Biosafety Office revises, simplifies procedures
by Dr. Jim Davis
New biosafety protocol application forms and a restructured Institutional Biosafety Committee are the latest in a succession of efforts to streamline approval of biosafety protocols. The Biosafety Office has cut the time required to review most protocols from a month to less than a week (the exception being protocols involving non-exempt recombinant DNA). Protocol application forms have been redesigned to minimize the amount of information required.
The Biosafety Office also is developing templates to help researchers establish laboratory- and risk-specific standard operating procedures. Biosafety Web pages are being revamped and an MCG biosafety manual is being created with forms and reference information more easily accessible.
Visit www.mcg.edu/services/ehs/biosafe/biosafe.htm for the new protocol application forms, instructions, examples and reference material.
The Biosafety Working Group, an advisory group established by Vice President for Research Dr. Frank Treiber comprising representatives from key campus research institutes, centers and departments, provided input to help strike a critical balance maintaining compliance with federal and state laws, regulations and guidelines, and reducing administrative burdens on researchers.
The Institutional Biosafety Committee reviews research plans for biological material, facilities and personnel training for research of all types, which must comply with guidelines determined by the National Institutes of Health to receive NIH funding. A complaint against MCG in late 2004 from the community activist group, The Sunshine Project, led the NIH to require that MCG inventory its research portfolio, identifying research projects and institutional policies and procedures not in compliance with guidelines and immediately rectify the irregularities. During these internal audits, additional violations of federal and state regulations and guidelines were discovered.
During this demanding period, Dr. Phillip Chandler, a research scientist in the Immunotherapy Center, became the committee’s chair and Dr. Stacey Kraemer was appointed institutional biosafety officer in the Division of Environmental Health and Safety, taking on the challenge of bringing standards up to compliance expectations without impeding research.
“Having been a biomedical researcher for over 17 years,” said Dr. Kraemer, “I can certainly appreciate all of the difficulties investigators face in maintaining a research program. I’m glad to have an opportunity to help improve the process.”
Now, with the construction of MCG’s first biosafety level 3 laboratories (facilities designed to contain highly contagious or deadly pathogens), the Biosafety Office is also helping to ensure these facilities meet the exacting requirements of the NIH and the Centers for Disease Control and Prevention.
– Dr. Davis is director of the Department of Environmental Health and Safety