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)
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
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
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
Open Date (Earliest Submission Date)
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)
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.
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.
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: [email protected]
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.
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 [email protected]} 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.
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: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Email: [email protected] (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: [email protected]
Tina Gatlin, Ph.D (Division of Genome Sciences)
National Human Genome Research Institute (NHGRI)
Telephone: 301-496-7531
Email: [email protected]
Heather A. Junkins, M.S. (Division of Genomic Medicine)
National Human Genome Research Institute (NHGRI)
Telephone: 301-496-7531
Email:[email protected]
Peer Review Contact(s)
Ken Nakamura, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-0838
Email: [email protected]
Financial/Grants Management Contact(s)
Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: [email protected]
Section VIII. Other
Information
Recently issued trans-NIH policy
notices may affect your application submission. A full list of policy
notices published by NIH is provided in the NIH
Guide for Grants and Contracts. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement.
Authority and Regulations
Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
Department of Health
and Human Services (HHS)
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