National Institutes of Health JustInTime Procedures

1
National Institutes of HealthJust-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

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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).

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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.

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What Documents Are Submitted Just-In-Time?

• IRB Approval (for projects involving human
  subjects)
• NIH may sometimes ask for UW-Madisons 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.

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IRB Approval

• PIs 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.

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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/g
uide/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.
• PIs 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-Madisons ACUC issues protocol approvals that
  are typically valid for 3 years.
• Research Animal Resource Center

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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/phs39
  8.html

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Other Support Requirements

• Other Support includes all financial resources,
  whether Federal, non-Federal, commercial or
  institutional, available in support of an
  individuals 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.

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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 years 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
  individuals 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.

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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.

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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 persons 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. Its
  okay for a technician or postdoc to be listed at
  100.

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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.

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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.

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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.

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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.
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JIT Record-KeepingCurrent RSP Practice

• Always keep a complete, final photocopy of all
  JIT documents submitted to NIH in RSPs proposal
  file.
• NIH sometimes loses JIT documents and requests
  them a 2nd (or 3rd) time you dont 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.

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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/N
  OT-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.

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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/po
  licy/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.

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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.
•