Tulane University Institutional Biosafety Committee (IBC)

Recombinant DNA- Exempt Registration Form

Complete, sign and submit this form to the IBC by e-mail to with ‘Exempt IBC Registration’ in the Subject line.

Principal Investigator:
Department/School:
Phone: / E-mail:

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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/office-biotechnology-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 ( )

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.


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*)? / Yes / No
2.  Cloning of toxin molecules with an LD50 of less than 100 nanograms per kilogram body weight (Section III-B*)? / Yes / No
3.  Introduction of DNA/RNA into Risk Group 2, Risk Group 3, Risk Group 4, or Select Agents (Section III-D-1*)? / Yes / No
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*)? / Yes / No
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*)? / Yes / No
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*)? / Yes / No
7.  Experiments involving genetically engineered plants (Section III-D-5, III-E-2*)? / Yes / No
8.  Experiments involving more than 10 liters of culture of recombinant DNA organisms or constructs (Section III-D-6*)? / Yes / No
9.  Generation of synthetic or recombinant DNA/RNA molecules containing two-thirds or less of the genome of any eukaryotic virus (Section III-E-1*)? / Yes / No
10.  Viable synthetic or recombinant DNA/RNA-modified microorganisms, cells, or viruses tested on whole animals (Section III-D-4, III-E-3*)? / Yes / No
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? / Yes
Yes
Yes / No
No
No
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.) / Yes / No
13.  Arthropods requiring arthropod containment level 2 (ACL2) or higher? / Yes / No
14.  Select Agents (defined by HHS/CDC/USDA Select agent Program) / Yes / No
15.  A requirement for biosafety level 3 containment (BSL3)? / Yes / 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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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.

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Typed Name of Principal Investigator / Signature of Principal Investigator / Date

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SEND A SIGNED COPY OF THIS FORM TO THE IBC OFFICE (scanned copy or electronic signature to ). Double click the signature field to electronically sign.

Received and reviewed by IBC

______

Lucy C. Freytag, Ph.D.

IBC Chair

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