Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)

Funding Opportunity Title
NHGRI Short Courses for Genomics-Related Research Education (R25 Clinical Trial Not Allowed)
Activity Code

R25 Education Projects

Announcement Type
Reissue of PAR-19-185
Related Notices

July 22, 2019 - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020. See Notice NOT-OD-19-109

Funding Opportunity Announcement (FOA) Number
PAR-22-095
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.172
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

Proposed short courses are expected to facilitate the development of scientists with the requisite research skills to advance the mission of NHGRI. Applications are encouraged that propose innovative, advanced-level courses that are intended to disseminate new knowledge, approaches, methods and techniques related to the scientific, medical, ethical, social and/or legal areas of genomics research. In addition to in-person instruction, courses that incorporate innovative or novel education models, such as project-based learning or virtual instruction, are encouraged.

Key Dates

Posted Date
February 01, 2022
Open Date (Earliest Submission Date)
December 24, 2022
Letter of Intent Due Date(s)

30 days before application due date

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
January 25, 2023 * January 25, 2023 * Not Applicable July 2023 October 2023 December 2023
January 25, 2024 * January 25, 2024 * Not Applicable July 2024 October 2024 December 2024
January 25, 2025 * January 25, 2025 * Not Applicable July 2025 October 2025 December 2025

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

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

Expiration Date
January 26, 2025
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 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: Immersive, advanced-level courses that are intended to disseminate new knowledge, approaches, methods and techniques related to the scientific, medical, ethical, social and/or legal areas of genomics research; this will help foster a pool of highly trained scientists in appropriate research areas to advance the mission of the NHGRI.

Background

As a leading authority in the field of genomics, the National Human Genome Research Institute (NHGRI) aims to be at the ‘Forefront of Genomics’ by accelerating scientific and medical breakthroughs that improve human health and well-being (see Strategic Vision). We do this by driving cutting-edge research, developing new technologies, and studying the impact of genomics on society.

Accomplishing this vision requires a highly qualified and diverse genomics workforce that has received training in cutting-edge tools, methods and approaches for scientific discovery and analysis. This requires expertise in the wide range of fields relevant to genomics – biological, physical and mathematical sciences, computer and engineering sciences, bioinformatics, biostatistics, epidemiology, medicine, bioethics, social and behavioral sciences, law, and the humanities. Thus, genomics-focused instruction in these fields will allow those who participate in NHGRI-supported research education to be better positioned to contribute to genomics research in the future. For the purposes of this R25 Funding Opportunity Announcement (FOA), the term “genomics” encompasses issues and activities in all of these research fields that are of interest to NHGRI (see Strategic Vision).

To adopt and adapt new methods and approaches, scientists need access to training and continuing educational opportunities throughout their career. Receiving training in novel or advanced tools, methods and/or approaches can be challenging for many scientists who may have limited time for, or access to, formal training at their home institutions. These challenges contribute to the limited current opportunities for scientists who would like to incorporate new genomics-related tools, methods or approaches into their research.

Objectives, Approaches

NHGRI invites R25 applications to support short advanced-level courses to facilitate the development of the next generation of investigators with the requisite research skills to advance the mission of NHGRI (see Strategic Vision). Short courses are intended to disseminate new knowledge, analyses, methods and techniques related to the scientific, medical, ethical, social and/or legal areas of genomics research.

Courses should be offered in one or more of the three topic areas listed below:

  • Genome Sciences: Courses that expose participants to genomic science concepts, including technology development, experimental approaches and analytical tools that facilitate research on the structure and function of the genome in human health and disease, are acceptable. Expanding the knowledge and skill set in the quantitative and informational sciences is critically necessary for developing future leaders in genomics research. Thus, the courses should emphasize education in bioinformatics, biostatistics, and genomic data science.
  • Genomic Medicine: The implementation of genomics into medicine requires that clinicians be provided with the knowledge and skills to effectively apply genomics in their practices. With advances in genomic technology, this course seeks to improve genomics literacy to address needs across a spectrum of clinical expertise. Courses should provide education in fundamental principles of genomics as well as how best to deliver genomics-based care in tailored settings, such as through routine primary care, specialized genetic clinics, etc. Short courses can be designed so that continuing medical education (CME) credit is obtainable but the course must be more than informational and must include concrete practical experience related to the conduct of research for physicians or other health professionals.
  • Genomes and Society: NHGRI addresses the many ethical, legal and social implications (ELSI) that have been raised by genomics research. Dissemination of knowledge of ELSI issues and instruction in ELSI research methods would keep participants alerted to issues that should be anticipated in genomics research involving human participants. Applications focused on ELSI are particularly encouraged.

Applicants are expected to describe the learning objectives for the proposed short course, how the proposed course will enhance existing skills and capabilities of the target participants and how the impact of the learning will be measured. In addition, applicants must describe how this education fills a unique and important skills gap in genomics that is not already well covered by existing courses or curricula. Applicants are encouraged to review and document existing courses (e.g., NHGRI’s funded courses) that are similar to the short course being proposed and specify why any similar courses are insufficient to address the need.

Courses are expected to be hosted as synchronous in-person instruction at an academic or research institution. In addition to in-person instruction, courses are encouraged to utilize virtual and remote-learning tools as appropriate.

In all components of the program, applicants are encouraged to incorporate best practices for education. Modern pedagogy (e.g., project-based or experiential models) and educational tools (e.g., online lectures or networking), can help enhance the experience of students/participants and enable them to better apply their new skills to their research questions. Examples include, but are not limited to, using project-based learning to focus on appropriate study designs for examining the impact of genomics on society, or reducing time spent in lectures by providing access to webinars prior to the in-person course. It is expected that the goal of the supported courses is to enable participants to return to their home institutions and begin to adopt what they have learned into their research, thereby fully incorporating cutting-edge genomics tools, methods, and approaches for into their research projects.

A proposed course must be at a minimum of 3 days (24 instructional hours) and completed in a 12-week period. The total number of instructional hours must be specified in the application. Courses must be offered annually. Programs that propose shorter courses (e.g., bootcamps, workshops) are not appropriate for this FOA. Moreover, this FOA is not intended to fund conferences or other workshops that were previously funded by, or are appropriate for support by, a R13/U13 conference grant. Also, this FOA is not intended to support mainly curriculum development. While minimal curriculum development is allowable, courses must be offered in the first year of support.

Participation in these courses must be open to individuals nationwide. Target participants can include those early in their careers (e.g., master’s level students, graduate students, medical residents, postdoctoral fellows, early-stage investigators) as well as established investigators (e.g., mid- and late-career researchers) who need new knowledge and skills that can be applied to their research area.

Enhancing Diversity

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. See Notice of NIH's Interest in Diversity,?NOT-OD-20-031,?for more details.

NHGRI recognizes that the value of the biomedical workforce is enhanced when individuals from diverse backgrounds are actively participating, and when all individuals are assured of a safe, respectful, and inclusive environment. NHGRI upholds this value and in 2021 published “Building a Diverse Genomics Workforce: An NHGRI Action Agenda”, which details the institute’s vision for training, employing and retaining a diverse genomics workforce. This R25 program is intended to address a major goal of that action agenda, which is to develop and support education and training programs that lead to independent research and clinical careers in genomics, and in particular, to facilitate representational diversity, inclusion and retention of individuals from diverse backgrounds. Therefore, NHGRI strongly encourages applicants to this funding opportunity to enhance diversity by increasing the involvement of faculty instructors and initiate the recruitment/retention of course participants from diverse backgrounds, including those from underrepresented groups. Applications must include a Recruitment Plan to Enhance Diversity (see Section IV.2) . Proposed plans will be assessed during the scientific and technical merit review of the application. Although the Recruitment Plan to Enhance Diversity will not be scored individually, it will be considered in the overall impact score. Awardees will be required to report on the effectiveness of plans to enhance diversity of underrepresented groups in annual Research Performance Progress Reports (RPPR) and the Final RPPR. A recommended format for reporting demographics can be found on NHGRI’s website. In addition, applicants are strongly encouraged to consider how the methodologies and approaches being taught in the proposed course can be reliably and validly applied across diverse groups, as well as how to address the consequences for communities/subpopulations that are disproportionally impacted by disease burden.

Only in safe, respectful, and inclusive environments can individuals achieve their fullest potential and support the mission of the NIH. Therefore, NIH is committed to changing the culture of science and to end discrimination and all forms of discriminatory practices, including harassment on the basis of race, color, national origin, sex/gender, disability, and age in NIH-funded activities. Harassment, in any form, is detrimental and presents obstacles that hinder an individual’s ability to fully participate in science. Consistent with NOT-OD-15-152, Civil Rights Protections in NIH-Supported Research, Programs, Conferences and Other Activities, it is expected that organizers of NHGRI-supported courses employ strategies similar to those identified in the guidance for R13 conferences (see NOT-OD-21-053) that seek to prevent or mitigate the effects of discrimination and harassment, sexual and otherwise. Applicants must outline their strategies in the required Institutional Environment and Commitment Letter of Support (see Section IV.2). Below are examples of strategies, which are not inclusive of all strategies, that could be employed to support a safe environment (applicants should consider additional strategies as appropriate):

  • Establishing a course code of conduct with clearly stated expectations of behavior, systems of reporting, and procedures for addressing inappropriate behavior. The code of conduct and reporting mechanisms should be clear and accessible to all course participants.
  • Providing resources to support participants who report incidents of harassment, including procedures for ensuring the safety of all course participants, up to and including removing a perpetrator from the course.
  • Conducting course climate surveys specifically related to sexual harassment and professional misconduct.
  • Soliciting feedback from participants, especially those from diverse backgrounds, suggesting areas for improvement of the learning environment

The course should be able to benefit more than the limited number that can attend in person. Over the period of support, it is expected that the course will be refined, improved, and sufficiently well documented and implemented, and to extend beyond in-person attendance, and beyond the end of the project period. A Dissemination Plan is a requirement of the FOA (see Section IV.2). Any course materials (e.g. videotaped lectures, slides, syllabi) must be made available and easily accessible to the public electronically. Funded investigators are expected to develop a website which includes, at a minimum, the course description, registration information, how to access course materials, and acknowledgement of NHGRI funding. Websites will be linked on NHGRI’s webpage which lists funded short courses.

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.

Applicants are strongly encouraged to contact NHGRI Program Staff for current information about program priorities and policies before preparing an application (see Section VII).

Non-Responsive Applications

Applications with one or more of the characteristics listed below will be considered non-responsive and will not be reviewed:

  • Courses that do not focus on one of the three topic areas listed above;
  • Proposed course is not at a minimum of 3 days and 24 instructional hours in length;
  • Proposed course activities are not completed within a 12-week period;
  • Proposed course is not offered in the first year and each subsequent year;
  • Proposed course is an adaptation of a current or previous R25-funded course that focuses on a different target population;
  • Education that is available to the proposed program participants through existing institutional courses;
  • Programs significantly devoted to curriculum development;
  • Programs that are primarily aimed at students or participants at a single institution or at a small number of institutions;
  • Informational courses that lack concrete practical experience related to the conduct of research, including continuing medical education courses for physicians or other health professionals; and
  • Applications that do not include an Institutional Environment and Commitment Letter of Support which includes strategies to maintain a safe, harassment-free environment for all course participants.

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
Renewal
Resubmission

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

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.

Award Budget

Application budgets are limited to $150,000 direct costs per year.

Award Project Period

The scope of the proposed project should determine the project period. The maximum 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). Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when they are in accordance with applicable cost principles.

Salary support for the PD/PI (or combination of multiple PD(s)/PI(s)) may not exceed 3.0 person months (25% full-time) effort per year. All personnel costs must be adequately justified and take into consideration yearly fluctuations in required effort.

Personnel costs may not exceed 30% of the total direct costs in any year. Costs to support the Course Instructor(s) are considered personnel costs.

Tuition and fee remission for personnel are not allowed.

Participant Costs

Participants are those individuals who are registered in the proposed course.

Participant costs must be itemized in the Participant/Trainee Support Costs (Section E) of the requested budget and sufficient justification must be provided. Participant costs are restricted and cannot be re-budgeted to non-participant costs.

Allowable participant costs include:

• Round-trip travel to and from the R25 course site for non-local participants.
• A budget of up to $500 per participant for course-related expenses, such as books, course materials, tuition, continuing education units (CEUs), etc., can be requested as a lump sum.
• A subsistence (or per diem) allowance of up to $300 per day of the course may be provided per participant for partial support of housing, meals, and local transportation.

When specifically identified and justified, these expenses must be itemized in the budget.

Unallowable participant costs include:

• Salary and fringe benefits
• Stipends
• Health insurance
• Gifts, such as hats, t-shirts, key rings, tote bags, etc.
• Social functions that include food and beverages outside of a major course-related event, such as a presentation by a keynote speaker
• Dues to professional organizations
• Foreign travel

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, and only when they are in accordance with applicable cost principles. When specifically identified and justified, these expenses must be itemized in the budget.

Consultant costs for program evaluation are limited to $5,000 direct costs per year.

Travel funds for PD/PI(s) and key staff should be requested and are limited to $5,000 direct costs per year. Foreign travel is not allowed.

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)

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.

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
  • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

The PD(s)/PI(s) should have a strong track record as an educator in a scientific area related to the topic of the proposed short course.

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 per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review.

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

Participants in R25 programs supported through this FOA should represent a regional/national pool that extends beyond the applicant institution. Participants are limited to master’s level students, graduate students, medical residents, postdoctoral fellows, and investigators.

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 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:

Lucia A. Hindorff, PhD, MPH
National Human Genome Research Institute (NHGRI)
Telephone: 240-271-1509
Email: hindorffl@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.

Other Attachments.

An Advisory Committee is not a required component of a Research Education program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file “Advisory_Committee.pdf”.

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.
PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy

Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below:

  • Proposed Research Education Program
  • Program Director/Principal Investigator
  • Program Faculty
  • Program Participants
  • Institutional Environment and Commitment
  • Recruitment Plan to Enhance Diversity
  • 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.

The Research Education Program Plan must:

  • Provide the underlying rationale and overall goal of the program, and evidence supporting the scientific need and timeliness, and why the educational goals of the program cannot be met through existing institutional programs or structures.
  • Describe the overall strategy, methodology, and analyses to accomplish the specific aims of the proposed research education program.
  • Describe the relevance of the proposed educational activities to the research priorities of NHGRI.
  • Describe the specific learning objectives for the proposed short course and how the proposed short course will provide genome-focused education in novel, state-of-the art tools, techniques, analyses and/or approaches to enhance existing research skills and capabilities of participants.
  • Describe the “value added” of the proposed, R25-supported short course. If existing education is widely available, applicants should clearly distinguish between the activities in the proposed research education short course and the existing educational opportunities, and justify how the proposed course fills an important gap.
  • Describe expected processes for: (a) planning and implementing the proposed educational activities; and (b) coordinating among existing training or research activities available at the site (where appropriate).
  • Describe the course scope, format, duration, and frequency, as well as planned instructional methods (e.g., didactics, project-based learning, in-person/remote instruction). Include a course syllabus.
  • Justify the course time allotted (total instructional hours), including justification that it is sufficient to cover the planned material.
  • Describe any innovative aspects of the course content and course instruction.
  • Explain the significance of the course and how it will be of relevance and interest at a regional or national level.
  • Describe currently available educational materials as well as any that will be developed as part of the proposed course.
  • Outline a plan to recruit a diverse pool of well-qualified students/participants. The application should indicate criteria for student selection and the number of participants expected per class.
  • Describe the plans for publicizing the availability of courses to the appropriate community of scholars and scientists.
  • Describe the educational and/or career level(s) of the planned participants, as well as the number of anticipated participants in each offering of the course.
  • Describe the importance of the course in meeting the needs of the intended participants and the likelihood of improving their skills.
  • Describe plans for interaction between faculty instructors and participants. If there are plans for videotaping, describe how this format will enhance the learning experience.
  • Describe any additional strategies or participant engagement that will be integrated, such as online coursework, refresher activities, or networking opportunities after participants return to their home institutions. This description should include timelines and durations of activities.
  • Describe how principles underlying rigorous and reproducible research will be incorporated throughout the proposed short course (see NIH Rigor and Reproducibility).
  • Describe how the short course may be refined or modified over time depending upon the outcome of the initial offering, participant feedback, and/or new developments in the field; all in order to enhance the program's overall effectiveness and ensure that the course continues to be at the cutting edge of genomics.
  • Describe approaches to managing potential problems and alternative strategies for their solutions.
  • Clearly describe benchmarks for success.
  • Describe how a safe and respectful learning environment will be maintained for all participants by providing an atmosphere free from all forms of discrimination and harassment, sexual or otherwise.

For Renewal Applications, the Progress Report must:

  • Describe the previously supported short course and its objectives.
  • List the benchmarks for success that were included in the previous application, and detail how they were obtained.
  • Provide the number and characteristics (including demographics) of participants in the past project period (see NHGRI’s website for the recommended format).
  • Describe any changes in administration or targeted participant groups during the prior funding period, if applicable.
  • Include a description of how the proposed course content and/or methodologies were updated over the course of the last funding period.
  • Describe materials disseminated.
  • Describe the original plan for sustainability or dissemination of the course in the last period of support in order to maintain the currency of the research education offered, and detail the results.
  • Detail the results of the course evaluation (e.g. knowledge/skills acquired, progress of education in the field), including highlighting positive program outcomes and lessons learned.
  • Describe what changes in the course are being proposed for this renewal, if any, based on outcomes of the course evaluation.
  • Describe if there is a continuing need for the research education to advance the NHGRI mission.

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.

Explain how the level of effort devoted by the program leadership to the program is sufficient to ensure that the program's intended goal is accomplished.

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.

List Program Faculty whose role is to develop, implement, direct, monitor, mentor, and/or evaluate in the proposed course as Key Personnel and provide their biographical sketches.

Provide information about the track records of the participating faculty as educators and information concerning their current engagement in research or other scholarly activity related to the mission of the NHGRI.

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

Describe the number of anticipated participants in each offering of the course. Provide details about the pool of expected participants including their qualifications, and the sources of this pool. Describe plans for announcing the short course, and strategies for recruiting participants nationally and for recruitment of an applicant pool that is predominantly composed of U.S. citizens and permanent residents. Describe application procedures and criteria for selection of participants, including information about plans to recruit and select participants whose research interests intersect with the mission of the NHGRI.

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 administration of the applicant institution should document institutional support and commitment to the goals of the course. The application should include a description of support (financial and otherwise) to be provided to the proposed course. This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the PD/PI and/or participating faculty, support for project-related expenses or participant compensation for activities, or any other creative ways to support the establishment and growth of the course.

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.

Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period, including successful and unsuccessful recruitment strategies. Provide the number and demographics of participants per year in the past project period (see NHGRI’s website for the recommended format).

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. Describe the timeline for evaluation and how this will provide useful data on the effectiveness of the research education program. Outline the processes for determining and evaluating outcomes.Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

The administration of the applicant institution should document institutional support and commitment to the goals of the course. The application should include a description of support (financial and otherwise) to be provided to the proposed course. This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the PD/PI and/or participating faculty, support for project-related expenses or student compensation for activities, or any other creative ways to support the establishment and growth of the course.

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.

Any course materials must be made available and easily accessible to the public electronically. Funded investigators are expected to develop a website which includes, at a minimum, the course description, registration information, how to access course materials, and acknowledgement of NHGRI funding. Websites will be linked on NHGRI’s webpage which lists funded short courses.

Letters of Support

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

This letter must include a commitment to maintain a safe and respectful learning environment for all participants by providing an atmosphere free from all forms of discrimination and harassment, sexual or otherwise. As described in the background section, institutions should outline their strategies to prevent or mitigate the effects of discrimination and harassment, sexual and otherwise as part of this letter.

Resource Sharing Plans

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

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

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

Appendix

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

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at grahambj@exchange.nih.gov when the application has been submitted. Please include the FOA number and title, PD(s)/PI(s) name(s), and title of the application.

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

The goal of this R25 program is to support immersive, advanced-level courses that are intended to disseminate new knowledge, approaches, methods and techniques related to the scientific, medical, ethical, social and/or legal areas of genomics research; this will help foster a pool of highly trained scientists in appropriate research areas to advance the mission of the NHGRI.

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 aims of the research education program are achieved, will they: (1) contribute to the skills development of highly trained scientists or health professionals in adequate numbers; and (2) provide a genomics-focused course that is novel in content to the participants?

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?

Specific to this FOA:

  • Does this proposed program duplicate, or overlap with, existing courses, research education, training, and/or career development activities currently supported at the applicant institution or available elsewhere?
  • Does the scope of the proposed project extend beyond that of adapting a current or previously supported course to focus on a different target population? Adaptation 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.
  • Are plans in place for ensuring that the course will change as new methods, resources, and analyses, knowledge, etc. become available?

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 to this FOA:

  • Are the scope and content of the course syllabus current and adequate to fulfill the course goals?
  • Are the quality and timeliness of the course content and syllabus adequate?
  • What criteria will be used for selecting participants?
  • Are the plans for publicizing the availability of courses to the appropriate community of scholars and scientists adequate?
  • If there are plans for videotaping, is the format one that would enhance the learning experience?
  • Are the overall strategy, methodology, and analyses well-reasoned, feasible, and appropriate to accomplish the specific aims of the proposed research education program?
  • Are potential problems, alternative strategies, and benchmarks for success presented?
  • Is the Dissemination Plan appropriate and sufficient for making course materials electronically available and easily accessible to the public?
  • Is the Evaluation Plan appropriate for an education program, rather than a research project (e.g., based on surveys completed by participants and/or publicly available information about participants)?
  • Is the timeline for evaluation adequately described and likely to provide useful data on the effectiveness of the research education program?
  • Is the process for determining and evaluating outcomes clear?

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 to this FOA: Is there reassurance that leadership will maintain a safe and respectful learning environment for all participants by providing an atmosphere free from all forms of discrimination and harassment, sexual or otherwise.

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.

Recruitment Plan to Enhance Diversity

How likely will the diversity plan increase the participation and retention of individuals from underrepresented groups, in the proposed course? Underrepresented groups include individuals from nationally underrepresented racial and ethnic groups, individuals with disabilities, individuals from disadvantaged backgrounds, and women. For more information, see NOT-OD-20-031 Notice of NIH’s Interest in Diversity.

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

For Renewals, the committee will consider the progress made in the last funding period, and the success of the program in attracting individuals from diverse populations, including populations underrepresented in biomedical, behavioral and clinical research on a national basis.

Additional Review Considerations

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

Recruitment Plan to Enhance Diversity

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), 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.

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

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 short courses.

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.

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

Any application awarded in response to this 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, including of note, but not limited to: 

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

Should the applicant organization successfully compete for an award, 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 (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Reporting

When multiple years are involved, recipients 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.

Awardees are required to report on the effectiveness of plans to enhance diversity of underrepresented groups in annual Research Performance Progress Reports (RPPR) and the Final RPPR.

NIH FOAs outline intended research goals and objectives .

Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

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 recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

In accordance with the regulatory requirements 45 CFR Part 75 and 2 CFR Part 200 and Appendix XII to 45 CFR Part 75.113 and 2 CFR Part 200.113, 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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Other Reporting Requirements

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 NHGRI expects to use the following evaluation measures:

For Courses for Skills Development:

  • Aggregate number and demographic characteristics of course participants
  • Content
  • Participants’ feedback on the program
  • Curricula or other resources shared with the research community

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://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)

Lucia A. Hindorff, PhD, MPH
National Human Genome Research Institute (NHGRI)
Telephone: 240-271-1509
Email: hindorffl@mail.nih.gov

Peer Review Contact(s)

Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8739
Email: pozzattr@exchange.nih.gov

Financial/Grants Management Contact(s)

Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: deanna.ingersoll@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 and 2 CFR Part 200.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.