IBC Minutes

VA Greater Los Angeles Healthcare System Research & Development Committee’s Institutional Biosafety Committee (IBC) oversees research involving laboratory-based biohazardous materials or DNA molecules to ensure safety and compliance with federal, state, and institutional guidelines.

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February 11, 2026

Members Present

Fredricka Martin, PhD, Chair (Voting)

Muhammad T. Bashir, MD, Co-Vice Chair (Voting)

Yasutada Akiba, MD, PhD, Research Scientist (Voting)

Ella Bronstein, Community Representative (Voting)

Yuxin E. Li, MD, PhD, Research Scientist/Clinician (Voting)

James Matsunaga, PhD, Research Scientist (Voting)

Erika Miller, Community Representative (Voting)

Agnes K. Nagy, PhD, Research Scientist (Voting)

Alternate Members Present

Bischoff, David, PhD, Voting Alternate for Noah Gross

Members Absent

Noor M. Alam, PhD, Co-Vice Chair (Voting)

Noah Gross, PhD, Research Biosafety Officer (RBSO) (Ex-Officio, Voting)

Xiaoyan Ren, MD, PhD, Research Scientist (Voting)

Mark Sitek, MS, Radiation Safety Officer (Ex-Officio, Voting)

Ben Spivey, Chief, Safety & Emergency Management (Ex-Officio, Voting)

Alternate Members Absent

Natalie Farnham, Industrial Hygiene, Voting Alternate for Ben Spivey

Non-Members Present

SRS Manager

IACUC Liaison

RCO

MR, Research Administration

MS, Industrial Hygiene

I. Call to Order: Dr. Martin called the meeting to order on February 11, 2026, at 1:51 p.m. There were 9 voting members present, meeting the quorum requirement of 7.

II. Chair’s Report

A. IBC Approval Length: The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules do not specify the length of IBC approval and have left it for the local IBC to decide. Members discussed a one-year approval where the IBC application is submitted yearly with the annual continuation form. Some members felt there was no need to submit it annually because the content in the application typically does not change from year to year. If there were changes, amendments would be submitted. Because of this, it was more appropriate to have a three-year approval period. One concern with reviewing the IBC application every three-years was keeping track of high-risk studies. The solution was to approve IBC applications for three years, except for studies with dual use screening. Dual use screening studies will be approved for one year and reviewed annually.

The IBC application will be required for new IBC applications, 3rd-year resubmissions, annually for dual-use studies and for amendments that affect the IBC status of the protocol.

Motion: Moved and seconded to approve IBC applications for three years except for those that contain dual-use screening which will be approved annually. 9 yes, 0 no, 10 abstentions. Motion Carried.

B. IBC Screening Form: The Chair will develop an IBC screening form that will be used to determine if a protocol will require an IBC review.

C. Animal Experiments Table: An animal experiment table outlining the NIH Guidelines for transgenic animals has been uploaded into IRBNet. The table is an useful guide to determine the appropriate NIH Guidelines Section for various transgenic animals.

III. Adjournment: The meeting was adjourned at 2:15 PM.

January 14, 2026

Members Present

Fredricka Martin, PhD, Chair (Voting)

Muhammad T. Bashir, MD, Co-Vice Chair (Voting)

Yasutada Akiba, MD, PhD, Research Scientist (Voting)

Ella Bronstein, Community Representative (Voting)

Yuxin E. Li, MD, PhD, Research Scientist/Clinician (Voting)

James Matsunaga, PhD, Research Scientist (Voting)

Agnes K. Nagy, PhD, Research Scientist (Voting)

Alternate Members Present

Bischoff, David, PhD, Voting Alternate for Noah Gross

Members Absent

Noor M. Alam, PhD, Co-Vice Chair (Voting)

Noah Gross, PhD, Research Biosafety Officer (RBSO) (Ex-Officio, Voting)

Erika Miller, Community Representative (Voting)

Xiaoyan Ren, MD, PhD, Research Scientist (Voting)

Mark Sitek, MS, Radiation Safety Officer (Ex-Officio, Voting)

Ben Spivey, Chief, Safety & Emergency Management (Ex-Officio, Voting)

Alternate Members Absent

Natalie Farnham, Industrial Hygiene, Voting Alternate for Ben Spivey

Non-Members Present

SRS Manager

IACUC Liaison

RCO

MR, Research Administration

MS, Industrial Hygiene

I. Call to Order: Dr. Martin called the meeting to order on January 14, 2026, at 2:08 p.m. There were 8 voting members present, meeting the quorum requirement of 7.

II. New Business

Review of New Projects

IRBNet ID 1907790-2

PI: Alam, MD Noor, Ph.D.

Study Title: Interactions of Sleep, Stress, and Tumor Progression in Glioblastoma

Study Summary: This study uses rDNA tools for precise monitoring (e.g., calcium imaging via GCaMP) and manipulation (e.g., chemogenetics via DREADDs) of neural and tumoral activity, to uncover mechanistic insights into GBM's impact on brain function and identify therapeutic strategies. The study involves AAV vector administered to brains of mice to transfer fluorescent marker genes to the mouse brain.

The recombinant AAV vectors are obtained from Addgene. These vectors are replication‑incompetent because the packaged genome contains only the ITRs and the transgene cassette; all rep/cap and helper functions are supplied in trans during production and are not present in the viral particles. Addgene‑supplied AAV lots undergo standard release testing and are certified free of replication‑competent AAV. Only CAAV‑negative lots will be used.

NIH Guidelines category: The breeding of transgenic mice falls under NIH Guidelines Appendix C-VIII. The rDNA experiments fall under NIH Guidelines Section III-E.

Laboratory biosafety level: BSL-1, ABSL-1

Biosafety work practices: BSL-1

Issues Requiring Modifications and/or Corrections: The Committee determined that the following contingencies and comments be forwarded to the PI, who must provide a satisfactory response to each before final approval can be considered.

Item 1: Part 1.8. Change Room 237 to Room 217.

Item 2: Part 4.12. Check the “Yes” box since the experiment involves transgenic mice.

Motion: Moved and seconded to require modifications for approval of this submission. 8 yes, 0 no, 0 abstentions, 0 recusal. Motion Carried.

IRBNet ID 1616170-8

PI: Marcus, Elizabeth, MD

Study Title: Mechanisms of Gastric Mucosal Response to H Pylori Infection at Acidic pH

Study Summary: The study includes carcinogenic pathogen Helicobacter pylori, Helicobacter pylori gene knockout and Adenovirus VQAdCMV. Mongolian gerbils are infected with kanamycin resistant Helicobacter pylori. rDNA molecules consist entirely of DNA from a prokaryotic host including indigenous plasmids or viruses when propagated only in that host (or closely related strain of the same species), or when transferred to another host by well-established physiological means.

NIH Guidelines category: III-F-4,6,8

Laboratory biosafety level: BSL-2, ABSL-2

Biosafety work practices: BSL-2

The study is exempt as III-F-4

Motion: Moved and seconded that the study is exempt under NIH Guidelines category III-F-4. 8 yes, 0 no, 0 abstentions, 0 recusal. Motion Carried.

III. Adjournment: The meeting was adjourned at 1:35 PM.

December 10, 2025

Members Present

Fredricka Martin, PhD, Chair (Voting)

Muhammad T. Bashir, MD, Co-Vice Chair (Voting)

Yasutada Akiba, MD, PhD, Research Scientist (Voting)

Ella Bronstein, Community Representative (Voting)

Noah Gross, PhD, Research Biosafety Officer (RBSO) (Ex-Officio, Voting)

Yuxin E. Li, MD, PhD, Research Scientist/Clinician (Voting)

Erika Miller, Community Representative (Voting)

Agnes K. Nagy, PhD, Research Scientist (Voting)

Members Absent

Noor M. Alam, PhD, Co-Vice Chair (Voting)

James Matsunaga, PhD, Research Scientist (Voting)

Xiaoyan Ren, MD, PhD, Research Scientist (Voting)

Mark Sitek, MS, Radiation Safety Officer (Ex-Officio, Voting)

Ben Spivey, Chief, Safety & Emergency Management (Ex-Officio, Voting)

Alternate Members Absent

Bischoff, David, PhD, Voting Alternate for Noah Gross

Natalie Farnham, Industrial Hygiene, Voting Alternate for Ben Spivey

Non-Members Present

SRS Manager

APCO

MR, Research Administration

UR, Industrial Hygeine

I. Call to Order: Dr. Martin called the meeting to order on December 10, 2025, at 1:21 p.m. There were 8 voting members present, meeting the quorum requirement of 7.

II. New Business

Review of New Projects

IRBNet ID 1615938-10

PI: Frost, Patrick, PhD

Study Title: Targeting the in Vivo Hypoxic Microenvironment of Multiple Myeloma as an Anti-Tumor Strategy

Study Summary: The experiment involves administering human multiple myeloma cells in vitro and in vivo. Human multiple myeloma tumor cells will be transfected with luciferase, which makes the cells emit light when they are exposed to luciferin and implanted into mice. This allows tumor growth to be monitored in vivo.

The vectors that will be used are BSL-1 plasmid vectors from Promega. The cells used are primary human multiple myeloma cells from ATCC, making it a BSL-2 project. The cells will be labelled with pGL4.5 plasmid (lacking origin of replication). The project uses transgenic mice (BNX mice from Jackson labs). The cells are implanted into mice, it is also ABSL-2. Since the experiment involves transgenic mice housed at ABSL-2 it is NIH category III-D.

NIH Guidelines category: IIID-4

Laboratory biosafety level: BSL-2, ABSL-2

Biosafety work practices: BSL-2

Item 1: Part 1.8. Change Room 237 to Room 217.

Item 2: Part 4.12. Check the “Yes” box since the experiment involves transgenic mice.

Motion: Moved and seconded to require modifications for approval of this submission. 10 yes, 0 no, 0 abstentions, 0 recusal. Motion Carried

III. Chair’s Report

IBC Review Schedule: The committee discussed the timing of IBC submissions and determined that IBC reviews will be performed for new submissions, at the time of annual continuations or for modifications that affect the IBC status of the protocol for research involving recombinant or synthetic nucleic acid molecules.

Motion: Moved and seconded to conduct IBC reviews for new submissions, at the time of annual continuations or for modifications that affect the IBC status of the protocol for research involving recombinant or synthetic nucleic acid molecules. 8 yes, 0 no, 0 abstentions. Motion carried

IV. Adjournment: The meeting was adjourned at 1:35 PM.

June 11, 2025

Members Present

Yasutada Akiba, MD, PhD, Chair (Voting)

Noor M. Alam, PhD, Co-Vice Chair (Voting)

Muhammad T. Bashir, MD, Co-Vice Chair (Voting)

Ella Bronstein, Community Representative (Voting)

Noah Gross, PhD, Research Biosafety Officer (RBSO) (Ex-Officio, Voting)

Kostyantyn Krysan, PhD, Research Scientist (Voting)

James Matsunaga, PhD, Research Scientist (Voting)

Agnes K. Nagy, PhD, Research Scientist (Voting)

Xiaoyan Ren, MD, PhD, Research Scientist (Voting)

Members Absent

Yuxin E. Li, MD, PhD, Research Scientist/Clinician (Voting)

Erika Miller, Community Representative (Voting)

Mark Sitek, MS, Radiation Safety Officer (Ex-Officio, Voting)

Ben Spivey, Chief, Safety & Emergency Management (Ex-Officio, Voting)

Alternate Members Absent

Bischoff, David, PhD, Voting Alternate for Noah Gross

Natalie Farnham, Industrial Hygiene, Voting Alternate for Ben Spivey

Jasvinder Singh, Voting Alternate for Ben Spivey

Non-Members Present

John Berard, PhD, SRS Coordinator

Fredricka C. Martin, PhD, Animal Program Compliance Officer (APCO)

David Oh, MD, RCO

Margaret A. Roch, BS, AA

I. Call To Order: Dr. Akiba called the meeting to order on June 11, 2025, at 1:02 p.m. There were 8 voting members present, meeting the quorum requirement of 7.

II. Announcements

III. Minutes

IV. New Business

A. Review of New Projects

IRBNet ID 1883625-1

PI: Golshani, Peyman, M.D., PhD.

Study Title: Dysfunctional neural dynamics of dentate gyrus granule cells in temporal lobe epilepsy

Item 1: Training Assurance Form. Check the “Physical hazards” box.

Item 2: PSP, Table A3. Check the” Hazardous drugs/Chemicals” box.

Item 3: PSP, Table B. For histology at the VA campus, which sections and immunostaining methods will be used, paraffin or cryostat, HRP histochemistry or immunofluorescence? Please add other chemicals if used for paraffin sections (ethanol, xylene, etc.) or HRP staining (H2O2, DAB, etc.) or nuclear staining (DAPI, etc.) to the table.

Item 4: PSP, Section H. Table D1 lists two viral vectors: AAV-DIO-GCAMP8f and AAV-DIO-HMDI. Please complete Table H for both vectors.

Motion: Moved and seconded to require modifications for approval of this submission. 8 yes, 0 no, 0 abstentions, 0 recusal. Motion Carried

B. Review of Amendments/Modifications

Dr. Matsunaga joined the meeting. There were 9 voting members present.

Drs. Alam and Bashir recused themselves from the discussion and votes on the following submission. There were 7 voting members present at the time of the vote.

IRBNet ID 1836306-2

PI: Alam, Noor, PhD

Study Title: Preoptic/Hypothalamic Mechanisms Of Sleep-Wake Regulation (2025)

Item 1: Chemical Inventory. Add and highlight Bupivacaine to the chemical inventory. Contact David.Bischoff@va.govto get the most recent copy of the chemical inventory.

Motion: Moved and seconded to require modifications for approval of this submission. 7 yes, 0 no, 0 abstentions, 2 recusals. Motion Carried

Drs. Alam and Bashir returned to the meeting following the vote. There were 9 voting members present.

Dr. Matsunaga left the meeting. There were 8 voting members present.

C. Review of Triennials

D. Review of Continuation Reviews:

IRBNet ID 1616023-9

PI: Kremen, Thomas, MD

Study Title: Targeting Molecules to the Enthesis via Novel Bisphosphonate Chaperones and Biomimetic Scaffolds

Primary Reviewer: Kostyantyn Krysan, PhD

Item 1: PSP, Part B3. Uncheck the "Yes" box in Part B3 as the instructions state to skip to part B5 if the chemicals will only be used outside the VA.

Item 2: PSP, Table B. Add "at UCLA only" to each of the chemicals in the able as they will only be used at UCLA.

Item 3: PSP, Part E1. Check the “Yes” box.

Item 4: PSP, Part F1. Both boxes are checked. Part A3 indicates animals will be used and the previous PSP stated rat limb tissue will be used. If animal specimens, tissues, or cells will be used, uncheck the “No” box and complete Table F. If not, check the “No” box in Part A3 and uncheck the “Yes” box in Part F1.

Item 5: PSP, Part H3. Check the “Yes” box.

Item 6: PSP, Table H3. Complete Table H3 because H2 indicates you will be treating cell cultures with other replication incompetent viral vectors

Item 7: PSP, Part L1. Check the “No” box.

Motion: Moved and seconded to require modifications for approval of this submission. 8 yes, 0 no, 0 abstentions, 0 recusal. Motion Carried

IRBNet ID 1626640-9

PI: Pisegna, Joseph R., MD

Study Title: Gastrointestinal neuropeptides regulation of appetite, metabolism, obesity, fatty liver and Non Alcoholic Steatohepatitis (NASH)

Issues Requiring Modifications and/or Corrections: None

Motion: Moved and seconded to approve this submission. 8 yes, 0 no, 0 abstentions, 0 recusal. Motion Carried

V. Unfinished Business

A. Final Approvals

1. Modifications

2. Triennials

3. Annual Continuations and PSPs

IRBNet ID 1616121-6

PI: Bischoff, David, PhD

Study Title: Role of Angiogenic CXC Chemokines in Intramembranous Bone Repair

PSP

B. Previously Approved Pending with Response Received and Under Review:

IRBNet ID 1657182-6

PI: Marcus, Elizabeth, MD

Study Title: The role of CagA/CagPAI in H. pylori-induced decrease in Na, K-ATPase as a mechanism of gastric injury

PSP

IRBNet ID 1616151-13

PI: Tsukamoto, Hidekazu, DVM, PhD

Study Title: Mitochondrial Dysfunction, Permeability Transition Pore, and Acute Pancreatitis

C. Previously Tabled Submissions For Which A Response Has Been Received.

D. Previously Reviewed Submissions For Which No Response Has Been Received.

IRBNet ID 1739101-2

PI: Benhammou, Jihane

Study Title: A lipid signaling network through stearoyl Co-A desaturase regulates hepatocellular carcinogenesis through YAP/TAZ activity

XI. Adjournment: The meeting was adjourned at 2:20 p.m. The next meeting is scheduled for July 9, 2025, at 1:00 p.m. via Teams.