National Institutes of Health “Just-In-Time” Procedures

1. National Institutes of Health“Just-In-Time” Procedures A Guide For Pre-Award Staff: Research & Sponsored Programs University of Wisconsin-Madison May 31, 2006 Stephanie Gray

2. Table Of Contents • What Is “Just-In-Time?” • What Documents Are Submitted “Just-In-Time?” • Reviewing & Processing NIH “Just-In-Time” Documents: Current RSP Practices • Common Problems with “Just-In-Time” Documents Submitted to RSP • Keeping a Copy of “Just-In-Time” Documentation in the RSP Proposal File

3. What Is “Just-In-Time?” • "Just-in-Time" began in 1996 as an initiative of the NIH Extramural Reinvention Laboratory under the auspices of the National Performance Review and government-wide efforts to create a government that works better and costs less. It began with K-awards and has expanded to include all new & competing renewal research grant and program project applications. • JIT postpones the collection of certain information that previously was included in all competing applications when submitted.The information for applications with a likelihood of funding is submitted "just-in-time" for awards to be made. Why Does NIH Use Just-In-time? • This delayed exchange of information relieves the administrative burden for the 75 to 80 percent of applicants who do not receive an award. • In addition, the information that is exchanged "just-in-time" for award is current, rather than several months old as was previously the case (which often necessitated a 2nd request for updated information, e.g., for other support).

4. “Just-in-Time” Instructions for the PHS-398 • Just-in-Time concept started with the K-series. These instructions are now incorporated into the Career Award section of the PHS-398 instructions. • Just-in-Time now applies to IRB and ACUC (RARC) approvals, human subjects training certification, as well as Other Support information, for all R-series, P-series and K-series grants. • Just-in-Time instructions are still occasionally seen in a PA or RFA. Be aware that the special instructions found in the relevant PA or RFA take precedence over the standard instructions in the PHS-398 kit.

5. What Documents Are Submitted “Just-In-Time?” • IRB Approval (for projects involving human subjects) • NIH may sometimes ask for UW-Madison’s FWA #FWA0005399. • Human Subjects Education Certification • Applies to all key personnel for projects involving human subjects. • All-Campus Animal Care & Use Committee (ACUC/RARC) Approval (for projects involving animal subjects) • Other Support* • New, Revised and Competing Renewals of Research Project Grants (R-series), Program Project Grants (P-series) and Career Development Awards (K-series). *Other Support is provided in the Program Plan of the application for Institutional NRSA Training Grants (T-series) at the time of proposal submission.

6. IRB Approval • PI’s usually submit a photocopy of their actual IRB approval letter to RSP for forwarding to NIH. • The IRB approval should be for this project and sponsor, but the title on the IRB approval does not have to match the title on the NIH grant application exactly. • Submit a copy of the IRB letter to NIH; or • NOTE: The IRB approval must be within one calendar year of the beginning date of the award. NIH cannot accept an IRB approval that is more than one year old.

7. NIH Certification of Human Subjects Training NIH requests certification of completion of human subjects training for all “key personnel” involved with the design and conduct of a project involving human subjects. See: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html NIH issued clarification of the requirement in September 2001 at: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-01-061.html UW-Madison has a certification letter template that is used to certify training to NIH. It is located at: http://www.rsp.wisc.edu/forms/NIHcover_letter.pdf The letter includes space for a list of Key Personnel involved in the design and conduct of the study. Other UW-Madison faculty, staff and students are required to complete the training, but do not have to certify completion to the NIH. The letter must be signed by the PI and submitted to RSP for institutional signature and submission to the NIH. The certification must be completed once for each project that involves human subjects. NIH usually requests this certification prior to making an award at the same time it requests the IRB approval and Other Support.

8. All-Campus Animal Care & Use Committee Approval • All NIH-funded projects involving animal subjects must have a valid ACUC (RARC*) approval before an award can be made. • PI’s should provide a copy of their ACUC (RARC) approval letter to RSP for forwarding to NIH. • The ACUC (RARC) approval should indicate that the project is to be funded by NIH. • The title listed on the ACUC (RARC) approval letter must match the title on the NIH grant application. • UW-Madison’s ACUC issues protocol approvals that are typically valid for 3 years. *Research Animal Resource Center

9. Other Support Information • See page 48 of the PHS-398 instructions for complete information on the Other Support format requirements. • A sample Other Support page is available in .rtf and .pdf formats on the NIH website at: http://grants1.nih.gov/grants/funding/phs398/phs398.html

10. Other Support Requirements • Other Support includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in support of an individual’s research endeavors, including but not limited to research grants, cooperative agreements, contracts, and institutional awards. Training awards, prizes or gifts are not included. • Information on active and pending other support is required for key personnel, excluding consultants. • For individuals with no active or pending support, indicate “None.” • Neither the application under consideration nor the current NIH award for this project (in the case of competing renewals) should be listed as other support. • If the support is provided under a consortium/subcontract or is part of a multiproject award, indicate the project number, PI, and source for the overall project and provide all other information for the subproject only.

11. Other Support Format • The following information should be listed for each other support item: • Project Number – If the sponsor identifies the grant with a code or number, include this. • Source – Identify the sponsor that is providing the funding. • Major Goals – A brief statement of the overall objectives of the project, subproject, or subcontract. • Dates of Approved/Proposed Project – The inclusive dates of the approved/proposed competitive segment. • Annual Direct Costs – For active projects, the current year’s direct cost budget amount should be listed. For a pending project, the proposed direct cost budget for the initial budget period should be listed. • Person Months(Formerly Percent Effort) – For an active project, provide the level of actual effort in person months (even if unsalaried) for the current budget period. Person months should be classified as academic, calendar and/or summer. For a pending project, indicate the level of effort in person months as proposed for the initial budget period. In cases where an individual’s appointment is divided into academic and summer segments, indicate the proportion of each devoted to the project. • Overlap – For each key personnel, after all the Other Support is listed, there should be a summary of any potential overlap with the active or pending projects and this application in terms of science, budget or committed effort.

12. Common Problems with Other SupportSubmitted to RSP • Faculty or administrative support staff sometimes simply cut and paste data from the last NIH Biosketch the person submitted to NIH. They then fail to update it or to add the extra information that is required on Other Support pages. • Out of date or inaccurate information.

13. Specific Problems to Look for on Other Support • Percentages of Effort rather than Person Months listed. • Person Months adds up to greater than 12 calendar, 3 summer or 9 academic months. • NIH guidelines indicate that commitment overlap occurs when a person’s time commitment exceeds the above limits, whether or not salary support is requested in the application. No individuals on the project may exceed the 12, 3 or 9 month limits. • In practice, UW-Madison should take care to be certain that faculty do not show even the above amounts of effort on Other Support, because this would not leave them time to write grant applications, teach or perform other duties. It’s okay for a technician or postdoc to be listed at 100%.

14. Specific Problems to Look for on Other Support • Overlap is not addressed. If there is no overlap, the Other Support page should indicate “none” for each individual. • If there is overlap (whether scientific, budgetary or commitment), the individual must indicate how this would be addressed if the proposal were funded. • In the case of effort overlap, it is usually sufficient to say something like, “In the event this proposal is funded, Dr. Doe would reduce effort on project XXX, in consultation with the appropriate program officer at ZZZ funding agency.” • In the case of budgetary overlap, the individual must address how the excess funds would be dealt with, or NIH may reduce the award. For example, an investigator might have to promise to relinquish an AHA Scientist Development Award award in order to avoid budgetary overlap with a pending NIH R01.

15. Specific Problems to Look for on Other Support • Other Support pages are missing for one or more Key Personnel. • Remember that anyone listed under Key Personnel must submit Other Support information. • Annual direct costs are wrong or missing. • Dates of projects are wrong or missing. • Expired projects are listed as active. • Denied or funded proposals are listed as pending. • Major goals summaries are missing. • Active support is incomplete, i.e., corporate funding is missing, etc.

16. Reviewing & Processing JIT Documents: Current RSP Practices • Review JIT information. If there appear to be any inaccuracies or overlap of effort, budget or science, contact the PI or his/her departmental representative to request resolution of the issues. • Once all issues are resolved, and you have final versions of JIT documents, assemble the package for signature.

17. Transmitting JIT Data to NIHCurrent RSP Practices Once you have verified all the Just-In-Time documents provided to RSP by the PI, assemble them together for review & signature by an authorized official. JIT information may be faxed or emailed to the requesting individual at NIH or uploaded/approved via NIH Commons.

18. JIT Record-KeepingCurrent RSP Practice • Always keep a complete, final photocopy of all JIT documents submitted to NIH in RSP’s proposal file. • NIH sometimes loses JIT documents and requests them a 2nd (or 3rd) time; you don’t want to have to reconstruct the information from scratch. • Also, JIT information officially becomes a part of the proposal and, therefore, is subject to Federal record-keeping requirements. • RSP should keep all documents related to a funded project for 3 years beyond the date of the filing of the final FSR. This includes all proposal information. If a proposal is unfunded, the proposal file should be kept and purged according to WI records law.

19. Why So Much Fuss About JIT Submissions? • NIH has issued a reminder notice urging grantees to be more vigilant in verifying Other Support information that is submitted to NIH. See: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-029.html • NIH is conducting site visits to review the accuracy of Other Support information that has been submitted to NIH. • False statements on Federal grant applications may be considered civil fraud and can render an applicant liable for damages of up to three times the amount of the grant award, under the Civil False Claims Act. • Faculty at a few institutions have been prosecuted under the Criminal False Claims Act and have gone to jail for submitting false Other Support.

20. NIH Grants Policy Statement Outlines Penalties for False Statements • The NIH Grants Policy Statement has a clear discussion of the penalties associated with submitting false information on grant applications at: http://grants1.nih.gov/grants/policy/nihgps_2001/part_i_2.htm • “The Program Fraud and Civil Remedies Act of 1986, 31 United States Code (U.S.C.) 3801, provides for the administrative imposition by HHS of civil penalties and assessments against persons who knowingly make false, fictitious, or misleading claims to the Federal Government for money, including money representing grants, loans, or benefits. A civil penalty of not more than $5,000 may be assessed for each such claim. If a grant is awarded and payment is made on a false or fraudulent claim, an assessment of not more than twice the amount of the claim may be made in lieu of damages, up to $150,000. Regulations at 45 CFR Part 79 specify the process for imposing civil penalties and assessments, including hearing and appeal rights.” • “The Criminal False Claims Act, 18 U.S.C. 287 and 1001, provides for criminal prosecution of a person who knowingly makes or presents any false, fictitious, or fraudulent statements or representations or claims against the United States. Such person may be subject to imprisonment of not more than 5 years and a fine.” • “The Civil False Claims Act, 31 U.S.C. 2739, provides for imposition of penalties and damages by the United States, through civil litigation, against any person who knowingly makes a false or fraudulent claim for payment, makes or uses a false record or false statement to get a false claim paid or approved, or conspires to defraud the Government to get a false claim paid. A "false claim" is any request or demand for money or property made to the United States or to a contractor, grantee, or other recipient, if the Government provides or will reimburse any portion of the funds claimed. Civil penalties of $5,000 to $10,000 may be imposed for each false claim, plus damages of up to three times the amount of the false claim. “ • “NIH also may administratively recover misspent grant funds pursuant to the authorities contained in 45 CFR Parts 74 and 92.”

21. Final Reminder About Compliance Approvals AWARD PROCESSING Compliance Approvals • Always make certain that appropriate compliance approvals are on file (and current) for Human Subjects, Animal Use, and Biosafety before creating an account.