Office of Research and Project Administration

Purpose

Ensuring the accuracy and timeliness of information used to make NIH grant awards is an important responsibility shared by both applicant institutions and NIH staff.  Equally important is the need to collect this information in a manner that reduces the burden on applicants and minimizes the number of requests from NIH staff for updated Just-in-Time information.   To achieve these goals, NIH is issuing this Guide Notice revising and clarifying the responsibilities of applicants and NIH staff to ensure that such information submitted to NIH is current and accurate at the time of award. 

Policy

Responsibilities of Applicant Institutions:

NIH grant applicants are responsible for verifying the accuracy and validity of all administrative, fiscal, and programmatic information at the time of submission.  This notice extends that policy to information submitted through the Just-in-Time process.  Applicants are responsible for promptly notifying NIH of any substantive changes to previously submitted Just-in-Time information up the time of award. This includes items such as Other Support changes that could lead to budgetary overlap, scientific overlap, or commitment of effort greater than 12 person-months for the PD/PI(s) or any Senior/Key Personnel; or any changes in the use or approval of vertebrate animals or human subjects. Similar to the NIH public policy requirements, applicants are responsible for establishing and maintaining the necessary processes to monitor its compliance with this policy and informing NIH of any problems or concerns. 

Recent changes to the eRA Commons Just-in-Time Submission Module have improved the electronic process by allowing individual submissions of each required element separate from other elements, and by providing the new capability to submit updated information electronically as many times as necessary.  

Responsibilities of NIH Staff:

NIH staff rely on applicant institutions to provide updated Just-in-Time information in a timely manner.  Any such submission will be considered current by NIH for use in making final award decisions for a period up to 120 days from the time of the submission.  During this period, NIH staff will normally not require or request any additional information from applicants unless the submission is considered inaccurate or incomplete.  On a case by case basis NIH staff may also request additional JIT information be submitted through the “Other Upload” function, such as revised budgets or changes to either the human subjects or vertebrate animals sections of the proposed project. Failure by applicants to address changes to Just-in-Time submissions prior to award (such as a change in status of the PD/PI(s) or Senior/Key Personnel, or changes in the use or approval of vertebrate animals or human subjects) does not diminish the applicant’s responsibility to address changes post-award by submitting a prior approval request to NIH in accord with the NIH Grants Policy Statement and the Terms and Conditions of Award.

Reminder of Existing Just-in-Time Requirements:

Several elements of a grant application are not required at the time the application is submitted. Instead, this information will be requested later in the review cycle (i.e., “just-in-time”) to ensure that it is current. The information eligible for just-in-time submission includes:

·       Current Other Support:  Provide active support information for all individuals designated in an application as senior/key personnel—those devoting measurable effort to a project. Other support includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual’s research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Training awards, prizes or gifts are not included. There is no form page for providing other support, although sample format pages are available at http://grants.nih.gov/grants/funding/phs398/othersupport.doc and http://grants.nih.gov/grants/funding/phs398/othersupport.pdf. Note that effort devoted to projects must be measured in person-months. 

o       For all senior/key personnel, provide details on how you would adjust any budgetary, scientific, or effort overlap if this application is funded.

o       For Career Development Award applications, information on all active support for the candidate, sponsor(s), co-sponsor(s), and Key Personnel may be requested by the awarding component prior to award.

·       Certifications:

o       IACUC Approval Date: If the proposed project involves research using live vertebrate animals, the verification date of IACUC approval along with any IACUC-imposed changes must be submitted.  Pending or out-of-date approvals are not acceptable. 

o       IRB Approval Date: If the proposed project involves human subjects research, the certification date of IRB review and approval must be submitted. Pending or out-of-date approvals are not acceptable. 

o       Human Subjects Education:  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.

·       Human Embryonic Stem Cells (hESCs): If the proposed project involves hESCs and the applicant did not identify a hESC line from the NIH Human Embryonic Stem Cell Registry in the application, the line(s) may be submitted as an “Other Upload” file.

·       Other Information Requested by the Awarding IC: NIH IC’s may also request additional Just-in-Time information on a case-by-case basis, such as revised budgets or changes to the human subjects or vertebrate animal sections of the application.

Applicants are advised to submit this information (signed by an authorized business official) only when requested by the awarding component. Applicants are strongly encouraged to submit this information using the Just-In-Time feature of the eRA Commons found in the Status section. For information on the eRA Commons visit: https://commons.era.nih.gov/commons/index.jsp.

Inquiries

For general inquiries concerning this policy contact:

Division of Grants Policy
Office of Policy for Extramural Research Administration
National Institutes of Health
6705 Rockledge Drive, Suite 350
Bethesda, MD 20892
Telephone: (301) 435-0938
FAX: (301) 435-3059
E-mail: GrantsPolicy@od.nih.gov

Brenda Kavanaugh
Assistant Director
Office of Research and Project Administration
University of Rochester
518 Hylan Building
Rochester, NY  14627
585-275-1504 (Telephone)
585-275-9492 (FAX)
Brenda.Kavanaugh@rochester.edu