Scott & White Healthcare Institutional Biosafety Committee (IBC) IBC Study Update / Change Request

Transcription

1 Scott & White Healthcare Institutional Biosafety Committee (IBC) IBC Study Update / Change Request 1 Submit the renewal electronically via attachment to: IBCOFFICE@swmail.sw.org 2 Fax a Signed copy of the report to the IBC Office FAX: Study Update / Change Request Instructions: Do not leave any blanks, incomplete reports will be returned for corrections. Section 1 - IBC Administrative Information Date of Report: Principal investigator: Protocol Title: IBC permit number: Section 2 Study Update / Change Request Type Please indicate the type of change/update that is being requested: Study Title - please complete Section 3 Change/Addition of funding please complete Section 4 Change in Laboratory Location please complete Section 5 Recombinant DNA (including viral and bacterial vectors) please complete Sections 6 and 13 Synthetic DNA/RNA, Prions please complete Sections 7 and 13 Toxins please complete Sections 8 and 13 Human or Non-human Primate Cells/Tissue/OPIM please complete Sections 9 and 13 Virus, Bacteria, Fungi, etc. please complete Sections 10 and 13 Nanomaterials please complete Sections 11 and 13 Addition of Animals please complete Section 12 1

2 Section 3 Study Title ( Not applicable) Please indicate the type of study title change: Addition of study title a. Please indicate new study title: b. Justification for change: c. Describe the new aims and procedures used in the new protocol title: Change of study title: a. Please indicate the old study title: b. Please indicate the new study title: c. Justification for change: d. Describe the new aims and procedures used in the new protocol title: Deletion of study title: a. Please indicate the study title being deleted: b. Justification for the title deletion (i.e., funding has ended): Section 4 Funding Information ( Not applicable) Please indicate the type of change to funding: Deletion of funding: a. Please indicate the funding source being removed: b. Justification for the removal: Addition of funding Please complete the table below: 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 2

3 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 Section 5 Laboratory Location ( Not applicable) Please indicate the type of change to the laboratory location: Removal of location(s) Location #1 a. Please indicate the location of the laboratory being removed: b. Justification for the removal: Location #2 a. Please indicate the location of the laboratory being removed: b. Justification for the removal: Location #3 a. Please indicate the location of the laboratory being removed: b. Justification for the removal: Addition of location please complete the below table: 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 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 3

4 Location #3 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 Section 6 Recombinant DNA Section ( Not applicable) Removal of Recombinant DNA Type of Agent Name of Agent Addition of Recombinant DNA please complete the following: 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) 4

5 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? 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 Viral/Adenovirus type 5 Yes, replication tested in HeLa cells CMV promoter 1 x 10 8 particles/ml E. coli, Sure cells TM 1 liter Amphotropic broad 5

6 Is the recombinant made in your lab? If not, where? If vector is a genome, what % has been deleted or substituted 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) Removal of Nonrecombinant or Synthetic DNA/RNA; Prions Type of Agent Name of Agent Addition of Nonrecombinant or Sythetic DNA/RNA; Prions please complete the following: 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 Name of Prion Pathogenic PrP Isoform Disease Natural Host 6

7 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) Removal of Toxin(s): Name of Toxin: Addition of Toxin(s) please complete the following: 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 7

8 spills/exposures? g. PI s previous work experience with the toxin(s) Section 9 Human or Non-human Primate Cells/Tissues/OPIM ( Not applicable) Removal of Cells/Tissues/OPIM Name of the Cells/Tissues/OPIM being removed: Addition of Cells/Tissues/OPIM please complete the following: 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 8

9 Section 10 Microorganism Section ( Not applicable Do not use this section if you are utilizing replication-incompetent viral vectors, use section 6) Removal of Microorganism: Type of Microorganism being removed: Name of Agent: Addition of Microorganism please complete the following: 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 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) 9

10 Section 11 Nanomaterials Section ( Not applicable) Removal of Nanomaterial(s): Description of the nanomaterial being removed: Addition of Nanomaterial(s) please complete the following: 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) Removal of animal(s) from the research: Type of Species being removed: Justification for removal: Addition of animal(s) to the research please complete the following: a. If live animals are to be used on this protocol, please complete the table below: Species Brief Description of Agent BSL Housing 10

11 Use 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: 11

12 f. Will transgenic or gene-targeted animals be bred on-site in a Scott & White facility? 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 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 Principal Investigator s signature: Date: 12