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

The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for recovery, prevention, and cure. An essential element of this mission is the support and career promotion of the future generation of exceptionally talented and creative new scientists who will transform the understanding and treatment of mental illnesses and enable NIMH to fulfill its vision of a world in which mental illnesses are prevented and cured. The NIMH supports a number of training and fellowship programs for pre- and postdoctoral training, as well as mentored career development awards for faculty in the early stages of their career. However, even with these career development mechanisms in place, to fulfill its mission of assuring a cadre of productive, highly innovative mental health investigators for the future, NIMH needs to support additional programs to identify and inspire the best new investigators and facilitate their establishing high impact, independent research programs in areas relevant to the mission of the NIMH. This award is intended to provide support for highly promising early stage investigators who may lack the preliminary data required for a traditional R01 and allow them to pursue their most innovative, creative, and potentially most impactful ideas at an earlier stage in their career.

To support its mission, NIMH has formulated a Strategic Plan with the following four overarching objectives:

1. Promote discovery in the brain and behavioral sciences to fuel research on the causes of mental disorders: http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml#strategic-objective1

2. Chart mental illness trajectories to determine when, where, and how to intervene: http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml#strategic-objective2

3. Develop new and better interventions that incorporate the diverse needs and circumstances of people with mental illnesses: http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml#strategic-objective3

4. Strengthen the public health impact of NIMH-supported research: http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml#strategic-objective4

These four Strategic Objectives can be viewed as a cumulative progression that begins with promoting discovery in the brain and behavioral sciences in order to better understand the workings of the brain that can be translated to the study of mental disorders. In effect, our efforts to understand how changes in the brain can lead to mental illness will inform (and be informed by) fundamental research to understand the trajectories of mental illnesses across the lifespan and across diverse populations. By learning more about the trajectories by which mental illnesses develop, we hope to stimulate innovative psychosocial and biomedical approaches that can preempt or change these trajectories before mental illness occurs. Finally, we will retain a strong focus on public health impact and create better methods for ensuring that our research reaches all whose lives are affected by mental illness, as well as those who are dedicated to their care.

In order to identify outstanding basic, translational and clinical investigators at the formative stages of their careers and assist them in launching innovative research programs with the potential to transform our understanding of the underlying mechanisms of mental illness and develop innovative treatments and prevention strategies, the NIMH has established this program of R01 research grants intended for early career researchers who have not received their first R01 research grant and are also Early Stage Investigators (ESI) according to NIH policy (NOT-OD-09-013). This program is designed specifically to support unusually creative investigators with highly innovative research ideas that may lack preliminary data necessary for a traditional R01. Accordingly, preliminary data is not required or expected but may be included to demonstrate feasibility. The program emphasizes both the potential of the PD/PI to be a future leader in the field and the innovation, creativity, and potential impact of the project. This program is expected to be highly competitive, and only a limited number of grants will be awarded per year.

Applications proposing clinical trials will be allowed if they respond to the experimental medicine approach to intervention development and testing described in the NIMH Policy for Submission of Applications Containing Clinical Trials NOT-MH-14-007. Under this approach, throughout all phases of intervention development and testing (i.e., from the development of novel interventions through effectiveness testing) projects should be designed to assess the relationship between underlying disease processes and the mechanisms of action through which an intervention produces therapeutic change. Accordingly, applicants that plan to utilize a clinical trial design, are required to propose studies that test 1) whether the intervention's intended targets were engaged and 2) a specific mechanism of action. Thus, intervention trials should be designed so that results, whether positive or negative, will provide information of high scientific utility and will inform decisions about whether further development or testing of the intervention is indicated. Applications submitted to this FOA that do not meet the requirements for NIMH clinical trials described in NOT-MH-14-007 will not be reviewed. For FOAs soliciting NIMH clinical trials, please see NOT-MH-14-007.

The applications in this program are distinguished from most other research grants in that the applications: 1) incorporate a statement of career goals relevant to the mission of the NIMH, 2) include a discussion of previous research experience, achievements, and impact on the field, 3) include active participation of an external advisory committee, and 4) require demonstration of the commitment by the institution to actively support the research program development of Program Director/Principal Investigator (PD/PI). Research projects proposed in response to this FOA will be expected to directly address the objectives and priorities of the NIMH strategic plan and to have a defined impact on our understanding of the pathophysiology, trajectories, effective treatment and/or prevention of psychiatric diseases. Applicants are strongly encouraged to contact NIMH Scientific/Research staff prior to submission to determine if their project meets the goals of the BRAINS program.

It is anticipated that the BRAINS program would be evaluated on a continuing basis by NIMH program staff to assess the impact of the program on the portfolio of the NIMH, as well as on the progression of the awardees' careers. Metrics to be used include, but are not limited to: publications (both numbers and impact factors); academic promotion of PD/PIs; awards; invited talks at national/international symposia; students and postdoctoral fellows trained in the PD/PI's laboratory; honors received by PD/PIs; committee service of PD/PIs; and subsequent grant support awarded. PD/PIs of awarded BRAINS grants will be requested to provide information for the evaluation and any subsequent program evaluations for a period of up to fifteen years after the award

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) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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 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.

Applicants must be designated Early Stage Investigators (ESI) by NIH as defined in NOT-OD-09-013. In addition, applicants must have faculty appointments which are tenure track or equivalent, generally at the level of Assistant Professor or equivalent, and have a research or health professional level degree (e.g., Ph.D., M.D., or equivalent) at the time of application. If the applicant is at an institution/organization that does not have a tenure track, he or she should hold an equivalent appointment and must have demonstrated support from the institution. Individuals must show that they have established research independence from a mentor, and have dedicated independent laboratory and research resources available to conduct the research proposed in the grant application.

Applicants will be expected to devote at least 6, and preferably up to 9, person months of effort to the award and have a long-term commitment to research relevant to the mission of NIMH. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Applicants must have a research career and a long-term commitment to a career in research on the causes, diagnosis, treatment and prevention of mental illnesses consistent with the core mission areas of the NIMH. The NIMH will decline applications not considered central to either the mission or the research priorities of the NIMH as part of the initial evaluation for responsiveness.

Applications proposing clinical trials will be accepted if they conform to the requirements specified in NOT-MH-14-007.

Potential applicants who anticipate developing or testing interventions that focus on measuring target engagement and mechanism of action are strongly advised to contact the Scientific/Research Contact for this FOA regarding the match between an application, current NIMH priorities, and the unique goals of this FOA.

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Investigators who have another scientifically distinct R01 application pending at the time of the BRAINS due date are eligible to submit a BRAINS application for a different project. However, since the BRAINS award is designed for Early Stage Investigators who do not have R01 support, individuals who receive a fundable score and accept funding for another R01, DP1 or DP2 award prior to the award of the BRAINS grant are not eligible to receive the BRAINS award.

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

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

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

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

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

• 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:

Kathleen C. Anderson, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health
6001 Executive Blvd, Room 6189 MSC 9617
Bethesda, MD 20892-9617
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-5944
Fax: (301) 480-4415
Email: [email protected]

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

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

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.

Other Attachments: Include a "Future Goals and Objectives" attachment (one page maximum) that briefly describes the career track and long-term research interests/objectives of the PD/PI with emphasis on how these interests/objectives relate to the mission of NIMH.

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

Biographical Sketch: The Personal Statement section of the biographical sketch should clearly describe the applicant’s scientific development from graduate school, the postdoctoral experience(s), through the present faculty position. Provide evidence to support your claim of innovation and creativity and describe the impact that your research has had on the field to date. For example, which experiences demonstrate your inclination to challenge paradigms and take intellectual risks, develop unique collaborations, integrate diverse sources of information, or develop novel approaches when new challenges or opportunities arise?

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

The PD/PI is encouraged to budget sufficient travel costs to present the results of the research at a variety of high-caliber technical meetings, at least one of which is devoted directly to mental health research and is widely attended by other NIMH grantees. A portion of the budget could include travel for external members of the advisory committee to meet yearly. In addition, the PD/PI should budget for travel to the NIH campus in Bethesda, MD each year in years 3-5 to present a seminar or participate in a research symposium. While requested as direct costs, consortium F&A does not count toward the direct cost cap.

Applicants are expected to devote at least 6 person months (50%) effort to the grant. However, after three full years of funding for this grant, should the PD/PI be successful in obtaining funding through another R01 or similar award, the effort on the BRAINS award may be negotiated with the NIMH program staff down to no less than 3.6 person months, (30%), if adequate progress has been made on the aims of the BRAINS award. In addition, the awardees' departments are encouraged to provide an additional 3-3.6 person months (25-30%) release time from clinical, teaching, and administrative duties in order to allow the awardee to devote a larger amount of time to research efforts.

Project Effort for mentored K-awardees: Mentored K awardees are encouraged to seek R01 or equivalent funding to support their research programs. Therefore, NIMH expects that such awardees may be particularly interested in seeking support through the BRAINS R01 program. Such PD/PIs are encouraged to consult with their mentored K Program Official at NIH prior to submission to ensure that the large effort commitments of both awards are feasible for their individual circumstance. However, since the BRAINS program requires a minimum of 6 person months per year, K-Awardees should not apply unless they will be in the final two years of the K-Award at the time of a BRAINS award in light of NIH policy limiting reduction in minimum required percent effort for K recipients (see NIH Guide NOT-OD-09-036).

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: In the Research Strategy applicants must address the following topics as they pertain to the research project proposed:

Significance:

• The challenge: What is the hypothesis or problem that will be addressed? If you are testing an unconventional, exceptionally novel hypothesis, how does it challenge the standard paradigm? If no paradigm exists, how will your project create one?
• The potential impact: Why is testing the hypothesis or solving the problem important to the mission of the NIMH and how does it specifically address one or more of the objectives or priorities in the NIMH Strategic Plan? Explain how a successful outcome has the potential to transform our understanding of the underlying mechanisms of mental illness, translate research to the clinic in order to develop effective interventions, prevent onset, improve diagnostic accuracy, and/or create cures. Applicants should describe how the research proposed directly addresses the mission and research priorities of the NIMH.

Innovation: State clearly and concisely what makes your project unusually innovative.

Approach: Provide enough information so that reviewers can determine what you are proposing to do. If your methodology is standard, what is unconventional and exceptionally innovative about your approach? How does your approach differ from what other investigators have attempted to do? If the approaches entail a high degree of risk, what will you do if these approaches are unsuccessful and how do the potential benefits/rewards outweigh the risks? If you are including collaborators on the project for aspects of the project that are not within your expertise, please describe their roles and how they will contribute to the success of the project and the career development of the PD/PI. NIMH also encourages applicants to include critical information about study design to enhance the rigor, reliability, and reproducibility of NIMH supported research (NOT-MH-14-004).

Also include:

• The appropriateness to the BRAINS program: Why is the proposed research uniquely suited to the stated goals of the BRAINS initiative, rather than a conventional research grant application?
• Timeline: Provide a timeline for the proposed research.

Advisory Committee

The PD/PI is expected to form an external advisory committee. Names of Advisory Committee members should not be listed in the application. This FOA uses the just-in-time concept for the External Advisory Committee members. The application should indicate the areas of scientific expertise and anticipated input, and any critical considerations in the selection of members, at the time of submission. The Advisory Committee is expected to meet at least annually to provide ongoing assessment of the progress of the research; to discuss future research goals, aims, and ideas; and to provide research career guidance to the awardee during the five years of the grant.

NIMH suggests an Advisory Committee structure such as the following: At least three scientists, two of whom are external to the Department, (one external to the University or Institution). One member should have research expertise similar to that of the PD/PI, and one should be an individual who is expert in human or clinical studies and who can provide input into the translation of the research. A schedule for the Advisory committee meetings should be included in the timeline. A copy of the minutes of meetings of the Advisory Committee should be provided to the NIMH as part of the annual progress report of the grant.

Letters of Support: The Chair of the Department where the PD/PIholds the primary academic appointment should provide a letter describing any tangible research support that has been committed to the PD/PI. This may include start up packages provided to the investigator, salary commitment, protected time for research, space and equipment allocations, core facilities that will be made available without charge-back, specialized training and mini-sabbatical experiences to promote career enhancement, etc. In addition, the letter should discuss the departmental commitment to protected research time for the applicant. The department is encouraged to provide release time so that the applicant will be able to devote at least 6, and preferably up to 9 person months (75%) of his/her professional effort to research (See Section III - Eligible Individuals (PD/PI)). The strength of the institutional support will be considered a factor in the review of the application.

If a previous postdoctoral or research mentor remains in the same Institution as the PD/PI, a letter should be included in the application and outline the respective roles of the PD/PI and the research mentor in the design and conduct of the proposed research. The research mentor should also indicate how the proposed research program is expected to be independent from the research directions of his/her laboratory.

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.

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.

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.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Institute of Mental Health (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 [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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

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.

For this particular announcement, note the following:

The BRAINS R01 grant supports the career advancement of exceptionally talented and promising ESIs who can implement innovative, ground-breaking, and potentially risky research projects that would transform the understanding and treatment of mental illness. Unlike traditional R01 applications, preliminary data are not required or expected but may be included. Reviewers should emphasize the following: 1) the importance of the scientific problem and potential impact of the research, 2) the novelty and innovativeness of the approach, and 3) evidence of the applicant's potential for creative and innovative research as an early stage investigator and as a future leader in the field.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIMH in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons. Following review by the appropriate scientific review group, candidates identified as the most promising investigators may be invited to NIMH in April-May of the fiscal year for interviews by program staff, NIMH leadership, and NIMH Director. Final selection of awardees will be made by the Director, NIMH, NIH based on 1) the outcome of the initial peer review, 2) the importance of the scientific problem and the potential impact of the research, 3) the novelty and innovativeness of the approach, and 4) evidence of the applicant's potential for creative and innovative research as an early stage investigator.

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.

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 potential significance of the proposed research exceptional, in terms of the magnitude of the expected impact on the field? If the applicant is attempting to verify a novel hypothesis, is it critical, for the field, that the hypothesis be verified or disproved? Is the work paradigm shifting or if no paradigm exists will this project create one? If the proposed work is successful does it have the potential to transform our understanding of the pathophysiology of mental illnesses, prevent their onset, improve diagnostic accuracy, and/or create cures?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the past achievements of the PD/PI suggest that the investigator is exceptionally innovative and likely to make paradigm-shifting, high-impact discoveries relevant to mental illness? Is there potential for the investigator to profoundly transform our understanding of the underlying mechanisms of mental illness or translate into the development of effective interventions, preventions or cures for mental disorders?

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 project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Is the project original and innovative? Is the hypothesis and/or the proposed methodology unconventional and exceptionally innovative?

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

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is the strength of the Institutional support to the career advancement of PD/PI evident?

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

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.

Applications from Foreign Organizations

Not Applicable

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIMH in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons. Following review by the appropriate scientific review group, candidates identified as the most promising investigators will be invited to NIMH in April-May of the fiscal year for interviews. Final selection of awardees will be made by the Director, NIMH, NIH based on 1) the outcome of the initial peer review, 2) the importance of the scientific problem and the potential impact of the research, 3) the novelty and innovativeness of the approach, and 4) evidence of the applicant's potential for creative and innovative research as an early stage investigator.

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

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

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

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

eRA 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: https://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: [email protected]

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: [email protected]

Kathleen C. Anderson, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-5944
Email: [email protected]

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

Rebecca Claycamp, CRA
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
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 Parts 74 and 92.