IUPUI Institutional Biosafety Committee
												     Study No. ____________
STUDY AMENDMENT 
											         Amend. No. ___________
Principal Investigator: ______________________________________  Department: ____________________
Building/Room Number: ____________________________________  Telephone: _____________________
Project Title:  _____________________________________________________________________________
_________________________________________________________________________________________
Funding Agency(s):  ________________________________________________________________________

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.  Factors to consider include:  virulence, pathogenicity, infectious dose, environmental stability, route of spread, communicability, operations, quantity, availability of vaccine or treatment, and gene product effects such as toxicity, physiological activity, and allergenicity.  Any strain more hazardous than the parent (wild-type) strain should be considered for handling at a higher Biosafety level.  Also consult OSHA requirements for guidance.

MINOR AMENDMENT*:
  Adding/removing co-investigators
  Adding/changing/removing cell lines
  Adding/changing/removing transgenic animals
  Other
*Submit amendment form and any supporting documents.  The amendment will be considered by an IBC member for expedited review. 

MAJOR AMENDMENT**:
  Adding/changing organism
  Adding/changing transgene
  Adding/changing infectious agents
  Other
**Submit amendment form, 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 IUPUI Institutional Biosafety/Biohazard Committee is given.

Investigator's Signature: __________________________________________  Date: _____________________
__________________________________________________________________________________________

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

Authorized IBC/BHC Signature: ________________________________________Date: __________________
Rev. 07/07