Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Deafness and Other Communication Disorders (NIDCD)

Funding Opportunity Title
NIDCD's Mentored Research Education Pathway for Otolaryngology Residents and Medical Students (R25 - Clinical Trial Not Allowed)
Activity Code

R25 Education Projects

Announcement Type
Reissue of RFA-DC-20-002
Related Notices

    See Notices of Special Interest associated with this funding opportunity

  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
  • July 22, 2019- Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020. See Notice NOT-OD-19-109.
Funding Opportunity Number (FON)
PAR-24-127
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.173
Funding Opportunity Purpose

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences.

To accomplish the stated over-arching goal, this NOFO will support educational activities with a primary focus on:

  • Research Experiences

Key Dates

Posted Date
February 09, 2024
Open Date (Earliest Submission Date)
May 14, 2024
Letter of Intent Due Date(s)

May 14 , 2024

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
June 14, 2024 June 14, 2024 Not Applicable November 2024 January 2025 April 2025
September 30, 2024 September 30, 2024 Not Applicable March 2025 May 2025 July 2025
January 29, 2025 January 29, 2025 Not Applicable July 2025 October 2025 December 2025
September 29, 2025 September 29, 2025 Not Applicable March 2026 May 2026 July 2026
January 29, 2026 January 29, 2026 Not Applicable July 2026 October 2026 December 2026
September 29, 2026 September 29, 2026 Not Applicable March 2027 May 2027 July 2027

All applications are due by 5:00 PM local time of applicant organization.

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.

Expiration Date
September 30, 2026
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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 overarching goal of this R25 program is to support educational activities that help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences.

The over-arching goal of this NIDCD R25 program is to support educational activities that help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences. To accomplish the stated over-arching goal, this NOFO will support educational activities with a primary focus on:

  • Research Experiences: For example, provide medical students and residents-investigators with educational career development activities and mentored research experiences in otolaryngology and to prepare them to pursue more in-depth research experiences and preparation for a research career.

 Background:

There is a critical workforce need for physician-scientists/clinician-investigators, i.e., those with clinical experience who conduct research and offer skills and perspectives directly related to human health, disease conditions, clinical decision-making, diagnoses, prevention, and improving health outcomes. Relatively few physicians and other health professionals are pursuing research careers, and existing opportunities may not maintain adequate numbers or diversity of physician scientists (Advisory Committee to the Director, Physician Scientist Workforce Report, 2014). The overall size of the current clinician investigator workforce constitutes only a small proportion of all NIH-funded research investigators, and this is particularly true for early-stage clinician investigators. Thus, new approaches are needed to recruit, prepare and retain more clinician-investigators from the large pool of potential researchers with health professional doctorates.

Each year in the United States, some 18,000 individuals earn an MD, while 600 individuals earn MD/PhDs and many of these clinical graduates subsequently hold positions in academic medicine, report research activity, and contribute substantial professional effort in research as clinician investigators. Among today’s NIH-funded clinician-investigators, about 60% hold a single health professional degree and 40% hold both health professional and research doctorate degrees. The data also indicate that women and individuals from underrepresented racial and ethnic groups still represent a particularly low proportion of this workforce. Thus, efforts to recruit even a slightly greater proportion of MDs, and retention of more MDs and MD/PhDs in research careers could significantly enhance and diversify the clinician investigator workforce. In order to achieve this goal more opportunities are needed to increase clinician's participation in research training, beginning during residency, aiming to facilitate their transition to become established clinical investigators. Applicants are encouraged to propose well-designed institutional programs that will provide medical students and resident-investigators with research opportunities that can stimulate investigative curiosity and foster transition to additional research career development, while also meeting requirements for medical board specialty eligibility.

In otolaryngology, as in many medical specialties, research participation during medical school and residency provides valuable experience and an early “on-ramp” to a research career. It is also recognized that many medical students, MDs as well as MD/PhDs with previous research experience benefit from research opportunities, as they master their research capabilities and hone their research skills while they move toward becoming established investigators in otolaryngology-related science. The NIDCD's Mentored Research Education Pathway in Otolaryngology for Residents and Medical Students R25 program aims to provide such research-in-residency educational activities and opportunities by supporting medical students interested in otolaryngology and resident-investigators while they complete their clinical and research experiences. It is anticipated that participants supported by this program will be engaged in experimental approaches, form mentor-mentee relationships and gain the additional research skills needed to enhance their competitiveness for the next research career step such as subsequent post residency individual research and career development applications and awards.

This NOFO also aims to facilitate effective interactions with the residency director(s), institutional research leaders, and medical boards and optimize program participants' access to existing institutional research resources. Program participants identified by the institution will be medical students and health professionals with medical doctoral degrees (i.e., MD) with or without additional PhD degrees, with promise and interest in careers as clinician investigators in otolaryngology.

This NOFO supports institutional programs proposing educational research activities and opportunities designed for medical students and resident-investigators to engage in research projects with experienced investigators in the field. Medical students can undertake either short-term research experiences or academic year research experiences (i.e., nine months). Medical students in full-time research experiences for 12 months are not permitted. With the goal of accelerating the transition of participating residents to subsequent research and career development support, resident-investigators can be appointed to the program for a minimum of 12 and maximum of 24 months, to be completed within the residency at a minimum of  at least 80% effort. Resident-investigators are required to have a full-time appointment at the applicant institution, and to commit a minimum of 9.6 person-months (80% effort to research over 12 months) of the residency. Resident-investigator research activities within the program can occur at any point during residency training provided that each research period is a minimum of 3 consecutive months of at least 80% effort within one year of residency, and all research periods add up to a minimum of 12 months and a maximum of 24 months. Less than 80% effort at any given time across any 4-week research period is not allowed. Applicants are strongly encouraged to customize the time commitment for the mentored research experience for each resident-investigator based on their needs and research experience. Example options for a 12-month total research experience could be (but not limited to):

  • Option A: 12 months during the PGY-2 or PGY-3 year;
  • Option B: Last 6 months of PGY-2 year and first 6 months of PGY-3 year;
  • Option C: 3 months during the PGY-2 year and 9 months during the PGY-3 year; or
  • Option D: 3 months in PGY-1 year, 3 months in PGY-2 year, and 6 months in PGY-3 year.   

If the research experience is split into time blocks, a cogent plan for continuity of the research experience between time blocks must be provided.

Medical students and resident-investigators who complete the program are expected to continue in the next appropriate step to prepare for a research career, which may include an appointment to an institutional training grant or career development award, a post-residency fellowship, or an individual career development award. These could include appointments to a Ruth L. Kirschstein National Research Service Award (NRSA) postdoctoral T32 and/or F32, appointments to institutional TL1/KL2 or K12 awards, individual K08 and K23 mentored career development awards, or other awards, depending on their research background and experience. The NIH encourages institutions to recruit prospective program participants from diverse backgrounds, including those from groups currently underrepresented in the biomedical sciences, and to help promote a diverse and inclusive clinician investigator workforce.  For more information, see NOT-OD-20-031.

Program participants are encouraged to apply for loan repayment for qualified educational debt in return for research engagement, if eligibility criteria are met (https://www.lrp.nih.gov/eligibility-programs).

Program participants may also consider research training opportunities and graduate medical research fellowships within the NIDCD intramural program https://www.nidcd.nih.gov/training/intramural-labs.

 Program Components:

Institutional Programs

This NOFO will support institutional programs that propose to engage medical students and resident-investigators in otolaryngology research training. Institutional program applications submitted in response to this NOFO must be characterized by:

  • Supporting research projects that include concepts of hypothesis-based, rigorous and reproducible research, the fulfillment of discovery and achievement of designated research milestones.
  • Supporting resident-investigators for a minimum of 80% of PGY salary for a minimum of one year and a maximum of two years during residency training.
  • Facilitating the transition from resident-investigator to established clinical investigator.
  • Creating a pathway for medical students to pursue clinical research training in otolaryngology residency.
  • Fostering active collaboration and direct interactions with mentors and residents from other training specialties (e.g. neurology, internal medicine, pediatrics, pathology, radiology, etc.).
  • Defining outreach strategies to recruit prospective program participants from underrepresented groups, such as those described in the Notice of NIH's Interest in Diversity.
  • Sharing research opportunities with less research-intensive residency programs and/or establishing collaborations with institutions.
  • Including, as relevant, access to training and career development resources through established research training programs (e.g. Ruth L. Kirschstein National Research Service Award (NRSA) institutional T32 programs, Clinical and Translational Science Awards (CTSA) programs, etc.).

 

Institutional Awards

This program will provide support for supplementary research and professional development activities that will contribute to successful research careers, including:

  • Research supplies and technical support, including but not limited to biostatistics consultation and/or research technician effort to complete research objectives.
  • Registration and material for short-term courses or workshops that provide research skills such as data science, implementation science or clinical trials, as well as others as directly related to the participant's project and research career goals.
  • Participation in workshops on oral and written communication of research and grant writing related to the research project.
  • Travel to attend scientific conferences and NIH sponsored workshops and present research findings.
  • Support for skill-building needed for research supervision and effective mentoring of clinician-investigators for research preceptors; preceptor skill-building should include topics such as aligning goals and expectations, effective communication, time management, mentoring for a diverse and inclusive workforce, understanding research funds flow in an academic health center, building a successful research team, job negotiation, identifying grant opportunities, navigating an IRB and/or animal protocol, as appropriate for the research project.

The proposed institutional educational and research experiences in otolaryngology residency program may complement ongoing research training and education occurring at the applicant institution, but the proposed research experiences must be distinct from those programs currently receiving Federal support (e.g., T32, T90, R25, TL1/KL2, KL2).  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.

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
Renewal
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trial(s).

Note: Appointed participants are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.

Funds Available and Anticipated Number of Awards

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

Award Budget

Award budgets are composed of salary and other program-related expenses, as described below. NIDCD will not accept applications requesting $499,999 or more in direct costs in any year.

Award Project Period

The total project period may not exceed 5 years.

Other Award Budget Information

Personnel Costs

Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds).

Administrative costs for Institutional Program: Up to $20,000 per year may be requested for administrative costs. This could include salary for the institutional PD/PI or support personnel, travel of the institutional PD/PI, or to defray costs for external advisory committee travel and time (if requested). Funds for medical school tuition are not permitted.

Participant Costs

Medical students can have either short-term and/or up to nine-month appointments. Participants may be paid if specifically required for the proposed research education program and sufficiently justified. Participant costs must be itemized in the proposed budget Funds for medical school tuition are not permitted.

 Resident-Investigators Compensation: Remuneration for Resident-Investigators is through salary and fringe benefits. The total salary requested must be based on a full-time appointment and be consistent with the postgraduate year (PGY) salary structure at the institution. There must be an employee-employer relationship between the Resident-Investigators and the institution. During the research period, Resident-Investigators will be paid 80% of their base PGY salary level set by the Institution. 

Resident-Investigators salary should be calculated for the months of full-time research engagement over a year: 

In one example, a participant engages in research for a year at a salary of $60,000, with a monthly salary of $5,000; the award will support 80% effort over 12 months, which equates to 9.6 person-months; the budget figure for this Resident-Investigators would be $48,000 ($5,000 x 9.6). 

Medical Students Compensation: medical students can have either short-term and/or up to 9 months. appointments. Regardless of the level of experience, medical student salary and fringe benefits should be comparable to the NRSA predoctoral stipend (https://researchtraining.nih.gov/resources/policy-notices), and/or comparable to the salary and fringe benefits established by institutional policies for individuals in similar positions. 

Travel: Up to $3,000 each year may be requested for each Resident-Investigator to attend or present research findings at domestic scientific conferences, and to support attendance at a NIH-sponsored workshop. Requests for travel to scientific meetings or workshops must be carefully justified, with specific examples.

Tuition: Funds for courses directly related to the research experience and/or research project are allowed. Funds for medical school tuition and/or to complete an academic degree or certification not directly related to the research experience of the participants and program activities are not permitted. This is not a degree granting program. Participants may be compensated for participation in activities specifically required by the proposed research education program, if sufficiently justified. Participant costs must be itemized in the proposed budget.

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 meeting(s) 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.

Other Program-Related Expenses

Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.

Program Supplementary Research Funds:

Medical students: Up to $4,200 per student may be requested for training related expenses including travel and/or tuition for courses specifically required for the research project.

Resident-Investigators: Up to $20,000 per year, per Resident-Investigator, may be requested and must be justified and consistent with the stage of development of the participant and the proportion of time to be spent in research and/or professional development activities. Supplementary research funds may be used to defray costs for registration for  courses or workshops (as described above) to obtain research skills, to support skill development for research preceptors of clinician-investigators, research supplies, or where well-justified, for technical support to contribute to the participating Resident-Investigator's research continuity.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, expenditures for equipment and consortium costs in excess of $25,000), rather than on the basis of a negotiated rate agreement.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

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

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal
  • Governments (Other than Federally Recognized)

Federal Governments

  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations

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.

Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

Applicant Organizations

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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) – A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019

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(s) must have a regular, full-time appointment (i.e., not adjunct, part-time, or emeritus) at the applicant institution. This person should hold a health professional degree (e.g. MD, MD/PhD), have an appointment in a clinical department, have clearly demonstrated education/mentoring experience and have a strong recent history of NIH funding. Exceptional individuals without a clinical doctorate and with demonstrated leadership and mentoring experience in clinical departments may also serve as PD/PI. If the sponsoring institution is a hospital affiliated with a medical school, the PD/PI must have an appointment in both the medical school and at the sponsoring institution. The PD/PI(s) will design and provide oversight for the entire program.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review. (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Program Faculty

Researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, 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.

Research preceptors should have research expertise and a successful track record of mentoring clinician investigators. One may consider co-preceptors whenever one preceptor has limited experience; in this case, the timing and interactions between co-preceptors with the program participants must be described. Where possible, clinician investigators with various educational backgrounds should have opportunities to serve as preceptors.

Participants

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.

Medical Students

Medical students can undertake either short-term research experiences or academic year research experiences (i.e., nine months). Medical students in full-time research experiences for twelve months are not permitted.

Resident-Investigators

For the purposes of this program, resident-investigators include individuals with health professional doctoral degrees (e.g., MD with or without a research doctorate) engaged in graduate medical education consisting of advanced clinical training (herein referred to as “residency”). Resident-investigators are required to have a full-time appointment at the applicant institution, and to commit a minimum of 9.6 person-months (80% effort to research over 12 months) of the residency.

Section IV. Application and Submission Information

1. Requesting an Application Package

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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed in this Notice of Funding Opportunity 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.

Page Limitations

All page limitations described in the How to Apply - Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

Follow all instructions provided in the SF424 (R&R) Application Guide.

SF424(R&R) Project/Performance Site Locations

Follow all instructions provided in the SF424 (R&R) Application Guide.

SF424(R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

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. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

Other Attachments:

Advisory Committee

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 NOT be named in the application nor should they be contacted until the review is completed. Please name your file “Advisory_Committee.pdf”.

Data Tables

Tables must be included to show: (a) participating faculty including research preceptors (including their sources of support and records in research education activities as described for this program), (b) the potential participant pool, and, for applicants with a previous history of funding for research education, (c) information about past participants in other awards and their subsequent activities. For this purpose, the following Data Tables must be used: Data Tables 2, 3, 4, 5A, 5B, 8A, and 8C. For Table 5A, the "Degree" information in the "Training Period" column should be omitted since this R25 NOFO supports short-term, non-degree training experiences. These tables are not subject to a page limit. They should be compiled as a single pdf file. The filename "Data_Tables.pdf" should be used and the file attached.  Please note that the race, ethnicity, or sex of program faculty, program participants, or past program faculty or participants will not be considered in the application review process or when making funding decisions.

Participating Faculty and Preceptors

Provide the biosketch in NIH format for each participating faculty members and preceptors including their role in the proposed program, active research support, and previous mentoring track record. They should be compiled as a single pdf file. The filename "Participating  Faculty and Preceptors.pdf" should be used and the file attached.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section below:” Institutional Environment and Commitment". The application must include a signed letter on institutional letterhead from a President, Provost, Dean or key institutional leader that describes the activities and resources provided by the institution that will ensure the success of the planned R25 program and its participants (not to exceed 10 pages). Institutional commitment to the following areas should be described in the letter.

  • Available staff, facilities, administrative initiatives, and educational resources for the successful implementation of the planned program.
  • Promoting diversity and inclusion at all levels of the research environment (program participants, staff, faculty, and leadership), through means consistent with applicable law; ensuring the research facilities and laboratory practices promote the safety of the participants; ensuring the research facilities are accessible to participants with disabilities; ensuring a positive, supportive and inclusive research and training environment for individuals from all backgrounds.
  • Ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices and to appropriately respond to allegations of such discriminatory practices (e.g., see NOT-OD-15-152).

They should be compiled as a single pdf file. The filename "Letters of Support.pdf" should be used and the file attached.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

SF424(R&R) Senior/Key Person Profile Expanded

Follow all instructions provided in the SF424 (R&R) Application Guide.

R&R Budget

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

  • Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
  • Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.
  • A single consolidated budget is required, with each item clearly justified.

 Participant costs for the proposed research experiences and professional development activities may include:

  • Research supplies including biostatistics consultation, technician time, core facility use, or other technical components needed to complete research activities.
  • Fees for  courses or workshops that provide exposure to fundamental concepts of study design and analysis appropriate for the research project as well as contemporary approaches to scientific rigor (for details, see NOT-OD-16-011).
  • Fees for workshops to develop research skills including clinical trial design, bioinformatics use of large databases, or other specific training related to the research project.
  • Fees for workshops to develop research-related presentation skills, publication preparation, grant-finding and grant-writing and other professional activities related to the research project.
  • Fees for workshops to develop skills needed for effective research supervision of clinician investigators, including support for effective mentoring; workshop topics might include aligning goals and expectations, effective communication, time management, mentoring for a diverse and inclusive workforce, understanding research funds flow in an academic career, building a successful research team, job negotiation, identifying grant opportunities, navigating an IRB and/or animal protocol, as appropriate for the research project. 
PHS 398 Cover Page Supplement

Follow all instructions provided in the SF424 (R&R) Application Guide.

PHS 398 Research Plan

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

Research Strategy

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
  • Program Director/Principal Investigator
  • Program Faculty
  • Program Participants
  • Institutional Environment and Commitment
  • Recruitment Plan to Enhance Diversity
  • Training Plan in Methods to Enhance Reproduciblity
  • Plan for Instruction in the Responsible Conduct of Research
  • Evaluation Plan
  • Dissemination Plan

Research Education Program Plan

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. As a reminder, applicants may choose to address one or more of the activities listed in Section I. Funding Opportunity Description.

Program Participants Research Education Opportunities. Applications should describe the available research opportunities, including the research problems to be addressed, and available methods and technology research skills to be acquired, that can prepare program participants for careers as clinician investigators. Include a description of how available research opportunities contribute to the concepts, treatments, or preventative interventions that drive a field. Applications must describe each of the items below.

  • Plans for recruitment, selection, and matching of participants with available research preceptors and opportunities.
  • Plans to develop and implement an assessment of research competencies and milestones for participants with and without a research doctorate. Competencies might include analysis of information and formulation of research questions, research collaborations, data acquisition and analysis, scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, as well as other research professional development activities.
  • Partnership with any existing NIH research programs, other less research-intensive residency programs, institutions that have a documented historical institutional mission of educating underrepresented students, and academic or non-profit partnerships where health professionals might engage in research. For example, residents might conduct research in global health through international organizations affiliated with their home institutions, or institutions in a geographic region might partner to offer broader research experiences than possible at one institution to support a network of resident researchers.
  • Participation in local, regional, and national scientific meetings.
  • Strategies designed to foster participants success including a description of how the planned R25 program will ensure that participants will complete the necessary activities to achieve milestones including:
    • Completion of research skill-building activities.
    • Assessment of research competencies.
    • PD/PI evaluation letter to include a written review of each participant's progress and promise.
    • Assistance to participants in the identification of an appropriate research career step including subsequent clinical fellowship, post-residency fellowship and any other career milestones.

Less experienced program participants may require a phased developmental period in which the award includes considerable skill-building followed by a period of supervised research. Candidates with more experience at the time of selection may already have an adequate theoretical or practical background and need a shorter developmental period.

Because resident-investigators uniquely must fulfill both research goals and clinical duties, it is essential that the program description include an annotated timeline indicating planned periods of research leading to research competencies, as well as periods of clinical duties leading to specialty board-eligibility. Evidence that the proposed institutional plan for clinical and research activities in residency is recognized as sufficient to prepare for board eligibility is required at the time of application.

For resident-investigators the applicant institution must provide research and clinical activities that lead to certification. Describe how the overall structure of the proposed program of research and clinical activities will lead to participant eligibility for certification or endorsement and oversight by the American Board of Otolaryngology - Head and Neck Surgery (ABOHNS https://www.aboto.org/). The overall structure of the institutional program must also include a process for determining if the program participants will require additional residency training time to achieve compliance with ABOHNS. Applicants must be aware that time dedicated to program activities cannot overlap with the time dedicated to clinical duties of the residency program and/or the time requirements of the ABOHNS.

Applications from institutions that have NIDCD-funded T32 programs that support MDs or MD/PhDs in otolaryngology residency training must describe how the proposed program will complement the existing program(s) and potential overlap between programs will be avoided.

       Progress Report for Renewal Applications

For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and evaluation of the training program.   

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.

Describe arrangements for the leadership of the program, and how the professional appointments and experience of the PD/PI will enhance these activities. Within the design of the program, the PD/PI must identify the residency director, departmental chairs, and research deans, and their roles in the program with respect to affiliation and responsibility should be clearly described. Provide a description of any planned meetings between the PD/PI, program participants and mentors/mentoring teams and how they will be implemented and documented. Provide evidence that the PD/PI is actively engaged as a clinician investigator in an area relevant to the application, with strong recent history of extramural funding.        

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 available research opportunities with participating preceptors, and their responsibilities to the program. Describe how research preceptors are selected and reviewed, and the timing and types of meetings planned between program participants and preceptors to ensure that each program participant receives the skills and knowledge he/she requires to achieve the goals of the program. Within the narrative, provide a list of the names, titles, and departmental affiliations of research preceptors, along with evidence of current research funding. Please note that the race, ethnicity, or sex of program faculty will not be considered in the application review process or when making funding decisions. 

Applicants should summarize key data from Tables 2, 8A, and 8C that highlight the mentoring records of participating faculty members and their roles in fostering the educational and career outcomes of medical students and early-stage health professionals.

Preceptors in basic sciences who may not have served as mentors of health professionals in the past but who have an extensive and successful mentoring record  can be assigned as part of mentoring team or as co-mentors. Teams of preceptors/mentors are allowed.

Program Participants. Applications must identify the career levels for which the proposed program is planned.

Provide details about the recruitment and selection strategies for program participants. Describe the pool of medical students available. Describe recent applicants to the residency and fellowship program(s), including the number of applications, interviews and matched residents. Discuss any unfilled residency positions, especially if they were designed to support a research pathway. Please note that the race, ethnicity, or sex of program participants will not be considered in the application review process or when making funding decisions.

For medical students and residents matriculated at the applicant institution, describe the range of previous research and educational experiences among the cohorts. Describe the criteria and strategy for selecting the intended program participants for this research program, and the eligibility criteria and/or specific educational background characteristics that are essential for participation.      

Institutional Environment and Commitment. Describe any additional aspects of the Institutional Environment and Commitment not addressed under “Facilities & Other Resources” or the required “Institutional Commitment Letter of Support,” described below. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. This section should not duplicate information provided elsewhere.

Describe the institutional environment for clinician investigators, including the extant clinician investigator workforce of participating faculty, research staff, protected time for research, graduate medical staff and students, and how this program is designed to enhance that workforce.

Describe the overall institutional research environment, including research faculty and staff, core facilities, resources, or any unique features available at the institution.    

Recruitment Plan to Enhance Diversity.

The applicant must provide a Recruitment Plan to Enhance Diversity . Include outreach strategies and activities designed to recruit prospective participants from  underrepresented groups described in the Notice of NIH's Interest in Diversity. Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups.

 

Applications lacking a Recruitment Plan to Enhance Diversity 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 and NOT-OD-22-055. 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 the responsible conduct of research will not be reviewed.

Evaluation Plan. 

Applications must include a plan for evaluating the activities supported by the award, and the success of the program in recruiting clinician-investigators and providing them with research experiences and related education that will prepare them to go on to more formal research training and career development programs. Institutions will be responsible for evaluating their own programs. Programs are encouraged to consider the characteristics of anticipated participants, the research experiences and interventions provided in the program to stimulate research careers, as well as the goals and measurable objectives to be used within the context of the NIH expectations and in line with their institutional settings and missions.

It is essential that applications describe goals appropriate for both participants with limited prior research exposure as well as those with substantive research experience including research doctorates, and where possible, information about any appropriate comparison groups. Programs are also encouraged to use qualitative approaches that measure aspects of participant or preceptor satisfaction, science identity (e.g., psychological processes by which people become inspired by science) or other measures where evidence may support persistence to a clinician investigator career.

The application must specify baseline characteristics (e.g., numbers of applicants, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the award in achieving its objectives. Programs are encouraged to collect information to be used for evaluation of the program, including metrics that will include, but are not limited to, the following:

  • Aggregate number and demographic characteristics of participants.
  • Subsequent educational/career progress, including:
  • Presentation of research completed in this program
  • Authorship of scientific publications in a STEM field
  • Participation in further research or career development training programs (e.g. post residency)
  • Completion of a subsequent research training or career development appointment or award
  • Application of and awards granted for research funding
  • Subspecialty board passage rate
  • Subsequent employment in a research or research-related field
  • Percentage of professional effort in research

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.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above: "Institutional Environment and Commitment.")

Resource Sharing Plan
Note: Effective for due dates on or after January 25, 2023, a Data Management and Sharing Plan is not applicable for this NOFO.

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:

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:

  • Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
  • The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
  • To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix

Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined 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 Information

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

Delayed Onset Study

Note: 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.

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply - Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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 form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NIDCD Research Training Officer by email at riverara@nidcd.nih.gov and the NIDCD Chief of the Review Branch by email at melissa_stick@nih.gov when the application has been submitted. Please include the NOFO number and title, PD(s)/PI(s) name(s), and title of the application.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this research education program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

 

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?

Are the available research opportunities likely to lead to improvements in scientific knowledge, technical capability, and/or clinical practice?

Does the proposed program provide suitable research skill-building for the background research proficiency of program participants?

Will the proposed mentored research activities facilitate the participants' ability to become clinician-investigators?

Is the proposed program likely to effectively provide research opportunities and skills needed for program participants with varied research backgrounds?

 

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?

If applicable, are the faculty leading the program good role models for the program participants by nature of their scientific accomplishments and track record of mentoring?

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? 

Are sufficient numbers of experienced research preceptors with appropriate expertise and funding available to support the number and level of program participants proposed in the application?

Is there evidence that the participating research preceptors have experience mentoring clinician-investigators?

Does the PD/PI have sufficient expertise and accessibility to other program faculty and Resident-Investigators to assess program participants research potential and provide guidance in selecting appropriate clinical fellowships and other research-focused activities?

 

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 program provide unique and innovative ways to leverage resources to develop a more diverse otolaryngology workforce?

Does the program propose unique and innovative ways to teach residents how to combine research and clinical practice?

Does the program provide unique and innovative ways to change the culture of an otolaryngology training program to value research and its contributions to clinical care?

 

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?

Does the strategy to be used adequately consider the varied research backgrounds of program participants?

Will research and research skill-building activities provide an appropriate foundation for subsequent research activity?

Are appropriate plans in place to ensure that research preceptors provide mentorship appropriate for clinician-investigators, including scheduled meetings with documentation?

When applicable, is there adequate documentation describing the responsibilities of the advisory committee with respect to the provision of input, guidance and oversight of the program? 

 

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?

Are the activities adequately integrated with the institution’s other programs to prepare clinician investigators?

Are the research facilities, resources (e.g., equipment, laboratory space, computer resources, subject populations), and professional development opportunities (e.g. seminars, workshops, professional development opportunities) adequate and appropriate?

Is there appropriate institutional commitment to fostering the program participant’s mentored research toward his/her research career goals? Will the proposed activities engage and enhance the existing clinician-investigator workforce?

Does the institutional environment for clinician-investigators in which the program will be conducted contribute to the probability of success?

Additional Review Criteria

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

 

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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals 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.

 

Does the Instruction in Methods for Enhancing Reproducibility plan describe how trainees will be instructed in principles important for enhancing research reproducibility including, at a minimum, evaluation of foundational research underlying a project (i.e., scientific premise), rigorous experimental design, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping, and transparency in reporting? Are the rigor and transparency components sufficiently well integrated into the overall curriculum? Are they taught at multiple stages of trainee development and in a variety of formats and contexts? Does the teaching synergize with elements of the curriculum designed to enhance trainees' abilities to conduct responsible research? Is there evidence that all program faculty reiterate and augment key elements of methods for enhancing reproducibility when trainees are performing mentored research in their laboratories?

 

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.

 

For Renewals, the committee will consider the progress made in the last funding period. Does the application describe the program’s accomplishments over the past funding period(s)? Is the program achieving its objectives? Has the program evaluated the quality and effectiveness of the activities, and is there evidence that the evaluation outcomes and feedback from participants have been acted upon? Are changes proposed that are likely to improve or strengthen the program during the next project period?

 

Not Applicable

Additional Review Considerations

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

 

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 prospective participants 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 and NOT-OD-22-055. 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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable. 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.

2. Review and Selection Process 

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policies and practices, 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 will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines 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 Deafness and Other Communication Disorders Advisory Council. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients 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 NOFO 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.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

Not applicable for R25 research education program awards.

4. Reporting

NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Failure by the recipient 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 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Other Reporting Requirements

  • The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed full time for eight weeks or more or the equivalent. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
  • Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.

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.

5. Evaluation

In carrying out its stewardship of human resource-related programs, NIH or its Institutes and Centers will periodically evaluate their R25 research education programs, employing the measures identified below.  In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from participants themselves.  Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants’ subsequent educational or employment history and professional activities.

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 NIDCD expects to use the following evaluation measures:

For Research Experience and Mentoring Programs Involving the Following Groups:

Medical Students:

  • Aggregate number and demographic characteristics of participants
  • Subsequent educational/career progress of participants, including:

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

Resident-Investigators:

  • Aggregate number and demographic characteristics of participants
  • Subsequent educational/career progress of participants, including: 

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    

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (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: 301-480-7075

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

Scientific/Research Contact(s)

Alberto L. Rivera-Rentas, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-1804
Email: riverara@nidcd.nih.gov

Peer Review Contact(s)

Melissa J. Stick, Ph.D., M.P.H.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-8683
Email: melissa_stick@nih.gov

Financial/Grants Management Contact(s)

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-0909
Email: myersc@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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