December 2011

1 | P a g e

MODIFICATION OF PROJECTS FUNDED BY THE 

QUALITY ENHANCEMENT RESEARCH INITIATIVE (QUERI)

1. EXPECTATION. Quality Enhancement Research Initiative (QUERI) expects all research 

projects it sponsors to be carried out according to the plan presented in the approved proposal. 

Approval of requests for modifications involve situations beyond the control of the Principal 

Investigator. Once funding has started, investigators must obtain formal approval from the 

Director, QUERI, for any significant change in objectives, methods, budget, time, key personnel, 

or location. Requests for changes must be submitted in writing by the medical center Director, 

through the Associate Chief of Staff (ACOS) for Research and Development (R&D) to the 

Director, QUERI, in conformance with the following procedures. A project that is changed 

without prior approval is at risk of termination.

2. PROCEDURES FOR REQUESTING A MODIFICATION

a. To permit careful review, all modification requests must be submitted as soon as the need 

becomes apparent and, in all cases, prior to the effective date of the proposed change. 

Approval requires that a strong rational be provided for the changes.

b. All requested modifications must be submitted electronically Via email to 

Linda.McIvor@va.gov and a copy to John.Midolo@va.gov The justification for every 

request must address in detail any implications for personnel, budget, timeline, and project 

feasibility (as applicable), and must include appropriate supporting documents, such as, 

new budget pages, Gantt charts, curriculum vitae (CV), etc. Adequate information must 

be provided to permit reviewer(s) to determine why the change is necessary and to allow 

thorough evaluation of the request.

c. Project modifications are viewed on an ongoing basis. Incomplete project modification

requests will not be reviewed and will be returned to the Principal Investigator. 

d. Requestors must send the project modification request with the modifications cover page 

electronically in a PDF file to: vhacohsrdpm@va.gov. Project modifications will be 

reviewed on an ongoing basis, provided all necessary documentation has been included in 

your request.

e. The following paragraphs address issues related to specific types of requested 

modifications.

(1) Increase in Time. Investigators are expected to complete project work within the 

approved-funding period and to notify QUERI early regarding any significant delay. Formal 

approval is required to extend a project-completion date, whether or not additional budget is also 

requested. All requests for additional time must be well justified, and the amount of time 

requested should be less than 6 months. If a project will not be completed by the end date, the PI 

must submit a modification request to extend the end date.

(a) Project Final Reports are due within 90 days of the project’s official end date. In rare 

circumstances, an extension of the due date can be requested. Requests for additional time to 

prepare the Final Report must be submitted to the assigned Scientific Program Manager (SPM) 
December 2011

2 | P a g e

through the Associate Chief of Staff (ACOS) for R&D. A “Request for Modification” is not 

required for this purpose.

(2) Change in Objectives. Approval must be obtained to add, delete, or significantly alter 

the objectives of a funded project. The written request must provide a detailed explanation of the 

proposed change, its rationale, and implications. A fundamental change in study design is not 

permitted unless prior approval has been obtained. It is the responsibility of the PI to provide 

IRB clearance for each site and OMB briefs, if they apply. 

(3) Change in Methods 

(a) Approval must be obtained to change any key component of the approved research plan. 

This includes, but is not limited to: sampling plan, source(s) of data, addition of another “arm” 

or comparison group, data collection instrument(s), data collection method(s), or analysis plan. 

A fundamental change in study design (e.g., elimination of a control group, use of retrospective 

instead of prospective data, etc.) is not permitted unless prior approval has been obtained. 

(b) The request for approval of methodological changes must include a clear description of 

how the proposed change differs from the methodology described in the approved proposal, why 

a change is needed, and how the proposed change will resolve the problem. The request must be 

supported with sufficient information to allow a comprehensive scientific review. As an 

example, if a modification affects prior patient accrual expectations, the request needs to include 

a replication and comparison to the power analysis used in the original, funded proposal, after 

appropriate adjustment for effect size, etc. It is the responsibility of the PI to provide IRB 

clearance for each site, OMB briefs if they apply, and a DSMB Data Analysis Plan if the project 

is a Randomize Clinical Trial and multisite. If an additional site is being added, please reference 

section 4.

(4) Adding Study Site

(a) A request for the addition of a study site may not be made without the approval of the 

Director, QUERI. The request for the addition of a site must include a clear description of why 

an additional or replacement site is required and how the proposed change will benefit the 

project. The request must be supported with sufficient information to allow a comprehensive 

scientific review. It is the responsibility of the PI to provide the site name, IRB, and the R&D 

clearance for each site, OMB briefs, if they apply; and a DSMB Data Analysis Plan, if a project 

is a Randomize Clinical Trial. 

(5) Change in Location

(a) QUERI projects are awarded to the medical facility where the PI is employed at the time 

of the award. If the PI or co-PI transfers to another VA facility, the project remains at the 

original facility until approval is secured for transferring the project to the new facility. 

(b) A request for transfer of a project between facilities must include written documentation 

from the medical center Director of each facility agreeing to the transfer. However, final 

approval rests with the Director, QUERI.
December 2011

3 | P a g e

(c). If the PI moves to another VA, and no longer wants to conduct research, the PI must 

provide written authorization agreeing to transfer the project to a new investigator. Approval of 

the change in PI must be obtained from the Director, QUERI before the new PI can assume 

responsibility for the project. 

(6) Change in PI (or Co-PI) Employment Status

(a) If the VA employment status of the PI or Co-PI drops below a 5/8 paid appointment, an 

eligible VA investigator must replace that PI. 

(b) The ACOS for R&D is responsible for notifying QUERI of a change affecting PI 

eligibility within 2 weeks of receipt of this information. This notification must be accompanied 

by a request for approval of a new PI and supporting information (see preceding subpar. 2e(5)).

(7) Change in Key Personnel

(a) The Principal Investigator (PI) and Co-PI (if one) are responsible for carrying the funded 

project through its completion. A change in PI or co-PI may not be made without the approval 

of the Director, QUERI. Supporting information submitted with any request to change a PI must 

be accompanied by a letter from the current PI indicating the PI’s agreement to relinquish 

responsibility for the project to the proposed new PI and a letter from the new PI accepting 

responsibility for the project. 

(b) Approval of Department of Veterans Affairs (VA) Central Office also is required to 

change any other project participants who are responsible, in whole or in part, for the design, 

execution, or management of the project, and for any change in their time commitment to the 

project. Medical centers must provide a CV of the new participant(s) and other supporting 

documents to permit HSR&D to assess their qualifications, competing commitments, etc. 

NOTE: For a funded project involving a mentor (e.g., Career Development) expects that the 

time commitment and geographic proximity of the awardee and mentor remain as presented in 

the approved project. If either the awardee or mentor seeks a decrease in time commitment or 

transfer to another facility, formal approval must be obtained. 

(8) Change in Budget

(a) QUERI approval must be requested in writing for any budget change. The request must 

contain a clear explanation as to why the awarded budget was inadequate. QUERI does not 

generally approve a budget increase of more than 20 percent of the originally approved project 

budget. PI must provide a summary budget (including degrees) and budget justification (a 

sample summary budget can be found: http://www.hsrd.research.va.gov/funding/sample-budgettable.xls )

(b) A request for an increase in budget must include a description of efforts taken locally to 

address the budgetary deficiencies, including use of local QUERI, HSR&D, R&D, or other 

resources.

(c) If funds need to be transferred to the next fiscal year, a project modification must be 

submitted even if the total amount requested stays the same.
December 2011

1 | P a g e

REQUEST FOR MODIFICATION OF QUALITY ENHANCMENT RESEARCH 

INITIATIVE SERVICE-FUNDED PROJECT

SAMPLE FORMAT OF COVER PAGE

1. Identifying Information

a. Project Number__________________________________________________________

b. Project Title_____________________________________________________________

c. Name of Principal Investigator_______________________________________________

d. Principal Investigator’s Department of Veterans Affairs (VA) Facility________________

e. Principal Investigator’s Telephone No._________________________________________

2. Request for a change in: NOTE: Check all that apply.

a. ___ Time (From: MM/DD/YYTo: MM/DD/YY, XMonths)

b. ___ Objectives

c. ___ Methods

d. ___ Location (site: )

e. ___ Key Personnel (Name: Degrees: )

f. ___ Budget (Total amount of increase: FYYY $ , FYYY $ )

3. Preferred effective date of requested change ____________________________

__________________________________________________________ _________

(Signature of Principal Investigator) (Date) 

__________________________________________________________ _________

(Signature of Center of Excellence or Research Enhancement Award (Date) 

 Principal Investigator (if applicable))

______________________________________________________________ _________

(Signature of Associate Chief of Staff for Research and Development) (Date) 

____________________________________________________________ _________

 (Signature of Medical Center Director) (Date) 
December 2011

1 | P a g e

PROJECT MODIFICATION CHECK LIST 

Type of project modification Supporting documentation required and implications

Project Extension Must provide justification

Must provide summary budget pages

Must provide Gantt Chart

IRB may have to also be extended-PI must provide approvals

Change Objective PI must provide justification

IRB may be required

Check for possible OMB issues

Methods PI must provide justification

Fundamental change in study design is not permitted

Check for possible changes in: IRB, OMB, and DSMB (if 

RCT) requirements

Add Study Site PI must provide justification

Site name 

IRB approval(s)

If project is a RCT and multisite, then it must report to the 

DSMB

Change in Location Letter from releasing VAMC and the accepting VAMC

Personnel PI must provide justification

Provide name and educational degrees

We do provide salary support for MD, Pharma, PT or RN (a 

clinical waiver can be used for Title 38 employees)

For change in PI:

o Must provide letter from PI relinquishing responsibility 

to new PI

o Provide letter from new PI accepting responsibility

o Letter from releasing VAMC and the accepting VAMC

o CV for new PI

o Biosketch 

o New budget

Budget PI must provide a summary budget table

Budget justification