Post-Submission Materials After the proposal has been submitted, there are different types of post-submission additional materials that the sponsor may request before a funding decision can be made: Just-in-Time JIT information is usually requested from the funding Institute as an automatic email if the grant is reviewed. There is no deadline. Or, depending on the proposal’s impact score and the Institute/Center’s (ICs) paylines (conservative funding cutoff point), the PI may receive a personal email from NIH requesting more specific information to be submitted by specific deadline. The email will note: “ THIS IS NOT A NOTICE OF GRANT AWARD NOR SHOULD IT BE CONSTRUED AS AN INDICATOR OF POSSIBLE AWARD. ” To see what information is required, click on the JIT link next to the application (in the “Action” column of the grant on eRA Commons) and also refer to the email from NIH. Click here for more information on preliminary review, collection of JIT, and award negotiations. Materials required usually include: Current and Pending Other Support Certifications (IRB/Human Subjects , IACUC/Animal subjects, Stem Cells, SBIR, STTR) Human subjects training certification for all key personnel if applicable Other information (Revised Budget, etc) Deadline date: The deadline dates vary. Please refer to the request email. Routing: Do not route JIT . Once completed in Cayuse, notify Dr. Indranil Basu at Indranil.firstname.lastname@example.org. Submission: JIT is submitted via eRA Commons. In some rare instances, you may need to email it to NIH. Tracking: You may use the “JIT” link under Actions in Status list of applications/grants. Please see NIH’s Just-in-Time Procedures for more information. When you prepare a JIT response, you should follow two processes, as outlined in Einstein’s JIT checklist. Upload in eRA Commons - Create a single PDF for each section in eRA Commons. You may upload only one document for each section. eRA Commons Steps Please do not submit the JIT to NIH until it has been approved by OGS. Upload and email OGS at least a day before the deadline. You should allow OGS additional time for review and approval if the due date falls on a major NIH deadline or requires budgetary review. Upload in Cayuse - Create a single PDF of the information (all sections combined into one document) uploaded on to eRA Commons, and upload this PDF into Cayuse SP. Notify OGS (email). Cayuse Steps: Log into Cayuse Sponsored Projects (SP) Select the applicable Proposal Number Navigate to the Proposal Attachment section of the proposal (Click on the attachment Icon on top bar) Select the document type “JIT” from the dropdown list on the new page and upload all applicable documents. Please name the documents appropriately such as Other Support Page, Biosketch, IACUC approval etc. Email OGS (Dr. Indranil Basu) with the subject “JIT – 21-XXXX [proposal number] and the due date” Department Administrator will upload all of the documents, submits or routes the JIT to the sponsor using the sponsor’s portal, and OGS/AOR will approve Other Support NIH requires the disclosure of all sources of research other support, financial conflicts of interest, and foreign components for all senior/key personnel on all research applications and awards. IC scientific program and grants management staff will review active and pending Other Support information before award to ensure there is no scientific, budgetary, or commitment overlap. Institutions are required to submit copies of foreign contracts and awards for all foreign activities and resources that are reported in Other Support. If they are not in English, recipients must provide translated copies. Applications must now use the revised Other Support format page as per NOT-OD-21-073. Please see NIH’s Other Support site and the NIH Disclosure Table for what to include. The Central Email Inbox for Bio-sketch and Other Support Inquiries can be sent to email@example.com. See NOT-OD-21-122 for details. Overlap Overlap Types of Overlap: Overlap may be scientific, budget, or commitment related. After listing all support, summarize for each individual any potential overlap with the active or pending projects and activities, other positions, affiliations, and resources and this application. NIH has added the following overlap statement which is saved as a pdf with an e-signature: Overlap (summarized for each individual): I, PD/PI or other senior/key personnel, certify that the statements herein are true, complete and accurate to the best of my knowledge, and accept the obligation to comply with Public Health Services terms and conditions if a grant is awarded as a result of this application. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. Signature: _______________________________ Date: ____________________________________ You can print, sign, and scan or sign the PDF electronically. Compliance Financial Conflicts of Interest Compliance addresses whether rules, regulations, policies and standards of conduct are adhered to while conducting human subjects research. Compliance encompasses federal, state and institutional requirements that apply to research activities. Financial Conflict of Interest: A financial conflict of interest exists when the institution's designated official(s) reasonably determines that an investigator’s significant financial interest (SFI) could directly and significantly affect the design, conduct, or reporting of the NIH-funded research. Investigators or Key Personnel must disclose their significant financial interests to their institution. FCOI requirement includes financial interests received from a foreign entity: Provided details on in-kind contributions, defined “gifts,” and outlined the purpose of the bio-sketch. Updated application forms and instructions for Bio-sketch and Other Support Updated data format and data collections in collaboration with NSF to reduce applicant and recipient burden Note: FCOI is separate and distinct from other support and foreign components Please see NIH’s FCOI policy or contact Dr. Saha or Einstein’s Financial Conflict of Interest Office (FCOI) for more information. FCOI – Financial Conflict of Interest - COI@einsteinmed.edu COI – Conflict of Interest – COI@einsteinmed.edu Foreign Components NIH defines a “foreign component” as the performance of any significant element or segment of the project outside the United States, either by the grantee or by a researcher employed by a foreign institution, whether or not grant funds are expended. We must disclose all research funds, resources, and other support to our research in grant applications in Research Support, Other Support Page during JIT, and RPPR submissions. For questions, please contact Dr. Saha. Submit the information to the Program Officer of your Federal grant(s) with the grant # through OGS. Please see NIH’s Foreign Interference Policy, NINDS’s site for Foreign Components, or the NIH Other Support FAQs for more information. More compliance topics are discussed on the Human Subject Research Planning and Development site. Preliminary Data Preliminary NIH continues to accept preliminary data as Post-Submission Material through May 2023 Councils. See NOT-OD-23-006. The Funding Opportunity Announcement (FOA) must allow preliminary data. NIH applicants for a single component application can submit 1 page preliminary data and 1 page for any other new information such as publications, patents, promotions, etc… in PDF. NIH applicants for a multi-component application can submit 1 page preliminary data and 1 page for any other new information such as publications, patents, promotions, etc… in PDF for each component. The deadline for submitting all post-submission materials, including preliminary data, will be 30 days before the study section meeting. This information should be submitted to the Scientific Officer, NOT the Program Officer. Submit one page PDF to the SRO listed in the Contacts section of the eRA Commons Status screen (Status Information online help). If you do not know the SRO, please send the information to Division of Receipt and Referral at firstname.lastname@example.org. (301) 435-0715 System for Award Management (SAM) Background Checks SAM.gov and SAM Background Checks Occasionally during the JIT and RPPR stages Einstein receives notifications from NIH to verify if one of our investigators is not barred from receiving Federal funds. OGS will contact the PI based on the GMS request and send the screenshot of the name provided. We must confirm that the name of the person that appears in the SAM exclusion list is not the same person at Einstein. To verify this, please follow these steps: Go to https://sam.gov/SAM/. On the Home page, click on “Entity Information”. Click on “Advanced Search”. Under “Select Domain”, click on “Exclusions”, select the Excluded Individual drop down arrow. Enter the individual’s first and last name and social security number (SSN) and click on “Add Individual”. The “Search Results” screen will appear. If there is no match, “No matches found” will be displayed. If there is a match, the results for the matching person(s) will be displayed. Determine if this is the same person that we have here at Einstein. Then, the PI must email OGS justifying why he/she is not the same person that appears in the SAM exclusion list (For ex: different middle name or residence). Here is an example of a required form from HRSA. Lastly, OGS will review the PI email or form and notify the sponsor of the findings. Note: If OGS cannot verify through SAM, we must contact Einstein Human Resources to complete a full background check. This will delay the JIT or RPPR process. For materials requires for specific applications (F, T, conference), please see the NIH Grants Policy Statement page I-60. NIH allows post-submission materials 30 days before the study section meeting. These materials must be processed through Dr. Basu in OGS. If funding is approved, the PI and DA will proceed to Award Set-Up.