East Carolina University

Institutional Biosafety Committee

REGISTRATION AMENDMENT*

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:

Please note: This amendment form is required only for protocols submitted on the original registration.

MINOR AMENDMENT*: / MAJOR AMENDMENT**:
Adding/removing personnel (see required training)
Note: All personnel must complete required training before beginning work on an IBC protocol. Please visit the Office of Prospective Health website 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 #: / Upgrade in containment level:
IACUC amendment #: / Current Biosafety Level:
Adding/changing/removing laboratory room numbers: / Proposed Biosafety Level:
Rooms being added: / Other
Rooms being removed:
Other
*Submit signed amendment form and any supporting documents. The amendment will be considered by an IBC member for administrative approval. / **Submit signed amendment form, additional protocols, and any supporting documents. The amendment will be considered in a convened meeting of the IBC
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 Date

[ ] Type name above and check for electronic signature

The amendment of this project has been reviewed and approved by the ECU Institutional Biosafety Committee.

Authorized IBC Member: / Date:
Office of Prospective Health: / Date:

Final Approval

Revised 8/4/2017