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

Silvio O. Conte Centers for Basic Neuroscience or Translational Mental Health Research (P50)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of PAR-14-120

Related Notices
  • May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062.
Funding Opportunity Announcement (FOA) Number

PAR-17-168

Companion Funding Opportunity

None

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

93.242  

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications for Silvio O. Conte Centers for Basic Neuroscience or Translational Mental Health Research. The institute seeks teams of researchers working at different levels of analysis and employing integrative, novel, and creative experimental approaches to address high-risk, high-impact questions in basic neuroscience research, or in translational research with the primary objectives of: (a) advancing the state of the science in basic brain and behavior research that will uncover and dissect the underlying mechanisms that will ultimately provide the foundation for understanding mental disorders; (b) supporting the integration and translation of basic and clinical neuroscience research on severe mental illnesses; and/or (c) advancing our understanding of the neurobehavioral developmental mechanisms and trajectories of psychopathology that begin in childhood and adolescence. The Conte Centers program is intended to support interdisciplinary basic neuroscience or translational research demonstrating an extraordinary level of synergy, integration, and potential for advancing the state of the field. This program is intended only for projects that could not be achieved using other, more standard grant mechanisms. The Conte Centers program also provides an opportunity to establish interdisciplinary basic neuroscience or translational research experiences for students and post doctorates.

Key Dates

 

Posted Date

February 17, 2017

Open Date (Earliest Submission Date)

April 24, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

May 24, 2017; May 24, 2018; May 24, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November 2017; October/November 2018; October/November 2019

Advisory Council Review

January 2018; January 2019; January 2020

Earliest Start Date

April 2018; April 2019; April 2020

Expiration Date

May 25, 2019

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Learn more about the various submission options.

Table of Contents

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

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


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Purpose

The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic neuroscience research or translational mental health research, paving the way for prevention, recovery, and cure. To advance this mission, this Funding Opportunity Announcement (FOA) encourages applications for Conte Centers for Basic Neuroscience or Translational Mental Health Research. The purpose of these Centers is to support interdisciplinary teams of researchers engaged in integrative, novel, and creative experimental approaches to address high-risk, high-impact scientific questions in basic neuroscience research or in translational research supported by the NIMH that will significantly advance the state of the science in brain and behavioral research to ultimately provide the foundation for understanding mental disorders and/or transform the understanding and treatment of mental illnesses, as well as developing data and other research resources that are available to the scientific community to further advance research in this field.   

It is important to note that in concert with other institutes and the leadership at the National Institutes of Health (NIH), the NIMH recognizes that basic scientific discovery powers the biomedical enterprise.  The NIMH, therefore, remains committed to maintaining a robust and broad research portfolio that spans the full spectrum of scientific pursuits from those aimed at uncovering and dissecting the underlying biological processes (with no obvious immediate link to disease) to those with more explicit relevance to disease and/or public health benefit. Conte Centers exemplify a collaborative, cutting-edge, interdisciplinary research program conducted at multiple levels of analysis that can span genes to circuits to behavior to disease in model systems and humans, from prenatal period through adulthood.  

Successful centers address a well-defined and unified scientific question (hypothesis) or problem.  Center projects may span any aspect of basic neuroscience or genomics supported by NIMH or the translational integration of neuroscience with clinical questions. Center projects may also include testing in humans to identify the etiology, pathogenesis, developmental progression, potential biomarkers and/or the mechanistic substrates of potential interventions with a view towards the eventual prevention or cure of mental disorders across the lifespan. Proposed Centers should be directed towards a well-defined and unified scientific question or problem and may include discovery-based as well as technology development components in support of the primary scientific question. The Conte Centers program is intended to support research that demonstrates an extraordinary level of synergy, integration, and potential impact on our understanding of basic brain mechanisms and/or the pathophysiology, progression, and treatment of mental disorders. The program is intended only for projects that could not be achieved using other, research project grant mechanisms. Support is provided both for individual research projects and for cores that are critical for the integration across Center components. Centers must be characterized by an interdisciplinary framework guiding highly integrated programs of cutting-edge research, and provide plans for rapid, widespread sharing of the resulting data, methods, and resources to accelerate basic or translational research relevant to mental disorders. A strong vision of how the Center will advance the field beyond the goals of the individual projects is essential for successful applications.

The Conte Centers program also provides an opportunity to establish interdisciplinary basic neuroscience or translational research experiences for students and post doctorates.

Background

Mental disorders affect approximately 15-20 percent of the U.S. population annually. These disorders include schizophrenia, bipolar disorder, anxiety, depression, autism spectrum disorders, obsessive compulsive disorder, post-traumatic stress disorder, attention deficit disorder, and eating disorders - many of which begin early in life. Tremendous strides have been made in recent years towards understanding the microenvironment (genes, molecules, and signaling pathways), brain systems (cells, circuits, and networks) and epigenetic and environmental factors involved in cognitive and affective processes as well as the underlying mechanisms that may be disrupted in mental disorders. New opportunities for expanding this understanding are presented by advances in genetic/genomic technologies, elucidation of epigenetic mechanisms that modify gene expression, imaging and molecular techniques that allow for assessment of multiple brain systems as mediators of integrated behaviors in individuals of all ages, and identification of novel molecules and pathways that regulate brain development/function or serve as possible targets for therapeutic discovery. Multi-channel and multi-modal recording and imaging techniques offer new opportunities to understand the function of neural circuits and networks as well as the ability to monitor and manipulate discrete populations of neurons important for understanding the systems disrupted in mental disorders. While exciting advances continue within specific disciplines, there is a growing need for collaborative research programs at the level of basic neuroscience or at translational levels that extend across traditional disciplinary boundaries.

Scope of Research

The primary purpose of each Conte Center is to support a multidisciplinary team of leading basic neuroscience, translational neuroscience, and/or clinical neuroscience researchers engaged in a highly integrated and focused program directed at a well-defined and unified scientific question (hypothesis) or problem. The institute seeks basic neuroscience Conte Centers as well as translational Conte Centers. A Conte Center, therefore, need not include both basic neuroscience and translational research foci. The Conte Center program continues to seek highly meritorious applications across the full spectrum of basic neuroscience research or translational research supported by the NIMH (the breadth of research supported by NIMH can be found at http://www.nimh.nih.gov/about/organization/dnbbs/index.shtml, http://www.nimh.nih.gov/about/organization/dtr/index.shtml). Conte Centers should comprise a collaborative, cutting-edge, multidisciplinary research program conducted at multiple levels of analysis that would be difficult to undertake within the confines of a single laboratory or a small-scale collaboration. 

The NIMH Strategic Plan (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml) was developed to inspire and support research that takes advantage of recent technological advances and opportunities, and to bring into sharper focus questions and perspectives that will transform the diagnosis, treatment, and prevention of mental disorders. Specific research opportunities in basic neuroscience or in translational research identified recently in relation to the plan’s four strategic objectives can be found on http://www.nimh.nih.gov/research-funding/research-priorities/index.shtml. NIMH also encourages projects that address the fundamental mechanisms that cut across current diagnostic categories as outlined in the Research Domain Criteria (RDoC) project. Please refer to the RDoC website for further information: 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.

Potential applicants are also encouraged to consult the reports of two National Advisory Mental Health Council (NAMHC) workgroups that further address identified areas of need and opportunity relevant to research on mental disorders. The NAMHC report, Transformative Neurodevelopmental Research in Mental Illness (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/neurodevelopment_workgroup_report.pdf), provides recommendations for advancing research on the neurodevelopmental origins of mental disorders with the goal of speeding the translation of basic neurodevelopmental findings into clinical research. The NAMHC report, From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illness (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/directors-message.shtml), provides guidance on promising research investments to be made with the goal of harnessing new therapeutic opportunities for the development of preemptive and personalized interventions. 

The Conte Centers program provides a mechanism for maximizing the potential for scientific synthesis and discovery across levels of analyses from genes and molecular signaling through systems level integration and behavior in humans and model systems across the lifespan. Thus, the Conte Centers program provides a unique opportunity to address one or more of the strategies and priorities outlined in the NIMH Strategic Plan and the related NAMHC reports. 

Some general characteristics of Conte Centers are listed below: 

  • Conte Center applications should be driven by the timeliness and richness of opportunities and integrate research projects across levels of scientific analysis. These levels of analysis can be tightly focused; for example, centers that propose a series of basic science projects using different model systems, approaches and methods, exploring different facets of related fundamental knowledge would be appropriate. Centers can also extend across a much wider range in levels of inquiry and span genetics, basic neuroscience, basic behavior and/or translational topics. Potential applicants are strongly encouraged to discuss their research concept and approach with the appropriate NIMH contact before developing their applications to ascertain that their concept is well aligned with NIMH interests and priorities and the goals of the Conte Center program [see section VII Agency Contacts].  
  • Conte Centers may include exploratory or high risk projects that add value to the Center and increase the potential for fundamental new discoveries towards understanding brain mechanisms directing the development and expression of behaviors including pathophysiology across the lifespan.  
  • Exploratory component projects using patient populations to test biomarkers or interventions developed/identified elsewhere within the Conte Center may be included in a Conte Center application only if they fully conform with NIMH policies for clinical trials (see: http://www.nimh.nih.gov/funding/clinical-trials-for-researchers/index.shtml). 
  • Conte Centers may include technology development as an element, but not as the main focus, of the Center. When technology development is an integral part of the scientific goals, it should be proposed as a project. When technology development is part of a standard service provided to support Center projects, it should be proposed as a Research Support Core. 
  • Research Support Cores provide research support functions, including administrative, animal, analytical, data management, diagnostic, recruitment, informatics, etc.
  • Conte Centers should comprise three or more research projects and one (administrative) or more cores.  
  • Centers may comprise projects and cores at a single institution or at multiple institutions. Collaborations between highly active laboratories using state-of-the-art methods are encouraged, even if this means that the investigators are geographically distributed. Plans for the synergistic integration of projects and cores within a Center, whether at a single institution or geographically distributed, should be well developed.

In addition to considering the strengths and weaknesses of the scientific premise that form the basis for the questions asked, the applications should be constructed to enhance reproducibility through rigor, consideration of sex and other relevant biological variables and incorporate the authentication of key biological and/or chemical resources (see: http://grants.nih.gov/reproducibility/index.htm).

Applicants are strongly encouraged to consult appropriate NIMH Scientific/Research staff, starting with the conceptualization process, to ascertain a good alignment of their planned Center goals with program priorities. 

The NIMH has interest in well balanced Conte Centers that incorporate contributions from a diverse pool of highly qualified investigators.

Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025). The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice.  Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. 

Student and Postdoctoral Research Experiences

It is expected that research opportunities and experiences for students and post doctorates supported by a Conte Center will be closely coordinated with existing formal research training programs at the participating institution(s).  As part of the Administrative Core, the Conte Center should provide opportunities for individuals to become engaged in the innovative interdisciplinary collaborative interactions driving the Center's research objectives and to obtain a broad, multidisciplinary perspective in the Conte Center research area.   

 
Communication

As part of the Administrative Core, Conte Centers are encouraged to include a communications element that includes a website and public outreach and dissemination activities.   

Website

Conte Centers are encouraged to develop and maintain a website targeted to a broad audience that describes the Conte Center and the implications of research supported by the Center towards advancing our understanding of the biology of mental disorders. 

Public Outreach and Dissemination

Encouraged outreach activities may include Conte Center-focused partnerships with local school systems, science museums or related institutions. These activities may involve participation of Conte Center investigators in special lectures or laboratory demonstrations as part of ongoing outreach programs, such as Brain Awareness Week, National DNA Day, and the NIMH Outreach Partnership Program (http://www.nimh.nih.gov/outreach/partnership-program/index.shtml). Visits from classroom groups would also be appropriate to include as an outreach activity.  

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
Renewals of applications submitted in response to PAR-14-120 or PAR-11-126
Resubmissions of applications submitted in response to PAR-14-120 and this FOA

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Direct costs are limited to $1.75 million in any one year.

Award Project Period

The total project period may not exceed 5 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

  • 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:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   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
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  allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

 Center Directors (PD/PIs) must have a demonstrated capacity to organize, administer, and direct the Center. They must also demonstrate leadership in the area of science proposed and have a strong record of high impact scientific achievements.  

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.

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).
Section IV. Application and Submission Information
1. Requesting an Application Package

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Email: NIMHCONTE@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12 pages

Admin Core (use for Administrative Core)

6 pages

Project

6 pages

Research Core (use for Research Support Core)

6 pages

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall: Required
  • Administrative Core: Required, maximum of 1
  • Projects: Required, minimum of 3
  • Research Support Cores: Optional, maximum of 3
Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

 Center Director (PD/PI) must have a demonstrated capability to organize, administer, and direct the Center. A Center Director must demonstrate leadership in the area of science proposed, have a strong record of high impact scientific achievements, and head at least one of the research projects and the administrative core.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.  

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)
 

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims:  Provide a concise description of the overall Center aims. Outline how the projects and core(s) will contribute to attaining the Center objectives.  

Research Strategy:  

The Research Strategy should begin with a brief overview of the center describing the scientific problems being addressed, the integration of the Center components, and why these components are essential for accomplishing the goals of the overall Center. The overview should be targeted to a broad audience and be concise. The overview should include:

1.  Goals, relevant background and significance and a description of the impact of the science proposed in relation to the state-of-the-art of the field. This section should also include an explanation of how the work proposed is innovative.

2.  Value added by an interdisciplinary Centers approach. This section should address why the proposed research justifies a Center and should include a description of the contribution of each of the projects and cores in achieving the Center’s major objectives, a description of how the Center as a whole will benefit from interdisciplinary interactions, an explanation of why this work cannot be accomplished by a cluster of R01s, and why the whole is significantly better than the sum of its parts.

3.  For the basic neuroscience centers, an explanation of the timeliness and the potential importance and relevance of the proposed research to advancing our understanding of the fundamental mechanisms of brain development, function, gene regulation or behavior. For the translational centers, an explanation of how the proposed work integrates component projects (basic, preclinical or clinical) with translational concepts to advance our understanding of disease etiology and/or treatment of mental health disorders. Disorders of interest to NIMH include depression, bipolar disorder, post-traumatic stress disorder, anxiety, schizophrenia, obsessive compulsive disorder, autism spectrum disorders, and other developmental disorders. NIMH is particularly interested in understanding fundamental brain changes that occur during sensitive periods of brain development and periods of increased vulnerability to psychopathology.

4.  If a scientific project or core involves risk, applicants should explain how the degree of risk will be counterbalanced by the benefits to be gained and how these benefits will impact the science in relation to the state-of-the-art of the field.  Applicants should also explain potential threats (if any) to data integrity and how these threats might affect the feasibility of the proposed research. 

5.  In this section applicants should address the strengths and weaknesses of the scientific premise forming the basis of their questions, enhancing reproducibility through rigor, sex and other relevant biological variables, and the authentication of key biological and/or chemical resources (see: http://grants.nih.gov/reproducibility/index.htm).

The Research Strategy should also include:

1.  Preliminary Data:  This section should include evidence for feasibility and preliminary findings and/or progress made during the previous funding period. This section should also present very clear evidence that the research team has been/will be able to work together effectively to accomplish the research proposed in the projects. 

2.  Center Approach:  This section should describe the working scientific and logistical design, as well as the resource support necessary to implement the research. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included. (Documentation of these arrangements should be included in the Letters of Support section.) Institutional support, if any, should be described in this section. 

3.  Timeline, Milestones, Evaluation Plan and Advisory Board:  A graphic Timeline and a descriptive Milestones section for the overall Center must be included in the Research Strategy section for the Overall Center. Milestones should be identified along the timeline. Milestones should be well described, quantifiable, and scientifically justified benchmarks at critical junctures as well as annual indicators of progress. This section should also include specific proof-of-concept test(s) along with any alternative strategies should any component efforts fail to perform as expected. The timeline should include the establishment of a to-be-named advisory board to be convened annually to assess progress and accomplishments, and to advise the Center. It is very important that potential advisory board members not be contacted or identified in advance (in the application) in order to minimize conflicts during the application review process and so that all individuals with appropriate scientific expertise remain eligible for consideration by NIMH review staff for the peer review panel that evaluates Conte Center applications. For new Conte Center applications, advisory board members should only be identified and convened after an application is funded.  For renewal applications, the names of individuals who served as advisory board members during the previous 5 years should be listed. During the project period, the Center Director will be expected to refer to these milestones in annual progress reports. 

Letters of Support: Include letters of support relevant to the overall center here. Letters detailing contributions to individual components should be placed in their respective individual Project and Core components. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. Do not submit in this component. All information on the sharing of resources should be included in the Administrative Core.

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.   

PHS Assignment Request Form (Overall)

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

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)
  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Administrative Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 
  • It is expected that the Center Director be the primary leader of the Administrative core. Multiple leads are allowed for the Administrative Core.
Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Each proposed Center Director must commit a minimum effort of 3 person months per year overall to the Center and be a leader of one of the projects and of the administrative core. The 3 person months should be a total of the Center Director's efforts on his/her project(s) and core(s). The 3 person month requirement also applies to any individual listed as a PD/PI in a multiple PD/PI Center.

Leaders of cores, including the administrative core, must commit a minimum effort of 1 person month per year to the core. If there are multiple leaders for the Administrative Core, the combined efforts of the identified Administrative Core Leaders must total 1 person month. 

The Administrative core budget should include costs for: 

  • Data and resource sharing (personnel, materials, banking, analysis, and shipping costs)
  • Investigator and advisory board travel
  • Website
  • Student and postdoctoral research and outreach

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Provide a concise description of the goals of the Administrative Core. 

Research Strategy:  

The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to support multidisciplinary systems biology research, student and postdoctoral research infrastructure and outreach, to foster synergy, and to support planning and evaluation activities.

Highlight features of the Administrative Core that will enhance the collaborative effort, including optimizing communication, decision-making and sharing between the Project and/or Scientific Core teams.  

Describe how each Project or Scientific Core (as applicable) will draw upon the Administrative Core and how it in turn will respond to Project or Research Support Core needs. The description of the Administrative Core should clearly indicate the facilities, resources, services and professional skills that the Core will provide. Moreover, information must be provided about how the collective operation of the Core will be effected in a coherent manner.

Additional information is encouraged:

  • Student and Postdoctoral Research:  Plans for engaging students and postdoctorates in the interactive processes underlying the Conte Center program and objectives should be described here. This section should also describe how research experiences in the Conte Center will synergize with existing institutional training programs.  
  • Website:  Plans for establishing and maintaining a Conte Center website targeted to a broad audience that describes the Conte Center and the implications of research supported by the Center for advancing our understanding of the biology of mental disorders should be described here.  The website should also include information pertaining to the sharing of resources with the scientific community. This website is intended to be distributed to a variety of educated audiences with broad backgrounds and interests, such as the NIMH Outreach Partners (see:  http://www.nimh.nih.gov/outreach/partnership-program/index.shtml).
  • Public Outreach/Dissemination Plan:  Outreach and dissemination activities that will inform the public about Conte Center activities and enhance science literacy should be described in this section. 

Letters of Support: Include letters of support relevant to the administrative core. 

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

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

Information on the sharing of all resources generated by Center activities should be consolidated and detailed in this section and include the following elements: 

  • Project management of resource sharing.
  • Description of what specific resources will be shared (e.g., model organisms, reagents, tools, software, etc.)
  • Schedule/timeline for availability of resources to other users.
  • Persons who will have access to the resources (written as broadly as possible to the extent consistent with applicable laws, regulations, rules and policies).
  • Plan for post award disposition of resources.

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.   

PHS Inclusion Enrollment Report (Administrative Core)

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

Project

When preparing your application in ASSIST, use Component Type ‘Project.’

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

SF424 (R&R) Cover (Project)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Application guide states that Project Narrative is required.  However it is only required for the Overall component. 

Other Attachments:  Each project that meets the NIH definition of a Clinical Trial (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html) must contain attachments #1-#4 listed below.  Attachments #5 - #8 should be provided if relevant.  All instructions must be followed for the required attachments. The details provided in these attachments should supplement, not duplicate, the information provided in the Research Strategy.  All attachments must be uploaded as separate pdf files. 

 1. Clinical Protocol Synopsis is a required attachment. 

[The filename "Clinical Protocol Synopsis.pdf" must be used for this attachment.]

The Clinical Protocol Synopsis is expected to include the following information which supports the Clinical Trial Protocol Overview section in the Research Strategy.

  •  Brief and/or Official Protocol Title
  •  Intervention to be tested:  A description of the intervention to be tested, and a brief description of the protocol to be followed in each arm of the trial.
  • Intervention / dosage and frequency: If applicable provide a description of the dose frequency and type of administration of the intervention(s).
  • Primary and important secondary endpoints: Specify the endpoints for the primary and, if applicable, important secondary endpoints.
  •  Study Population: A description of the study population, including the sample size, gender, age, demographic group, required health status, and geographic location.
  •  Recruitment plans: A discussion of the availability of potential participants for the proposed study and the ability of participating sites to recruit and retain the proposed target number of participants.
  •  Retention plans: Approaches to be used for retention, cooperation and follow-up of those enrolled and to address any anticipated changes in the composition of the study population over the course of the trial.
  • Group Assignment: Describe methods used to assign participants to study groups (treatment arms) and randomization.
  • Subject Participation Duration: Time it will take for an individual participant to complete all study visits. When possible provide a brief snapshot of the protocol’s schedule of events capturing time points and planned activity at study visits. For example:
  • Week 1 Screening/Baseline Visit (4 hours) - eligibility criteria, obtain informed consent, screening assessment(s), labs, etc.
  • Week 2,4,6,8, Study Visit(s) (3 hours) – intervention(s), assessment(s), labs, scan(s) etc.;
  • Week 12 and 18 Follow-up visits (3 hours) - assessment(s), labs, scan(s) etc.
  • Week 24 End of study visit (2 hours) - assessment(s), labs, scan(s) etc.) ).
  • Study Duration: Estimated time (in months) from when the study opens to enrollment until: (a) completion of data collection; and (b) final data analyses.
  •  Availability of Investigational Product (IP) and IND/IDE status: If applicable, provide a summary of the availability of IP and support for acquisition and administration. Please indicate the IND/IDE status of the IP, if applicable, and whether or not the investigators have had any interactions with the Food and Drug Administration (FDA). If the agent currently has an IND/IDE number, provide that information. Note that the NIH IC may request consultation with the FDA and the IND/IDE sponsor about the proposed clinical trial after peer review and prior to award.
  • Eligibility Criteria
  • FDA info on early feasibility studies: If applicable, provide FDA info available on early feasibility studies.

Applications that lack the Clinical Protocol Synopsis are considered incomplete and will not be peer reviewed.

2.  Clinical and Data Monitoring Plan is a required attachment

The filename "Clinical and Data Monitoring Plan.pdf" must be used for this attachment.

For each clinical trial proposed, create a document entitled "Clinical and Data Monitoring Plan".

Each Plan includes 2 parts: The Clinical Monitoring Plan for the quality assurance of the proposed clinical trial through clinical monitoring activities, and the Data Monitoring Plan for the quality controls proposed through data monitoring activities.

The NIH requirements for monitoring clinical trials as described below are in addition to the application's Data and Safety Monitoring Plan (DSMP) attachment on the PHS 398 Research Plan form which describes how patient safety in the trial will be monitored, and the regulatory requirement in 45 CFR 46 for on-going review and approval of all non-exempt human subjects research by the IRB of record.

Part A: The purpose of the Clinical Monitoring Plan is to verify that the clinical trial is being conducted, and documented in accordance with the Protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

  • Describe the persons/entity responsible for conducting the monitoring (e.g., contracted Clinical Research Associate, Data Coordinating Center, Independent study monitor from the Clinical Coordinating Center)
  • Describe the frequency of planned monitoring activities (e.g., Study Initiation, Interim Visits, Study Close Out), locations where the monitoring will occur (e.g., participating clinical sites, data center, clinical coordinating center) and what data will be reviewed.
  • Provide an overall description of the monitoring plan to ensure adherence to the protocol, adequate documentation of the consenting process, and the quality and consistency of the study intervention(s), including fidelity monitoring for behavioral interventions. Include methods to monitor study intervention and system to record and manage exceptions and deviations. If applicable, describe monitoring of participating facilities such as labs or pharmacies for adequate handling and storage of investigational product(s) and study specimens. Include a description to assure that the investigational product(s) accountability and reconciliation are performed adequately during and at the end of the trial per applicable regulatory requirements.
  •  Describe plans for handling any deficiencies that are uncovered and in cases of serious deficiencies the appropriate reporting to relevant authorities, including but not limited to the IRB of record, DSMB if one is assigned, FDA if applicable, institutional officials and the NIH.

Part B: The purpose of the Data Monitoring Plan is to ensure that validated systems and controls are in place to assure the integrity of the clinical research data being collected for the proposed study:

  • Describe methods and systems for data collection (e.g., Case Report Forms/CRFs), data entry, data verification and data validation. Describe the data query process and frequencies and any planned mitigation strategies in the event of noncompliance.
  • Describe methods and systems to ensure data confidentiality and subject privacy.

Describe process for locking the final trial datasets and the planned procedures on data access and sharing, as appropriate.

Applications that lack the Clinical and Data Monitoring Plan are considered incomplete and will not be peer reviewed.

3. The Milestone Plan is a required attachment

The filename "Milestone Plan.pdf" must be used for this attachment.

Applicants are required to provide detailed project performance and timeline objectives. This section must include an overview of the project timeline for the following general milestones, as applicable:

  •  Finalization of clinical protocol (with program agreement, if applicable)
  • Registration of clinical trial in ClinicalTrials.gov
  •  Completion of regulatory approvals
  • Enrollment of the first subject
  • Enrollment and randomization, if applicable of 25%, 50%, 75% and 100% of the projected study population, including women, minorities and children (as appropriate)
  • Completion of data collection time period

Completion of primary endpoint and secondary endpoint data analyses

  • Completion of final study report
  • Reporting of results in ClinicalTrials.gov.

These milestones will be negotiated at the time of the award, as appropriate.

Applications that lack the Milestone Plan are considered incomplete and will not be peer reviewed.

4. Common Data Elements Applicability is a required attachment

The filename "Common Data Elements Applicability.pdf" must be used for this attachment.

Applicants are required to provide a description of their plans to consider applicability of Common Data Elements (CDEs).

Investigators are encouraged to consult the Portal and to describe if NIH-supported CDEs will be used in the proposed clinical trial. If CDEs are not applicable, applicants are expected to explain why.

NIH encourages the use of common data elements (CDEs) in clinical research, patient registries, and other human subjects 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.

Applications that lack the 'Common Data Elements Applicability' attachment are considered incomplete and will not be peer reviewed.

5. Clinical Protocol Schedule of Events

The filename "Clinical Protocol Schedule of Events.pdf" must be used for this attachment.

The clinical protocol schedule of events is to capture a snapshot of the time it takes for protocol procedures to be completed by an individual participant during the trial.

For example:

  • Week 1 Screening/Baseline Visit (4 hours)- eligibility criteria, obtain informed consent, screening assessment(s), labs, etc.
  • Week 2,4,6,8, Study Visits (3 hours) –intervention(s), assessment(s), labs, scan(s) etc.
  • Week 12, and 18 Follow-up Visits (3 hours)- assessment(s), labs, scan(s) etc.
  • Week 24 End of study visit (2 hours)- assessment(s), labs, scan(s) etc.

This document may be provided in a tabular format.

6. Statistical Analysis Plan

The filename "Statistical Analysis Plan.pdf" must be used for this attachment.

This is a more detailed analysis plan, including a valid analysis if an NIH defined Phase III Clinical Trial.

7. Investigator Brochure or Package Insert

The filename "Investigator Brochure or Package Insert.pdf" must be used for this attachment.

The Investigator Brochure or package insert may be attached for a clinical trial testing a drug or biologic.

8. Material safety data sheet (MSDS)

The filename "Material safety data sheet (MSDS).pdf" must be used for this attachment.

Labeling information or summary of safety information from prior studies may be attached for a clinical trial testing a significant risk investigational device for which an application for a new Investigational Device Exemption (IDE) will be submitted. 

Project /Performance Site Location(s) (Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 
  • It is expected that each Research Project leader be at the forefront in the area of science proposed and have a successful record of bringing novel and significant projects to fruition as the principal investigator.
  • The Center Director must be a leader of one of the projects. 

Budget (Project)

Budget forms appropriate for the specific component will be included in the application package.

Leaders of each Project must commit a total minimum effort of 1.8 person months per year to each project. Multiple project leaders are allowed for Projects.  If there are multiple leaders on a Project, the combined efforts of the identified project leaders must total 1.8 person months per year per Project. 

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project)

Introduction to Application: An Introduction to Application is allowed for each component for resubmission applications.

Research Strategy:  

Significance:  Describe the overall goals and the impact of the science proposed in the project in relation to the state-of-the-art of the field. This section should also explain the contribution of the project to the overall goals of the Center, how the project will interact with and benefit from other components of the Center and the appropriateness of the center approach and environment.

Innovation:  Describe the unique and innovative contributions that will be made by this project.  Explain how these contributions will synergize with the rest of the Center to achieve more than what could be achieved through an independent research project.

Approach:  Describe the feasibility of the proposed experiments, the advantages of any new methodologies, the potential pitfalls, and alternative approaches for the project and how these might impact on progress in the overall Center.

Environment:  Describe the scientific environment in the context of anticipated interactions between this project and other components of the Center and anticipated progress in the overall Center. 

Clinical Trial Protocol Overview:  Projects that meet the NIH definition of a Clinical Trial (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.htm) must include a Clinical Trial Protocol Overview. This section must include:

• A summary of the study protocol’s objectives describing the scientific rationale and clinical need for the trial, the condition or focus of study, the trial’s potential impact, an assessment of the previous preclinical and clinical studies and their quality.

• A description of the study design which should include the following information:

  • Primary Purpose (e.g., Treatment, Prevention, Diagnostic, etc.)
  • Type of Intervention (e.g., Drug, Biologic, Device, Behavioral)
  • Study Phase (e.g., Pilot, Phase 1, 1/2, 2, 2/3, 3, or 4)
  • Interventional Model (e.g., single-group, parallel, cross-over, factorial)
  • Masking (e.g., open, single blind, double blind)
  • Allocation (e.g., single-arm, randomized, non-randomized)

NIH recognizes the role of both effectiveness/pragmatic versus efficacy trials and understands that all elements will not apply to all trial types (e.g., frequent patient visits, 100% source data verification, frequent site monitoring) for example for large simple effectiveness trials. Applicants should ensure applicable elements are provided based on the type of trial planned (e.g., efficacy, effectiveness, randomized registry or pilot trials).

Letters of Support:  Include letters of support relevant to the project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.  All information on the sharing of resources should be consolidated in the Administrative Core.

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.    

PHS Inclusion Enrollment Report (Project)

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

Research Support Core

When preparing your application in ASSIST, use Component Type 'Research Core'

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

SF424 (R&R) Cover (Research Support Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Support Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Support Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Application guide states that Project Narrative is required.  However it is only required for the Overall component. 

Facilities and Other Resources: The description of the Research Support Core should indicate how its facilities, resources, services, and professional skills will be leveraged to provide services to the proposed center.

Project /Performance Site Location(s) (Research Support Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Support Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Research Support Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 
  • It is expected that Research Support Core leaders demonstrate competence in the area of science proposed and have a record of interacting and working well with other investigators at their institution and elsewhere.   

Budget (Research Support Core)

Budget forms appropriate for the specific component will be included in the application package.

Leaders of Research Support Cores must commit a minimum effort of 1 person month per year to the Research Support Core. Multiple leaders are allowed for Research Support Cores. If there are multiple leaders, the efforts of the identified leaders must total 1 person month per year per core. 

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Support Core)

Introduction to Application:  An Introduction to Application is allowed for Resubmissions. 

Specific Aims:   Provide a concise description of the goals of the Research Support Core.  Explain how the Research Support Core will contribute to attaining the Center objectives. 

Research Strategy:  A Research Support Core can be a laboratory, a facility, a service, or other shared resource that supports other Center components in their activities. Descriptions for the core should include a brief overview and a description of the services and resources to be provided to other Center components. This section should address how the core will contribute to the overall goals of the Center as well as which projects will be supported by the Research Support Core and the manner in which that support will be rendered by the core. Issues to be addressed include: quality control, procedures for selecting projects that use the Research Support Core, cost effectiveness, and increased efficiency. While scientific activities per se are not an essential part of a Research Support Core, quality assurance activities that evaluate its operations and are directed at problem identification and improvement of core functioning are appropriate.   

Letters of Support:  Include letters of support relevant to the Research Support Core. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.  All information about Resource Sharing Plans should be consolidated in the Administrative Core section of the application. 

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.     

PHS Inclusion Enrollment Report (Research Support Core)

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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 and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. Other Submission Requirements and Information

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads 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.

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 (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

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 - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center proposed).

Scored Review Criteria - Overall

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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Does a Basic Neuroscience Center application propose timely and compelling work for advancing our understanding of the fundamental mechanisms of brain development, function, gene regulation and/or behavior?  Does a Translational Neuroscience Center application propose work that clearly integrates component projects (basic, preclinical or clinical) with translational concepts to advance our understanding of disease etiology and/or treatment of mental health disorders? Are the clinical trials necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? Does the project cite prior relevant trials or systematic reviews that would help to justify why this trial is needed and inform its design?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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?

  • Center Director (Project Director):  Has the proposed Center Director demonstrated capacity to organize, administer, and direct the Center?  Has he/she demonstrated leadership in the area of science proposed, have a strong record of scientific achievements, and head at least one of the research projects and the administrative core?  
  • Research Project Leaders:  Are the proposed Research Project Leader(s) at the forefront in the area of science proposed with a successful record of bringing novel and potentially high risk projects to fruition as the principal investigator?  Do the individual(s) bring complementary and integrated expertise to the overall Center?  For project leaders of Clinical Trials:  Do the lead/leaders and key personnel have clinical trial-specific expertise and experience; the ability to organize, manage and implement the proposed clinical trial and meet study milestones and timelines?  Do they have appropriate capacity in study coordination, data management and statistics?  For a multicenter trial, is the organizational structure appropriate? 
  • Core Leader:  Do the proposed core leader(s) have demonstrated competence in the area of science proposed and have a record of interacting and working well with other investigators at their institution and elsewhere?   
Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  Does the application include an adequate explanation of how the work proposed is innovative? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Center 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?   

Is an interdisciplinary Center approach necessary and suitable for the proposed work? Will an integrated Center approach add significantly to what could be accomplished through other modes of research support?  Are the management plans appropriate? If multiple institutional sites are involved does the application include a detailed description of the cooperative administrative arrangements?

Is there a clear, detailed plan for managing the Center's research and administration, fostering synergy, ensuring appropriate prioritization of research, needed course corrections and problem identification and resolution, and effective sharing of resources, that conveys a high likelihood of effective, productive management of the Center as a whole? Is there an organizational structure that will facilitate coordination and integration of Center activities and progress?

If potential threats to the data integrity are known about the proposed research, will these threats affect the feasibility of the proposed research?

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the clinical and statistical hypothesis being tested? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified? Is there a plan to complete data analysis within the proposed period of the award?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure data collection? Is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed?  

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?   

Additional Review Criteria - Overall

As applicable for the Center 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.

Center Components:  Individual Center Components (Administrative Core, Research Support Cores, Projects and Projects Involving Patients) will be assessed for relevant strengths and weaknesses in the context of the Overall Center but will not be scored.

Additional Review Criteria - Administrative Core:

  • Is the Administrative Core leader(s) qualified and experienced in the administration of a large, multi-component research program?
  • Do the Core leaders clearly describe how the scientific cores will draw upon the Administrative Core and how it will in turn respond to scientific core needs?  Do the Core leaders clearly indicate the facilities, resources, services and professional skills that the Core will provide and how the collective operation of the Core will be effected in a coherent manner?
  • Are the opportunities for students and postdoctorates likely to provide them with a good understanding of the collaborative interactions driving the Conte Center research program and a broad background in the Conte Center research area?  Are the plans to integrate Conte Center trainees with ongoing institutional training activities at the participating institution(s) appropriate?
  • If a public outreach and dissemination plan is proposed, is it of high quality, and likely to reach a broad and diverse audience, and likely to increase science literacy?
  • Are there plans for establishing and maintaining a Conte Center website targeted to a broad audience that describes the Conte Center and the implications of research supported by the Center for advancing our understanding of the biology of mental disorders? 

Additional Review Criteria - Projects

  • Does the project make an important contribution to the Center as a whole?
  • Is this project well integrated with the scientific objectives of the Center?
  • Is an explanation provided as to how the contributions of each project will synergize with the rest of the Center to achieve more than could be achieved through an independent research project?
  • Are the conceptual design, methods, and analyses adequately developed, well integrated, and well-reasoned?
  • Is the proposed project feasible? Do the projects take advantage of any new methodologies?  Are potential pitfalls identified or alternative approaches for the project and how these might impact on progress in the overall Center?  Are available resources identified and is a clear explanation provided regarding how these resources will contribute to the success of the overall goals of the center?
  • Is the Project Leader at the forefront of the area of science proposed?
  • Is the project original and innovative?

Additional Review Criteria - Projects that meet the NIH definition of Clinical Trials

  • Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers?  Are the plans to add or drop enrollment centers, as needed, appropriate?
  • If international site(s) is/are proposed, does the application adequately address potential complexities of executing the clinical trial in these sites?
  • If multi-sites/centers are proposed, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and (4) operate within the proposed organizational structure?

Additional Review Criteria - Research Support Cores:

  • Are the Research Support Cores appropriate and necessary for the proposed studies?
  • Do the proposed plans address the qualifications, past performance (if applicable), and time commitments of the Research Support Core Leader(s)?  Is there evidence that appropriate expertise will be available to carry out the functions proposed for each core?
  • Are the conceptual designs, methods, and analyses adequately developed, well integrated, and well-reasoned?

Clinical Data Monitoring Plan

(for projects that meet the NIH definition of Clinical Trials)

  • Are the procedures for clinical data monitoring and quality control of data adequate?  Are standardized systems and controls in place for data monitoring to ensure data integrity and to assess the effect of the intervention?

Study Timeline and Milestones

(for projects that meet the NIH definition of Clinical Trials)

  • Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
  • Are appropriate, evaluative milestones clearly defined for the aims associated? Are the milestones feasible and quantifiable with regard to specific aims and timeline? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)? 
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 Center 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

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

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the Center 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) Genomic Data Sharing Plan .


Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 NIMH in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Applications will be assigned  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). As of January 18, 2017, NIH requires registration of all clinical trials whether required under the law or not. See, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-149.html.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Milestones: Future support of a study funded under this FOA is contingent upon adequate participant recruitment based on projected milestones.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

Recruitment Reporting and Trial Registration:

NIMH requires reporting of recruitment milestones for participants in all NIMH extramural-funded clinical research studies proposing to enroll 150 or more subjects per study, and all clinical trials, regardless of size (see http://grants.nih.gov/grants/guide/notice-files/NOT-MH-16-013.html).  This expectation will be stated in the notice of grant award. 

The NIMH expects trial registration and results reporting for all NIMH-supported clinical trials, regardless of whether or not they are subject to FDAAA (see

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-149.html). This expectation will be stated in the notice of grant award.

In the annual progress reports and in the final progress report, Center Directors will be asked to provide the following:

  • A discussion of how the Center activities advanced the state of the field in ways that are not possible through a series of independent projects.
  • A brief summary of the progress of each component (individual projects and cores) in the context of the overall goals of the Center.
  • A summary of the novel scientific interactions that were fostered by the Center.

Conte Centers may receive an administrative site visit during the third year at the time of their annual advisory board meeting.

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. 

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA 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)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Basic Neuroscience Applications:

Susan Koester , Ph.D.

Division of Neuroscience and Basic Behavioral Science

National Institute of Mental Health (NIMH)

Telephone: 301-443-3563

Email:  koesters@mail.nih.gov

Chiiko Asanuma, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health (NIMH)
Telephone: 301-443-5288
Email: casanuma@mail.nih.gov

Translational Applications (Adult):

Steven J. Zalcman, M.D.
Division of Translational Research
National Institute of Mental Health (NIMH)
Telephone: 301-443-1692
Email: szalcman@mail.nih.gov

Translational Applications (Developmental):

Kathleen C. Anderson, Ph.D.
Division of Translational Research
National Institute of Mental Health (NIMH)
Telephone: 301-443-5944
Email: kanders1@mail.nih.gov

Student and Postdoctoral Research & Communication: 
Nancy L Desmond, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health (NIMH) 
Telephone: 301-443-3107 
Email: ndesmond@nih.gov 

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858 
Email: tjarosik@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 Part 75.

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