IBC Minutes for the University of Virginia, Charlottesville VA
September 1st,  2026
8:30 AM-10:30 AM by Zoom

Glynis Kolling (Chair), called the meeting to order. Members in attendance were Jennifer Kershner (BSO), Stacy Agar (local non-affiliated member), Aaron Mills (IBC member), Brett Moreau (IBC member), Tom Leonard (EHS Director), Danielle Cook (IBC member),  Ira Schulman (IBC member), Paul Skoglund (IBC member/IBC contact), Sam Driver (local non-affiliated member), Raphael Malbrue (Director (CCM) and Animal Containment Expert), and Matthew Crawford (IBC member). The 12 members present exceeded the quorum threshold of seven. Dave Clark, the Associate Biosafety Officer, attended the meeting to observe the proceedings. Dr. Kolling reminded everybody that anyone who might have a conflict of interest participating in review of a particular protocol should be placed in a breakout room during the discussion of that protocol unless requested to stay and answer questions.

  1. The minutes from the meeting of August 4th, 2026, were approved with no dissent.
  2. Review of Prior Business.
    1. None at present.
  3. The following IARs have no changes from last year or exhibit a minor modification such as stating that they are not using AAV at BSL-1, making room changes, moving inventory to storage only, changing sourcing of materials, small changes to text, or similar changes. All these protocols were approved at either BSL-2 or at BSL-1/BSL-3 (when indicated) with no dissent but pending successful laboratory inspection, training, or clerical modifications in indicated cases:
    1. ABEBAYEHU, DANIEL (10756-20) was reviewed by Leonard and Moreau. He studies the crosstalk between immune and stromal cells during fibrosis and tissue regeneration, using viral expression strategies, HDM, and recombinant DNA (III-D-1). There are training issues to address before approval.
    2. CAI, LIHENG (5981-18) was reviewed by Schulman and Kershner. He studies the effect of soft matrix materials on the responses exhibited by bacterial cells, eukaryotic cells, and tissues, using bacteria and cell lines. 
    3. CASANOVA, JAMES (098-99) was reviewed by Malbrue and Leonard. He studies Salmonella infection, signaling through small GTPase proteins and the mechanisms underpinning Gram-negative bacterial binding to cells using BSL2 agents, HDM, and recombinant DNA (III-D-1). There are training issues to address before approval.
    4. CRISS, ALISON (623-08) was reviewed by Agar and Malbrue. She studies the interaction of pathogens and the immune system, specifically examining interactions between Neisseria gonorrhoeae and neutrophils as well as the cellular activities of anthrax and pertussis toxins, using various BSL-2 agents, biotoxins, HDM, and recombinant DNA (III-D-2).
    5. EBRAHIM, SEHAM (9987-22) was reviewed by Agar and Mills. She studies the role of the septin complex in the gastrointestinal tract and its potential role in the progression of colorectal cancer using viral expression strategies, HDM, NHPDM, and recombinant DNA (III-D-1).
    6. GARCIA-BLANCO, MARIANO (10413-23) was reviewed by Kershner and Moreau. He studies RNA virus infection and autoimmune disease, using the BSL-2 agents Coronaviruses, Coxsackie virus, Dengue viruses, hepatitis B, lentivirus, HDM, and recombinant DNA (III-D-1).
    7. HEYSELL, SCOTT (6810-19) was reviewed by Schulman and Malbrue. He studies human infection with Mycobacterium tuberculosis using HDM.
    8.  LOBO, PETER (023-97) was reviewed by Malbrue, Kolling, and Cook. He studies the role of IgM anti-leukocyte autoantibodies in preventing or reducing HIV-1, SIV, and Hepatitis C viral infection of peripheral blood lymphocytes using various BSL-2 agents, biotoxins, and HDM.
    9.  MISRA, MADHUMSMITA (11453-24) was reviewed by Mills and Agar. She studies the clinical impact of regular, repeated, intranasal oxytocin administration to children with autism spectrum disorder on bone density, formation, and resorption, using HDM.
    10. PRICE, RICHARD (407-06) was reviewed by Crawford and Mills. He studies Parkinson's Disease by developing disease models and then evaluating therapies using viral expression strategies, HDM, and recombinant DNA (III-D-1). There are training issues to address before approval.
    11. PROCTOR, ELIZABETH (12835-25) was reviewed by Leonard and Schulman. She studies the molecular and cellular mechanisms driving Alzheimer’s disease, using AAV at BSL1, BSL2 viral vector expression strategies, HDM, and recombinant DNA (III-E-1).
    12. SHELL, STEVEN (6117-18; UVA Wise) was reviewed by Schulman and Kershner. He studies Xeroderma pigmentosum using HDM at UVA Wise.
    13. SHEYBANI, NATASHA (9452-22) was reviewed by Mills and Moreau. She develops novel gene therapy treatments targeting brain tumors using AAV, HDM, and recombinant DNA (III-D-1, III-E-1). There are room and training issues to address before approval.
    14. SHEYNKMAN, GLORIA (8472-29) was reviewed by Crawford and Agar. She studies vascular development and disease, using BSL2 agents and HDM.
    15. SHIN, JUNG-BUM (744-10) was reviewed by Leonard and Mills. He studies sensory hair cells in mice using KO mice, human and monkey cell lines, viral expression strategies, and recombinant DNA (III-D-1).
    16. SONKUSARE, SWAPNIL (4415-16) was reviewed by Kershner and Schulman. He studies how endothelial cells are regulated by calcium using HDM. There are training issues to address before approval.
    17. WANG, YUH-HWA (2937-13) was reviewed by Malbrue and Crawford. She studies the DNA stability of cloned human fragile site genomic regions, using HDM.
    18. ZHOU, ANNY (12076-24) was reviewed by Moreau, Kolling, and Cook. She studies lung disease including COPD, asthma, and idiopathic pulmonary fibrosis using influenza virus, rhinovirus, viral expression strategies, HDM, and recombinant DNA (III-D-1).
  4. The following IARs have few changes from last year but were discussed in committee:
    1. BAILLEY, STEFANIE (11487-24) was reviewed by Moreau and Agar. He develops and evaluates T-cell immunotherapies using virial expression strategies, HDM, and recombinant DNA (III-D-1). She needs to update the lab's location currently listed as TBD in Narrative Question #3. In Narrative Question #4, she needs to remove mention of 70% ethanol as a chemical disinfectant from the first sentence. There are training issues to address before approval.
    2. CULVER, SILAS (13139-25) was reviewed by Mills and Crawford. He studies the (pro)renin receptor in obesity and diabetes, using  viral vector expression strategies, HDM, and recombinant DNA (III-D-1). He needs to add his new gene target ACOX1 to the recombinant DNA section of the protocol. He also needs to answer Narrative question #9 Yes to account for his work with E. coli. 
    3. DEVALL, MATTHEW (131-90-25) was reviewed by Kolling, Schulman, and Cook. He studies the genetic and environmental factors associated with colorectal cancer using HDM and recombinant DNA (Exempt). In Narrative question #1 it is stated that Dr. Devall is not actively leading this work. He needs to clarify what is meant by this statement, identify who is actively leading this work, and who should hold  this IAR if not Dr. Devall.
    4. LI, HUI (693-09) was reviewed by Kolling, Leonard, and Cook. He studies gene regulation during normal development and disease, using viral expression strategies, HDM, NHPDM, and recombinant DNA (III-D-1). In the HDM section he needs to add another section in the Hazards/ Risks question to specifically describe the risks of PBMC’s and T cells and include information as to how they are acquired. In the transgenic Animals with enhanced risk section, he needs to provide more information as to the enhanced risk to personnel that is seen to arise from these animals. There are training issues to address before approval.
    5. PANZER, MATTHEW (8555-21; MOD) was reviewed by Kershner and Crawford. He operates the Center for Applied Biomechanics using HDM. In the Hazards/ Risks (HDM) section he needs to merge all the HDM risks into one section to avoid repetition. However, he needs to specifically include mention of Post-Mortem Human Subjects (PMHS), and mention that the risk is from known or unknown human pathogens. There are training issues to address before approval.
    6. RAMAKRISHNAN, GIRIJA (696-09) was reviewed by Kolling, Kershner, and Cook. She studies the immune response to C. difficile infection as well as biofilm formation in Mycobacterium avium using various BSL-2 agents, HDM, biotoxins, and recombinant DNA (III-D-1; III-D-2). In the BSL2 Hazards/ Risks discussion of Mycobacterium avium intracelluare she needs to specify whether the source of patient or healthy donor that is declared is from commercial sources, or a collaborator, or otherwise acquired.
    7. ZEGARRA RUIZ, DANIEL (11022-23) was reviewed by Kolling, Malbrue, and Cook. He studies the role of T cells in autoimmune disease, using  BSL-2 agents and Biotoxins. He needs to add a sentence or two to Narrative question #1 describing how Diphtheria toxin, Pertussis toxin, and staphylococcal enterotoxins are used experimentally in the lab.
  5. Discussion and review of modified protocols that are not annual renewals- Reviewers can review just the modification or notice other changes as well. Other changes can either be made during that revision cycle or addressed at the subsequent annual review at the reviewee’s discretion. (Note that this type of review leads to approval with no change in annual renewal date):
    1. ANDERSON, KRISTEN (10542-23; MOD) was reviewed by Crawford and Moreau. She engineers T cells to recognize, attack, and irradicate cancer cells, using viral expression strategies, HDM, and recombinant DNA (III-D-1; III-E-1). She is adding RCAS-TVA work at BSL1. She needs to describe her new RCAS-TVA work in the recombinant DNA section under guideline III-E-1, and to update the current III-D-1 declaration to specify that it applies to the retrovirus and lentivirus work. In Narrative question #4, she needs to update her reference to 70% ethanol to clarify that it cannot be used as a disinfectant, and to change the answer to Narrative questions #10A, #12A, and #16 to account her RCAS work. 
    2. MAULDIN, ILEANA (9980-22; MOD) was reviewed by Schulman and Moreau. She is running the Molecular Immunologic and Translational Sciences Core Facility (MITS); this registration allows investigators with BSL-2 approval to access this facility. This Core facility provides both storage options as well as various assays using cell culture, ex-vivo, in-vitro and in-vivo techniques to researchers bringing their own samples. She is adding adenovirus and lentivirus to her protocol. She needs to clarify whether she will also be using AAV, as it is mentioned in the text. She also needs to modify Narrative questions 10D and 12C to reflect the new agents. There are room issues to address before approval.
    3. SLINGLUFF, CRAIG  (127-00; MOD) was reviewed by Crawford and Mills. He studies the immune response to melanoma to develop therapeutics, using BSL2 agents, biotoxins, and HDM. He is adding adenovirus and lentivirus to his protocol. He needs to add a recombinant DNA section to reflect the new viral vectors. He also needs to consolidate his Hazards/Risks (HDM) statement and update his IRB approval number answer.
    4. STUREK, JEFFREY (7885-20; MOD; BSL3) was reviewed by Malbrue and Leonard. He is studying COVID-19 and other disease pathophysiology by assaying for circulating immune system markers and genetic factors in samples collected from patients using BSL2 agents, including viral expression strategies, SARS CoV-2 at BSL3, HDM, and recombinant DNA (III-D-1). He is adding cerebral spinal fluid (CSF) to his protocol. He needs to add a sentence to Narrative question #1 to describe his experimental use of both cerebral spinal fluid and pericardial fluid. He also needs to provide an opening statement of a sentence or two in Narrative question #1 to provide context to reviewers as to what the overarching research aims are. He also needs to provide a CSF- specific risk statement, including to state whether CSF will be procured from individuals with known or suspected prion disease, including CJD, or if such collection will be excluded.
    5. SUN, JIE (9062-21; BSL3; MOD) was reviewed by Kershner and Schulman. He studies the role of the immune response in generating pulmonary inflammation and exaggerated inflammatory cytokine production produced by viral infection with influenza, respiratory syncytial, and SARS-CoV-2 viruses using various BSL-2 and BSL-3 agents, HDM, NHPMP, biotoxins, and recombinant DNA (III-D-1). He is adding AAV at BSL2 to his protocol. Because Wei Qian is leaving the end of September, the IBC requests that he be removed from the Narrative question portions of the protocol that mention him as the BSL-3 contact person, so that resubmittal of another protocol modification for IBC review in a month does not have to occur. 
    6. TANIUCHI, MAMI (9435-22; MOD) was reviewed by Kolling, Mills, and Cook. She develops PCR-based assays for pathogens in stool and wastewater using a significant number of BSL-2 agents as positive controls as well as the HDM inventory item stool. She is adding coronaviruses to her protocol. In Narrative question #1, she needs to  define LMICs (as low- and middle-income countries) at first mention. In the BSL2 Hazards/Risks section she needs to specify whether SARS-CoV-2 is purchased in the heat-inactivated form, or if the inactivation done locally. There are training issues to address before approval.
  6. Discussion and review of annual renewal protocols that contain modifications:
    1. GRIFFIN, DONALD (5602-17) was reviewed by Moreau, Kolling, and Cook. He studies the potential role of utilizing biomaterial substrates such as hydrogels in regenerative medicine, using HDM. He is adding human waste wound exudate to his protocol. He needs to add a sentence or two to Narrative question #1 to describe what he will be doing experimentally with waste wound exudate, to add waste wound exudate as an HDM agent, and to provide a Hazards/Risks statement for waste wound exudate. In Narrative question #4 he needs to specifically state that it is 10 % bleach (final concentration) for liquid decontamination and to update the surface decontamination time with 10% bleach to 10 minutes.
    2. JOMAA, AHMAD (9455-22) was reviewed by Leonard and Crawford. He studies the structure of the human ribosome with cryo-electron microscopy, using BSL2 agents, HDM, and recombinant DNA (III-D-1). He is adding lentivirus to his protocol. He needs to add a sentence or two to Narrative question #1 to describe both what he will be doing experimentally at BSL1 containment, and what he will be doing experimentally with lentivirus. He  also needs to provide a recombinant DNA section to describe his lentiviral experiments. In Narrative questions #5 and #8 he needs to clarify whether he will be using human cells or human tissues and to specify that the virus mentioned is lentivirus. There are room issues to address before approval.
    3. MICHAELASSI, FRANCESCO (13171-25) was reviewed by Agar and Kershner. He studies the pathological mechanisms underlying peripheral neuropathies using HDM. He is adding cell lines to his protocol. The IBC would either like for Narrative question #2 to be answered no, or else change mention of  “Workforce Health” to “WorkMed” in that question.
  7. Discussion and review of new protocols:
    1. None at Present.
  8. Mid-Month Review and Administrative review:
    1. None at Present.
  9. Discussion and Review of ACUC protocols with IBC Concerns
    1. ANDERSON, KRISTIN (4434; MOD) was reviewed by Kershner, Kolling, and Cook. She engineers T cells to recognize, attack, and irradicate cancer cells, using viral expression strategies, HDM, and recombinant DNA (III-D-1). She is adding the RCAS oncogene delivery system. She needs to update her duration of handling animals at ABSL2 containment to the duration of the experiment for her RCAS oncogene delivery administration experiments. 
    2. JASH, ARJIITA (NEW) was reviewed by Kolling, Leonard, and Cook. She studies the in vivo role of Dendritic cells in immunity using mice and biotoxins. This is a new protocol titled “Mechanism of Antibody Mediated Immune Enhancement (AMIE) during RBC alloimmunization” using diphtheria toxin. She needs to address the route, volume and frequency of diphtheria toxin administration more clearly, and not in the past tense.
    3. KAPLAN, HARRIS (NEW; ABSL1 protocol with AAV at ABSL1) was reviewed by Malbrue and Moreau. He studies the cellular and circuit mechanisms underpinning mouse neuronal function and behavior, using AAV at BSL1, avian receptor-dependent rabies virus at BSL2, and recombinant DNA (III-D-1; III-E-1). He needs to provide the maximum AAV concentration in viral genomes or genome copies per milliliter and the corresponding maximum total viral dose administered per animal. He also needs  to state the maximum number of intracranial injection sites and AAV administrations per animal and clarify whether an animal may receive a mixture or co-injection of more than one AAV construct. The dose, volume, route, frequency, and construct combinations must match IAR 13893-26. He also needs to clarify whether the 80 CD-1 training animals will receive recombinant AAV. If AAV will be administered, he needs to identify the approved construct or constructs, maximum titer, total dose, route, injection frequency, and number of sites, and apply all AAV–ABSL-1 labeling and handling requirements to these animals. If the training animals will receive only sterile saline, dye, or another nonviral surrogate, he needs to state this explicitly.
    4. LEE, DANIEL (4189; 3rd year) was reviewed by Kershner and Kolling. He uses CAR-T approaches to study the treatment of various cancers in both research and clinical settings, using viral expression strategies, HDM, and recombinant DNA (III-D-1). There were no changes to the biological agents section of his protocol. He needs to separate his mentions of the Glioblastoma (GBM) cell line and the U87 cell line better in some manner. He also needs to update all the species procedures regarding PPE to remove mention of  shoe covers, and to address why room MR4 G147 was removed and whether tail vein injections are still performed in a BSC.
    5. MICHAELASSI, FRANCESCO (NEW) was reviewed by Schulman and Agar. He studies the pathological mechanisms underlying peripheral neuropathies using HDM. He is adding a xenograft experiment using a well-established human cell line. He needs to select cell lines as the HDM agent rather than unfixed organs and tissues. These human cells are considered to shed for the duration of the experiment, so he needs to hold animals at ABSL2 containment for the duration of the experiment. 
    6. MOHI, GOLAM (4190; 3rd year) was reviewed by Mills and Schulman. He studies hematopoiesis and the molecular pathogenesis of leukemia, using viral expression systems, HDM, and recombinant DNA (III-D-1). There were no changes to the biological agents section of his protocol. He needs to update his protocol to include AML cells. 
    7. SUN, SHENGYI (4466; 3rd year) was reviewed by Moreau and Agar. She studies the role of misfolding of proteins in the endoplasmic reticulum and mechanisms of clearing mis-folded proteins from cells using various BSL2 viral vector expression strategies, HDM, and recombinant DNA (III-D-1). There were no changes to the biological agents section of her protocol. Her protocol was approved at ABSL2 with no dissent. 
    8. THAKUR, ARCHANA (4179; 3rd year) was reviewed by Leonard and Kershner. She studies bispecific antibody activated T-cells as anti-tumor agents using lentivirus, HDM, and recombinant DNA (III-D-1). There were no changes to the biological agents section of her protocol. Her protocol was approved at ABSL2 with no dissent.
    9.  ZHANG, HONGJI (4580; MOD) was reviewed by Crawford and Malbrue. He studies the role of preoperative exercise therapy and the effects of inflammation on the liver immune microenvironment in the context of liver ischemia and reperfusion and Metabolic Disfunction -associated Steatohepatitis (MASH) and MASH-associated hepatocellular carcinoma development using viral expression strategies, HDM, biotoxins, and recombinant DNA (III-D-1). He added a new species procedure titled “Liver I/R Injury with and without Tumor Injection”. He needs to remove repeated text in two places the "Duration of hazardous shedding" text box. He also needs to describe his control AAV construct.
  10. IBC and Biosafety issues:
    1. Jenni Kershner, Biosafety officer, continued to discuss a potential recent occupational exposure to human cell lines in the Dr. Erdbruegger lab. A  student was incorrectly sent to Employee Health after a presumed ocular exposure to human cell lines, and she was then sent between Employee Health and Student Health. However, since this was a research laboratory incident, she should have reported directly to UVA WorkMed since they are the occupational health provider for researchers. However, further investigation determined that this was likely not an exposure to HDM, but an assumed exposure because of a likely Cavicide exposure. The exposed person had sprayed her gloves with Cavicide after working with HDM and then had experienced discomfort in her eyes, likely due to the ethanol present in Cavicide. No evidence was produced that an actual exposure to HDM occurred. Jenni also mentioned that there is now a wall-mountable Biological Exposure Response Guide that she recently created to help direct personnel to the correct location to proceed to after a lab incident, and that Vernell is now handing out this new Guide to be wall mounted during her lab inspections across campus. This guide was created after discussion of the WorkMed/Student health/Employee Health reporting issues that occurred concerning this incident at the August IBC meeting.
    2. Jenni Kershner, Biosafety officer, discussed a Lab Acquired Infection for wild-type Shigella in the Dr. Agaisse lab. This student reported to Urgent care several days after having worked with Shigella in the lab with symptoms and was then transported to the emergency room. This was an undergraduate in the lab who had done this Shigella work on the benchtop. The student was appropriately registered but had apparently touched his face while working and became sick starting in July but recovered completely and participated in the subsequent incident investigation. This is not an incident reportable to the NIH, and the IBC discussed whether the committee should respond in some manner. It was decided that a letter from the IBC would be appropriate. The PI did review the Biosafety Manual and biosafety practices and precautions during a lab meeting directly after the confirmed incident and this type of work will now be done in a BSC rather than on the benchtop going forward, and the IBC felt this was an appropriate response to this incident. 
    3. Jenni Kershner, Biosafety officer, discussed an anonymous compliance report that was received by EHS. This report indicated personnel were seen handling biological agents without gloves and not using proper technique to transport biological agents. However, when investigated the details contained within this anonymous report could not be confirmed. In response to this anonymous compliance report a blast email was sent to 800+ researchers stressing that UVA has a Culture of Safety, Security, and Responsibility. In addition, the CCM leadership team conducted prompt retraining of vivarium supervisors. 
    4. Glynis Kolling, IBC Chair, and Jenni Kershner, Biosafety officer, discussed an NIH request for comments on the Draft NIH Policy for Research Involving Biohazards, which would replace the existing NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acids. This policy will change many things including transitioning to a risk -assessment based evaluation of a much broader range of biological agents, a change the distinction between exempt and non -exempt recombinant DNA (as these would go away), and more robust incident reporting guidelines. These comments are due to the NIH by October 19th , and Lori McMahon wants to have a UVA- produced comment submitted through her office by that date. Tom and Jenni are in the process of developing a draft comment document that will be circulated to the IBC at the next meeting, to present to Lori as a possible UVA submission comment from her office. 
    5. Glynis Kolling, IBC Chair, and Jenni Kershner, Biosafety officer, discussed the possibility of conducting regular IBC review and approval of ACUC protocols that would occur mid-month in-between regular IBC meetings in certain circumstances. This discussion focused on what types of protocols could be treated in this manner, who would be responsible for these reviews, whether a second monthly meeting will be required, and whether increase compensation for IBC members would be involved.
    6. Glynis Kolling, IBC Chair, mentioned that the next IBC meeting will be held live in MR6 2501 on October 6th.
  11. IRE Business:
    1. None at present.
  12. Renewals over 30 days old:
    1. None at present.
  13. Renewals over 60 days old:
    1. None at present.
  14. ACUC protocols for IBC over 30 days old:
    1. None at present.
  15. Renewals over 60 days old:
    1. None at present.
  16. ACUC protocols for IBC over 60 days old:
    1. None at present.
  17. New PIs who are in the process of doing their visits and training:
    1. MAILMAN, RICHARD (13521-26; NEW; originally submitted as MCINTIRE, WILLIAM (369-06; NEW for Richard Mailman as PI) was reviewed by Kolling and Moreau. In the William McIntire submission, the work was described as molecular cloning to produce expression constructs. He needs to provide more detail about the work he is doing, the pathogens he is using, and to add additional detail throughout the protocol. In Narrative question #4, he needs to state that liquid decontamination is with 10 % bleach (final concentration). The text of his protocol is now approvable, but he requires the installation of an eyewash in his lab space before his New Lab Inspection can occur. An eyewash has now been installed in his lab space, and we are scheduling the final inspection at present.