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-mailing an electronic copy to biosafety@research.usf.edu and including a scanned copy of the signed personnel and signature pages. 5. For more guidance, contact Farah Moulvi at (813) 974-0954 or Debbie Howeth at (813) 974-5091. 1. 1.1 1.2 Basic Information Principal Investigator: Department: Building: E-mail: Office Phone(s): PI’s Study Coordinator: Coordinator’s E-mail: Location(s) of Experiments – Building/Room (indicate all): Type of Registration: 1.3 Single Project Campus Mail: Office Room#: Fax: Lab Phone: Coordinator Phone: Multi-Project New Registration 3rd Year Renewal Registration Replacing Previous IBC Study # 1.4 Project Title(s) (if multi-project, list titles of each project and assign a number to each): 1.5 Sponsor(s) List intramural and/or extramural sources: 2. Recombinant DNA Project Information 2.1 RCDC 001.13 Rev. 01/2015 Briefly describe your research objectives in lay terms: Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments USF Institutional Biosafety Committee Page 1 2.2 3. Provide below or attach a one-page description of the specific laboratory procedures (e.g., culturing, vortexing, incubating, etc.). 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. Biosafety Procedures 3.1 Does the study involve the generation or use of more than 10 liters of culture? No. Yes. (Note: This project may require review and approval by NIH/OBA. Contact the USF Institutional Biosafety Officer at (813) 974-0954.) 3.2 A. Indicate the types of experimental manipulations which you will use that have the potential to generate aerosols/splashes (check all that apply). Homogenization Centrifugation Sonication Dissection Pipetting Cell sorter and/or flow cytometry Other procedures specific for your protocol: [Please specify] None. Go to Question 13.4 B. What special practices/procedures will you use for containment of aerosols/splashes for the above-mentioned experimental manipulations in Question 3.2? 3.3 Indicate the Safety Equipment you will use (check all that apply) Stomachers Safety Blender (e.g. shatter proof jar-double walled: blender rotors leak proof) Low aerosolization pipette tips Mechanical or electronic pipettors Chemical fume hood (for chemical use) Centrifuge with safety cups or sealed rotor heads Other: [Please specify] Use of Sharps 3.4 Indicate the Safety Practices to be used with Sharps (needles, scalpels, etc.) Substitute glassware with plastic ware, when possible Do not bend, break or recap needles Do not bend, break or recap scalpels Dispose of sharps in red sharps containers I will/have consider(ed) the use of appropriate and effective sharps to eliminate or minimize occupational exposure. Not Applicable NOTE: An engineered sharp has a physical attribute built into the sharp device that effectively reduces the risk of an exposure incident. Examples of such devices include retractable needles, hinged needle shields, needleless IV connectors, sliding sheath/sleeve and needle guards. 3.5 RCDC 001.13 Rev. 01/2015 Indicate the Personnel Protective Equipment that will be used (check all that apply). Particulate respirators: N 95 (HEPA) N 100 (HEPA) Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments USF Institutional Biosafety Committee Page 2 Face Shield Lab Coats (front buttoned) Safety Glasses/Goggles Double gloves Lab gown (Tie backs) Gloves Disposable Suits/coveralls with attached hood and boots Other: [Please specify] NOTE: The use of particulate masks, such as N-95, requires medical evaluation, fit testing, and training prior to their use per OSHA regulations. 3.6 Do you intend to use a Biological Safety Cabinet (BSC)? No. Explain what safety procedures you will use instead of the BSC to eliminate the risk of aerosol exposure: Yes. BSC should be certified annually. What was the date of the last certification? RCDC 001.13 Rev. 01/2015 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments USF Institutional Biosafety Committee Page 3 4. Vector Backbone Information 4.1 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 1 A=adenovirus, AAV=Adeno-associated virus, R=retrovirus, L=lentivirus, ONC=Oncoretrovirus, 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 001.13 Rev. 01/2015 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments USF Institutional Biosafety Committee Page 4 4.2 Are you using a replication competent virus? If so provide justification for its use. 4.3 Indicate the Biosafety Containment Level (BSL) if different than the BSL specified in Table 2.1. BSL-1 5. BSL-2 BSL-3 Insert DNA Source 5.1 Indicate the original source(s) of DNA you intend to clone (check all that apply). Bacterial Protozoan Viral Fungal Human Mammalian Parasitic Synthetic Other: [Please specify] 5.2 Please list the insert DNA and the biological function of the gene product or sequence that will be inserted, if applicable, the vendor/investigator from which the DNA was acquired. 5.3 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? 5.4 Is this gene involved in cell growth control and/or tumor induction (i.e., oncogene, tumor suppressor, growth factor, cytokine, apoptosis inducer or inhibitor)? No. Yes. 5.5 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] 5.6 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 )? No. Go to Section 6. 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. RCDC 001.13 Rev. 01/2015 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments USF Institutional Biosafety Committee Page 5 5.7 6. 7. 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. 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. rDNA Cloning 7.1 Will rDNA cloning be done using human or animal pathogens as hosts to generate mutated strains of these pathogens? No. Yes. Please describe the host-vector system which will be the recipient of the rDNA 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 001.13 Rev. 01/2015 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments USF Institutional Biosafety Committee Page 6 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 If administering rDNA viral vectors into human, are assay systems used to measure the titer of replication competent viruses that may be present? No. Please justify. Yes. Describe the assay system and action plan if revertants are detected. 8.4 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. 8.5 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 RCDC 001.13 Rev. 01/2015 Will you administer recombinant DNA to animals or use animal tissue? No. Go to Section 10. Yes. Specify the animal species: ________________ Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments USF Institutional Biosafety Committee Page 7 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 9.3 days or entire study. If administering rDNA into animals using viral vectors, 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. 9.4 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? 9.5 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. 9.7 Route of agent administration. Intravenous Intraperitoneal Other: [Please specify] Subcutaneous Intramuscular 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? RCDC 001.13 Rev. 01/2015 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments USF Institutional Biosafety Committee Page 8 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 of standard household bleach (5.25% sodium hypochlorite) to water. This needs to be made fresh at least weekly and preferably stored in opaque containers) 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 Please list 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? Please be aware that exposure to retroviral and lentivitral vectors may theoretically, although extremely rare, lead to insertional mutagenesis. RCDC 001.13 Rev. 01/2015 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments USF Institutional Biosafety Committee Page 9 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 1. Contact AmeriSys at 1-800-455-2079 (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 (melridge@admin.usf.edu). 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) 2160153. Moffitt Personnel: Moffitt Incidents Website per Moffitt Work Related Injury policy EH-13 If you have a protocol specific exposure management plan which is different than above, describe in the space provided below. 10.3 By checking this box, I affirm that I will provide protocol/procedure specific training for personnel working with organisms or viruses containing recombinant DNA molecules and inform them of any potential hazards/risks including an immunocological condition which may increase the risk of infection. They will also be instructed and trained in lab-specific clean up procedures for biohazardous spills and PI provided laboratory specific training? NOTE: For general biohazard spill procedures access the following website http://www3.research.usf.edu/dric/biosafety/resources.asp . 11. Decontamination and Disposal 11.1 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 of standard household bleach (5.25% sodium hypochlorite) to water. This needs to be made fresh at least weekly and preferably stored in opaque containers) 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. 11.2 RCDC 001.13 Rev. 01/2015 Indicate how biohazardous solid waste will be decontaminated and disposed. Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments USF Institutional Biosafety Committee Page 10 Autoclaved Time: minutes Temp: (recommended 121C, 15 p.s.i. for 30 minutes minimum) Chemically inactivated: [Please specify] Packaged as biohazardous waste per USF policy Other: [Please specify] 11.3 12. Celsius Indicate how biohazardous liquid waste will be decontaminated and disposed. Autoclaved Time: minutes Temp: Celsius Chemically inactivated: [Please specify] Packaged as biohazardous waste per USF policy Other: [Please specify] Storage and Transport 12.1 Will the organism harboring the rDNA used/generated in these experiments be transported or transferred outside of the room in which they are stored? No. Yes. Answer A and B below. A. To what location(s) outside of your laboratory will you transport/transfer these recombined biological materials? B. When transporting/transferring materials, the materials must be placed inside a watertight primary container, which is then placed into a watertight, leak proof and durable secondary container for transportation, with absorbent material placed between the two containers to absorb contents of the container in case of possible spill. I will transport material in accordance with the above described procedure. 12.2 Will any of these organisms and/or viruses containing recombinant DNA be shipped via commercial carrier (e.g., Federal Express)? No. Yes. Identify the person(s) that will be preparing the recombinant DNA molecules for shipping and provide their Transportation of Dangerous Goods training dates. 12.3 Will any of these materials be imported from or exported to one or more foreign countries? No. Yes. All shipments must meet federal and state transportation regulations and USF policies. Respond to A, B, C, and D below: A. List the materials to be imported and/or exported. B. List the country of origin or destination for each. C. Indicate whether this is a one-time shipment or part of a series of shipments. D. Attach a copy of the USDA permit, CDC permit, and/or Dept. of Commerce permit. RCDC 001.13 Rev. 01/2015 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments USF Institutional Biosafety Committee Page 11 13. Personnel The Institutional Biosafety Committee (IBC) must be notified of any new personnel who will be directly involved in the conduct of the experiment and/or for whom a potential risk exists by virtue of their presence within the research environment. 13.1 List the names of all personnel involved and have each person initial the following assurance: I have read and understand the nature of these experiments. 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: http://www3.research.usf.edu/dric/biosafety/docs/biosafety-manual.pdf I have attended/will attend the annual USF biosafety training indicated.* Name Initial here Date Biosafety Training* Training Date E-mail Occupational Health Evaluation Completed Yes No Yes No NA Yes No Yes No NA Yes No Yes No NA Yes No Yes No NA Yes No Yes No NA Yes No Yes No NA Yes No Yes No NA Yes No Yes No NA Yes No Yes No NA Yes No Yes No NA * The following types of training classes are required: Core – Must be completed by those who have not completed it previously. Continuing Education – Must be completed annually. Special Topics – Required for persons involved in certain types of work. For current Biosafety training information, please go to: http://www3.research.usf.edu/dric/biosafety/education.asp RCDC 001.13 Rev. 01/2015 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments USF Institutional Biosafety Committee Page 12 14. Laboratory Inspection 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 biosafety@usf.edu or (813) 9745091 or (813) 974-5110. Information on biosafety containment levels and other guidance is available in the NIH Guidelines for Research Involving Recombinant DNA Molecules, the Biosafety in Microbiological and Biomedical Laboratories, 5th Edition , and the USF Institutional Biosafety Manual. Investigators are encouraged to consult these sources to ensure that their laboratories meet the required standards for sound biosafety practices. A Sample BSL-2 Checklist is provided to help you prepare for a laboratory inspection. 14.1 Has your laboratory been scheduled for inspection? Yes. Please provide the date: No. Inspection is pending due to: Does not apply because the laboratory involved is BSL-1. 15. Investigator Assurance I agree to use lab practices that meet the biosafety level (BSL) specified in this application. I will begin the work described only after obtaining approval of the IBC and will notify the IBC of any changes in the approved application. I will report any and all accidents or illnesses related to this work to the IBC in a timely fashion. I understand the NIH Guidelines as they pertain to the research described and will conduct this research in compliance with these regulations. I have the knowledge and training required to safely handle the materials described. I acknowledge my responsibility for the conduct of this research in accordance with University Policy and the USF Institutional Biosafety Manual . I acknowledge my responsibility to secure and control the biological agents used in this project. ____________________________________________ Signature of Principal Investigator RCDC 001.13 Rev. 01/2015 ___________________ Date Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments USF Institutional Biosafety Committee Page 13 Appendix A – Biosafety References Biosafety in Microbiological and Biomedical Laboratories, 5th Edition Material Safety Data Sheets (MSDS) for Infectious Agents Risk Group Classification for Infectious Agents USF Institutional Biosafety Manual NIH Guidelines for Research Involving rDNA Molecules Biological Spill Response Appendix B – Response to Laboratory Personnel Bloodborne Pathogen (BBP) Exposure The following emergency response guidelines shall be followed when a laboratory worker has been exposed to potentially infectious agents, including bloodborne pathogens to ensure prompt and appropriate care. BBP Exposure is defined as “A percutaneous injury (a needlestick or cut with a sharp object) or contact of mucous membrane or non-intact skin with blood, tissue or other body fluids that are potentially infectious”. Some post-exposure treatments must be started within 1-2 hours of exposure, so time is critical. If Percutaneous and/or Non-Intact Skin Accidental Exposure Occurs: Secure sharp device in sharps container Wash the exposed site thoroughly with soap and water Remove contaminated clothing Report exposure to supervisor immediately If Mucous Membrane Accidental Exposure Occurs: Flush eyes, nose and/or mouth with copious amounts of water at the nearest faucet or eye wash station. Remove contaminated clothing Report exposure to supervisor immediately If you are exposed to a Bloodborne Pathogen: Immediately report all possible work-related exposures to potentially infectious agents, including BBP’s to your supervisor. Exposures are to be reported immediately by the supervisor or department designee by telephone to AmeriSys 1(800)455-2079 (24 hours a day/7 days per week). During working hours (M-F, 8-5PM) the USF Worker’s Compensation Insurance specialist Meica Elridge should also be contacted at (813) 974-5775 or by email at melridge@admin.usf.edu. 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 by pager (813) 216-0153. If you become ill or injured on the job: An employee who becomes ill or is injured as the result of a job-related incident must report the incident to the supervisor immediately no matter how minor the injury may appear to be. Effective January 1, 2009, all work-related injuries or illnesses are to be reported by the supervisor or department designee by telephone to: AmeriSys 1(800)455-2079 (toll free). For additional information on how to report a work-related injury or illness go to the USF Worker’s Compensation website at: http://usfweb2.usf.edu/humanresources/employee-relations/workers-comp.asp USF Employees, Residents, and Student Assistants classified as “Volunteers”: You must report all potential BBP exposures to your supervisor and then call Amerisys. RCDC 001.12 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments Rev. 06/2014 USF Institutional Biosafety Committee Page i USF Students not on official “Volunteer” status and not employed by the University: Your care must be paid for through your student/personal insurance or by some other means If you are the supervisor: When an employee reports a work-related injury or illness, take prompt action to 1. Ensure the employee receives necessary medical attention. In case of emergency, call 911 or immediately send the employee to a hospital emergency room. Call AmeriSys as soon as practicable at 1-800-455-2079 to report the work-related injury or illness. 2. With the injured or ill employee, immediately call AmeriSys at 1-800-455-2079 to report the work-related injury or illness so the employee can receive appropriate care. Except in cases of emergency, the injured or ill employee must be present with the supervisor when the injury or illness is reported. 3. Complete the Accident Investigation Report for Supervisors and forward to Human Resources within 24 hours. 4. Take action to correct any safety hazards to prevent the same or similar injury or illness from occurring again. For questions on how to report a work-related injury or illness or other workers’ compensation issues, contact Workers’ Compensation Insurance Specialist Meica Elridge at (813) 974-5775 or melridge@admin.usf.edu. Reports may be faxed to (813) 974-7535. RCDC 001.12 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments Rev. 06/2014 USF Institutional Biosafety Committee Page ii