Overcoming regulatory gaps in biological materials oversight by enhancing IBC protocol review

Abstract In the United States, several regulations and federal policies govern the use of potentially biohazardous materials in research and industry. Part of this oversight is assigned by mandate to Institutional Biosafety Committees (IBCs). However, most research entities give additional responsibilities to their IBC to take advantage of a standing body with significant expertise in review and oversight of biohazardous research. Two case studies are provided to highlight functions of the IBC which are not mandated, yet are critical for safe and responsible research. There are also types of biohazardous work that are currently unregulated and receive no review from an IBC or other group of subject matter experts, leaving a gap in safety oversight. To mitigate the hazard of working with potentially hazardous unregulated biological material, the necessity of performing a risk assessment and of performing a hazard review by subject matter experts, such as those on an IBC, is of paramount importance.