Fillable FormD-ProtMod-A DATE APPLICATION

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FormD-ProtMod-A DATE APPLICATION

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Page 1 of 6
Document #0354
OFFICE FOR RESEARCH USE ONLY
DATE RECEIVED OR REVISED:
VERSION:
*ONLY TYPED FORMS WILL BE ACCEPTED*
IBC Protocol No.:
Modification No.
1. PROJECT TITLE:
2. PRINCIPAL INVESTIGATOR:
Name (Last, First):
Email
Change in PI Contact Information: Complete the section below only if there has been a change that was not previously
reported to IBC.
Department Affiliation: Mailing Address
1
: Work Phone Number:
Email Address:
3. Nature of Modification (check all that apply) - Use this form for modifications to approved recombinant or
synthetic nucleic acid and/or infectious agent/toxin IBC protocols unless the study involves human gene transfer or use
of an infectious agent in human. For studies of involving humans- Please contact the IBC directly for guidance.
a. Gene inserted i. Transgenic Plant
b. Plasmid or vector systems j. Principal Investigator
c. Infectious agent k. Project Title
d. human or NHP cells, cell lines, or OPIM l. Project Personnel
e. Host systems m. BSL or Biosafety Practices
f. Whole Animal n. Locations
g. Transgenic Animal o. Other (e.g. funding sources, etc.)
h. Whole Plant
FORM D - Modification of an
Approved IBC Protocol
Ver
sion 1.0
Idaho State University, Office for Research
Institutional Biosafety Committee (IBC)
1651 Alvin Ricken Drive, Pocatello, ID 83201-8046
P
hone: 208-282-2
179 Fax: 208-282-4723
ISU Protocol Modification - Form D/IBC
IBC Protocol No. ________
Version 1.0
Page 2 of 6
Document #
4. Summary of Requested Modification- Answer each applicable section COMPLETELY and BE
SPECIFIC.
a. Addition of New Genes or Classes of Genes- List the following: 1) genes of interest, 2) species of
origin, 3) source of DNA/RNA, 4) the function of the gene, 5) the plasmid/vector system used, 6) the
host, and 7) manipulations.
b. Change or Addition of plasmid or vector system: List the following 1) Plasmid or vector, 2) Source, 3)
genes inserted, 4) species of origin, 5) source of DNA/RNA, 6) the function of the gene, 7) host, 8) if
vector is attenuated, provide description of attenuation, 9) packaging cell line (if applicable), 9) host
range of the vector, and 10) antibiotic selection marker.
c. Change or Addition of Infectious Agent: List the following: 1) infectious agent and strain, 2) Source, 3)
concentration and volume, 4) Risk group, 5) recommended biosafety level (BSL) for handing this
agent, 6) describe the pathogenicity or attenuation (if applicable), 7) describe the potential signs and
symptoms of exposure/infection by this agent, 8) procedures to be performed, 9) Is this agent listed
as a Select Agent by the CDC or USDA? If the answer to question 9 is yes- Contact IBC office prior
to submission of this modification.
ISU Protocol Modification - Form D/IBC
IBC Protocol No. ________
Version 1.0
Page 3 of 6
Document #
d. Change or Addition of human or NHP cell, cell line, or OPIM: List the following: 1) cell, cell line, or
OPIM, 2) Source, 3) any pathogen screening performed, 4) known infecting pathogens or intended
infecting pathogens, 5) recommended biosafety level (BSL2 or above) for handing these materials, 6)
describe the potential BBP hazards.
e. Change or Addition of host system: List new hosts- 1) Laboratory E. Coli Hosts, 2) Non E. Coli Hosts
(e.g., other microorganisms), 3) Pathogenic E. coli Hosts, 4) Cell lines, 5) other. For each organism
listed above describe the pathogenicity or attenuation of the organisms.
f. Change or Addition of Whole Animal Work: Provide the following: 1) a description of the species
used, 2) construct, organism or toxin to be administered, 3) dose and volume administered, 4) the
route of administration, 5) where all work will be conducted, 6) where the animals will be housed
post-administration for the duration of the project, 7) the duration of experiment, 8) the biosafety level
for this portion of the project, 9) whether treated animals will need to be transported post-exposure,
and 10) IACUC number (if applicable) covering the project. If work in animals is new to the project.
PI must indicate for BSL2 that procedures outlined in BSL2 manual section 4.13 will be followed.
ISU Protocol Modification - Form D/IBC
IBC Protocol No. ________
Version 1.0
Page 4 of 6
Document #
g. Change or Addition of Transgenic Animal Work: For transgenic/knockout/knockin provide the
following: 1) a complete description of the construct that will be used for production, 2) the species to
be used, 3) whether PI or another source will produce the animals, 4) the IACUC number covering
the project, if applicable.
h. Change or Addition of Whole Plant Work: Provide the following: 1) a description of the species used,
2) construct to be administered, 3) amount administered, 4) the route of administration, 5) where all
work will be conducted, 6) where the plants will be grown/maintained post-administration, 7) the
duration of experiment, 8) whether treated plants will need to be transported post-exposure, 9) PPE
used during experiments, and 10) the biosafety level/containment practices for this portion of the
project. If plants will be infected with a plant pathogen, is this pathogen listed as a Select Agent by
the USDA? If the answer to this question is yes- Contact IBC office prior to submission of this
modification.
i. Change or Addition of Transgenic Plant Work: Provide the following: 1) a description of the construct
that will be used for production of transgenic plants, 2) the species used, 3) whether PI, or another
source will produce the transgenic, 4) where the plants will be grown/maintained, 5) the duration of
experiment, 6) whether treated plants will need to be transported post-exposure, 7) PPE used during
experiments, and 8) the biosafety level/containment practices for this portion of the project.
j.
Change in Principal Investigator - New PI:
First Name:
Last Name:
Email:
Phone: Departmental Affiliation:
Mailing Address: Reason for Request:
ISU Protocol Modification - Form D/IBC
IBC Protocol No. ________
Version 1.0
Page 5 of 6
Document #
Funding Agency:
Has Funding Agency been notified?
YES NO
k. Change in Protocol Title:
New Title:
Reason for Request:
l. Addition of Personnel: For all new personnel list the following: 1) Full name; 2) Email; 3) Degree; 4)
Mandatory Biosafety Training (Training must be within the last 3 years) 5) If applicable;
Bloodborne Pathogen (BBP) Training Date (Per OSHA requirements this must be updated annually);
6) If applicable, Shipping Training Date (Training must be within the last 3 years- attach shipping
training certificate); 7) Specific procedure(s) or techniques each personnel will be performing in this
protocol and years of experience/expertise with the procedures; and 8) If personnel are not trained,
the personnel responsible for training must be indicated along with that person’s expertise with the
procedures/techniques in question if not listed on the protocol. Personnel added after approval of the
protocol must be added via a modification containing the information requested above.
#1 1) Full
Name:
2) Email:
3) Degree:
4) Biosafety
Training Date
(must be within
last 3 year):
5) BBP Date
(must be within
last year):
6) Shipping
Date:
7) Procedures/Experience with Procedures: 8) Trainer:
#2 1) Full
Name:
2) Email:
3) Degree:
4) Biosafety
Training Date
(must be within
last 3 year):
5) BBP Date
(must be within
last year):
6) Shipping
Date:
7) Procedures/Experience with Procedures: 8) Trainer:
ISU Protocol Modification - Form D/IBC
IBC Protocol No. ________
Version 1.0
Page 6 of 6
Document #
m. Change in Biosafety Level or Biosafety Practices: Attach a revised copy of the biosafety manual
template and outline changes below. A revised signature page for PI and personnel from the manual
must be attached to this modification document.
n. List new location of work/storage- List Room number and Building name for location of work and/or
storage
o. Other (e.g. funding sources, or other items not covered under specific categories listed):
5. AGREEMENT TO NOT INITIATE ANY CHANGES IN RESEARCH PRIOR TO SUBMISSION and/or
APPROVAL per ISU IBC Policy on use of recombinant and synthetic nucleic acids or infectious
agents and toxins in research.
____________________________________________________________________________
___________________
Signature of Principal Investigator
Date
Typed or printed PI name:
The agreement must be signed by the principal investigator if modification is submitted as
hard copy to IBC. If IBC receives modification as an email attachment, modification must
be sent by PI or if sent by PI’s representative, PI must be copied on email correspondence.
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FormD-ProtMod-A DATE APPLICATION

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Completed 5 December 2019

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