Vaccine Virus Infection Case
November 2009 – The CDC reported in its Morbidity and Mortality Weekly Report (MMWR) that a man in Virginia acquired a vaccine virus infection at a Virginia academic institution. The CDC concluded in its investigation that the individual had been exposed to a VACV strain that had contaminated the seed stock from the laboratory where the man worked. The case underscores the importance of adherence to ACIP vaccination recommendations for laboratory workers and use of safety precautions when working with non-highly attenuated VACV. For more information visit the cdc website:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5829a1.htm?s_cid=mm5829a1_e
New Version of NIH rDNA Guidelines
10/2/09-- The latest version includes the current biosafety guidance for research with potentially pandemic influenza viruses, and harmonizes with the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (5th edition) and other regulatory policies. The new version is available on the NIH website and provides additional guidance regarding the biosafety level containment practices, training, animal containment and occupational health.
Importance of Monitoring Plans
7/15/09--The New England Journal of Medicine published a July report highlighting the importance of having a well-designed monitoring plan when subjects in a research study become ill. The case referenced involves a patient who was enrolled in a gene-therapy trial to treat rheumatoid arthritis. The patient contracted a fatal infection, however due to the close monitoring investigators were able to determine the cause of death was unrelated to the agent administered in the trial.
Click here to read the entire article from the July 9, 2009 Edition
Army Lab Discloses Unmarked Vial Concerns
7/10/09--The US Army Medical Research Institute of Infectious Diseases (USAMRIID) disclosed to Science magazine in July that it has found more than 9,200 unlisted vials while examining its inventory as the lab has been under intense scrutiny after the FBI implicated a former researcher in a 2001 anthrax attack. The samples represent approximately 13 percent of its 70,000 vials, and the lab’s deputy commander admits the institute’s lax security measures make it possible that unlisted samples could have been removed from the lab prior to the inspection.
The lab originally halted all research over a four-month period to inventory every vial involved in active research from its 330+ freezer and refrigerator facility following a 2005 incident, but the lab still didn’t have a complete inventory. One of the rules from the 2002 Bioterrorism Act, CFR 73.17, requires labs maintain an accurate, current inventory for each select agent, including the quantity and where it is stored.
Click here to read the entire article from the July 26, 2009 Edition
Biosafety Symposium Coming to St. Paul Campus
6/17/09--The American Biological Safety Association’s Midwest chapter is holding their Summer Symposium August 2-4 at the Continuing Education and Conference Center on the St. Paul Campus. This symposium satisfies part of the continuing education requirement for IBC members and will focus on biosafety training—past examples to future applications.
Symposium topics include Development and Implementation of Biosafety Training Programs, Exercises & Drills, Biosafety Issues in Open Laboratories, Institutional Biosafety Committee Software, and Updates from NIH/OBA. The program also includes Respiratory Protection for Infectious Agents training (CEUs Available), NuAire Factory Tour, BSC Training & Dinner Cruise, and Facility Tours at the University of Minnesota: Raptor Center, Equine Center, BSL3 Veterinary Necropsy & Alkaline Digester.
Registration rates are discounted if submitted before July 4, 2009. There is also separate registration for a respiratory workshop specifically for biological agents that will be presented by Lisa Brosseau in the School of Public Health on Sunday afternoon that can be registered for separately from the rest of the symposium.
For more information visit: http://www.mabion.org and http://www.mabion.org/mabion%20summer%20symposium%202009%20v2.pdf
Consortium on Law and Values Lecture Series
6/1/09--The Consortium has posted archives of its video lectures on its website for interested parties. The 2008-09 series focused on Synthetic Biology: The Science, Ethics & Law of Creating New Life. The featured lectures include:
Synthetic Genomics: Risks and Benefits for Science and Society
Robert Friedman, PhD, J. Craig Venter Institute
The Paradigm Shift of Synthetic Biology: Tensions Between Innovation and Security
Prof. Arti K. Rai, JD, Duke Law School
Dialogue and Notes on Synthetic Biology
Prof. Drew Endy, PhD, Stanford University
Past lecture series are also available such as the 2007-08 series on Neurogenomics, the global biofuels debate, assisted reproduction and its markets, oversight of biomedical technologies, and emissions responsibilities within and between nations and the 2007-08 series centered on Nutrigenomics, nutraceuticals, and direct-to-consumer marketing of genomic nutritional profiling, and science and politics--controversies in regulation and national security.
OBA Launches Annual Reporting Tool for Human Gene Transfer Trials
11/06/08--The National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) has updated the Genetic Modification Clinical Research Information System (GeMCRIS) — a web-accessible database of human gene transfer clinical trials.
A new feature has been added that allows investigators and sponsors conducting human gene transfer trials to create and submit annual reports via a secure electronic interface within GeMCRIS. With this tool, reports can be submitted instantaneously to NIH OBA. The annual reporting module allows for safety information to be uploaded directly into GeMCRIS using an excel spreadsheet template. The entire annual report can then be submitted electronically through GeMCRIS, or additional information can be submitted separately to NIH OBA.
Investigators and sponsors can save their NIH OBA submission on their own computer and send a copy to the FDA in accordance with 21 CFR 312.33.
The electronic reporting tool is key to efforts by both NIH and FDA to improve oversight and facilitate investigator reporting for human gene transfer trials
The public GeMCRIS site is available at: http://www.gemcris.od.nih.gov/.
Investigators and sponsors who wish to use the system to submit annual reports and/or adverse events occurring on human gene transfer trials registered with NIH OBA should send a written request on institutional letterhead by U.S. mail or fax to: GeMCRIS Systems Administrator, NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892; Fax: 301-496-9839.
IBC Offers NIH Required Training for IBC Researchers
11/1/07 - Nationally recognized biological safety expert, Robert J. Hashimoto, will be offering training November 15 and 16 for Principal Investigators and laboratory staff on biological safety in the lab and implementation of the NIH Guidelines for Research Involving Recombinant DNA Molecules.
Attendance at one of these training sessions will satisfy NIH training requirements and count toward Responsible Conduct of Research continuing education requirements.
Hashimoto will offer three different sessions in the Mayo Memorial Auditorium:
- Session 1 - Thursday, November 15, 2007
9:30 AM - 10:30 AM --Biological Safety in the Laboratory
10:45 AM - 11:45AM -- Implementation of the NIH Guidelines
- Session 2 - Thursday, November 15, 2007
1:30 PM - 2:30 PM -- Biological Safety in the Laboratory
2:45 PM - 3:45 PM - Implementation of the NIH Guidelines
- Session 3 – Friday, November 16, 2007
9:30 AM - 10:30 AM-- Biological Safety in the Laboratory
10:45 AM - 11:45 AM -- Implementation of the NIH Guidelines
Contact IBC Research Compliance Supervisor Rachel Whitwam at 612-626-2161 if you have any questions and RSVPs to ibc@umn.edu are appreciated, but not required. Please indicate the number of attendees and which of the three sessions you plan to attend.
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