Maili Winther Grants Associate Just-In-Time

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 program- specific 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 R01June 5 Scientific Merit ReviewOctober-November Advisory Council RoundJanuary Earliest Project Start DateApril Approximately 11 months Decreased burden on PI, study team, IRB, IACUC offices to develop and approve protocols for studies that will not be funded

Notification JIT link in the Commons Automated request from GMS Please note deadlines for Just in Time information.

Notification Why we don’t respond to JIT link and automated s Link and automated s typically come out soon after peer review, still far ahead of start date Link and automated s issued for grants that might not be recommended for funding If JIT is submitted in response to link or automated , 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 summary Any inconsistencies between grant and protocol are worked out between PI and IRB/IACUC staff Verification of approval is ed 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 SAMPLE ANDERSON, R.R. ACTIVE 2 R01 HL (Anderson) 3/1/1997 – 2/28/ calendar NIH/NHLBI $186,529 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. PENDING DCB (Anderson) 12/01/2002 – 11/30/ calendar National Science Foundation $82,163 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. OVERLAP None

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 effort 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 EXAMPLE 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 modified 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 trials Training awards, prizes, or gifts are not included Exclude grant for which you are submitting JIT