USC IBC PROTOCOL MODIFICATION INSTRUCTIONS
(Protocol Modification Form is on Page 4)
1. Protocol modifications (e.g., a change of the rDNA host-vector system to another
prokaryotic, eukaryotic or viral species, addition of biological agent, select agent or
carcinogen) require IBC review and approval before implementation of the changes.
2. Please submit an original Request for IBC Protocol Modification form and typed narrative
that describes the proposed change. Modification forms must be signed by the Principal
Investigator and dated before submission.
3. Modification requests can be submitted by e-mail to IBC@caps.usc.edu or hard copy to:
Environmental Health & Safety
Institutional Biosafety Committee (IBC)
CHP 148, Mail Code 9005
4. The IBC Chair and/or Biosafety Officer will perform an initial review of the modification.
An IBC subcommittee may review some types of modifications to existing protocols. Other
types of modifications may require full committee review. Modifications that change the
nature of the original application may require a new protocol submission for full committee
review prior to initiation of such experiments.
5. It is recommended that all modifications be submitted on or before an IBC deadline.
Deadlines and meeting dates are posted on the IBC Website at:
http://capsnet.usc.edu/LabSafety/BioSafety/IBCSection
6. Modifications that are submitted for Chair review but require full committee review will be
reviewed according to the posted deadlines on the Web (i.e., modifications received after an
IBC deadline that require a full committee review will be held until the next IBC deadline.)
Submission Procedure for Full Committee Review:
 Submit an original Request for IBC Protocol Modification form, typed narrative by 5
p.m. on or before an IBC deadline to the Environmental Health and Safety Office.
 The IBC will review the modification at a convened IBC meeting.
Submission Procedure for IBC Chair Review:
 Submit an original Request for IBC Protocol Modification form, typed narrative, to the
Environmental Health and Safety Office.
 All submissions received by Friday at 5 p.m. of a given week will be considered for
Chair review the following Friday.
IBC Protocol Modification Instructions 7/21/06
Page 1 of 4
INFORMATION TO INCLUDE IN THE NARRATIVE DESCRIPTION:
Provide a detailed description of the proposed change. Include in the description the following
information related to the desired change:
A. Addition or change to the rDNA host-vector system:
1. Please list separately each new, changed or deleted host-vector system.
 Identify the host(s) to be used (e.g., target of gene transfer). Examples: E. coli, S.
cerevisiae, human/animal cells, whole animals, humans.
 Identify the vector(s) to be used. Examples: Bacterial plasmids, yeast plasmids,
cultured cell plasmid vectors, baculoviruses, transforming viruses
 Identify the nature of the DNA sequence, including the species of origin (i.e., specific
gene, promoter, expressed product and function (if known).
 Provide species designations for all organisms where possible.
 If foreign gene product(s) will be purified, indicate which foreign gene product will
be purified and describe the procedures for purification
2. Include experimental operations, procedures or techniques that might increase the risk
associated with the use of recombinant DNA materials (e.g., creation of aerosols).
3. If replication-incompetent vectors will be used, include information about how
incompetent vectors will be tested for reversion mutations (e.g., endpoint dilution
analysis, plaque assay).
4. Identify the risk group (RG) classification of the recombinant or etiologic agent(s) and
the proposed biosafety level (BSL).
5. Describe any changes to the decontamination and/or disposal practices described in the
application.
6. Indicate why the new procedure(s) should be a modification of the existing project
rather than a new protocol submission.
7. Indicate whether a new source of funding is associated with the new procedure.
8. Describe how personnel have been (or will be) trained to handle the new or changed host
vector system.
9. In addition, please modify the relevant Addendums (e.g., Addendums I, V, VI) on the
original protocol to reflect the addition of the new host-vector system, and include them
with your protocol modification submission.
B. Biological, Carcinogenic, Select Agents, or DOJ Chemical Precursors
1. Please list separately each new, changed or deleted agent.
2. Include experimental operations, procedures or techniques that might increase the risk
associated with the use of the biological or carcinogenic materials (e.g., creation of
aerosols).
3. Identify the risk group (RG) classification of the recombinant or etiologic agent(s) and
the proposed biosafety level (BSL).
4. Describe any changes to the decontamination and/or disposal practices described in the
application.
5. Indicate why the new procedure(s) should be a modification of the existing project
rather than a new protocol submission.
6. Indicate whether a new source of funding is associated with the new procedure.
IBC Protocol Modification Instructions 7/21/06
Page 2 of 4
7. Describe how personnel have been (or will be) trained to handle the new or changed
agent.
8. In addition, please modify the relevant Addendums (e.g., Addendums V, VI, VII) on the
original protocol to reflect the addition of the new biological, carcinogenic, select agent,
or DOJ chemical precursor, and include them with your protocol modification
submission.
C.
Personnel changes
To add personnel:
1. Provide the names of personnel to be added. Include degree, job title, department, and
tasks assigned.
2. Describe how personnel have been (or will be) trained to handle the agents described in
this protocol application.
 If laboratory personnel attend pertinent safety courses (e.g., Lab Safety Orientation,
Blood-borne Pathogens, Respiratory Protection), provide the name of the training
course in this section of the application (or attach documentation).
 Investigator training must be documented in writing (per OSHA training
requirements). For more information about this requirement, please contact
Environmental Health and Safety directly.
To delete personnel:
1. Provide the names of personnel to be removed.
2. Identify what the person’s responsibilities were on the project and who will assume
those responsibilities.
3. If no one will be taking over responsibilities, explain how their responsibilities will be
managed, or indicate which procedures will no longer be performed.
4. Indicate the date the person should be removed from the protocol.
D. Room Changes (e.g., laboratory/surgery rooms or housing location):
1. Provide information about the new building and room number where agent(s) will be
used/stored.
2. Indicate whether any buildings or rooms listed on the protocol should be removed.
E. Contact Information Changes (e.g., mailing address, telephone, fax, email, pager)
1. Provide the new information on an attached sheet.
IBC Protocol Modification Instructions 7/21/06
Page 3 of 4
REQUEST FOR IBC PROTOCOL MODIFICATION
University of Southern California
Institutional Biosafety Committee
PI NAME:
PROTOCOL#
PHONE NUMBER:
TITLE:
MAILING ADDRESS:
E-MAIL ADDRESS:
MAIL CODE:
1. Please check the appropriate box(es) for all necessary changes to the approved protocol.
rDNA host-vector system:
Addition of a new rDNA host-vector system
Change(s) to an approved rDNA host-vector system
Change(s) in the experimental operations, procedures or techniques used
Change(s) to the approved decontamination and/or disposal practices
Biological, Carcinogenic, Select Agents or DOJ Chemical Precursor:
Addition of a new agent
Change(s) in the experimental operations, procedures or techniques used
Change(s) to the approved decontamination and/or disposal practices
Personnel:
Adding new personnel -List here:
Deleting personnel -List here:
Locations:
Change of procedure/storage rooms
Change of investigator contact information (e.g., mailing address, telephone, fax, e-mail)
Other:
Indicate the change:
2. Attach a typed narrative that describes the modification. Please refer to the modification
instructions for submission requirements and required information for IBC review. Changes
must not be implemented until IBC approval is granted.
P.I. Signature _________________________________________ Date: ___________________
Inclusion of this modification into the referenced protocol has been approved by the IBC.
________________________________________________
Signature of IBC Chair or designee
_______________________
Date