JIT and the Research
Proposal
Now what?
Is it JIT?
• Does your grant proposal meet the criteria for JIT?
• If so , submit grant proposal
• Is your score in fundable range?
• IF SO, submit your IRB or IACUC proposal immediately
• Make sure it was received by the committee
• Respond to any requests for changes or clarifications ASAP so you are
ready in case funding is imminent
JIT notification
• Please consider that an unapproved or unsubmitted research
application can hold up the speed of a JIT funding opportunity
• IACUC review and approval
• No approval could place “animal restrictions” on grant so no spending
will be allowed in that part of the work
• Training
• IRB review
• 45 CFR 118 Federal guidelines do allow for “contingent approval”
• Training
• Human Embryonic Stems Cell or other committees’ review
• Make sure your
• Make sure to have all of your paperwork ready in case funding is
granted
• Make sure your Departments chairs and administrators make
this clear to all PIs so that there is no rush to approval, and
additional stress is placed on review committees
• Make sure to have all of your paperwork ready in case funding is
granted
Hit the ground running
But you’re not ready for review yet!
• Some long term projects might not have research materials or
procedures finalized when awards are incoming
• Multi-year studies in which research preparation occurs in the first year
or two
• Review units cannot review an incomplete research plan
• Researchers are caught in a catch-22 regarding approval; they
cannot get funding without review and approval, but cannot get
review and approval without funding
NSF .118 determination letter for IRB
• On June 27, COGR released a letter that it had developed in
partnership with NSF worked with NSF. The letter can be
submitted to NSF for proposals lacking definite plans for
involvement of human subjects to meet approval needs before
awards.
• The letter will be included in the planned October NSF Proposal
and Award Policies and Procedures Guide
NSF .118 determination letter
• “§46.118 Applications and proposals lacking definite plans for
involvement of human subjects.
• Certain types of applications for grants, cooperative agreements,
or contracts are submitted to departments or agencies with the
knowledge that subjects may be involved within the period of
support, but definite plans would not normally be set forth in
the application or proposal….. These applications need not be
reviewed by an IRB before an award may be made. However,
except for research exempted or waived under §46.101(b) or(i),
no human subjects may be involved in any project supported by
these awards until the project has been reviewed and approved
by the IRB, as provided in this policy, and certification submitted,
by the institution, to the department or agency.”
NSF .118 determination letter
NSF .118 determination letter
• “the Authorized Organizational Representative is required to….”
• This means that YOU have to track it!
Other funding sources
• Successful strategies depend on the funding source, and
individual program officer
• The .118 determination letter may work
• Another letter of intent may work
• Or, as a very last option, researchers may submit an IRB
application using rough drafts.
• FINALIZED RESEARCH PROCEDURES MUST UNDERGO IRB REVIEW ONCE
THEY’RE FINALIZED