Division of Research Integrity & Compliance
Institutional Biosafety Committee
Registration Document for the Use of Non-Exempt Recombinant DNA
USF requires that all recombinant DNA work conducted at or supported by this university be registered with and approved by the Institutional Biosafety Committee (IBC) prior to initiation of the project.
Instructions:
1. If your recombinant DNA experiment meets the definition of any of the Non-Exempt categories referenced in NIH guidelines (Section III-D) to complete this registration form.
2. Please provide complete information for every item. Blank or incomplete items may delay the processing of your application.
3. Completed forms may be submitted by:
· E-mail to and followed with mailed hard copies of signature pages bearing original signatures.
· Mail to Farah Moulvi, Institutional Biosafety Officer, Division of Research Integrity & Compliance, MDC 35
· BSL-2 or BSL-3 laboratories must pass inspection before initial approval for research activities can be granted for this proposed study. The Principal Investigator is responsible for scheduling an inspection by contacting the Biosafety Staff at or (813) 974-5091 or (813) 974-5110.
4. Please consult the NIH Guidelines for Research Involving Recombinant DNA Molecules and the USF Institutional Biosafety Manual for information needed to complete this registration form.
5. For more information, contact Farah Moulvi at (813) 974-0954 or Debbie Howeth at (813) 974-5091.
RCDC 001.11 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments Page 15
Rev. 04/25/2011 USF Institutional Biosafety Committee
Part A – Basic Information
RCDC 001.11 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments Page 15
Rev. 04/25/2011 USF Institutional Biosafety Committee
A.1 Principal Investigator: Name]
Department: Campus Mail:
Building: Office Room#:
E-mail: Fax:
Office Phone(s): Lab Phone:
PI’s Study Coordinator: [Name] Coordinator Phone:
Coordinator’s E-mail:
Location(s) of Experiments – Building/Room (indicate all):
A.2 Type of Registration (see Appendix A for definitions): Single Project Multi-Project
A.3 New Registration
3rd Year Renewal Registration Replacing Previous IBC Study #
A.4 Project Title(s) (if multi-project, list titles of each project and assign a number to each):
A.5 Sponsor(s) List intramural and/or extramural sources:
Part B - Recombinant DNA Project Information
B.1 Briefly describe your research objectives in lay terms:
B.2 Provide below or attach a one-page (maximum) description of the specific laboratory procedures (e.g., culturing, vortexing, incubating, etc.) and specific safety precautions regarding these procedures for handling the recombinant DNA molecules and/or organisms and viruses containing recombinant DNA molecules. Describe the procedures by detailing the specific physical manipulations (not “why” the manipulations are being done). Include the animal and animal tissue(s) handling procedures that will be used during the experiment, if applicable.
RCDC 001.11 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments Page 15
Rev. 04/25/2011 USF Institutional Biosafety Committee
2. Vector Information
2.1 Provide all requested information for each rDNA vector that will be used in this project in the table below.
Item # / Type1 / Vector Name (including Serotype or strain if applicable) / Source2 / Risk Group3(RG) / Biosafety Level3 (BSL) / Locations of Use / Locations of Storage (if different)
1
2
3
4
5
6
7
8
9
10
RCDC 001.11 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments Page 15
Rev. 04/25/2011 USF Institutional Biosafety Committee
1 A=adenovirus, R=retrovirus (including lentivirus), N=non-viral, O=other viral vector (please specify)
2 Specify the type and name of source (e.g., vendor – Clontech, Invitrogen; off-campus collection – Univ. of CA).
3 Refer to the NIH Guidelines, and the BMBL for RG and BSL designation.
RCDC 001.11 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments Page 15
Rev. 04/25/2011 USF Institutional Biosafety Committee
RCDC 001.11 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments Page 15
Rev. 04/25/2011 USF Institutional Biosafety Committee
2.2 Are you using a replication competent virus? If so provide justification for its use.
2.3 If using a replication –deficient virus, the possibility of homologous recombination with endogenous viruses may exist. Indicate the reversion rate and describe recombination event for such a possibility for each of the viral vectors identified in Table 2.1.
2.4 Are assay systems used to measure the titer of replication competent viruses that may be present?
No. How will you ensure that replication competent viruses are excluded?
Yes. Describe the assay system and action plan if revertants are detected.
2.5 Indicate the Biosafety Containment Level (BSL) if different than the BSL specified in Table 2.1.
BSL-1 BSL-2 BSL-3
3. DNA Source
3.1 Indicate the original source(s) of DNA you intend to use (check all that apply).
Bacterial Protozoan Viral Fungal
Human Mammalian Parasitic Synthetic
Other: [Please specify]
3.2 Provide the species or strain of the source for the rDNA and, if applicable, the vendor/investigator from which the DNA was acquired.
3.3 If a protein is expressed, what is the biological function of the gene product or sequence that will be inserted?
3.4 Can the expression of your gene product be harmful (e.g., toxic) to humans, animals or plants?
No.
Yes. Do you anticipate a local or systemic expression?
3.5 Will a deliberate attempt be made to obtain expression of a foreign gene(s) (a foreign gene is one which is originally exogenous to the host-vector system used)?
No. Go to Section 4
Yes. Indicate what protein(s) the gene produces.
3.6 Is this gene involved in cell growth control (i.e., oncogene, tumor suppressor, growth factor, cytokine, apoptosis inducer or inhibitor)?
No.
Yes.
3.7 Could exposure to the gene(s) result in tumor induction in humans, animals, or plants?
No.
Yes. Specify the type of tumor that may develop:
3.8 Indicate the host (target recipient) of the vector-recombinant DNA combination by checking all that apply.
Animals Human E. coli Cell culture
Plants Other: [Please specify]
4. Recombinant DNA that Encode for Toxins or Toxic Materials
RCDC 001.11 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments Page 15
Rev. 04/25/2011 USF Institutional Biosafety Committee
4.1 Does the gene that you are cloning produce a toxin (e.g., microbial toxins such as the botulinum toxin, tetanus toxin, diphtheria toxin and Shigella dysenteriae neuro toxin) or is the toxin a select agent (See Select Agent list )?
RCDC 001.11 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments Page 15
Rev. 04/25/2011 USF Institutional Biosafety Committee
No. Go to Section 5.
Yes. Specify the toxin below. (Note: This project may require review and approval by NIH/OBA. Contact the USF Institutional Biosafety Officer at (813) 974-0954.
5. Drug Resistance Trait
5.1 Will there be transfer of a drug-resistance trait to microorganisms that are not known to acquire that trait naturally, when such acquisition could compromise the use of a drug to control disease agents in humans, animals, or plants?
No. Go to Section 6.
Yes. Please do A and B:
A. Contact the USF Institutional Biosafety Officer at (813) 974-0954.
B. Prior approval from the NIH/OBA Recombinant Advisory Committee (RAC) is required. Attach a copy of the letter of approval from NIH/OBA.
6. Plants, Insects, Protozoans
6.1 Do you intend to transfer recombinant DNA into a germ line (permanent change) in order to establish a transgenic plant line, insect, and/or protozoan?
No. Go to section 7.
Yes. What are the anticipated or known immediate/long-term adverse events associated with the deliberate/accidental release of the transgenic plant, insect, and/or protozoa to the environment?
6.2 What safety practices, safety equipment, and engineering control(s) are in place to
prevent the accidental and/or deliberate release of the transgenic plant, insect
and/or protozoa to the environment?
6.3 Will the project at any time require the release of an organism containing rDNA molecules into the environment?
No. Go to Section 7.
Yes. (Note: This project may require review and approval by NIH/OBA. Contact the USF Institutional Biosafety Officer at (813) 974-0954.
7. rDNA Cloning
7.1 Will rDNA cloning be done using human or animal pathogens as host-vector systems
No.
Yes. Please describe the host-vector system.
RCDC 001.11 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments Page 15
Rev. 04/25/2011 USF Institutional Biosafety Committee
7.2 Will cloning be done using source DNA from human or animal pathogens that have been classified as Risk Group 3, Risk Group 4, and/or Select Agents?
RCDC 001.11 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments Page 15
Rev. 04/25/2011 USF Institutional Biosafety Committee
No. Go to Section 8.
Yes. (Note: This project may require review and approval by NIH/OBA. Contact the USF Institutional Biosafety Officer at (813) 974-0954.)
8. Human Use
8.1 Will human subjects and/or human clinical specimens be used in any aspect of the experiment?
No. Go to Section 9.
Yes.
8.2 Will there be transfer of DNA, recombinant DNA, or RNA derived from recombinant DNA to human subject(s) (i.e., gene therapy)?
No.
Yes. If yes, submit these five documents:
A. Informed Consent form
B. Copy of the IRB application
C. Sponsor’s investigational brochure
D. Protocol
E. A copy of the letter of review from NIH/OBA
8.3 Does the study involve the use of human cells and/or human clinical samples?
No.
Yes. List the type(s) of human clinical specimens you intend to use.
8.4 Has this research protocol been reviewed and approved by the IRB?
No. Date of Intended Submission to IRB: ______
Yes. IRB study #: ______Date approved: ______
Approval Pending - Date Submitted to IRB: ______
9. Animal Use
9.1 Will you administer recombinant DNA to animals or use animal tissue?
No. Go to Section 10.
Yes. Specify the animal species: ______
9.2 Indicate the Animal Biosafety Containment Level (ABSL) at which the project will be conducted in the vivarium:
ABSL-1 ABSL-2
The animals will be housed at ABSL-2 for days or entire study.
NOTE: Research activities requiring an Animal Biosafety Level 3 (ABSL-3) containment facility are prohibited due to the lack of facilities.
9.3 Will you insert recombinant DNA into a germ line (permanent change) in order to establish a transgenic or gene-targeted animal?
No.
Yes. What are the anticipated or known immediate/long-term adverse effects or changes in phenotype/or genotype (e.g., early disease onset/resistance, immunodeficiency) of such a change on the animal?
9.4 Does the study involve creation of transgenic or gene-targeted mice through the Moffitt Small Animal Modeling and Imaging – SAMI Core Facility?
No.
Yes. Please have the SAMI Staff Scientist initial the following assurance:
The creation of transgenic mice by pronuclear DNA injection of ES cells into blastocysts will be done at the Moffitt SAMI Core Facility in accordance with standard safety procedures described and approved in corresponding SAMI Core Facility IACUC application.
Name / Please Initial / Date9.5 List the animal facility (e.g., College of Medicine, VA Hospital, College of Public Health, LSA, SRB) and the area/room number(s) where the animals will be housed or used.
9.6 What kind of expression do you expect the recombinant DNA to exhibit in the animal?
Transient in vivo expression (e.g., injection of plasmids or transfected cell line in animal).
Permanent expression (e.g., creation of transgenic animal).
9.7 Route of agent administration.
Intravenous Intraperitoneal Subcutaneous Intramuscular
Other: [Please specify]
9.8 Has this research protocol received approval from the USF Institutional Animal Care and Use Committee (IACUC)?
No. Date of Intended Submission to IACUC: ______
Yes. IACUC study #: ______Date approved: ______
Approval Pending - Date Submitted to IACUC: ______
9.9 Will the rDNA molecule and/or the organism containing the rDNA molecule present
any risk of exposure to animal care staff?
No. Go to Section 10.
Yes. Answer A, B, C, and D.
A. What animal sources/routes (e.g., urine, feces, blood, bite/scratch), that may contain the rDNA microorganism or the product of the gene expressed, present a potential risk of exposure to the animal care staff?
B. What Personnel Protective Equipment is required to be worn by the animal care staff to protect them from potential risk of exposure from the animal source(s) mentioned in 4.9.A?
Face masks: N 95 (HEPA) N 100 (HEPA)
Face Shield Head covers
Safety Glasses/Goggles Double gloves
Lab gown Gloves Tyvek/Disposable Suits Shoe covers
Lab coats Other: [Please specify]
Surgical Mask
C. What safety practices are in place to protect the animal care staff from potential risk of exposure from the animal source(s) mentioned in part A?
D. The IBC requires a minimum concentration of 10% bleach solution as the primary disinfectant. If using 10% bleach solution as the primary disinfectant check this box.
10% Bleach Solution (1:10 dilution bleach to water)
If using an alternative disinfectant, specify in box below, the name, active ingredient, concentration and an exemption for use of this disinfectant.
NOTE: Unless noted on this application with an explanation and approved by the IBC, all other disinfectants (e.g., 70% alcohol) are secondary disinfectants to be used after the 10% bleach.
10. Medical Information
10.1 Are there any risks of disease and/or adverse effects (e.g. – altered immune response/immunosuppression/allergenicity/toxicity) to humans, animals, and/or plants that might result from exposure to the organisms or viruses containing recombinant DNA molecules?
No.
Yes. Describe the potential adverse effects to humans, animals, plants and/or the environment for each rDNA molecule:
10.2 By checking this box, I affirm that in the case of an exposure incident my laboratory personnel (Faculty, staff, students and visitors) have been instructed to follow the Exposure Management Plan as described below:
USF Personnel:
RCDC 001.11 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments Page 15
Rev. 04/25/2011 USF Institutional Biosafety Committee
1. Contact OptaComp at 1-877-518-2583 (24 hours a day/7 days per week) --- During working hours (M-F, 8 – 5 PM) the USF Worker’s Compensation Insurance Specialist Meica Elridge should also be contacted at (813) 974-5775, or ().
2. In the event that follow-up is necessary following initial care from the USF Workers’ Compensation Provider, please contact the USF Medical Health Administration (Employee Health) office at (813) 974-3163, or pager (813) 216-0153.