Download Updated August 2013 IBC Office: (612)626

Updated August 2013
IBC Office: (612)626-5654 or [email protected]
CHANGE IN PROTOCOL FORM
If the associated study is approved in eProtocol, please do not use this form.
Please initiate an Amendment in eProtocol. Contact the IBC office with questions.
IBC Code #:
Principal Investigator:
Primary
Project Title:
Please list the biological agents you are already approved to use under this protocol:
Indicate the type of changes requested (check all that apply):
1. Add title(s)
2. Add/remove laboratory personnel
3. Add/remove laboratory rooms or work area location
4. Amend experimental activities
5. Add infectious agents or biological toxins
6. Add gene transfer method
7. Add genes, DNA, or RNA sequences
1. If you are requesting additional title(s) to this project, please list below:
1a. Does the addition of the new title(s) include changes to experimental or safety procedures?
No, I confirm there are no changes to IBC approved experimental or safety procedures. (If you have no
other changes to request, you may skip subsequent questions.)
Yes. Describe changes in Question 4.
2. Personnel Changes
ADD Personnel
Name
(Last, First)
U of M
U of M
Employee
x.500 ID
or
(ex.
Student
smith001)
ID
Role in Project
Receive
Mail from
IBC
Completed Training
Lab Bio
Safety 1
NIH
Bloodborne
Guidelines 2 Pathogens 3
<Select>
<Select>
<Select>
<Select>
<Select>
<Select>
1−Required for all new personnel
2−Required for personnel working with rDNA
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3−Required for personnel working with human/zoonotic infectious agents, human blood, human body fluids, and/or unfixed
human/non-human primate tissue or cell lines.
REMOVE Personnel
Name (Last, First)
1.
4.
Name (Last, First)
2.
5.
Name (Last, First)
3.
6.
3. Location Changes
Add/Remove
Location
Add
Building
Room
Remove
Biosafety Cabinet
Certification Date
Shared Space
Choose One
Choose One
Choose One
Choose One
Choose One
Changes to IBC Approved Procedures and Experimental Activities
4. Briefly summarize the change(s) requested.
4a. Describe the rationale for the proposed change(s).
4b. Describe any potential implications the change(s) may have on health and safety:
5. Additional infectious agents or biological toxins to be added:
6. Please check and describe the NEW gene transfer method:
Physical methods (e.g., pronuclear injection, electroporation, “gene gun”, etc.)
Describe:
Host-Vector system (e.g., replication deficient lentiviral vector from commercial vendor)
Vector(s) used:
Source:
Other (e.g., nanoparticles, liposomes, etc.)
Describe:
6a. Describe each new method of gene transfer and its biosafety features. If the vector is derived from a
Risk Group 3 virus, provide justification for downgrading to BSL-2 containment, including key information
embodying the downgrading. (e.g., usage of commercially available system, specific mutations/deletions
rendering the virus replication-defective, nature of pseudotyping, low relative risk of mutation/recombination
restoring replication competence, any feature embodying biological safety of the vector system.)
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6b. Provide a scientific rationale for using the gene transfer method(s) proposed. You may cite publications
which document the safety and utility of this method. Please do not include actual articles or publications with
your submission.
7. List new genetic material to be transferred:
Genes, DNA or RNA
e.g. GFP (green fluorescent protein)
Species of Origin
jellyfish
Function of Gene
marker
8. Please attach applicable supporting documents for proposed changes.
Attach detailed Standard Operating Procedures (SOPs) for any changes to experimental activities
described above.
If the proposed changes affect methods for decontamination and/or waste disposal, attach an updated
Decontamination and Spill Clean-up Plan and/or Biological Waste Disposal Plan.
Attach a map of each new vector.
9. Assurance by Principal Investigator
Electronic submission of this form from the Principal Investigator’s X.500 email address confirms his/her
agreement to perform all activities according to the NIH Guidelines for Research Involving Recombinant DNA
Molecules and use biosafety practices described in the CDC/NIH Publication Biosafety in Microbiological and
Biomedical Laboratories (BMBL). Additional conditions required by the Institutional Biosafety Committee on
behalf of the University of Minnesota will also be followed.
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