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Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title
NIAID Research Education Program Advancing the Careers of a Diverse Research Workforce (R25 Clinical Trial Not Allowed)
Activity Code

R25 Education Projects

Announcement Type

New

Related Notices

November 3, 2023 - This PAR has been reissued as PAR-23-282.

NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available

November 9, 2022 - Notice of Change to Award Information in PAR-21-258, NIAID Research Education Program Advancing the Careers of a Diverse Research Workforce (R25 Clinical Trial Not Allowed) . See Notice NOT-AI-23-004

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018.

September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice NOT-OD-21-181.

August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169.

August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170

April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109

NOT-OD-19-109 - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020. NOT-OD-19-109

Funding Opportunity Announcement (FOA) Number
PAR-21-258
Companion Funding Opportunity

None

Assistance Listing Number(s)

93.855

Funding Opportunity Purpose

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research

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

  • Courses for Skills Development
  • Research Experiences
  • Mentoring Activities

Key Dates

Posted Date
July 16, 2021
Open Date (Earliest Submission Date)
August 10, 2021
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

September 10, 2021; January 25, 2022; May 25, 2022; January 25, 2023; May 25, 2023

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)

September 10, 2021; May 7, 2022; September 7, 2022; May 7, 2023; September 7, 2023

All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related 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.

Scientific Merit Review

Non-AIDS Applications: November 2021; July 2022; November 2022; July 2023; November 2023

AIDS Applications: November 2021; July 2022; November 2022; July 2023; November 2023

Advisory Council Review

Non-AIDS Applications: January 2022; October 2022; January 2023; October 2023; January 2024

AIDS Applications: January 2022; October 2022; January 2023; October 2023; January 2024

Earliest Start Date

Non-AIDS Applications: March 2022; December 2022; March 2023, December 2023; March 2024

AIDS Applications: March 2022; December 2022; March 2023, December 2023; March 2024

Expiration Date
September 08, 2023
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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 may be delayed or not accepted for review.


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 overarching goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.

NIAID seeks to further promote diversity in research training and education programs by developing programs that ultimately support the increased participation and retention of undergraduate, graduate, health professional students, postdoctoral fellows, and early career investigators from nationally underrepresented backgrounds as defined in the Notice of NIH’s Interest in Diversity, NOT-OD-20-031. By supporting educational activities that enhance the diversity of the biomedical, behavioral and clinical research workforce, NIAID strives to increase the pool of current and future research investigators from diverse backgrounds, including from groups underrepresented within NIAID mission areas, and facilitate the career advancement and/or transition of participants to the next step in their scientific careers.

The mission of the National Institute of Allergy and Infectious Diseases (NIAID) is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. In addition, NIAID has a unique mandate which requires the Institute to respond to emerging public health threats. Furthermore, the mission includes educational activities that complement the training of the next generation of scientists in NIAID-related research areas. NIAID is committed to the development of a biomedical research workforce that is reflective of the diversity in the U.S. Thus, NIAID seeks to promote diversity in all of its training and research programs and to increase the participation of underrepresented groups in order to develop a highly competent and diverse scientific workforce capable of conducting state-of-the-art research in NIAID mission areas.

Background

The NIH (NIH) recognizes the need to diversify the scientific workforce by enhancing the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral, and social sciences research workforce. Diversity at all levels from the types of science to the regions in which it is conducted to the backgrounds of the people conducting it contributes to excellence in research training environments and strengthens the research enterprise. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual interests to address complex scientific problems. Many benefits flow from a diverse NIH-supported scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of research, enhancing public trust, and increasing the likelihood that health disparities and the needs of underserved populations are addressed in biomedical research. NIH strives to ensure that future generations of researchers will be drawn from the entire pool of talented individuals, bringing different aptitudes, perspectives, interests, and experiences to address complex scientific problems. NIH seeks to enhance the diversity of the biomedical research workforce by supporting individuals from a variety of backgrounds at multiple training and career stages in a variety of institutions and educational settings across the country.

Program Need

Promoting diversity in the extramural scientific workforce is critical to the success of the NIH mission and is consistent with the mandates of the 21st Century Cures Act. While scientific workforce diversity supports the NIH mission, expanding the pool of research investigators from nationally underrepresented backgrounds in the biomedical workforce remains an elusive goal. The NIH has a longstanding commitment to training the next generation of biomedical scientists and supporting training of students from diverse backgrounds, for example groups underrepresented in biomedical research, through a variety of fellowships, career development awards, and institutional training. In spite of recent advances, individuals from certain groups and backgrounds are underrepresented in the biomedical sciences research workforce as described in the Notice of NIH’s Interest in Diversity.

The severity of the underrepresentation of these groups increases throughout the training stages. For example, students from certain racial and ethnic groups, including Blacks or African Americans, Hispanics or Latinos/Latinas, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders comprise approximately 39 percent of the college population, but earn approximately only 17 percent of bachelor’s degrees, and 13 percent of doctoral degrees in the life sciences. Additionally, while the U.S. has seen a significant increase in the number of Ph.D. degrees in the biomedical sciences earned by scientists from historically underrepresented racial and ethnic groups in the biomedical research workforce, a corresponding increase in the ranks of the faculty in basic science departments has not occurred. In 2006, individuals from backgrounds underrepresented in the biomedical sciences constituted approximately 25% of the U.S. population, and 15% of recent medical graduates, but only 7.5% of full-time medical faculty. Over time, these rates also have remained stagnant. In 2020, individuals from underrepresented backgrounds represented approximately 33% of the U.S. population and 13% of recent medical graduates, but only 7.3% of full-time medical faculty. Active interventions are necessary to prevent the loss of talent at each level of educational advancement.

Program Approach

This NIAID Research Education Program Advancing the Careers of a Diverse Research Workforce is a specialized program designed to foster the development of research scientists from diverse backgrounds, including diverse career stages and underrepresented backgrounds. Thus, the NIAID encourages applications from applicant organizations that propose innovative courses for skills development, research experiences, and mentoring activities and that focus on factors that have been shown to affect retention of groups nationally underrepresented in biomedical research, including, but not limited to scientific networks, mentoring, and attention to structural and institutional environments regarding inclusion. Programs that target more than one career stage and/or career transitions for career progression and advancement are strongly encouraged. Programs in response to this FOA should focus on asset models and leadership opportunities, rather than solely on deficit models of approach and remediation.

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

  • Courses for Skills Development: For example, to provide advanced courses or curricula in a specific discipline, research technique, or research area, clinical procedures for research, specialized research techniques, grant writing, scientific writing, or research methodology, and/or courses or workshops to develop scholarly potential to prepare participants for graduate school admissions, successful completion of a research-focused doctoral-level degree, and careers in the biomedical research workforce to facilitate the development of a sophisticated cadre of investigators with the requisite scientific research skills to advance the mission of NIAID. Courses or curricula may include elements that promote research skills and career skills of the participants. The format of the courses may involve a traditional in-person approach, online and/or virtual activities, a hybrid of both approaches, or other methods. NIAID expects that the course(s) for skills development provide innovative, state-of-the-art, evidence-based education that relates to the mission of NIAID, and is derived from biomedical, behavioral, or clinical research findings. The courses may include didactic and hands-on elements that promote the research and career skills of the participants.
  • Research Experiences: For example, to provide hands-on exposure to research, to prepare participants for graduate and health professional school admissions, successful completion of research-focused doctoral-level degrees, and careers in the biomedical research workforce; and/or for graduate and medical, dental, nursing, and other allied health professional participants to become acquainted with the important role of health professionals in the biomedical research enterprise, and to enhance knowledge, interest, and entrance into basic biomedical, translational, or applied clinical research as a career related to the NIAID mission; to provide research experiences and related training not available through formal NIH training mechanisms; to provide hands-on authentic research experiences that reflect ownership of a project and provide opportunity for meaningful contribution to the research in question. NIAID expects that the research experiences supported by this FOA are related to the participants' area of science, tailored to the needs and career levels of participants, and sufficiently different such that the experience expands or extends their skills, and addresses some area of NIAID extramurally supported research. NIAID expects that mentoring will be provided in conjunction with planned research experiences and participants will design individualized development plans (IDPs) that are compatible with their needs and experience.
  • Mentoring Activities: This FOA will support the development, implementation and evaluation of mentoring activities and mentoring networks that reflect the research priorities of the NIAID. While there is no universally accepted definition of scientific mentoring, it is widely recognized as an important element for career development. Proposed programs are, therefore, expected to contribute to building a skilled cadre of investigators in requisite areas to advance the NIAID mission. For example, mentoring may include dedicated efforts at providing not only technical expertise, but also advice, insight, and professional guidance on the development of career skills. Such activities may include periodic scheduled contacts with participants through a variety of methods, including the use of various mentoring materials, webinars, phone/Zoom calls, or email follow-ups, development of mentoring networks that facilitate scholarly writing and grantsmanship, promoting successful transitions from one career stage to another, providing leadership development, helping to identify potential research collaborators; and/or helping to establish multidisciplinary, translational collaborations in order to foster and nurture a career trajectory towards an independent research career within a NIAID-related mission area.

Where applicants are planning to propose mentoring networks, NIAID expects them to be structured to provide significant new opportunities, and should comprise efforts substantially beyond any ongoing mentoring, networking, or research education within academic programs, institutions, or pre-existing networks; or educational collaborations among institutions. Proposed mentoring networks are expected to enhance the participants professional development and to nurture their career development and trajectory towards independent research in NIAID mission areas. Mentoring networks may propose to include individuals from a single career stage or may bridge several career stages. Given the broad mission of NIAID, the content chosen for a proposed mentoring network is expected to be of sufficient breadth to provide reasonable assurance of the ability to recruit a high-quality pool of potential participants annually and to ensure that a critical mass of mentors and participants are involved in the network. Participants should be actively engaged in the network for a period of no less than one year, maintaining regular contact with mentors and peers within the network during that time. Expected outcomes for individuals participating in mentoring networks include, but are not limited to, subsequent involvement in research; subsequent employment in NIAID mission areas; subsequent independent grants support from NIH or other sources; and/or authorship of scientific publications. Mentoring networks may be regional or national, or designed to link complementary organizations or institutions. For example, an applicant organization may wish to partner with other organizations to develop a national training network.

The NIH realizes that quality mentorship is critical to the recruitment and retention of scientists from underrepresented groups. Therefore, this FOA welcomes programs aimed at improving the caliber of mentorship. Examples include, but are not limited to workshops to educate mentors on establishing and sustaining effective research mentoring relationships (e.g. summer course or a workshop accompanying a scientific meeting within the mission of NIAID in which case-based scenarios may be used to educate mentors on various relevant ethical, professional and cultural issues facing students today for example, effective communication and mentoring compacts, or addressing cultural awareness, among others). Mentors from all demographic backgrounds should be encouraged to participate in the proposed program.

NIAID recognizes that some eligible institutions may not have enough active researchers with extramural funding to support on-campus research experiences. Such institutions can establish collaborative arrangements with research-intensive institutions that have a significant number of faculty mentors with NIH or other extramural research support to have their participants benefit from off-campus research experiences.

Annual Awardee Workshop:

As a part of this research education program, NIAID requires program participant attendance (including the Program Director/Principal Investigator and one key person) at an annual awardee workshop at NIH to further foster networking, collaboration, mentorship, and career development of each cohort to foster needed support in preparation for research independence.

Applications Not Responsive to this FOA

Applications lacking plans to include all three activities described above (courses for skills development, research experiences, and mentoring activities) will be considered non-responsive and will not be reviewed. The emphasis on each activity need not be equal, however each one must be included.

Applicants are strongly encouraged to contact the Scientific/Research Contact(s) for information about priorities and policies before preparing an application.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs,

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

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
Resubmission
New

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

Application budgets are limited to $351,000 direct costs per year, and must reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is five 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).

Participant Costs

Participants may be compensated for participation in activities specifically required by the proposed research education program, if sufficiently justified. Participant costs must be itemized in the proposed budget.

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

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

Expenses for foreign travel must be exceptionally well justified.

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

Because the R25 program is not intended as a substitute for an NRSA institutional training program (e.g.,T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.

.Costs of research supplies and participant travel during the period of appointment to relevant educational or national scientific meetings are allowed.

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.

In addition, limited program evaluation costs are allowed up to a maximum of $3,000 for the 5-year project period.

Indirect Costs

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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


Other

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

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

Foreign 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.
  • 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 should have research, teaching, and/or academic administrative experience. Early stage investigators are eligible to serve as PD/PIs, as long as doing so will not detract from their research program and career advancement. If a scientific/professional society is identified as the applicant organization, the advisory board of the given society or organization should identify an affiliated member to serve as PD/PI and work with them to develop an application for support.

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

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.

Participants

Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents.

Participants are limited to the following individuals:

  • Undergraduate students and master level graduate students.
  • Graduate/health professional (e.g., medical, dental, nursing, and other allied health) students, medical residents, postdoctoral fellows, and/or early career faculty. For this program "early career faculty" must be within the first 8 years of their first faculty appointment.
  • Participants may be from a single career stage, or programs may propose to bridge several career stages of participants.
  • Participants may be early career researchers that are moving into new research areas relevant to the NIAID research.

Note that high school students may not be supported as participants under this FOA.

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 instructions in 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

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

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

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

The letter of intent should be sent to:

James T. Snyder, Ph.D.
Telephone: 240-669-5060
Email: [email protected]

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission

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

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.

Other Attachments.

  • An Advisory Steering Committee is not a required component of a Research Education program. However, if an Advisory Steering Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file Advisory_Steering_Committee.pdf
  • Responsive applications are required to include a Research Education Outcomes attachment that includes the information requested below. The Research Education Outcomes attachment must be in pdf format with a filename of "Research_Education_Outcomes.pdf". Including the following information in a table format is allowed (4 pages maximum): outcomes and subsequent educational/career progress as appropriate to career stage about recent (past 5 years) partcipants (including partcipants in a pilot program) and the pool of potential applicants, such as:
  • Aggregate number and demographic characteristics of participants
  • Educational level of participants
  • Successful enrollment in an advanced degree program (e.g., M.D., or Ph.D.)
  • Successful completion of a graduate degree program in a NIAID-research related field
  • Subsequent authorship of scientific publications or scientific presentations to outside conferences in a biomedical field
  • Subsequent participation in a formal research training or career development program in a NIAID-related research field
  • Subsequent participation in NIAID-related research

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

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

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

R&R Budget

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

  • Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
  • Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.
  • Applicants should also budget for the cost of the PD/PI and one (1) key person to attend a two-day annual awardee workshop held by the NIAID in the Washington, D.C. metro area each year of the award.
PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy

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
  • Dissemination Plan

Research Education Program Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.

If collaborations or partnerships exist, provide detailed information of an integration plan across the partnering institutions to improve academic and research competitiveness for the participants. Adaptations of existing research education programs may be considered innovative under special circumstances (e.g., the addition of unique components and/or a proposal to determine portability of an existing program.

Describe the approach that will be used to develop and implement the Research Education Program, including the overall goals and objectives of the program, the number of participants to be supported, and how the program will be advertised. Provide a brief rationale for each activity (e.g., courses, seminars, workshops, research experiences, mentoring activities). Applications should provide sufficient rationale by showing how the activities will assist in strengthening the career development of selected participants and lead to completion of milestones (i.e., anticipated intermediate steps toward the objectives). Applications must demonstrate use of evidence-based approaches to justify interventions or activities proposed in the research plan. Applicants are encouraged to review the substantial pedagogical literature concerning predictors of success in research careers and examine additional data/report sources at https://extramural-diversity.nih.gov/diversity-reports and other sources. A timetable for completing the planned activities should be included.

Describe planned processes for: (a) selecting participants, (b) planning research and educational activities and selecting mentors for participants, (c) evaluating participant progress, (d) coordinating among existing training or research activities available at the site and (e) assessing the quality of the research education activities. The success of any funded program will be based largely on participant outcomes. Progress towards achieving participant outcomes may be tracked through achieving sequential milestones in research (i.e., short-term outcomes) and advancing the science and practice of an area of research (i.e., intermediate outcomes).

Describe the approach that will be used to develop and implement the Research Educational Program, including:

  • The overall goal(s) and specific measurable objectives (including anticipated milestones, defined as anticipated intermediate steps toward the objectives) that the institution expects to accomplish within the NIAID Research Education Program Advancing the Careers of a Diverse Research Workforce.
  • A brief rationale for, and a detailed description of, all three educational activities in meeting the goal(s) of the proposed program: research experiences, mentoring activities and courses for skills development. Also describe the role of the faculty/personnel involved.
  • Describe how the proposed program content will address the training needs of the diverse research workforce for biomedical, behavioral and clinical research that support NIAID mission areas.
  • Briefly outline the proposed schedule/timeline of activities. Discuss any perceived impediments to implementing the proposed activities and alternative strategies to achieve the specific objectives.
  • Research experiences should demonstrate that participants will have meaningful experiences in the laboratories or research groups of investigators who are actively engaged in biomedical research. This hands-on exposure to research can be during the academic year and/or summer.
  • Discuss how the program will lead to the enrichment of the research skills and/or competence of participants engaged in research in NIAID-related research areas.
  • Discuss asset models and leadership opportunities for participants.
  • Address potential problems, alternative strategies, and provide proposed benchmarks for success.
  • Provide plans for coordination and communication between multiple sites and quality control assurances for remote research experiences as applicable.

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.

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. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award. Describe criteria for selecting participating research faculty.

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. Describe participation selection process and criteria (including, who will be on the selection committee; their experience evaluating such applications. Applications must include a description of the potential applicant pool (including number and percent) based on the selection criteria established for the proposed program.

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

The applicant should clearly state the alignment of enhancing scientific workforce diversity to its mission and accountability to promote a climate of inclusion for participants within the applicant organization/institution. The applicant must document the requisite administrative/technical capacity, and if applicable, support for the management of a collaborative multisite research education and research education project.

Recruitment Plan to Enhance Diversity (NOT-OD-20-031):

The applicant must provide a recruitment plan to enhance diversity. Include outreach strategies and activities designed to recruit prospective participants from diverse backgrounds, e.g. those from groups described in the Notice of NIH's Interest in Diversity. Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups.

Applicants may wish to include data in support of past accomplishments. Applicants might coordinate with participant recruitment efforts of the medical school(s), graduate school(s), and/or the institution(s) or organization(s), as applicable.

Applications lacking a diversity recruitment plan will not be reviewed.

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

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

Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements. Given the focus on enhancing diversity, the emphasis of the evaluation activities should be on assessment of the overall impact of the program on the applicant’s baseline numbers (as appropriate) and efforts to accomplish the proposed goals of enhancing the diversity of the NIAID-research related workforce, climate surveys to measure changes in attitudes toward diversity and inclusion, improvement of the overall program outcomes, and retention of participants in NIAID-related research, research career trajectories, and independent research careers. The evaluation strategy and plan must be based on appropriate literature and cited methodology and should identify the selected evaluator and present their credentials.

Applications that lack an evaluation plan will not be reviewed

Dissemination Plan. A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops. Publication of the program’s findings and outcomes in peer-reviewed journals is highly encouraged.

Letters of Support

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

Letters of collaboration from partner organizations, sites, and/or institutions should be provided by authorized officials from the partner institutions addressing their institutional commitment to the proposed project and program goals. As applicable, key faculty or senior investigators at partner organizations who will have substantial involvement in curricula development, research training, mentoring, courses and skills development, or other activities should submit letters.

All applicants should include a letter of support indicating institutional/organizational commitment.

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.

The following modifications also apply:

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application.There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

  • 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.

The following are allowable Appendix materials:

  • Required Research Education Activities. To adequately assess the content of the didactic portion of the research education program, the application may include syllabi/outlines of all required research education activities (e.g., syllabi for courses, mentor training materials, professional development workshops, career exploration opportunities, skills development activities).
  • Participant Selection and Appointment Procedures (3 pages maximum). Materials may include, but not be limited to, appointment protocols and/or blank applications.
  • Evaluation and Assessment Instruments. Applicants may provide blank surveys, rubrics, and/or forms used to (a) document and monitor participant progress and (b) determine whether the program and its environment are effective inclusive, safe, and supportive.

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.

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.

For this particular announcement, note the following:

The goal of this R25 program is to support integrated educational activities, including research experiences, courses for skills development, and mentoring activities, that support educational activities that complement and/or enhance the training of a diverse research workforce to meet the biomedical, behavioral and clinical research needs of programs that support NIAID’s research agenda. Program participants may include undergraduates, postbaccalaureate fellows, graduate/medical/dental/nursing students, other allied health professionals, medical residents, postdoctoral fellows, and/or early career faculty.

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 convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?

Specific to this FOA: If the objectives of the application are achieved, will the proposed NIAID R25 Program enhance the training of a diverse research workforce to meet biomedical, behavioral and clinical research needs? Will the program lead to the development of a diverse group of highly trained scientists in increased numbers and in NIAID-related research areas? Does the proposed program provide evidence of the effect it will have on the enrichment of the research skills and/or competence of participants engaged in research in NIAID-related research areas?

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?

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?

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?

Specific for the FOA: Does the approach address asset models and leadership opportunities, rather than just deficit models and remediation? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of development, will the strategy establish feasibility, and will any risky aspects be managed? Is the proposed plan for dissemination of the education program sound and likely to provide data on the effectiveness of the education program? Is the approach feasible and appropriate to achieve the stated research education goals?

Are the requirements and timetable for completing the planned activities, the plan for program advertisement, and the size and caliber of the applicant pool appropriate to achieve the described program goals? Are the mentoring capability and quality of research programs at mentor institutions outlined and sufficient to support the scope of the R25? Are the selection criteria for participants; workshops, seminars, and meetings; and the mechanisms for getting feedback from participants clearly described and appropriate for ensuring that the program meets its goals? Does the information provided on outcomes and subsequent educational/career progress support the likelihood of success for the proposed 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?

Specific for this FOA: If multiple sites or organizations are participating, is this participation from the partnering organizations or institutions adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites and quality control assurances for remote research experiences (if appropriate)? Do the participating institutions or organizations have expertise in providing educational opportunities to participants from diverse backgrounds underrepresented in NIAID research mission areas? If so, are outcomes described for previous or currently supported programs? How will this proposed program fit with the existing environment? What is the stated commitment for assuring a climate of inclusion for the R25 program participants? If applicable, are plans for an Advisory Steering Committee presented and is the proposed expertise adequate?

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.

Revisions

Not Applicable

Renewals

Not Applicable

Additional Review Considerations

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review, and a Data Management and Sharing Plan is not applicable for this FOA.

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.

If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination 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 National Institute of Allergy and Infectious Diseases, 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 will receive a written critique.

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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the 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, Recipients, 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 Trainee 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 recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

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

A final RPPR and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement.

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, NIH may request information from databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants subsequent educational or employment history and professional activities.

Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.

In evaluating this research education program NIAID expects to use the following evaluation measures:

  • Educational level of participants
  • Content
  • Participants feedback on the program
  • New knowledge or skills acquired

Undergraduate Students:

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

Successful completion of an undergraduate degree in a STEM field
Enrollment in an advanced degree program in a STEM field

Graduate 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

Postdoctorates and Early Career 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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

Scientific/Research Contact(s)

Madelyn Reyes, DNP, FAAN
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-594-5945
Email: [email protected]

Peer Review Contact(s)

James T. Snyder, PhD
Telephone: 240-669-5060
Email: [email protected]

Financial/Grants Management Contact(s)

Paula Acevedo
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-2860
Email: [email protected]

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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