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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.

 

 

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

The Quantum Technologies Translation Award Program (QuTech), made possible through investments by the Connecticut Office of Innovation (CTNext), supports the derisking of use-inspired innovations centered on quantum and quantum adjacent technologies through Academic / Industry partnerships.  The program provides up to $40,000 to help accelerate the translation of UConn/UCH developed quantum and quantum adjacent technologies / applications for real world impact. QuTech is open to UConn/UCH researchers who have:

  1. Completed research and developed (at minimum) a Proof of Concept,
  2. A use-inspired application with strong market potential and a path for IP protection, and
  3. A partnership with an established quantum-related company or startup (the proposing team cannot have an ownership stake in the partner company).

Funds can be used for:

  1. Supporting students to conduct experiments designed to de-risk the technology for targeted applications,
  2. External validation of the technology and/or its use cases with an industry and/or startup partner, and/or
  3. Use of in-house or external resources critical for de-risking the technology.

Applications will be reviewed by internal and external researchers familiar with quantum technologies and/or associated markets.

Important Dates (all due dates by 12 noon) 

  • 2/24/25 – program opens.
  • 3/31/2025 Full Proposal deadline.  Submissions are made via the Quest Portal
  • Award Notifications are expected in May, 2025

Award details:

  • The OVPR anticipates funding up to up to 4 awards of $40,000.
  • Award periods will be for one year
  • Awards will be funded in two equal payments.  The second payment will be made six months into the award period, pending completion of milestones, submission of a report, and adherence to program guidelines.
  • QuTech awards are intended to support the translation of quantum-related innovations developed within the labs / research groups of UConn/UConn Health faculty members.  Funds cannot be used for
    • a) continuing previous/ongoing commercialization projects,
    • b) costs related to creating/operating start-up companies, or
    • c) development activities that take place within startup companies.
  • Awardees will be connected with commercialization experts from OVPR’s Technology Commercialization and Venture Development group.  Awardees should expect to work closely with TCS to discuss progress/obstacles, undergo commercialization-related training, and to gain access to advice and resources that will enhance the project’s chances for commercial success.  Awardees are required to work with TCS's IP team to protect their innovation (target: provisional patent filing 6 months to 1 year after project launch).

Eligibility / IP & Licensing Requirements:

The QuTech program is available to UConn/UConn Health faculty members, within the following parameters:

  • IP: Projects should have intellectual property at their core. To be eligible, project-related UConn IP must exist and a UConn invention disclosure must be filed prior to applying.  Projects based on IP not developed at UConn are not eligible.
  • Startups and License Options: If a startup related to the QuTech project exists at the time of award, an option agreement must be taken within 6 months of the award.  If a startup company related to the project is formed at any point in the future, an option agreement must be taken within six months of the startup creation.
  • Effort and Salary:
    • The award does not pay for any PI salary or for time spent on the project
    • Although no minimum effort level is required for QuTech projects, a PI/Co-PI must have institutionally-funded research time available during the award period to lead and complete the project.
    • Research Professors / those whose positions are contingent on grant-funding (soft money positions) must include details about their institutionally-funded research time as part of the budget justification to confirm eligibility.
  • UConn Primary Appointment:
    • PIs must be faculty or staff whose primary appointment is at UConn/UConn Health. Awards are available to tenure-track, tenured, Clinical, Research, and in-Residence faculty with Assistant Professor rank or higher.
    • Researchers with primary appointments to CCMC, Jackson Labs, or TIP or other startup companies are not eligible to apply.
    • Individuals who are not eligible to apply as a PI may be able to serve as a collaborator/consultant on an eligible PI’s project.
  • Number of submissions: Eligible faculty may only submit one proposal as lead PI. Investigators may serve as collaborator on multiple projects.

Proposal Submission Instructions:

Elements to include in the full application are as follows:

  1. A one-paragraph abstract (type or copy/paste into a form on Quest).
  2. Project plan document three page maximum, 11-pt font and 1” margins), including
    1. Problem/Unmet need: Describe the problem or unmet need that the innovation will address.
    2. Description of the innovation: Describe the innovation or technology concept.
    3. Estimate Market Size:
      1. Which industries are likely to adopt the technology? Why is this technology important for these industries?
      2. Please describe the total available market this technology addresses (TAM) and how much of the TAM this technology will address.
    4. Competing Products:
      1. Identify any currently available products/technologies and explain why they do not adequately satisfy the problem or unmet need.
      2. Explain how the proposed innovation is different from or better than those that are already available.
    5. Intellectual property (IP): Describe your IP position, and the competitive IP landscape. List your current patent applications or patents pending as well as any granted patents related to this project. If you currently have no patent applications, please mention plans for future invention disclosures.
    6. Commercialization Plan:
      1. Explain how the proposed de-risking activities will allow you to achieve the major milestones required to further develop the technology for market entry.
      2. Describe your plans for funding development of this technology beyond the QuTech grant (through SBIR/STTR, Angel and VC funding, etc).
    7. Preliminary evidence: Summarize any preliminary data available that substantiates the proposed innovation usefulness for the applications envisioned.
    8. Proposed work with project milestones: Outline the proposed scope of work approaches with timelines and a clearly defined set of objective milestones to be completed by the end of the initial award period.  Please include an analysis of how the proposed activities will sufficiently de-risk the innovation to allow for further commercial development.
  3. Biosketches/CVs: Please include brief biosketches/CVs (formatted as appropriate for your field) for all PIs/Co-PIs (No more than 3 pages).  Include your most recent publications or those most relevant to the work proposed.  Also include current/pending support from external sponsors and UConn sources (including start-up funding).  Biosketches/CVs may be uploaded as one PDF or as separate PDF documents.
  4. Budget: Provide a preliminary budget estimate and proposed use of funds. Please see Internal Funding Budget Guidelines for instructions and a budget template.
  5. The budget spreadsheet should be converted to PDF format prior to upload.

              Review Criteria

              Proposals will be scored based on the following criteria:

               

              Market Need—does the innovation address an unmet need and is there evidence that there is a market for the proposed solution?

              • Does the applicant make a strong case that there is a need/problem that needs to be met?
              • Is the science/technology strong enough to evidence its success
              • Does the proposal include data about how much of the market the technology may realistically capture?

               

              Innovation and Novelty—Is the innovation novel and/or does it make a significant improvement over currently-available solutions?

              • Does the proposal make a convincing argument that the innovation is novel and or makes a significant improvement over currently-available solutions?
              • Is there existing or the potential for intellectual property protection?
              • To what degree does the innovation solve the unmet need differently (e.g., better, faster, cheaper) than the current state-of-the art?
              • If novel, is the innovation a disruptive technology, a platform technology, or an incremental improvement over the current state-of-the art?

               

              Commercialization Plan—Is there a realistic path for commercializing the innovation?

              • Does the proposal present a path to bring the innovation forward to market?
              • Does the proposal present plans for future financing of the project, such as SBIR/STTR or industry investment?
              • For future development, will this technology require regulatory approval?  If so, does the proposal address plans for successfully navigating the process?
              • Does the applicant point to any obvious potential licenses / commercial partners for this innovation?

               

              Approach and Feasibility—Are the activities proposed attainable in the proposed timeline and are they consistent with the high scientific/scholarly standards?

              • Does the investigator/team have appropriate expertise and laboratory facilities available to conduct the work?
              • Does the project include the involvement of a UConn core facility or a third party be required to complete the work (e.g prototype development)?  If so, have appropriate commitments been obtained?
              • To what degree will the activities proposed de-risk and advance the development of the innovation?

               

              Postaward Considerations

              QuTech awardees agree to provide regular progress reports to the OVPR during and after the award period. Reports fall into four categories:

              • Consultations with TCS: Awardees are expected to connect regularly throughout the award period with their point of contact within OVPR Technology Commercialization Services to discuss progress, to talk through potential problems, and to consider future steps and additional resources that may be of use. Each PI will work with their TCS contact to set up the best check-in schedule, but it is expected that consultations would happen at least on a quarterly basis.
              • Six-month Reporting: After six months of each award period, applicants will be asked to submit a progress report via the Quest Portal.  After review of this report, the second payment of the award period will be made to the award account.
              • Annual Reports: Recognizing that investments made by the OVPR can often take some time to produce their full results, we will be asking that all recipients of OVPR Internal Funding, including QuTech, submit outcomes reports over the life of the project. This will allow us to better understand the impact of internal funding and make the case for it continuing / increasing.
                • Reporting requirements: PIs will need to prepare a brief report, using this Award Report Template to summarize project progress within one month of posting final expenses unless an extension from the OVPR has been received.
                  • We’ll be interested in hearing about the results of your project,
                  • the significance of those results, and
                  • gathering statistics about graduate students supported, publications, external grants / patents received, other projects launched, etc.
                  • Other questions may also be included as needed. The OVPR may request updates annually for up to five years following the end of the award period to track the development of the project longitudinally.

              Program Contacts

              The QuTech program is jointly administered by OVPR Technology Commercialization Services and Internal Funding Program.

              Program Director
              Dr. Vivek Ramakrishnan
              Director, Venture Development, OVPR Technology Commercialization Services
              vivek.ramakrishnan@uconn.edu

              Dr. Matt Mroz
              Manager, Research Development Services
              matthew.mroz@uconn.edu

              Program point of contact (Contact for information on program/process, application status, award management/extensions)

              Charlotte Nelson
              Internal Funding Coordinator
              research@uconn.edu

              Reminder: Transition Amendments for UConn IRB

              Posted on by

              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

              Posted on by

              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

              NEW!

              *Updates to Federal Policy*

              USG Policy for Oversight of Dual Use Research of Concern (DURC) & Pathogens with Enhanced Pandemic Potential (PEPP)

               

              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.

               

              The 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, research institutions, institutional review entities (IREs) and federal funding agencies.

               

               

              NIH issued a notice on January 10, 2025. NIH intends to implement the DURC & PEPP Policy effective May 6, 2025. NIH will 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.

               

              • UConn and other research institutions have been awaiting additional guidance regarding how Federal Funding Agencies plan to implement the DURC & PEPP Policy.
              • In the meantime, the UConn IRE is working to develop procedures to best assist PIs with the new requirements.
              • New Proposals: PIs may be asked to complete an Initial Assessment.
                • Help to determine if proposed research is subject DURC & PEPP Policy.
                • Templates in Kuali coming soon!
                • IRE will be in touch with labs that may be impacted.
                • The IRE is here to help! See contact information below, and reach out with any questions.

               

              Framework for Nucleic Acid Synthesis Screening

               

              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.

               

              Institutional Review Entity (IRE)

               

              • IRE is an entity established by the research institution to execute institutional oversight responsibilities described in Section 5.2, with the attributes described in Section 5.2.B of the USG Policy on Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP).
              • UConn's IRE was established as a subcommittee of the IBC in 2014. The IRE authority and responsibilities were implemented in accordance with provisions outlined in the 2014 USG Policy on DURC.
              • With the expansion in scope of research subject to the DURC & PEPP Policy, the IRE will begin holding regular meetings to review potential Category 1 and Category 2 experiments.

              More details to come!

               

              For additional information or assistance with compliance with the new policy, contact:

               

                  Name Title Phone Email
                  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

                   

                  Links below contain additional resources such as fact sheets, templates, and FAQs.

                   

                  Resources

                  Additional resources and summaries on the new policy can be found below.

                  Fact Sheet - DURC & PEPP Policy

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                  Agents & Toxins

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                  Institutional Workflow - DRAFT

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                  COMING SOON!

                  PI Initial Assessment Tool

                  UConn Policy on DURC & PEPP

                  Risk-Benefit Assessment Template

                  Risk Mitigation Plan Template

                  FAQs

                  Frequently Asked Questions (FAQs)

                  My lab does not receive federal funding, but RG2 pathogens are modified to enhance virulence and transmissibility. Do I need to comply with this policy?

                  • DURC & PEPP Policy is applicable to non-federally funded research at institutions that receive federal funding, via term and condition awards. Since UConn is sponsored by federal funding agencies, your work should be assessed by the IRE.

                  Who is responsible to determine if research is subject to the DURC & PEPP Policy?

                  • PIs assess research initially, to identify covered research. PI assessments are reported to the sponsor and if the PI believes the project meets Category 1 or Category 2, the IRE must be notified as well.
                  • UConn IRE will provide a Self Assessment Tool to aid PIs in conducting this assessment.

                  I assessed my proposed research and my determination was that our new project may be subject to Category 2 oversight. What do I do now?

                  • Contact the IRE and your sponsor. Do not begin work on any new experiments. The IRE must conduct an assessment of the PI's determination, which will result in one of the following workflows.
                  • IRE Determination = Not Subject to Policy: The institution will notify the sponsor and the PI. Work can be initiated according to DURC & PEPP; however, other regulations may apply (e.g. NIH Guidelines). Contact the IBC to ensure the lab has all approvals necessary.
                  • IRE Determination is Category 1 or 2 = Subject to Policy: Ensure sponsor is notified, and work with IRE to draft risk benefit analysis, and risk mitigation plans. Sponsor must conduct thorough review.

                  Additional FAQs - S3: Science Safety Security, ASPR

                  Current Life Science Policies – DURC and P3CO, expiring May 6, 2025

                  Current Federal Policies on Life Sciences Research - Expiring May 6, 2025

                  USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC)

                  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.

                  The 2014 DURC Policy will expire effective May 6, 2025; and will be replaced with the USG Policy on Oversight of DURC and PEPP described at the top of this page.

                  Potential Pandemic Pathogen Care and Oversight (P3CO)

                  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:

                  1. 2012 Federal DURC Policy
                  2. 2014 Institutional DURC Policy
                  3. 2017 OSTP Potential Pandemic Pathogen Care and Oversight (P3CO)
                  4. 2017 HHS P3CO Framework

                  IRB Office Hours

                  Posted on by

                  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

                   

                  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.

                  Cede Application Form

                  External Personnel Log

                  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.

                  Standard Protocol Template

                  Ethnographic Protocol Template

                  Repository 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.

                  Data Security Assessment Form

                  IND Assessment Worksheet

                  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.

                  Sample Recruitment Flyer Template (with tabs).docx