Scott & White Healthcare Institutional Biosafety Committee (IBC) IBC Initial Application

Transcription

1 Scott & White Healthcare Institutional Biosafety Committee (IBC) IBC Initial Application 1 Submit the renewal electronically via attachment to: IBCOFFICE@swmail.sw.org 2 Submit the Investigator s NIH-style biosketch via attachment 3 Fax a Signed copy of the report to the IBC Office FAX: Initial Application Instructions: Do not leave any blanks, incomplete reports will be returned for corrections. Section 1 - IBC Administrative Information Date of Report: Protocol Title: IBC permit number (to be completed by IBC Office staff): Principal investigator Name: Department: Office address (Room and building): Phone: After hours phone: address: Laboratory/Alternative Contact Name: Office address (Room and building): Phone: After hours phone: address: Department Chair Name: Phone: address: Personnel involved in project: Last Name First Name address Role on permit 1

2 PLEASE TE: All personnel must be current on all applicable Health and Safety training prior to IBC granting approval. All personnel must complete required training and education prior to IBC granting approval Any questions regarding IBC training programs and certifications should be directed to the IBC Office at Section 2 Funding Information a. Is this project NIH funded? b. List ALL funding sources that are supporting this protocol: Provide all funding for this project if there is more than one funding source Provide the funding start and end dates Include internal (departmental) funding (e.g. start up ) Funding Source Grant #s and active dates of the grant c. Is funding administered through Scott & White? (Mark X for Yes/No in un-shaded box) d. If to the question directly above, name the institution responsible for administering the grant 2

3 Section 3 Project Description A. Non-technical abstract Please describe in lay terms, to enable IBC community representatives to understand, the nature and purpose of the research. Do not exceed 500 words. B. Scientific Research Description Please outline all experimental procedures, practices, and manipulations to be performed with hazards Identify all manipulations that may increase risk to personnel or the environment and describe how these risks will be mitigated. Briefly describe your experience with the manipulations described in this section. Describe the decontamination and waste disposal methods. Do not copy/paste from a grant proposal Section 4 Biosafety Level Containment and Risk Group a. Indicate the risk groups (or class) of ALL material(s) used in the project. Risk Group 1 Agents are T associated with disease in healthy adult humans Risk Group 2 Agents are associated with human disease that is rarely serious. There are often preventive or therapeutic interventions available. Risk Group 3 Agents are associated with serious or lethal human disease for which preventive or therapeutic interventions MAY be available. Risk Group 4 Agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are T USUALLY available. b. Indicate the biosafety level(s) at which work is performed for this project BSL-1 Low risk agents (generally risk group 1), special containment equipment not required Work is done on open bench tops Standard microbiological practices are observed 3

4 Biohazard signs should be posted BSL-2 Moderate risk agents (generally risk group 2), biosafety cabinets, restrictions to research areas All BSL-1 containment and practices plus the following: Laboratory access is restricted when experimental work is in progress Personnel have specific training in handling agents Biological safety cabinets (BSC) or other physical containment devices are used for potential aerosol generation procedures Biohazard signs must be posted Specific PPE (personnel protective equipment) and entrance requirements BSL-2+ Moderate-High risk agents (generally risk groups 2 or 3), BSL-2 containment with BSL-3 practices All BSL-2 containment and practices plus the following: Laboratory access is restricted Personnel have specific training in handling of agents All procedures are performed in biological safety cabinets (BSC) Biohazard signs must be posted Written safety policies provided by the investigator defining laboratory procedures, waste disposal, disinfection and medical surveillance Centrifuge safety cups must be used Section 5 Hazard Information Will be utilizing (check all that apply and fill out the corresponding sections): Recombinant DNA (including viral and bacterial vectors) please complete Section 6 Synthetic DNA/RNA, Prions please complete Section 7 Toxins please complete Section 8 Human or Non-human Primate Cells/Tissue/OPIM please complete Section 9 Virus, Bacteria, Fungi, etc. please complete Section 10 Nanomaterials please complete Section 11 **Please complete the subsequent sections that correspond to this section. After those section(s) are complete, please skip to section 12 and complete the remainder of the application. 4

5 Section 6 Recombinant DNA Section ( Not applicable) a. What NIH category fits your project (Refer to: for details, or contact the Scott & White IBC Office) Section III-A (Transfer of drug resistance genes into microorganisms that are not known to acquire the trait naturally) Section III-B (Cloning of toxins LD 50 < 100 ng/kg body weight) Section III-C (Transfer of rdna, DNA, or RNA derived from rdna into human subjects) Section III-D (rdna from Risk Groups 2, 3, or 4 agents, or restricted agents as vector systems; infectious or defective DNA or RNA viruses. Whole animals or plants; Large volumes) Section III-E (rdna involving < 2/3 of the genome of any eukaryotic virus in the absence of helper virus or plasmids; Whole plants; Transgenic rodents) Section III-F (exempt experiments) b. Construct description (please complete the table below using one column per construct (deletion or mutation series of a single gene may be listed in one column; use additional sheet(s) if necessary) Name and Provider of Gene Gene Function Vector Name Construct 1 Construct 2 Construct 3 Construct 4 Construct 5 Example Green Fluorescent Protein from Clonetech Expression Marker pgem-zf Vector Type/Species and Strain Is the vector replication competent? Documentation? Viral/Adenovirus type 5 Yes, replication tested in HeLa cells 5

6 Expression control elements (promoters, enhancers, etc.) Conc/titer of rdna (infectious particles/ml) Host and Strain, if applicable Largest Production Volume of Host Host Range Is the recombinant made in your lab? If not, where? If vector is a genome, what % has been deleted or substituted CMV promoter 1 x 10 8 particles/ml E. coli, Sure cells TM 1 liter Amphotropic broad mammalian host range UNC Gene Therapy Center 30% c. Biosafety Level recommended for your work: d. PI s previous work experience with the DNA/vectors: Section 7 Nonrecombinant or Synthetic DNA/RNA; Prions ( Not applicable) a. Are you handling DNA or RNA from pathogenic microorganisms? b. Are you handling oncogenic DNA sequences? c. Are you handling DNA containing drug resistance genes? d. Are you working with Prions? If, please complete the table below 6

7 Name of Prion Pathogenic PrP Isoform Disease Natural Host e. If to questions a-d, please list the provider(s) of the agents: f. If to questions a-d, please explain the safety precautions that the lab will observe to avoid exposures and environmental release: g. If to questions a-d, list what sharps will be used and how will they be disposed: Section 8 Toxins Section ( Not applicable) a. Are you handling toxins of biological origin? If, list the name and provider of the toxin(s): b. In what form will the toxin(s) be received? c. What is the LD 50? d. What is the highest amount that you will possess? e. Do you agree to comply with Appendix I of the BMBL, which includes maintaining an inventory system, secure storage, and proper use of primary and secondary containment ( f. If there is a written emergency plan for spills/exposures? g. PI s previous work experience with the toxin(s) Section 9 Human or Non-human Primate Cells/Tissues/OPIM ( Not applicable) 7

8 a. Are you handling human or non-human primate cells/tissues/fluids? b. PI s previous experience in handling cells/tissue/fluid: If, please complete the table below Cells/Tissue/Fluid Dervation Pathogen Screening Performed Use of Cells BSL Section 10 Microorganism Section ( Not applicable Do not use this section if you are utilizing replication-incompetent viral vectors, use section 5) a. Which category of microorganism is being used? Bacteria Fungi Protozoa Archaea Unicellular Algae Parasitic Worms Virus b. List each agent, its risk group, biosafety level and provider: Agent (genus, species, strain) Risk Group Is an Antibiogram Available BSL Maximum Quantities Produced Provider 8

9 c. PI s working experience with the agent(s) listed above: d. Are any of the agents on the Select Agent list? (**At present no research can be conducted with any Select Agents at Scott & White) Section 11 Nanomaterials Section ( Not applicable) a. Describe the nanomaterial being used/generated: b. Is the nanomaterial carbon based? c. Is the nanomaterial metal based? d. Quantities of nanomaterial to be used/generated: e. Personal Protective Equipment (PPE) to be used (list): Section 12 Animal Section ( Not applicable) a. If live animals are to be used on this protocol, please complete the table below: Species Brief Description of Agent Use BSL Housing 9

10 b. Please explain any needs to remove animals from housing biocontainment and describe how animals will be safely transported back and forth: c. Has an Institutional Animal Care and Use Committee (IACUC) application been submitted for this recombinant research? If, provide the IACUC protocol number to be linked to this rdna project (provide the temporary number or the date of submission, if the IACUC number is not yet known): If you are not the named PI on the linked animal protocol application, provide the name of the investigator on the IACUC protocol: Please Note: Recombinant DNA work described in an IACUC protocol must correspond to recombinant DNA research approval by the IBC d. Will animal tissues or cells be used in vitro? For example, do you plan to harvest tissues for culture or analysis? If, explain: e. Will transgenic or gene-targeted animals be used? If, explain: f. Will transgenic or gene-targeted animals be bred on-site in a Scott & White facility? 10

11 If, provide the expected containment for the breeding/housing of the animals: g. Will recombinant agents be administered to live or intact animals? For example, viral vectors, transfected cells, plasmids, or the transplantation of genetically modified cells, tissues or organs to live animal subjects. Section 13 Human Subject Section **Please note: If human subjects are involved the project must be reviewed by the Western IBC. Please contact the IBC Office prior to submission** a. Does work involve human subjects, unfixed human tissues or blood, or human cell lines that are obtained directed from human participants? b. Will an Institutional Review Board (IRB) application been submitted? If, please provide the IRB protocol. c. Will human tissues or primary cells (indicates that the cell cultures are directly derived from the subjects blood or tissues) be used in vitro? If, please describe the use of the tissues or cells in your research: If, skip to the next section d. Is this a gene transfer proposal (deliberate transfer of recombinant DNA, or DNA or RNA from recombinant DNA into human subjects)? What is Human Gene Transfer? The deliberate transfer of recombinant DNA or DNA or RNA derived from recombinant DNA into human subjects Examples: Use as a marker in cells Production of a potentially therapeutic substance Replacement or compensation of defective genes To stimulate the immune system to fight disease 11

12 Section 14 Safety Equipment Section a. Biological Safety Cabinets: Cabinet 1 Type: Location: Last Certification: Cabinet 2 Type: Location: Last Certification: Cabinet 3 Type: Location: Last Certification: b. Autoclave available: Type: Location: c. Handwashing sink available: Type: Location: d. Eye wash station available: e. Chemical Fume Hood available: Last Certification Date: Section 15 Personal Protective Equipment (PPE) Please indicate the PPE that is required for work on this protocol. Gloves Type: Nitrile Latex Neoprene Butyl Eye Protection Type: ANSI-approved goggles ANSI-approved glasses Face shield Foot Protection Shoe Covers Protective Clothing Type: Lab coat Coveralls Apron Head covers Sleeve covers Shoe covers Boots Other: 12

13 Respiratory Protection Type: Surgical Mask Half face mask Full face mask N95-type respirator PAPR Other List: Section 16 Chemicals a. Will any chemicals require special handling such as reactive compounds, known human carcinogens or those with LD 50 < 50 mg/kg be used in this research project? b. If, does the lab have access to MSDS? c. If chemicals require special handling, please list all chemicals that meet these criteria. Section 17 Signage a. Does the laboratory have appropriate signage at the entry to the lab and within the lab? If, please contact the biosafety office. Section 18 Emergency Plan a. Does the laboratory have an emergency plan of action in place for potential exposure/release of agents or laboratory injuries? 13

14 If, please contact the biosafety office. Section 19 Research Facilities Section Please provide information for all locations, including the facility used for work with animals or human subjects (clinical areas), as applicable to your described project. Please provide the procedures performed in each location, for example, cell transfections, propagation of plasmids, administration of viral vector into animals, animal housing, etc. Please provide the IBC approved biosafety level of the location, not the procedural biosafety level. If a specific site is not currently IBC approved, please contact the IBC Office. Location #1 Location #2 Location #3 Room number and building Describe procedures for this location Provide approved biosafety level Room number and building Describe procedures for this location Provide approved biosafety level Room number and building Describe procedures for this location Provide approved biosafety level Important Information regarding Facilities Inspections and Biosafety Operations Manuals For laboratories intending to operate at BSL-2+ (BSL-2 enhanced), the IBC will T provide approval for research until the following conditions are verified: A Biosafety Operations Manual must be reviewed by the IBC, and other authorized officials as required for the designated biosafety level Lab facilities must be inspected by the IBC For questions, or to schedule an inspection appointment, contact the IBC Office at or visit the website at 14

15 Section 20 Shipping a. Will this proposal involve the shipping of biohazardous materials? If Yes, please provide the names of all staff members that will be involved in shipping: Name Role on proposal **Please Note: All staff members involved in shipping of biohazardous materials must be up to date on biohazardous shipping training. Please contact the IBC Office for more information. Section 21 Spill Assessment Please indicate the appropriate disinfectant for decontamination that will be used in case of a spill for the agent(s) specified in this application. Agent Disinfectant 15

16 Investigator Assurance a. I agree to conduct this research in accordance with the compliance policies of the Scott & White Institutional Biosafety Committee, including all required training of students, staff, and other professionals participating in this research b. I have consulted Section IV-B-7 of the NIH Guidelines describing the responsibilities of the Principal Investigator and hereby agree to comply fully with all provisions of the NIH Guidelines c. I agree to comply with the requirements specified by the IATA Guide for Shipment of Infectious Substances and/or Biological Substances category B ( d. I agree that all faculty, staff, and students working on this project will follow these recommendations as a condition of the Scott & White Institutional Biosafety Committee approval of this project e. I agree to accept responsibility for training and safety of all the laboratory personnel involved in this project. All research personnel are familiar with and understand the potential biohazards and relevant biosafety practices, protective equipment and techniques and emergency procedures f. I understand that I am responsible for assuring that my research facilities are in compliance with local, state, and federal environmental laws and regulations g. I understand that all changes in the research permit (including changes in the source of DNA, host-vector systems, dosage ranges, approved BSL level of laboratory facilities changes, etc.) or research participants must be reported to the IBC Office and all other Scott & White regulatory offices in connection with this protocol. h. If funded by an extramural source, I assure that this application accurately reflects all procedures involving recombinant DNA or materials under the NIH Guidelines as described in the funding grant proposal i. The information within this report is accurate to the best of my knowledge j. I understand that yearly renewal is required for continuing approved research k. I understand that all permits must be resubmitted for committee review after a term of three years TE: The IBC Office and IBC in conjunction with the Safety Compliance Office reserve the right to conduct inspections of the research facilities at any time. Principal Investigator s signature: Date: 16