Participating Organization(s)
National Institutes of Health (NIH)
Components
of Participating Organizations
National Institute of Neurological Disorders and Stroke (NINDS)
Funding Opportunity Title
NINDS Postdoctoral Mentored Career
Development Award (K01 - No Independent Clinical Trial Allowed)
Activity Code
K01 Research Scientist Development Award - Research & Training
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
PAR-20-050, K01 Research Scientist Development Award - Research & Training
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
The purpose of the NINDS Postdoctoral Mentored Career
Development Award is to support the ability of outstanding, mentored
postdoctoral researchers to develop a potentially impactful research project
with a comprehensive career development plan that will enable them to launch
an independent research program. Candidates are encouraged to apply for
support from this NINDS K01 any time between the second through fourth year
of cumulative mentored postdoctoral research experience, and may be supported
by this NINDS K01 within the first 6 years of cumulative postdoctoral
research experience. Because the completion of a strong, well-planned,
thorough career development plan, in addition to development of an impactful
research project, is a critical aspect of this K01, applications are strongly
encouraged early in the postdoctoral eligibility window. By the end of the
proposed K01 award period, the candidate should be poised to begin an
independent research career with a well-developed, impactful research project
and the expertise required to become a leader in the field.
This Funding Opportunity Announcement (FOA) is designed
specifically for applicants proposing research that does not involve leading
an independent small clinical trial. Applicants to this FOA are permitted to
propose research experience in a clinical trial led by a mentor or co-mentor.
Applicants proposing an independent small clinical trial as lead
investigator, should apply to the companion FOA (PAR-20-050).
Key Dates
Open Date (Earliest Submission Date)
Letter of Intent Due Date(s)
Application Due Date(s)
Standard
dates apply.
The first standard due date for this FOA is February 12,
2020.
All applications are due by 5:00 PM local time of
applicant organization. All types of non-AIDS
applications allowed for this funding opportunity announcement are due on
the listed date(s). Applications 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)
Standard
AIDS dates apply.
The first AIDS application due date for this FOA is May 7,
2020
All appilcations are due 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 the listed date(s).
Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.
Expiration Date
New Date May 8, 2023 per issuance of NOT-NS-23-044. (Original Expiration Date: January 8, 2023)
Required
Application Instructions
It is critical that applicants follow the Career Development
(K) 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 may be delayed or not accepted for review.
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
overall goal of the NIH Research Career Development program is to help ensure
that a diverse pool of highly trained scientists is available in appropriate scientific
disciplines to address the Nation's biomedical,
behavioral, and clinical research needs. NIH Institutes and Centers
(ICs) support a variety of mentored and non-mentored career development award
programs designed to foster the transition of new investigators to research
independence and to support established investigators in achieving specific
objectives. Candidates should review the different career development (K) award
programs to determine the best program to support their goals. More information about Career programs may be found
at the NIH Extramural Training Mechanisms website.
The objective of this NINDS Postdoctoral Mentored Career
Development Award (K01) is to provide support for the development of a
potentially impactful research project, combined with a sustained period (up to
4 years) of intensive research career development under the guidance of an
experienced mentor. The project, together with the skills and knowledge
obtained, should form the basis for the candidate's projected independent
research program. Candidates are eligible to apply for this postdoctoral K01
support in years two through four of cumulative postdoctoral research
experience, and may be supported by the NINDS postdoctoral K01 within the first
6 years of cumulative postdoctoral research experience (this eligibility window
applies to new and resubmission applications). Although guided by one or more
postdoctoral mentors, the candidate will be primarily responsible for the
oversight and conduct of the proposed research project. By the end of the K01
award period, the candidate should be poised to begin an independent research
career, and have a well-developed, potentially impactful project that can be
continued by the K01 awardee in an independent research position.
NINDS has several mechanisms to support mentored,
postdoctoral research. This NINDS K01 is intended to facilitate the development
of impactful, innovative projects and career development activities that will
prepare outstanding, mentored postdoctoral investigators for an independent
research career. Successful applicants for this award are intended to be those
who have previous high quality research accomplishments, innovative and/or
creative ideas, and a potentially impactful project for which they have already
obtained some high-quality preliminary data. The candidate's research mentor(s)
should have an outstanding record of research accomplishment, including a
history of attention to the highest principles of experimental design and data
analysis and interpretation. In addition, it is anticipated that the primary
mentor will have a record of successfully mentoring others towards their goal
as independent researchers. It is acceptable for research to be conducted under
the guidance of a primary mentor who has outstanding research credentials but
limited track record in training others. In this case, however, there must be
one or more additional mentors who are integral to the research career
development program and who have a strong training record (including a strong
record of trainees who transition to independent research positions). The
research project being developed should hold promise to produce highly
significant results and future discoveries that will advance the goals of the
NINDS mission. The candidate should show promise, via his/her prior
accomplishments, as well the plans, ideas and presentation in this application,
to be a leader in his/her field.
Projects are encouraged at all levels of investigation,
including basic science, that are targeted to understanding central and/or
peripheral nervous system processes but may not have direct disease-relevance,
basic science with direct relevance to one or more neurological diseases or
disorders, or clinical (patient-oriented) research. The integrated program of
research and career development is expected to provide applicants with the
breadth and depth of understanding that will place them at the forefront of
their scientific field.
The production of highly impactful research and pursuit of a
competitive, successful research career will require that candidates have a
strong working knowledge of their experimental system as well as strong written
and oral communication skills. Thus, in addition to high quality, published
data and expertise in a research area, the research and career development plan
should promote:
- A strong foundation in quantitative reasoning, research design,
methods, statistics and analytic techniques appropriate to the proposed
research;
- An understanding of, and adherence to, the principles of strict
scientific method that ensures robust and unbiased experimental design,
methodology, analysis, interpretation and reporting of results;
- An expert understanding of the tools and methods used;
- A breadth of understanding that will enable the candidate, by the
end of the postdoctoral training period, to stay current with the rapid
expansion of new ideas, approaches and technologies in the candidate's research
area;
- Opportunities to present research findings and interact with
members of the scientific community at national meetings, as the work
progresses;
- The opportunity to publish the research findings as first author;
and
- Professional skills and the scientific credentials needed to
transition to the next stage of the applicant's research career
The completion of a strong, well-planned, thorough career
development plan, in addition to development of an impactful research project,
is a critical aspect of this K01. Consequently, applications are strongly
encouraged from candidates who are at the earlier end of the eligibility
window, to ensure sufficient time to accomplish the career development goals of
this FOA.
Note: This Funding Opportunity Announcement (FOA) is designed
specifically for applicants proposing research that does not involve leading an
independent small clinical trial. Applicants to this FOA are permitted to
propose research experience in a clinical trial led by a mentor or co-mentor.
Applicants proposing an independent small clinical trial as lead investigator,
should apply to the companion FOA (PAR-20-050).
Applicants to this FOA are permitted to propose research experience in a
clinical trial led by a mentor or co-mentor.
See Section VIII. Other
Information for award authorities and regulations.
Section II. Award Information
Funding Instrument
Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.
Application
Types Allowed
New
Resubmission
The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types. Only those application types listed here are allowed
for this FOA.
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
Award budgets are composed of salary and other
program-related expenses, as described below.
Award Project Period
The total project period may not exceed 48 months.
Other Award Budget
Information
Salary
The maximum allowable salary for an applicant at the time
of award (i.e. for year 1 of the award) is the applicant's base postdoctoral
salary at the time of application plus 5%. Thereafter, awardees are entitled
to the same % salary increase in subsequent years as NRSA postdoctoral
fellows at the same career level. In the event that the K01 scholar moves to
a faculty position, salary may be adjusted to be consistent with the base
salary of this new position. NIH will
contribute up to $95,000 per year toward the salary of the career
award recipient. Further guidance on budgeting for career development
salaries is provided in the SF424 (R&R) Application Guide.See also NOT-OD-17-094
The total NIH contribution to salary, however, may not
exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.
Other Program-Related Expenses
NIH will contribute $30,000 per year toward the research
development costs of the award recipient, which must be justified and
consistent with the stage of development of the candidate and the proportion
of time to be spent in research or career development activities.
Salary for mentors, secretarial and administrative
assistants, etc. is not allowed.
Indirect Costs
Indirect Costs (also known as Facilities &
Administrative [F&A] Costs) are reimbursed at 8% of modified total direct
costs.
NIH grant policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made from this FOA.
Section III. Eligibility
Information
1. Eligible Applicants
Eligible Organizations
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving
Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of
Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions
of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally
Recognized)
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally
recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
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 allowed.
Required Registrations
Applicant
Organizations
Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.
- Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.
- System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.
- 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 to register in eRA Commons.
Organizations can register with the eRA Commons as they are working through
their SAM or Grants.gov registration, but all registrations must be in place by
time of submission. eRA Commons requires organizations to identify at least one
Signing Official (SO) and at least one Program Director/Principal Investigator
(PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active DUNS number and SAM registration in order to
complete the Grants.gov registration.
Program
Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing
Official, they must have two distinct eRA Commons accounts, one for each role.
Obtaining an eRA Commons account can take up to 2 weeks.
Eligible Individuals (Program Director/Principal
Investigator)
Any candidate with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her mentor and organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups and individuals with disabilities are always encouraged to
apply for NIH support. Multiple PDs/PIs are not allowed.
By the time of award, the individual must be a citizen or a
non-citizen national of the United States or have been lawfully admitted for
permanent residence (i.e., possess a currently valid Permanent Resident Card
USCIS Form I-551, or other legal verification of such status.
This FOA is only open to candidates with a research
doctorate (Ph.D. or equivalent) or candidates who have a clinical doctorate but
will not have a license to practice clinically for the duration of the K01
award. Individuals who currently have a license to practice clinically, or will
have a license to practice clinically at any time during the K01 period, are
not eligible. Candidates with a clinical doctorate (M.D. or equivalent) who are
or will be licensed to practice clinically are encouraged to use either the
K08, K23 or K99 mechanisms. This NINDS K01 will support only those in mentored,
postdoctoral research positions. Individuals with any kind of faculty position
(including Instructor, Research Assistant Professor, etc.) are not eligible to
apply for this NINDS postdoctoral K01. If a K01 awardee transitions to a faculty
position within the first 18 months of this award, the award will be
terminated. However, if the awardee transitions to a faculty position after the
first 18 months of the award, up to 12 months of the remaining time on the
award may be used to support the scholar in the independent position.
In addition to standard, automatic NIH leave policies,
fellows who have children while supported by an award made under this FOA,
either through childbirth or adoption, are encouraged to consider requesting a
six-month paid extension of their K01. NINDS may provide one six-month
extension during the mentored postdoctoral period to ensure that K01 research
and career development can be completed. Requests must be submitted in writing,
following the procedures described in the NIH Grants Policy Statement, Section
12.13.1.
Current and former PDs/PIs on NIH research project (R01),
program project (P01), center grants (P50), SBIR/STTR (R41, R42, R43, R44),
other major individual career development awards (e.g., K01, K07, K08, K22,
K23, K25, K76, K99/R00), as well as current and former leads of sub-projects of
program project (P01), sub-projects of center grants (P50), or the equivalent of
any of these mechanisms, are not eligible. Current and former PDs/PIs of an NIH
Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award
(R36) remain eligible.
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, and each is from a
different candidate.
The NIH will not accept duplicate or highly overlapping
applications under review at the same time. An individual may not have two or
more competing NIH career development applications pending review concurrently.
In addition, 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).
Candidates may not submit research project grant (RPG)
applications concurrently with the K application, nor can they have a K
application and R01 or equivalent application pending simultaneously. K award
recipients are encouraged to obtain funding from NIH or other Federal sources
either as a PD/PI on a competing research grant award or cooperative agreement,
or as project leader on a competing multi-project award as described in NOT-OD
18-157.
Level of Effort
At the time of award, the candidate must have a full-time
appointment at the applicant institution. Candidates are required to commit a
minimum of nine person months of effort (i.e., 75% of full-time professional
effort) to their program of career development during the mentored phase.
Candidates may engage in other duties as part of the professional effort not
covered by this award, as long as such duties do not interfere with or detract
from the proposed career development program.
Candidates who have VA appointments may not consider part of
the VA effort toward satisfying the full time requirement at the applicant
institution. Candidates with VA appointments should contact the staff person in
the relevant Institute or Center prior to preparing an application to discuss
their eligibility.
After the receipt of the award, adjustments to the required
level of effort may be made in certain circumstances. See NOT-OD-09-036 for more details.
Mentor(s)
Before submitting the application, the candidate must
identify a mentor who will supervise the proposed career development and
research experience. The mentor should be an active investigator in the area of
the proposed research and be committed both to the career development of the
candidate and to the direct supervision of the candidate's research. The mentor
must explicitly document the availability of sufficient research support that
can be used as needed for the proposed K01 project and facilities for the
highest quality research. Candidates are encouraged to identify more than one
mentor, i.e., a mentoring team (or advisory committee), if this is deemed
advantageous for providing expert advice in all aspects of the research career
development program. In such cases, one individual must be identified as the
primary mentor who will coordinate the candidate's research. The candidate
should work with the mentor(s) in preparing the application. The mentor, or an
integral member of the mentoring team, should have a successful track record of
mentoring individuals at the candidate's career stage, including a record of
prior mentees progressing to independent research positions. In addition, all
mentors should have a record of conducting research of the highest quality with
respect to experimental design and data analysis and interpretation. The mentor(s)
should be committed to developing the K01 applicant towards an eventual goal as
a competitive candidate for an independent research position.
Institutional Environment
The applicant institution must have a strong,
well-established record of research and career development activities and
faculty qualified to serve as mentors in neuroscience research. Applications
must include evidence of appropriate institutional commitment to the
development of the K01 applicant as a competitive candidate for an independent
research position. This commitment does not require the promise of a future
faculty position, but includes access to all the space and facilities required
to conduct the proposed research, as well as access to resources (both
financial and otherwise) required for the highest quality approach to the
proposed research and the development of expertise required for future success
as an independent scientist.
Section IV. Application
and Submission Information
1. Requesting an
Application Package
The application forms package specific to this opportunity
must be accessed through ASSIST, Grants.gov Workspace or an institutional
system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are
available in Part 1 of this
FOA. See your administrative office for instructions if you plan to use an
institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the Career Development
(K) Instructions in the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for review.
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 SF 424 (R&R) Application Guide and should be used for preparing an
application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide
must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide
must be followed.
Other Project Information
All instructions in the SF424 (R&R) Application Guide
must be followed.
SF424(R&R) Senior/Key Person Profile Expanded
All instructions in the SF424 (R&R) Application Guide
must be followed.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must
be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide
must be followed.
PHS 398 Career Development Award Supplemental Form
The PHS 398 Career Development Award Supplemental Form is
comprised of the following sections:
1. Candidate
2. Research Plan
3. Other Candidate Information
4. Mentor, Co-Mentor, Consultant, Collaborators
5. Environment & Institutional Commitment to the Candidate
6. Other Research Plan Sections
7. Appendix
All instructions in the SF424 (R&R) Application Guide must
be followed, with the following additional instructions:
Candidate Section
All instructions in the SF424 (R&R) Application
Guide must be followed, with the following additional instructions:
Candidate
Information and Goals for Career Development
Candidate’s Background
- Describe the candidate's goals and commitment to a research
career.
- Describe prior training and how it relates to the objectives and
long-term career plans of the candidate. This description should include a
discussion of how the prior training and research, together with this proposed
training and research, will position the candidate to successfully pursue an
impactful research project subsequent to completion of the K01 period of
support.
- Describe the candidate's research efforts to this point in
his/her research career, including any publications, prior research interests
and experience.
- Provide evidence of the candidate's potential to develop
into an independent investigator. Usually this is evident from publications,
prior research interests and experience, and reference letters.
Career Goals and Objectives
- Describe a systematic plan: (1) that shows a logical progression
from prior research and training experiences to the research and career
development experiences that will occur during the career award period and then
to independent investigator status; and (2) that justifies the need for further
career development to become an independent investigator.
Candidate’s Plan for Career
Development/Training Activities During Award Period
- The candidate and the mentor are jointly responsible for the
preparation of the career development plan. A career development timeline is
often helpful. The mentor and any co-mentor may form a mentoring team (or an
advisory committee) to assist with the development of a program of study and/or
to monitor the candidate's progress through the career development program. It
can be best to propose a "gap-based" plan, in which both the
applicant and mentor describe the candidate's current expertise and
deficiencies, and the plan to eliminate deficiencies. The career development
and research aspects of the plan should be thoughtfully integrated, and
designed to develop the necessary knowledge and research skills in scientific
areas relevant to the candidate's career goals, and to prepare the candidate to
develop into a leader in his/her field. Training plans should be specific to
the candidate and the candidate's goals; it is advantageous to provide
detailed, not vague, descriptions of activities.
- Describe plans to provide opportunities for the candidate to
network with other scientists and present research findings at national
meetings, and to publish as first author as the research progresses.
- Describe the plans for formal and/or informal training in
experimental design and statistical methodology in the context of prior
training, as well as design and analytical skills needed for the proposed
research project and the anticipated future needs for the candidate. Candidates are expected to leave the K01 career development
period with an extremely strong understanding of experimental design and the
principles underlying statistics and relevant analyses. The application
should carefully describe how this will be achieved.
- Describe the activities designed to enhance the candidate's
professional skills (e.g. oral, written, leadership, etc.) needed for a
successful research career.
- Describe how the candidate will, by the end of the
postdoctoral training, have a broad understanding of the field of neuroscience
that will prepare him/her to stay current with the rapid expansion of new
ideas, approaches and technologies in the candidate's research area.
Research Plan Section
All instructions in the SF424 (R&R) Application
Guide must be followed, with the following additional instructions:
Research
Strategy
- A sound research project that is consistent with the candidate s
level of research development and objectives of his/her career development plan
must be provided. The research description should demonstrate the quality of
the candidate’s research thus far and also the novelty, significance,
creativity and approach, as well as the ability of the candidate to carry out
the research. The application should clearly distinguish the research of the candidate
from the research of others in the environment (using the first person singular
narrative when appropriate, and attribution to others when appropriate is strongly
encouraged. Writing the entire application in the first person plural narrative
will likely prevent reviewer understanding of the candidate's own ideas,
research activities and skills acquisition).
- High quality preliminary data should be provided in support of
the research plan and the research approach. The candidate should describe the
experimental approach as it relates to the best available methods for data
collection for achievement of the experimental goals.
- The research project should demonstrate an understanding of
rigorous, thoughtful, unbiased experimental design, explicit determination of
appropriate sample size, and plans for expert use of appropriate statistical
and quantitative techniques for data analysis. The plan should also provide a
thoughtful discussion of planned analyses, interpretation and alternative
possible results and approaches.
- The application must also describe the relationship between the
mentor's research and the candidate's proposed research plan. Although this is
a mentored career development award, it is expected that the research project
will be primarily overseen and conducted by the candidate, and is intended to
form the basis for the candidate's future independent research program (i.e.
the candidate should own a project to take out of the mentor's laboratory, with
which the mentor will not compete).
- If the applicant is proposing to gain experience in a clinical
trial led by a mentor or co-mentor as part of his or her research career
development, describe the relationship of the proposed research project to the
clinical trial.
Training
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). See SF424
(R&R) Application Guide for instructions.
Mentor, Co-Mentor, Consultant, Collaborators
Section
All instructions in the SF424 (R&R) Application
Guide must be followed, with the following additional instructions:
Plans and Statements of Mentor and Co-mentor(s)
- The candidate must name a primary mentor who, together with the candidate,
is responsible for planning, directing, monitoring, and executing the proposed
program. The candidate may also nominate co-mentors as appropriate to the
goals of the program.
- The mentor should be recognized as an accomplished investigator
in the proposed research area and have a track record of success in training
and placing independent investigators.
- One or more mentors integral to the research and career
development of the candidate must have a track record of success in training
and progression of trainees into independent research positions.
- The mentor is expected to conduct research with the highest
standards of experimental design and analysis, and provide a mentoring plan to
ensure development of this expertise and adherence to these principles by the
candidate.
- The mentor should provide an explicit description of sufficient
independent research support and commitment to cover the costs of the proposed
research project in excess of the provided funding of this award.
- Where feasible, women, individuals from diverse racial and ethnic
groups, and individuals with disabilities should be involved as mentors to
serve as role models.
- Include a statement of candidate percent effort committed to the
research and career development program. The candidate must commit at least 9
person-months (75% of full-time professional effort) to the research and career
development program and related career development activities. If committed
effort is less than 100%, describe the non-research commitments and the time
required for those commitments.
- The application must include a statement from the mentor
providing: 1) information on his/her research qualifications and previous
experience as a research supervisor; 2) a plan that describes the nature of the
supervision and mentoring that will occur during the proposed award period; 3)
a description of the mentor's perception of the needs and deficiencies of the
candidate, and the mentor's general and specific approaches to filling in the
gaps of the candidate's expertise and skills; 4) a plan for career progression
for the candidate to move from the mentored career stage to independent
research investigator status; and 5) a plan for monitoring and facilitating the
candidate's research, publications, and progression towards independence.
- Similar information must be provided by any co-mentor. If more
than one co-mentor is proposed, the respective areas of expertise and
responsibility of each should be described. Co-mentors should clearly describe
how they will coordinate the mentoring of the candidate. If any co-mentor is
not located at the sponsoring institution, a statement should be provided
describing the mechanism(s) and frequency of communication with the candidate,
including the frequency of face-to-face meetings.
- The primary mentor must agree to provide annual
evaluations of the candidate’s progress as required in the annual progress
report.
- The mentor(s) must describe what part of the proposed
project belongs to the K01 candidate, and state that the candidate will have
overall responsibility for, and ownership of, this portion of the project and
be able to take this portion of the project to an independent research position,
use it to pursue additional grant funding and that the mentor will not compete
with the candidate on the project that is "owned" by the candidate.
- If the applicant is proposing to gain experience in a
clinical trial as part of his or her research career development, the mentor or
a member of the mentoring team must include a statement to document leadership
of the clinical trial, and appropriate expertise to guide the applicant in any
proposed clinical trials research experience.
Letters of Support from Collaborators,
Contributors and Consultants
- Signed statements must be provided by all collaborators and/or
consultants confirming their participation in the project and describing their
specific roles. Information, such as that found in biosketches, which clearly
documents the appropriate expertise in the proposed areas of
consulting/collaboration, should be provided. Collaborators/consultants are
generally not directly involved in the development of the career of the
candidate as an independent investigator.
- Advisory committee members (if applicable): Signed statements
must be provided by each member of the proposed advisory committee. These
statements should confirm their participation, describe their specific roles,
and document the expertise they will contribute. These individuals should
provide their biographical sketches.
Environmental and Institutional
Commitment to the Candidate
All instructions in the SF424 (R&R) Application
Guide must be followed, with the following additional instructions:
Description
of Institutional Environment
- The sponsoring institution must document a strong,
well-established research and career development environment related to the
candidate's area of interest. This should include high-quality resources, space
and key faculty members and other investigators capable of productive
collaboration with the candidate.
- Describe how the institutional research environment is
particularly suited for the development of the candidate's research career and
the pursuit of the proposed research plan.
Institutional
Commitment to the Candidate’s Research Career Development
- The sponsoring institution must provide a statement of commitment
to the candidate's development into a productive, independent investigator and
to meeting the requirements of this award. It should be clear that the
institutional commitment to the candidate is not contingent upon receipt of
this career award.
- Provide assurances that the candidate will be able to devote a
minimum of 9 person-months (75% of full-time professional effort) and up to 12
person-months (100% of full time professional effort) to the development of
their research program. Any effort not related to the K01 research and career
development should be devoted to activities related to the development of the
candidate's career as an independent scientist.
- The institution must document that the candidate will have
appropriate office and laboratory space, and access to equipment, and other
resources and facilities (including access to clinical and/or other research
populations) to carry out the proposed research plan.
- Provide assurance that appropriate time and support will be
available for any proposed mentor(s) and/or other staff consistent with the
career development plan.
Appendix
Limited items are allowed in the Appendix.
Follow all instructions for the Appendix as described in the SF424 (R&R)
Application Guide; any instructions provided here are in addition to the SF424
(R&R) Application Guide instructions.
PHS Human Subjects and Clinical Trials Information
When involving human subjects research, clinical research,
and/or NIH-defined clinical trials (and when applicable, clinical trials
research experience) follow all instructions for the PHS Human Subjects and Clinical
Trials Information form in the SF424 (R&R) Application Guide, with the
following additional instructions:
If you answered Yes to the question Are Human Subjects
Involved? on the R&R Other Project Information form, you must include at
least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials
Information form or 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 with the following additional instructions:
- For FOAs that do not allow independent clinical trials, do not
complete Section 4 Protocol Synopsis information or Section 5 - Other Clinical
Trial-related Attachments.
Delayed
Onset Study
Note: Delayed
onset does NOT apply to a study that can be described but will not start
immediately (i.e., delayed start).
All instructions in the SF424 (R&R) Application Guide
must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide
must be followed.
Reference Letters
Candidates must carefully follow the SF424 (R&R)
Application Guide, including the time period for when reference letters will
be accepted. Applications lacking the appropriate required reference
letters will not be reviewed. This is a separate process from submitting an
application electronically. Reference letters are submitted directly through
the eRA
Commons Submit Referee Information link and not through Grants.gov.
3. Unique Entity Identifier
and System for Award Management (SAM)
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) using ASSIST or other electronic submission
systems. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the
application due date. and time. If a Changed/Corrected application is
submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the
NIH Policy on Late Application Submission.
Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.
Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review
(E.O. 12372)
This initiative is not subject to intergovernmental
review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH
Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH
Grants Policy Statement.
7. Other Submission
Requirements and Information
Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper
applications will not be accepted.
Applicants must complete all required registrations
before the application due date. Section
III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission
process, visit How to
Apply Application Guide. If you encounter a system issue beyond your
control that threatens your ability to complete the submission process on-time,
you must follow the Dealing
with System Issues guidance. For assistance with application submission contact the
Application Submission Contacts in Section
VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in
the Credential field of the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS
number it provides on the application is the same number used in the
organization’s profile in the eRA Commons and for the System for Award
Management (SAM). Additional information may be found in the SF424 (R&R)
Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review, NIH. Applications that are incomplete or non-compliant will
not be reviewed.
Post Submission Materials
Applicants are required to follow the instructions for
post-submission materials, as described in the policy. Any instructions provided here are in
addition to the instructions in the policy.
Section V. Application Review Information
Only the review criteria described below will be considered
in the review process. Applications
submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review
system.
For
this particular announcement, note the following: Reviewers
should evaluate the candidate’s potential for developing an independent
research program that will make important contributions to the field, taking
into consideration the years of research experience and the likely value of the
proposed research career development as a vehicle for developing a successful,
independent research program.
Overall Impact
Reviewers should provide their assessment of the likelihood that
the proposed career development and research plan will enhance the candidate s
potential for a productive, independent scientific research career in a
health-related field, taking into consideration the criteria below in
determining the overall impact score.
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.
Candidate
- Does the candidate have the potential to develop as an
independent and productive researcher?
- Are the candidate's prior training and research experience
appropriate for this award?
- Is the candidate’s academic, clinical (if relevant), and research
record of high quality?
- Is there evidence of the candidate’s commitment to meeting the
program objectives to become an independent investigator in research?
- Do the reference letters address the above review
criteria, and do they provide evidence that the candidate has a high potential
for becoming an independent investigator?
- Based on prior publications, accomplishments and the quality of
the proposed research and career development activities, does the candidate
have the potential to develop into an independent and productive researcher,
and show promise to be a leader in his/her field?
- Does the candidate's prior work demonstrate a dedication to the
principles of rigorous experimental design, statistical treatment and unbiased
analysis?
Career
Development Plan/Career Goals and Objectives/Plan to Provide Mentoring
- What is the likelihood that the plan will contribute
substantially to the scientific development of the candidate and lead to
scientific independence?
- Are the candidate's prior training and research experience
appropriate for this award?
- Are the content, scope, phasing, and duration of the career
development plan appropriate when considered in the context of prior
training/research experience and the stated training and research objectives
for achieving research independence?
- Are there adequate plans for monitoring and evaluating the
candidate’s research and career development progress?
- Based on the candidate's prior experience and career development
plan, will the candidate become expert in experimental design, relevant
statistical needs and methodology, relevant data analysis and quantitative
reasoning?
- Does the career development plan provide adequate opportunities
to present research findings and meet with scientists in the community at
national meetings as the work progresses?
- Does the career development plan explicitly describe the
opportunity for the applicant to publish the research findings as first author?
- Will the career development plan provide the professional skills
needed for the applicant to transition to the next stage of his/her research
career?
- Is the career development plan, combined with the proposed
research project, expected to develop the candidate into a leader in his/her
field?
- Is the proposed duration of this award sufficient to complete a
strong, thorough career development plan, in addition to developing an
impactful research project?
- Is there confidence that, by the end of the postdoctoral training
period, the candidate will have a broad understanding of the field of
neuroscience that will prepare him/her to stay current with the rapid expansion
of new ideas, approaches and technologies relevant to the candidate’s research
area?
- If proposed, will the clinical trial experience contribute to the
applicant’s research career development?
Research Plan
- Is the prior research that serves as the key support for the
proposed project rigorous?
- Has the candidate included plans to address weaknesses in the
rigor of prior research that serves as the key support for the proposed
project?
- Will the research plan ensure an understanding and application of
the principles of strict scientific methods that ensure robust and unbiased
experimental design, methodology, analysis, interpretation and reporting of
results?
- Has the candidate presented adequate plans to address relevant
biological variables, such as sex, for studies in vertebrate animals or human
subjects?
- Are the proposed research question, design, and methodology of
significant scientific and technical merit?
- Is the research plan appropriate for the candidate based on the
candidate's prior record and proposed career development plan, and objectives?
- Will the research plan provide a strong foundation in
quantitative reasoning and analytic techniques appropriate to the proposed
research?
- Are the tools and methods used appropriate for the proposed
research? Will the research plan provide the applicant with an expert
understanding of the tools and methods used?
- Is the applicant's proposed research sufficiently distinct from
the sponsor's ongoing research to suggest that the applicant contributed to the
development and design of the project, and has primary responsiblity for the
oversight and conduct of the research? Is the distinction between the
candidate's research and that of others in the environment clear from the
application?
- Is the proposed research project well-developed, and likely to be
impactful with the potential for highly significant results and future
discoveries, and to form the basis of the candidate's future independent
research program?
- If proposed, will the clinical trial experience contribute to the
research project and/or the applicant's research career development?
- If proposed, will the clinical trial experience contribute to the
proposed research project?
Mentor(s), Co-Mentor(s),
Consultant(s), Collaborator(s)
- Are the qualifications of the mentor(s) in the area of the
proposed research outstanding?
- Does the mentor, or an integrally involved co-mentor, have a
strong record in developing postdoctoral researchers into independent
researchers?
- Does the mentor(s) adequately address the candidate's potential
and his/her strengths and areas needing improvement?
- Is there adequate description of the quality and extent of the
mentor’s proposed role in providing guidance and advice to the candidate?
- Is the mentor’s description of the elements of the research
career development activities, including formal course work adequate?
- Is there evidence of the mentor s, consultant s, and/or
collaborator’s previous experience in fostering the development of independent
investigators?
- Is there evidence of the mentor's current research productivity
and peer-reviewed support?
- Is the mentor currently productive in research and does he/she
have appropriate support? Does the mentor publish research findings of the
highest quality with regard to technical and methodological implementation and
unbiased, well-controlled experimental design?
- Is active/pending support explicitly committed by the mentor as
available to the proposed research project and adequate?
- Are there adequate plans to monitor and evaluate the career
development of the awardee's progress toward independence?
- Does the mentor explicitly describe the portion of the
candidate's project that belongs to the candidate and which the candidate can
take to launch an independent research program without competition from the
mentor?
- Do the named collaborators/consultants have the appropriate
expertise for their proposed contributions? Is there evidence that the
collaborators/consultants are committed to the project, and that their
involvement will add value to the candidate's research and career development plan?
- If the applicant is proposing to gain experience in a clinical
trial as part of his or her research career development, is there evidence of
the appropriate expertise, experience, and ability on the part of the mentor(s)
to guide the applicant during participation in the clinical trial?
Environment
& Institutional Commitment to the Candidate
- Is there clear commitment of the sponsoring institution to ensure
that a minimum of 9 person-months (75% of the candidate’s full-time
professional effort) will be devoted directly to the research and career
development activities described in the application, with the remaining percent
effort being devoted to an appropriate balance of research, teaching,
administrative, and clinical responsibilities? If less than 100% of the
candidate's effort is devoted to the proposed career development and research
plan, are the activities that consume the remaining percent effort directly
appropriate for the candidate's career goals?
- Is the institutional commitment to the career development of the
candidate appropriately strong?
- Are the research facilities, resources and training
opportunities, including faculty capable of productive collaboration with the
candidate adequate and appropriate?
- Is the environment for the candidate’s scientific and
professional development of high quality?
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.
Study
Timeline for Clinical Trials
Is the study timeline described in
detail, taking into account start-up activities, the anticipated rate of
enrollment, and planned follow-up assessment? Is the projected timeline
feasible and well justified? Does the project incorporate efficiencies and
utilize existing resources (e.g., CTSAs, practice-based research networks,
electronic medical records, administrative database, or patient registries) to
increase the efficiency of participant enrollment and data collection, as
appropriate?
Are potential challenges and
corresponding solutions discussed (e.g., strategies that can be implemented in
the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human
subjects but does not involve one of the categories of research that are exempt
under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3)
potential benefits to the subjects and others, (4) importance of the knowledge
to be gained, and (5) data and safety monitoring for clinical trials.
For research that involves human
subjects and meets the criteria for one or more of the categories of research
that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the
justification for the exemption, (2) human subjects involvement and
characteristics, and (3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines for the Review of Human
Subjects.
Inclusion of Women, Minorities, and
Individuals Across the Lifespan
When the proposed project involves human subjects and/or
NIH-defined clinical research, the committee will evaluate the proposed plans
for the inclusion (or exclusion) of individuals on the basis of sex/gender,
race, and ethnicity, as well as the inclusion (or exclusion) of individuals
across the lifespan (including children and older adults) to determine if it is
justified in terms of the scientific goals and research strategy proposed. For
additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion
in Clinical Research.
The committee
will evaluate the involvement of live vertebrate animals as part of the
scientific assessment according to the following criteria: (1) description of
proposed procedures involving animals, including species, strains, ages, sex,
and total number to be used; (2) justifications for the use of animals versus
alternative models and for the appropriateness of the species proposed; (3)
interventions to minimize discomfort, distress, pain and injury; and (4)
justification for euthanasia method if NOT consistent with the AVMA Guidelines
for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as
they would any other application proposing the use of vertebrate animals. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.
For Resubmissions, the committee
will evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.
Not Applicable
Not Applicable
Additional Review Considerations
As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.
Training in the
Responsible Conduct of Research
All applications for support under this FOA must
include a plan to fulfill NIH requirements for instruction in the Responsible
Conduct of Research (RCR). Taking into account the level of experience of the
applicant, including any prior instruction or participation in RCR as
appropriate for the applicant’s career stage, 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
mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration
of Instruction - the number of contact hours of instruction (at least eight
contact hours are required); and 5) Frequency of Instruction instruction
must occur during each career stage and at least once every four years. Plans
and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and
the summary statement will provide the consensus of the review committee. See
also: NOT-OD-10-019.
Reviewers will assess the information provided in
this section of the application, including (1) the Select Agent(s) to be used
in the proposed research, (2) the registration status of all entities where
Select Agent(s) will be used, (3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and (4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).
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 (GDS).
Authentication of Key Biological and/or Chemical
Resources
For projects involving key biological
and/or chemical resources, reviewers will comment on the brief plans proposed
for identifying and ensuring the validity of those resources.
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 the NINDS
Scientific Review Branch 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 appropriate national Advisory Council or Board. The following
will be considered in making funding decisions:
1. Scientific and technical merit of the proposed project as determined by
scientific peer review.
2. Availability of funds.
3. 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.
Institutional Review Board or Independent Ethics Committee
Approval: Grantee institutions must ensure that all protocols are reviewed by
their IRB or IEC. To help ensure the safety of participants enrolled in
NIH-funded studies, the awardee must provide NIH copies of documents related to
all major changes in the status of ongoing protocols.
2. Administrative and
National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH
Grants Policy Statement as part of the NoA. For these terms of award,
see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part II:
Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for
Specific Types of Grants, Grantees, and Activities. More information is
provided at Award
Conditions and Information for NIH Grants. More specifically, for K Awards,
visit the Research
Career Development ( K ) Awardees section of the NIH Grants Policy Statement.
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 https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html;
and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of
Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to
the Federal Awardee Performance and Integrity Information System
(FAPIIS) requirements. FAPIIS requires Federal award making officials to
review and consider information about an applicant in the designated integrity
and performance system (currently FAPIIS) prior to making an award. An
applicant, at its option, may review information in the designated integrity
and performance systems accessible through FAPIIS and comment on any
information about itself that a Federal agency previously entered and is
currently in FAPIIS. The Federal awarding agency will consider any comments by
the applicant, in addition to other information in FAPIIS, in making a
judgement about the applicant’s integrity, business ethics, and record of
performance under Federal awards when completing the review of risk posed by
applicants as described in 45 CFR Part 75.205 Federal awarding agency review
of risk posed by applicants. This provision will apply to all NIH grants and
cooperative agreements except fellowships.
3. Reporting
When multiple years are
involved, awardees will be required to submit the Research Performance Progress
Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual
Career Development (K) RPPRs must be followed. The Mentor’s Report must include
an annual evaluation statement of the candidate’s progress.
A final RPPR, invention
statement, 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.
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.
In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of
information reported in the System for Award Management (SAM) about civil,
criminal, and administrative proceedings in connection with the award or
performance of a Federal award that reached final disposition within the most
recent five-year period. The recipient must also make semiannual
disclosures regarding such proceedings. Proceedings information will be
made publicly available in the designated integrity and performance system
(currently FAPIIS). This is a statutory requirement under section 872 of
Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010
of Public Law 111-212, all information posted in the designated integrity and
performance system on or after April 15, 2011, except past performance reviews
required for Federal procurement contracts, will be publicly available. Full
reporting requirements and procedures are found in Appendix XII to 45 CFR Part
75 Award Term and Conditions for Recipient Integrity and Performance Matters.
In carrying out its stewardship of human resource-related
programs, the NIH may request information essential to an assessment of the
effectiveness of this program from databases and from participants themselves. Participants
may be contacted after the completion of this award for periodic updates on
various aspects of their employment history, publications, support from
research grants or contracts, honors and awards, professional activities, and
other information helpful in evaluating the impact of the program.
We encourage inquiries
concerning this funding opportunity and welcome the opportunity to answer questions
from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application
errors and warnings, documenting system problems that threaten submission by
the due date, and post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
GrantsInfo (Questions regarding application instructions,
application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-637-3015
Grants.gov Customer Support (Questions regarding Grants.gov
registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Scientific/Research Contact(s)
Stephen Korn, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]
Peer Review Contact(s)
Ernest Lyons, Ph.D.
National Institute of Neurological Disorders and Stroke
(NINDS)
Telephone: 301-496-9223
Email: [email protected]
Financial/Grants Management Contact(s)
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
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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