IBC Proposal No.__________________________
Recombinant DNA:
Infectious agents:
Exempt- ________
Containment Level
Covered by
_____________
Section III.C ____
Section III.D.____
Section III.E.____
Toxins or
tumorigenic material:
_____________
INSTITUTIONAL BIOSAFETY COMMITTEE
Complete and submit this form to the Institutional Biosafety Committee if your research
involves recombinant DNA, synthetic nucleic acid molecules, infectious agents, and/or
tumorigenic materials.
NIH Guidelines can be found at: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
CDC Guidelines can be found at: http://www.cdc.gov/biosafety/publications/bmbl5/
I. Identification
1. Title of Project
2. Sponsoring Agency
3. Principal Investigator
Department
Campus Phone
E-mail address
4. Co-Principal investigator
Department
Campus Phone
E-mail address
5. Date Submitted
6. Date Research to Begin
FOR C USE ONLY
Received by IBC:
____________________________
Date
_____________________________
Chairperson
Approved by IBC:
____________________________
Date
_____________________________
Chairperson
II. SUMMARY (Please provide a brief (50-75 word), non-technical summary of your
project):
III. IDENTIFICATION OF POTENTIAL BIOHAZARDS
Check all that apply
____Recombinant DNA
_____Synthetic nucleic acid molecules
____Infectious agents
____Toxins
____Tumorigenic materials
____Select Agent Transfer Program (42CFR 72.5)
(These agents are listed at:
http://www.selectagents.gov/resources/List_of_Select_Agents_and_Toxins_2012-12-4English.pdf)
Risk Group Classification for Infectious Agents:
http://www.absa.org/riskgroups/index.html
[Radioisotopes must be registered with the Radiation Safety Officer. Protocols involving
animals must be approved by the IACUC.]
IV. PROJECT INFORMATION
Please read the Guidelines for Recombinant DNA Research and/or the CDC Biosafety in
Molecular Biology Laboratories for infectious agents and tumorigenic materials
(websites for both of these documents are referenced above). It is the PI's responsibility
to determine the appropriate section and containment level that apply to the research
described below. If you have questions concerning these issues, please contact an IBC
member or the Chair of the Committee.
A. Describe the experimental protocol involving recombinant DNA, infectious agents
and/or tumorigenic agents in sufficient detail that the IBC can evaluate the containment
level appropriate for the work. You may attach the abstract or project summary from the
supporting grant proposal. Do not attach the entire proposal.
IF THIS PROPOSAL INVOLVES NON-EXEMPT RECOMBINANT DNA
RESEARCH, ANSWER SECTIONS B-F. OTHERWISE SKIP TO G.
B. What is the origin of the cloned DNA? Please give the common and scientific name
of the source organism(s) and the experimental source (library, PCR, synthetic
oligonucleotide) of this DNA.
C. What is the nature of the cloned DNA (anonymous marker, toxin gene, non-coding
sequence, etc.)?
D. Describe all hosts and vectors to be used in cloning this DNA.
E. Are you attempting to express this DNA in the host? ____________________
Are you proposing to grow more than 10 liters of the recombinant DNA in a single
experiment? _____________________
F. Based upon your answers to B-E, what is the appropriate section and containment
level for this experimental protocol?
SKIP TO SECTION H IF YOUR WORK ONLY INVOLVES RECOMBINANT
DNA.
G. If you research involves infectious agents and/or tumorigenic agents (but not
recombinant DNA), what is the appropriate section and containment level for this
experimental protocol?
H. Where will this research be conducted? Specify the building and rooms and describe
how these facilities meet the NIH and/or CDC Guidelines.
I. Have you prepared a biosafety manual detailing containment procedures to be
followed at this site for these experimental protocols? ____ Yes ____ No
If no, please explain.
V. Other Project Participants
A. Are there other individuals involved in the experimental protocol other than the PI
and CoPI? ____ Yes ____ No
If yes, please identify these individuals and their respective roles in the project.
B. Do any of these individuals have any history of chronic gastrointestinal disorder or
long-term treatment with steroids, immunosuppressives drugs, or antibiotics?
____Yes ____ No
If yes, please identify them.
INVESTIGATOR ASSURANCE FOR RESEARCH INVOLVING
RECOMBINANT DNA, INFECTIOUS AGENTS AND/OR TUMORIGENIC
MATERIAL
(Please submit this page with PI signature as part of the IBC application.)
VI. Assurance by the Principal Investigator
1. I have consulted the section of the NIH Guidelines which describes the
responsibilities of the Principal Investigator and hereby agree to comply fully
with the provisions of the Guidelines.
2. If funded by an extramural source, I assure that this application accurately
reflects all procedures involving recombinant DNA, infectious agents and/or
tumorigenic material described in the grant proposal soliciting these funds.
3. Any change in the research protocol or participating personnel will be reported
to the in writing to the Institutional Biosafety Committee.
4. The information presented in this application is accurate to the best of my
knowledge.
__________________________________
Signature of Principal Investigator
__________________
Date
The IBC reserves the right to inspect research facilities at any time.
Please submit this form to IBC Chair.