Just-in-Time JIT features and UMass approaches

JIT purpose In an effort to focus the NIH review on the science and to save the applicant time and effort, NIH defers the submission of several proposal elements for most R-series grants until after completion of the peer review process and prior to award.

Timesaving JIT features Deferred submission of the following items:  Current Other Support  IACUC approval  IRB approval  Human Subjects Training/certification

When JIT call for information activates All Principal Investigators with applications receiving a peer review percentile of 20% or less, regardless of the assigned Institute’s pay line will receive a notice requesting the deferred JIT information.

When to submit JIT information  NIH first announces the requirement to submit JIT information on the eRA Commons website accessible by the PI and OGCA. Note appearance of “JIT” in the “Action” field.

When to submit JIT info (cont.) With “JIT” splashed up on the PI’s Commons site, it is important to note:  Save the champagne -- funding is not guaranteed at this stage  UMass cannot submit the JIT information until either the PI or OGCA receives an from an NIH Grants Specialist calling for JIT documentation

When to submit JIT information; timing Once the Grants Specialist contacts UMass:  NIH expects submission of the JIT information within two weeks of this notice  NIH understands IRB and IACUC review may take longer and allows additional time for the approval process  Contact the NIH grants specialist immediately when JIT splashes on the Commons if IACUC or IRB review is required in order to secure maximum time needed for protocol review process - can take over a month depending on timing of next monthly review.

UMass IACUC & IRB contacts  IACUC (animals) contact: Hilary Woodcock  IRB (Humans) contact: Marg Burggren

Assembling JIT information: Other Support Current Other Support (OS):  See sample format and follow exactly  Provide OS ONLY for “Key personnel” listed in the proposal. Do not provide for “Other Significant Contributors”  List all federal and non-federal support  Be sure to verify that the effort reported on this OS is current and correct.

Other Support (cont.) Verify that the effort reported on this OS document is current and correct!!! (excuse the obnoxiousness, but this is critical to get right, NIH is very fastidious when it comes to effort reporting)

Other Support (cont.)  Information on Other Support assists awarding agency staff in the identification and resolution of potential overlap of support. Overlap, whether scientific, budgetary, or commitment of an individual’s effort greater than 100 percent (i.e., 12 person months), is not permitted.

Other Support (cont.)  Information on active and pending Other Support is required for Key Personnel, excludes consultants and “Other Significant Contributors”. For individuals with no active or pending support, indicate “None.” Neither the application under consideration nor the current PHS award for this project should be listed as Other Support.  If the support is provided under a consortium/subcontract arrangement or is part of a multiproject award, indicate the project number, principal investigator, and source for the overall project, and provide all other information for the subproject only.

Other Support Instructions for selected items  Project Number: If applicable, include a code or identifier for the project.  Source: Identify the agency, institute, foundation, or other organization that is providing the support.  Major Goals: Provide a brief statement of the overall objectives of the project, subproject, or subcontract.  Dates of Approved/Proposed Project: Indicate the inclusive dates of the project as approved/proposed. For example, in the case of NIH support, provide the dates of the approved/proposed competitive segment. (continued)

Other Support Instructions for Selected Items  Annual Direct Costs: In the case of an active project, provide the current year’s direct cost budget. For a pending project, provide the proposed direct cost budget for the initial budget period.  Percent Effort/Person Months: For an active project, provide the level of actual effort in person months (even if unsalaried) for the current budget period. Person months should classified as calendar (for calendar year appointments) or academic and summer (for academic appointments. For a pending project, indicate the level of effort in person months as proposed for the initial budget period. In cases where an individual’s appointment is divided into academic and summer segments, indicate the proportion of each devoted to the project.  Overlap: After listing all support, summarize for each individual any potential overlap with the active or pending projects and this application in terms of the science, budget, or an individual’s committed effort.

Assembling JIT information – IACUC Certification If Vertebrate Animals are involved, provide the IACUC approval date  Contact: Hilary Woodcock Research Compliance Coordinator

Assembling JIT information – IRB Certification If Human Subjects are involved, provide the IRB approval date.  Contact: Marg Burggren Human Subjects Compliance

Assembling JIT information – Human Subjects Education For grants involving Human Subjects, each of the listed key personnel involved in human subjects research must complete an educational program in the protection of human subjects. OGCA must verify this training has occurred. Proof of training are kept on file at the Human Research Protection Office:  Contact: Marg Burggren Human Subjects Compliance

Submitting JIT information – last step  Upload all JIT information onto the eRA Commons, unless instructed by NIH Grants Specialist to provide hard copy  OGCA reviews the information for compliance and works with the PI to revise the documentation as needed  When JIT documentation is in order, OGCA submits