Fillable Form B Select-AgentsV2 FORM B - Protocol for Use of Infectious Agents in Research

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Form B Select-AgentsV2 FORM B - Protocol for Use of Infectious Agents in Research

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OFFICE OF RESEARCH USE ONLY
DATE RECEIVED OR REVISED:
VERSION:
*
ONLY TYPED FORMS WILL BE ACCEPTED
*
If this protocol is a resubmission, which protocol(s) is it intended to replace: Old IBC Protocol No.(s):
DATE APPLICATION COMPLETED:
IBC No. (Will be assigned initially by IBC office):
1. PROJECT TITLE:
2. PRINCIPAL INVESTIGATOR:
Name (Last, First):
Campus OR Work Phone Number:
Department Affiliation:
Mailing Address
1
:
Choose One, if Applicable:
New Address - Change for all other
active protocols
E-mail Address (use ISU email
if ISU employee or student):
1
For on campus investigators use Department and Mail Code. For off campus investigators provide complete mailing address.
3. PERSONNEL for CORRESPONDENCE: List personnel below who should be copied on the correspondence.
Name (Last, First):
Name (Last, First):
Name (Last, First):
Campus or Work Phone Number:
Campus or Work Phone Number:
Campus or Work Phone Number:
Department Affiliation:
Department Affiliation:
Department Affiliation:
E-mail Address (use ISU email if ISU employee
or student)
:
E-mail Address (use ISU email if ISU
employee or student)
:
E-mail Address (use ISU email if ISU
employee or student)
:
Mailing Address
:
Mailing Address
1
:
Mailing Address
1
:
Choose One, if Applicable:
New Address - Change for all protocols
Choose One, if Applicable:
New Address - Change for all protocols
Choose One, if Applicable:
New Address - Change for all protocols
Research Coordinator (Not Directly
Involved with IA/Toxins)
Research Coordinator (Not Directly
Involved with IA/Toxins)
ALL personnel who work directly with infectious agents or toxins must be listed in
Personnel Section (V).
FORM B - Protocol for Use of
Infectious Agents, Toxins and
Select Agents in Research
Version 1.0
Idaho State University, Office of Research
Institutional Biosafety Committee (IBC)
1651 Alvin Ricken Dr.
Pocatello, ID 83201
Phone: 208-282-2714 Fax: 208-282-4723
http://www.isu.edu/research/integrity/bio.shtml
Page 1 of 8 Document #
ISU Protocol for Use of Infectious Agents in Research - Form B/IBC
IBC Protocol No. ________
Version 1.0
I. Use of Infectious Agents/Toxins/Select Agents not involving rDNA:
I a. Name of the Agent(s) and Strain(s):
I b. Source of the Agent:
I c. 1. Maximum concentration and volume of the Agent(s) that will be used:
I c. 2. Maximum concentration and volume of the Agent(s) that will be stored:
I d. LD
50
or infectious dose in humans (if known):
I e. Risk Group classification (See Appendix B of NIH Guidelines)
http://www4.od.nih.gov/oba/rac/guidelines_02/APPENDIX_B.htm:
1 2 3 4 Animal Pathogen Plant Pathogen
I f. For each organism listed above describe the pathogenicity or attenuation of the organism: or N/A
I g. Indicate the location of ALL lab(s)/rooms in which the work will take place:
Room No.
, Building Name ; Room No. , Building Name ; Room No. , Building Name
I h. Indicate in which animal facility animal work will take place and type of housing in which animals will be
maintained:
Facility Name. BSL1 Standard Housing BSL2 Biohazard Housing BSL3 Biohazard Housing
I i. Indicate the location of ALL lab(s)/rooms in which the agents will be stored:
Room No.
, Building Name ; Room No. , Building Name ; Room No. , Building Name
I j. Indicate if any of the agent(s) are a select agent: Yes No
If yes, contact ISU Environmental Health and Safety Office at 996-7429 regarding use of select agents
I k. Indicate the highest biosafety level (BSL) required for this project: 1 2 3
Note: All work involving human or nonhuman primate cells/tissues requires yearly bloodborne
pathogen training and is considered BSL2. Biosafety level refers to the combination of laboratory
practices and techniques, safety equipment and laboratory facilities under which the project can be
conducted safely. For guidance on appropriate biosafety levels for specific agents refer to
Biosafety in Microbiological and Biomedical Laboratories, 5
th
Edition from the CDC and NIH
available at
http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm
A LABORATORY-SPECIFIC BIOSAFETY MANUAL MUST BE COMPLETED AND
SUBMITTED WITH THIS PROTOCOL. For work conducted at BSL1 or BSL2, complete the
appropriate biosafety manual template provided on IBC website. For BSL3, contact IBC
office to discuss biosafety manual requirements. FAILURE TO SUBMIT A MANUAL WITH
THE PROTOCOL WILL RESULT IN PROTOCOL BEING RETURNED TO PI WITHOUT
REVIEW.
Page 2 of 8 Document #
ISU Protocol for Use of Infectious Agents in Research - Form B/IBC
IBC Protocol No. ________
Version 1.0
I l. Will shipping off-campus of any potentially infectious biological material (PIBM) be done? PIBM includes but is not
limited to human/nonhuman primate cell lines, diagnostic samples or tissues, infectious organisms, and viral vectors.
Yes No If Yes, Provide a description of what will be shipped, how (e.g. ground or air) and where it
will be shipped:
Name of person(s) responsible for shipping:
NOTE: Personnel responsible for shipping must complete shipping training. Please see IBC website
(http://www.isu.edu/research/integrity/bio.shtml) for additional details. Copy of training certificates must be
submitted with protocol to obtain approval.
II. Purpose of the research project:
In layperson’s language, describe the overall purpose of the project in a few sentences.
III. Description of the research project
III a. Description of In Vitro Work:
Describe ALL in vitro procedures that involve manipulation of the infectious agents, toxins, or select agents.
Page 3 of 8 Document #
ISU Protocol for Use of Infectious Agents in Research - Form B/IBC
IBC Protocol No. ________
Version 1.0
III b. Description of In Vivo Work:
Provide a description of ALL of the following: a) species, b) organism, toxin, or select agent to be administered, c)
dose and volume administered, d) the route of administration, e) where the work will be conducted, f) where the
animals will be housed post-administration for the duration of the project, g) if the animals will require transport of
any kind while they are infected*, h) the duration of experiment, i) IACUC number for the project, and j) the
biosafety level for this portion of the project. If there is more than one study being proposed, describe each study
independently and answer all questions. * Transport of infected animals will only be approved when it is either
scientifically and/or logistically required, transport procedures and precautions are described, and it is approved by
both the IACUC and IBC.
Page 4 of 8 Document #
ISU Protocol for Use of Infectious Agents in Research - Form B/IBC
IBC Protocol No. ________
Version 1.0
IV. List ALL Funding Support for work on this protocol- (a must be completed for all protocols; b, c, e & f,
must be completed for each external funding source supported by this protocol; d may be left blank, if
funding agency does not assign numbers or number has not been assigned at time of submission to IBC)
Funding Support 1
a. Funding Agency (e.g. NIH, foundation, departmental,
currently not funded):
b. Funding PI:
c. Title of funding proposal:
d. Number Assigned by funding agency: e. Proposal Approval Form Number:
e. Funding Status Funded: Pending:
Funding Support 2
a. Funding Agency (e.g. NIH, foundation, departmental,
currently not funded):
b. Funding PI:
c. Title of funding proposal:
d. Number Assigned by funding agency: e. Proposal Approval Form Number:
f. Funding Status Funded: Pending:
Funding Support 3
a. Funding Agency 3 (e.g. NIH, foundation, departmental,
currently not funded):
b. Funding PI:
c. Title of funding proposal:
d. Number Assigned by funding agency: e. Proposal Approval Form Number:
f. Funding Status Funded: Pending:
Page 5 of 8 Document #
ISU Protocol for Use of Infectious Agents in Research - Form B/IBC
IBC Protocol No. ________
Version 1.0
V a. List the following information for all personnel who will be handling and infectious agents, toxins or
select agents on this protocol
1) Full name
2) Email (use ISU email if employee or student)
3) Degree
4) Mandatory Biosafety Training Date (Training must be within the last 3 years)
5) If applicable, Bloodborne Pathogen 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) List specific procedure(s) or techniques each personnel will be performing in this protocol and years of
experience/expertise with the specific procedures
8) If 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 in this section. Personnel added after approval of
the protocol must be added via a modification containing the information requested above.
Be specific and add additional tables as necessary
#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:
#3 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:
#4 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:
Page 6 of 8 Document #
ISU Protocol for Use of Infectious Agents in Research - Form B/IBC
IBC Protocol No. ________
Version 1.0
6) Procedures/Experience with Procedures: 7) Trainer:
#5 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:
#6 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:
V b. Personnel Training
For those protocols involving use of viral vectors and/or infectious agents, describe the specific training
provided by the PI to personnel as to the potential risks involved with this work and the safety precautions
to be used.
Page 7 of 8 Document #
ISU Protocol for Use of Infectious Agents in Research - Form B/IBC
IBC Protocol No. ________
Version 1.0
VI. Assurances
The Principal Investigator assures that the use of infectious agents, toxins, or select agents will be conducted in
accordance with the ISU Institutional Biosafety Committee Policies.
The Principal Investigator assures that modifications as required by the ISU Institutional Biosafety Committee Policy
will be submitted for review and approval prior to initiation including the following: 1) Any changes to infectious agents
or toxins, 2) Any new infectious agent, 3) Any change in Biosafety Level, 4) Any change in location, and 5) Any
addition of personnel.
The Principal Investigator assures that the use of infectious agents, toxins, or select agents will be conducted in
accordance with the Biosafety in Microbiological and Biomedical Laboratories from the CDC and NIH accessed at
http://www.cdc.gov/biosafety/publications/bmbl5/
.
The Principal Investigator assures that the use of infectious agents, toxins, or select agents will be conducted in
accordance with ISU Biological Safety Program Manual accessed at
http://www.physics.isu.edu/health-
physics/tso/bioman.html.
___________________________________________________________________________
___________________
Signature of Principal Investigator
Date
Typed or printed PI name:
Page 8 of 8 Document #
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Form B Select-AgentsV2 FORM B - Protocol for Use of Infectious Agents in Research

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Completed 5 December 2019

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