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

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.)

• 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.
• 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.
• 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.

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.

• 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.

  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.

  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.

  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.