Who is an investigator?
Per the U.S. Public Health Service (PHS) definition, an “investigator” is the principal investigator (PI) and any other person (regardless of title or position) identified by the PI as someone 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.
How has the UConn FCOI policy changed?
UConn’s revised FCOI policy was effective on August 24, 2012 and corresponds with the 2011 Public Health Service revised financial conflict of interest (FCOI) regulations (42 CFR 50). These regulations apply to any institution receiving funds from a PHS entity.
Significant Financial Interest (SFI) – PHS funding:
- With regard to any publicly traded entity, an SFI exists if the value of any remuneration* received from the entity in the twelve months preceding the disclosure and the value of any equity interest* in the entity as of the date of disclosure, when aggregated, exceeds $5,000; or
- With regard to any non-publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s Immediate Family) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities.
*For purposes of this definition, remuneration includes 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
Significant Financial Interest (SFI) – Non-PHS funding:
- An equity interest that when aggregated for the Investigator and the Investigator’s Immediate Family exceeded $5,000 over the last 12 months, and/or is expected to exceed $5,000 in value over the next 12 months as determined through reference to public prices or other reasonable measures of fair market value; or when the Investigator (or the Investigator’s Immediate Family) holds a 5% or greater equity interest (e.g., partnership, ownership, stock, stock option, or other ownership interest) in a single publicly traded entity or holds any equity interest in a non-publicly traded entity; or
- Salary, royalties or other payments not from the University for services (e.g., consulting fees or honoraria) that when aggregated for the Investigator and the Immediate Family over the last 12 months exceeded $5,000 or are expected to exceed $5,000 over the next 12 months.
Investigators governed by FDA regulations would also have a Significant Financial Interest if one or more of the following apply:
- Compensation made to the investigator in which the value of compensation could be affected by the outcome of the study/research project.
- A proprietary interest in the tested product, including but not limited to, a patent, trademark, copyright or licensing agreement.
- Significant payments of other sorts, which are payments that have a cumulative monetary value of $25,000 or more made by the sponsor of a covered study to the investigator or the investigators’ institution to support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for one year following completion of the study.
The term Significant Financial Interest does not include the following types of financial interests:
- Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or
- Income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
- Travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
Appointed by the Vice President for Research, the UConn Financial Conflicts of Interest in Research Committee (FCOIRC) is a faculty committee with responsibility for the identification and management of financial conflicts of interest as relates to the conduct of research at the University. The FCOIRC includes broad representation of the campus community.
All UConn investigators must submit a financial disclosure electronically within the UConn InfoEd External Interests module (https://www.infoed.uconn.edu).
The FCOIRC meets regularly to review financial disclosures, identify financial conflicts of interest (FCOIs) in the conduct of research, and to assign appropriate management or mitigation plans for identified FCOIs.
FCOI training requirements, as specified under federal regulations and UConn policy, will be complete once an investigator has submitted a financial disclosure form within the UConn InfoEd External Interests system.
All PHS-funded and DOE-funded investigators must complete the UConn FCOI training pursuant to PHS regulations 42 CFR 50.604(b)(1-3), DOE Interim COI policy, and institutional policy prior to engaging in PHS or DOE-funded research and at least every four (4) years thereafter as well as under the following circumstances (in the timeframes noted in parentheses):
- When the University’s FCOI policy changes such that investigator requirements are affected (within 60 days).
- When an investigator is new to the University (prior to engaging in PHS or DOE-funded research).
- When the University finds that an investigator is not in compliance with the Policy or a management plan, as applicable.
The Financial Conflict of Interest in Research program supports the UConn (Storrs campus, four regional campuses, the School of Social Work, and the School of Law) research community with understanding and complying with University requirements related to financial conflicts of interest (FCOIs) in research.
Who is an Investigator?
- 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.” *For DOE funded projects, the definition states that the Principal Investigator or any other person, regardless of title or position, who is responsible for the purpose, design, conduct, or reporting of a project.
What are my responsibilities as a UConn investigator?
- Review and be knowledgeable of the UConn policy on financial conflicts of interest in research, including the definition of Significant Financial Interest (SFI) and how it applies to you.
- Promptly and fully disclose all SFIs, including those of a spouse or dependent child, that reasonably relate to your institutional responsibilities; and, if applicable, comply with FCOI management or mitigation plans.
- Submit a financial disclosure within the UConn InfoEd External Interests / FCOI system: https://www.infoed.uconn.edu/
- Annually while engaged in research activities;
- Within 30 days of acquiring or discovering a new SFI;
- At the time of submission of a new research proposal for funding (a new disclosure is required unless a current disclosure has previously been made);
- Prior to expending research funds (a new disclosure is required unless a current disclosure has previously been made).
- Understand that completion and submission of the financial disclosure form also satisfies the FCOI training requirement, as required under federal regulations and UConn policy.
- Investigators, coordinators, and persons obtaining consent must also disclose any project-specific SFIs pursuant to UConn Human Subjects Protection Program Institutional Review Board (IRB) policies.
What other resources are available to help Investigators?
The role of the UConn/UConn Health Stem Cell Research Oversight (SCRO) Committee is to ensure that human embryonic stem cell (hESC) and human induced pluripotent stem cell (hiPSC) research is well-justified and that inappropriate and/or unethical research is not conducted. Its mandate is to provide oversight of ethical issues related to the derivation and research use of human pluripotent stem cell lines at all schools, colleges, campuses, and research arms of the UConn/UConn Health per University policy, regardless of the source of funding. From a legal perspective, the review and approval of human embryonic stem cell research by a SCRO committee or its equivalent is required by the State of Connecticut. At a deeper level, SCRO committees exist to protect both the public interest and the progress of biomedical stem cell research. The ethical mandate of the SCRO Committee is to ensure that appropriate respect is given to the value of human life.
SCRO approval is required prior to any of the following:
- All research involving human embryonic stem cells (hESCs) (SCRO approval is required by the State of Connecticut and University policy.)
- In vitro human induced pluripotent stem cell (hiPSC) research involving the generation of gametes, embryos, or other totipotent cells (SCRO approval is required by University policy.)
- In vivo research involving introduction of human induced pluripotent stem cells (hiPSC) directly into prenatal animals or into the central nervous system of post-natal animals or elsewhere in the animal where cells could potentially enter the central nervous system (SCRO approval is required by University policy.)
- Stem cell research project funded by the State of Connecticut through the Connecticut Bioscience Innovation Fund, including those that do not use human embryonic stem cells (SCRO approval is required by the State of Connecticut.docx.)
- All research involving the development of brain or neural organoids or embryo organoids using hESCs or hiPSCs
- All research involving Very Small Embryonic-Like (VSEL) stem cells
Initial IACUC Training is a requirement for everyone working with live vertebrate animals at the University of Connecticut in accordance with the policies and guidelines set forth in the “Public Health Service Policy on Humane Care and Use of Laboratory Animals” (PHS 1986), the “Guide for the Care and Use of Laboratory Animals” (ILAR 2011), the USDA Animal Welfare Regulations (CFR 1985) and the “Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching.”
Retraining is required for faculty PIs on a triennial basis (once every three years). All other animal users (staff, post-doctoral fellows, graduate students and undergraduates) must complete IACUC retraining on an annual basis.
Initial IACUC Training
The University’s Institutional Animal Care and Use Committee (IACUC) requires that all faculty, staff and students who work with live vertebrate animals attend an initial IACUC training session. This will provide an overview of federal, state and University regulations, policies and procedures as well as general information related to the care and use of animals at the University.
ALL INITIAL IACUC TRAINING IS PROVIDED ONLINE VIA SYNCHRONOUS WEBEX EVENTS. Please navigate through the links provided below to sign up for an IACUC training session. When using the sign-up link, please use the Register link on the associated page. You should receive an “Approval” email after signing up. If you have any questions or concerns regarding sign-up, please contact iacuc@uconn.edu.
Presentation Dates and Times:
Please note: Sessions start promptly. Latecomers risk not receiving credit.
Day |
Time |
Session Name |
Presenter |
Sign-Up Link |
Tuesday, August 12, 2025 |
11:00 AM |
IACUC Initial Training |
Megan Hiller, IACUC Specialist |
WebEx |
Retraining Options
The IACUC requires retraining for all animal users. Within a year (for Faculty who are Principal Investigators, three years) after the initial classroom training session, animal users must complete one of the following retraining options in order to receive approval for continued animal use:
- Completion of an animal subjects web-based exam on the Collaborative Institutional Training Initiative (CITI) Program website (www.citiprogram.org). Please login to the CITI Program site using your Institutional Login credentials (Log In Through My Institution) and selecting University of Connecticut – Storrs & Regional Campuses so that you can enter your UConn NetID username and password to access the CITI Program website. Depending on the course one selects, it may take approximately 1-6 hours to complete. Please note that completion of any of the web-based courses can be spread over a period of time. They do not have to be completed in a single session. Currently, the course modules available include:
- UConn IACUC, A Review
- Working with the IACUC
- Essentials for IACUC Members
- Post-Procedure Care of Mice and Rats in Research
- Working with Amphibians in Research Settings
- Working with Fish in Research Settings
- Working with Mice in Research Settings
- Working with Rats in Research Settings
- Working with Gerbils in Research Settings
- Working with Hamsters in Research Settings
- Working with Guinea Pigs in Research Settings
- Working with Rabbits in Research Settings
- Working with Cats in Research Settings
- Working with Dogs in Research Settings
- Working with Swine in Research Settings
- Working with Non-Human Primates in Research Settings
- Working with Zebrafish (Danio rerio) in Research
- Wildlife Research
- Working with Reptiles in a Research Setting
- Documented attendance at or participation in one of the sessions offered by the Biological Health & Safety section of Environmental Health & Safety. This training is designed for laboratory personnel who work with research animals. Topics include principles/concepts of biosafety, agent classes and safety levels, engineering controls, personal protection equipment, work practices, biological agent use and transport information and biological waste management issues.
- Documented repeat attendance at the in-house classroom session presented by ACS/IACUC. The session lasts approximately 1.5 hrs.
- Documented attendance at any special seminar session that may be specifically offered by Research Compliance Services or Animal Care Services in the future to fulfill this training requirement.
- Documented attendance at a training session offered by a recognized scientific society or organization that addresses animal use in research and/or animal welfare concerns. Please consult with Research Compliance Services in advance to determine whether the session you would like to attend meets this retraining requirement.
The IACUC has members whose backgrounds & experience are relevant to the Committee’s responsibilities, including veterinarians, non-scientists, and scientists representing schools and colleges that use animals, as well as members who are not affiliated with the University in any way other than as a member of the IACUC.
The Institutional Official appoints the IACUC members.
Chair: Randall Walikonis, PhD, randall.walikonis@uconn.edu 860.486.9031
Institutional Official: Michael Centola, MHS, CIP, Associate Vice President for Research Integrity centola@uchc.edu
Interim Attending Veterinarian: Ramaswamy M. Chidambaram, BVSc, MSc, PhD, DACLAM, ramaswamy@uchc.edu
The University of Connecticut/Storrs has an Assurance of Compliance #D16-00077/A3124-01. It was most recently renewed and approved by the Office of Laboratory Welfare (OLAW) effective February 18, 2025 and is valid for a period of four years, expiring on February 28, 2028.
Those affiliated with animal research may access the University of Connecticut/Storrs PHS Assurance by going to this link.
Institutional Animal Care and Use Committee (IACUC) protocols are reviewed once per month; the typical turnaround time from submission to approval is 6-8 weeks. Please allow sufficient time to secure approval when approvals are required to meet funding deadlines.
Protocols must be submitted electronically in Microsoft Word format to iacuc@uconn.edu
Submission Deadline Date |
IACUC Meeting Date |
Tuesday, March 18, 2025 |
Tuesday, April 8, 2025 |
Tuesday, April 1, 2025 |
Tuesday, April 22, 2025 |
Tuesday, April 22, 2025 |
Tuesday, May 13, 2025 |
Tuesday, May 27, 2025 |
Tuesday, June 17, 2025 |
Tuesday, July 1, 2025 |
Tuesday, July 15, 2025 |
Tuesday, July 29, 2025 |
Tuesday, August 19, 2025 |
Federal Stop-Work or Grant Termination Directives
These guidelines are intended to assist investigators who may be at risk for or have received a directive from a federal funding agency to stop, pause, terminate or otherwise prematurely end a research study involving animals. Please contact the IACUC Office promptly if you receive a stop-work directive and/or would like to discuss further.