Meeting Minutes
Doc. No.: IBC-FORM-19 V.01.4 Page 3 of 3
Effective Date 04 AUG 2025
o The Site confirmed that study personnel are sufficiently trained in the practices and
techniques required to safely work with the IP.
o The Site confirmed that staff members receive Bloodborne Pathogens training.
o Occupational Health Recommendations: Staff who are pregnant or breastfeeding,
immunocompromised, or have ongoing inflammatory skin conditions or severe eczema
should not handle preparing the study agent. Staff who have open wounds or cuts which
may be exposed to the agent should consider consulting with the PI or occupational
health prior to handling the study agent.
o The Committee had no additional significant comments or recommendations regarding
the description of the potential risks and occupational exposure hazards associated with
handling the IP in this clinical trial, or the proposed mitigation strategies, as detailed in
the Risk Assessment.
• The Committee reviewed the Site's facility details, relevant study-specific procedures and
practices, the PI's credentials and other applicable information provided by the Site for the
purposes of the IBC review.
o The Chair noted that this is a Change in Research to change the Principal Investigator to
Dr. Douglas Orr. The Committee had no concerns with this change.
o The Site verified that the information provided by the Chair was accurate.
Motion: A motion of Full Approval for the study at BSL-2 was passed by unanimous vote. There
were no votes against and no abstentions.
• Contingencies stated by the Committee: None
• Stipulations stated by the Committee: None
Review of Incidents: Nothing to report
IBC Training: Nothing to report.
Reminder of IBC Approval Requirements.
Adjournment: The IBC Chair adjourned the meeting at 3.42 PM
Post-Meeting Pre-Approval Note: None
