Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Mental Health (NIMH)

Funding Opportunity Title

Biobehavioral Research Awards for Innovative New Scientists (BRAINS) (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of RFA-MH-11-050

Related Notices

  • October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

RFA-MH-13-110

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.242 

Funding Opportunity Purpose

The Biobehavioral Research Awards for Innovative New Scientists (BRAINS) award is intended to support the research and research career development of outstanding scientists who are in the early, formative stages of their careers and who plan to make a long term career commitment to research in specific mission areas of the NIMH.  This award seeks to assist these individuals in launching an innovative clinical, translational, basic or services research program that holds the potential to profoundly transform the understanding, diagnosis, treatment, or prevention of mental disorders.  Each year the BRAINS program will focus on a specific area of research and/or research career development need.  For FY 2013 and FY 2014, the BRAINS program will focus on the research priorities and gap areas identified in the NIMH Strategic Plan (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml) and the Research Domain Criteria (RDoC) project (http://www.nimh.nih.gov/research-funding/rdoc/index.shtml).  

Key Dates
Posted Date

June 18, 2012

Open Date (Earliest Submission Date)

September 23, 2012

Letter of Intent Due Date

September 23, 2012, September 23, 2013

Application Due Date(s)

(Extended to November 1, 2013 per NOT-OD-14-003), Originally October 23, 2012; October 23, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February 2013, February 2014

Advisory Council Review

May 2013, May 2014

Earliest Start Date(s)

July 1, 2013; July 1, 2014

Expiration Date

(Extended to November 2, 2013 per NOT-OD-14-003), Originally October 24, 2013

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives
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 careers.  However, even with these career development mechanisms in place, to fulfill its mission of assuring a cadre of productive, 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 vibrant, independent research programs in areas relevant to the mission of the NIMH.

Research Scope and Goals

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 expected to be highly competitive, and only a limited number of grants will be awarded per year.

Research programs supported by this funding opportunity seek to promote career advancement of the most highly creative and promising new scientists who are committed to enabling NIMH to fulfill its mission and can bring innovative, ground-breaking, and potentially risky research initiatives and thinking to transform the understanding and treatment of mental illnesses.  Special emphasis will be placed on multi-disciplinary research approaches, utilizing humans and/or model organisms that directly address the four objectives of the NIMH Strategic Plan.  NIMH also strongly encourages the submission of applications that translate findings from basic science into new treatments addressing fundamental mechanisms that cut across current diagnostic categories as outlined in the Research Domain Criteria (RDoC) project. Please refer to the information on the RDoC website for further information about this project: http://www.nimh.nih.gov/research-funding/rdoc/index.shtml.  Research that incorporates approaches to uncover the biological mechanisms underlying sex and/or gender differences in mental disorders is also encouraged.

Examples of research topics that address priorities, gaps and opportunities consistent with the four NIMH Strategic Objectives include, but are not limited to:

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 active participation of an external advisory committee, and 3) require demonstration of the commitment by the institution to actively support the research program development of the Program Director(s)/Principal Investigator(s).  Research projects proposed in response to this Funding Opportunity Announcement (FOA) will be expected to directly address the objectives and sub-objectives 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 program 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 Program Director(s)/Principal Investigator(s; awards; invited talks at national/international symposia; students and postdoctoral fellows trained in the Principal Investigator's laboratory; honors received by Program Director(s)/Principal Investigator(s); committee service of Program Director(s)/Principal Investigator(s); and subsequent grant support awarded.  Program Director(s)/Principal Investigator(s) of awarded BRAINS grants will be requested to provide information for the evaluation and any subsequent program evaluations for a period of up to ten years after the award.    

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New 

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

Funds Available and Anticipated Number of Awards

NIMH intends to commit approximately $5,000,000 in FY 2013 and FY2014 to fund 7-10 new awards in response to this FOA in both FY2013 and FY2014. Future year amounts will depend on annual appropriations.

Award Budget

An applicant may request a budget for direct costs up to $1.625 million dollars with no more than $400,000 in direct costs for any single year.  Although requested as direct costs, consortium F&A does not count toward the direct cost cap.

Award Project Period

The total project period for an application submitted in response to this FOA may not exceed five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

Foreign Institutions

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.

Required Registrations

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

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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.

This Funding Opportunity Announcement will not utilize the multiple PD(s)/PI(s) option.

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.  Applicants are strongly encouraged to discuss their research plans with an NIMH Program Officer prior to submission to ensure eligibility.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Resubmission applications are not permitted in response to this FOA.  Previously unfunded applications submitted in response to RFA-MH-11-050, RFA-MH-10-060 or RFA-MH-09-100 may not be revised and resubmitted.  Applicants who previously applied to RFA-MH-11-050, RFA-MH-10-060 or RFA-MH-09-100 and are still eligible as an NIH-defined Early Stage Investigator may submit a new application for a different project in response to this FOA. Renewal applications are not permitted in response to this FOA.

Applicants may submit more than one application, provided each application is scientifically distinct.

Applicants may not simultaneously submit identical/essentially identical applications under both this FOA and another PHS funding opportunity announcement.  Investigators who have another scientifically distinct R01 application pending at the time of the BRAINS receipt deadline 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 the regular R01 prior to the award of the BRAINS grant are not eligible to receive the BRAINS award.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

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:  kanders1@mail.nih.gov

Required and Optional Components

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

Page Limitations

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

PHS 398 Research Plan Component

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

The Research Plan should follow SF424(R&R) Application Guide for font size, type density and margins.  In the Research Strategy applicants must address the following topics as they pertain to the research project proposed:

Significance:

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

Approach:  How will you attempt to verify the novel hypothesis, or solve the problem? 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.

Also Include:

Advisory Committee

The Program Director(s)/Principal Investigator(s) 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 Principal Investigator, 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 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.

A description of the role of the Advisory Committee (but not names of potential members) should be included as an attachment in Item 12, Other Attachments.

Institutional Support

The Chair of the Department where the Program Director(s)/Principal Investigator(s) holds the primary academic appointment should provide a letter (attached as a letter of support in the PHS398 Research Plan Component of the SF424 application, Item 14) describing any tangible research support that has been committed to the Program Director(s)/Principal Investigator(s). 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 (Program Director(s)/Principal Investigator(s)). 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 Program Director/Principal Investigator, a letter (attached as a letter of support, in the PHS398 Research Plan Component of the SF424 application, Item 16) should be included in the application and outline the respective roles of the Program Director/Principal Investigator 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.

Future Goals and Career Objectives and Biography

Two narrative presentation sections, “Future Goals and Objectives” and “Personal Statement” should be included in the application.  The Future Goals and Objectives should be included as an attachment (item 12, under Other attachments). The “Future Goals and Career Objectives” section (one page maximum) should briefly describe the career track and long-term research interests/objectives of the Program Director(s)/Principal Investigator(s) with emphasis on how these interests/objectives relate to the mission of NIMH.  The “Personal Statement” section, which is part of the expanded 4 page 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 in your research.  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?

Budget

Applicants may request up to five years and up to $1.625 million in total direct costs to be allocated according to the research needs of the PD/PI but not to exceed $400,000 in direct costs in any single year.  These funds can be used for research-related expenses and salary support. 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 (See Grants Policy Statement). 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).

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the potential significance of the proposed research exceptional, in terms of the magnitude of the impact and the size of the community affected?  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 origins of mental illness, 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? If the PD/PI does not have a history of doing exceptionally innovative, high-impact research, does the logic of the experimental plan suggest that there is some likelihood of success? 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?  Does the information in the timeline inspire confidence that the PD/PI will be able to document progress in each year of the award and either complete the project or demonstrate that it is not feasible, despite good-faith efforts, during the term of the award? If the approach involves a high degree of risk, has the applicant adequately explained what he/she will do if the approach is unsuccessful? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

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 Program Director(s)/Principal Investigator(s) evident? 

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.  

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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. lThe following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

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

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

Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

Scientific/Research Contact(s)

Kathleen C. Anderson, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6189, MSC 9617
Bethesda, MD 20892-9617
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 443-5944
FAX:  (301) 480-4415
Email:  kanders1@mail.nih.gov

Peer Review Contact(s)

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD 20892-9606
Telephone:  (301) 443-3534
FAX: (301) 443-4720
Email:  armstrada@mail.nih.gov

Financial/Grants Management Contact(s)

Rebecca Claycamp, CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room, 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
FAX:  (301) 443-6885
Email:  rclaycam@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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