Research Integrity & Compliance
Institutional Biosafety Committee
Registration Document for the Use of Sections III-E and III-F Recombinant DNA
USF requires that all recombinant DNA work Sections III-E and III-F conducted at or supported by this university be registered with by the Institutional Biosafety Committee (IBC).
Instructions:
1. If your recombinant DNA experiment meets the definition of any of the categories described in this form, i.e. Sections III-E and III-F complete this registration form.
2. Please provide complete information for every item. Blank or incomplete items may delay the processing of your application.
4. Completed forms may be submitted by emailing an electronic copy to and include a scanned copy of signature pages bearing original signatures.
6. For more guidance, contact Farah Moulvi at (813) 974-0954 or Debra Howeth at (813) 974-5091.
1. – Basic Information
1.1 Principal Investigator:
Department: Campus Mail:
Building: Office Room#:
E-mail: Fax:
Office Phone(s): Lab Phone:
PI’s Coordinator: [Name] Coordinator’s phone:
Coordinator’s E-mail:
Location(s) of Experiments – Building/Room (indicate all):
1.2 Type of Registration (see Appendix A for definitions): Single Project Multi-Project
1.3 Project Title(s) (if multi-project, list titles of each project and assign a number to each):
1.4 Will this protocol use any VA resources: No Yes
2. –rDNA Information
2.1 Does the construct contain viral DNA that represents more than 2/3 of any eukaryotic viral genome?
No.
Yes. This registration is not exempt: Do not use this form - please complete the Registration Document for the Use of Non-Exempt Recombinant DNA.
2.2 Is the viral construct from DNA of Risk Group 3, 4, or restricted agents?
No.
Yes. This registration is not exempt: Do not use this form - please complete the Registration Document for the Use of Non-Exempt Recombinant DNA.
2.3 Does the study involve the deliberate transfer of rDNA into one or more human subjects?
No.
Yes. This registration is not exempt: Do not use this form - please complete the Registration Document for the Use of Non-Exempt Recombinant DNA.
2.4 Does the study involve generation of transgenic animals or plants?
No.
Yes. This registration is not exempt: Do not use this form - please complete the Registration Document for the Use of Non-Exempt Recombinant DNA.
2.5 Does the study involve the generation of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight?
No.
Yes. This registration is not exempt: Do not use this form - please complete the Registration Document for the Use of Non-Exempt Recombinant DNA.
2.6 Does the study involve the generation of more than 10 liters of culture?
No.
Yes. This registration is not exempt: Do not use this form - please complete the Registration Document for the Use of Non-Exempt Recombinant DNA.
2.7 Does this study involve the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally and if so, could this acquisition compromise the use of the drug to control disease agents in humans, animals, and/or plants?
No.
Yes. This registration is not exempt: Do not use this form - please complete the Registration Document for the Use of Non-Exempt Recombinant DNA.
3. NIH Guidelines Determination
3.1 Which section of the NIH Guidelines does your research with recombinant or synthetic nucleic acids involve: (select all that apply)
Section III-E-1 Recombinant or synthetic nucleic acid molecules containing no more than two-thirds of the genome of any eukaryotic virus may be propagated and maintained in cells in tissue culture using BL1 containment (with the exception of DNA from Risk Group 3, 4, or Select Agents/Toxins).
Section III-E-2 Experiments involving nucleic acid molecule-modified whole plants, and/or experiments involving recombinant or synthetic nucleic acid molecule-modified organisms associated with whole plants, except those that fall under Section III-A, III-B, III-D, or III-F.
Section III-E-3 Experiments involving the generation of rodents in which the animal's genome has been altered by stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived therefrom, into the germ-line (transgenic rodents). Only experiments that require BL1 containment are covered under this section; experiments that require BL2, BL3, or BL4 containment are covered under Section III-D-4
Section III-F Exempt from the NIH Guidelines
Registration Document for the Use of Section III-E and III-F Recombinant DNA
USF Institutional Biosafety Committee
RCDC 009.6
Rev. 08/2016 Page 1
4. Recombinant or Synthetic Nucleic Acid information:
4.1
Nature of the Inserted DNA Sequence/Expressed gene* / Host(s) / Vector(s) / Intended Use of rDNA*** Indicate organism, clone bank, species, etc., with literature citation, if appropriate (i.e., What is the gene being used? What is the protein to be expressed?).
** Describe the intended use of the recombinant DNA molecule.
Registration Document for the Use of Section III-E and III-F Recombinant DNA
USF Institutional Biosafety Committee
RCDC 009.6
Rev. 09/2016 Page i
4.2 Briefly describe your research project (in lay terms) and include the biological function of the gene product (protein) that you wish to express.
4.3 Indicate the Biosafety Containment Level at which the project will be conducted (defined in Appendix G of the NIH Guidelines or Appendix C of this form):
BSL-1 BSL-2
5. Investigator Assurance
· I agree to use lab practices that meet the Biosafety Level specified in this application.
· I understand the NIH Guidelines as they pertain to the research described and will conduct this research in compliance with these regulations.
· I will report all accidents or illness related to this work to the IBC in a timely fashion.
· I have the knowledge and training required to safely handle the materials described.
· I agree to conduct these experiments in accordance with all USF IBC policies and the USF Biosafety Manual).
· I acknowledge my responsibility to secure and control the rDNA used in this project.
· I will train all staff on laboratory specific procedures
______
Signature of Principal Investigator Date
Appendix A: Biosafety References
· Biosafety in Microbiological and Biomedical Laboratories, 5th Edition
· USF Institutional Biosafety Manual
· NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
· Biological Spill Response
Registration Document for the Use of Section III-E and III-F Recombinant DNA
USF Institutional Biosafety Committee
RCDC 009.6
Rev. 09/2016 Page i