Tulane University Institutional Biosafety Committee (IBC)
Recombinant DNA- Exempt Registration Form
(January 1, 2013 – December 30, 2013)
Complete, sign and submit this form to the IBC by e-mail to ibc@tulane.edu with ‘Exempt IBC
Registration’ in the Subject line.
Principal Investigator:
Department/School:
Phone:
E-mail:
----------------------------------------------------------------------------------------------------------------------Please review this entire form prior to completion, and provide information as requested.
 Research involving Select Agents or requiring Biosafety Level 3 (BSL3) containment must be
registered and approved by the IBC.
Complete the Project Questionnaire on the following page. If you answer all of the questions ‘NO’ and you
believe your projects involve only Exempt Experiments (as defined by the NIH Guidelines), sign the
Investigator’s Assurance at the end of this document and submit this registration.
If you answer any of the questions ‘YES’, you may not be exempt and must submit a complete IBC
protocol for review and approval. For Non-Exempt rDNA experiments requiring prior approval of the IBC
(as outlined in sections IIIA-D of the NIH Guidelines) research must be suspended until IBC approval is
obtained. For Non-Exempt rDNA experiments requiring simultaneous submission to the IBC with
initiation of research (as outlined in sections IIIE of the NIH Guidelines) research must be suspended until
a completed IBC Protocol Form is submitted.
All research involving recombinant DNA molecules must comply with the NIH Guidelines for Research
Involving Recombinant or Synthetic Nucleic Acid Molecules and the Tulane University Institutional
Biosafety Committee (IBC) Policy Manual for the Use of Recombinant DNA.

Find information about Tulane IBC in our webpage:
http://tulane.edu/asvpr/biosafety/committee/index.cfm

The NIH Guidelines* and information about Risk Groups are found in this link:
http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines_new.pdf

Updated information about required levels of biocontainemnt are found in the CDC/NIH Biosafety in
Microbiological and Biomedical Laboratories (BMBL)
http://www.cdc.gov/biosafety/publications/bmbl5/

Refer questions to the IBC office (ibc@tulane.edu )
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IBC January 2013
Project Research Questionnaire
Check 'Yes' or 'No' to the following questions (refer to the NIH Guidelines* or consult Tulane
IBC for more information).
The relevant section of the NIH Guidelines is referenced for questions 1-12.
Do any of your projects:
1.
2.
3.
4.
5.
include the deliberate transfer of a drug resistance trait to microorganisms
that are not known to acquire the trait naturally; and if YES could such
acquisition compromise the ability to control disease agents in humans,
veterinary medicine, or agriculture? (Section III-A-1)
include cloning toxin molecules with an LD50 of less than 100 nanograms
per kilogram body weight (Section III-B*)?
include experiments involving the deliberate transfer of recombinant DNA, or
DNA or RNA derived from recombinant DNA, into one or more human
research participants (Section III-C*)?
include experiments using Risk Group 2, Risk Group 3, Risk Group 4, or
Select Agents as host-vector systems (Section III-D-1*)?
include experiments in which DNA from Risk Group 2, Risk Group 3, Risk
Group 4, or Select Agents is cloned into nonpathogenic prokaryotic or lower
eukaryotic host-vector systems (Section III-D-2*)?
6. include experiments involving the use of infectious rDNA or rRNA viruses or
defective DNA or RNA viruses in the presence of helper virus in tissue culture
systems (Section III-D-3*)?
7. include experiments with recombinant influenza virus? (III-D-7)
8. include experiments involving whole animals in which the animal’s genome
has been altered by introduction of DNA into the germ line (i.e. transgenic
animals) (Section III-D-4, III-E-3*).
If “YES”:
8a. Does the animal contain a transgene encoding more than 50% of the
genome of an exogenous eukaryotic virus?
8b. Is the transgene under the control of a gamma-retroviral promoter?
9.
include experiments involving viable rDNA-modified microorganisms tested
on animals (Section III-D-4, III-E-3*)?
10. include experiments involving genetically engineered whole plants (Section
III-D-5, III-E-2*)?
11. include experiments involving more than 10 liters of culture of rDNA
modified organisms (Section III-D-6*)?
12. include experiments involving the formation of recombinant DNA molecules
containing no more than two-thirds of the genome of any eukaryotic virus
propagated in tissue culture (Section III-E-1*)?
13. involve Select Agents (defined by HHS/CDC/USDA Select agent Program)
14. require biosafety level 3 containment (BSL3) ?
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
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IBC January 2013
INVESTIGATOR'S ASSURANCE
1. I confirm that all persons conducting this work at Tulane University (including students, fellows,
technicians, and collaborators) have:
i. been adequately trained in good laboratory/ microbiological practices and aseptic techniques, and I
have kept records of this training;
ii. received instruction on the specific hazards/risks associated with the work and are aware of the specific
safety equipment, PPE, practices, and behaviors required during the course of the work and use of
these facilities.
2. I will immediately report to the Biological Safety Officer any spill of biohazardous material, any
equipment or facility failure (e.g., ventilation failure), and/or any breakdown in procedure that could
result in potential exposure of laboratory personnel and/or the public to biohazardous material.
3. I confirm that any proposed change(s) to my work that would result in an increased level of biohazard
will be reported to the IBC before the change is implemented.
4. I confirm that no work requiring IBC approval will be initiated or modified until approval is received.
5. I have read and understand my responsibilities as Principal Investigator outlined in Section IV-B-7 of
the NIH Guidelines and the Tulane University Institutional Biosafety Committee (IBC) Policy Manual
for the Use of Recombinant DNA, and agree to comply with these responsibilities.
6. I certify that the information provided within this application is accurate to the best of my knowledge.
I also understand that, should I use the project described in this application as a basis for a funding
proposal (either intramural or extramural), it is my responsibility to ensure that the description of the
work in the funding proposal is identical in principle to that contained in this application.
Typed Name of Principal Investigator
Signature of Principal Investigator
Date
Received and reviewed by IBC
_____________________________
Lucy C. Freytag, Ph.D.
IBC Chair
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IBC January 2013