Icahn School of Medicine at Mount Sinai

Icahn School of Medicine at Mount Sinai Institutional Biosafety Committee Meeting Notes June 17, 2014

Present: Drs. Albrecht, Felsenfeld, Johnson, Lee, Simon, Wallach; Mr. Aminian, Ms. Schneier

Also Present: Dr. Dirk Homann

1) Changes in the Committee roster

Dr. Simon introduced Benhur Lee, MD, PhD, who recently joined Mount Sinai as a Professor of Microbiology and has agreed to serve on the Institutional Biosafety Committee as of July 2014. Dr. Ben tenOever will rotate off the committee as of June 30, 2014.

2) Approval of Minutes

The minutes of the May 15, 2014 meeting were approved.

Dr. Simon thanked members for their input on the assessment of the NIH/NIAID Centers of Excellence for Influenza Research and Surveillance contract, Dr. Garcia-Sastre’s Dual Use Research of Concern (DURC) project. The IBC letter was sent to GCO which submitted the document to the NIH on June 24, 2014.

3) Planned Experiments Under Review by IACUC/Dr. Homann

At the request of Dr. R. Miller, Director of the Center for Comparative Medicine and Surgery, Dr. Homann summarized for the IBC the viruses that he studies, all of which are at BSL-2 level.

4) Protocols:

a) (Homann) Two previous BS-Approvals for Procedures The issue was tabled pending IACUC review. The pathogens require BSL2 practices and precaution. Additional SOPs and protocols may be requested to protect immuno- compromised or pregnant individuals. The committee members will comment on the pending IACUC protocol.

b) (Aird) Pre-approval for two clinical studies which are not under NIH Guidelines, but are still reported to the IBC since we are requiring BSL-2 practices and reporting of any (S)AE’s No vote was necessary on this protocol, which was previously reviewed by Dr. Simon and Mr. Hauck.

c) (Basler) “Replication Complex of Reston Virus” Work with different mammalian expression plasmids encoding Reston virus proteins (less than 2/3 of the genome) are proposed. No infectious virus can be generated with these reagents. The protocol was approved for work at BSL-2.

5) New Business

The DURC sub-committee reviewed a risk mitigation and communication plan developed by Dr. Garcia Sastre for project 008: Role of the PB1-F2 of H7N9 viruses in pathogenesis (part of the Center for Research on Influenza Pathogenesis grant). The subcommittee found the risk mitigation and communication plan appropriate and proposed to approve the document. The full committee followed this recommendation. The risk mitigation and communication plan will be submitted to NIH by the PI.