Download All research involving recombinant DNA molecules must comply

Tulane University Institutional Biosafety Committee (IBC)
Recombinant DNA- Exempt Registration Form
Complete, sign and submit this form to the IBC by e-mail to [email protected] 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.
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.
Non-Exempt rDNA experiments that fall under Sections III-A-D of the NIH Guidelines require IBC approval
prior to initiating the research. Research must be suspended until IBC approval is obtained.
Non-Exempt rDNA experiments that fall under Section III-E of the NIH Guidelines require IBC registration
simultaneous with initiation of research. 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://osp.od.nih.gov/officebiotechnology-activities/biosafety/nih-guidelines

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 ([email protected] )
Note: All research requiring Biosafety Level 3 (BSL3) containment, arthropods requiring arthropod
containment level 2 or 3 (ACL2 or ACL3) or research involving Select Agents must be registered and
approved by the IBC prior to initiating the research.
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IBC February 2017
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 involve:
1. Transfer of a drug resistance gene into microorganisms that could
compromise the use of the drug to control disease in humans, veterinary
medicine, or agriculture (Section III-A*)?
2. Cloning of toxin molecules with an LD50 of less than 100 nanograms per
kilogram body weight (Section III-B*)?
3. Introduction of DNA/RNA into Risk Group 2, Risk Group 3, Risk Group 4,
or Select Agents (Section III-D-1*)?
4. Cloning DNA/RNA from Risk Group 2, Risk Group 3, Risk Group 4 , or Select
Agents into nonpathogenic prokaryotic or lower eukaryotic host-vector
systems (Section III-D-2*)?
5. Cloning DNA/RNA from Risk Group 1 agents into nonpathogenic
prokaryotic or lower eukaryotic host-vector systems other than E. coli K12,
Saccharomyces spp., B. subtilis, or B. lichenformis (Section III-E*)?
6. Tissue culture of recombinant Risk Group 2, Risk Group 3, or Risk Group
4 viruses including defective viruses in the presence of helper virus. (Section
III-D-3*)?
7. Experiments involving genetically engineered plants (Section III-D-5, III-E2*)?
8. Experiments involving more than 10 liters of culture of recombinant DNA
organisms or constructs (Section III-D-6*)?
9. Generation of synthetic or recombinant DNA/RNA molecules containing twothirds or less of the genome of any eukaryotic virus (Section III-E-1*)?
10. Viable synthetic or recombinant DNA/RNA-modified microorganisms, cells, or
viruses tested on whole animals (Section III-D-4, III-E-3*)?
11. Involving use of transgenic animals or alteration of the genome or germ-line by
stable introduction of synthetic or recombinant nucleic acids (Section III-D-4,
III-E-3*)?
10a. Does the animal contain a transgene encoding more than 50% of the
genome of an exogenous eukaryotic virus?
10b. Is the transgene under the control of a gamma-retroviral promoter?
12. The deliberate transfer of synthetic or recombinant DNA or RNA into one or
more human research participants (Section III-C*)? (The approval of this
protocol will not be effective until IRB approval is received.)
13. Arthropods requiring arthropod containment level 2 (ACL2) or higher?
14. Select Agents (defined by HHS/CDC/USDA Select agent Program)
15. A requirement for 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
Yes
Yes
No
No
No
* Consult the NIH Guidelines at http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines. Updated
information about required levels of Biosafety are found in the CDC/NIH Biosafety in Microbiological and Biomedical
Laboratories (BMBL) http://www.cdc.gov/biosafety/publications/bmbl5/
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IBC February 2017
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 instructions 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.
7. I understand that an electronic signature has the same legal effect and can be enforced in the same way as a
written signature.
X
Typed Name of Principal Investigator
Signature of Principal Investigator
Date
SEND A SIGNED COPY OF THIS FORM TO THE IBC OFFICE (scanned copy or electronic signature to [email protected]).
Double click the signature field to electronically sign.
Received and reviewed by IBC
_____________________________
Lucy C. Freytag, Ph.D.
IBC Chair
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IBC February 2017