pre-award process, just-in-time, JIT, other support, pending support, certification of IRB approval, verification of IACUC approval, human subjects education requirement, human embryonic stem cells, hescs, genomic data sharing institutional certification, SBIR funding agreement certification, STTR funding agreement certification, other information requested by the awarding IC
2.5.1 Just-in-Time Procedures
NIH uses Just-in-Time 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. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. procedures for certain programs and award mechanisms (each NOFO 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; 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.)
Applicants will be notified (primarily by e-mail) when Just-in-Time 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. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. information is needed. This notification is not a Notice of Award "The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system." 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 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. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. feature in the eRA Commons. In some circumstances the GMO may ask for information in addition to the descriptions below, e.g., if the application involves hESCs and the applicant did not identify a hESC from the NIH Registry in the application.
The requirement for applicants to verify the accuracy and validity of all administrative, fiscal, and programmatic information extends to information submitted through the Just-in-Time 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. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. process. Applicants are responsible for promptly notifying NIH of any substantive changes to previously submitted Just-in-Time 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. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. information up to 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 The PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered senior/key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered senior/key personnel if they meet this definition. Senior/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. "Zero percent" effort or "as needed" are not acceptable levels of involvement for those designated as 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 and informing NIH of any problems or concerns. Failure to address changes to Just-in-Time 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. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. submissions prior to award does not diminish the applicant's responsibility to address changes post-award by submitting a prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). request to NIH in accord with Administrative Requirements-Changes in Project and Budget-NIH Standard Terms of Award.
Other Support. Information on other active and pending support will be requested as part of the Just-in-Time 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. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. procedures. Other support includes all resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant. This includes:
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Resources and/or financial support from all foreign and domestic entities that are available to the researcher. This includes but not limited to, financial support for laboratory personnel, and provision of high-value materials that are not freely available (e.g., biologics, chemical, model systems, technology, etc.). Institutional resources, such as core facilities or shared equipment that is made broadly available, should not be included in Other Support, but rather listed under Facilities and Other Resources.
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Consulting agreements, when the PD/PI or other senior/key personnel will be conducting research as part of the consulting activities and the activities fall outside of their appointment at the applicant or recipient institution.
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In-kind contributions, e.g., office/laboratory space, equipment, supplies, or employees or students supported by an outside source. If the time commitment or dollar value of the in-kind contribution is not readily ascertainable, the recipient must provide reasonable estimates.
Other support does not include training awards, prizes, or gifts. Gifts are resources provided where there is no expectation of anything (e.g., time, services, specific research activities, money, etc.) in return. An item or service given with the expectation of an associated time commitment is not a gift and is instead an in-kind contribution and must be reported as Other Support.
Reporting of other support is required for all individuals designated in an application as senior/key personnel-those devoting measurable effort to a project. Each PD/PI or other senior/key personnel must electronically sign their respective Other Support form prior to submission. This signature certifies that the statements are true, complete, and accurate. Information on Other Support is not specifically requested for Program Directors, training faculty, and other individuals involved in the oversight of training grants since applicable information is collected in other sections of a training grant application. It is also not requested for individuals categorized as Other Significant Contributors.
Recipients are expected to establish and maintain effective internal controls (e.g. policies and procedures) to ensure that individuals designated in applications as senior/key personnel fully disclose all Other Support information to their institution as soon as it becomes known. When a recipient organization discovers that a PI or other Senior/Key personnel on an active NIH grant failed to disclose Other Support information outside of Just-in-Time 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. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. or the RPPR, as applicable, the recipient must submit updated Other Support to the Grants Management Specialist named in the Notice of Award "The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system." as soon as it becomes known.
For Other Support submissions that include foreign activities and resources, recipients are required to submit copies of contracts, grants, or any other agreement specific to senior/key personnel foreign appointments and/or employment with a foreign institution as supporting documentation. If they are not in English, recipients must provide translated copies. This does not include personal service contracts, or employment contracts for fellows supported by foreign entities.
The supporting documentation must be provided as part of the Other Support PDF following the Other Support Format page. See NIH Other Support page for forms, instructions, and other resources.
IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. scientific program and grants management staff will review this information before award to ensure the following:
- Sufficient levels of effort are committed to the project.
- There is no scientific, budgetary, or commitment overlap.
- Scientific overlap occurs when (1) substantially the same research is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific research objective and the research design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source.
- Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.
- Commitment overlap occurs when an individual's time commitment exceeds 100 percent (i.e., 12 person months The metric for expressing the effort (amount of time) PD/PI(s), faculty and other senior/key personnel devote to a specific project. The effort is based on the type of appointment of the individual with the organization; e.g., calendar year, academic year, and/or summer term; and the organization's definition of such. For instance, some institutions define the academic year as a 9-month appointment while others define it as a 10-month appointment.), whether or not salary support is requested in the application.
- Overlap, whether scientific, budgetary, or commitment of an individual's effort greater than 100 percent, is not permitted. Any overlap will be resolved by the IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. with the applicant and the PD/PI at the time of award.
- Only funds necessary for the approved project are included in the award.
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Any foreign resources that meet the definition of a foreign component have received appropriate prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements)..
See NIH Other Support for format page, instructions and the NIH disclosure table.
Certification of IRB Approval. If the proposed project involves human subjects research, a certification to NIH that all non-exempt research involving human subjects has been reviewed and approved by an appropriate IRB must be submitted. Pending or expired approvals are not acceptable. See Public Policy Requirements/Human Subjects for additional information.
Verification of IACUC Approval. If the proposed project involves research with live vertebrate animals, verification of the date of IACUC approval of those sections of the application that involve use of vertebrate animals along with any IACUC-imposed changes must be submitted. Pending or out-of-date approvals are not acceptable. See Public Policy Requirements/Animal Welfare for additional information.
Human Subjects Research 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. See Public Policy Requirements/Human Subjects/Education in the Protection of Human Research Participants for additional information.
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) should be included in the Just-in-Time 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. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. submission.
Genomic Data Sharing Institutional Certification. If the proposed project involves research subject to the Genomic Data Sharing policy for the generation of human genomic data (including within the Data Management and Sharing Plan, as applicable), investigators must submit an Institutional Certification, or, in some cases, a Provisional Institutional Certification. Institutional certification forms and directions for completing them are available on the NIH GDS Data Sharing website. This certification must be submitted as a "Genome Data Sharing Certification" filein the eRA Commons Just-in-Time 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. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. module.
SBIR Foreign Disclosure Form. For SBIR and STTR competing applications, applicants must submit the Required Disclosure of Foreign Affiliations or Relationships to Foreign Countries form. See NIH SBIR and STTR Foreign Disclosure requirements for more information. This form must be submitted as an "SBIR STTR Foreign Disclosure Form" file in the eRA Commons Just-in-Time 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. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. module.
SBIR Funding Agreement Certification. For SBIR applicants, provide only upon request the SBIR Funding Agreement Certification described in Section 2.18 of the Supplemental Grant Application Instructions. The certification is available in fillable formats at: https://grants.nih.gov/grants/forms/manage_a_small_business_award.htm. This should be submitted as an "Other Upload" in the eRA Commons Just-in-Time 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. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. module.
STTR Funding Agreement Certification. For STTR applicants, provide only upon request the STTR Funding Agreement Certification described in Section 2.19 of the Supplemental Grant Application Instructions. The certification is available in fillable formats at: https://grants.nih.gov/grants/forms/manage_a_small_business_award.htm. This should be submitted as an "Other Upload" in the eRA Commons Just-in-Time 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. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. module.
My Bibliography Report of Publications. For renewal applicants to research training programs, a My Bibliography Report of Publications arising from work conducted by trainees while supported by the training grant will be collected in the Interim/Final Research Performance Progress Report.
Other Information Requested by the Awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.. NIH IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.'s may also request additional Just-in-Time 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. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. information on a case-by-case basis, such as revised budgets or changes to the human subjects or vertebrate animals sections of the application. If required, these changes must be submitted as an "Other Upload" file in the eRA Commons Just-In-Time module.