Institutional Biosafety Committee (IBC)

Verification of the Identity of Attenuated Pathogens

This policy covers all attenuated pathogens which meet the following criteria:

  1. the attenuated pathogen is derived from a known, virulent pathogen that requires BSL3 or BSL4 biosafety containment;
  2. attenuation results in decreased virulence of the organism;
  3. attenuation results in a reduction in the level of biosafety containment in which the attenuated pathogen can be handled, compared with the biosafety level required for the safe handling of the non-attenuated counterpart.

As is the case with all proposed studies at Boston University, work with any pathogen, including attenuated pathogens, cannot be initiated (and the pathogens cannot be brought into BU) without prior approval from the Institutional Biosafety Committee (IBC).

Policy

  • The identity of any attenuated pathogen must be verified before it can be handled at the lower biosafety containment level of the attenuated pathogen. Verification should be by restriction analysis or another method that has been proven to rigorously distinguish the wild-type and attenuated pathogens. Verification should be conducted on the received stock and, whenever possible, verification should be carried on an individual clone of the incoming attenuated pathogen. Only material from the verified clone (or stock) can be studied at the lower biosafety level.
  • Verification should be carried out by the receiving BU laboratory pursuant to an IBC-approved protocol for verification. The attenuated pathogen must not be received at BU until after the IBC-approval of the protocol for verification, including how and where the specimen will be stored upon receipt. Upon receipt of the specimen the pathogen must be handled at the higher biosafety level of the non-attenuated, wild-type pathogen until the specimen has been verified to contain only the attenuated pathogen that can be safely handled at the lower biosafety level. Verification must be submitted to the IBC, or their designee, for review prior to transferring the attenuated pathogen to the lower containment level.
  • If the identity of an attenuated pathogen cannot be verified, it must be handled at the higher biosafety level of the non-attenuated wild-type pathogen.

Also see