"USDA also makes biodefense grants; but does not enforce its own biosafety regulations in doing so. Formerly, all recipients of USDA biotechnology research grants were required to sign and submit a Research Assurance Statement certifying that they would comply with the NIH Guidelines and, thus, form and operate a local IBC to review research.
FAILURE OF INSTITUTIONAL BIOSAFETY COMMITTEES
In addition to the oversight gaps among private sector and government labs, there is widespread failure by institutions with registered IBCs to actually operate committees that meet and attend to their duties. The Sunshine Project has been publicly documenting these failures since 2003,7 shortly after the NRC’s Fink Committee published its report Biotechnology Research in an Age of Terrorism, which recommended that IBCs form the front line for the safety and security of research with biological weapons agents.
• The IBC of the University of Georgia is responsible for reviewing research at the USDA
Southeast Poultry Research Laboratory (SEPRL) in Athens, GA. SEPRL is where the first
experiments to bring back to life the major genes of 1918 influenza occurred. In 2003, the Sunshine Project asked the University for the minutes of its IBC review of these experiments. It transpired that no minutes existed because no IBC review was performed of the research, which involved creation of an extraordinarily dangerous and novel influenza strains. In fact, the University of Georgia does not appear to have ever held an IBC meeting until 23 March 2006, a few days after the Sunshine Project again asked for its minutes.
• The Rockefeller University in New York City is a major biomedical research institute. Asked for minutes of its IBC in 2004, the University refused to provide any records yet peremptorily demanded that the Sunshine Project state that it has “fully complied” with the request for minutes. Eventually, Rockefeller was forced to reveal that its IBC had met once in 2003, to review a single project (and nothing else). The most recent meeting before that was in 1998. In 2006, Rockefeller refused to reply to renewed requests for its IBC minutes.
• The Southwest Foundation for Biomedical Research (SFBR) in San Antonio, Texas, operates the county’s only private BSL-4 laboratory and it refuses to produce documentation of its IBC actually reviewing projects.
• Asked for its IBC minutes in 2004, Emory University in Atlanta, Georgia could not produce minutes reflecting committee review of a single research project. Despite its huge research portfolio, at none of its meetings from 2001 to 2004 did the Emory IBC review biosafety of any project. Instead, Emory's IBC hears general presentations from staff about biological, chemical, and radiological safety.
• Utah State University states that its IBC approved at least 48 research protocols before the committee was ever organized. Utah State could not produce any minutes of meetings of its IBC, except those of an emergency meeting - its first ever - called after the Sunshine Project requested its IBC minutes.
• The Venter Institute, formerly known as The Institute for Genomic Research in Rockville, MD, has historically not had a functional IBC to review its research. (This is discussed in more detail in “Failure of NIH Oversight”.). Despite that fact, a Venter-led consortium studying synthetic biology risks recently suggested that IBCs could take the lead in review of synthetic biology experiments."  |