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Does Evaluation Require IRB Review?

Research studies involving human subjects require IRB review.  Evaluative studies and activities do not.  It is not always easy to distinguish between these two types of projects and projects frequently have elements of both.  Therefore, the decision about whether review is required should be made in concert with the IRB.

If you think that your project is limited to evaluative activities and therefore not subject to IRB oversight, please contact the IRB office at 6-8802 to discuss. 

The regulatory definition of research is defined as:

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Evaluative studies are defined as:

Systematic collection of information about the activities, characteristics and outcomes of programs to make judgments about the program (or processes, products, systems, organizations, personnel, or policies), improve effectiveness, and/or inform decisions about future program development.

Below are elements that are common to evaluation and research projects.  This list is not intended to be comprehensive and not all elements are required in order for a project to be considered research or evaluation.  Rather, this list of elements can be used to assist faculty in determining whether an activity involves research requiring IRB review.

Common Elements

Evaluation

Research

Determines merit, worth, or value Strives to be value-free
Assessment of how well a process, product, or program is working Aims to produce new knowledge within a field(designed to develop or contribute…)
Focus on process, product, or program Focus on population (human subjects)
Designed to improve a process, product, or program and may include:

-needs assessment

-process, outcome, or impact evaluation

-cost-benefit or cost-effectiveness analyses

May be descriptive, relational, or causal
Designed to assess effectiveness or a process, product, or program Designed to be generalized to a population beyond those participating in the study or contribute broadly to knowledge or theory in a field of study (designed to develop or contribute to generalizable knowledge)
Assessment of program or product as it would exist regardless of the evaluation May include an experimental or non-standard intervention
Rarely subject to peer review Frequently submitted for peer review
Activity will rarely alter the timing or frequency of standard procedures Standard procedures or normal activities may be altered by an experimental intervention
Frequently, the entity in which the activity is taking place will also be the funding source May have external funding
Conducted within a setting of changing actors, priorities, resources, and timelines Controlled setting (interaction or intervention) or natural setting (observation which may or may not include interaction or intervention)

 

Informed by:

Coffman, J.  (2003).  Ask the Expert: Michael Scriven on the Differences Between Evaluation and Social Science Research.  The Evaluation Exchange, 9(4).  Retrieved January 8, 2012 from https://madvilletimes.com/

National Center for Justice Planning. (2012) Research and Evaluation Overview.  Retrieved on November 28, 2012 from https://www.ncja.org/

National Institutes of Health (2012). Evaluation Basics. Retrieved on November 28, 2012 from https://www.nigms.nih.gov/Research/Evaluation/

Oklahoma State University Institutional Review Board.  IRB Toolbox.  Program Evaluation: When is it Research? Retrieved on November 28, 2012 from https://compliance.vpr.okstate.edu/irb/irb-toolbox.aspx

Patton, M. Q. (1997). Utilization focused evaluation: The new century text. Thousand Oaks, CA: Sage.

Scriven, M. (1991). Evaluation thesaurus (4th ed.). Newbury Park, CA: Sage.

U.S. Government Accountability Office.  (2005).  Performance Measurement and Evaluation.  Retrieved January 8, 2012 from https://www.gao.gov/special.pubs/gg98026.pdf

Source material for this policy guidance was provided by Oregon State University. The UConn IRB gratefully acknowledges this support.

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Pre-Award Or Advance Account Request

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  • Team 1 - K. Jabarkhail, B. Dauphinais, S. Corbin
    Team 2 - M. Niewinski, L. Abell, C. Wells, S. Warren
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    IP Policy

    In addition to publications, presentations, and graduate theses, which communicate research findings to scientific colleagues throughout the world, research may also result in an invention. Inventions and their commercialization have always been a significant component of this country’s economic growth. Technology is critical to our international competitiveness and economic health. As a result, a large number of state and federal laws have been developed to facilitate this process and increase the rate at which valuable inventions move from the laboratory into the marketplace. The policies below govern this process at the University of Connecticut.

    Policies Regarding Research Collaborations with Industrial Partners and Technology Transfer

    OVPR Staff Resources

    Welcome to the OVPR Staff Resources Page!

    If you are looking for information that cannot be found here, please reach out to us at ovprhr@uconn.edu for assistance.

    The OVPR Operations Team provides administrative, financial and technical staff and programmatic support across all UConn and UConn Health locations. We are the “people-support” people of the OVPR!

    Check back frequently for announcements and current information.

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    Official Info and Action Items for OVPR Staff:  OVPR Minute

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    Overview of The Office of the Vice President for Research (6 minutes)

    Recruitment Poster:  Careers In Research Administration

    OVPR NEO Presentation and Handout

    Important for Members of AAUPGuidance in Matters Pertaining to Merit, Workload, ByLaws, and Promotion and Tenure for OVPR Non-Tenure-Track and In-Residence Faculty Positions

    Policies, Procedures & Guidance

    Subrecipient Monitoring

    Project Risk Assessment

    Before executing a subrecipient agreement, and every two years thereafter, the subrecipient must complete and submit a Subrecipient Profile Questionnaire, which allows the University to identify project specific risks. Where the assessment reveals a high potential for risk, Sponsored Program Services (SPS) will propose a risk mitigation strategy before proceeding with the subaward.  The risk assessment takes into account several factors, including the following:

    • Type of subrecipient organization (for-profit/not-for-profit/small business/corporation/ foreign/domestic)
    • Whether the subrecipient is subject to the Single Audit requirements.  Subrecipients not subject to Single Audit requirements must provide more information regarding their financial status and systems as part of the Subrecipient Profile Questionnaire
    • Subaward value relative to the prime award
    • University’s prior relationship with the subrecipient
    • Organizational and individual conflict of interest
    • Necessary IRB and/or IACUC protocols

    Post-Award Subrecipient Monitoring

    The University is responsible for monitoring the activities of subrecipients to ensure that awarded funds are used for authorized purposes and that performance goals are achieved.

    • At least annually, SPS will review subrecipient’s financial stability, financial processes, and controls as follows:
      •  Subrecipients subject to Uniform Guidance (UG) that expend $750,000 or more of federal funds annually are subject to Single Audit requirements.  Annual Single Audit certifications are retrieved from the Federal Audit Clearinghouse.  If the Single Audit is not available from the Federal Audit Clearinghouse, SPS will be request Audit Certification directly from the Subrecipient.  In the event of an unfavorable audit certification, SPS will confirm that the subrecipient has taken appropriate and timely corrective action(s)
      • Subrecipients not subject to Single Audit requirements must provide annual audited financial statements
    • SPS will review the audit documentation and determine whether or not the Subrecipient’s risk designation requires reevaluation

    Federal Funding Accountability and Transparency Act (FFATA) Reporting

    As of October 1, 2010, all Federal grants of $30,000 and over are subject to the Federal Funding Accountability and Transparency Act (FFATA). FFATA requires UConn to report any subawards executed in the previous month that exceed $30,000, where UConn is the prime recipient. SPS staff use the FFATA Subaward Reporting System (FSRS) to enter, submit, and update the required FFATA reporting, which must be submitted by the end of the month following the month of full execution of the initial agreement or any subsequent amendment resulting in a subaward value of greater than $30,000.

    Progress Monitoring, Technical Reports and Deliverables

    • SPS, the responsible University PI, and department grant administrators will jointly determine the frequency and scope of departmental monitoring procedures. A “risk-based” approach to subrecipient monitoring is recommended with the frequency and intensity of monitoring driven by the terms of the prime award and the criteria identified in the section of this procedure titled Subrecipient Pre-Qualification Review.
    • PIs will monitor the progress of subrecipient work scope at least on a quarterly basis
    • Options for review include informal progress reports via phone conversations, e-mail communications, or face-to-face discussions, formal technical reports or other deliverables specified in the agreement required and due on specific dates. Subrecipient invoices will be submitted to the University PI
    • Subrecipient is required to submit invoices adhering to the following criteria:
      • Expenditures are reported for current period and cumulative period
      • Expenditures are itemized by cost category
      • Cost share and/or match is reported on each invoice
      • Invoice must also include the following:
        • Subrecipient’s name and address
        • Subaward Agreement Number and University account number
        • Project period and period of invoice
        • Invoice number and date prepared
        • Subrecipient contact person with respect to the invoice
        • Certification on each invoice as to the truth and accuracy of the invoice
      • Final Invoice must be submitted by subrecipient within forty-five (45) days of end date
    • PI will review and approve invoices from subrecipients to ensure that:
      • Expenditures are consistent with the proposed budget
      • Costs are incurred within the period of performance and are allowable
      • Expenses are aligned with technical progress
      • Cost sharing is appropriately reflected if required
    • The PI must sign the invoice to indicate that review has been completed and that the invoice has been approved for payment.

    Submitting Invoices for Payment

    The Principal Investigator must approve invoices for payment. This task may not be delegated.

    Resolving Invoice Issues

    • If PI identifies a concern with subrecipient performance, the PI will request clarification from the subrecipient PI.
    • If department grant administrators identify any unusual, apparently excessive, or potentially unallowable charges invoiced by a subrecipient and if the explanations from the subrecipient are insufficient to render a prudent judgment on the allowability of the cost, the department grant administrator shall refer the matter to SPS for resolution with the subrecipient’s institutional authorities.
    • When SPS is satisfied that the issues are resolved, they will notify the department and PI to proceed with approval for payment. Invoices will not be approved for payment until all issues or concerns have been resolved.

    Closeout of Subawards

    OVPR SPS, in collaboration with department administrators and/or PI, will begin subaward closeout actions immediately following conclusion of the subaward period of performance. Subawards will be processed for closeout and formally closed within a 60-day time period, unless SPS grants the department an extension. A subaward may not be formally closed until all of the following closeout requirements have been met:

    • Final review of costs charged to the University and final close-out of all commitments, accrued costs, or payables.
    • Receipt of final invoice from subrecipient and Subrecipient Release and Certification Form (Attachment C)
    • Receipt of all required deliverables as specified in the subaward, patent/invention documentation, and equipment reports. Final verification of technical completion will be indicated by the PI’s signature and date on the final invoice.

    Reports

    Technical Reports

    Principal Investigators are responsible for preparing and submitting both interim and final technical reports, which typically include a description of the work performed, results of the work and any related publications resulting from the work. The SPS should be copied on the cover letter accompanying the interim and final technical report.

    Financial Reports

    Preparation of Financial Reports is the responsibility of the OVPR SPS. These reports are generally due within 90 days of the award expiration on federal awards; the deadline may be even shorter for state and private awards. Inability or failure to submit reports within the stipulated time frame can result in the suspension of funding and/or a delay in the release of future funding. All expenditures related to the project must be processed, open encumbrances closed, cost sharing verified, and the account(s) reviewed for errors or necessary changes in order to prepare the final financial report. The following policies are to be followed to ensure that the University of Connecticut is operating in compliance with sponsor terms and Federal policies such as OMB Uniform Grant Guidance and Cost Accounting Standards and to ensure that Sponsored Program Services is able to prepare an accurate and timely final financial report for submission to the sponsoring agency as well as close the account in the University’s accounting system, Kuali Financial System (KFS).

    OVPR SPS will prepare and send to the Principal Investigator (PI) a draft report of final financial expenditures. There may be several items to which the PI is asked to respond. These include review of overexpenditures, expenditures after the end date, documentation of cost sharing, and identification of any charges not yet recorded in the University’s financial system (KFS). It is essential that these drafts are reviewed and returned within the time frame stated on the draft from OVPR SPS. In order to comply with sponsor reporting requirements, OVPR SPS will prepare finals based on the draft if the PI does not respond within the allotted time. Any unallowable expenditure, as well as any expenditure that remains unrecorded and therefore unbilled, will then become the responsibility of the PI and his/her Department Head or Dean.

    Expenditures

    It is the responsibility of the PI to charge expenditures to his/her sponsored program in strict accordance with the budget specified in the agreement.  PIs should avoid incurring overdrafts on projects.  The PI or designee should review each account’s financial status monthly.  Detailed and summary financial project reports are distributed to PI’s.  Financial information can also be reviewed online daily through the University’s Kuali Financial System (KFS).  Accounts should be reviewed carefully for incorrect salary distribution, incorrect charges, and other errors.

    Accounting statements can also be used as a management tool to determine the award balance available for expenditures, the spending level of each cost category (e.g., salary, travel, equipment), the status of open encumbrances, and any cost sharing commitments that must be fulfilled.  Discrepancies should be followed up and resolved immediately.  Any questions regarding an account statement should be directed to the project’s Grant Manager in SPS.  The Grant Manager is there to help PIs manage their projects, and can provide a wealth of valuable assistance in this regard.

     

    Program Income

    Program income must be identified, appropriately documented, and the resulting revenue and expenses properly recorded and accounted for.  Therefore, a separate account will be established by SPS in KFS to record program income.  Program income funds should be utilized to cover project expenditures according to the program income treatment required by the award.  If a portion of the income is the result of activities that are not directly related to the sponsored award, it is necessary to prorate the program income to identify the proportion attributed to the sponsored award.  Program income earned during the project period should be expended prior to expending sponsored funds during the period of performance.  Efforts should be made to avoid having unexpended program income remaining at the end date of the grant.

    In the event a grantee has unexpended program income remaining at the end of an NSF funded grant, it must be remitted to NSF by crediting costs otherwise chargeable against the grant. If it is not possible to record the credit via ACM$ (NSF’s electronic system for drawing down funds from and crediting funds back to the NSF), the excess program income must be remitted to NSF electronically or by check payable to the National Science Foundation. See the Program Income Guidance for additional information.

     

    Summer Salary Charged to Sponsored Projects Guidance

    Please note this guidance is limited to the allowability of charges to sponsored project funds and does not address other University fund sources.

    Salary and Corresponding Effort

    Generally salary charged to a sponsored project has to correspond to effort devoted exclusively to the activities supported by the project.  This is always the case with federal projects.

    For example, if 100% of salary is charged to a sponsored project, then the individual being paid would be entirely committed to work on that project and would not have time to do other activities.

    Activities which are typically unallowable to be charged to a federally sponsored project

    Activities that are not directly in support of the sponsored project may not be part of the effort of charged to the sponsored project.  These activities include but are not limited to:

      • Advising students (outside the scope of the sponsored project charged)
      • Unsponsored research
      • Administrative committees
      • Preparing new or renewal proposals
      • UConn teaching and curriculum development
      • Peer reviews
      • Refereeing and/ or writing other scholarly publications

    Sponsor Salary Limitation

    Some sponsors, such as agencies that fall under DHHS, limit or cap the amount of salary that can be charged.  Salary up to the cap may be charged to a sponsored project.  The amount over the cap cannot be directly charged to the project.

    9 and 10 months faculty who plan to be entirely funded by sponsored projects

    Guidance to Investigators: To better enhance compliance with sponsor requirements, 9- and 10-month faculty who plan to receive 100% support on summer projects should make a minimum of one week available to account for activities that cannot be charged to sponsored programs.

    The OVPR will fund one half of one week of summer salary for faculty members who intend to work and receive pay on sponsored projects for the entire summer, to assist and better account for non-sponsored activities. The remaining half of one week should be funded by another unrestricted source of funds (IDC for example). There is no change to current practice for 9- or 10-month faculty members who are not 100% committed to a sponsored project for the entire summer.

    For assistance for 9 or 10 month faculty planning to be 100% funded over the summer contact Research Finance:

    researchfinance@uconn.edu

    Julie Schwager, 860-372-2531, julie.schwager@uconn.edu

    SummerSalaryCalculator

    FREQUENTLY ASKED QUESTIONS

    Who is responsible for the non-OVPR covered portion of the week?  The PI may use their IDC or other unrestricted account(s) or may work with their department heads, center/institute directors, and deans to identify other sources of funding for the other one-half week.

    Do PIs have to fund a full week off non-sponsored accounts? OVPR guidance is that minimally one week should be funded from non- sponsored funds.

    What type of accounts can be used for the non-OVPR portion?  With the exception of sponsored accounts and related match accounts, any other discretionary university account would be acceptable (for example: IDC, salary savings, royalty, or residual account)

    Who publishes the updated form and when can I find it? This is an HR form.  Please see the HR website: A Guide to Unclassified Offer Letters | Human Resources (uconn.edu)

    Where can I send completed forms? researchfinance@uconn.edu

     

    Account Overdrafts

    All overdrafts are the responsibility of the PI. Overdrafts on an account will result in a negative cash position until they are resolved. Overdrafts result from expenditures made to the account in error, project expenditures that were greater than the awarded budget, or expenditures that are charged after the project end date.

    If expenditures were made to the account in error, after the end date, or in excess of the approved budget, a cost transfer should be initiated by the PI to move the expenditures to the appropriate account(s). All cost transfers must be fully documented and processed in a timely manner (See the Policy and Procedures on Cost Transfers). All deficits should be cleared within the fiscal year that they occur, especially those charges that are to be transferred to a departmental account. The PI is responsible for reviewing sponsored accounts for overdrafts periodically during each fiscal year. Sponsored Programs Services will mail notices of overdrafts to each PI on a monthly basis.

    It is the responsibility of the PI and his/her department to clear any remaining deficits within 60 days of account expiration. This will allow the sponsored account to be closed within the time specified in the agreement and to be removed from the University’s KFS system in a timely fashion. Failure by the Investigator and his/her Department Head or Chair to identify an appropriate account to which to allocate the over draft will cause the SPS to shift the deficit to an unrestricted departmental account or to any of the PI’s discretionary accounts, including the indirect return accounts and/or salary savings accounts.

    Open Encumbrances

    The Principal Investigator or his/her designee should periodically monitor encumbrances and communicate any problems with the appropriate department (such as Purchasing or Accounts Payables).

    All encumbrances to be liquidated should be cleared within 60 days of the award expiration date to ensure their inclusion on the final financial report. All open commitments have to be liquidated or closed in order to close an account in KFS.

    The PI should continue to monitor all accounts, whether they are past the end date or not, to ensure that commitments are properly closed out.

    Cost Transfers

    When submitting a General Ledger Transfer in KFS or completing the cost transfer request form, please address all of the following items:

    • Justification – provide a detailed explanation that justifies the need to transfer an expense that had been previously approved on another account. Include in your justification why the charge was originally charged to the account from which it is being transferred and how the expenditure benefits the new account.
    • Required Documentation – At the time you submit your request on-line, provide SPS with copies of supporting documentation.  If a cost transfer pertains to salary adjustments please provide copies of the approved payroll authorizations.
    • Timeliness – process all cost transfers within 90 days after the end of the calendar month in which the transaction appears on the University’s month end accounting statements and within 90 days of the end date of the project.

     

    The following list represents some acceptable reasons for cost transfers between accounts:

    • To correct a clerical error on an original transaction (e.g. a transposition of account numbers)
    • To transfer sponsor approved pre-award costs to a sponsored account once it has been established
    • To transfer salary to align with actual effort devoted
    • To transfer expenditures to a new account number representing new budget period for the same award
    • To remove expenditures determined to be not allowable/allocable to the account after review of account financial statements
    • To move costs resulting in an account overdraft to an unrestricted account
    • To move expenditure in part or in whole for items that were later used for purpose/project other than originally intended or determined to benefit more than one project

     

    The following list represents some unacceptable reasons for cost transfers between accounts:

    • To transfer costs to resolve an account overdraft to another sponsored account
    • To transfer costs to spend the balance of an award

     

    Departments should submit a cost transfer via the General Ledger Transfer edoc within KFS for sponsored awards and related accounts (e.g. match accounts) except for:

    • Payroll cost transfers
    • Expenses that are currently charged to a non-project account that posted in a prior fiscal year
    • Direct cost overage of less than $25

    Guidance for General Ledger Transfers

    Departments should submit a cost transfer via the online cost transfer request form for the following:

    • All payroll cost transfers
    • Expenses that are currently charged to a non-project account that posted in a prior fiscal year

    Guidance for Payroll Cost Transfers – Supporting Documentation

     

    Cost Sharing

    Cost sharing on a sponsored program is a contribution to the cost of the project not funded by the sponsor. Direct cost sharing refers to funds expended by the University on behalf of a sponsored project and includes personnel, equipment, and supplies. Mandatory cost sharing is required to be reported on the financial reports and to be supported through the accounting records.

    Identification of the source of cost sharing is to be made at the time the proposal is submitted. Cost sharing/match accounts are to be set up for each grant as required and used to charge the cost sharing expense. These accounts should be established at the time the award is received and set up in the University’s KFS system.

    A periodic review of the financial statements will ensure that cost sharing commitments are being met and that unrestricted funds to cover the cost share commitment have been transferred in a timely manner to the cost sharing/match accounts. Transfers from unrestricted accounts to the cost sharing accounts should be made in the fiscal year in which the costs are to be incurred.