DRAFT

The OCTR office supports investigators, research staff, and sponsors by providing expert guidance through the complexities of clinical trial budgets, contract negotiations, and financial compliance at UConn Health.

Our Mission

We ensure that all clinical research conducted at UConn Health complies with federal and state regulations as well as institutional policies — while helping researchers move their studies forward efficiently and responsibly.

What We Do

Our team partners with researchers to provide:

Budget Development & Management

• Build detailed Budget Workbooks for each study to compile an internal study cost estimate.
• Collaborate with PIs to create viable budgets for all clinical trials opened at UConn Health that accrue that accrues John Dempsey Hospital (JDH) and/or UConn Medical Group (UMG) and/or dental charges.
• Establish and reconcile Banner research accounts

Contract Negotiation

• Industry-sponsored and investigator-initiated trials
• University-to-university agreements
• Cooperative group and foundation-supported trials

Financial Compliance & Oversight

• Audit ongoing clinical trials for compliance with institutional, state, and federal requirements

Connect with Us

The Human Research Protection (HRP) Education & Outreach (E&O) program is a unified cross-campus initiative to provide education and outreach to all who are involved in research involving human subjects. Our mission is to equip researchers with the knowledge and tools needed to navigate the regulatory landscape of human subjects research.

Through proactive engagement, the program aims to support researchers and promote ethical practices that enhance understanding of human subjects protections across the university community.

The HRP Education & Outreach program goals are to:

• Inform the research community about the latest developments in human subjects protection, including news, guidance, and regulatory updates.
• Educate researchers, IRB members, and IRB staff through tailored outreach and ongoing learning opportunities.
• Support investigators through compliance reviews, self-monitoring tools, and personalized assistance to promote high-quality, ethically sound research.

By offering these resources, we seek to reduce compliance burdens and foster a culture of collaboration and integrity in research involving human participants.

Contact Us

We are here to support your research. Reach out to ask questions, request a consultation, or share feedback.

Email: hrp-education@uconn.edu

Team Contacts:

• Joan Levine, MPH, CIP – Team Lead
• Rebecca Burke, MS
• Ellen Ciesielski

Human Research Protection Compliance Monitoring Program

Human subjects research at UConn and UConn Health is monitored by the HRP Education & Outreach program. The goal of the monitoring program is to assess compliance of human subjects research with federal, state, local law, and UConn policies, identifying areas for improvement, and providing recommendations and support based on best practices, current policies and the principles set forth in the Belmont Report. More information about the monitoring program can be found in our policies and standard operating procedures.

All active studies are subject to such reviews, including exempt research or studies where a reliance agreement is in place with another institution.

Studies may be randomly selected for a compliance review or chosen for other reasons as described in the applicable policies and procedures. Categories of compliance reviews include routine, informed consent, for-cause, IRB-directed, and investigator-initiated.

A detailed report summarizing the review findings, required actions, and recommendations will be sent to the researcher. Additionally, findings from the review may be shared with individuals responsible for research oversight to reinforce compliance with policies and regulatory requirements. Findings from these reviews help inform and shape future educational offerings.

Related Policies & Procedures:

• UConn Health HSPP Monitoring of IRB Approved Studies Policy 2009-005.0
• UConn HRPP Standard Operating Procedures

The Institutional Review Entity (IRE) is established by the research institution to fulfill oversight responsibilities as outlined in USG DURC-PEPP Policy and the USG Implementation Guidance for identification, review, and oversight of life sciences research that is within Category 1 and Category 2 as defined by that policy.

On May 5, 2025, a new Executive Order (EO) was issued calling for modifications to the 2024 United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (often referred to as the “USG DURC-PEPP Policy”).

As the institution awaits additional guidance on how the provisions outlined in the May 5, 2025, EO may impact future research operations, researchers should continue to adhere to all applicable rules, regulations, and processes under the purview of UCH IRE, including all expectations set forth by the current USG-DURC-PEPP Policy (outlined in greater detail below).

UCH implements these federal oversight requirements through the UCH Life Sciences Research of Concern Policy, which outlines institutional responsibilities, investigator expectations, review procedures, and risk mitigation requirements for research falling within the scope of the USG DURC-PEPP Policy.

About the USG DURC-PEPP Policy

At UCH, the USG DURC-PEPP Policy applies to all research, regardless of funding source, which meets the criteria for DURC-PEPP research. Federal sponsors may delay the release of funds if a project identified as DURC-PEPP research does not fulfill all requirements for compliance with the USG DURC-PEPP Policy. This includes research funded or sponsored by federal grants, contracts, cooperative agreements, and other agreements. The United States Government  USG DURC-PEPP Policy supersedes previous DURC policies and the 2017 Enhanced Potential Pandemic Pathogens Framework (P3CO). The USG DURC-PEPP Policy does not supersede, but complements, other existing federal regulations, including the Select Agent Regulations.

All UCH Principal Investigators (PIs) proposing or conducting research involving biological agents and toxins must assess whether or not their research potentially falls under the USG DURC-PEPP Policy.  Specifically, PIs proposing to work with or generate any replication-competent infectious agent or proposing to work with a toxin of any amount from the Federal Select Agents and Toxins list must make an assessment of whether the research is reasonably anticipated to be within the scope of Category 1 or Category 2 research. If DURC-PEPP research is identified, the PI must work with the UCH Institutional Review Entity (IRE) (ibc@uchc.edu) to develop a risk-benefit assessment and risk mitigation plan that the funding agency must approve before the work can begin.

 

Categories of Research

 

Category 1 Research

 

Scope: Involves biological agents or toxins from a pre-determined list, which includes over 80 specific agents and toxins (including all select agents and toxins + all RG4 and many/most RG3 agents). These include Bacillus cereus Biovar anthracis, Botulinum neurotoxins, Coxiella burnetii, Ebola virus, Francisella tularensis, SARS-CoV, and others.

 

Experimental Outcomes: The research is reasonably anticipated to result in, or does result in, one or more of the following nine outcomes:

 

Increase transmissibility of a pathogen within or between host species.

Increase the virulence of a pathogen or convey virulence to a non-pathogen.

Increase the toxicity of a known toxin or produce a novel toxin.

Increase the stability of a pathogen or toxin in the environment or increase its ability to disseminate.

Alter the host range or tropism of a pathogen or toxin.

Decrease the ability to detect a human or veterinary pathogen or toxin using standard diagnostic or analytical methods.

Increase resistance of a pathogen or toxin to clinical or veterinary prophylactic or therapeutic interventions.

Alter a human or veterinary pathogen or toxin to disrupt the effectiveness of preexisting immunity via immunization or natural infection.

9.Enhance the susceptibility of a host population to a pathogen or toxin.

 

Category 2 Research

 

Scope: Involves a Pathogen with Pandemic Potential (PPP) or a Pathogen with Enhanced Pandemic Potential (PEPP). These include pathogens like H5N1 influenza virus, SARS-CoV-2, and MERS-CoV.

 

Experimental Outcomes: The research is reasonably anticipated to result in, or does result in, one or more of the following four outcomes:

Enhance transmissibility of the pathogen in humans.

Enhance the virulence of the pathogen in humans.

Enhance the immune evasion of the pathogen in humans by modifying it to disrupt pre-existing immunity via immunization or natural infection.

Generate, use, reconstitute, or transfer an eradicated or extinct PPP or a previously identified PEPP.

 

Responsibilities

 

Researchers/PIs:

Conduct initial and ongoing self-assessments of research associated with the agents that fall under the DURC policy.

Collaborate with the IRE on risk-benefit analyses.

Draft and implement Risk Mitigation Plans (RMPs) in coordination with the IRE when research is classified as Category 1 or 2.

Ensure ongoing compliance with approved RMPs for Category 1 or 2 research.

 

Institutional Oversight:

Establish and maintain internal policies/procedures for DURC and PEPP oversight.

Maintain records of assessments, RMPs, and compliance activities.

Assess research with agents that fall under the new DURC policy to determine if research falls under Category 1 or 2.

Submit required reports to federal agencies.

Provide education and training to researchers and staff involved in high-risk research.

 

Appendix: Category 1 Agents and Toxins List:

HHS Select Agents and Toxins 

 

Abrin

Bacillus cereus Biovar anthracis 

Botulinum neurotoxins

Botulinum neurotoxin producing species of Clostridium 

Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7)

Coxiella burnetii

Crimean-Congo haemorrhagic fever virus

Diacetoxyscirpenol

Eastern Equine Encephalitis virus

Ebola virus

Francisella tularensis

Lassa fever virus

Lujo virus

Marburg virus

Mpox virus

Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments (Reconstructed 1918 Influenza virus)

Ricin

Rickettsia prowazekii

SARS-associated coronavirus (SARS-CoV)

SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors

Saxitoxin

 

South American Haemorrhagic Fever viruses: 

 

Chapare

Guanarito

Junín

Machupo

Sabia

Staphylococcal enterotoxins (subtypes A,B,C,D,E)

T-2 toxin

Tetrodotoxin

 

Tick-borne encephalitis complex (flavi) viruses:

 

Far Eastern subtype

Siberian subtype

Kyasanur Forest disease virus

Omsk hemorrhagic fever virus

Variola major virus (Smallpox virus)

Variola minor virus (Alastrim)

Yersinia pestis

 

Overlap Select Agents and Toxins 

 

Bacillus anthracis

Bacillus anthracis Pasteur strain

Brucella abortus

Brucella melitensis

Brucella suis

Burkholderia mallei

Burkholderia pseudomallei

Hendra virus

Nipah virus

Rift Valley fever virus

Venezuelan equine encephalitis virus

 

USDA Veterinary Services (VS) Select Agents and Toxins 

 

African horse sickness virus

African swine fever virus

Avian influenza virus

Classical swine fever virus

Foot-and-mouth disease virus

Goat pox virus

Lumpy skin disease virus

Mycoplasma capricolum 

Mycoplasma mycoides

Newcastle disease virus

Peste des petits ruminants virus

Rinderpest virus

Sheep pox virus

Swine vesicular disease virus

 

USDA Plant Protection And Quarantine (PPQ) Select Agents and Toxins 

 

Coniothyrium glycines (formerly Phoma glycinicola and Pyrenochaeta glycines)

Peronosclerospora philippinensis (Peronosclerospora sacchari)

Ralstonia solanacearum

Rathayibacter toxicus

Sclerophthora rayssiae

Synchytrium endobioticum

Xanthomonas oryzae

 

For biological agents affecting humans that have not been assigned a Risk Group in the NIH Guidelines, agents affecting humans that are recommended to be handled at BSL3 or BSL4 per the BMBL guidance are subject to the USG DURC-PEPP Policy

 

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), Appendix B, Risk Group 4 and subset of Risk Group 3 

 

Risk Group 4 (RG4) – Viral Agents 

 

Arenaviruses

Guanarito virus

Lassa virus

Junin virus (except the candid #1 vaccine strain listed in Appendix B-II-D Risk Group2 (RG2) – Viruses)

Machupo virus

Sabia

Bunyaviruses (Nairovirus)

Crimean-Congo hemorrhagic fever virus

Filoviruses

Ebola viruses

Marburg viruses

Flaviruses – Group B Arboviruses

Tick-borne encephalitis virus complex including Absetterov, Central European encephalitis, Hanzalova, Hypr, Kumlinge, Kyasanur Forest disease, Omsk hemorrhagic fever, and Russian spring-summer encephalitis viruses

Herpesviruses (alpha)

Herpesvirus simiae (Herpes B or Monkey B virus)

 

Paramyxoviruses

Equine Morbillivirus (Hendra virus)

Hemorrhagic fever viruses as yet undefined

 

Risk Group 3 (RG3) – Bacterial Agents Including Rickettsia* 

 

Bartonella

Brucella including B. abortus, B. canis, B. suis

Burkholderia (Pseudomonas) mallei, B. pseudomallei

Coxiella burnetii (except the Phase II, Nine Mile strain listed in Appendix B-II-A, Risk Group 2 (RG2) – Bacterial Agents Including Chlamydia)

Francisella tularensis (except those strains listed in Appendix B-II-A, Risk Group 2 (RG2) – Bacterial Agents Including Chlamydia)

Orientia tsutsugamushi (was R. tsutsugamushi)

Pasteurella multocida type B -“buffalo” and other virulent strains

Rickettsia akari, R. australis, R. canada, R. conorii, R. prowazekii, R. rickettsii, R. siberica, R. typhi (R. mooseri)

Yersinia pestis (except those strains listed in Appendix B-II-A, Risk Group 2 (RG2) – Bacterial Agents Including Chlamydia)

 

Risk Group 3 (RG3) – Viruses and Prions* 

 

Alphaviruses (Togaviruses) – Group A Arboviruses

Chikungunya virus (except the vaccine strain 181/25 listed in Appendix B-II-D Risk Group2 (RG2) – Viruses)

Semliki Forest virus

Venezuelan equine encephalomyelitis virus (except the vaccine strains TC-83 and V3526, see Appendix-II-D (RG2) – Viruses)

Other viruses as listed in the reference source (see Section V-C, Footnotes and References of Sections I through IV)

Arenaviruses

Flexal

Lymphocytic choriomeningitis virus (LCM) (neurotropic strains)

Bunyaviruses

Hantaviruses including Hantaan virus

Rift Valley fever virus

Coronaviruses

SARS-associated coronavirus (SARS-CoV)

Middle East respiratory syndrome coronavirus (MERS-CoV)

Flaviviruses- Group B Arboviruses

Japanese encephalitis virus (except those strains listed in Appendix B-II-D Risk Group2 (RG2) – Viruses)

Yellow fever virus

Other viruses as listed in the reference source (see Section V-C, Footnotes and References of Sections I through IV)

Orthomyxoviruses

Influenza viruses 1918-1919 H1N1 (1918 H1N1), human H2N2 (1957-1968), and highly pathogenic avian influenza H5N1 strains within the Goose/Guangdong/96-like H5 lineage (HPAI H5N1).

Poxviruses

Monkeypox virus (Clade I & Clade II containing nucleic acids coding for clade I MPVX virus virulence factors)

Prions

Transmissible spongiform encephalopathies (TSE) agents (Creutzfeldt-Jacob disease and kuru agents)(see Section V-C, Footnotes and References of Sections I through IV, for containment instruction)

 

EXCLUDED RG3 Agents: 

 

Human immunodeficiency virus (HIV) types 1 and 2

Human T cell lymphotropic virus (HTLV) types 1 and 2

Simian immunodeficiency virus (SIV)

Mycobacterium tuberculosis, Mycobacterium bovis

Clade II of MPVX viruses unless containing nucleic acids coding for clade I MPVX virus virulence factors

Vesicular stomatitis virus

Coccidioides immitis (sporulating cultures; contaminated soil)

Histoplasma capsulatum, H. capsulatum var. duboisii

Sponsored Program Services (SPS) is developing a comprehensive compliance program. As the program develops, opportunities will be listed on the links available on the sidebar.

Purpose

In order to comply with federal regulations (USDA and PHS) and the Guide for the Care and Use of Laboratory Animals, UConn Health’s IACUC has established a policy on euthanasia of sick animals by CCM veterinary staff.

Action

1. When sick animals are found by animal caretakers (ACT), a sick report is written up and an email is sent to the PI and/or contact individual identified on cage cards.
2. The CCM Veterinary Services is also cc’d on the e-mail correspondence for their evaluation.
3. If the animal is displaying signs of humane endpoints as identified in the animal care and use protocol or has a Body Condition Score (BCS) of 2 or less, veterinary staff will send an email to the PI and/or contact individual with recommendation of euthanasia. This may or may not be after consultation with the Attending Veterinarian.  If the recommendation is for euthanasia of the animals, the email will include a due date and time for corrective action to the research staff. The PI must respond by email within 24 hours.  If no response is received, this will be interpreted as consent by the PI to the medical opinion of the veterinary staff as to the disposition of the animal.  The PI will be charged accordingly.
4. If the veterinary staff identify the same animal during their routine veterinary clinical rounds, they will euthanize the animal and report it to PI and the IACUC.
5. If the animal is moribund or in severe distress, the Veterinary Services can euthanize the animal immediately and notify the PI/research staff. If the animals are under Death as an Endpoint or EAE studies, they should be posted in the room or identified at cage level to avoid confusion.

Effective Dates: January 31, 2025 through December 31, 2027

This policy has been approved by a majority vote of the UConn Health IACUC

Statement of Compliance

The University of Connecticut (UConn) Health Center Institutional Review Boards (UConn Health IRBs) are organized and operate in accordance with applicable laws, regulations, and guidelines in the United States including, but not limited to, U.S. Food and Drug Administration (FDA) 21 CFR Parts 50 and 56, U.S. Department of Health and Human Services regulations 45 CFR Part 46,  International Conference on Harmonisation (ICH) Good Clinical Practice (GCP), and the Belmont Report. Where appropriate, UConn Health IRBs comply with additional regulations and guidelines as required in specific research jurisdictions.

UConn Health IRBs are registered with FDA and OHRP and UConn Health Federalwide Assurance (FWA) is approved by OHRP:

• UConn Health IRB Panel 1 Registration #: IRB00000451
• UConn Health IRB Panel 2 Registration #: IRB00000452
• IRB Organization (IORG) #: IORG0000266
• FWA#: 00006064

The UConn Health Human Subjects Protection Program has been fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) since 2006.

The primary responsibility of UConn Health IRBs is to ensure that the rights and welfare of the human subjects who participate in research studies are protected.

Download the Compliance Statement

Federalwide Assurance

FWA#00006064, Expiration Date: July 7, 2031

Terms of the FWA

IRB Panel Information

• IRB Rosters
  • Panel 1
  • Panel 2

IRB Registration Numbers

• UConn Health IRB Panel 1 Registration #: IRB00000451
• UConn Health IRB Panel 2 Registration #: IRB00000452

IRB Review Fees

• IRB Fee Schedule

QUICK TAKES

 

Welcome to the IACUC “Quick Takes” training page.  These short (generally less than 5 minutes) videos are full of information for you as you work with laboratory animals here at UConn Health.  This will be a library of videos – we will upload videos as we go along.

If you have an item you’d like to see as a Quick Take, or maybe you’d like to star in one, please email the IACUC office with your suggestion.

 

Quick Takes
Welcome to Quick Takes from the IACUC Chair [featuring Dr. Stephen Crocker]  (1:05)
An Animal Bit/Scratched Me – What Do I Do? [featuring Dr. Tim LeDean, Maria Clement, and Hunter Panier] (7:26)
Animal Safety Protocols (Biohazard, Chemical Hazard, or Combination)
Animal Protocols, Animal Safety Protocols, and IBC Registrations – a Primer  (5:36)
Classification of Modifications of Protocols [featuring Mike Michaud] (3:57)
Classification of Surgical and Non-Surgical Procedures  (4:22)
CMGM services  (16:15)
CO2 Euthanasia of Laboratory Rodents (5:26)
Compassion Fatigue [featuring Dr. Jonathan Pohl and Richard Pohl] (13:04)
Continuing Problems – They Keep Popping Up (9:52)
Death as an Endpoint  (3:25)
Expired Drug Training- 2026 update (10:04)
Drug Mixtures [featuring Carson Karanian and Crystol Vicente] (3:45)
Housing Animals in Containment Rooms – What You Need to Know  – COMING SOON
Obtaining Research Controlled Substance Licenses [featuring Steve Jacobs] (3:20)
PAWS Review Notification – Am I In trouble?
Reporting Animal Welfare Concerns [featuring Dan Sasso] (4:19)
Reporting Unexpected Morbidity and/or Mortality [featuring Morgan LeDoyt]  (4:39)
Sick Reports – What do I do?
Transportation of Laboratory Animals to PI Laboratories [featuring Robert Gottlieb] (3:07)
Use of Photography [featuring Joanne Walker]  (8:05)
What Information Can You Find on the IACUC website?
What Information is Required on Cage Cards? [featuring Angela Thompson] (3:43)
3R Search for Alternatives [featuring Marissa Iverson and Ryan Beach] (12:47)
REUNITED SERIES
RRIT, RRCF, RNRIT – What are all of these forms? [featuring Drs. Jenna Bartley and Ron Wallace] (7:34)
Veterinary Consultation – What is required? [featuring Dr. Ramaswamy Chidambaram] (2:28)
EVENTS
LAB FAMILY FEUD, JANUARY 28, 2025
CONVERSATIONS WITH CCM, MARCH 18, 2025
CONVERSATIONS WITH THE IACUC, JUNE 10, 2025
CONVERSATIONS WITH THE CMGM, SEPTEMBER 9, 2025
JEOPARDY, OCTOBER 28, 2025
INFOED TRAINING SERIES
Overview
Section 1
Section 2
Section 3
Section 4
Section 5
Section 6
Section 7
Section 8
Section 9
Section 10
Section 11
Section 12
Section 13
Section 14
Modification
How to submit
	How to respond to review
Delegates