NIH Mentored Career Development Awards K Series Part 5

1
NIH Mentored Career Development Awards (K Series)
Part 5

• Thomas Mitchell, MPH
• Department of Epidemiology Biostatistics
• University of California San Francisco

2
What happens to your grant application after it
is submitted to NIH?

• 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.
• Grant applications for K awards, responses to
  RFAs, and program project grants are reviewed
  within the Institute (e.g., NHBLI, NCI, NIAID).

3
What happens to your grant application after it
is submitted to NIH?

• Investigator-initiated research projects (R01,
  R03, R21) are reviewed within the CSR.
• They are assigned to an integrated review
  group, which are clusters of study sections that
  review similar science.
• For the majority of applications, these review
  groups are categorized into 3 main areas
• Molecular and Cellular Mechanisms
• Clinical and Population-based Studies
• Physiological Systems.

4
What happens to your grant application after it
is submitted to NIH?

• Each of these main areas is split into different
  IRGs, which are further divided into numerous
  study sections.
• Once the IRG is identified, the application is
  assigned to one of the constituent study
  sections.
• Referral officers also must choose, from NIHs 25
  institutes and centers, the one most appropriate
  to fund an application.

5
What happens to your grant application after it
is submitted to NIH?

• You can request assignment to a specific study
  section and institute (see Examples 1 and 2).
• 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.

6
After assignment to a study section

• The SRA who heads the study section reads all
  applications, analyzes content, checks for
  completion, and decides which reviewers are most
  suitable to review an application and whether
  there are conflicts of interest between reviewers
  and applicants.
• Applications are sent to reviewers 6 8 weeks
  before they meet. Each application has one
  primary reviewer, one or more secondary
  reviewers, and one or more discussants.

7
After assignment to a study section

• At the beginning of the study section meeting,
  reviewers are asked to identify those
  applications with the highest scientific merit.
• 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.
• Applications from early stage investigators
  (ESIs) are reviewed before other applications
  from more senior investigators.
• Early stage investigators are within 10 years
  of their terminal degree and have not yet
  competed successfully for an R01.
• Many NIH institutes have a higher (more
  favorable) payline for R01 applications from
  ESIs.

8
At the study section meeting

• 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.

9
At the study section meeting

• They then proceed to summarize their reviews
  (they usually give an initial rating or score).
• 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 applicants eRA
  Commons file.

10
NIH Scoring Procedures

• Numerical rating
• 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 (significance,
  approach, innovation, investigator, and
  environment).
• Reviewers will use a new 9-point rating scale.
• 1 exceptional 9 poor.
• Individual reviewers mark scores and all
  reviewers scores are averaged and multiplied by
  10 to give an overall score for each application
  (e.g., 35).

11
NIH Scoring Procedures

• Percentile conversion
• Research grant applications (e.g., R01s, R03s,
  R21s) are assigned a percentile rank.
• The conversion of priority scores to percentile
  rankings is based on scores assigned to
  applications reviewed during the current plus the
  2 previous grant cycles.
• K awards do not receive a percentile ranking.

12
Summary Statements(the pink sheets)

• 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.

13
To Fund or Not to Fund?

• Members of the institutes advisory council meet
  3 times a year to decide which applications to
  fund.
• Council members do not provide a
  scientific/technical review of individual
  applications however, they do consider which
  applications best meet the institutes overall
  mission and funding priorities.

14
To Fund or Not to Fund?

• The institutes 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.

15
To Fund or Not to Fund?

• Funding considerations
• New investigators get bumped up in ranking.
• An institute may decide to fund a project that is
  highly relevant to an institutes priorities,
  even if the priority score and percentile is
  above the payline.

16
Resubmissions

• If you are not funded on the 1st round, you can
  resubmit your application once.
• Must use same title as initial application.
• Many grant applications that are not funded on
  the 1st round are subsequently funded as
  resubmissions.
• If the scientific goals, methods, or scope of the
  research project changes substantially, it could
  be considered as a new submission

17
Resubmissions

• 3-page introduction to resubmission
• Must address each reviewers criticisms.
• Based on these 3 pages, your resubmission must be
  viewed by reviewers as fully responsive to their
  concerns if you are to get a fundable score.
• Youve addressed all their issues.
• Theyre satisfied with all your responses.
• No issues remain unresolved.
• See Examples 3, 4, 5, and 6.