Research OSPA:JIT Process

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Just-in-Time Process

Effective Date

September 1, 2013

Statement of the Issue

Just-in-Time (JIT) refers to information that a sponsor (e.g., the National Institutes of Health (NIH), Department of Defense (DoD) agencies, etc.) requests after an application has been peer reviewed and is within a range of possible funding. Receiving a Just-in-Time request does not guarantee or indicate in any way whether an applicant will get an award.

Applicable Policy/Regulation

A. [Grants Policy Statement – Part I: NIH Grants – General Information, Section 2.5.1 Just-in-Time Procedures]

B. NIH uses Just-in-Time procedures for certain programs and award mechanisms. (Each sponsor’s proposal solicitation or Funding Opportunities Announcement (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 (both active and pending) for senior/key personnel; verification of Institutional Animal Care & Use Committee (IACUC) approval of the project’s proposed use of live vertebrate animals; certification of Institutional Review Board (IRB) approval of the project’s proposed use of human subjects; and evidence of compliance with the education in the protection of human research participants requirement. Other program-specific information may also be requested.

C. This is a standard notice and request for information from all principal investigators (PI) with grant applications receiving an impact score of 40 or less (regardless of the sponsor’s payline). Applicants will be notified (by e-mail) when Just-in-Time information is needed. This notification is not a Notice of Award, nor should it be construed to be an indicator of possible funding. Applicants should only submit this information when requested. Information must be submitted electronically using the Just-in-Time feature in the eRA Commons.

D. [Just-in-Time Q&A]

E. NIH Just-in-Time SOP: http://www.niaid.nih.gov/researchfunding/sop/Pages/jit.aspx and http://www.niaid.nih.gov/researchfunding/grant/strategy/Pages/3justintime.aspx

F. [notice]

Process

A. The Principal Investigator (PI) will receive notification one of two ways: a. Standard email from sponsor. The NIH issues automatic Just-in-Time emails for all applications that get an overall impact score of 40 or less. These requests should arrive to the PI and the business office within 15 days after the percentile rank.
b. Personalized email from the NIH Institute or Center when funding is likely
B. Prepare the following documents:
c. Other Support Pages for all named senior/key personnel, those devoting measureable effort to the project. NOTE: Post-doctoral and graduate students do not meet the definitions of senior/key personnel.
d. IACUC approval letter, if applicable
e. IRB approval letter, if applicable
f. Human Subjects Education, if applicable
g. Human Embryonic Stem Cells (hESCs), if applicable
h. Other information as requested by the awarding Institute or Center, if applicable
i. F&A rate agreement letter (to be loaded as the last document in the “other upload” section)
C. Either the PI or the Grants Specialist will upload these documents as PDF files in the NIH Just-in-Time (JIT) feature in eRA Commons. After uploading all the documents, notify Assistant Director to review before submission.
D. Grants Specialists with an AO role may submit electronically via [
|eRA Commons
]
==== Deadline ====

There’s a general deadline of two weeks to submit after receiving the JIT notification email. The NIH grants management specialist may set a different due date. Applicants are encouraged to submit the Other Support and Human Subjects Education information at least 60 days (or sooner if requested by the Institute or Center) before the proposed project period start date. NIH understands that obtaining research compliance approvals may take more than two weeks. Therefore, you may submit these approvals at the earliest date they are available.

Other Considerations

JIT procedures also allow an applicant to defer 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 until after completion of the peer review and prior to funding. You may submit more than one JIT in eRA Commons. For example, the first JIT submission could document other support pages. The second JIT submission documents would include the certifications related to the application. Be sure to check with sponsor about how to submit certification of approvals after other JIT documents have been submitted.

Definitions

A. //Just-in-Time// - The process in which NIH policy allows the submission of certain elements of a competing application to be deferred until later in the application process, after review, when the application is under consideration for funding.

B. //Other Support// - Includes all financial resources, whether federal, non-federal, commercial or organizational, available in direct support of an individual's research endeavors, including, but not limited to, research grants, cooperative agreements, contracts, or organizational awards. Other support does not include training awards, prizes, or gifts.

C. //Institutional Animal Care & Use Committee (IACUC)// - The PHS Policy on Humane Care and Use of Laboratory Animals incorporates the U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training, and requires the grantee to maintain an animal care and use program based on the Guide for the Care and Use of Laboratory Animals. An Institutional Animal Care and Use Committee (IACUC) appointed by the Chief Executive Officer or designee, is federally mandated to oversee the institution's animal program, facilities, and procedures (Public Law 99-158, Sec. 495). IACUC review and approval is required for all PHS supported activities involving live vertebrate animals prior to funding.

D. //Institutional Review Board (IRB)// - An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the organization with which it is affiliated. The Institutional Review Board has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction.

E. //Human Subject Education// - The University of Texas at Dallas IRB requires that all individuals working with human subjects in research complete an instructional program before the IRB will review an application. This policy reflects UT Dallas' commitment to the protection of the rights and welfare of human subjects in research and incorporates the requirements of the National Institutes of Health (NIH).

Sample Just-in-Time Email from NIH

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