IBC Amendments and Annual Reviews

Amendments

If substantial changes are made during the course of ongoing approved research, then the proposal must be amended.  A substantial change would include such things as: a change in research class or biosafety level; a new select agent; a new pathogen; a major modification of a unique, non-commercial expression vector; any change in an expression vector resulting in increased levels of transgene expression; large changes in the nature of an inserted gene (ie: oncogene, virulence, origin or replication).  The committee will review the amendment and investigators will be notified by email of the committee’s decision and any action needed.

To submit an amendment: open the original electronic copy of the registration form for that protocol, update the form to reflect the changes and send it to Dan Hibbing.  The following items should also be in or attached to the email:

1. Write a brief synopsis outlining the original work approved by the committee.

2. Explain the changes describing the nature of the insert, modification of the vector or changes in the host.

 Annual Reviews

Each ongoing project must be reviewed periodically.  The Biosafety Officer will review any changes to ongoing research, as well as consider changes in regulations, law or university policy that may necessitate changes to the protocol.  Small changes can be made at the periodic review but substantial changes should be amended at the time of the change as stated above.  Reviews will be requested by email.  If you receive a review request please follow the instructions in the email.