Department of Health and Human Services
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

Initiative to Maximize Research Education in Genomics: Diversity Action Plan (R25)

Activity Code

R25 Education Projects

Announcement Type

Reissue of PAR-13-063

Related Notices
  • September 17, 2019 - This PA has been reissued as PAR-19-380.
  • November 26, 2018 - NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Research Grant Applications. See Notice NOT-OD-18-228.
  • NOT-OD-18-009 - Reminder: FORMS-E Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2018.
  • September 20, 2017 - Updates to Active Funding Opportunity Announcements to Prepare for Policy Changes Impacting Due Dates On or After January 25, 2018. See NOT-OD-17-114.
  • August 17, 2017 - Notice To Allow Additional Travel Funds for DAP Participants in: Initiative to Maximize Research Education in Genomics: Diversity Action Plan (R25). See Notice NOT-HG-17-013.
  • May 31, 2017 - Notice To Add Acceptance of Revisions to PAR-16-345. See Notice NOT-HG-17-007.
  • May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062.
  • August 24, 2016 - Notice of Correction to PAR-16-345. See Notice NOT-HG-16-025.
Funding Opportunity Announcement (FOA) Number

PAR-16-345

Companion Funding Opportunity

RFA-HG-19-012, RM1 Research Project with Complex Structure

PAR-16-436, Centers of Excellence in Genomic Science (CEGS) (RM1)

PAR-19-204, Centers of Excellence in Genomic Science (RM1 Clinical Trial Optional)

Catalog of Federal Domestic Assistance (CFDA) 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 over-arching goal of this NHGRI R25 program is to support educational activities that enhance the diversity of the biomedical, behavioral and clinical research workforce in genomics. This funding opportunity announcement seeks to expose underrepresented students at the undergraduate, postbaccalaureate and graduate levels to the foundational sciences relevant to genomics to enable them to pursue careers that span all areas of interest to NHGRI--genome sciences, genomic medicine and genomics and society.

To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on Research Experiences based on the foundational sciences relevant to genomics: genomic sciences (e.g. computational biology, quantitative sciences, bioinformatics and technology development); genomic medicine (e.g. biostatistics, epidemiology, bioinformatics); and genomics and society (e.g. bioethics, social and behavioral sciences, law, the humanities) and Courses for Skills Development appropriate for the career level and proposed outcome for the activity. Complementary didactic activities are also encouraged, especially those academic courses in the foundational sciences that have the potential to increase opportunities for success at the next academic level. Courses are limited to those that are an integral part of the academic preparedness for a formal academic program such as GRE courses and foundational courses in the relevant areas listed above to prepare participants for graduate school.

Key Dates
Posted Date

June 27, 2016

Open Date (Earliest Submission Date)

August 25, 2016

Letter of Intent Due Date(s)

30 days before application due date.

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS 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
Advisory Council Review
Earliest Start Date
Expiration Date

May 26, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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


Table of Contents

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

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

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The 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) enhance the diversity of the biomedical, behavioral and clinical research workforce; (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.

Background

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 (see: NOT-OD-15-053).

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 researchers, 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 identified as underrepresented in the biomedical, clinical, behavioral and social sciences. Please see Section III.3 for more information.

The National Human Genome Research Institute (NHGRI) is committed to enhancing the pool of individuals from diverse backgrounds who have the training to pursue careers in genome sciences, genomic medicine, and genomics and society research. Genome sciences and genomic medicine research offer tremendous opportunities for improving human health, and genomics and society research offers the chance to not only improve human health, but also to explore some of the most profound ethical, legal and social issues of our time. NHGRI wants the best minds to engage in this research. There are extraordinary career opportunities in genome sciences, genomic medicine, and genomics and society research in which all should have an opportunity to participate. The very nature of genome sciences, genomic medicine, and genomics and society research demands a diversity of viewpoints and scientific interests. A major emphasis of this research will be the development of: resources and methods and technologies that will accelerate research in understanding the structure of genomes; understanding the biology of genomes; understanding the biology of disease; advancing the science of medicine; and improving the effectiveness of healthcare. The significant societal ramifications of this research will also need to be addressed. It is clearly desirable to have individuals involved who bring diverse perspectives to this research, including an interest in understanding diseases that disproportionately affect some populations. Genome sciences, genomic medicine, and genomics and society research will affect all populations and thus all groups need to participate in setting the research agenda and examining the broader issues raised by it.

Although genomics is a relatively new scientific discipline, its roots are in the foundational sciences of biomedical, physical, mathematical, computer and engineering sciences, biostatistics, epidemiology, bioinformatics, bioethics, social and behavioral sciences, law, and the humanities. Interventions early in the careers of underrepresented high school students have been effective in engaging undergraduate students in genomics research and has led to college enrollment in science-related fields (Rohrbaugh, M. C. and V. G. Corces (2011). "Opening Pathways for Underrepresented High School Students to Biomedical Research Careers: The Emory University RISE Program." Genetics 189(4): 1135-1143). In addition, surveys of undergraduate students from underrepresented backgrounds participating in a capacity building learning environment in Genomic Science shows that students benefit from programmatic interventions that (a) create opportunities in science fieldwork and research, (b) preparing them for graduate school, and (c) serve as a pipeline for science research and careers. (Rivera, H. H. and D. Murray (2014). "An Exploratory Assessment." Developing Pathways for Underrepresented Minorities Into Genomic Science 4(4)). The need to enhance the capacity for genomic research is also discussed in a paper by LeManuel Lee Bitsoi in which he focuses on the paucity of American Indians and Alaska Natives receiving doctoral degrees in the biological sciences in 2007-2008 as 0.0024% (http://genetics.ncai.org/enhancing_genomic_research.cfm). Similarly, as part of a larger meeting to discuss engaging Latinos in the future of genomic science, there was a call to recruit more Latino students into genomic careers ( http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2004_03_12/noDOI.8211124177913892849). Few, if any reports focus on the training of persons with disabilities or from disadvantaged backgrounds in genomics related programs or careers.

The research mission of the NHGRI has expanded beyond the original goal of the Human Genome Project--the sequencing of the human genome-- to encompass a broad range of studies aimed at understanding the structure and function of the human genome and its role in health and disease. The success of NHGRI research programs rests on the ability to develop new technologies, resources, and methods, to support the safe and effective use of genomic approaches in the basic and clinical sciences and medicine. This requires expertise in the foundational sciences relevant to genomics--biomedical, physical, mathematical, and computer and engineering sciences, biostatistics, epidemiology, bioinformatics, bioethics, social and behavioral sciences, law, and the humanities.

Training in genome sciences, genomic medicine and genomics and society research have become embedded in most if not all research programs at the NHGRI. Thus training in the foundational disciplines of genome science, genomic medicine, and genomics and society will allow those who participate in NHGRI-supported research activities to be well poised to contribute to biomedical research in the future.

The over-arching goal of this NHGRI R25 program is to support educational activities for undergraduates, postbaccalaureates, and graduate students to enhance the diversity of the biomedical, behavioral and clinical research workforce in the areas of genome sciences, genomic medicine and genomics and society.

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

  • Research Experiences: For example, for undergraduate students: to provide hands-on exposure to genomics research and relevant courses, to reinforce their intent to graduate with a science degree, and/or to prepare them for graduate school admissions and to expose them to the relevant foundational scientific disciplines in: genomic sciences (computational biology, quantitative sciences, bioinformatics), genomic medicine (biostatistics, epidemiology, bioinformatics), and genomics and society (e.g. bioethics, social and behavioral sciences, law, the humanities) not available through formal NIH training mechanisms.
  • Courses for Skills Development: Courses are limited to those that are an integral part of the academic preparedness for a formal academic program such as GRE courses and foundational courses in the relevant scientific areas listed above to prepare participants for graduate school.

This Funding Opportunity Announcement (FOA) is an expansion of PAR-13-063 which accepted applications only from a limited number of NHGRI high-profile programs. Since this program started in 1992 first as NHGRI's Minority Action Plan, followed by the Diversity Action Plan, there are many academic and research institutions with significant peer-reviewed research activity in the three broad areas of interest to NHGRI: genome sciences, genomic medicine and genomics and society. The intent of this FOA is to expand the number of institutions participating in this program to include significant research programs in genomic medicine and genomics and society.

The purpose of the Diversity Action Program is to expose interested undergraduate, post baccalaureate, and graduate students from underrepresented groups to the foundational sciences underpinning research in genome sciences, genomic medicine and genomics and society as well as to participate in research projects, to enhance their academic skills in relevant academic courses, to develop critical thinking skills, to develop the speaking and writing skills to present scientific findings, and to provide guidance about how to successfully navigate to the next career level.

It is assumed that the institutions that apply for this award will:

  • have faculty with broad experiences in one or more of the three areas of genomics relevant to NHGRI;
  • have experienced mentors who have worked with underrepresented individuals in traditional NIH training programs; and
  • be able to demonstrate that related research education programs at their institution will work collaboratively with the Diversity Action Plan (DAP) program to ensure a smooth transition of DAP participants to the next career phase.

The guiding principles of what can be supported under this funding opportunity announcement are that participants:

  • should be exposed to appropriate didactic training in the foundational disciplines for genome sciences, genomic medicine, and/or genomics and society in order to develop critical thinking skills as appropriate for their career level and research focus;
  • should receive research experiences that do not focus on any particular disease or groups of diseases but skills and knowledge that are generally applicable to a variety of biomedical research questions;
  • must be so prepared that they can use this knowledge and these experiences to move to the next stage of their career; and
  • must be in a research environment where they will have an opportunity to select from a variety of genome science, genomic medicine and/or genomics and society research experiences and mentors.

The types of research experiences that can be supported under this award include:

  • summer or semester research experiences and courses for skills development for undergraduate students with the objective of pursuing a doctoral degree in one of the foundational sciences relevant to genome sciences, genomic medicine or genomics and society;
  • Up to two years of full-time support forpost baccalaureate research and courses for skills development with the objective of transitioning to an F31 or other source of peer-reviewed support for graduate school; participants may take academic courses, but may not be enrolled in a formal graduate program; and
  • up to 24 months part-time support for graduate school with the objective of transitioning to an F31 or other source of peer-reviewed support.

Note: Although a subset of these activities primary goal may be increasing diversity, all activities, with the exception of those supporting curriculum or methods development, must account for their efforts at recruiting underrepresented individuals. These efforts should be appropriate and reasonable for the nature of the proposed activity. See below: Diversity Recruitment and Retention Plan.

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. In addition, institutions that have more than one NHGRI-supported R25 diversity and/or T32 programs should demonstrate coordination and collaboration such that there is synergy amongst the 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
Renewal
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?

Clinical Trials Not Allowed for due dates on or after January 25, 2018: Only accepting applications that do not propose clinical trials

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 for genome sciences and genomic medicine activities are limited to $300,00 per year direct cost. Application budgets for genomic and society activities are limited to $100,000 per year direct cost.

Award Project Period

The project duration must not exceed 5 years.

Other Award Budget Information
Personnel Costs

Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds). Personnel costs (adminstrative and clerical costs, as well as salaries of the PD/PI) associated with directing, coordinating, administering, and implementing the program should be well-justified, reasonable, and may not exceed 30% of the total direct costs in any year of the project period.

Participant Costs

Participants may be paid if specifically required for the proposed research education program and sufficiently justified. Participant support costs must be itemized in the proposed budget.

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

With strong justification, participants in the research education program may receive per diem for conference travel unless such costs are furnished as part of the registration fee. Participants may also receive funds to travel to and from the institution providing the research experience, defray partial tuition and other education-related expenses.

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

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

Other Program-Related Expenses

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

Program evaluation costs are limited to $5,000 per year.

Costs for Graduate Record Exam and relevant academic courses for skills development, if appropriate, to increase the chances of participants succeeding in graduate school or applying for admission to graduate school.

Travel funds to attend NHGRI's annual training meeting may be requested for participants who are in a program that lasts nine months or longer or returning for a second summer undergraduate research experience.

Indirect Costs

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

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

Governments

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

Other

  • Native American Tribal Organizations (other than Federally recognized tribal governments)

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) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

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

The PD/PI must have significant research funding from NIH in one of the areas relevant to NHGRI's research programs-genome sciences, genomic medicine and genomics and society.

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. Only one award will be made per institution for activities that focus on genome sciences, genomic medicine and genomics and society. Institutions that already have an award in one of these three areas are not eligible to apply for an award in the same area, but can apply for an award in a different area.

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

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

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

Because participants are expected to have the opportunity to pursue their research and educational experiences from a variety of genomic research problems, it is expected that the program faculty will have significant research programs in one or more of the three research programs relevant to genomics.

Institutions that have more than one R25 diversity program and/or NHGRI-supported T32 programs should demonstrate coordination and collaboration such that there is synergy amongst the programs.

Participants

NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences, as described in NOT-OD-15-053. For the purpose of this announcement, institutions are required to identify participants who will enhance diversity on a national basisThese groups include:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, and Native Hawaiians and other Pacific Islanders.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at, http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf.

C. Individuals from disadvantaged backgrounds, defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.

2. Individuals who come from an educational environment such as that found in certain rural or inner-city environments that has demonstrably and directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

The disadvantaged background category (C1 and C2) is applicable to programs focused on high school and undergraduate candidates.

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., Inside the Double Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and Mathematics http://her.hepg.org/content/t022245n7x4752v2/fulltext.pdf).

The program-supported participants are selected by the applicant institution.

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

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Tina Gatlin, Ph.D.
Telephone: 301-480-2280
Email: christine.gatlin@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information Component

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

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

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. To minimize possible conflicts during the peer review process, potential Advisory Committee members should not be contacted or recruited until the peer review process has been completed. 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.

Provide evidence that the PD/PI has significant peer-reviewed support from NIH in one or more of the three research areas of interest to NHGRI: genome sciences, genomic medicine and genomics and society, that the research is at the cutting edge of genomics and that the PD/PI is a demonstrated leader in the field. Examples of significant peer-reviewed support are: multiple research grants, center grants, database grants, and complex grants.

Collectively the Program Faculty's research should provide different approaches to genomic research problems relevant to the NHGRI mission so that the research experiences for participants are not focused on one particular approach, disease(s) or health condition.

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.
  • Training coordinators are allowed as long as their roles in the program implementation are clearly defined and significantly different from the roles of the PDs/PIs. The duties and responsibilities of the training coordinators must be well described in the budget and must include a strong justification. The number of person months must be strongly justified in relation to the number of program participants.
  • Costs of consultants for evaluation of the program is allowed; however, if the evaluator is an employee of the applicant institution, the cost must be included in the category of key personnel salary (effort listed in person months).
  • . The total compensation package for undergraduate and postbaccalaureate participants should be reasonable for the work performed and consistent with the compensation paid to all participants in similar circumstances, regardless of the source of support for the activity.
PHS 398 Cover Page Supplement

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

PHS 398 Research Plan Component

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

Research Strategy

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

  • Proposed Research Education Program
  • Program Director/Principal Investigator
  • Program Faculty
  • Program Participants
  • Institutional Environment and Commitment
  • Diversity Recruitment Plan
  • Plan for Instruction in the Responsible Conduct of Research
  • Evaluation Plan
  • Dissemination Plan

Research Education Program Plan

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

Describe the program’s purpose, goals, and intended outcome.

Describe the type of courses for skills development and research experiences proposed for undergraduates, post baccalaureate students, and graduate students.

Describe how students will attain critical thinking skills relevant to their career level.

Describe how the students will be exposed to research projects that will give them the foundational knowledge and skills that can be applied to a broader range of genomic problems.

Describe how the PD/PI and program faculty will prepare students to move successfully to the next career level.

Describe how the program training coordinator will be integrated with the program faculty to facilitate the program.

Describe the educational level of the participants to be reached, the time and duration of their participation and the content of the didactic training and opportunities for research experiences to be conveyed.

Explain the basis and rationale for the program and any educational principles or evidence of past success that it may be based on.

If applicable, describe how the applicant will coordinate and collaborate with other NHGRI-supported R25 diversity and/or T32 programs to provide synergy amongst the programs.

Where applicable, describe the plans for tracking the program’s participants, recruiting appropriate participants to the program, including retention strategies attracting participants who will contribute to the diversity of the program.

For renewal applications, describe how this plan resulted in getting participants to their next career level. Special attention should be paid to unique aspects of the plan that resulted in successful outcomes.

For renewal applications, provide information on the :

  • Participants who applied for admission to a program at their next career level;
  • Participants who were offered admission to a program at their next career level;
  • Participants who actually enrolled in a program at their next career level;

Participants who completed an academic program at their next career level.

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. Program training coordinators should be an integral part of the research team.

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.

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.

Provide evidence that during the duration of this grant the institution will have a significant number of peer-reviewed research projects, e.g. multiple research grants, a large center

grant, database grant or cooperative agreement, etc. in one or more of the following areas: genome sciences, genomic medicine and genomics and society in order to provide participants with a variety of experiences. Demonstrate that research and educational experiences should focus on the relevance of the foundational genomc disciplines to the research and not focus on particular disease(s) or health conditions.

Recruitment Plan to Enhance Diversity:

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.

Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

  • Individuals who applied for admission to the research education program,
  • Individuals who were offered admission to the research education program,
  • Individuals who participated in the research education program.

For those individuals who participated in the research education program, the report should include information about the duration of education and aggregate information on the number of individuals who finished the program in good standing. Additional information on the required Recruitment and Retention Plan to Enhance Diversity is available at Frequently Asked Questions: Recruitment and Retention Plan to Enhance Diversity (Diversity FAQs).

Applications lacking a diversity recruitment and retention 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 an individual plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements. Awardees are encouraged to participate in program-wide evaluation and tracking plans supported by NHGRI.

Dissemination Plan. A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops.

Letters of Support

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

Resource Sharing Plans

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

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

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide .

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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: 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. Add 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at bettie_graham@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 our Post Submission Application Materials policy.

Section V. Application Review Information

Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical, behavioral, and clinical research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: This funding opportunity seeks to provide research experiences and education for students at the undergraduate, post baccalaureate and graduate levels from diverse backgrounds underrepresented in scientific disciplines relevant to genomics: genome sciences (e.g. computational biology, quantitative sciences, bioinformatics); genomic medicine (e.g. biostatistics, epidemiology, bioinformatics), and genomics and society (e.g.bioethics, social and behavioral sciences, law, the humanities) to enable them to pursue careers in genomics that spans all areas of interest to NHGRI--genomic sciences, genomic medicine and genomics and society.The goal of the research experience and courses for skills development are to ensure that participants successfully progresses to the next stage of their careers.

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?

Will the activities enhance the pool of individuals from underrepresented racial/ethnic groups, disabled persons, and individuals from disadvantaged backgrounds in the fields of genome sciences, genomic medicine and/or genomics and society? Are the goals clearly stated and achievable? Will the planned activities develop the critical thinking skills of the participants? Are the types of research experiences and education clearly articulated for the appropriate career level of the participant? Are genomics or ethical, legal and social implications (ELSI) topics prominently integrated into planned activities? How does the plan take advantage of the genomics and ELSI research infrastructure of the applicant institution and other similar programs supported by NHGRI and the PD's/PI's institution? What is the value added and how does this program differ from ongoing activities? Will the proposed program of activities result in the participants being able to use their foundational knowledge, skills, expertise in genomics research?

Investigator(s)

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

If there are several research groups involved, collectively will they provide the expansive type of research and didactic experiences in genomics and ELSI research so that the experiences received are not focused on any particular disease, diseases or health conditions? Are individuals with the right expertise in the foundational sciences relevant to genome sciences, genomic medicine and/or genomics and society involved in the development and management of the program? Does the PD/PI have sufficient involvement in the program? Does the program leverage ongoing activities designed and managed by others? Do the PD/PI and key personnel maintain an appropriate level of involvement to ensure the substantial and unique added value critical to research in genome sciences, genomic medicine and/or genomics and society? Does the training coordinator have the scientific expertise to implement activities that are essential for the success of the participants and their anticipated career? Is the training coordinator sufficiently integrated with the key personnel and with the various PDs/PIs participating in the R25 program?

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?

For activities that support undergraduates, post baccalaureates and graduates, are there any unique activities that will increase the number of students pursuing doctoral degrees versus medical degrees? For all participants, are there unique activities or opportunities that have the potential to increase critical thinking skills appropriate for the career level?

For renewal applications, were any innovations implemented by the grantee successful?

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?

Are the activities commensurate with the program goals? Does the approach have the potential to enhance the critical thinking skills appropriate for the career level? Will the activities facilitate participants moving successfully to the next phase of their educational or career program? Will the experiences be generally applicable to a broader range of genomic and ELSI research programs? Are measurable outcomes adequately described? Are the milestones appropriate? Is genomics or ELSI prominently integrated into planned activities? How will this program provide experiences in the foundational sciences of the relevant research activity? Does the applicant demonstrate that s/he will work collaboratively with genome scientists, other relevant genome research education and research training programs, and with the NHGRI-supported Data Analysis and Coordinatinag Center?

For renewal applications, how successful was the program isin getting participants to the next phase of their career?

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? Collectively, do the research groups provide access to a broad set of research experiences in genome sciences, genomic medicine and/or genomics and society so that the participants can use the skills, knowledge and expertise to function in any research program focused on genomics? Does the institution have sufficient and varied peer-reviewed projects in the areas of interest--genome sciences, genomic medicine and genomics and society--to sustain an infrastructure consistent with the intent and duration of this program? If applicable, are the plans to coordinate and collaborate with other NHGRI-support R25 diversity and/or T32 programs adequate such that there will be synergy amongst the programs? Does the institution have the potential to sustain an intense research program in genome sciences, genomic medicine and genomes and society for at least ten years?

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six 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 Children

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 children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

For Renewals, the committee will consider the progress made in the last funding period, and the success of the program in (1) attracting and retaining individuals from, populations underrepresented in biomedical, behavioral and clinical research on a national basis and (2) successfully transitioning participants to the next phase of their careers.

Revisions

Not Applicable

Additional Review Considerations

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

Recruitment Plan to Enhance Diversity

Not Applicable

Training in the Responsible Conduct of Research

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan. If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHGRI, 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 . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Human Genome Research. 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.
  • Only one R25 grant per institution per research area (genome science, genomic medicine or genomics and society), to include already funded R25s, will be made.
3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information
1. Award Notices

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

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

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

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

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.

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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 http://www.hhs.gov/ocr/civilrights/understanding/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.

3. Reporting

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

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

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

Other Reporting Requirements

A final progress report 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 Research Experience and Mentoring Programs Involving the Following Groups:

Undergraduate Students:

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

Successful completion of an undergraduate degree in a STEM field

Enrollment in a doctoral or MD/Ph.D program in genomics or ELSI

Postbaccalaureate Students

  • Aggregate number and demographic characteristics of participants
  • Subsequent enrollment in a doctoral or MD/Ph.D program in genomics or ELSI
  • Subsequent educational/career progress of participants, including:

Successful completion of a graduate program in genomics or ELSI research

Subsequent participation in a formal research training or career development program in genomics or ELSI

Subsequent participation in research

Subsequent employment in a research or research-related field

Subsequent authorship of scientific publications in genomics or ELSI research

Subsequent submission of an individual F fellowship application

Subsequent postdoctoral position in a genomics or ELSI environment

Subsequent independent research grant support from NIH or another source

Graduate Students:

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

Successful completion of a graduate program in genomics or ELSI research

Subsequent participation in a formal research training or career development program in genomics

Subsequent participation in research

Subsequent employment in a research or research-related field

Subsequent authorship of scientific publications in genomics or ELSI research

Subsequent submission of an individual F fellowship application

Subsequent postdoctoral position in a genomics or ELSI environment

Subsequent independent research grant support from NIH or another source

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Email: support@grants.gov

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

Scientific/Research Contact(s)

Joy Boyer, B.A. (Division of Genomics and Society)
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-4997
Email: jb40m@nih.gov

Tina Gatlin, Ph.D (Division of Genome Sciences)
National Human Genome Research Institute (NHGRI)
Telephone: 301-496-7531
Email: gatlincl@mail.nih.gov

Heather A. Junkins, M.S. (Division of Genomic Medicine)
National Human Genome Research Institute (NHGRI)
Telephone: 301-496-7531
Email:junkinsh@mail.nih.gov

Peer Review Contact(s)

Ken Nakamura, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-0838
Email: ken_nakamura@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.

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