| Name | Title | |
|---|---|---|
| Jen Lamontagne | Assistant Director, Business Integrations and Solutions | jennifer.lamontagne@uconn.edu |
| Paula Engler | Research Reporting Analyst and Research IT Help Desk | paula.engler@uconn.edu |
| Cyndi Guest | Faculty Accruals Specialist | cyndi.guest@uconn.edu |
| Charlie Tuttle | Oracle PL/SQL Developer/DBA and Research IT Help Desk | charlie@uconn.edu |
| Kristin Winot | Functional Analyst/Effort Reporting Specialist | kristin.winot@uconn.edu |
Effective June 1, 2025, the UConn IBC will make approved meeting minutes publicly available, by posting records on this site.
This procedure is pursuant to the provisions outlined in the NIH OSP Memorandum “Implementation Update: Promoting Maximal Transparency Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules” (NIH Notice: NOT-OD-25-082).
In compliance with the NIH Guidelines, the IBC meeting minutes document the committee’s review of experiments that fall within the scope of Section III. Research activities not subject to the NIH Guidelines are not reflected in these records.
IBC Minutes
In accordance with state FOI and the requirements of the NIH Guidelines, only approved IBC minutes will be posted publicly. Records in draft form are not subject to public records requests. Please refer to the NIH OSP FAQs IBC Meetings and Minutes for additional details. The UConn IBC follows current NIH guidance to ensure compliance.
The Institutional Biosafety Committee (IBC) of the University of Connecticut (UConn) is committed to promoting the advancement of research and teaching activities, by ensuring that all experiments involving biological materials are conducted in full compliance with local, state, and federal regulations and guidelines. As required by the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), all institutions that conduct research with recombinant/synthetic nucleic acids (rsNA) and receive NIH funding, must maintain an active IBC. With the cooperative effort of Principal Investigators (PIs), the IBC conducts risk assessments for hazards associated with the use of biological materials, and promotes the safe use of such materials by enhancing lab personnel’s understanding of biosafety practices and procedures, as defined in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) issued by the Centers for Disease Control and Prevention (CDC).
Pursuant to Section IV-B-2 of the NIH Guidelines, the IBC was originally established to review and approve “Experiments Covered by the NIH Guidelines”, as defined under Section III. Compliance with the NIH Guidelines is a requirement for institutions that accept NIH funding and conduct covered experiments. As such, compliance with the Guidelines is a term and condition of funding for all labs at UConn working with rsNA, regardless of funding source.
Due to increased regulations and rapid advancements in life sciences research, the scope of the IBC has evolved over time. IBC approval is required for all biological materials including but not limited to:
The IBC collaborates with Biosafety to ensure compliance with other federal and state regulations, such as Connecticut Department of Public Health (DPH), Centers for Disease Control and Prevention (CDC), Animal Plant Health Inspection Service (APHIS), etc.
If you are interested in joining an exciting committee that oversees biological research at UConn, email ibc@uconn.edu or the IBC Program Director at danielle.delage@uconn.edu.
The IBC must comprise no fewer than five members. At least two members shall not be affiliated with the institution (apart from membership on the IBC). Unaffiliated members represent the interest of the surrounding community with respect to health and protection of the environment.
UConn’s IBC consists of faculty, staff, and unaffiliated community members. All committee members contribute to the professional competency necessary to review the broad scope of research and teaching activities at the University.
Last Revised: 03/03/2025
The Institutional Biosafety Committee (IBC) of the University of Connecticut (UConn) is committed to promoting the advancement of research and teaching activities, by ensuring that all experiments involving biological materials are conducted in full compliance with local, state, and federal regulations and guidelines. As required by the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), all institutions that conduct research with recombinant/synthetic nucleic acids (rsNA) and receive NIH funding, must maintain an active IBC. With the cooperative effort of Principal Investigators (PIs), the IBC conducts risk assessments for hazards associated with the use of biological materials, and promotes the safe use of such materials by enhancing lab personnel’s understanding of biosafety practices and procedures, as defined in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) issued by the Centers for Disease Control and Prevention (CDC).
Pursuant to Section IV-B-2 of the NIH Guidelines, the IBC was originally established to review and approve “Experiments Covered by the NIH Guidelines”, as defined under Section III. Compliance with the NIH Guidelines is a requirement for institutions that accept NIH funding and conduct covered experiments. As such, compliance with the Guidelines is a term and condition of funding for all labs at UConn working with rsNA, regardless of funding source.
Due to increased regulations and rapid advancements in life sciences research, the scope of the IBC has evolved over time. IBC approval is required for all biological materials including but not limited to:
The IBC collaborates with Biosafety to ensure compliance with other federal and state regulations, such as Connecticut Department of Public Health (DPH), Centers for Disease Control and Prevention (CDC), Animal Plant Health Inspection Service (APHIS), etc.
The IBC must comprise no fewer than five members. At least two members shall not be affiliated with the institution (apart from membership on the IBC). Unaffiliated members represent the interest of the surrounding community with respect to health and protection of the environment.
UConn’s IBC consists of faculty, staff, and unaffiliated community members. All committee members contribute to the professional competency necessary to review the broad scope of research and teaching activities at the University.
If you are interested in joining an exciting committee that oversees biological research at UConn, email ibc@uconn.edu or the IBC Program Director at danielle.delage@uconn.edu.
NIH has launched an initiative to update biosafety policies and oversight to address emerging risks from rapidly advancing science and technology. To support this effort, OSP plans to strengthen partnerships with institutional oversight bodies and reinforce the role of IBCs, aligning with other oversight committees such as IRBs and IACUCs.
NIH is requesting feedback from stakeholders (researchers, IBC members, etc.) regarding what they think should be included in a modern biosafety policy. A portal has been established for public comment on this initiative, which is linked below:
While comments submitted through the portal can relate to any aspect of biosafety oversight, NIH is particularly interested in hearing individual opinions regarding:
Be sure to follow University Policy when submitting personal comments.
Disclaimer Example: The opinions expressed are my own and do not reflect the views or positions of the University of Connecticut.
For additional information, please visit the NIH OSP website: https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy#tab2/
Last Revised: 12/16/2025
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 human research study. Please contact the IRB Office if you have any questions or need assistance.
The IRB module of InfoEd was updated on December 16th. For the system to work as intended, most open studies will need to be transitioned to the new application form:
The following studies need to be migrated:
The following projects do not need to be migrated:
When are transition amendments due?
For more information, please see the Study Migration Guide. User Guides are also available on the Human Subjects Module webpage.
The Research Integrity & Compliance (RIC) team invites students and faculty to attend virtual (via Webex) and in-person office hours for assistance with IRB submissions and human subjects research regulations.
RIC staff will be available to answer questions regarding IRB submissions, human subjects regulations, post-approval support, and general IRB guidance.
Office hours schedule:
Location: Whetten Graduate Center, 2nd floor, Room 211
Location: Whetten Graduate Center, Giolas Conference Room, 2nd floor
Location: Whetten Graduate Center, 2nd floor, Room 211
To schedule an in-person or virtual appointment, please follow the link below:
https://nexus.uconn.edu/secure_per/schedule1.php?stser=4475
RIC Education & Training Sessions
The RIC office also offers educational and training sessions for researchers, research teams, and classes on topics, such as informed consent, successful IRB submissions, post-approval research management, category of review, research subject to FDA regulations, and other human subjects research best practices.
For questions about IRB office hours or educational sessions, please contact Joan Levine at joan.levine@uconn.edu.
Subrecipient Information and Compliance Form – To be provided along with subaward proposal documentation (scope of work, detailed budget and budget justification, additional documents required by proposal guidelines) when forwarded to Pre-Award Services (as part of an initial prime application/proposal) or in support of requests to sponsor for post-award addition of subaward/subcontract
Subrecipient Profile Questionnaire – Requested by SPS from subrecipients who are not members of the Federal Demonstration Partnership (FDP) to collect information used during required SPS risk assessment
External Investigator Financial Disclosure Form – Completion required by all responsible personnel from other institutions which do not have a compliant Financial Conflict of Interest policy.
Provides full instructions for initiating a subaward-related Purchase Requisition (for new subawards) or Purchase Order Action (for subaward amendments).
Provides a listing of subaward-related actions corresponding to common prime award activities.
We’re excited to have you join our research community. To ensure compliance with local, state, and federal regulations, all projects involving biological materials at UConn must be reviewed and approved by the Institutional Biosafety Committee (IBC) prior to the start of any research activities.
Getting Started with HuskySMS
Before research can begin, Environmental Health and Safety (EHS) must add your lab to the HuskySMS database; uconn.scishield.com. Once your lab’s dashboard is set up, Principal Investigators (PIs) and lab personnel can log in using your UConn NetID and password and will have access to the following:
Lab Dashboard
- General lab information
- Hazard listings
- Compliance summary
Training Module
- Assign applicable job activities to lab members under the “Members” tab
- Ensures required safety trainings are automatically prompted
Inspections Module
- Tracks lab safety and compliance inspections
Bio Module
- Used for IBC registration review and approval (see below for details)
Complete the IBC Registration (Biological Summary)
All IBC registrations are submitted through the HuskySMS system; uconn.scishield.com. Log in using your UConn NetID and password.
Bio Profile — from lab dashboard, click “Bio” tab
- Summary: Overview of lab projects and biological materials
- Registration Summary: Displays IBC submission status, review history, approval dates, and registration renewal deadlines
IBC Registration — drop-down lab in left nav, click “Bio Summary”
- Initial set up is done using the Biological Registration Wizard which guides you through completing the required forms.
- Upon logging into HuskySMS, prompts to complete the Biological Registration Wizard can be found at the top of your home page. These reminders will continue until submission.
- Complete one Project Form, which depending on the biological materials selected, may prompt additional surveys, tables, or forms (e.g., Pathogen Registration Form, Viral Vector Form).
- Amendments can be submitted by updating applicable sections of the approved bio-summary. Please be sure the registration status is NOT under “IBC Review”. Edits during this stage of review can delay approvals.
- Once complete, certify and submit for IBC review.
Tip: Only one Research Project Form should be completed per bio-summary. If you have multiple projects, list them in the “Description of Experimental and Procedural Details” section (e.g., Project 1: …, Project 2: …). This helps avoid duplicate submissions and streamlines the review process.
Resources
The IBC Guidance Document provides step-by-step instructions for completing your registration. Additional Quick Guides and Job Aids are available on the EHS website.
Timeline
Determining when research can begin depends on the nature of the work being conducted. Once the IBC receives your biological summary, a determination will be made regarding when lab activities may commence.
See Level of Review Required below for additional details.
Level of Review Required
UConn’s IBC review process includes two categories, based on the type of work proposed:
Full Committee Review
Required for projects involving:
- Covered experiments under the NIH Guidelines
- Risk Group 2 (RG2) pathogens
- Biological toxins
Administrative Review by the Biosafety Officer (BSO)
The IBC has delegated authority to the BSO for certain submissions, with notification to the full committee at the next scheduled meeting. These include:
- Projects classified as exempt under NIH Guidelines
- Work that does not involve recombinant or synthetic nucleic acid molecules
Submission Deadlines
To be included for review during the next IBC meeting agenda, please submit your registration by the applicable submission deadline which can be found on the IBC Meeting Dates page.
Questions?
If you have any questions about the HuskySMS Bio Module or the IBC registration process, feel free to contact us at ibc@uconn.edu.
Last Revised: August 15, 2025
Executive Order on Improving the Safety and Security of Biological Research
Questions can be sent to: SciencePolicy@od.nih.gov
USG Policy for Oversight of Dual Use Research of Concern (DURC) & Pathogens with Enhanced Pandemic Potential (PEPP)
Previous implementation date was set to take effective May 6, 2025. The Policy for Oversight of DURC & PEPP (herein referred to as DURC & PEPP Policy) will supersede previous DURC and P3CO Life Science Policies.
Implementation Guidance document contains agent specific details, examples of research within the scope of the policy, and tools to aid in compliance for all involved in life sciences research - PIs, institutions, IREs and federal funding agencies.
NIH issued a notice on January 10, 2025, announcing intentions to implement the DURC & PEPP Policy effective May 6, 2025. NIH stated that they would provide additional details and requirements, including applicable grant and cooperative agreement activity codes, specific implementation timelines, and information regarding implementation for other NIH funding mechanisms, in future Guide Notices. As of May 5, 2025 no additional guidance has been provided.
In the meantime, the UConn IRE is working to develop procedures to best assist PIs with the new requirements.
PI ResponsibilitiesApplicability: New Proposed & Ongoing Research |
|
| Complete
Initial Assessment |
|
| Assessment Results
NOT DURC or PEPP |
|
| Assessment Results
may be DURC or PEPP |
|
 |
|
| Name | Title | Phone | |
|---|---|---|---|
| Danielle Delage, CPBCA | IBC Program Director | 860.486.1838 | danielle.delage@uconn.edu |
| David Cavallaro, MS, RBP, CBSP | Biosafety Officer | 860.486.3180 | david.cavallaro@uconn.edu |
Policy effects the purchase of oligonucleotides and benchtop synthesis equipment. Federally funded PIs must purchase applicable materials from suppliers who screen orders for sequences of concern (SOCs). SOCs are unique to specific pathogens. Applicable materials must be purchased from Providers or Manufacturers that publicly state adherence to the Policy (on website or provide documentation). Labs may be contacted more frequently from vendors in the process of verifying legitimacy; additional documentation may be requested. How granting agencies will monitor adherence to this policy is unclear.
Links below contain additional resources such as fact sheets, templates, and FAQs.
Additional resources and summaries on the new policy can be found below.
PIs must complete initial assessments when research involves modifying pathogens or toxins.
PIs will answer questions in the form to determine if the project may meet the scope of DURC or PEPP oversight requirements. Must be completed at the time of proposal for new research, so the IPR Form can be completed accurately. For ongoing research, assessments can be completed as requested, or any time you would like to assess the work in the lab!
Contact ibc@uconn.edu if you need assistance! We are happy to schedule a time to meet remotely and walk through the form with you.
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UConn Policy on DURC & PEPP
Risk-Benefit Assessment Template
Risk Mitigation Plan Template
Life sciences research is essential to the scientific advances that underpin improvements in public health and safety, agriculture (including crops and other plants and animals) the environment, materiel, and national security. Despite its value and benefits, certain types of research conducted for legitimate purposes can be utilized for both benevolent and harmful purposes. Such research is called “dual use research”. The current policy defines DURC as a subset of dual use research defined as life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
2014 Institutional DURC Policy
Research involving biological agents and toxins is essential to the scientific advances that improve national and global health and safety. Such research does not come without potential biosafety and biosecurity risks. Work with pathogens and toxins must be carefully considered. Appropriate risk mitigation strategies must be implemented to protect personnel and public health and safety.
Current regulations, policies, and guidelines regarding oversight for such work are as follows:
2017 OSTP Potential Pandemic Pathogen Care and Oversight (P3CO)
Implementation Update: Improving the Safety and Security of Biological Research
Notice Number: NOT-OD-25-112
Key Dates
Release Date: May 7, 2025
Issued by
NATIONAL INSTITUTES OF HEALTH (NIH)
Purpose
The purpose of this notice is to inform the biomedical research community of the following immediate actions NIH is taking in response to the May 5, 2025, Executive Order on Improving the Safety and Security of Biological Research.
Background
NIH continues to emphasize that robust biosafety and biosecurity practices are essential for both promoting and protecting critical, life-saving research. As life sciences research evolves, so must the framework for safeguarding its conduct and results. The May 5, 2025, Executive Order on Improving the Safety and Security of Biological Research takes additional steps to strengthen oversight of research that could or will make a naturally occurring pathogen or toxin more dangerous to American citizens, and directs OSTP and the National Security Advisor to work with federal agencies to revise or replace existing policies overseeing this research. A new policy, to be delivered within 120 days, will replace the proposed DURC/PEPP Policy set to take effect May 6, 2025. Until this new policy is in place, research meeting the definition of dangerous gain-of-function research is to be paused.
For the purposes of this Notice and, as defined in the Executive Order, dangerous gain-of-function research means scientific research on an infectious agent or toxin with the potential to cause disease by enhancing its pathogenicity or increasing its transmissibility. Covered research activities are those that could result in significant societal consequences and that seek or achieve one or more of the following outcomes:
(a) enhancing the harmful consequences of the agent or toxin;
(b) disrupting beneficial immunological response or the effectiveness of an immunization against the agent or toxin;
(c) conferring to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitating their ability to evade detection methodologies;
(d) increasing the stability, transmissibility, or the ability to disseminate the agent or toxin;
(e) altering the host range or tropism of the agent or toxin;
(f) enhancing the susceptibility of a human host population to the agent or toxin; or
(g) generating or reconstituting an eradicated or extinct agent or toxin.
NIH will continue to provide updates regarding implementation of this Executive Order in alignment with the Administration’s guidance, including information on research halts or suspensions. Importantly, an effective and trustworthy oversight system is predicated on an interlocking framework with accountability shared across all partners. NIH encourages all life sciences researchers to assess their research portfolios to ensure we, as a research community, are proactively safeguarding the conduct of biomedical research to fulfill the NIH mission.
Inquiries
Please direct all inquiries to: NIH Office of Science Policy, SciencePolicy@od.nih.gov
On May 5, 2025, President Trump issued an Executive Order on Improving the Safety and Security of Biological Research, which pauses dangerous research that could or will make a naturally occurring pathogen or toxin more dangerous to American citizens, and directs the Director of the Office of Science and Technology Policy (OSTP) and the National Security Advisor to work with funding agencies to develop such a policy within 120 days. This new Policy is intended to replace the 2024 United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC/PEPP Policy) and supersedes its implementation at NIH previously set to take effect today.
NIH will work closely with OSTP and our federal partners to ensure the safe and secure conduct of biological research. NIH will also provide more guidance regarding implementation of this Executive Order in the coming weeks.
Questions may be sent to SciencePolicy@od.nih.gov.
Updated UConn Policy on Life Sciences Research of Concern
Fact Sheet
Workflows
Templates
The Research Integrity & Compliance (RIC) team invites students and faculty to attend virtual (via Webex) and in-person office hours for assistance with IRB submissions and human subjects research regulations.
RIC staff will be available to answer questions regarding IRB submissions, human subjects regulations, post-approval support, and general IRB guidance.
Office hours schedule:
Monday, January 27, 2025: 10:00am – 1:00pm (Virtual via Webex).
Wednesday, January 29, 2025: 1:00pm – 4:00pm (In Person)
Location: Whetten Graduate Center, Giolas Conference Room, 2nd floor
To schedule an in-person or virtual appointment, please follow the link below:
https://nexus.uconn.edu/secure_per/schedule1.php?stser=4475
RIC Education & Training Sessions
The RIC office also offers educational and training sessions for researchers, research teams, and classes on topics, such as informed consent, successful IRB submissions, post-approval research management, category of review, research subject to FDA regulations, and other human subjects research best practices.
For questions about IRB office hours or educational sessions, please contact Joan Levine at joan.levine@uconn.edu.
The InfoEd Human Subjects module supports the submission and review of human subjects research protocols and related activities.
Major updates to the Human Subjects Module were implemented on December 16, 2024. The User Guides below apply to the updated application form and procedures. The How To Materials apply to those who are still working with the old forms and procedures.
Most active studies will need to be migrated to the new form for the system to work as intended. Information and instructions, including important deadlines, are available in the Study Migration GuideUPDATED 09-05-2025.
USER GUIDES – NEW
HOW TO MATERIALS – OLD
For technical issues with InfoEd, please email era-support@UConn.edu.
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