Bumps in the Road

1
Bumps in the Road

• NIH Regional Seminar
• April 7-8, 2005
• Albuquerque, New Mexico

2

• Presenters
• Carol Alderson, Assistant Grants Policy Officer,
  Office of Policy for Extramural Research
  Administration (OPERA)
• Irene Grissom, Chief Grants Management Officer,
  National Center for Research Resources (NCRR)

3
The proposal gets a fundable score, and it is
selected for funding
4
what can slow down the award process?

• Budgets with Inadequate Justification
• Delays Sending JIT Information
• Missing Information for Key Personnel
• Other Support Indicates Scientific,
• Budgetary, or Commitment Overlap
• Checklist FA that Doesnt Make Sense
• Out of Date IRB/IACUC Approvals

5
what can slow down the award process?

• Lack of Population Data for Clinical Grants
• Information Sent Without Identification
• Lack of Institutional Signatures
• A Noncompetitive Renewal Missing Interim Required
  Prior Approvals

6
Most Important Documents at the Time of Award

• Relevant RFA or PA
• Summary Statement
• Notice of Grant Award (NGA)
• NIH Grants Policy Statement

7
Notice of Grant Award (NGA)

• Recipient is Grantee Institution
• PI Name Included
• Award for the Current Budget Period
• Budget and Project Period Dates
• Terms and Conditions

8
NGA Terms and Conditions

• Generalciting the CFR, the Grants Policy
  Statement
• Informationale.g. closeout term
• Grant specific
• What is restricted
• What must be done by when to lift the restriction
• Failure to follow the restriction means
  disallowance of costs, enforcement actions,
  including termination

9
The NGA also tells you

• The name of the Grants Management Officer who
  signed the NGA
• Contact information for the Grants Specialist
• Contact information for the Program Officer

10
NIH Grants Policy Statement

• The Bible for grants and cooperative agreements
• Provides guidance on almost every policy issue
• An exception to the Grants Policy Statement is
  rare and may only be done with the approval of
  the Grants Management Officer

11
OKso when do I really need an institutional
signature?????
12
Required Prior Approvals

• Change in Scope
• Preaward Costs gt90 Days Prior to Effective Date
  of New or Competing Award
• Change in Key Personnel
• Change in Grantee Institution
• Addition of a Foreign Component
• Changes in Grantee Organizational Status

13
Required Prior Approvals

• Changes to Award Terms and Conditions or
  Undertaking Any Activities Disapproved or
  Restricted as a Term of Award
• Second No-Cost Extension
• Retention of Research Grant Salary/Fringe Benefit
  Funds When a K Award is Made
• Transferring Costs from Trainee Costs

14
Examples of Possible Change in Scope

• Change in specific aims
• Substitution of one animal model for another
• Change from approved use of animals or human
  subjects
• Shift in research emphasis to a different disease
  area
• Application of new technology -- i.e., changing
  to a different type of assay

15
Indicators of Change in Scope?

• Significant Rebudgetingi.e., when expenditures
  in a single direct cost budget category deviate
  by more than 25 of the total costs awarded
  (current year budget supplements)
• Transfer of the performance of substantive
  programmatic work to a third party
• Incurrence of patient care costs if not
  previously approved

16
Expanded Authorities Allows for

• Many cost-related flexibilities
• 90 days pre-award costs
• Automatic carryover of unobligated balances
  (except for centers, cooperative agreements,
  clinical trials, Phase I SBIR/STTRs, and NRSAs
  (Ts and Fs)
• Program income
• One-time no-cost extension of up to 12 months

17
Change of Status of PI and Other Key Personnel

• Withdrawal of PI or Key Personnel
• Named on NGA
• Absence for Period of 3 Continuous Months
• Reduction of Effort by 25 or More Percent
• of Level Approved at Award

18
Significant Change in Effort of Key Personnel

• How much is significant?. 25 of what???
• When does the PI have to notify the NIH?
• What happens if s/he doesnt?

19
Unobligated Funds

• Estimated unobligated balance greater than 25 of
  current years total budget (current year budget
  supplements)
• Lack of progress
• Too much money awarded
• Explanation/justification required

20
Carryover

• When do you need to request it?
• What needs to be requested, when?

21
Change of Institution

• Midyear / Partial Year Transfer
• Anniversary Transfer

22
Change of Institution

• What Is Needed from Old Institution
• Relinquishing Statement PHS 3734 with effective
  termination date AND award amount relinquished
  from the CURRENT year and with equipment to be
  transferred.
• Final FSR includes unobligated balance from
  carryover to be transferred
• Final Invention Statement

23
Change of Institution

• What Is Needed from New Institution
• Face Page with Appropriate Approvals
• Budget Pages OR Narrative Budget Info
• Updated Biosketch
• Statement Indicating Status of Research
  Plans/Specific Aims
• Updated Other Support
• Resources Page
• Checklist Page

24
Change of Institution

• And when and how do we get the money from the old
  institution???

25
Change of anything

• 45 CFR 74.21 (f) Recipients shall immediately
  notify the HHS awarding agency of developments
  that have a significant impact on the
  award-supported activities. Also, notification
  shall be given in the case of problems, delays,
  or adverse conditions which materially impair the
  ability to meet the objectives of the award. This
  notification shall include a statement of the
  action taken or contemplated, and any assistance
  needed to resolve the situation.

26
Supplemental Requests

• Exception not the rule
• Change in scope requires competitive request
• Administrative supplements
• Single, isolated emergency
• Unanticipated cost increases
• Project momentum until Type 2 is funded (bridge
  funding)
• Near-certain immediate major advance
• Minority/disability/reentry supplement