Risk Assessment For Use Of Engineered Genetic Materials In Clinical Research

By Scott Swindle, Assistant Director, Biosafety Services

Since the COVID-19 outbreak and the expedited search for a vaccine, the use of engineered genetic materials has rapidly expanded in clinical trials. Before vaccines or drugs using these materials can be approved for commercialization, however, they must undergo a risk assessment by the Institutional Biosafety Committee (IBC) to identify and mitigate potential risks associated with biological materials and ensure the safety of researchers and the public.

To ensure high biosafety standards are met, the assessment looks at hazard identification, risk evaluation, and risk management strategies concerning the engineered genetic material. By accessing the article, researchers and institutions will discover the benefits of a thorough IBC risk assessment, including compliance with regulations and standards, enhanced safety measures, and improved communication among research team members.