Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institute of Mental Health (NIMH)
Reissue of PAR-17-080
See Notices of Special Interest associated with this funding opportunity
PAR-21-228 R25 Education Projects
PAR-20-094 R25 Education Projects
PAR-20-096 R25 Education Projects
PAR-17-485 R25 Education Projects
93.242
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.
To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:
and in particular, mentoring networks. Networks may be national or regional. All proposed networks should provide significant new opportunities, and should comprise efforts substantially beyond any ongoing mentoring, networking, or research education within academic programs, institutions, or pre-existing networks; or educational collaborations among institutions. Participants in proposed mentoring networks are limited to graduate/medical students, medical residents, postdoctoral scholars, and/or early-career faculty. Proposed networks are expected to enhance the participants' professional development and to foster their career trajectory towards independent mental health research. Proposed programs are thus expected to contribute to the development of a skilled cadre of investigators in requisite scientific research areas to advance the objectives of the NIMH Strategic Plan.
Janaury 17, 2020
30 days before the application due date
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.
April 2021, April 2022, April 2023
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.
The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The over-arching goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.
The over-arching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.
To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on Mentoring Activities:
The goal of this FOA is to augment the education and training of the scientific workforce to meet the nation’s biomedical, behavioral, and clinical research needs in the mission areas of the NIMH (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml). The NIMH R25 Program currently provides four thematic funding opportunities: 1) short courses for mental health-related research education (PAR-20-096 ); 2) research education programs supporting psychiatry residents (PAR-20-094 ); 3) mentoring networks for mental health research education (PAR-20-080 ); and 4) research education mentoring programs for HIV/AIDS researchers (PAR-17-485). Applications in the area of HIV/AIDS research education will only be accepted in response to PAR-17-485 and subsequent reissuances.
While there is no universally accepted definition of scientific mentoring, it is widely recognized as an important element for career development. Recommendations made by National Advisory Mental Health Council Workgroups on Research Training (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/investing-in-the-future_42525.pdf ) and Neurodevelopment (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/neurodevelopment_workgroup_report_33553.pdf ) encourage the NIMH to support programs that provide state-of-the-art, pedagogical opportunities for individuals during the formative stages of their careers. The Council Workgroup reports also acknowledge the important role that mentors play in the career development of scientists.
This FOA is limited to applications proposing mentoring networks for participants who are graduate/medical students, medical residents, postdoctoral scholars, and/or early-career faculty. Mentoring networks may propose to include individuals from a single career stage or may bridge several career stages. The NIMH expects all programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities, and women. Participants should be actively engaged in the network for a period of no less than one year, maintaining regular contact with mentors and peers within the network during that time. Expected outcomes for those individuals participating in mentoring networks include subsequent involvement in research, subsequent employment in a mental health research field, authorship of scientific publications, and/or subsequent independent research grant support from NIH or other sources. Mentoring networks may be national or regional, or designed to link two or more complementary organizations or institutions. An applicant organization may wish to partner with other organizations to develop a national mentoring network. As noted in the recommendations of the NAMHC Workgroup on Research Training (https://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/investing-in-the-future_42525.pdf), national scientific professional organizations may be effective partners in efforts to establish national mentoring networks.
This FOA will support the development, implementation, and evaluation of innovative mentoring networks encompassing non-HIV/AIDS research topics; didactic content; and mentoring expertise that reflect the research priorities of the NIMH. The interests of the NIMH are broad, spanning from basic neuroscience, human genetics/genomics and translational research to interventions and mental health services research across the lifespan. The content area chosen as the scientific focus for the proposed mentoring network should be of sufficient breadth to provide reasonable assurance of the ability to recruit a high-quality pool of potential participants annually and to ensure that a critical mass of mentors and participants are involved in the network.
The scope of a mentoring network should be broad enough to accomplish a set of goals rather than a single goal. For example, the network could advance the broad career goals of participants; facilitate scholarly writing and grantsmanship; provide access to a network of skilled mentors who are outstanding researchers but not available at the home institution of the participant; promote successful transitions from one career stage to another; provide leadership development; help to identify potential collaborators; and help to establish interdisciplinary or translational collaborations. However, it is expected that an over-arching goal of any mentoring network is to facilitate the professional success of participants as independent researchers and members of the research community.
All proposed networks should provide significant new opportunities, and should comprise efforts substantially beyond any ongoing mentoring, networking, or research education within academic programs, institutions, or pre-existing networks or educational collaborations among institutions. That is, there should be a clear "value added" from the R25-supported mentoring network.
Applicants are strongly encouraged to contact NIMH Scientific/Research staff for current information about priorities and policies before preparing an application (see Section VII).
Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs,
See Section VIII. Other Information for award authorities and regulations.Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Note: Appointed Participants are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.
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The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets may not exceed $200,000 in direct costs annually and are expected to reflect actual needs of the proposed project.
The scope of the proposed project should determine the project period. The maximum period is 5 years.
Personnel costs (administrative and clerical costs, as well as salaries of the PD/PI and other investigators/faculty) associated with directing, coordinating, administering, and implementing the program should be well-justified, reasonable, and may not exceed 25% of the total direct costs in any year.
Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.
While generally not an allowable cost, with strong justification, participants in the research education program may receive per diem unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition and other education-related expenses.
Expenses for foreign travel must be exceptionally well justified.
Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by an R25 program, as participants, but may not receive salary or stipend supplementation from a research education program.
Because the R25 program is not intended as a substitute for an NRSA institutional training program (e.g.,T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.
Consultant costs may not be used to substitute for Personnel costs.
While well-justified costs for supplies are allowable, "seed" or pilot funds to support research project activities are not allowable costs.
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
If multiple sites are involved in the research education program, the applicant institution must be one of these sites. The need for and use of multiple sites must be justified.
The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
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.
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.
The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.
The PD/PI should have a strong track record as a leader, educator and/or mentor in an area relevant to the scientific focus of the proposed mentoring network and should be actively engaged in research in an area related to the mission of the NIMH.
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:
Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award, and for a period of no less than one year.
Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents. Participants are limited to graduate/medical students, medical residents, postdoctoral scholars, and/or early-career faculty.
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guideexcept where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.
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:
Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.
Other Attachments.An Advisory Committee is not a required component of a Research Education program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file Advisory_Committee.pdf .
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below:
Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.
The description should include the educational and/or career level(s) of the planned participants.
Applicants should propose a program that includes mentoring, resources, and interactive opportunities in a specific scientific content area as the framework for the proposed mentoring network. Describe the rationale for the mentoring model and the scientific content area chosen, as well as the relationship of the scientific content area to the mission and Strategic Plan of the NIMH. The chosen content area should be of sufficient breadth to provide reasonable assurance of the ability to recruit a high-quality pool of potential participants annually and to ensure that a critical mass of mentors and participants is involved in the network. The network should enhance the participants' professional development and foster their career trajectories towards independent mental health research.
Describe the framework for, and the components of, the proposed mentoring network, e.g., their rationale, the grounding in experience and pedagogical theory, and the justification in terms of the long-term goals of the proposed mentoring network. Describe how state-of-the-art approaches to mentoring, research education and scholarship will be employed in the network.
Describe the scientific need for and timeliness of the network, how the network complements existing training or didactic opportunities (as appropriate), how educational goals and objectives relate to the mission and current research priorities of the NIMH, and the rationale for the career stage(s) of the participants in the proposed mentoring network. Provide programmatic detail on the specific activities proposed (e.g., curricula, seminars, involvement in hands-on research activities at the participant's home institution), and how the accomplishment of objectives will be measured. Describe expected processes for: (a) planning and implementing the proposed educational activities, (b) selecting mentors for participants, and (c) if applicable, coordinating among existing training or research activities available at a site or across multiple sites. Note that there should be a clear value added from the proposed, R25-supported mentoring network. Describe how the mentoring network may be modified over time depending upon the outcome of initial progress and participant feedback and/or new developments in the field, in order to ensure that the research education continues to be at the cutting edge.
Describe the proposed structure of the network. It is expected that a combination of didactic interactions (e.g., in the form of week-long summer institutes and/or regularly occurring webinars), one-on-one, and small group discussions will be components of any proposed mentoring network. Both formal and informal interactions between mentors and participants are expected. Applicants are encouraged to take advantage of contemporary communication strategies, e.g., distance learning and social networking, as appropriate for the goals of their network.
A plan for program leadership must be provided. The plan should describe leadership team responsibilities, frequency of meetings, and other relevant information. Describe the composition of the program leadership team, identifying the role (e.g., PD(s)/PI(s), planning committee lead, education director) and the desired expertise of members. A plan for the leadership team's involvement in approval and selection of participants should be included. Describe how the leadership team will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of participants, and the evaluation of the overall effectiveness of the program. Key leadership team members, including PD(s)/PI(s) from each participating institution or organization, should be named in the application; other leadership team members may be appointed at a later date. However, in renewal applications, leadership team members should be named. If an optional advisory committee is proposed (see above), distinguish the role and function of the advisory committee from the role and function of the leadership team.
For Renewal Applications, the Progress Report should describe the results of the outcomes measured, the number and characteristics of participants in the past project period, materials disseminated, and any changes in administration, design/objectives, or targeted participant groups during the prior funding period. The description of the proposed network for the next funding period should highlight how the program continues to offer research education at the scientific cutting-edge as well as any changes in activities that are planned to maintain the currency of the research education offered. Renewal applications should describe the continuing need for the existing network to advance NIMH's goal of a well-trained pool of researchers with state-of-the-art knowledge and skills essential for achieving the Institute's research priorities.
Program Director/Principal Investigator. Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs,their leadership approach, and governance appropriate for the planned project.
Without duplicating information provided in the bioskectch provide evidence that the PD/PI has a mentoring track record and/or leadership track record with respect to research training and career development programs or activities.
Program Faculty. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles. Describe the qualifications and responsibilities of the participating faculty. Program faculty may have one or more roles, e.g., instructor, instructor and mentor, or mentor only. Describe the anticipated number of mentors who will participate in the mentoring network and their desired qualifications.
Program Participants. Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned. Provide details about recruiting and selecting participants. Describe the pool of expected participants, its anticipated size, qualifications, recruitment strategies, and sources of this pool. Provide strategies for recruiting participants nationally, if applicable and for recruitment of an applicant pool that is predominantly composed of U.S. citizens and permanent residents. Describe plans for announcing and advertising the network nationally or regionally, application procedures, and criteria for evaluation and selection of participants including information about plans to recruit and select participants whose research interests intersect with the strategic objectives of the NIMH (http://www.nimh.nih.gov/about/strategic-planning-reports/strategic-research-priorities/index.shtml). Describe planned methods for reviewing the participants' progress, for identifying and addressing any problems, and retention strategies.
Institutional Environment and Commitment. Describe the institutional environment, reiterating the availability of facilities and educational resources (described separately under Facilities & Other Resources ), that can contribute to the planned Research Education Program. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must be attached as part of Letters of Support (see below). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.
If multiple institutions are participating in a single application, they should all be clearly involved in the planning, implementation, and assessment of the program, and should all provide appropriate documentation of institutional commitment.
Recruitment Plan to Enhance Diversity (NOT-OD-20-031): Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.
A.
The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders.
In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this program. For more information on racial and ethnic categories and definitions, see NOT-OD-15-089.
Students from low socioeconomic (SES) status backgrounds have been shown to obtain bachelor’s and advanced degrees at significantly lower rates than students from middle and high SES groups (see https://nces.ed.gov/programs/coe/indicator_tva.asp), and are subsequently less likely to be represented in biomedical research. For background see Department of Education data at, https://nces.ed.gov/; https://nces.ed.gov/programs/coe/indicator_tva.asp; https://www2.ed.gov/rschstat/research/pubs/advancing-diversity-inclusion.pdf.
Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008902/).
Women have been shown to be underrepresented in doctorate-granting research institutions at senior faculty levels in most biomedical-relevant disciplines, and may also be underrepresented at other faculty levels in some scientific disciplines (See data from the National Science Foundation National Center for Science and Engineering Statistics: Women, Minorities, and Persons with Disabilities in Science and Engineering, special report available at https://www.nsf.gov/statistics/2017/nsf17310/, especially Table 9-23, describing science, engineering, and health doctorate holders employed in universities and 4-year colleges, by broad occupation, sex, years since doctorate, and faculty rank).
Upon review of NSF data, and scientific discipline or field related data, NIH encourages institutions to consider women for faculty-level, diversity-targeted programs to address faculty recruitment, appointment, retention or advancement.
New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of trainees from underrepresented backgrounds and may wish to include data in support of past accomplishments.
Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:
For those individuals who participated in the research education program, the report should include information about the duration of education and aggregate information on the number of individuals who finished the program in good standing. Additional information on the required Recruitment Plan to Enhance Diversity is available at Frequently Asked Questions: Recruitment Plan to Enhance Diversity (Diversity FAQs).
Applications lacking a diversity recruitment and retention plan will not be reviewed.
Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.
Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.
Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.
Dissemination Plan. A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops.
A letter of institutional commitment must be attached as part of Letters of Support (see section above: Institutional Environment and Commitment."
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:
Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Inclusion Enrollment Report
When conducting clinical research, follow all instructions for completing the PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials InformationAll instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Delayed Onset StudyNote: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
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
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). 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.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
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.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The goal of this R25 program is to support educational activities that will enhance the participants' professional development and foster their career trajectories towards independent mental health research. Applications should be characterized by state-of-the-art approaches to mentoring and research education, scholarship, and documentation of a strong need in the research community for the proposed mentoring network. Renewal applications should also demonstrate a continuing need for the existing network to advance NIMH's goal of a well-trained pool of researchers with state-of-the-art knowledge and skills essential for achieving the Institute's research priorities.
Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?
To what extent will implementation of the proposed program enhance the professional development of the participants and foster their career trajectories towards independent mental health research through a state-of-the-art mentoring network?
Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? 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?
Is the caliber of program leadership and participating faculty, in terms of their research interests, expertise, mentoring records and research education leadership in the area of the proposed program, appropriate for their roles on the project?
Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?
Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?
Is the approach feasible and appropriate to achieve the stated research education goals? Are the methods, including networking strategies, group and one-on-one interactions, and didactics appropriate for the program objectives? Is sufficient interaction planned between faculty and participants to achieve the goals of the network? Are potential problems and alternate strategies adequately discussed? Is there adequate description of the sources of the pool of expected participants and their qualifications? Are the stated plans for announcing and advertising the network, recruiting participants regionally or nationally, application procedures, and criteria for evaluation and selection of participants appropriate to achieve a highly qualified cohort of participants? Does the evaluation plan adequately describe how outcomes will be determined and evaluated? Where applicable, is there a well-defined plan to disseminate user-friendly course materials to the broader scientific community?
Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?
If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)?
For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) 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 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.
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 Renewals, the committee will consider the progress made in the last funding period, and the success of the program in attracting individuals from diverse populations, including populations underrepresented in biomedical, behavioral and clinical research on a national basis.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Recruitment Plan to Enhance Diversity
Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Taking into account the specific characteristics of the proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also: NOT-OD-10-019. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Not Applicable
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
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.
If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination 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 the NIMH in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications: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.6. 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.
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.
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.
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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.htmlPlease contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.htmlor 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.
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.
Programs that involve participants should report on education in the responsible conduct of research and complete a TraineeDiversity Report, in accordance with the RPPR Instruction Guide. 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 agreementsare 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.Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.
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.
Each RPPR should include the following tabular information for each budget period of the current project period: participant name, most recent degree, year(s) of participation in the mentoring network, career stage (graduate/medical student, medical resident, postdoctoral scholar, early-career faculty), and home institution.
A final RPPR 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.Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.
In evaluating this research education program NIMH expects to use the following evaluation measures:
For Research Experience and Mentoring Programs Involving the Following Groups:
Graduate/MedicalStudents:
Successful completion of a STEM graduate program
Subsequent participation in a formal research training or career development program in a STEM field
Subsequent participation in research
Subsequent employment in a research or research-related field
Subsequent authorship of scientific publications in a STEM field
Subsequent independent research grant support from NIH or another source
Postdoctorates and Early Career Investigators:
Subsequent participation in research
Subsequent employment in a research or research-related field
Subsequent authorship of scientific publications in a STEM field
Subsequent independent research grant support from NIH or another source
Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:GrantsInfo@nih.gov(preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email:support@grants.gov
SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg
See http://www.nimh.nih.gov/funding/training/contacts-for-research-training-and-career-development-programs.shtml for Scientific/Research Contacts at the NIMH.
Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: nick.gaiano@nih.gov
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov