Download Biosafety Form - University of Idaho

Institutional Biosafety Committee
Biosafety Form
IBC#
INSTRUCTIONS:
1. Complete this Biosafety Form (Click here for complete instructions)
2. Complete a Biosafety Manual
3. Send completed information to [email protected]
SECTION 1: PROJECT INFORMATION
TODAY’S DATE:
A. CHECK ONE OF THE FOLLOWING BOXES:
New Submission
Renewal
Amendment (Do NOT proceed, instead send in an Amendment)
OSP proposal numbers
associated with this work
(Mark with NA if not applicable)
B. CHECK ALL THAT APPLY. (Complete Sections 2-7 as determined)
Recombinant DNA (Rec DNA) (Complete Section 2)
Biological Agents (Not Rec DNA) (Complete Section 3)
Select Agents & Toxins or EAR / ITAR Cat XIV (Complete Section 3 & 4)
Human Subjects Research (Complete Section 5)
Animal Activities (Complete Section 6)
Plant Activities (Complete Section 7)
C.
REGULATIONS & GUIDELINES FOR PROPOSED RESEARCH: CHECK ALL THAT APPLY.*
USDA/APHIS
*By checking the appropriate box, you indicate that
CDC / Select Agents
you have read the guidelines and agree to comply.
NIH (Must be checked for all Rec DNA activities)
Other (Specify):
D. GENERAL INFORMATION:
Scope of Work Title:
Principal Investigator (PI):
Name:
E-mail:
Phone:
Department:
Mail code:
Campus Location:
E.
Co- PI
Other Contact
SCOPE OF WORK (Describe in layman’s terms)
1. Provide a general description of your research goals and aims.
2. For Rec DNA/RNA/Synthetic DNA, Biological Agents, and/or “Select Agent & Toxins”: Include a description
of research activities & agent manipulation(s). Provide sufficient detail for the
requisite(section IV-B-2b-1) IBC risk assessment also see BMBL (Section II).
1.
2.
Section 1 continues on page 2
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F.
LOCATION(s): Include all building locations and activities where proposed research will be performed.
Location: (Moscow/
Building Name:
Room Number(s):
Activity:
Biosafety Rec
Twin Falls/Etc)
Level:
DNA
G. PERSONNEL ON PROJECTS INVOLVING EXPORT CONTROLLED ITEMS (EAR and ITAR Category XIV) &
PERSONNEL REQUIRING MEDICAL SURVEILLANCE: (e.g. ABSL-3 animal work, work requiring respirators, work
where vaccines are available and recommended, etc. For questions contact the Biosafety Officer)
(NOTE: After IBC approval, submit an amendment to add new personnel.)
Name:
Position:
H. Principal Investigator’s Certification
(Electronic submission from your Uidaho e-mail constitutes your electronic signature.)
The electronic submission of this form constitutes your agreement to:
 Ensure that personnel receive appropriate training in safe laboratory practices and procedures before any
work begins and at least annually thereafter (acknowledged by signatures in the lab’s Biosafety Manual).
 Follow medical surveillance practices as required in the Biosafety Manual and inform all personnel about
appropriate emergency response information.
 Inform the Biosafety Officer of any research-related accident or illness as soon as possible after its
occurrence. Complete and submit a University accident report form.
 Submit an amendment for significant modifications to the scope of work.
 Adhere to all applicable federal, state, local regulations/guidelines and relevant policies in the UI
Administrative Procedures Manual (APM).
 Send a copy of this completed form to your department head/chair.
The University of Idaho will monitor for compliance throughout the duration of the approved biosafety work.
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SECTION 2: RECOMBINANT DNA
A. DNA/RNA source(s):
Origin:
(rat/human/etc)
B.
Source:
Institution/Name of source:
List of vector/viral delivery system(s): (List transgenic plants/animals/organisms here also)
Host*
Vector
Vector Type
Host range of
Function of
(e.g. plasmid)
vector or
inserted/deleted
unknown
DNA sequences*
Biosafety
Level*
*For acquired transgenic material fill in the sections indicated with a (*) only.
C.
Will you attempt to express foreign gene(s)?
Yes No
a. If yes, list proteins to be produced:
Section 2 continues on page 4
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D. Recombinant DNA information: NIH Category III-A through III-F work
Check Yes or No for each of the following statements:
Yes No - Introducing foreign DNA or RNA into a vector or organism to clone or express it.
Yes No - Deliberate transfer of drug resistance trait to microorganisms that are not known to
acquire the trait naturally.
Yes No – Experiments involve more than 10 liters of culture.
Yes No - Transfer of “Rec-DNA” or “RNA derived from Rec-DNA” into human subjects.
Yes No
N/A – Is helper virus present in a tissue culture system that involves infectious or
defective viruses?
The DNA or RNA to be cloned:
Yes No - Is from a Risk Group 3 agent.
Yes No - Is from a Risk Group 4 agent.
Yes No - Is a “Select Agent and Toxin” or other restricted agent.
Yes No - Represents more than two-thirds of the genome of a Risk Group 1 or 2 organism.
Yes No - Encodes a known oncogene.
Yes No - Encodes a control element that may extend the host range.
Yes No - Is from an exotic plant or exotic infectious agent.
Yes No - Encodes molecules known to be toxic to vertebrates at LD-50 of less than 100ng/kg body
weight.
The host/vector system used for introducing foreign DNA or RNA:
Yes No - Is either the host or vector from a Risk Group 3 agent.
Yes No - Is either the host or vector a Risk Group 1 or 2 virus that infects eukaryotic cells and
contains more than two-thirds of the viral genome.
Yes No – Is the host into which I am introducing foreign DNA or RNA a cell or organism other than
E. coli K-12 or its derivatives, Saccharomyces cerevisiae, S. uvarum, Bacillus subtilis, or B.
licheniformis?
SECTION 3: BIOLOGICAL AGENTS (NOT RECOMBINANT DNA)
A. List all biological agent(s) to be used for the proposed research:
Name of
Type
Source:
Institution/Name
biological agent
of source:
*Potential harm either direct or indirect:
1. Harms humans
4. Harms animals
2. Doesn’t harm humans
5. Doesn’t harm animals
3. Unknown harm to humans
6. Unknown harm to animals
B.
Potential
Harm*
Biosafety
Level
7. Harms plants
8. Doesn’t harm plants
9. Unknown harm to plants
Are any of the Biological Agent(s) listed on the Select Agents & Toxins list or as an Export Controlled item
(EAR and ITAR Category XIV)?
Yes No If yes, fill out Section 4
Page 4 of 6
SECTION 4: SELECT AGENTS & TOXINS or EXPORT CONTROLLED ITEMS (EAR and ITAR Category XIV)
If you are not a registered user under the CDC Select Agents program, you will need to contact the
Office of Research Assurances at [email protected] or 885-6162.
A. Is the proposed Select Agent strain excluded from any CDC or APHIS Select Agent regulations?
Yes No
a.
If yes, list excluded agents:
B.
Do you possess, store, work with, or transport toxins listed on the “Select Agents & Toxins” list?
Yes No
a. If yes, are the proposed quantities at or below the permissible toxin amounts?
Yes No - If yes, List toxin & quantity:
C.
List all Select Agents & Toxin(s) (Other Export Controlled Items):
Select Agents & Toxins:
SECTION 5: HUMAN SUBJECTS (Use of cells/tissues/fluids of human origin)
A. Human material(s):
Human material:
(blood, cell line,
etc)
Source:
Institution/Name
of source:
Primary/
Secondary: *
*”Primary-living” is material obtained from live human subjects.
“Primary-deceased” is material obtained from deceased individuals.
“Secondary-publically available” is material obtained from commercial sources (e.g. ATCC).
“Secondary-not publically available” is material obtained from sources that are not available to the public.
B.
Are any of the materials listed as “Primary-living” or “Secondary-not publically available”?
(Human Materials obtained from commercial sources such as ATCC are exempt from IRB oversight.)
Yes No
a. If yes, you will need Institutional Review Board approval.
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SECTION 6: ANIMAL ACTIVITIES Note: Purchase or transfer of transgenic rodents is exempt from IBC oversight.
A. Are live animals used in this project?
Yes No
If yes, you will need Institutional Animal Care and Use Committee approval.
a. Will there be infectious agent challenges to animals? (Not transgenic animals)
Yes No
(If Yes, complete section 3 & if applicable section 4)
B. Are transgenic animals used in this project?
Yes No
a. Will there be infectious agent challenges to transgenic animals?
Yes No
(If Yes, complete section 2 & 3 & if applicable section 4)
b. Are transgenic rodents used in this project?
Yes No
(If No, complete section 2)
c. Do breeding experiments involve rodents that contain more than 50% of the genome of an
exogenous eukaryotic virus from a single family?
Yes No N/A (If Yes, complete section 2)
d. Do breeding experiment involve rodents whose transgene is under the control of a gamma
retroviral long terminal repeat?
Yes No N/A (If Yes, complete section 2)
C. Animal material(s) obtained from Non-UI sources :
Origin:
Animal Material:
Source:
Institution/Name
(mice/rat/etc)
(blood, organ, etc)
of source:
SECTION 7: PLANT ACTIVITIES
CHECK ALL THAT APPLY. (Provide additional information if requested)
Transgenic field trials (Complete Section 2 and Provide GPS map and USDA permit or notice)
Transgenic plants located in lab(s) and growth chamber(s) (Complete Section 2)
Greenhouse trials
Other permitted environmental release (Provide copy of permit)
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