uconn
Roles & Responsibilities
CURRENTLY UNDER REVISION
UConn and IBC
As a condition for NIH funding of recombinant or synthetic nucleic acid molecule research, institutions shall ensure that such research conducted at or sponsored by the institution, irrespective of the source of funding, shall comply with the NIH Guidelines.
Information concerning noncompliance with the NIH Guidelines may be brought forward by any person. It should be delivered to both NIH OSP and the relevant institution. The institution, generally through the Institutional Biosafety Committee, shall take appropriate action. The institution shall forward a complete report of the incident recommending any further action to the Office of Science Policy, National Institutes of Health, preferably by e-mail to: NIHGuidelines@od.nih.gov; additional contact information is also available within the Guidelines and on the OSP website (www.osp.od.nih.gov).
In cases where NIH proposes to suspend, limit, or terminate financial assistance because of noncompliance with the NIH Guidelines, applicable DHHS and Public Health Service procedures shall govern. All NIH-funded or non-NIH funded projects involving recombinant or synthetic nucleic acid molecules must comply with the NIH Guidelines.
Non-compliance may result in: (i) suspension, limitation, or termination of financial assistance for the noncompliant NIH-funded research project and of NIH funds for other recombinant or synthetic nucleic acid molecule research at the institution, or (ii) a requirement for prior NIH approval of any or all recombinant or synthetic nucleic acid molecule projects at the institution.
Principal Investigators (PIs)
Institutional Biosafety Committee
Mission Statement:
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).
Overview:
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:
- recombinant or synthetic nucleic acid molecules (rsNA),
- bacteria, their phages and plasmids,
- viruses and viral vectors,
- biological toxins,
- fungi, prions and parasites,
- human and animal cells, blood, tissues, body fluids, etc.,
- transgenic and wild type animals, plants, and
- animal remains and insects that may harbor zoonotic pathogens.
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.
Committee Membership:
The IBC is actively recruiting new committee members!
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
Institutional Biosafety Committee
Mission Statement:
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).
Overview:
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:
- recombinant or synthetic nucleic acid molecules (rsNA),
- bacteria, their phages and plasmids,
- viruses and viral vectors,
- biological toxins,
- fungi, prions and parasites,
- human and animal cells, blood, tissues, body fluids, etc.,
- transgenic and wild type animals, plants, and
- animal remains and insects that may harbor zoonotic pathogens.
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.
Committee Membership:
The IBC is actively recruiting new committee members!
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
IBC Submission, Forms, & Templates
IBC Submissions – Biological Summary
UConn uses HuskySMS, an electronic management system, to review and approve IBC registrations and amendments. EHS must add new labs to the HuskySMS database. Once EHS sets up the lab’s dashboard, PIs and personnel will have access to the “Bio”, “Inspections”, and “Training” modules.
Log into HuskySMS with your UConn NetID and password.
IBC Registrations: Researchers must complete the Biological Summary within the “Bio” module, to register research or teaching activities that involve biological materials.
IBC Amendments: Once a lab’s registration is active, amendments can be completed with HuskySMS as well. Simply review and revise applicable sections of the bio-summary, and ensure the PI certifies and submits changes within the system.
Please feel free to reach out to ibc@uconn.edu with any questions regarding the HuskySMS Bio module.
Additional IBC Forms:
To report incidents involving biological materials, please download and complete the Incident Reporting Form linked below. Examples of incidents that should be reported include: needlesticks, percutaneous or mucous membrane exposures, spills outside of primary containment, etc.
Biological Incident Reporting Form
Templates:
Lab Specific Biosafety Manual (LSBM)
Due to state and federal regulations, LSBMs are required for all BSL-2 laboratories. Regulators such as CT DPH and NIH, will inspect to ensure BSL-2 labs LSBMs are available and accessible. Lab members must review the LSBM on an annual basis. Training dates can be handwritten on the form, or lab member training records can printed from HuskySMS and added to the binder.
Biosafety will provide template LSBM binders as needed. If you would like to schedule a time for an LSBM binder to be delivered to your lab prior to the Biosafety Audit, please send an email request to ibc@uconn.edu.
PIs are responsible for including laboratory specific information within the LSBM, to ensure the manual is specific to the biohazards in the lab. This may include, but is not limited to: Standard Operating Procedures (SOPs), agent specific Pathogen Safety Data Sheets, Bloodborne Pathogens fact sheets, etc.
Below, links can be found to pathogen risk assessments for some of the more common biohazards fat UConn. Feel free to incorporate them into your LSBM if applicable, or use them as a guide to create your own.
- Pathogen Risk Assessment- Human Cell Lines.pdf
- Pathogen Risk Assessment- Listeria monocytogenes.pdf
- Pathogen Risk Assessment- Lentivirus and Lentiviral Vectors.pdf
- Pathogen Risk Assessment- Staphylococcus aureus.pdf
- Pathogen Risk Assessment- Streptococcal sp..pdf
Last Revised: 02/28/2025
Guidelines – Stop Work Orders
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 human research study. Please contact the IRB Office if you have any questions or need assistance.
UConn Quantum Technologies Translation Award (QuTech) Program
Reminder: Transition Amendments for UConn IRB
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:
- Open studies that received approval or exemption determination from UConn Storrs IRB prior to the system updates (December 16, 2024);
- Open studies that were approved by an external, non-UConn IRB, that have a record in InfoEd.
The following projects do not need to be migrated:
- Research studies that are closed;
- Determinations that a project is not research or projects that are determined not to involve human subjects (aka NHSR determinations);
- Projects for which data collection is complete, and the only remaining activities are data analysis;
- Projects that can be closed because they no longer involve human subjects.
When are transition amendments due?
- Projects that require continuing review with the continuing review application submitted after March 16, 2025 must have been migrated to the new form via a transition amendment prior to the continuation.
- Effective March 16, 2025, projects that do not require continuing review must be updated via a transition amendment the next time a submission to the IRB is needed.
For more information, please see the Study Migration Guide. User Guides are also available on the Human Subjects Module webpage.
Register for IRB Office Hours – Human Subjects Research Support
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:
- Wednesday February 26, 2025: 10:00am – 1:00pm (In Person)
Location: Whetten Graduate Center, 2nd floor, Room 211
- Tuesday March 4, 2025: 1:00pm – 4:00pm (Virtual via Webex)
- Monday March 24, 2025: 10:00am – 1:00pm (In Person)
Location: Whetten Graduate Center, Giolas Conference Room, 2nd floor
- Wednesday April 9, 2025: 3:30pm – 6:30pm (Virtual via Webex)
- Tuesday April 22, 2025: 10:00am – 1:00pm (In Person)
Location: Whetten Graduate Center, 2nd floor, Room 211
- Wednesday May 14, 2025: 10:00am – 1:00pm (Virtual via Webex)
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.
Subaward Resources
Forms
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.
Other Resources
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.
New Researchers
Welcome to UConn! To ensure compliance with local, state, and federal regulations, all work with biological materials* at UConn must be reviewed by the IBC, prior to initiation of research.
EHS must add new labs to the HuskySMS database. Once EHS sets up the lab’s dashboard, PIs and personnel will have access to the “Bio”, “Inspections”, and “Training” modules.
- Timing of beginning research depends on the work being conducted in the lab.
- Once the IBC receives the biological summary, a determination can be made as to when lab activities can begin.
All IBC registrations are completed within the HuskySMS database, where you can log in using your UConn NetID and password. The IBC guidance document will assist you in getting your IBC registration setup. Additional HuskySMS Quick Guides and Job Aides are also available on the EHS website.
Only one Research Project Form should be completed in the bio-summary. Multiple projects can be included in the “Description of Experimental and Procedural Details” section (e.g. Project 1:…, Project 2:…). This will help to ensure surveys and forms are only completed once.
At UConn, we have two categories of review and approval processes, depending on the nature of the work planned. Submissions that require full committee review include projects that fall under covered experiments per the NIH Guidelines, or those that include RG2 pathogens or biological toxins.
The IBC has delegated authority to the BSO to approve administrative matters with notification to the full committee during the next regularly scheduled meeting. Examples include but are not limited to projects that are classified as exempt under the NIH Guidelines and those that do not include recombinant/synthetic nucleic acid molecules. Additional details regarding review and approval process can be found here.
Please complete the registration process, by the applicable submission deadline listed on our website, so the IBC can include the registration on the next meeting agenda.
Feel free to reach out to ibc@uconn.edu with any questions regarding the HuskySMS Bio module.
Last Revised: 03/01/2025
IRE – DURC & PEPP
IRB Office Hours
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.
Human Subjects Module
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 Guide.
USER GUIDES – NEW
HOW TO MATERIALS – OLD
- Show or list my existing human subjects IRB protocol applications.pdf Updated
- Search for an existing human subjects IRB protocol application.pdf Updated
- Create a new re-approval (continuation), amendment, protocol deviation, or adverse events submission for an existing approved human subjects IRB protocol.pdf
- Respond to a human subjects IRB protocol application that requires modifications to secure an approval determination.pdf
- Add institutional forms and upload supporting documents for a human subjects IRB protocol – All Submission Types.pdf
- Review and approve human subject IRB protocol routing submissions.pdf
For technical issues with InfoEd, please email era-support@UConn.edu.
IRB Submissions, Forms & Templates
The InfoEd IRB Module has been updated!
See the InfoEd Updates page for more information. User Guides are also available.
NEW studies with external funding and studies with more than 2 external collaborators/study personnel for which single IRB review (by UConn/BRANY) is being requested are now submitted to BRANY IRB.
Please visit the BRANY IRB tab under IRB Reliance for more information. |
IRB Submission Platform
Applications to the IRB, including requests for review by BRANY IRB, requests for other external IRBs to serve as the reviewing IRB, and Human Subjects Research Determinations and requests are submitted using the Human Subject/IRB Module of the UConn InfoEd eRA Portal at https://www.infoed.uconn.edu. The platform has undergone significant updates, users are strongly encouraged to consult the new User Guides before using the system.
Migration of Existing Studies to the New Application Form
The IRB module of InfoEd was updated on December 16, 2024, The system does not allow for an automatic migration of documents and information from existing InfoEd records. Additionally, the upgraded system includes questions built into the application that were not previously captured electronically. As such, currently approved studies will need to be manually transitioned by the investigator to the upgraded version. Please see the Migration of Study Information guide for details.
Adding Undergraduate Students to InfoEd
Undergraduate students are not auto-populated into InfoEd. Each undergraduate student must be manually added to the system. Click here to add undergraduate students to InfoEd prior to adding these students as personnel on a study. Adding the students before completing the application form will result in less time and effort completing the form as it can take 20 minutes for the student’s name to become available in the system.
Uploading CITI training completion reports to InfoEd
Please follow these instructions for uploading CITI completion reports.docx as part of your IRB protocol submission. Completion reports are only required when (1) adding UConn personnel who completed training elsewhere or (2) adding non-UConn personnel.
Submission Forms
The new IRB application form in InfoEd will ask you to upload certain supplemental forms and materials. Be sure to check this page to ensure that you are using the current versions, most of our forms and materials have been updated or will be updated soon. For assistance with preparing your IRB submissions, contact the IRB Office at irb@uconn.edu to schedule a help session. If you experience technical issues with InfoEd, please contact era-support@uconn.edu.
Human Subjects Research (HSR) Determination
Investigators who are unsure if their proposed activity constitutes “human subjects research” according to federal regulations, may submit a request for a Human Subjects Research (HSR) Determination through InfoEd. Investigators are especially encouraged to submit for a determination when there are plans for dissemination as requests for IRB documentation are increasingly common. Based on the information provided, the IRB Office will determine if the proposed activity meets the regulatory definitions of “human subjects” and “research” and either grant a Not Human Subjects Research (NHSR) letter or advise as to next steps regarding the need to secure formal exemption or approval from the IRB.
This form is also used for 45 CFR 46.118 certifications (aka Approval in Principle, Development Only, Delayed Onset). A grant or contract may require certification of IRB approval as a condition of submitting for or releasing funds but before definitive plans for the involvement of human subjects have been fully developed (e.g., measures or tools need to be developed, animal studies are needed). Refer to 4.1.15.2 in the NIH Grants Policy Statement or the NSF Proposal & Award Policies and Procedures Guide (PAPPG), Chapter II: proposal Preparation Instructions, Section E(5) for information. Note that 45 CFR 46.118 certifications are not limited to proposals submitted to Federal Agencies.
Human Subjects Research (HSR) Determination Form
IRB Reliance Forms
Please see the IRB Reliance pages (IRB Reliance – General, BRANY IRB) for instructions and information about requests for external IRBs to serve as the IRB of record for a study and for requests for the UConn IRB to serve as the IRB of record for other entities (including UConn Health). Requests to cede review to an external IRB, including BRANY IRB, are initiated in InfoEd. Requests for UConn to serve as the IRB of record for other entities are initiated outside of the system using the Request for UConn to Serve as the IRB of Record Form on the IRB Reliance – General webpage.
BRANY IRB template forms are available on the BRANY IRB webpage.
Request for UConn to Serve as the IRB of Record
Protocol Templates
A study protocol must be included with all applications to the IRB for expedited or convened board review. Protocols for exempt studies are optional at this time, but may be requested by the IRB staff when the application alone doesn’t provide sufficient detail.
Ethnographic Protocol Template
Supplemental Forms
Based on study specifics, the IRB Application Form may guide you to upload one or more supplemental forms. A Data Security Assessment Form (DSAF) is required for all exempt, expedited, and convened board submissions.
International Research Supplement
IRB Conflict of Interest (COI) Disclosure Form
Language Translation Certification Form
Request for HIPAA Waiver or Alteration
Sample Demographic Worksheet – for Continuations
Consent/Authorization Templates
Informed Consent Resource for Secondary Research with Data and Biospecimens: https://osp.od.nih.gov/wp-content/uploads/Informed-Consent-Resource-for-Secondary-Research-with-Data-and-Biospecimens.pdf
Consent Checklist for Investigators.docx
For Non-exempt (Expedited, Full Board Review) Studies:
Adult Consent Form Template.docx
Simplified Consent Form Template.docx This template may be used in conjunction with the template for the adult consent form for people with communication disorders. Emily Myers, Ph.D. developed this form for research participants with communication disorders, such as aphasia, and generously provided permission for its use by others. This form or another method may be proposed when enrolling individuals with communication disorders where the process will help facilitate comprehension and enable participants to make informed decisions about research participation.
Parent Permission Form Template.docx (for participants under 18 years old)
Assent Form for Minor Participants.docx (under 18 years old) Federal regulations do not dictate how minor assent is documented. This template is designed to be used with younger children with the content of the Adult Consent or Parent Permission Form used as a guide. The assent process should convey the information noted in the assent template using age-appropriate language. Use of this template is not required; Investigators should develop assent processes and forms that are appropriate for the population that they will enroll. For example, when enrolling teens, it may be more appropriate to have an assent form that is similar to the Adult Consent or Parent Permission Form.
HIPAA Authorization Form Template.docx (A HIPAA Authorization Form is needed in addition to a research consent form when the research includes the access, use, or disclosure of Protected Health Information (PHI) unless a waiver of the requirement for authorization is approved or another exception applies (e.g., use of a Limited Data Set with a Data Use Agreement).
For Exempt/Limited Studies:
Exempt Study Adult Prospective Agreement/Consent Form Template.doc
Exempt Study Parent Prospective Agreement/Permission Form Template.doc (for participants under 18 years old)
Exempt Study Assent Form for Minor Participants.docx (under 18 years old) Federal regulations do not dictate how minor assent is documented. This template is designed to be used with younger children with the content of the Adult Consent or Parent Permission Form used as a guide. The assent process should convey the information noted in the assent template using age-appropriate language. Use of this template is not required; Investigators should develop assent processes and forms that are appropriate for the population that they will enroll. For example, when enrolling teens, it may be more appropriate to have an assent form that is similar to the Adult Consent or Parent Permission Form.
Recruitment Flyer Template
Important! When preparing an announcement for the Daily Digest, Lifeline or similar, please be reminded that online platforms often have character limits that could impact study postings; tag lines and headings should provide information about the study and should not emphasize that subjects are paid for participation. The IRB study number is required on any announcement.