Denise A Barringer

The meeting addressed several agenda items, including the conflict of interest recusal for Dr. Shilpa S. Dhar regarding project RM00007811-RN00_AM5. Reports were presented by the Manager of Environmental Health & Safety and the Director of Environmental Health & Safety Administration, both stating nothing to report. The agenda included reviews of new protocols. For BSL-2 New Protocols, several protocols were approved with contingencies: RM00008602-RN00 concerning COVID Spike mRNA mix in animals, RM00004922-RN01 involving lung cancer promotion mechanisms via COPD condition, RM00004887-RN01 for a clinical protocol involving engineered NK cells in astrocytoma patients, RM00008586-RN00 involving melanoma cell lines and fecal microbiota transplantation, RM00008605-RN00 concerning CAR-T cell therapy for B-cell lymphoma, RM00001309-RN02 studying lung tissue regeneration, RM00008580-RN00 regarding an advanced melanoma study using a modified HSV1 virus, RM00001523-RN02 involving the functions of mutated mTOR, RM00008558-RN00 concerning efficacy in multiple myeloma, RM00007811-RN00_AM5 involving amendments to a protocol with lentiviral and non-viral vectors targeting gastric adenocarcinoma, RM00000781-RN02_AM8 adding an adenovirus backbone for a study on aging and Alzheimer's research, RM00006199-RN00_AM1 updating personnel and IACUC protocol numbers, RM00007111-RN00_AM7 with minor edits to an experimental plan, RM00002650-RN01_AM11 adding elements for transfer via MTA, RM00005849-RN00_AM60 updating an IACUC protocol number, RM00006297-RN00_AM8 updating an IACUC protocol number related to HIV-1 variants, RM00006717-RN00_AM9 adding retroviral backbones and HEK293 derived cell lines, RM00008452-RN00_AM1 adding a lentiviral plasmid, RM00000627-RN02_AM16 adding an objective related to aging and Alzheimer's research, RM00004137-RN01_AM2 adding agents for in vivo administration, RM00000599-RN02_AM10 involving extensive vector list consolidation, RM00006480-RN00_AM7 adding an adenovirus backbone and utilizing the sleeping beauty system, RM00000187-RN02_AM8 updating vector information, RM00004261-RN01_AM2 updating IACUC protocol and grant funding details, RM00000378-RN02_AM9 adding a new IACUC protocol, RM00000505-RN02_AM5 involving updates to various vectors and cell lines, RM00000201-RN02_AM2 updating an IACUC protocol number, and RM00003599-RN01_AM5 concerning the removal of human cell lines. Section 8 addressed Administrative Modifications for protocol RM00007111-RN00_AM8.

The Institutional Biosafety Committee meeting addressed the approval of past meeting minutes, conflict of interest recusals related to specific projects involving Dr. Humam N. Kadara, and reports from the Adverse Events and Safety Committee. The primary focus was the review and approval of numerous new protocols falling under BSL-2, involving various investigators and protocols utilizing non-viral, viral, and microbial agents across different cell lines and animal systems. Several protocols were approved with contingencies pending clarifications or amendments, such as those involving gene manipulation for cancer research and vaccine candidate testing.

The meeting covered several topics, including a report of adverse events and safety committee updates. There was discussion and approval with contingencies for new BSL2 protocols involving viral and non-viral systems, cell lines, and microbial agents, focusing on studies related to cancer and immune responses. Modifications to existing protocols were also reviewed and approved, including updates to IACUC protocols and personnel changes.

The meeting covered various topics, including reports from the Adverse Events and Safety Committees, as well as the Recombinant DNA (RM) Subcommittee. The committee reviewed and approved new transgenic animal protocols, including those related to gliomagenesis, neurodegeneration, and colon cancer research. Additionally, the committee discussed and approved several new BSL 2 protocols involving viral and non-viral systems, cell lines, and microbial agents for studies on cancer cells, gene expression, and immunotherapy. Administrative modifications and updates to existing protocols were also reviewed and approved, including changes to IACUC information, the addition of new cell lines and genes, and updates to microbial agents.

The meeting included a report of adverse events and a report from the Safety Committee, both indicating nothing to report. The Recombinant DNA (RM) Subcommittee also provided a report. The committee reviewed and approved several new BSL2 protocols with contingencies, involving various investigators, document numbers, and NIH Guidelines categories. These protocols covered a range of agents, including viral systems, cell lines, and microbial agents, used in different research settings and with specific biosafety levels. Modifications with new BSL2/BSL3 agents/procedures/PI changes were also discussed and approved with contingencies for multiple investigators and projects.