Effort Change Justification Examples and Guidance
Last updated 11/11/2024
Sponsor Approval Level – GOOD EXAMPLE
SAMPLE GENERAL LETTER – Effort Reduction for Key Personnel (i), Sponsor Approval Level
03/01/2024 (ii)
Name of Program Officer (PO) and Grants Management Specialist (GMS)
Address
Email address of PO/GMS for the specific award
RE: Agency ID and Title (e.g., 5R01-HL0111111-04, Study of genetic factors).
Dear PO Name and GMS Name,
I am writing to request that my effort as principal investigator (PI) on the above referenced award be decreased from a rate of 2.6 calendar months to a rate of 1.2 calendar months for the remainder of the budget period (07/01/2023 – 06/31/2024), effective 04/01/2024 (iii). For all remaining budget periods my effort will be 1.2 calendar months (iv).
The scientific justification for this reduction in effort is as follows: As we reported in our RPPR, we successfully completed patient enrollment in budget period 3 and met our target enrollment of 75 patients at the Duke site. Beginning in period 4, our work will focus on patient follow up, data collection, and analysis. The day-to-day operations of the work is conducted chiefly by the clinical research coordinator and by the investigator [provide name]. As PI, my work is currently focused on the data analysis, and the effort needed to achieve this is less than originally planned. Our accelerated pace of enrollment has put us in this phase of the project faster than originally anticipated. Thus, we estimate that 1.2 calendar months is appropriate for the scientific work (v). This reduction will result in approximately $16,800 dollars being freed up and we propose to use these funds to increase support for our subrecipient, the University of Chapel Hill, as that site requires additional staff to assist in increasing recruitment numbers to meet their target. This change will more accurately reflect the effort needed for the PI and will ensure the most appropriate allocation of financial resources.
This reduction will have no impact on the scope of the project, nor will it impact our ability to complete the project on time (vi).
Regards,
PI Signature (vii) ____________________________ ORA Signature ________________________
PI Name _______________________________ ORA Name ___________________________
Title __________________________________ Title ________________________________
Cc: PO Name
Grant manager name
(i) Access best practice for effort commitment change guidance here
(ii) NIH requires prior approvals to be submitted at least 30 days prior to the effective date of the change.
(iii) Include a future effective date and whether this reduction is for the budget period or remainder of the project.
Note: We should not be submitting retroactive requests.
(iv) Please make sure the letter includes the following information:
- Name and role of person receiving the effort reduction
- Current approved effort level (what was originally proposed or the last sponsored approved commitment level) and the requested reduction level in person months
Note: Multiple effort reduction request for the same PI/Senior Key person could raise concerns with our sponsor.
(v) Provide a thorough scientific justification, including the following:
- Why we need an effort reduction (this should be specifically based on the science of the project. ORA will not approve any reduction request that are for non-scientific reasons)
- A narrative discussing the available funds. Provide acknowledgement that we would like to retain the funds, how much is available and how we plan on using it
Note: We need to be able to address why the project is able to continue successfully with a reduced effort amount and still retain the available funds. Failure to provide this information could result in reduction of the award. Remember this is a request for consideration and not an automatic approval.
(vi) All effort reduction requests should state that the reduction will not impact the scope of the project nor our ability to complete the project within the proposed timeline. If the scope will be impacted, then the request needs to explain how the scope will change.
(vii) All effort reduction requests should be signed by the PI, the investigator (if applicable), and ORA.
Sponsor Approval Level – POOR EXAMPLE that will not be submitted to Sponsor
SAMPLE GENERAL LETTER – Effort Reduction for Key Personnel (i), Sponsor Approval Level
04/01/2024
Name of Program Officer (PO) and Grant Management Specialist (GMS)
Address
Email address of PO and GMS for the specific award
RE: Agency ID and Title (e.g., 1R01-HL012345-01, Study of genetic factors).
Hello,
I am writing to request that my effort as principal investigator (PI) on the above referenced grant be decreased from a rate of 10% to a rate of 1% (ii), effective January 1, 2024 (iii).
I have received a number of new awards over the last year that require my time. I will have my lab manager conduct the experiments remaining for this grant and I will dedicate 1% of my time to oversee the staff to ensure the work is completed on time (iv). We will also leverage some of the staff that are currently working on another R21 and have them work on this grant to ensure progress (v).
[Insert a statement about commitment to project completion].
Regards,
PI Signature ____________________________ ORA Signature ________________________
PI Name _______________________________ ORA Name ___________________________
Title __________________________________ Title ________________________________
Cc: PO Name
Grant manager name
(i) Access best practice for effort commitment change guidance here
(ii) Effort should be expressed in person months depending on the appointment (Calendar, Academic or Summer).
(iii) Effort reduction requests need to begin on a future date and will not be submitted without a required future effective date.
(iv) All effort reduction requests need to be based on the scientific work completed and proposed. ORA cannot request an effort reduction because the PI has received additional awards; does not have sufficient funds to pay the PI/Senior Key individual at the commitment level or salary level; have changed work assignments within the institution; or other non-scientific reasons. If the reduction is not based on the scientific activities of the project, the effort must be assigned to a similarly skilled investigator on the existing research team or replaced with Senior Key individual.
(v) It is not appropriate to mention other projects or grants in a prior approval request. This can imply overlap and should be addressed in Other Support documents. The focus should be on the scientific work on THIS grant only.
SAMPLE NIH LETTER – Changing PI Status, Sponsor Approval Level (i)
Today’s Date
Name of Program Officer (PO) and Grant Management Specialist (GMS)
Address
Address
Email address of PO and GMS for the specific award
RE: Agency ID and Title (e.g., 1R01-HL012345-01, Study of genetic factors).
Dear PO and GMS Name,
We (ii) are writing to request replacement of the Principal Investigator Dr. Duke, with Dr. Jones, on the referenced project as of [DATE].
As PI, Dr. Jones will assume scientific, administrative and fiscal management of the overall project (iii). Dr. Jones has 20 years of experience in [area of expertise] and has worked with Dr. Duke as Co-Investigator on this project over the past three years.
As PI, Dr. Jones’ effort commitment is at a rate of 1.5 calendar months for the remainder of the current budget period. The effort commitment for subsequent years is at a rate of 2.5 calendar months per year, consistent with the rate of effort committed by Dr. Duke (iv).
There is no financial impact to the project as a result of this PI transfer (v). This change is not related to concerns about safety and/or work environment (vi).
Please find attached a Biosketch and Other Support document for Dr. Jones.
Regards,
Current PI Signature ____________________________ ORA Signature ________________________
Current PI Name _______________________________ ORA Name ___________________________
Title _________________________________________ Title ________________________________
New PI Signature _______________________________
New PI Name __________________________________
Title __________________________________________
Add additional signature blocks if necessary
Cc: PO Name
Grant manager name
Attachments: Other Support and Biosketches for any PI changes (vii)
(i) Includes changes between Multiple PD/PI and Single PD/PI models; replacement of "contact" PI.
(ii) The language needs to be tailored to the specific circumstance. Work with PI to get this information.
(iii) Justify NEW PI’s expertise and experience to fulfill the role and availability of effort to assume responsibility. If NEW PI is currently on project as an investigator, identify the additional effort to assume the PI position. released effort. If the current PI is leaving Duke and moving to a new institution, state whether Duke will subcontract with the new institution and what level of effort they will commit. Include a scientific justification for the change in PI at this point, and if/how it will affect the project programmatically and financially.
(iv) It is expected that the level of effort committed by the NEW PI will be the at the level of effort committed by the original PI. Although this may vary depending on the programmatic year of the project, it is also expected that if the NEW PI had an existing role on the project, that the new PI role will be additive effort. If the NEW PI’s effort level does not match the original PI’s effort, provide the rationale that the NEW PI will be able to accomplish the remaining tasks with less effort.
In this hypothetical example, Dr. Duke has already completed 1 CM of the 2.5 CM commitment for the current budget year, so Dr. Jones will commit 1.5 CM to match the original commitment.
(v) If there is a financial impact to the project due to the transfer of the PI, state the anticipated dollar impact and how these funds will be used in the current and future years. If a subcontract will be necessary to continue the work with the current PI at their new institution, address the impact to the project.
(vi) Only included this statement if accurate. If the change is being made because of concerns about safety and/or work environment, please contact ORA/ORS leadership as applicable.
(vii) If this is a Multiple Principal Investigators [MPI] project, you would need an updated MPI plan as well). Some sponsors may also require a letter from the new PI for agreement to the new arrangements.
Duke Central Approval Level Effort Change Justifications
Duke Central Approval Level does not require a formal letter on letterhead. However, the scientific justification for reduction in effort is expected to follow the same parameters as a Sponsor Approval Level justification to ensure sufficient details and scientific justification to provide a clear understanding of the purpose, sources, and conclusions in the review. This information will serve as both internal and external audit documents.
Provide a project specific explanation of why the effort needs to be reduced. State whether the effort will be reassigned to another researcher, or the work can be completed with the reduced effort. State the effective date for the reduction and end date, i.e., are you requesting a reduction for the a period of time, the current budget period, the subsequent budget periods or for the remainder of the project. The effective beginning date should be prospective as we should not be submitting retroactive prior approval requests.
Include whether the effort reduction changes the scope or negatively impacts the ability to successfully complete the project as originally outlined in the specific aims. (The previous RPPR/annual report should support this assessment.) Ensure you identify the person’s role on the project, the current level of effort and the proposed new effort.
Access guidance for best practice for effort commitment changes here
Duke University’s practices and systems are designed to ensure expenditures are charged in a timely manner in direct support of a specific sponsored program. Retroactive adjustments to effort commitments should be made on a timely basis and provide sufficient information to identify why the late adjustment is occurring. Effort allocations are the prospective assignment and eCRT certification (reviewed quarterly; certified annually) is the retrospective confirmation or after-the-fact certification of an individual’s actual time and effort spent for a specific project. Retroactive changes in effort commitment must match our internal systems (SAP iForms and eCRT).
SAMPLE JUSTIFICATION – Effort Reduction for Senior Key Personnel, Duke Central Approval Level
Identify investigator, enter the effort reduction amount and dates for effort reduction period. Example:
Provide a project-specific justification for the modification and describe how funds released because of this reduction will be used.
Example:
As communicated by the PI, Dr. Jones, "Dr. Smith is a cardiothoracic radiologist, whose role is to read and interpret CT scans. In the early years of this project, the bulk of the work is related to technical development and optimization, as well as recruitment and enrollment. At the beginning of Year 3, Dr. Smith’s effort commitment has been reduced to 0.12 calendar months to account for his interaction with the team and IRB oversight." Effort will increase to 0.6 calendar months in Year 4 when CT scans are available for reading and interpretation. Funds released by the reduction in effort for the current year will be used appropriately toward adjustments in non-key personnel effort during Year 3 in direct support of this project.
Unacceptable Duke Central Approval Level Effort Change Justifications
Unacceptable: Dr. Duke's overall effort availability was lower than anticipated at the time of proposal submission and our need for her expertise for the study was less than initially planned.
Effort availability was lower than anticipated implies potential effort overlap at time of award acceptance.
Unacceptable: Dr. Duke is unable to commit 10% FTE. She spoke with the PI and they agree to 5% FTE.
Unable to commit is vague -- could imply potential effort overlap; PI and investigator discussion and agreement is needed but does not provide basis for effort reduction.
Unacceptable: PI (name) and investigator (name) agree to reduce FTE to 1% instead of 10.0% as originally intended.
Need basis for reduced effort; are tasks assigned to another qualified team member (Senior Key person)
Unacceptable: Dr. Duke was recently awarded an R35, which requires 51% of her effort. Efforts had to be reduced elsewhere to make space for the required effort on the R35.
When a Senior Key person is changing effort equal to or greater than 25% to accept a new award, replacement effort should be considered first for the current project. Is there another Senior Key investigator that is qualified to do the work that can replace this effort? If the answer is "no", then the PI must provide a plan for how the work will be performed. If the answer is "yes", we can replace the current investigator with a new investigator or increase the effort for another Senior Key investigator already on the project. In either situation, the PI needs to consider the assigned tasks.
Unacceptable: The award was cut by 14% from what was proposed and Dr. Duke's effort was reduced from 10% (1.2 cm) to 1% (0.12 cm). The justification for this request was to align her effort with the reduction in the total award amount.
For NIH, a budget that is cut 25% or more may be negotiated based on changes in the specific aims. If the budget is cut less than 25%, the PI must request changes in the budget or accept the award as is. If Duke accepts a reduced budget, the application remains as originally submitted, including all committed effort levels. NIH provides a up to a 25% threshold for changes/adjustments in effort committed. Effort changes = 25% or greater must be based on the original work required by the project as you agreed to when accepting the award.
Unacceptable: Dr. Duke received a K23 award which requires 75% effort and the 2.4 cm on this project will be subsumed under the K award.
Complementary or subsumed effort must be approved in writing by the sponsor.
Unacceptable: Funds for Year 4 are running low. The PI is reducing the effort for all the Senior Key personnel by 50% so it can be moved to the clinical research staff.
Effort reductions must be based on assigned tasks and changes to those tasks. If rebudgeting needs to occur, the department should follow GAP 200.160. The committed effort remains the same as the original application requested unless there are changes to the tasks assigned to the Senior Key investigator.
Unacceptable: Dr. Duke is no longer available to work on this project *. Effort commitment needs to be changed to zero.
*Working on other projects, on FMLA, retired, transferred to another institution, changed departments, on temporary assignment outside Duke, disagrees with the PI, does not have enough time, no longer interested in this project, and a host of other reasons that do not relate to the tasks assigned to the committed effort in the original application.
When reducing effort equal to or greater than 25%, the justification must be based on the tasks assigned as described in the original application. If removing a Senior Key investigator, the committed tasks should be assigned to another Senior Key research team member. If the original individual is no longer available, describe the tasks that will be assigned to the replacement and the level of effort the replacement will project. The Effort Management team will process both the removal of the original investigator and the addition of the replacement (increase in effort) investigator in one action. If there is no qualified replacement, the PI should describe how the work will be accomplished.
Unacceptable: Any information that DOES NOT directly address the tasks assigned to a specific Senior Key investigator as described in the original application, the current state of the research progress and the changes to the project.
Senior Key effort is expected to be replaced by another senior key investigator to complete the assigned tasks. If the PI determines that the investigator’s work is complete (no additional effort required), then the PI should state the scientific work assigned to the investigator is complete. If the PI determines that effort can be reduced from the original commitment, then an explanation based on the status of the tasks should be documented. If the PI determines that the work can be distributed across the research team, then the names, tasks and effort assignments should be detailed to update our internal records or to reflect these changes as necessary.