Participating Organization(s)
National Institutes of Health (NIH)
Components
of Participating Organizations
National Institute on Drug Abuse (NIDA)
Funding Opportunity Title
NIDA Research Education Program for
Clinical Researchers and Clinicians (R25)
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 NIDA R25 program is to support educational activities that complement
and/or enhance the training of a workforce to meet the nation’s biomedical,
behavioral and clinical research needs. This FOA is intended to support
research education activities that enhance the knowledge of substance abuse
and addiction research. The program is intended for those in clinically
focused careers and/or those training for careers as clinicians/service
providers, clinical researchers or optimally a combination of the two. This
mechanism may not be used for support of non-research-related clinical
training.
To accomplish the stated over-arching goal, this FOA will
support creative educational activities with a primary focus on Courses
for Skills Development and Research Experiences.
Open Date (Earliest Submission Date)
Letter of Intent Due Date(s)
30 days prior to the application due date'
Application Due Date(s)
Any due dates on or after Jan 25, 2018 must use reissued FOA.
July 21, 2016; July 21, 2017;July 20, 2018, 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)
September 7, 2016; September 7, 2017; and September 7,
2018; by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on 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.
Scientific Merit Review
October/November 2016; October/November 2017;
October/November 2018.
Advisory Council Review
January 2017; January 2018; January 2019.
Earliest Start Date
April 2017; April 2018; April 2019
Expiration Date
New Date January 24, 2018 per reissuance of FOA (Original Expiration Date: September 8, 2018)
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.
The over-arching goal of this NIDA R25 program is to
support educational activities that complement and/or enhance the training of
a workforce to meet the nation’s biomedical, behavioral and clinical research
needs.To accomplish the stated over-arching goal, this FOA will support creative
educational activities with a primary focus on:
- Courses
for Skills Development: Activities may include advanced courses
in a specific discipline or research area, clinical procedures for research,
neuroethics in clinical research, specialized research techniques, or other
topics that would complement and enhance the research experiences proposed. Additionally,
careeer development seminars and workshops such as grant writing, manuscript
preparation and building a successful career path are encouraged.
- Research
Experiences: Activities include hands-on exposure to research for
undergraduate students and research experiences for graduate and medical
students, postdoctorates, and/or early career faculty. The nature of research
experiences should be tailored to the needs and career level of participants.
It is expected that mentoring will be provided in conjunction with planned
research experiences.
The proposed research education programs must include both courses
for skills development and research experiences. However, primary emphasis
should be given to research experiences. Courses for skills development should
be proposed in conjunction with research experiences.
Background
There is a shortage of well-qualified researchers prepared
to conduct clinical, translational, prevention, health services, and treatment
research with drug users/abusers and those affected by drug use/abuse,
including underserved populations such as children, adolescents, women,
elderly, and those from diverse sexual, racial, or ethnic backgrounds. A
related need is for increased numbers of clinicians/service providers who are
sufficiently sophisticated consumers of research to evaluate and apply
research-based findings. Despite recent progress in providing opportunities for
clinicians, such as specialty research training programs, and certification in
addiction medicine, there remains a need for coordinated research education in
this area. This is especially true for medical residents and fellows, as well
as other health services providers.
Purpose
and Description of the Program
The overall objective of this funding opportunity
announcement (FOA) is to ensure that highly trained clinical scientists will be
available in adequate numbers and in appropriate scientific areas to reduce the
burden of substance abuse, addiction, and their related health consequences. To
accomplish the overall objective, the NIDA Research Education Program will
support research experiences and courses for skills development in the mission
areas of the NIDA. This FOA is intended to support research education
activities that enhance the knowledge of substance abuse and addiction
research. The program is intended for those in clinically focused careers
and/or those training for careers as clinicians/service providers, clinical
researchers or optimally a combination of the two. Researchers with basic
neuroscience, physical science, or quantitative backgrounds who are obtaining
clinical research experiences to apply their knowledge to translational or
clinical problems in substance abuse or addiction are eligible to participate. This
FOA uses the NIH definition of clinical research (https://grants.nih.gov/grants/glossary.htm#ClinicalResearch).
This mechanism may not be used for support of non-research-related clinical
training, although it would be appropriate for the research experiences that
complement residency or other clinical training.
The program may support candidates at one or more of the
following career levels: medical/graduate student, postdoctoral fellow, medical
resident, and/or independent scientist. Advanced undergraduate students
(juniors, seniors)/pre-medical students may participate if their participation
is complementary to the broader research education program (See Section III. Eligibility Information).
Consistent with the NIH global health research mission, NIDA
is committed to developing clinical research expertise and sustainable research
infrastructure both outside and within the United States. Although this
research education opportunity is primarily for domestic programs, NIDA also
encourages applications from low-and-middle income countries (LMIC) where there
is a serious drug epidemic or crisis, as well as recruitment of researchers and
clinician/scientists from these regions. Applicants must demonstrate their
program's public health relevance for the United States, namely, how their
programs and/or training of candidates will impact U.S. epidemics. Partnerships
between domestic and foreign institutions are also encouraged.
Depending on the different strengths of the applicant
institutions, it is expected that research education activities will vary in
how they are formalized and integrated. Although research experiences and
courses for skills development are required activities in the proposed program,
various strategies for integrating the activities to support the goals of the
program may be utilized. These approaches may include, but are not limited to short-term
laboratory rotations; project-based research participation; collaborative
networks to provide research experiences at another site; presentations of
research at local and national conferences; career development workshops or
seminars; and other coursework on substance abuse research topics. Based on the
proposed research experiences, there must be commitment of a sufficient number
of investigator/faculty to provide necessary research context. An adequate
commitment of investigator/faculty time for mentoring is critical for these
educational programs.
Research education activities may be in any topic area
related to substance abuse and addiction. However, the following are examples
of particular relevance to this FOA: etiology; clinical assessment and
diagnostics; treatment; prevention; services research; clinical neuroscience;
medical consequences of drug abuse; and pre-clinical research as it pertains to
translational research. Interdisciplinary research education is encouraged and
may include co-morbid conditions. In addition, NIDA encourages clinical
research training on HIV/AIDS in drug users to reduce HIV incidence by developing,
testing, and implementing strategies to improve HIV testing and entry into
prevention services; to improve HIV therapy through research to ensure early
initiation of HIV treatment, retention and engagement in care, and achievement
and maintenance of optimal prevention and treatment responses; and to address
HIV-associated comorbidities, coinfections, and complications.
Although NIDA expects applicants to propose their own
research education programs, some examples of programs that would be of
interest to NIDA are listed below. Although the examples below do not include a
description for courses for skills development, courses are a required activity
for each research education program proposed:
- Research experiences provided to patient-oriented clinicians
(including residents) or postdocs designed to facilitate the translation of
bench discoveries. Patient-oriented clinicians may include those from low- to
middle-income foreign countries and regions experiencing new and/or serious
drug use epidemics (e.g., MD, PhD, MD/PhD, DO, DSW, DSN, DDS).
- Creation of a research track within a residency or medical student
program in order to provide either a solid research basis for future clinicians
or an intense research experience to prepare clinician scientists for a
research career.
- Provide mentored clinical research experiences to postdoctoral participants
and/or independent scientists by leveraging underused networks, associations,
consortia, or other frameworks.
- Involve early stage predoctoral and advanced undergraduate
students in clinically oriented programs (e.g., pre-medical, or medical school,
public health, social work, counseling, and psychology students) in mentored clinical
research on substance abuse as a part of broader proposed research education
program.
- Research experiences that involve patient-oriented clinicians or
those training for clinical careers in interdisciplinary research or research
that translates approaches from basic behavioral, social science, neuroscience,
and biomedical fields, to prevention, treatment, or services research. Examples
of interdisciplinary and translational approaches include:
- Use of
cognitive, affective, and social neuroscience to develop and evaluate
behavioral and pharmacological treatment interventions for drug abuse and
addiction.
- Interdisciplinary
approaches that facilitate the translation of prevention or treatment interventions
with evidence of efficacy into novel populations, or patient-oriented (e.g., primary
care) or other health care settings.
- Research experiences provided to infectious-disease trained
clinicians or predoctoral students and postdoctoral students training in
clinical careers, designed to enhance their commitment to and participation in
the substance use/abuse field.
Educational partnerships to facilitate translational and
interdisciplinary research, and/or collaborations between multiple institutions
of the same type are highly encouraged. The following are examples of
organizations/institutions that may comprise an educational partnership: basic
and applied research institutions, drug abuse treatment organizations, and
primary care organizations. For any educational partnership or collaboration,
research education activities must be integrated across
partnering/collaborating institutions and the applicant institution must act as
the lead or coordinating organization.
Applicants are strongly encouraged to contact NIDA Scientific/Research
staff for current information about targeted priorities before preparing an
application (see Section VII).
Research education programs may
complement ongoing research training and education occurring at the applicant
institution, but the proposed educational experiences must be distinct from
those training and education programs currently receiving Federal support. R25
programs may augment institutional research training programs (e.g., T32, T90)
but cannot be used to replace or circumvent Ruth L. Kirschstein National
Research Service Award (NRSA) programs.
See Section VIII. Other
Information for award authorities and regulations.
Section II. Award Information
Funding Instrument
Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.
Application Types Allowed
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
Although the size of the award may vary with the scope of
the research education program proposed, it is expected that applications
will not exceed $350,000 in total direct costs annually.
Award Project Period
The scope of the proposed project should determine the
project period. The total project period, however, may 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).
Participant Costs
Participants may be paid a salary or subsistence allowance
if specifically required for the proposed research education program and
sufficiently justified. Participant costs must be itemized in the proposed
budget
Allowable participant costs depend on the educational level/career status of
the individuals to be selected to participate in the program, and may include
fringe benefits. Amounts for all participants must conform to the
established, consistently applied salary and wage policies of the institution
and reflect the percentage of time/effort devoted to the program.
With strong justification, participants in the research
education program may receive partial costs of meals and lodging except when
such costs are furnished as part of the registration fee. Participants may also
receive funds to defray partial tuition, travel, and other education-related
expenses. Expenses for all travel must be exceptionally well justified.
Individuals supported by NIH training and career development mechanisms (K,
T, or F awards) may receive, and indeed are encouraged to receive,
educational experiences supported by an R25 program as participants, but may
not receive salary or stipend supplementation from a research education
program.
Because the R25 program is not intended as a substitute for an NRSA
institutional training program (e.g.,T32), costs to support full-time
participants (supported for 40 hours/week for a continuous, 12-month period)
are not allowable.
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.
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)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally
Recognized)
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally
recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
- Non-domestic (non-U.S.) Entities (Foreign Institutions)
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 eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible
to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are 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 be engaged in research and teaching in an area relevant to the
mission of NIDA. In a multiple PD/PI collaboration, one or more PD(s)/PI(s)
must be actively engaged in substance use/addiction research.
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. However, an
individual may be named as a PD/PI on only one application.
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,
research support, and mentoring experience relevant to the proposed program.
Mentors must be committed to continue their involvement throughout the total
period of the mentee’s participation in this award.
Participants
This funding opportunity is intended for those in clinically
focused careers and/or those training for careers as clinicians/service
providers, clinical researchers or optimally a combination of the two. This FOA
uses the NIH definition of clinical research (https://grants.nih.gov/grants/glossary.htm#ClinicalResearch).
The program may support candidates at the following career levels: advanced
undergraduate student (juniors, seniors)/pre-medical student, medical/graduate
student, postdoctoral fellow, medical student, medical residents, and/or
independent scientist. Researchers with basic neuroscience, physical science, or
quantitative backgrounds who are obtaining clinical research experiences to
apply their knowledge to translational or clinical problems in substance abuse
or addiction are eligible to participate. This mechanism may not be used for
support of non-research-related clinical training, although it would be
appropriate for the research experiences that complement residency or other
clinical training. Those in clinically focused career paths at the
undergraduate level are eligible to participate, as long as the following two
conditions are met:
- Undergraduate students must be juniors or seniors in a clinically
focused program. Pre-medical students are also eligible. Post-baccalaureate
students are not eligible to participate in this program.
- The undergraduate research education and training must be a
complementary component of the overall proposed program and not the sole or
primary component. The undergraduate program component should be well
integrated with the overall program, and further the goals/objectives stated in
this FOA.
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:
[email protected]
Office of Extramural Policy and Review
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550
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. If the application
proposes an Advisory Committee to monitor progress (recommended), a plan must
be provided for the appointment of members and conduct of duties. Composition,
desired expertise of members, roles and responsibilities, frequency of
meetings, and other relevant information should be included. A plan for
Advisory Committee approval and selection of participants should be included.
Describe how the Advisory Committee will function in providing oversight of the
development, implementation, and evaluation of recruitment strategies, the
recruitment and retention of candidates, and the evaluation of the overall
effectiveness of the program. Proposed Advisory Committee members should be
named in the application if they have been invited to participate at the time
the application is submitted. Renewal applications with Advisory Committees
should include the names of all committee members during the past project
period. Please name your file Advisory_Committee.pdf.
The filename provided for each Other Attachment
will be the name used for the bookmark in the electronic application in eRA
Commons.
SF424(R&R) Senior/Key Person Profile Expanded
Follow all instructions provided in the SF424 (R&R)
Application Guide.
R&R Budget
Follow all instructions provided in the SF424 (R&R)
Application Guide with the following additional modifications:
- Include all personnel other than the PD(s)/PI(s) in the Other
Personnel section, including clerical and administrative staff. Use the section
on Participant/Trainee Support Costs to include all allowable categories of
funds requested to support participants in the program. State the number of
Participants to be supported by the proposed research education program.
- Provide a detailed justification for each category for which
funds are requested. A justification is required for each category of
participant support cost.
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 described below:
- Proposed
Research Education Program
- Program
Director/Principal Investigator
- Program
Faculty
- Program
Participants
- Institutional
Environment and Commitment
- Diversity
Recruitment Plan
- Plan for
Instruction in the Responsible Conduct of Research
- Evaluation
Plan
Research Education Program Plan
Proposed
Research Education Program. While the proposed research
education program may complement ongoing research training and education
occurring at the applicant institution, the proposed educational experiences
must be distinct from those research training and research education programs currently
receiving federal support. When research training programs are on-going in the
same department, the applicant organization should clearly distinguish between
the activities in the proposed research education program and the research
training supported by the training program. The research education program plan
should describe how the research education acivities will contribute to the
goals of the program. The plan should provide programmatic detail on the
courses for skills development and research experiences proposed. Courses
should provide sufficient depth and breadth to complement the program.
Applicants should include the sequence and timetable of the planned courses. Applicants
should also describe planned processes for: (a) conducting and monitoring
recruitment and selection of participants, (b) planning research and
educational activities, (c) selecting mentors for participants, and (d)
coordinating among existing training or research activities available at the
site. Include a description of the education and/or career levels of the
planned participants and how the program activities are geared toward
participants' experiences and career levels.
Renewals. Applicant should
describe progress made in last funding period, which includes details on
program's ability to attract and retain individuals from diverse populations,
including populations underrepresented in biomedical, behavioral and clinical
research on a national basis. Additionally, the successful career outcomes of
previous program participants should be described. Describe how participant
outcomes met program expectations.
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 NIDA, 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
Participants. Applications must describe the intended
participants, and the eligibility criteria and/or specific educational
background characteristics that are essential for participation in the proposed
research education program. Identify the career levels for which the proposed
program is planned. Describe the expected outcomes of participating in the
program.
Institutional
Environment and Commitment. Describe the institutional
environment, reiterating the availability of facilities and educational
resources (described separately under Facilities & Other Resources ), that
can contribute to the planned Research Education Program. Evidence of
institutional commitment to the research educational program is required. A
letter of institutional commitment must be attached as part of Letters of
Support (see below). Appropriate institutional commitment should include the
provision of adequate staff, facilities, and educational resources that can
contribute to the planned research education program.
Recruitment
Plan to Enhance Diversity: Fostering diversity in the
scientific research workforce is a key component of the NIH strategy to
identify, develop, support and maintain the quality of our scientific human
capital (NOT-OD-15-053).
Every facet of the United States scientific research enterprise from basic
laboratory research to clinical and translational research to policy
formation requires superior intellect, creativity and a wide range of skill
sets and viewpoints. NIH’s ability to help ensure that the nation remains a
global leader in scientific discovery and innovation is dependent upon a pool
of highly talented scientists from diverse backgrounds who will help to further
NIH's mission.
Research shows that diverse teams working together
and capitalizing on innovative ideas and distinct perspectives outperform
homogenous teams. Scientists and trainees from diverse backgrounds and life
experiences bring different perspectives, creativity, and individual enterprise
to address complex scientific problems. There are many benefits that flow from
a diverse NIH-supported scientific workforce, including: fostering scientific
innovation, enhancing global competitiveness, contributing to robust learning
environments, improving the quality of the 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,
such as:
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).
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 a plan for evaluating the
activities supported by the award. The application must specify baseline
metrics (e.g., numbers, educational levels, and demographic characteristics of
participants), as well as measures to gauge the short or long-term success of
the research education award in achieving its objectives. Wherever appropriate,
applicants are encouraged to obtain feedback from participants to help identify
weaknesses and to provide suggestions for improvements.
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 modification:
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 Assignment Request Form
All instructions in the SF424 (R&R) Application Guide
must be followed.
Foreign Institutions
Foreign (non-U.S.) institutions must follow policies
described in the NIH
Grants Policy Statement, and procedures for foreign institutions described
throughout the SF424 (R&R) Application Guide.
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.
Requests of $500,000 or more for direct costs in any year
Applicants requesting $500,000 or more in direct costs in any
year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks
before submitting the application and follow the Policy on the Acceptance for
Review of Unsolicited Applications that Request $500,000 or More in Direct
Costs as described in the SF424 (R&R) Application Guide.
Post Submission Materials
Applicants are required to follow our Post Submission Application Materials policy.
Section V. Application Review Information
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: The
goal of this R25 program is to support educational activities that complement
and/or enhance the training of a workforce to meet the nation’s biomedical,
behavioral and clinical research needs. NIDA seeks to ensure that highly
trained clinical scientists will be available in adequate numbers and in
appropriate scientific areas to reduce the burden of substance abuse,
addiction, and their related health consequences. To accomplish these objectives,
the NIDA Research Education Program will support research experiences and
courses for skills development in the mission areas of NIDA and for those in
clinically focused 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? Are the research experiences relevant
to current problems of substance use and addiction?
Investigator(s)
Is the PD/PI capable of providing both administrative
and scientific leadership to the development and implementation of the proposed
program? Is there evidence that an appropriate level of effort will be devoted
by the program leadership to ensure the program's intended goal is
accomplished? If applicable, is there evidence that the participating faculty have
experience in mentoring students and teaching science? If applicable, are the
faculty good role models for the participants by nature of their scientific
accomplishments? If the project is collaborative or multi-PD/PI, do the
investigators have complementary and integrated expertise; are their leadership
approach, governance and organizational structure appropriate for the project?
Innovation
Taking into consideration the nature of the proposed
research education program, does the applicant make a strong case for this
program effectively reaching an audience in need of the program’s offerings?
Where appropriate, is the proposed program developing or utilizing innovative
approaches and latest best practices to improve the knowledge and/or skills of
the intended audience? Does this proposed program duplicate, or overlap with,
existing research education, training and/or career development activities
currently supported at the applicant institution or available elsewhere?
Adaptations of existing research education programs may be considered
innovative under special circumstances, e.g., the addition of unique components
and/or a proposal to determine portability of an existing program.
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? Will the research experiences allow
participants to acquire current research tools and methods? If an Advisory
Committee is not proposed, are there adequate plans for meeting the overall
needs for the administration of the grant? If an Advisory Committee is proposed,
is it appropriate and adequate for meeting the overall needs for the
administration of the grant? Are benchmarks, plans, and procedures to capture,
analyze and report program outcome measures adequately specified and described?
Do courses for skills development provide sufficient depth and breadth to
complement the program and maximize the likelihood of achieving the stated
goal? Are the courses specifically geared to participants' experience and
career level, and are the sequence and timetable of the courses appropriate? If
evaluation instruments are used, are they adequately described and justified?
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?
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
attracting and retaining individuals from diverse populations, including
populations underrepresented in biomedical, behavioral and clinical research on
a national basis. The committee will also consider the successful career
outcomes of previous participants. Acceptable career outcomes include clinical
researcher, clinician scientist, practicing clinician, and the various stages
preceding these careers as appropriate.
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
Peer reviewers will separately evaluate the
recruitment plan to enhance diversity after the overall score has been
determined. Reviewers will examine the strategies to be used in the recruitment
of individuals from underrepresented groups. Additionally, reviewers will
evaluate the overall progress madeThe review panel’s evaluation will be
included in the summary statement. Plans will be rated as acceptable or unacceptable,
and the summary statement will provide the consensus of the review committee.
Training in the
Responsible Conduct of Research
Taking into account
the specific characteristics of the proposed research education program, the
level of participant experience, the reviewers will evaluate the adequacy of
the proposed RCR training in relation to the following five required
components: 1) Format - the
required format of instruction, i.e., face-to-face lectures, coursework, and/or
real-time discussion groups (a plan with only on-line instruction is not
acceptable); 2) Subject Matter - the breadth of subject matter,
e.g., conflict of interest, authorship, data management, human subjects and
animal use, laboratory safety, research misconduct, research ethics; 3) Faculty
Participation - the role of the program faculty in the instruction; 4) Duration
of Instruction - the number of contact hours of instruction, taking
into consideration the duration of the program; and 5) Frequency of
Instruction instruction must occur during each career stage and at
least once every four years. See also: NOT-OD-10-019. The review panel’s evaluation will be
included in the summary statement. Plans
will be rated as acceptable or unacceptable, and the summary
statement will provide the consensus of the review committee.
Applications from
Foreign Organizations
Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of unusual
talent, resources, populations, or environmental conditions that exist in other
countries and either are not readily available in the United States or augment
existing U.S. resources.
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 NIDA, 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 on Drug Abuse. The following will be
considered in making funding decisions:
- Scientific and technical merit of the proposed project as
determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
3. Anticipated Announcement
and Award Dates
After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.
Information regarding the disposition of applications is available in the NIH
Grants Policy Statement.
Section VI. Award
Administration Information
1. Award Notices
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the 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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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
- The institution must submit a completed Statement of Appointment (PHS Form
2271) for each participant appointed full time for eight weeks or more or
the equivalent. Grantees must submit the PHS 2271 data electronically using the
xTrain system. More information on xTrain is available at xTrain (eRA
Commons). An appointment or reappointment may begin any time during the
budget period, but not before the budget period start date of the grant year.
- Participant Termination Notice: Within 30 days of the end of the
total support period for each participant, the institution must submit a
Termination Notice (PHS Form
416-7) via xTrain for each participant appointed full time for eight weeks or more, or the
equivalent.
A final 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, NIDA
expects to use the following evaluation measures:
For Courses for Skills
Development:
- Aggregate number and demographic characteristics of participants
- Educational level of participants
- Content
- Participants feedback on the program
- New knowledge or skills acquired
For 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 an advanced degree program in a STEM
field
Graduate
Students:
- Aggregate
number and demographic characteristics of participants
- Subsequent
educational/career progress of participants, including:
Successful completion of a STEM graduate program
and degree
Subsequent participation in a formal research
training or career development program in a STEM field
Subsequent participation in research
Subsequent employment in clinical research or as a
clinician
Subsequent authorship of scientific publications
in a STEM field
Subsequent independent research grant support from
NIH or another source
Postdoctorates
and Early Career Investigators:
- Aggregate
number and demographic characteristics of participants
- Subsequent
educational/career progress of participants, including:
Subsequent participation in research
Subsequent employment in clinical research or as a
clinician
Subsequent authorship of scientific publications
in a STEM field
Subsequent career development award or 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)
Belinda E. Sims, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1533
Email: [email protected]
Will M. Aklin, Ph.D.
Division of Therapeutics and Medical Consequences
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6173
Email: [email protected]
Yu (Woody) Lin, M.D., Ph.D.
Integrative Neuroscience Branch
National Institute on Drug Abuse (NIDA)
Telephone: 301 435-1318
Email: [email protected]
Beth Babecki, M.A.National Institute on Drug Abuse (NIDA)
Telephone: 301-435-0899
Email: [email protected]
Steve Gust, Ph.D.
International Research Program
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1118
Email: [email protected]
Flair Lindsey
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-0779
Email: [email protected]
Peer Review Contact(s)
Mark Swieter, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2755
Email: [email protected]
Financial/Grants Management Contact(s)
Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6710
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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