uconn

HRPP/IRB Administration

Office of the Vice President for Research
Research Integrity & Compliance
438 Whitney Rd. Ext., Unit 1246
Storrs, CT 06269-1246
irb@uconn.edu

 

Name Title Phone Email
Karen Christianson Program Manager – HRPP/IRB karen.2.christianson@uconn.edu
Doug Bradway Senior Administrative Program Support doug.bradway@uconn.edu
Joan Levine Education & QA/QI Specialist joan.levine@uconn.edu
Nicole Ferrari IRB Program Specialist nicole.ferrari@uconn.edu
Jocelyn Springfield IRB Program Specialist jocelyn.springfield@uconn.edu
Jeanelle Graham IRB Program Specialist jeanelle.graham@uconn.edu
Elizabeth Locke IRB Program Specialist elizabeth.locke@uconn.edu
Gabrielle Dayacap IRB Program Specialist gabrielle.dayacap@uconn.edu
HRPP/IRB Office Main Line 860.486.8802 irb@uconn.edu
HRPP/IRB Office Fax Line 860.486.5381
Technical Support
Research IT Help Desk 860.486.7944 era-support@uconn.edu

For questions about:                                                                                                        Contact:

InfoEd Submissions
Technical Questions/Troubleshooting Research IT Help Desk
Non-Technical Questions – submission components, routing, InfoEd data entry questions/concerns and expiration and reminder notices irb@uconn.edu
IRB Submission Type
Full Board Review (H25-XXXX) Jocelyn Springfield
Exempt (X25-XXXX), Limited (L25-XXXX), and Expedited (H25-XXXX) Review Doug Bradway

Jeanelle Graham

Amendments, including PI changes Jocelyn Springfield

Jeanelle Graham

Protocol Deviations, Adverse Events, Reportable Information Joan Levine
Not Human Subject Research Determinations (D25-XXXX, NHSR25-XXXX) Doug Bradway
46.118 Approvals Lacking Definite Plans (Just-In-Time/118) Doug Bradway
Personnel Changes (Except PI or Non-UConn Personnel) irb@uconn.edu 
Involvement of Other IRBs/Non-UConn, External Investigators
Non-UConn investigators listed on protocol submissions/Use of Individual Investigator Agreements/Reliance Agreements/IRB Authorization Agreements/Cooperative Agreements, Coded Data Agreements/UConn Investigators listed on Non-UConn protocol submissions irb-reliance@uconn.edu
Permission to Recruit at UConn for External Investigators

Please note, use of this form also applies to cross-campus recruitment requests (e.g., UConn Storrs requests to recruit from UConn Health).

Online Request Form
Training
General Human Subjects Training and Education, Requests for Training, Workshops, and Presentations Joan Levine
Signatory Requests and Funder Requirements
Certificates of Confidentiality, Institutional Certifications, dbGAP Access Assurance irb@uconn.edu

 

FCOI Contacts

Central email: fcoi@uconn.edu

Name Title Phone Email
Michael Centola, MHS, CIP Associate Vice President-Research Integrity & Compliance centola@uchc.edu
Meg Johnson, JD, CIP Director, Conflicts of Interest and Research Integrity 959.262.4139 meg.johnson@uconn.edu
Kristen Tremblay, MPH, CCRP Research Compliance Monitor 860.679.3276 kristen.tremblay@uconn.edu
Gus Fernandez-Wolff, DVM, CHRC Research Compliance Monitor 860.679.8125 gustavo.fernandez@uconn.edu

For Public Accessibility requests for information regarding FCOIs related to Public Health Service-funded research, please complete the Public Accessibility Request form.

IACUC Contacts

Institutional Animal Care and Use Committee

UConn Storrs

438 Whitney Rd Ext

Storrs, CT 06269

Email: iacuc@uconn.edu

 

Committee Contacts

Name Title Email
Megan Hiller (Christianson), MPH IACUC Specialist megan.christianson@uconn.edu
Lisa Roberts IACUC Specialist lisa.m.roberts@uconn.edu
Joe LoTurco, PhD IACUC Chair joseph.loturco@uconn.edu
Morty Ortega, PhD IACUC Vice-Chair morty.ortega@uconn.edu
Ramaswamy M. Chidambaram, BVSc, MSc, PhD, DACLAM Interim Attending Veterinarian ramaswamy@uchc.edu
Nick Lacafta, MS Functional Analyst nicholas.lacafta@uconn.edu

 

Leadership Contacts

Name Title Email
Michael Centola, MHS, CIP AVP, Research Compliance and Integrity centola@uchc.edu
Melanie Lucas, MS, CPIA Director of Research Compliance – Animal Research and Safety melanie.lucas@uconn.edu

Storrs-UConn Health F&A

Because Storrs and UCH are two separate entities both from the standpoint of the state and for federal grants (and have different financial systems), this places us in a situation similar to the University of Maryland, University of Massachusetts and Cornell University. We used the Cornell model to develop guidelines to promote intercampus collaborations between Storrs and UCH and placed them on our website earlier this year. This has assisted researchers in understanding the procedures at the other campus and resolved issues that in the past have been a concern.

We currently have a global MOA between Storrs and UCH and create individual agreements for each project. They are simple and are put in place quickly.

Additionally the current practice is for the prime recipient to waive F&As on the first $25K of the sub-award if including them would diminish proposed direct costs.

In situations where amount of project cost funding is capped and the subrecipient’s F&As are included in the total direct costs, the subrecipient organization will not include its F&As in the budget. Once awarded, the prime recipient will share its F&As with the subrecipient proportionately to the awarded direct costs. This will be implemented for all future grants.

Awards

In addition to being the University’s authorized representative for grants, contracts and other agreements from government agencies, private industry, and non-profit foundations and the central point of coordination for sponsored projects, Sponsored Program Services administers grants and contracts on behalf of the University.

Activities include establishing new awards and budgets in the University’s accounting system (KFS) and assisting with pre-award coding requests, approving and processing re-budgets of expenditures, cost transfers, no-cost extensions and preparation of final financial reports.

Awards Management also provides guidance and consultation on issues such as applicable regulations, allowable costs, cost share and match requirements as well as monitor account activity for adherence to terms and conditions of awards and applicable policies and regulations.

All grant management policies at the University are derived from Federal, State and University policies and regulations such as Office of Management and Uniform Grant Guidance.

FCOI Glossary

PLEASE NOTE: 

  • Investigator is defined as “The principal investigator and any other person (regardless of title or position) who is responsible for the design, conduct or reporting of research or educational activities. This may include faculty and research staff (research associates and assistants, postdoctoral fellows, graduate students, visiting scientists engaged in research conducted at the University) as well as consultants.”
See below for additional FCOI terms and definitions:
Any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes.
Any experiment in which a drug is administered or dispensed to, or used, involving one or more human subjects. An experiment here is any use of a drug, except for the use of a marketed drug in the course of medical practice.
Any experiment that involves a test article and one or more human subjects, and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of the chapter, regarding non-clinical laboratory studies.
Any domestic or foreign, public or private, organization (excluding a Federal agency) from which an Investigator (and spouse and dependent children) receives remuneration or in which any person has an ownership or equity interest.
A situation in which significant financial interests in a business, or other personal considerations provided by a business, may compromise, or have the appearance of compromising, an Investigator’s professional judgment in conducting or reporting research, the results of which could affect the aforementioned business, either directly or indirectly. An FCOI exists when the University, through its designated official(s), reasonably determines that an Investigator’s Significant Financial Interest is related to a research project and could directly and significantly affect the design, conduct or reporting of the research.
A living individual about whom an Investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information.
An individual who is, or becomes, a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.
The Investigator’s spouse/domestic partner and dependent children.
Any domestic or foreign, public or private, entity or organization (excluding a Federal Agency) that is applying for or that receives NIH research funding.
An Investigator’s professional responsibilities on behalf of the University, which include research, teaching, and service as, e.g., outlined in the Policy on Faculty Professional Responsibilities
A product of the intellect that has commercial value, including copyrighted works, patents, business methods, and industrial processes.
The principal investigator and any other person (regardless of title or position) who is responsible for the design, conduct or reporting of research or educational activities. This may include faculty and research staff (research associates and assistants, postdoctoral fellows, graduate students, visiting scientists engaged in research conducted at the University) as well as consultants.
This is the first step for institutions in determining whether a financial conflict of interest exists. A significant financial interest is related to the research if an institution, through its designated official(s), reasonably determines that the significant financial interest could be affected by the funded research, or is in an entity whose financial interest could be affected by the research.
Salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this Policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
An individual company, or any entity which takes responsibility for the initiation, management, and/or financing of a research project, but which does not actually conduct the investigation.

Post-Award Forms

Re-Budgeting Request Form
Used to request that the expenditure budget for a sponsored project account be revised to meet project needs.

 

No-Cost Extension Request Form *Now in Jira*
Used to request extra time to complete work on a sponsored project without additional funds being provided by the sponsor.

 

Cost Transfer Request Form

Used to request that a previously recorded expenditure be moved to or from a sponsored project account.

 

Pre-Award or Advance Account Request Form

Used to request that a KFS account be established prior to the start date of a project or receipt of the award notice.

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

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.

Back to Researcher’s Guide

Pre-Award Or Advance Account Request

  • This field is for validation purposes and should be left unchanged.
  • If you are filling out the form on behalf of someone else, enter your contact information here.
  • Award Information

  • MM slash DD slash YYYY
  • Select your grant manager team. Refer to the list below.
  • Team 1 - K. Jabarkhail, B. Dauphinais, S. Corbin
    Team 2 - M. Niewinski, L. Abell, C. Wells, K. Pfau
    Team 3 - K. Jabarkhail, J. McNeal, D. Ives
    Team 4 - D. Parciasepe, C. Rodgers, S. Parker, A. Sierra
  • Explanation

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  • Drop files here or
    Max. file size: 250 MB.
      If so, please provide documentation to the SPS office.

    Rebudget Request

    Read the Rebudget FAQ Sheet to get help when filling out this form.

    Fields marked with an asterisk (*) are required.

    • This field is for validation purposes and should be left unchanged.
    • Principal Investigator Information

    • Administrative Contact Information

      In case additional information is needed. If you are submitting this form on behalf of the PI, please put your contact information here.
    • Select your grant manager team. Refer to the list below.
    • Team 1 -K. Jabarkhail, B. Dauphinais, S. Corbin
      Team 2 - M. Niewinski, L. Abell, C. Wells, K. Pfau
      Team 3 - K. Jabarkhail, J. McNeal, D. Ives
      Team 4 - D. Parciasepe, C. Rodgers, S. Parker, A. Sierra
      Research Excellence Program / Scholarship Facilitation Fund - Matthew Mroz
    • Transaction Information

    • AmountObject Code FromObject Code To 
    • Explanation

    • Max. file size: 250 MB.

    Cost Transfer Request Form

    Policies, Procedures & Guidance

    Subrecipient Monitoring

    Project Risk Assessment

    Before executing a subrecipient agreement, and every two years thereafter, subrecipient organizations that are not members of the Federal Demonstration Partnership 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 develop 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 (the greater proportion of subaward:prime award, the greater the risk)
    • 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 prime recipients including UConn to report any subawards executed in the previous month that exceed $30,000. As of March 8, 2025, SPS staff use SAM.gov 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 Project Risk Assessment (see above).
    • PIs will monitor the progress of subrecipient work scope on at least 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 the PI identifies a concern with subrecipient performance, 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

    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.