Biosafety Bulletin Vol 2 Issue 1 – April 2015

A quarterly newsletter from the BU Office of Institutional Biosafety Committee
See the PDF of the April 2015 Biosafety Bulletin

Boston University Biosafety Manual

BU Biosafety Manual defines the biological safety policies and procedures pertaining to research operations at Boston University and Boston Medical Center. Annual updated manual is available online.

IBC Policies & Procedures

The above-mentioned website is an excellent source for all IBC related policy and procedure documents including PI responsibility, strain verification, training policy, viral vectors, human embryonic stem cell, inactivated biological samples, biologicals with an increased potential to cause laboratory acquired infection, and more.

Human Gene Transfer Protocol Review

The IBC and the Human Gene Therapy Subcommittee recently reviewed and approved a human gene transfer protocol which studies the safety and effectiveness of hepatocyte growth factor plasmids injected into the leg of subjects with critical limb ischemia.

IBC also hosted a training session entitled “Gene therapy protocol review: NIH guidelines”.

Regulatory Updates

United States Government has released a new policy for the Dual Use Research of Concern (DURC) last year. Concerned PIs are encouraged to view this document at our website to assess applicability of this policy in their research.

News from IBC office

IBC welcomed the new Chairperson, Dr. Deborah Stearns-Kurosawa, Ph.D. She is an Associate Professor at the BU Pathology and Laboratory Medicine department and a long-time member of the IBC committee.

  • RIMS automated e-mail alerts PI and personnel about important requirements for proper maintenance of research compliance. Pay close attention to these e-mails.
  • When submitting an IBC protocol, assess carefully the submission type. If it does not fall into specific requirements or within the annual renewal/3-year renewal submission time frame, you will continue to receive those reminder emails.
  • If your research has IRB and IACUC component, be aware that the order of approval is IRB>IBC>IACUC. This means that to get approval of an IACUC protocol, you must get your IBC approval first. Similarly, if IRB approval is needed, it must be obtained before your IBC protocol can be approved.
  • For an IBC protocol to be approved, appropriate lab safety training and ROHP clearance must be obtained for EACH personnel listed on the protocol. Lab safety and ROHP clearance is also a must for the PI of a protocol, no matter whether a PI works on the bench or not. PI is the sole responsible person for any hazard and safety related issue. If a PI is not involved with any benchwork, he/she must contact ROHP office to find an appropriate resolution.
  • Make sure that BSL and ABSL designations of research space used in your protocol matches in both “Research Facility Information” page and “Material Used in Research” page.

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