"How Do I" respond to NIH JIT requests?

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Has an e-mail or other request from NIH come to the PI or ORA requesting JIT information? If yes, continue.

Please note, a “JIT” link next to a grant number on the eRA Commons is not a request for JIT information. The appearance of this link signifies that your application has completed the peer review process and has received a rank for which funding may be possible. We should wait to submit the JIT response until a specific JIT request from NIH grants management has been received by the PI or ORA.

The JIT request may include a specific due date. The JIT response should be prepared and submitted to ORA a minimum of five full business days prior to the NIH due date. You should allow ORA additional time for review if the response due date falls on a major NIH deadline.

Checklist

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Forward that request to your Sr. Sponsored Projects Specialist in ORA as soon as possible.  ORA Contact list; ORA Departmental Assignments

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If human subjects and/or vertebrate animals are involved in the project, the Sr. Sponsored Projects Specialist will ask you to send additional documents to the IRB or the IACUC. When asked, forward those documents directly to the individuals in the IRB and/or IACUC in the format requested.

 If you are contacted by the IRB and/or the IACUC regarding any questions or discrepancies that arise during their comparison of the grant to the protocol, respond directly to those individuals and resolve any issues directly with them.

Tip: The IRB and IACUC compare the grant application to the cited protocols. Please allow at least 10 business days for IRB review and at least 5 business days for IACUC review, and please note that additional time may be required to resolve any issues discovered during review.

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Coordinate with your co-investigators and appropriate departmental personnel to obtain up-to-date and accurate Other Support pages for all Key Personnel.

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If an IRB protocol or an IRB exemption is involved in the project, work with your co-investigators and appropriate departmental/divisional personnel to obtain copies of human subjects research compliance training certificates for all Key Personnel involved with human subjects research.

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Prepare and sign a cover letter for your Sr. Sponsored Projects Specialist’s countersignature detailing the documents that will be forwarded to NIH.

If NIH Grants Management included any specific questions in the JIT request (i.e. preferred start date), please include that information in the cover letter.

This letter should be addressed to the Grants Management Specialist, list the grant number, and reference “JIT”. Sample Cover Letter

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Ensure that the JIT response package includes all items requested by NIH, along with a copy of the JIT request.

Tip: At the direction of the IACUC, do not send IACUC approval letters directly to NIH. JHU considers these letters internal documents.

The IRB/IACUC approval certifications will be generated by ORA.

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The JIT response delivered to ORA should include the original, one copy of the paperwork, and contact information for pick up.

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After ORA review, fax the final, ORA-approved JIT response to NIH Grants Management.

Tip: Keep a copy of the fax confirmation.

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Please contact the Sr. Sponsored Projects Specialist assigned to your department to determine if this process can be used in your specific situation, since not all JIT responses may be accommodated by the eRA Commons.

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A cover letter is not required.

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The following information and documents should be submitted in an e-mail to your Sr. Sponsored Projects Specialist:

1.  Other Support for all Key Personnel should be submitted in one MS Word or .pdf file.

2.  A copy of the human subjects research compliance training certificate for anyone who has not taken the JHU SOM training (paper copy via fax or .pdf file via e-mail).

Note: A JIT response is not sent to NIH until it is “submitted” on the NIH eRA Commons by a signing official in ORA.

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When initially notified by the PI of the JIT request, ORA strongly recommends that the Department/Division Administrator ensure that a copy of the JIT request has been forwarded to ORA in order to facilitate the review process.

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Review Other Support pages for accurate listing of all active and pending support.

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Review Other Support pages for accurate actual effort (for active grants) and committed effort (for pending grants).

Tip: Effort must be listed as full percentages, e.g., 12% or 13%, instead of 12.5%.

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Please note that Other Support should not exceed 100%. In addition, if an MD has 95% or greater effort or a PhD has 100% effort, the department must confirm research effort at this level.

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Review Other Support to ensure that an overlap statement for scientific, budgetary, and effort overlap is included. If none, so state.

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Ensure that the JIT response packet includes all items requested by NIH, along with a copy of the JIT request. Please note: The protocol certifications will be generated by ORA.

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The JIT packet delivered to ORA should include the original, one copy of the paperwork, and contact information for pick up.

  
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ORA will forward any JIT requests we receive to the PI and Department/Division representative.

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ORA will compare Other Support information for Key Personnel to the ReSource database.

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ORA will confirm whether the P.I. has provided all information requested by NIH.

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ORA will prepare animal approval letter after confirmation of grant vs. protocol review by IACUC.

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ORA will prepare IRB approval letter after confirmation of grant vs. protocol review by IRB.

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ORA will verify whether Human Subjects Education training certificates have been included for all relevant Key Personnel.

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ORA will countersign the cover letter, which includes a listing of the items requested by NIH.

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ORA will call the PI/designee for pick-up of the signed documentation.

Tip: ORA is beginning to respond to JIT requests by electronic submission to the eRA Commons. Because not all JIT responses will be accommodated by the eRA Commons, please contact the Sr. Sponsored Projects Specialist assigned to your department to determine if this process can be used in your specific situation.

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ORA will enter the IACUC approval date into the NIH eRA Commons after confirmation of grant vs. protocol review by IACUC.

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ORA will enter the IRB approval date into the NIH eRA Commons after confirmation of grant vs. protocol review by IRB.

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ORA will confirm human subjects research compliance training for those individuals who have completed the School of Medicine training module. (The PI must submit to ORA certification of training for individuals who completed modules other than the JHU SOM module.)

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ORA will upload the final, approved Other Support for all Key Personnel (from the one MS Word or .pdf file that the PI provided).

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The ORA signing official will electronically submit the information on the NIH eRA Commons.

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ORA will forward to the PI and the Department/Division administrative contact the automatic e-mail confirmation from the NIH eRA Commons indicating that the JIT response has been submitted.