Transcript Mentored Career Development Awards (K series)

NIH Mentored Career Development
Awards (K Series)
Part 5
Thomas Mitchell, MPH
Department of Epidemiology & Biostatistics
University of California San Francisco
Human Subjects Research
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A part of the peer review process will include
careful consideration of protections from
research risks for study participants, as well as
the appropriate inclusion of women, minorities,
and children (see Example 1).
The study section will assess the adequacy of
the safeguards of the rights and welfare of
research participants and the appropriate
inclusion of women, minorities, and children.
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Evaluation of the inclusion plans will be factored into
the overall score for scientific and technical merit.
Budget Issues
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Mentored K awards provide salary support for
the candidate (usually $75,000/year) plus
$25,000 to $50,000/year to cover the costs of
the proposed training and research.
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The amount of salary support and funds for research/training
may differ by institute.
You may not receive salary support from
federally funded sources in Years 1 – 3 of the K
award, although you may be a principal
investigator on your own R01, R03, or R21 in
Years 4 and 5.
Budget Issues (cont’d)
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A detailed, itemized budget is not required by
NIH; however, you are required to provide a
detailed description and justification for specific
items in the budget.
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See Example 2.
Although an itemized, detailed budget is not
required by NIH, it is required for internal review
by UCSF (but not submitted to the NIH)
Biosketches
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This section must include the biographical sketches of all
Key Personnel and Other Significant Contributors.
All biosketches must include a “Personal Statement”
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See Example 3.
The section on publications should be limited to 15
(include only the most relevant, recent, and important)
For the candidate only, the section on Publications must
be divided into the following categories:
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Original research
Non-experimental articles (e.g., literature reviews, book
chapters)
Books, pamphlets, etc.
Facilities and Other Resources
Equipment
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Describe the facilities and Other Resources
used to conduct the research.
Describe capacities, pertinent capabilities,
relative proximity, and extent of availability to the
project.
If research involving “Special Agents” will occur,
the biocontainment resources available at each
site should be described.
See Example 4
Abstract
& Project Narrative
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The Abstract is limited to 30 lines of text (size 11
font, .5” margins).
The Abstract should describe both the career
development plan and the research plan.
The Project Narrative should be only 2 or 3
sentences long; it should explain the relevance
of the proposed research to public health.
See Example 5.
Cover Letter
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You must include a cover letter with your K
award application.
It should request assignment to a specific institute.
 It must also list the names, department affiliation,
and institution of 3-5 referees submitting letters of
reference (see Example 6).
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Letters of reference are critically important and should
address the candidate’s competence and potential to
develop into an independent investigator.
Letters of reference must be submitted electronically by
the referee through the eRA Commons.
Task List
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Develop a list of all components of your grant
application package, including those required by
the UCSF Office of Sponsored Research (OSR).
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See Example 7.
Indicate who is responsible for completing each
component.
Develop this list in collaboration with your RSA
(research support analyst), who will help you
compile the grant application for submission to
the OSR and NIH.
What happens to your grant application
after it is submitted to NIH?
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All grant applications are reviewed, initially, in
the Center for Scientific Review (CSR).
Referral officers (all of whom have advanced
degrees) examine applications and decide
whether they will be reviewed by a study section
within the CSR or will be assigned directly to an
NIH institute, which will assign it to one of their
“in-house” study sections.
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Grant applications for K awards, responses to RFAs,
and program project grants are reviewed within the
Institute (e.g., NHBLI, NCI, NIAID).
What happens to your grant application
after it is submitted to NIH?
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Within 10 days of the completion of
application assignment (which may be up to 6
weeks after the application is received at
NIH), a notice will appear in your NIH eRA
Commons file listing the study section and
potential funding institute.
Upon receipt of this notice, applicants can
question the study section or institute
assignments by contacting either the study
section SRA or the Referral Officer.
At the Study Section Meeting
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As part of the initial scientific merit review
process, reviewers are asked to identify those
applications with the “highest scientific merit”.
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At the meeting, those applications are discussed and
scored.
Applications not so identified are “streamlined.”
They are not scored or discussed at the
meeting, but reviewers’ written critiques are
provided to the applicant, and the applicant may
subsequently revise and resubmit the
application.
At the study section meeting
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Study section meetings usually last 2 days.
The chairperson and the SRA jointly conduct the
meeting.
Representatives from various NIH institutes are
encouraged to attend but must sit in chairs set
back from the conference table and may not
participate in the discussions.
The chair, who is also a reviewer, asks the
primary and secondary reviewers to tell the
study section how enthusiastic they feel about
an application.
At the study section meeting
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They then proceed to summarize their reviews
(they usually give an initial rating or score).
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After discussion, which potentially involves the entire
study section, they may change their rating (for better
or worse) and state their final priority score.
From either their own analysis or the discussion, the
other study section members privately score the
application on their vote sheets, which the SRA
collects at the end of the meeting.
One week after the meeting, priority score information
is sent to the applicant’s eRA Commons file.
NIH Scoring Procedures
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Numerical rating
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Each scored grant application is assigned a single,
global score that reflects the overall impact that the
project could have on the field, based on the 5 review
criteria (signficance, approach, innovation,
investigator, and environment).
Reviewers will use a new 9-point rating scale.
1 = exceptional; 9 = poor.
Individual reviewers mark scores in whole figures
(e.g., 2, 4, 6), and the individual scores are averaged
and then multiplied by 10 to give an overall score for
each application (e.g., 22).
Summary Statements
(the “pink sheets”)
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Primary and secondary reviewers are asked to modify
their critiques during the study section meeting
(removing, for example, criticisms that are negated
through discussion among reviewers).
Otherwise, the reviewers’ critiques are included in the
summary statement, essentially unaltered by the SRA.
Additionally, the SRA prepares a “Resume and Summary
of Discussion” that conveys the highlights (major
strengths and weaknesses) of the discussion that led to
the final score.
Summary statements are sent to applicants 6 to 8 weeks
after the study section review.
To Fund or Not to Fund?
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Members of the institute’s advisory council
meet 3 times a year to decide which
applications to fund.
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Council members do not provide a
scientific/technical review of individual
applications; however, they do consider which
applications best meet the institute’s overall
mission and funding priorities.
To Fund or Not to Fund?
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The institute’s director and other staff members
reach their final decisions after considering both
the opinions of its advisory council and the study
section review statements.
“Payline”: Each institute sets its own payline,
which is the numeric or percentile “cut-off” for
funding.
Your priority score will appear in your eRA
Commons file within a week of the study section
meeting.