The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering

By Scott Swindle, Assistant Director & Affiliated IBC Vice Chair, Biosafety Services

Recombinant DNA technologies and genetically modified biological agents are increasingly utilized across a broad spectrum of therapeutic applications, marking a significant trend in clinical trial research.

These investigational products (IPs) introduce unique hazards that may not be familiar to clinical personnel responsible for their handling. Unlike conventional hazards such as antineoplastic drugs or infectious materials, recombinant therapeutics require tailored policies and procedures for safe handling due to their specific risks.

Addressing this gap in hazard communication and safe handling practices is crucial, and an institutional biosafety committee (IBC) plays a pivotal role in developing standard operating procedures (SOPs) to mitigate these risks effectively. This blog explores the necessity of hazard communications in the context of clinical research involving recombinant therapeutics, outlining key components that should be included in an effective SOP.

Key considerations include comprehensive risk assessment protocols, specific guidelines for containment and disposal, personnel training requirements, emergency response procedures, and strategies for ongoing monitoring and review. By implementing robust hazard communication strategies and SOPs, institutions can ensure the safe and ethical conduct of clinical trials involving genetically modified biological agents, safeguarding both research integrity and participant safety.