Part 1. Overview Information

Participating Organization(s)
National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title
NIH Science Education Partnership Award (SEPA) (R25 - Clinical Trial Not Allowed)
Activity Code
R25 Education Projects
Announcement Type

Reissue of PAR-17-339

Related Notices

May 11, 2020 - Notice of Change to Eligibility for PAR-20-153. See Notice NOT-GM-20-031.

July 26, 2019- Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128

August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137

Funding Opportunity Announcement (FOA) Number
PAR-20-153
Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed on each due date. See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.859

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 complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

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

  • Courses for Skills Development
  • Research Experiences
  • Mentoring Activities
  • Curriculum or Methods Development
  • Outreach

Information on current SEPA projects can be found at: https://www.nigms.nih.gov/Research/crcb/sepa/Pages/default.aspx and https://www.nihsepa.org

Applicants are strongly encouraged to consult with the SEPA Scientific/Research Contact to be advised on the appropriateness of the intended project for SEPA program objectives and the priorities of the NIGMS.

Key Dates

Posted Date

March 30, 2020

Open Date (Earliest Submission Date)
June 14, 2020
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)
July 14, 2020; July 13, 2021; July 13, 2022,by 5:00 PM local time of applicant organization. All types of applications allowed for this funding opportunity announcement are due on these dates.

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

AIDS Application Due Date(s)
Not Applicable
Scientific Merit Review
October/November 2020, October/November 2021, October/November 2022
Advisory Council Review
January 2021, January 2022, January 2023
Earliest Start Date
April 2021, April 2022, April 2023
Expiration Date
July 14, 2022
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.

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The over-arching goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.

The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

To assure the vitality and continued productivity of the research enterprise, the NIGMS provides leadership in training the next generation of scientists, in enhancing the diversity of the scientific workforce, and in developing research capacity throughout the country.

The SEPA program supports P-12 and informal science education (ISE) activities that: (1) enhance the diversity of the biomedical, behavioral and clinical research workforce and (2) foster a better understanding of NIH-funded biomedical, behavioral and clinical research and its public health implications.The SEPA program targets two primary audiences: (1) SEPA formal or classroom-based projects, provide STEM content, pedagogical expertise, and problem solving skills to teachers, students, and families in communities not generally supported by advanced and innovative educational practices: (2) SEPA informal science education (ISE) activities, conducted in outside-the-classroom venues as well as in science centers and museums, target both workforce diversity and improved public health literacy.

Applications that target pre-kindergarten to grade 12 (P-12) or ISE topics that are not be addressed by existing school, community, or ISE-based activities are encouraged.

Proposed projects:

  • May focus on any area of NIH-funded research
  • Must address broader impact issues, i.e., the potential to benefit society and contribute to the achievement of specific, desired workforce diversity and capabilities, societal, and health literacy outcomes.

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

  • Courses for Skills Development : For example, advanced courses in a specific discipline or research area, or specialized research or analytical skills such as biostatistics and datascience.
  • Research Experiences: Research experiences for P-12 teachers and students that will provide hands-on exposure to research methods and concepts that are not available through conventional teacher training or classroom activities.
  • Mentoring Activities: Programs that provide mentors and near-peer role models, in terms of age, gender, race, and ethnicity, for P-12 students.
  • Curriculum or Methods Development: For example, to improve biomedical, behavioral, or clinical science education, or to develop novel instructional approaches or computer and data science-based educational tools.
  • Outreach: Activities that enhance workforce diversity, community health and medicine knowledge through dissemination of educational resources and biomedical, behavioral and clinical research findings.

Examples of projects within the scope of activity of SEPA include:

  • Innovative and inquiry-based P-12 curricula that will increase student interest in STEM topics.
  • Understanding of the scientific research process to improve biomedical, behavioral, or clinical science education.
  • Virtual reality or artificial intelligence-based educational tools.
  • Community-based participatory research (CBPR) projects on important health prevention issues such as obesity, diabetes, opioid addiction and vaping
  • Citizen science or crowd-sourcing projects where non-scientists participate in scientific research either alone or in collaboration with scientists.
  • Maker Movement projects where students and teachers learn by "doing" or "making" inside or outside-the-classroom.
  • Veterinarian-based P-12 projects that will encourage students to consider careers in veterinary medicine or projects designed to educate students, teachers, and the community on the need for, and the ethical use of, animals in research.
  • Curriculum or methods development activities for P-12 teachers that provide instruction in novel approaches to STEM topics that challenge the current knowledge base of pedagogy and problem based learning.
  • Interactive digital media (IDM)-based projects where scientists partner with educators and developers to create learning resources for P-12 students, teachers, and the public. IDM applications may include, but are not limited to: interactive curricula; attitude changes towards game-based learning; new skills development; teamwork and group activities; public participation in scientific research (citizen science) projects; and behavioral changes in lifestyle and health.
  • Public service announcements, documentaries, films, radio, TV, and other media-based community health literacy resources.
  • Science center and museum-based exhibits, traveling exhibits, and public outreach activities e.g., science cafes and community health fairs, that will educate students, teachers, and the community on health-related topics.
  • Quantitative and computational skill-building educational resources for a data-science literate workforce.
  • Collaborations and leveraging with the following programs and other educational organizations:


New areas of high SEPA programmatic interest include:

  1. Educational activities, where participants have access to research-generated data, that will train students for informatics, bioinformatics, data science careers.
  2. Embedded math and reading content for projects targeting P-8 student participants.
  3. Adaptations of successful SEPA programs in new locations or with new populations.

NOTE: SEPA funding does not support large scale STEM or ISE projects where the total cost of the project will exceed the total amount of the requested SEPA award, e.g., "seed money" for a project larger and longer term than the proposed SEPA project.

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 the 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.

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

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.

NIGMS intends to commit an estimated total of $2,000,000 per fiscal year for new awards.

Award Budget

Direct costs are limited to $250,000 annually.

Award Project Period

The SEPA project period is 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).

Participant Costs

Participants for this FOA are those individuals who are involved in the proposed research education activity. 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.

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.

The Annual SEPA PD/PI Conference is held in Washington, DC. PD/PI(s) are expected to attend this meeting and are encouraged to bring key personnel, e.g., the project evaluator, to the annual conference. Funds to support travel to the annual conference should be requested in the budget.

A minimum of ten percent (10%) of the direct costs requested must be devoted to project evaluation.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of consortiums in excess of $25,000,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)


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
  • Charter Schools
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.

2. Cost Sharing

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

3. Additional Information on Eligibility

 

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)

An eligible institution, defined as a university, an independent college/institute, a museum, a hospital, or a professional society, may submit one application per due date. An institution with an active SEPA award is ineligible to submit another SEPA application.

Organizations with a contractual fee for service or consortium partnership with an active SEPA award may submit a SEPA application if the proposed new project is independent of the existing SEPA contractual, fee for service or consortium partnership.

It is appropriate for applicants to use an existing P-12 or ISE project strategy and infrastructure as the platform for a new SEPA application. The proposed new SEPA project may complement, but cannot overlap, the ongoing P-12 or ISE project at the applicant organization.

Special Notes

  1. SEPA projects ending their SEPA project grant period are strongly encouraged to utilize their SEPA-generated infrastructure, partnerships, and evaluation tools to develop a new SEPA project. The proposed project must have a new scope of activity or target audience.
  2. NIGMS will now accept applications for the replication or adaptation of successful SEPA programs at different location(s) or institution(s).

Applicants are strongly encouraged to contact Scientific/Research staff to discuss eligibility and appropriateness of topic prior to committing significant effort in preparing a SEPA application.

 

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 in SEPA programs should be reflective of the proposed project goals and the P-12 and/or communities of interest listed in the application. In addition, if a proposed project could be of significant benefit to a particular population of participants, e.g., a STEM learning game with specific applicability for students with physical or developmental disabilities, the applicant should plan for the inclusion of those populations.

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.

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 Guideexcept where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.

 

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

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

  • 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 by email to:

Tony Beck, Ph.D.

Email: beckl@mail.nih.gov

Page Limitations
All page limitations described in the SF424 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.

Project Narrative. The Project Narrative should discuss the broader impact potential for the proposed SEPA project to benefit society and contribute to the achievement of specific, desired workforce diversity, societal and health literacy outcomes.

Other Attachments. An Advisory Committee is not a required component of a Research Education program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Advisory committee members should not be identified or contacted prior to receiving an award.

SF424(R&R) Senior/Key Person Profile Expanded
Follow all instructions provided in the SF424 (R&R) Application Guide.

An independent evaluator must be identified as a member of of the key personnel. The independent evaluator must be free from direct or perceived conflict of interest and have formal training and experience in P-12 STEM or ISE evaluation methodology and statistics as demonstrated by relevant publications or reports. These r qualifications should t be documented in the evaluator's Biosketch.

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.
  • The PD/PI must devote a minimum of 1.2 person months (10% of a 12-month calendar appointment) to the proposed project. In the case of multiple PD/PI (MPI) projects, the Contact PD/PI must devote a minimum of 1.2 person months effort to the project. Non-contact PD(s)/PI(s) must each devote a minimum of 0.6 person months effort to the project.
  • Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.
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 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

 

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

The proposed research education plan should target underserved communities and/or identified needs in the health-related and scientific workforce, and build upon evidence-based practices from the STEM education field and include:

  • Clear goals and anticipated outcomes
  • Development of critical thinking and communication skill
  • Cultural relevance to the target audience
  • Input from the teachers, community, and other stakeholders
  • Potential to build a sustainable STEM education capacity for the community
  • Potential for replication

The project should:

  • Be hypothesis driven such that it will advance the field of evidence-based STEM education practices
  • Generate resources that will increase career opportunities for underrepresented minorities and women, groups traditionally underrepresented in STEM fields.
  • Improve teacher STEM content and pedagogical effectiveness through professional development.

Content of the proposed SEPA project must align with the Practices, Crosscutting Concepts, and Core Ideas of the Next Generation Science Standards (NGSS). The NGSS are pre-college science standards created through a collaborative, state-led process and identifies what students need to know and be able to do to be a functional citizen, which includes being scientifically literate and an effective member of the U.S. workforce. A detailed justification should be presented for proposed projects where the proposed Disciplinary Core Ideas do not specifically align with NGSS in terms of STEM content or grade level.

NOTE: All projects that target pre-kindergarten, elementary, or middle school (P-8), regardless of the topic, must have embedded instructional content designed to improve: (1) student numeracy, i.e., basic computational arithmetic, essential mathematics, social mathematics, survival skills for everyday life, quantitative literacy, mathematical literacy, and an aspect of mathematical power; and (2) critical reading comprehension skills.

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. SEPA encourages the inclusion of project faculty who can serve as role models or near-peer mentors of age, gender, race, or ethnicity similar to the target audience(s). Projects with role models/mentors must include a description of the mentor selection and training process.

Classroom-based P-12 SEPA projects must have a rigorous evaluation plan, which may be the equivalent to a Randomized Controlled Trial (RCT) or Well-Matched Case Comparison Study.

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. SEPA applicants are also encouraged to ensure that their programs can effectively include and engage students with learning and physical disabilities In addition, if a proposed project could be of significant benefit to a particular population, e.g, a STEM educational game with specific applicability for students with physical or developmental disabilities, there should be a discussion of the plan to include those populations.

Students:

  • Intended participants and rationale for the target audience(s) selection.
  • Eligibility and/or specific educational background characteristics essential for participation.
  • Grade level(s) for participation.
  • Potential for the proposed STEM research education project to to increase student STEM content knowledge and to stimulate student interest in health and medicine career opportunities.

Teachers:

  • Intended participants and rationale for the target audience(s) selection.
  • Eligibility and/or specific educational background characteristics essential for participation.
  • Grade level(s) for participation.
  • Potential for the proposed research education project to increase applicant's pedagogical skills and STEM content knowledge.

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.

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.

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:

  1. 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 NIH programs to enhance diversity. 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).

  2. 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.

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

    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.

    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.
  4. 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 trainees from underrepresented backgrounds and may wish to include data in support of past accomplishments.

NOTE: Applications lacking a diversity recruitment plan will not be reviewed.

Plan for Instruction in the Responsible Conduct of Research. A responsible Conduct of Research (RCR) plan should be tailored to the participants involved in the supported project. SEPA projects with a goal of stimulating interest in, and providing exposure to, STEM topics, such as curricula development, after-school science clubs, museum exhibits, mobile laboratories, and interactive digital media (IDM)-based projects should use innovative strategies to address RCR, and do not necessarily need to meet the same strict RCR standards as traditional research education programs. For all other applications, the RCR 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, on-line instruction, coursework, and/or real-time discussion groups; 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 should 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.

Projects proposing student or teacher laboratory internships must include plans to improve the culture and practice of laboratory safety through the implementation of best safety practices in the laboratory as described by the UC Center for Laboratory Safety (UCCLS).

Evaluation Plan. Applications must include a plan for rigorous evaluation of 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.

Descriptions of outcome measures, the purpose of data collected, and how those data will be used in assessing the efficiency of a particular research education program should be clearly stated.

The evaluation plan should build upon current knowledge in the field, provide quantitative assessment of project impact, and advance our understanding of STEM learning.

SEPA classroom-based projects must utilize an evaluation design equivalent to a Randomized Controlled Trial (RCT) or a Well-Matched Comparison study to evaluate project effectiveness.

SEPA out-of-classroom projects must have a rigorous evaluation plan to measure impact. When appropriate, proposed out-of-classroom projects are encouraged to employ evaluation designs equivalent to an RCT or a Well-Matched Case Comparison evaluation design.

. Please note that the use of an evaluation design similar to an RCT or Well-Matched Case Comparison Study does not mean that a proposed project is clinical research. Program evaluation in R25-supported programs is not considered clinical research, and information on the characteristics of participants should not be included in the PHS Human Subjects and Clinical Trials Information section. For additional information, please see the NIH Definition of Clinical Research.

The Evaluation Plan should detail the data to be collected during the conduct of the project, how the data will be analyzed, and what evaluation instrument(s) will be used.

The use of an external evaluator is not mandated in this FOA. However, the evaluator must be independent, i.e., free of real or perceived conflict of interest. The evaluator must have formal training and experience in P-12 STEM evaluation methodology and statistics, as demonstrated by relevant publications or reports. As indicated in the instructions for the SF424 (R&R) Senior/Key Person Profile Expanded form, evaluator expertise in STEM education must be documented in the Biosketch section of the application. The evaluator should provide training and technical assistance as necessary to key staff and project partners to ensure integrity and adequacy of data capture, analysis and reporting.

PD(s)/PI(s) and other Key Personnel may collect evaluation data. However, analysis of evaluation data must be performed by the independent evaluator.

Projects proposing to replicate an existing or components of an existing SEPA project should include a Process Evaluation plan.

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.

All SEPA applications must include a project website development plan for dissemination of resources developed as the result of SEPA funding. The website may be a new website or a SEPA-specific component added to an existing website. The SEPA website must be launched within 6 months from the initial award date. Credit text for NIH, NIGMS and SEPA must be displayed on the website Home Page.

 

A letter of institutional commitment must be attached as part of Letters of Support (see section above:”Institutional Environment and Commitment"). Letters of support from superintendents, principals and other decision makers should be provided to demonstrate commitment to the proposed project.

 

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.

 

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

 

When involving NIH-defined 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.

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

Please note that the use of an evaluation design similar to an RCT or Well-Matched Case Comparison Study does not mean that a proposed project is clinical research. Program evaluation in R25-supported programs is not considered clinical research, and information on the characteristics of participants should not be included in the PHS Human Subjects and Clinical Trials Information section.

For additional information, please see the NIH Definition of Clinical Research.

Study Record: PHS Human Subjects and Clinical Trials Information

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.

Below are examples of allowable and unallowable costs frequently requested in SEPA applications. This list is a guide to help applicants when preparing budget requests. This list does not include all allowable and unallowable costs for an application. Applicants should review the NIH Grants Policy Statement for a complete list of allowable and unallowable costs as well as any section of this announcement that specifically mentions allowable and unallowable costs.

Allowable Costs

  • Meals - When certain meals are an integral and necessary part of a meeting or conference (i.e., a working meal where business is transacted), grant funds may be used for such meals only when consistent with terms of award and policies of the grantee institution.
  • Computers - Materials and supplies used for the performance of a Federal award may be charged as direct costs. In the specific case of computing devices, charging as direct costs is allowable for devices that are essential and allocable, but not solely dedicated, to the performance of a Federal award.
  • Incentives - Incentive payments to volunteers or patients participating in a grant-supported project or program are allowable. Incentive payments to individuals to motivate them to take advantage of grant-supported health care or other services are allowable if within the scope of an approved project.
  • Compensation – Participants in the research education activity may be paid a compensation based on the level of involvement and time devoted to their participation in the grant activity.

Unallowable Costs

  • Stipends – Unallowable on research education (R25) awards. Participants may receive compensation for their participation in the research education activity.
  • Scholarships/Fellowships/Student Aid - Payments made for educational assistance (e.g., scholarships, fellowships, and student aid costs) may not be paid from NIH research grant funds even when they would appear to benefit the research project.
  • Honorarium - Unallowable when the primary intent is to confer distinction on, or to symbolize respect, esteem, or admiration for, the recipient of the honorarium. A payment for services rendered, such as a speaker's fee, is allowable.
  • Promotional items – Promotional items and memorabilia, including medals, gifts, and souvenirs are unallowable. Entertainment costs - Costs of entertainment, including amusement, diversion, and social activities, and any associated costs, are unallowable, except where specific costs that might otherwise be considered entertainment have a programmatic purpose and are authorized either in the approved budget for the Federal award or with prior written approval of the NIH awarding IC.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

The goal of this R25 program is to support educational activities that: (1) provide P-12 STEM resources that will increase teacher STEM content and teaching skills, (2) stimulate the interest of students from underserved communities in careers in basic and clinical medical research and (3) educate the community on the correlation between lifestyle and health.

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.

 

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?

Does the proposed research education program address an important problem or critical question in research education or other key STEM issues? How will implementation of the proposed program encourage students from underserved communities to consider careers in health and medicine? Does the proposed project incorporate what is known about effective STEM education practices? Will this project generate resources that will increase career opportunities for underrepresented minorities and women, groups traditionally underrepresented in STEM fields? Will the projectimprove teacher effectiveness through professional development? Is the proposed program hypothesis driven such that it may advance the field of evidence-based STEM education practices?

 

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?

Will there be an appropriate level of effort by the program leadership to ensure the program's success? Do the PD(s)/PI(s) or key personnel have expertise in evaluation that is relevant to the proposed project? If it is appropriate for the proposed project, do the program faculty include role models or near-peer mentors of age, gender, race, or ethnicity similar to the target audience(s)?

 

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?

Is the proposed research education program characterized by innovation and scholarship? Is a clear case made for the proposed innovation? Does the proposed program challenge current research education paradigms or address an innovative hypothesis and critical barriers to progress in the STEM field? Are the proposed concepts, approaches, methodologies, tools, or technologies novel? Does the research plan maintain a balance between innovation and novel application of established STEM curriculum, pedagogy, and evaluation metrics? Does the applicant make clear case made, based on published reports, for using current, well-tested techniques to develop and implement the proposed project?

 

Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?

Is the project design culturally relevant to the target audience? Is there input from the teachers, parents, community, and other stakeholders that will generate buy-in and ownership? If appropriate for the proposed project, is the plan for teacher professional development in science content and pedagogical skills, both pre-service and as a continuing education process for in-service teachers, well described? Does the content of the proposed project align with the Next Generation Science Standards? If appropriate, is there a plan for a public outreach component?

Evaluation Plan: Does the evaluation staff have the appropriate training and experience in evaluation methodology to manage the proposed evaluation plan? Is the percent effort of the independent evaluator and key project personnel sufficient? Is the evaluation plan based on appropriate literature and best practices in the STEM field? Does the Logic Model clearly link the proposed inputs and activities with short-, mid-, and long-term outcomes? Are the evaluation benchmarks, timeline, and metrics sufficient to capture, analyze, and report outcome measures that would determine the success of the project in achieving its objectives? Does the evaluation plan have the flexibility to allow for shifting goals and program changes? Is there a discussion of the selection and appropriateness of control groups? If applicable, are the plans for obtaining feedback from participants adequate to measure the quality and effectiveness of the proposed P-12 STEM project?

Dissemination Plan: Is the dissemination plan well-designed and appropriate for the materials that will be created? Is Are the proposed dissemination material(s) relevant to the target audience and are the target audiences likely to be aware of these resources? Does the dissemination plan include underrepresented racial and ethnic groups, individuals from disadvantaged backgrounds, and individuals with disabilities? Does the dissemination plan include both genders? Does the dissemination plan take reasonable steps to ensure meaningful access to their programs and activities by Limited English Proficient Persons (LEP) persons? Will the dissemination plan leverage and/or support collaborations with other SEPA projects, NIH-funded programs, or other federal agency-supported P-12 projects? Do the PD(s)/PI(s) discuss plans for posters, presentations, workshops, and other dissemination practices at local, regional, and national conferences? Are there plans to utilize cutting-edge social media venues such as Wikis, YouTube, Facebook, etc?.

Website: Are the plan and timeline for the proposed SEPA project website development satisfactory?

 

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?

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

 

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

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

 

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

 

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

 

Not Applicable

 

Not Applicable

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

 

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

 

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

In addition, and as applicable to the proposed program, reviewers will evaluate the plan to improve the culture and practice of laboratory safety.

The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

 

Not Applicable

 

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

 

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

If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.

 

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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.

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 appropriate national Advisory Council or Board. 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.
  • Geographic distribution of the awards.

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.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.

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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html 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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

This project/exhibit was made possible by a Science Education Partnership Award (SEPA), Grant Number ________, from the National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIGMS or NIH.

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.

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

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

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

 

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, NIGMS expects to use the following evaluation measures:

For Courses for Skills Development:

  • Aggregate number and demographic characteristics of participants
  • Educational level of participants
  • Content
  • Participants’ feedback on the program
  • New knowledge or skills acquired

For Programs Focusing on Curriculum or Methods Development:

  • Aggregate number and demographic characteristics of participants exposed to the new curricula or methods
  • General educational level of participants
  • Effectiveness of the new curricula or methods assessed by skills/competencies gained compared to existing curricula or methods
  • Dissemination and/or adoption of the new curricula or methods

For Outreach Programs:

  • Aggregate number and demographic characteristics of individuals reached
  • Educational levels of participants
  • Assessment of increased awareness, knowledge, or understanding of science- or research-related concepts, processes, or careers

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

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)

Tony Beck, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: beckl@mail.nih.gov

Peer Review Contact(s)

Masquood Wani, Ph.D.
Center for Scientific Review (CSR)
Email: wanimaqs@csr.nih.gov

Financial/Grants Management Contact(s)

Christy Leake
National Institute of General Medical Sciences (NIGMS)
Email: Christy.leake@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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