To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission.  The RDoC db web site provides tools to help investigators develop appropriate strategies including a list of critical steps in the data submission process, including informed consent language and GUID generation; and - a customizable Excel worksheet that allows the applicant to estimate the costs associated with data sharing.

Investigators submitting data to RDoC db are expected to certify the quality of all data generated by grants funded under this FOA prior to submission to RDoC db and to review their data for accuracy after submission.  Submission of descriptive/raw data is expected semi-annually.  Submission of analyzed data is also expected semi-annually.  Submission of published data is expected at the time of publication, and submission of data not yet published is expected at the end of the project period.  RDoCdb staff will work with investigators to help them submit data types not yet defined in in the RDoCdb data directory.  Questions about RDoCdb may be addressed to [email protected]. 

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.

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

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

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.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the project propose to explain an important individual psychiatric symptom or a highly coherent cluster of psychiatric clinical phenomena, independent of traditional diagnostic boundaries? Does the project investigate organizing dimensions of psychopathology that cut across multiple disorders as traditionally defined?  Does the project have potential to inform future diagnostic systems based on genetics, neuroscience, and psychology? Does the project have potential to explicate or validate one or more of the domains or their subsidiary constructs that have been addressed by RDoC consensus workshops, i.e., Negative Valence Systems, Positive Valence Systems, Cognitive Systems, Working Memory (subsidiary of Cognitive Systems), Social Processes, and/or Arousal/Regulatory Systems? 

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?

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? Are the proposed studies designed to develop innovative ways of understanding mental disorders in clinical studies on the basis of experimental research criteria rather than traditional diagnostic categories?

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 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? Does the project pursue construct evaluation via convergent measurement across at least two units of analysis?  Does the application have a well-justified plan to include patients from multiple diagnostic groups as appropriate for explicating the dimensions and constructs of interest in the study design?  If the study includes patients from a single diagnostic group is there a particularly strong justification for examining constructs of interest within one diagnostic category?

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?

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.

Conformity to RDoC Concepts

Does the proposed work addresses clinically important psychiatric phenomena? To what extent would proposed work evaluate RDoC constructs across at least two units of analysis, and via dimensional, rather than categorical, assessment methods?  

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.

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.

Not Applicable

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.

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.

Not Applicable

Not Applicable

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.

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.

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).

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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIMH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

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

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

eRA Service Desk (Questions regarding ASSIST, 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)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Michael Kozak, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-6471
Email:  [email protected]

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email:  [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email:  [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.