IBC Amendment Form - Office of Research Compliance

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Indiana University
Institutional Biosafety Committee
STUDY AMENDMENT*
*To be used with the old IBC protocol form only (IUPUI / IUB).
Principal Investigator:
Department:
Email:
IBC Protocol #:
Originally Approved On:
Approved Biosafety Level:
Project Title:
Funding Agency(s):
VA Affiliated:
IBC Amendment #:
Perform a risk assessment per Section II-A-3 of the NIH Guidelines in order to determine the appropriate level of review by the IBC.
Submit all materials as a Word documents to your campus’ IBC:
IUPUI: ibcbhc@iupui.edu
IUB: iubibc@indiana.edu
Please note: This amendment form is required only for protocols submitted on the legacy protocol form. Amendments made to
protocols on the new protocol form (11/2014) should be made directly on the protocol form (Sec. I-C-2). Please submit this form as
a Word document.
MINOR AMENDMENT*:
MAJOR AMENDMENT**:
Adding/removing personnel (see required training)
Note: Please include IU email address in the description below.
Note: All personnel must complete required training before
beginning work on an IBC protocol. Please visit the IBC
Training webpage for more information.
Adding new plant or animal species
Adding/changing/removing cell lines
Adding/changing transgene
Adding/changing/removing transgenic animals
Adding/changing infectious agents
IACUC study #:
IACUC amendment #:
Adding/changing/removing laboratory room numbers:
Rooms being added:
Upgrade in containment level:
Current Biosafety Level:
Proposed Biosafety Level:
Other
Rooms being removed:
Other
*Submit amendment form and any supporting documents. The
amendment will be considered by an IBC member for expedited
review.
Rev. 03/15
**Submit signed amendment form, a signed
revised IBC Protocol Submission Form, and any
supporting documents. The amendment will be
considered in a convened meeting of the Biosafety
Committee.
Describe the proposed change(s) and rationale for the change(s):
NOTE TO INVESTIGATORS: Study amendments may not be instituted until approval from the Institutional Biosafety Committee is
given. Retain this form for your records.
Investigator:
Date:
Principal Investigator Signature
[ ] Type name above and check for electronic signature
Date
The amendment of this project has been reviewed and approved by the IUPUI Institutional Biosafety Committee.
Authorized
IBC Member:
Date:
IBC Office:
Date:
Final Approval
Rev. 03/15
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