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 Pathway for Otolaryngology Residents and Medical Students (R25 - Clinical Trial Not Allowed)

Activity Code

R25 Education Projects

Announcement Type

New

Related Notices

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 Announcement (FOA) Number

RFA-DC-20-002

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) 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 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 FOA will support creative educational activities with a primary focus on     Research Experiences. In particular, this FOA seeks applications from institutional programs that can provide outstanding educational activities to medical students and resident-investigators in otolaryngology and foster their ability to transition to individual career development research awards. The program will support institutions to create a pathway in otolaryngology research careers through structured programs for medical students and resident-investigators with defined program milestones. Program participants 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, fellowship, or individual career development award.

Key Dates
Posted Date

September 22, 2020

Open Date (Earliest Submission Date)

September 23, 2020

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

October 23, 2020; June 10, 2021; February 10, 2022; October 11, 2022; June 13, 2023 apply.

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2021; November 2021; July 2022; March 2023; November 2023 apply.

Advisory Council Review

May 2021; January 2022; October 2022; May 2023; January 2024 apply

Earliest Start Date

July 2021; April 2022; December 2022; July 2023; April 2024 apply

Expiration Date

June 14, 2023

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions will not be reviewed


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


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

    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 goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.

    The over-arching goal of this  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 FOA will support creative 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 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 FOA 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 FOA 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 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 and retain individuals from groups currently underrepresented in the biomedical sciences, and to enhance the diversity of the clinician investigator workforce (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 FOA 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 FOA 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 80% of PGY salary for a minimum of one year and a maximum of two years during residency training.
    • Supporting a maximum of two medical students per year and a minimum of one and a maximum of four resident-investigators each year.
    • 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 strategies to enhance the diversity of the biomedical workforce as defined by 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 support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New
    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 FOA.

    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.

    Need help determining whether you are doing a clinical trial?

    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. A minimum of one to a maximum of four residents must be supported in each year of the program.

    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 1 year 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 short-courses directly related to the research experience and/or research project are allowed. Funds for medical school tuition are not permitted.


    Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.

    While generally not an allowable cost, with strong justification, participants in the research education program may receive per diem unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition and other education-related expenses.

    Expenses for foreign travel must be exceptionally well justified.

    Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by an R25 program, as participants, but may not receive salary or stipend supplementation from a research education program.

    Because the R25 program is not intended as a substitute for an NRSA institutional training program (e.g.,T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 9-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 short-term courses or workshops 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 and expenditures for equipment), 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 FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

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

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

    • ·    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)

    Only medical schools, and residency and/or post-residency fellowship programs recognized by the Accreditation Council for Graduate Medical Education (ACGME) may be included in the proposed program.

    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 Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

    Required Registrations

    Applicant Organizations

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

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

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

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

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

    3. Additional Information on Eligibility
    Number of Applications

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

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
    Program Faculty and Research Preceptors

    Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

    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, as well as those from backgrounds underrepresented in biomedical science should have opportunities to serve as preceptors.

    Participants

    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.

    By the time of the appointment to the program, individuals must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e. possess a currently valid Permanent Resident Care USCIS Form 1-551, or other legal verification of such status.

    Institutional Environment

    The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

    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 FOA. 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 Research  (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.

    Letter of Intent

    Not Applicable

    Page Limitations

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

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    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.  

    Describe the institutional research environment and the clinician investigator workforce including faculty, research staff, graduate medical staff and students.

    Describe the plan for how this program will benefit from any extant NIH research, training and career development programs, affiliations with other institutions, and academic or non-profit partnerships where program participants might engage in research.

    Other Attachments. Advisory Committee

    An Advisory Committee is not a required component of a research training program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research 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 assess 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. The filename "Advisory Committee.pdf" should be used and the file attached.

    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 in diverse populations, (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 FOA supports short-term, non-degree granting 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.

    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 succesful implementation of the planned program.
    • ·    Promoting diversity and inclusion at all levels of the research environment (program participants, staff, faculty, and leadership); ensuring the research facilities and laboratory practices promote the safety of the participants; ensuring the research facilities are accessible to participipants 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, including providing any required notifications to NIH or OCR (e.g., see NOT-OD-15-152).
    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 short duration 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 Component

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

    Research Strategy

    The 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
    • ·    Diversity Recruitment Plan
    • ·    Plan for Instruction in the Responsible Conduct of Research
    • ·    Evaluation 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.

    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 program, institutions that will increase the diversity of the biomedical workforce as defined by NIH's Interest in Diversity, 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.

    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.        

    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. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.

     

    Describe the 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.

    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 records can be assigned as part of mentoring team or as co-mentors. Teams of preceptors/mentors are allowed.        

    Program Participants. Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels  for which the proposed program is planned.

    Provide details about 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.

    For medical students and residents matriculated at the applicant institution, describe the overall demographic distributions, and 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 the institutional environment, reiterating the availability of facilities and educational resources (described separately under “Facilities & Other Resources”), that can contribute to the planned Research Education Program. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must be attached as part of Letters of Support (see below). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

    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 (NOT-OD-20-031):

    Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints . NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

    Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

     Underrepresented Populations in the U.S. Biomedical, Clinical, Behavioral and Social Sciences Research Enterprise
    In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

    A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this program. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity (https://www.govinfo.gov/content/pkg/FR-1997-10-30/html/97-28653.htm).

    B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at, https://www.nsf.gov/statistics/2017/nsf17310/static/data/tab7-5.pdf.

    C. Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria:

    1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act (Definition: https://nche.ed.gov/mckinney-vento/);

    2. Were or currently are in the foster care system, as defined by the Administration for Children and Families (Definition: https://www.acf.hhs.gov/cb/focus-areas/foster-care);

    3. Were eligible for the Federal Free and Reduced Lunch Program for two or more years (Definition: https://www.fns.usda.gov/school-meals/income-eligibility-guidelines);

    4. Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces.ed.gov/pubs2018/2018009.pdf);

    5. Were or currently are eligible for Federal Pell grants (Definition: https://www2.ed.gov/programs/fpg/eligibility.html);

    6. Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www.fns.usda.gov/wic/wic-eligibility-requirements).

    7. Grew up in one of the following areas: a) a U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer (https://data.hrsa.gov/tools/rural-health), or b) a Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas  (qualifying zipcodes are included in the file). Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition.

    Students from low socioeconomic (SES) status backgrounds have been shown to obtain bachelor’s and advanced degrees at significantly lower rates than students from middle and high SES groups (see https://nces.ed.gov/programs/coe/indicator_tva.asp), and are subsequently less likely to be represented in biomedical research. For background see Department of Education data at, https://nces.ed.gov/; https://nces.ed.gov/programs/coe/indicator_tva.asp; https://www2.ed.gov/rschstat/research/pubs/advancing-diversity-inclusion.pdf.

    D. Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008902/).

    Women have been shown to be underrepresented in doctorate-granting research institutions at senior faculty levels in most biomedical-relevant disciplines, and may also be underrepresented at other faculty levels in some scientific disciplines (See data from the National Science Foundation National Center for Science and Engineering Statistics: Women, Minorities, and Persons with Disabilities in Science and Engineering, special report available at https://www.nsf.gov/statistics/2017/nsf17310/, especially Table 9-23, describing science, engineering, and health doctorate holders employed in universities and 4-year colleges, by broad occupation, sex, years since doctorate, and faculty rank).

    New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of prospective participants from underrepresented backgrounds and may wish to include data in support of past accomplishments.

    Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).  The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. See also  NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

    Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.

    Evaluation Plan.

    Applications must include a plan for evaluating the activities supported by the award, 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

     

    Resource Sharing Plans

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

    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 Policy on Late Application Submission.

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

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

    For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:
    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review 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 FOA 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. Any instructions provided here are in addition to the instructions 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 R25 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.

    Significance

    Does the proposed program address a key audience and an important aspect or important need in research education? Is there compelling 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?

    Investigator(s)

    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?

    Innovation

    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?

    Approach

    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? 

    Environment

    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.

    Protections for Human Subjects

    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.

     

    Inclusion of Women, Minorities, and Individuals Across the Lifespan

    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.

     

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

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

     

    Resubmissions

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

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations

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

    Recruitment Plan to Enhance Diversity

    Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of 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.

    Training in the Responsible Conduct of Research

    Taking into account the specific characteristics of the proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years.  See also: NOT-OD-10-019. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

    Applications from Foreign Organizations

    Not Applicable

    Select Agent Research

    Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan

    Budget and Period of Support

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    2. Review and Selection Process

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


    As part of the scientific peer review, all applications:

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

    Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

    Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Deafness and Other Communication Disorders Advisory Councill. The following will be considered in making funding decisions:

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

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

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

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

    Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

    Institutional Review Board or Independent Ethics Committee Approval: Grantee 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 awardee 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency.  The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.  Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

     

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

     

    Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.    

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

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted. Programs that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the RPPR Instruction Guide.  

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

    Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

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

    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. Grantees 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.

     

    4. Evaluation

    In carrying out its stewardship of human resource-related programs, the 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, NIDCD 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, NIDCD 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: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

     

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    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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