title: An evaluation of the role and effectiveness of institutional biosafety committees in providing oversight and security at biocontainment laboratories.
abstract: Institutional biosafety committees (IBCs) have been charged with the oversight and review of biosafety at thousands of biocontainment labs nationwide, hundreds of which are high-level BSL-3 and BSL-4 labs. In light of the recent rapid proliferation of BSL-3 and BSL-4 facilities and the increases in research in the areas of biodefense, select agents, recombinant DNA, and synthetic biology and dual-use research, questions have been raised about whether IBCs are fulfilling their oversight responsibilities. This article reviews information on the responsibilities and expectations of IBCs as currently constituted and provides an analysis of IBC performance from survey data of hundreds of research institutions over the past several years. The findings highlight serious ongoing problems with IBCs' adherence to NIH Guidelines. This raises questions about the current voluntary governance framework as an effective system to monitor and oversee U.S. research facilities, including high-containment facilities, and their research activities. The findings strongly suggest the need for immediate improvement or replacement of the IBC system.
authors.affiliation: SETI Institute, Carl Sagan Center for Study of Life in the Universe, Mountain View, California 94043, USA. mracemom@aol.com
authors.forename: Margaret S
authors.initials: MS
authors.lastname: Race
authors.forename: Edward
authors.initials: E
authors.lastname: Hammond
mesh_terms: D026683:Advisory Committees; D003264:Containment of Biohazards; D019983:Guideline Adherence; D017408:Guidelines as Topic; D007753:Laboratories / Q000191:economics; D009316:National Institutes of Health (U.S.); D017149:Private Sector; D015397:Program Evaluation; D012380:Role; D012637:Security Measures; D014481:United States