University of Alabama
Application for Recombinant DNA - Biological Safety Program
Investigator ________________________________________________________________
Building(s) ________________________________
Room(s) ____________________
Dept ____________________________________
Date _______________________
All research conducted at the University of Alabama involving R-DNA must meet current NIH
guidelines. See Federal Register of April 2002 (or most recent) at http://www.niehs.nih.gov/odhsb/ .
Under all circumstances, whether or not your cloning research is exempt, you must fill out the
Application for Recombinant DNA.
These guidelines group protocols into six classes based on their perceived risk. Five of these classes
require review by a local committee. High-risk experiments require review by national committees. The
Institutional Biological Safety Committee (IBSC) is the local committee that reviews experiments
identified by the R-DNA Registration Document. You, as the PI, are responsible for determining the
status of your experiments and completing and submitting this R-DNA Registration Document.
Many experiments considered safe are exempt from filing and review, i.e., cloning a non-toxic gene from
a non-pathogenic organism in a suitable phage or plasmid propagated in E.coli K-12 employing standard
microbiological techniques. Such experiments are defined as “exempt” in Section III-F and Appendices A
& C of the Guidelines. If the experiments are in this class (III-F), we ask that the researcher/teacher
submit a R-DNA Registration Form to obtain IBSC documentation of exempt status, since some granting
agencies now require this documentation. Please be aware, however, that there are factors – large-scale
culture, releasing organisms containing recombinant DNA from the lab – which shift an exempt
procedure to the non-exempt class.
Office
___________________________________
Room
#
Lab
___________________________________
Phone
#
Building and Room(s) where project will take place:
Project
Title:
Office Phone #
______________________________
E-mail
Address:
______________________________
____________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
Project _____________
Period:
to
____________
Granting
Agency:
_____________________________
Briefly describe the goal of your experiment in non-scientific terms (Layman’s Terms):
Please list the names, telephone numbers, and e-mail addresses of those who may come into contact with the agents listed in this
registration document:
Name:
Office Telephone #
Emergency Telephone #
________________________
________________________
________________________ ________________________
________________________ ________________________
________________________ ________________________
________________________
________________________
________________________ ________________________
________________________
________________________ ________________________ ________________________
________________________
________________________
________________________ ________________________
Where
is
this
project
carried
______________________________________________________
Which of the six NIH categories
apply to the proposed project?
III-A
III-B
III-C
III-D
III-E
III-F
E-mail Address:
out?
Require IBSC approval, RAC review and NIH
Director approval before initiation.
Require NIH/OBA and IBSC approval before
initiation.
Require IBSC and Institutional Review Board
approval and RAC review before research
participant enrollment.
Require IBSC approval before initiation.
Require IBSC approval simultaneous with
initiation.
Exempt experiments. (Although no registration is
required for exempt experiments, please
complete this entire form for IBSC review.)
N/A
NIH: National Institutes of Health
OBA: Office of Biotechnology Activities
RAC: Recombinant DNA Advisory Comm.
Which level of containment applies to
the proposed project?
Biosafety Level
1 2 3 4
Animal Biosafety Level 1 2 3 4
I am not sure of the
______ appropriate biosafety level
for my research.
Plant Biosafety Level 1 2 3 4
Recombinant DNA experiment and/or project details (use additional sheets if necessary)
Host/Environment
Esherichia coli K-12
Other Bacteria
Nonpathogen
Pathogen Risk Group 2 (BSL-2)
Pathogen Risk Group 3 (BSL-3)
Toxin Gene
Drug Resistance Gene
Yeast/YAC
Tissue Culture Cells
R-DNA/Plasmids
Segment of Virus
Virus Vector
If Virus Vector:
Characterized/FDA or NIH approved/Novel
Intact Laboratory Animal Recipient
R-DNA/Plasmids
Transgenic
Virus Vector
SCID/Nude
Has Institutional Animal Care and Use
Committee been notified?
Yes [ ]
Yes [ ]
Yes [ ]
Yes [ ]
Yes [ ]
Yes [ ]
Yes [ ]
Yes [ ]
Yes [ ]
Yes [ ]
Yes [ ]
Yes [ ]
AAV [ ]
No [ ]
BSL-1 [ ] BSL-2 [ ]
No [ ]
No [ ]
No [ ]
No [ ]
No [ ]
BSL-1 [ ] BSL-2 [ ] BSL-3 [ ]
No [ ]
BSL-1 [ ] BSL-2 [ ] BSL-3 [ ]
No [ ]
BSL-1 [ ] BSL-2 [ ]
No [ ]
No [ ]
BSL-1 [ ] BSL-2 [ ]
No [ ]
BSL-1 [ ] BSL-2 [ ]
No [ ]
BSL-1 [ ] BSL-2 [ ] BSL-3 [ ]
Adeno [ ] Retro [ ] Vaccinia [ ] Other [ ]
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
Species:
BSL-1 [ ]
BSL-1 [ ]
BSL-1 [ ]
BSL-1 [ ]
BSL-2 [ ]
BSL-2[ ]
BSL-2 [ ] BSL-3 [ ]
BSL-2 [ ] BSL-3 [ ]
Human Subject Recipient
Yes [ ]
No [ ]
R-DNA/Plasmids
Pathogen
Virus Vector
Plants/Insects
Field Release
Is a deliberate attempt made to obtain
expression of foreign gene(s) in the cloning
vehicle?
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
Has IRB Been Notified? Yes [ ]No [ ]
IRB Approval Number:
BSL-2 [ ] BSL-3 [ ]
BSL-2 [ ] BSL-3 [ ]
BSL-2 [ ] BSL-3 [ ]
BSL-2 [ ] BSL-3 [ ]
If yes, what proteins, materials, or
antigens?
Will this project require large-scale fermentation (>10 liters) of
organisms containing recombinant DNA molecules?
Yes
No
Will this project, at some point, require the release of
organisms containing recombinant molecules into the
environment?
Yes
No
Will this project involve the use of transgenic plant or animal
species?
If yes, please identify
species:
Yes
No
Will there be any attempt to transfer recombinant DNA
molecules in vivo to plant or animal systems (other than tissue
culture)?
Yes
No
Will there be a petition to NIH for exemption from the
guidelines?
Yes
No
If Yes, attach a copy of any USDA permits or applications.
Describe procedures for responding to an accidental spill and/or release
Indicate any precautionary medical practices. Explain the requirement.
Attach a short, clear summary of your proposed recombinant experiments that will explain their
essential features. Avoid jargon and excess technical detail. Include the following and any other
data that you feel has important bearing upon the decision-making process. Explain the
significance of the experiments and exactly why you are performing operations that make the
experiments non-exempt. If appropriate, explain and justify the use of pathogenic organisms not
named in Appendix B of the NIH Guidelines, or of the Biological Containment Host-Vector System
if it is important for the safety of the experiment and not named in Appendix E. Describe any
special precautions required for containment and personal safety.
Additional Comments/Information
I hereby apply for approval of my plans for experiments involving recombinant DNA molecules. I
am familiar with, and agree to abide by, the provisions of the current NIH Guidelines (April 2002
Federal Register (or later) and appendices), and any other specific NIH or University of Utah
instructions pertaining to the proposed project. I agree to provide the IBC prompt written
notification of any significant changes in these protocols or of any major accidents involving
recombinant DNA molecules. I agree to comply with NIH requirements pertaining to shipment and
transfer of recombinant DNA materials. I certify that all herein provided information is accurate
and complete.
I accept responsibility for the safe conduct of work with this material as indicated on any page of
this form. I will ensure that all personnel receive appropriate training in regard to proper safety
practices and personal protective equipment needed for this work and that all building occupants
are educated when warranted. I certify that all herein provided information is accurate and
complete.
Print Name:
Date:
Signature:
Approve
Registration #:
******** This box is for Institutional Biosafety Committee (IBC) use only **********
Approve with
Disapprove
Conflict of Interest
Stipulations
Approval #:
Containment Level:
Stipulations:
Signature IBC
Member:
Date