EXPIRED
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Developmental AIDS Research Center on Mental Health and HIV/AIDS (P30)
P30 Center Core Grants
Reissue of PAR-11-019
PAR-15-196
PAR-15-197, P30 Center Core Grants
93.242
The National Institute of Mental Health (NIMH) Division of AIDS Research (DAR) encourages applications for Center Core grants (P30) to support Developmental AIDS Research Centers (D-ARC). The D-ARC is intended to provide infrastructural support that facilitates the development of high impact science in HIV/AIDS and mental health that is relevant to the NIMH mission. This FOA intends to support innovative, interdisciplinary research in several areas, including basic, neurological (i.e., neuro-AIDS), behavioral and social, integrated biobehavioral, applied, clinical, translational, and implementation science.
May1, 2015
August 14, 2015
30 days prior to application due date
September 14, 2015, September 14, 2016, September 14, 2017 , by 5:00 PM local time of applicant organization. All types of 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.
September 14, 2015, September 14, 2016, September 14, 2017 by 5:00 PM local time of applicant organization. All types of 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.
November 2015; November 2016; November 2017
January 2016; January 2017; January 2018
April 2016; April 2017; April 2018
September 15, 2017
Not Applicable
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; 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 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.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The National Institute of Mental Health (NIMH) Division of AIDS Research (DAR) encourages applications for Center Core Grants (P30) to support Developmental ARCs (D-ARC). These D-ARCs are intended to provide infrastructural support that facilitates the development of high impact science in HIV/AIDS relevant to the NIMH mission. The D-ARC supports innovative, interdisciplinary research in several areas, including basic, neuro-AIDS, behavioral and social, integrated biobehavioral, clinical, translational, and implementation science. The intent of D-ARC support is that the proposed Core activities will allow the D-ARC to compete successfully for an full NIMH AIDS Research Center (ARC) after their D-ARC award period.
In both behaviorally-focused and neuro-AIDS Centers, the intent is to support research that addresses the most current research priorities in the field. The proposed Center priorities should align with the National HIV/AIDS Strategy, and international research directions outlined in guidance from the Office of AIDS Research (OAR) at the NIH. D-ARC awards permit the centralized coordination of affiliated research activities, foster the development of scientific innovations and new collaborations, encourage interdisciplinary research, and facilitate the dissemination of public health advances to implementing agencies, academia, affected communities, and policymakers. These Centers have the potential to support studies in a variety of areas including biological, biomedical, behavioral, neuroscience, mental health, prevention, clinical sciences, and implementation science research.
Potential research areas that may serve as organizing themes or key areas of interest for the overall research strategy of the Center include but are not limited to:
D-ARCs are expected to make several important contributions. First, Centers should demonstrate excellence and leadership in thematic areas that capitalize on the expertise of affiliated investigators. In this way, D-ARC affiliated scientists serve as thought leaders who can guide the field in new directions in HIV/AIDS prevention and treatment research based on the accumulating evidence. Second, given infrastructural support, D-ARCs are expected to compete successfully for funding from NIH and other sources and, in doing so, address key scientific questions relevant to their thematic areas of interest.
Applicants are strongly encouraged to develop and maintain collaborations with industry, government, community, implementing agencies, and other scientific networks and institutions in order to optimize the impact of Center-supported scientific advances and activities. In all potential thematic areas, Center programs are expected to address the key disparities that are evident in HIV prevention and treatment. For example, progress through the HIV care continuum is quite variable there are stark differences in subpopulations that do not progress to controlled viral load. To address continuing research to service gaps, informed by local needs, D-ARCs are encouraged to develop collaborations with entities funded by the Centers for Disease Control and Prevention (CDC), the Human Resource Services Administration (HRSA), other implementing agencies, and/or local (e.g., city, state) health departments.
In a related vein, D-ARCs have the potential to assemble the evidence base critical to health policy decision-making pertaining to resource allocation, strategic priorities, and best practices. Those D-ARCs with an intervention science emphasis are encouraged to advance the science of dissemination and implementation of evidence-based interventions that have the potential to lower HIV incidence and prevalence and improve health outcomes when delivered as part of full-scale programs. In these ways, D-ARCs are expected to serve as local, regional, national, and global resources for rigorous HIV/AIDS prevention, treatment, and implementation science.
Applicants are strongly encouraged to consult with the Scientific/Research Contacts listed in Section VII with regard to questions concerning research areas that are of highest priority.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
New
Resubmission
Revision
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Applicants may request up to $550,000 direct costs per year
The total project period may not exceed four 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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
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.
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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
D-ARC application investigators must have a minimum of 3 active NIMH research project awards (R-series) and 1 additional NIH award at the time of application and over the project period of the award. Centers unable to maintain the minimum required number of awards may be phased out.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
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.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise 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.
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:
The letter of intent should be sent to:
Email: NIMHReferral@mail.nih.gov
Component Types Available in ASSIST |
Research Strategy/Program Plan Page Limits |
Overall |
12 pages |
Admin Core |
6 pages |
Developmental Core |
6 pages |
Research Core |
6 pages |
Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.
Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.
The application should consist of the following components:
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.
Complete entire form. Descriptive Title of Applicant’s Project: Applicants should clearly indicate in the application title that the application is for a D-ARC award.
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Follow standard instructions.
Facilities and Other Resources: Applications should describe the institutional commitment to the Center. A strong commitment of the parent institution can be demonstrated by providing sufficient resources and space to ensure organizational stability and fulfillment of Center objectives.
Collaborations with community-based organizations (CBOs) can be included in descriptions of the research environment.
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.
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
The Center Director must be an internationally recognized scientist and an accomplished administrator capable of leading a complex, interdisciplinary organization to achieve its key aims and objectives. He or she must be able to develop short- and long-term strategic objectives and plans for identifying and responding to emerging priorities and initiatives. Directors have final responsibility for the scientific, administrative, and operational aspects of their Centers.
Center Directors may be the PD/PI for only one NIH Center grant.
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.
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.
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.
Specific Aims: Describe thematic aims of the overall Center and outline how the different Cores will contribute to these aims.
Research Strategy:
The Research Strategy section of the application must include an overall description of the proposed Center, including objectives and integrating theme; justification of Center goals and proposed organization; and a diagram illustrating the organization and function of the programmatic and advisory structure of the Center.
Organize the Research Strategy into sections on Significance, Innovation, and Approach. The Overall Research Strategy should describe the impact that a Center could have to enhance HIV/AIDS research at the applicant institution(s) and exert a sustained influence on the HIV/AIDS research field. Use this section to describe the proposed Overall Research Strategy and the Strategic Plan of the Center and how it will contribute to meeting the goals and objectives of the Center Program. Also, explain the rationale for selection of the strategies, opportunities, action plans and outcome measurements proposed to accomplish the specific aims.
Significance. Describe the effect that a Center award would have on Center investigators HIV/AIDS research efforts. Summarize HIV/AIDS science at the institution that justifies the need for Center support. Describe how the proposed Center provides added value to HIV/AIDS research conducted at the institution. Demonstrate the Center s ability to support the research base, foster synergy, and enhance HIV/AIDS research collaborations.
Innovation. Describe how Center resources will be utilized in unique ways to achieve the scientific goals of HIV/AIDS investigators at the institution. Provide the degree of variety across the disciplines involved in HIV/AIDS research projects within the Center structure. Illustrate unique ways to incorporate community involvement, collaboration, and outreach in the Center.
Approach. Describe the Center scientific planning process. Describe the leadership plan for the Center. The roles and responsibilities of the Center Director and Core Directors should be described.
A strategic plan must be outlined that identifies the immediate and long-term research goals of the Center. A process for implementing the activities to achieve the goals set by the Center should be clearly defined. Center applications should identify the highest priority goals with a detailed plan of activities to meet those goals for each year of the award. Goals for each successive year should build on those identified for the first year of funding.
Applicants should describe clearly how interactions and collaborations of key personnel will enhance and expand the development and productivity of Center research efforts, and how other investigators will benefit from shared resources, formal and informal planning activities, and developmental or pilot support provided by the Center award.
Letters of Support: The applicant must provide a letter(s) from the appropriate institutional official(s) (e.g., Dean, President, or Provost) that describes financial and other resource support for the Center that will be provided by the applicant institution.
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:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When 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.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
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.
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.
Budget forms appropriate for the specific component will be included in the application package.
The Center Director is expected to devote a minimum of 3.6 person months to their role.
The Administrative Core may include a limited number of administrative and clerical personnel, with a detailed description of their responsibilities for the Center, only if all the following conditions are met: 1) the administrative or clerical services are integral to a project or activity; 2) individuals involved can be specifically identified with the project or activity; and 3) the costs are not also recovered as indirect costs. Rent may be allowed only in unusual and exceptional circumstances whereby the applicant institution has a documented shortage of space on campus.
Travel expenses for key personnel to attend annual NIMH AIDS Research Center Directors meetings in Washington DC should be budgeted. Limited support is available to cover travel of the Administrative Core Director and other investigators to scientific meetings that are justified as essential to the conduct of research supported by the Center. Travel of technical staff for training that is justified as essential to enhancing the quality of the research projects is also an allowable expense
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.
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims: All Centers must have an Administrative Core that provides scientific direction and administrative leadership, performs key decision-making functions, develops and implements strategic plans, monitors and evaluates progress toward Center goals and objectives, and ensures efficient fiscal operations. The Specific Aims should describe how the Core administration will coordinate and manage activities across the Center and have an impact on the research infrastructure and strategies.
Research Strategy: Organize the Research Strategy into sections on Significance, Innovation, and Approach.
Significance. Explain the role of the Administrative Core in the Center as a whole and the responsibility of the Core for the overall administration, coordination and management of the Center.
Innovation. Explain the unique utilization of Core resources to achieve the scientific goals of all HIV/AIDS investigators at the participating institutions.
Approach. A well-developed administrative plan is integral to the success of the Center and must be clearly defined in the application. The plan should include a discussion of the structure, referencing, as necessary, the roles of administrative staff, including the functions to be performed.The Administrative Core should clearly identify personnel and resources needed to oversee the Center and ensure management of the Cores. The Core must provide a clear and explicit discussion of how fiscal and other resources will be prioritized, allocated, and managed.
The process for implementing the activities to achieve the goals set by the Center should be clearly defined. Mechanisms for internal review, decision-making, and priority-setting processes appropriate to planned activities must be defined. Appropriate criteria and review processes for evaluating affiliated investigators' ongoing participation in the Center should be established and include such factors as productivity, research direction, and overall contribution.
The application should articulate a plan to measure progress toward strengthening the research capacity of the institution. Evidence of such impacts may include broad dissemination of research products, citations by other published materials, increased applications for research funding support, or other indicators of scientific advancement.
The administrative structure must include an external advisory committee charged with providing objective advice and evaluation of Centers' strategic directions, research programs, community engagement, capacity building, and other key activities. A plan for meeting with the advisory committee should be outlined and a process for responding to its recommendations should be delineated. Information from this advisory committee meeting should become part of the annual progress report, including the date/s of the meeting; a brief, written report from the advisory committee; and the Administrative Core Director’s written responses to the advisory committee's recommendations, if any.
Procedures should be outlined for a set of specific actions used to conduct the affairs of the Center, and how various tasks will be accomplished within the Center. Policies and procedures should describe, for example:
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:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type 'Developmental Core'
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Developmental Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Developmental Core)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Developmental 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) (Developmental 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 (Developmental Core)
Budget (Developmental Core)
Budget forms appropriate for the specific component will be included in the application package.
Developmental Cores may use up to 10% of the annual P30 award to offer short-term funding support for preliminary studies that will inform the development of larger, peer-reviewed research applications that can compete successfully for NIH or other funding. These funds can only be used to support 1 2 year, formative or feasibility studies proposed by new or established investigators, including the research activities of newly recruited faculty.
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 (Developmental Core)
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims: Describe briefly how the Core will expand and promote the research priorities of the Center and how it will support the next generation of HIV/AIDS researchers.
Research Strategy: Organize the Research Strategy into sections on Significance, Innovation, and Approach. Describe how the proposed activities will contribute to meeting the Center’s goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims. This section also should indicate the relevance of the Developmental Core to the Overall Research Strategy of the Center application.
Significance. Describe the effect that the Developmental Core would have on Center investigators HIV/AIDS research efforts. Describe how the Core provides added value to HIV/AIDS research conducted at the institution, and describe the Core’s ability to support the next generation of HIV/AIDS researchers.
Innovation. Explain the unique utilization of Core resources to achieve the scientific goals of HIV/AIDS investigators at the institution.
Approach. The Developmental Core can serve a range of Center functions, such as capacity building, providing internal peer review and support services, funding pilot or preliminary research, facilitating science generation, education in grant and manuscript writing, organizing seminars and conferences, and establishing new interdisciplinary collaborations that address emerging scientific priorities.
A Developmental Core can support 1 2 year, formative or feasibility studies proposed by new or established investigators, including the research activities of newly recruited faculty. These pilot award projects are expected to be innovative, interdisciplinary research that addresses the highest priority HIV prevention and treatment science that will position the investigator(s) for subsequent research that aligns with NIMH DAR priorities.
A systematic approach for soliciting, reviewing, and selecting rigorous pilot studies should be described in this section of the application. All pilot projects must comply with applicable NIH policies and the evidence that proposed plans for protection of human subjects; inclusion of women, minorities, and children; and assurance of animal welfare must be submitted to the NIMH Program Official prior to study initiation.
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:
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.
Planned Enrollment Report (Developmental Core)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Developmental Core)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
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 Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Research Core)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Research 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) (Research 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 Core)
Budget (Research Core)
Budget forms appropriate for the specific component will be included in the application package.
The time commitment of a Research Core Director should be based on the breadth and complexity of the Core and the effort needed to administer it but should not fall below 2.4 person months.
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 Core)
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims: Clearly state how the Core will contribute to the goals of the Center, how this Core will provide services to HIV/AIDS research beyond what is currently available, and/or increase effectiveness by sharing expertise or centralizing labor-intensive tasks, how it will encourage and facilitate collaborative work, or provide user training to new investigators.
Research Strategy: Organize the Research Strategy into sections on Significance, Innovation, and Approach. Describe how the proposed activities will contribute to meeting the Center's goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims. This section should also indicate the relevance of the Core to the Overall Research Strategy of the Center application. Applicants should describe the operation of the Core.
Significance. Describe the effect that a Core would have on Center investigators HIV/AIDS research efforts. Describe how the Core provides added value to HIV/AIDS research conducted at the institutions. Describe the strengths of the Core.
Innovation. Describe how Core resources are utilized in unique ways to achieve the scientific goals of HIV/AIDS investigators at the participating institution.
Approach. A Research Core can be developed around any research activity that can provide resources to Center investigators. A Research Core is expected to be used as a shared resource and services and are intended to provide access to knowledge and technology that enhance the research productivity of the Center, scientific interaction within the Center and consultation being provided by the Center. A Research Core provides access to services that facilitate the research and strengthen the administrative and organizational cohesion of the Center. A Research Core should clearly describe a plan for identifying new or expanded services that it provides. In addition, a Research Core should clearly describe a plan for identifying potential users of the shared resources, and for providing the resources to investigators who may request them. The potential benefits of these resources and a mechanism to evaluate these benefits must be detailed in the description of a Research 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:
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.
Planned Enrollment Report (Research Core)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Research Core)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
For information on how your application will be automatically assembled for review and funding consideration after submission go to: https://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multiproject_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.
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. Applications that are incomplete and/or non-compliant will not be reviewed.
In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at nimhreferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow our Post Submission Application Materials policy.
Important Update: See NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the 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).
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.
Does the Center address an important problem or a critical barrier to progress in the field? 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 the application provide a compelling rationale that describes the benefit that a Center award would have for Center investigators HIV/AIDS research efforts?
Does the application describe how the proposed Center provides added value to HIV/AIDS research conducted at the institution, and demonstrate the Center’s ability to support the research base, foster synergy, and enhance HIV/AIDS research collaborations?
Does the thematic framework and research agenda focus on a significant public-health topic consistent with the HIV/AIDS research priorities of NIMH?
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?
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 describe how the utilization of Center resources in unique ways will achieve the scientific goals of HIV/AIDS investigators at the institution?
Does the application provide the degree of variety across the disciplines involved in HIV/AIDS research projects within the Center structure, and illustrate unique ways to incorporate community involvement, collaboration, and outreach in the Center?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the 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 a strategic plan outlined which identifies the immediate and long-term goals of the Center, and a well-defined process for implementing the activities to achieve the goals set by the Center?
Will the proposed Center structure and activities put the Center in a good position to compete for a full AIDS Research Center after their D-ARC award period?
For the Center as a whole, is the coordination among the operations and a Research Core adequately explained? Does the application describe each Core’s essential function and aims, relevance to the Center’s thematic area(s), and added-value to the HIV/AIDS science at the institution?
Is there synergistic potential among the Center research components? Is there justification for a Research Core and pilot/developmental studies in terms of the central theme and the overall research goals of the Center?
Does the Center have the potential to achieve a whole greater than the sum of its parts? Are the plans for interactions with participating institutions and organizations adequately explained? Are the management plans and arrangements feasible?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the 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.
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed 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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Not Applicable
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIMH in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Awardee-selected projects that involve clinical research require prior approval by NIH prior to initiation.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov
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: 301-945-7573
Christopher Gordon, PhD
National Institute of Mental Health (NIMH)
Telephone: 240-627-3867
Email: cgordon1@mail.nih.gov
David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: armstrada@mail.nih.gov
Jane Lin
National Institute of Mental Health (NIMH)
Telephone: 301-443-2229
Email: linja@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.