download report

Transcript Just-In-Time

Maili Winther
Grants Associate
Just in Time
 NIH uses Just-in-Time procedures for certain programs and award mechanisms
(each FOA will include specific guidance on the use). These procedures allow
certain elements of an application to be submitted later in the application
process, after review when the application is under consideration for funding.
The standard application elements include other support information for
senior/key personnel; certification of IRB approval of the project’s proposed
use of human subjects; verification of IACUC approval of the project’s proposed
use of live vertebrate animals; and evidence of compliance with the education in
the protection of human research participants requirement. Other programspecific information may also be requested using this procedure. (Applications
in response to RFAs also may be subject to these procedures. The RFA will
specify the timing and nature of required submissions.)
Why Just in Time?
Cycle II
New R01
June 5
Scientific Merit Review
Advisory Council Round
Earliest Project Start Date
11 months
Decreased burden on PI, study team, IRB, IACUC offices to develop and approve
protocols for studies that will not be funded
 JIT link in the Commons
 Automated Email
 Email request from GMS
 Please note deadlines for Just in Time information.
Why we don’t respond to JIT link and automated emails
 Link and automated emails typically come out soon after
peer review, still far ahead of start date
 Link and automated emails issued for grants that might not
be recommended for funding
 If JIT is submitted in response to link or automated email,
typically GMS will request updated information again close
to the start date
Major Components
 Certification of IRB/IACUC approval
 Human Subjects Education Requirement
 Other Support
Certification of IRB/IACUC approval
 Grant vs. Protocol Review
 Federal government mandates a review to verify that protocol adequately covers
the proposed work in the grant
IRB/IACUC protocol number(s) should be sent to respective Grants Associate
Grants Associate requests a grant vs. protocol review with designated
IRB/IACUC staff and sends protocol number(s), copy of grant, and COEUS PD
Any inconsistencies between grant and protocol are worked out between PI and
Verification of approval is emailed to respective Grants Associate. GA will submit
IRB/IACUC approval to sponsor in accepted format (i.e. Commons, OF310,
animal approval letter, etc.)
Reminder: as a general practice, we do not share our IRB/IACUC protocol
numbers with sponsors (FOIA, etc.)
Human Subjects Education Requirement
 If the proposed project involves human subjects research,
certification that any person identified as senior/key personnel
involved in human subjects research has completed an education
program in the protection of human subjects must be submitted.
 Suggestion: Save copies of certifications for future use
Other Support
2 R01 HL 00000-13 (Anderson)
3.60 calendar
3/1/1997 – 2/28/2002
Chloride and Sodium Transport in Airway Epithelial Cells
The major goals of this project are to define the biochemistry of chloride and sodium transport in airway epithelial cells and
clone the gene(s) involved in transport.
DCB 950000 (Anderson)
2.40 calendar
12/01/2002 – 11/30/2004
National Science Foundation
Liposome Membrane Composition and Function
The major goals of this project are to define biochemical properties of liposome membrane components and maximize liposome
uptake into cells.
Other Support
 Effort vs. Salary
 Over-commitment – Cannot exceed 12 calendar months active support. When calculating
total active support, include pending effort on grant for which you are submitting JIT. If
over-committed, need to reduce effort to accommodate pending grant effort.
 Need to account for clinical, teaching, administrative time when determining total research
 If a significant reduction in effort is needed in order to accommodate pending effort, need to
include in the overlap statement how the effort will be adjusted if the grant is awarded
If the pending grant is awarded, my effort will be adjusted as follows: I will stop
devoting effort for Gates #19790 (0.6 months to 0 months), and will reduce
effort on CDC-DCT#3 (from 1.2 CM to .6 CM). I will also reduce effort on the
S&T Project (from 2.4 CM to 0.6 CM). Each of these projects is in the final
months of funding. If other pending applications are awarded, effort will be
adjusted accordingly so as not to exceed 11.4 calendar months.
Other Support
 Cannot have 0 CM effort (by definition)
 Need to discuss with PI how other support should be
Note: NIH is looking at all efforts from all NIH institutes and
have called us out on discrepancies
Clinical Research effort – the PI on a clinical research project
is supposed to be giving measurable effort; effort is usually
very minimal; if there are several clinical trials, you must list
them all, but can allocate a cumulative effort for all clinical
Training awards, prizes, or gifts are not included
Exclude grant for which you are submitting JIT