Institutional Biosafety Committee (IBC) IBC Application and Amendment Form Version 04.07.2014 Date of Application: Indicate if this submission is an “initial” application, 5 year “renewal” or “amendment”: Principal Investigator: Degree(s): Position: Department: Email: Telephone/Office: Cell/After hours: Name and email of my coordinator/co-investigator to copy email correspondence: Project Title: Funding Source: Grant # (If applicable): Awarded or Pending? Enter “X” for ALL categories that this proposed research will involve and complete all applicable parts . _X _ PART A: General Information for ALL Research Projects requiring IBC Oversight. PART B: Research includes use of blood/ body materials (human or non-human primates), cell lines, or OPIM PART C: Research includes use of animals or animal parts PART D: Research includes use of biological toxins or potentially infectious agents PART E: Research includes use of transgenic animals OR recombinant DNA PART G: Medical Information for Bioagents (Exposure requires treatment beyond medical standard of care) Enter protocol number or “pending” if other regulatory approvals are required. IACUC Protocol # or Animal Tissue Use Form # IRB Protocol # [Research with human interaction/contact - includes any interaction where the investigator "touches" the subject, e.g. physical examination, surgery, or "instrumenting" the person as in auditory testing, providing inhalers, etc] As Principal Investigator of this project, I attest that the information contained in this application is accurate and complete. I accept the responsibility for the safe conduct of work with this study at the Biological Safety Level practices and procedures assigned by the IBC. I will inform all personnel, who may be at risk of potential exposure of the conditions of this work. I assure that all personnel will receive adequate training to perform all activities safely and IBC#: ______________ Amendment# ________ IBC Oversight is required for research with human/animal contact or use of biological materials, pathogens, toxins or rDNA. Use the “IBC Request for Exemption” form for research without human contact (e.g., surveys, interviews, data analysis). completing it. This format allows edit and spelling/grammar check functions. SUBMIT APPLICATION IN WORD FORMAT BY EMAIL TO: [email protected]. Coordinators/Co-investigators submitting in behalf of the PI must cc the PI on the email for IBC acceptance of the application. The approved application
Transcript
Institutional Biosafety Committee (IBC)
IBC Application and Amendment Form Version 04.07.2014
Date of Application: Indicate if this submission is an “initial” application, 5 year “renewal” or “amendment”:
Principal Investigator: Degree(s): Position: Department: Email: Telephone/Office: Cell/After hours: Name and email of my coordinator/co-investigator to copy email correspondence:
Project Title:
Funding Source: Grant # (If applicable): Awarded or Pending? Enter “X” for ALL categories that this proposed research will involve and complete all applicable parts._X_ PART A: General Information for ALL Research Projects requiring IBC Oversight. PART B: Research includes use of blood/ body materials (human or non-human primates), cell lines, or OPIM PART C: Research includes use of animals or animal parts PART D: Research includes use of biological toxins or potentially infectious agents PART E: Research includes use of transgenic animals OR recombinant DNA PART G: Medical Information for Bioagents (Exposure requires treatment beyond medical standard of care)
Enter protocol number or “pending” if other regulatory approvals are required.IACUC Protocol # or Animal Tissue Use Form # IRB Protocol # [Research with human interaction/contact - includes any interaction where the investigator "touches" the subject, e.g. physical examination, surgery, or "instrumenting" the person as in auditory testing, providing inhalers, etc]
As Principal Investigator of this project, I attest that the information contained in this application is accurate and complete. I accept the responsibility for the safe conduct of work with this study at the Biological Safety Level practices and procedures assigned by the IBC. I will inform all personnel, who may be at risk of potential exposure of the conditions of this work. I assure that all personnel will receive adequate training to perform all activities safely and proficiently. I will not carry out the work described in the attached application until it has been approved by the IBC and all requirements have been met. Where applicable, I agree to comply with the NIH requirements pertaining to shipment and transfer of recombinant DNA materials. I acknowledge my responsibility for the conduct of this research in accordance with Section IV-B-7 of the NIH Guidelines: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
Principal Investigator’s Signature: _____________________________________________ Date: ____________________
Sign and submit only this first page to the IBC Office at 433 Bolivar St, RCB#206, New Orleans, LA 70112. Email the application to the [email protected] as per the above instructions.
___This protocol application was approved by the LSUHSC-NO IBC. Annual re-approval will be required and routine inspections should be expected. You must submit an amendment prior to implementing any changes.
___This amendment was approved by the LSUHSC-NO IBC. Annual re-approval will be bound to the approved date of the application which this document amends.
IBC Chairman Signature: _________________________________ Date of IBC Approval: _______________
IBC#: ______________
Amendment# ________
IBC Oversight is required for research with human/animal contact or use of biological materials, pathogens, toxins or rDNA. Use the “IBC Request for Exemption” form for research without human contact (e.g., surveys, interviews, data analysis).
INSTRUCTIONS: ALWAYS download the latest version, and then save this form before completing it. This format allows edit and spelling/grammar check functions. SUBMIT APPLICATION IN WORD FORMAT BY EMAIL TO: [email protected]. Coordinators/Co-investigators submitting in behalf of the PI must cc the PI on the email for IBC acceptance of the application. The approved application will be emailed as a pdf document. Part B, C, D, E or G may be deleted if not applicable.
Provide an answer to each of the following items. Where applicable, enter “none” or “not applicable”. The Center for Disease Control has a manual that is particularly informative on their website http://www.cdc.gov/biosafety/. Additional websites are provided in various sections of this application to assist in the completion of this form.
1. Provide an estimated start date and expected duration of the study.
2. List all locations where this project will be conducted. If not located on LSUHSC campus, provide the name and address of the institution/clinic.
3. Briefly describe this project in NON-TECHNICAL LANGUAGE. If amending a previously approved IBC application, describe the changes requested and complete all applicable sections related to the change.
4. Describe sequentially all experimental procedures and techniques in this protocol.
5. List all research materials, agents and/or organisms that are specifically associated with this project except list blood, tissue or cell samples in Part B and animals/animal parts in Part C.
Research Materials orAgents/Organisms (by GENUS species for bacteria, virus, parasites, etc.; e.g., Escherichia Coli)
RISK GROUP(1,2,3,4)
Source or Vendor
Are materials, bioagents listed in your inventory? (see #7)
Bldg/Room where stored (if not on LSUHSC-NO campus, include physical address
Bldg/Room where used
Place “X” if room is shared
Risk Group (from NIH Recombinant DNA Guidelines (USA, 2002)) http://www.absa.org/riskgroups/index.htmlRG1: Agents that are not associated with disease in healthy adult humans. This includes a list of animal viral etiologic
agents in common use. RG2: Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic
interventions are often available. RG3: Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions
may be available (high individual risk but low community risk). RG4: Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions
are not usually available (high individual risk and high community risk). For assistance selecting biological material(s) risk group and biosafety level, visit American Biological Safety Association (ABSA) resource page at http://www.absa.org/riskgroups/index.html. The ABSA data base for infectious agent classification is http://www.absa.org/riskgroups/bacteria.html.
6. List any research material in this protocol that is listed by the government in any of the following categories. You must also contact the LSUHSC-NO Director of Office of Research Services for additional registrations.
PART A: General Information for ALL Research ProjectsAll research conducted at this institution must conform to regulations and guidelines for biosafety that have been established by various authorities. This form will document and confirm that Biosafety concerns have been addressed or determined non-applicable for your protocol. IRB and IACUC approvals will be contingent upon concurrent IBC approval where applicable.
“Select Agent” [http://www.selectagents.gov/] “Dual Use” [http://www.access.gpo.gov/bis/ear/pdf/ccl1.pdf] “Dual Use Research of Concern” [http://oba.od.nih.gov/biosecurity/bio_usg_activities.html]
7. For work conducted in a LSUHSC-NO laboratory, indicate the date of your last On Site Bioinventory Update: (Enter “N/A” if you do not maintain a laboratory subject to LSUHSC-NO policy*)
*Biological Materials Inventory and Control is required to ensure compliance with federal regulations; investigators must maintain an accurate inventory detailing the type, amount, and location of ALL biological materials under their supervision via the On Site database. To access the On Site inventory database, click on: http://172.20.240.20:1568/.*1
The inventory must be updated when new biological materials are added or materials are removed from the laboratory, when there is a significant change in quantity of biological materials or a change in location of the storage or use of biological materials, and must be updated at least annually. To review the complete LSUHSC-NO policy, click on: Biological Materials Inventory and Control Policy.*Note 1: To login to On Site, use your LSUHSC-NO user name and password. Instructions for entering the biological inventory are available "click here" or at the login screen. For additional assistance (i.e., granting PI designate access to manage inventory, adding labs/materials, or login assistance) contact the Biosafety Officer at 504-568-6585.
*Note 2: If biological materials for this research protocol are not yet in PI possession, ensure they are input into On Site as soon as they are received in the laboratory.
8. List each biosafety concern associated that is specifically associated with this project and how each will be addressed.
Concerns with either Research Materials/Activity, Equipment, Radiation or Biohazardous Waste
BSL of work to be performed (1,2,3,4)
List potential hazards to personnel, clinic, and/or the animal facility
List what PPE, SOPs, specific practices, precautions, or procedures will be used to safely conduct this work
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Biosafety Levels BSL1: Standard microbiological practices are followed; work can be performed on an open lab bench or table; PPE (lab coats, gloves, eye protection) are worn as needed; frequent decontamination of surfaces; an available sink for hand washing. The lab should have doors to separate the working space and access is limited.
BSL-2: In addition to BSL-1 considerations, appropriate PPE includes lab coats and gloves, eye protection and face shields as needed; all procedures that can cause infection from aerosols or splashes are performed within a biological safety cabinet. Decontamination of surfaces after using; an autoclave or an alternative method of decontamination is available for proper disposals. The laboratory must separate doors with access to the laboratory restricted when work is being conducted; sink and eyewash are readily available; biosafety signs on door.
BSL-3: In addition to BSL-2 considerations, lab personnel are under medical surveillance and might receive immunizations for microbes they work with; access to the laboratory is restricted and controlled at all times; appropriate PPE must be worn, and respirators might be required; all work with microbes must be performed within an appropriate biological safety cabinet; a hands-free sink and eyewash are available near the exit. Exhaust air cannot be recirculated, and the laboratory must have sustained directional airflow by drawing air into the laboratory from clean areas towards potentially contaminated areas. Entrance to the lab is through two sets of self-closing and locking doors.
BSL-4: In addition to BSL-3 considerations, containment requirements include a change of clothing before entering, shower upon exiting and decontaminate all materials before exiting. All work with the microbe must be performed within an appropriate Class III BSC or by wearing a full body, air-supplied, positive pressure suit. The laboratory is in a separate building or in an isolated and restricted zone of the building. The laboratory has dedicated supply and exhaust air, as well as vacuum lines and decontamination systems.
9. All laboratories, clinical facilities and equipment that will be used to conduct this protocol must meet the applicable standards set forth by this institution and federal or state regulations. Are there areas or items that require attention? If “yes”, identify concerns or needs and how these will be rectified (e.g., proper ventilation, flooring, radiation protective barrier, wash station, current hood inspection). Also, indicated if you have contacted the LSUHSC-NO Environment Health & Safety Department for guidance to attain or create Safe Practices Standards (SOP).
10. Complete the table for research materials that will be commercially shipped or transported by study personnel either within and/or outside of the LSUHSC-NO Campus. [On-line Training for Shipping Biological Materials is required: http://www.is.lsuhsc.edu/safety/training.aspx#Shipping_Biological_Materials_Training].
Material Method: Personnel transport, Courier, Commercial Shipper
If toxin or select agent, DOT division and UN classification
Location From
Location To
Personnel packing, shipping, transporting
Personnel Shipping Training
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11. Are there any special treatments beyond the medical “standard of care” in treating human exposure to research materials or with novel or uncommon infectious agents? (Examples include gene therapy viruses or pathogenic bacteria with multiple antibiotic resistance.)
If “Yes”, identify material/agent and briefly explain medical treatment required, then complete Part G. 12. Beyond the required LSUHSC-NO Biosafety and Bloodborne Pathogen training, describe what specific
instructions and training will be given to any personnel associated with this protocol (including animal caretakers) to ensure safety in the performance of activities described in this protocol and of safety procedures for dealing with accidents related to this protocol. (e.g. lab orientation and safety procedures, use of equipment, making/storing cell cultures, animal procedures, radiation safety)
13. List all personnel who are authorized to participate and have been trained to perform their assigned activities. Approval of the proposed experiment(s) is given only for the identified personnel listed below. Once approved, submit the Change in Personnel Form to add personnel to this project. All training must be completed prior to participation.
The Principal Investigator is responsible for informing all personnel of potential hazards, safe work practices, availability of medical surveillance, and that they understand and will follow all approved laboratory practices and procedures. The Principal Investigator assures that all personnel have completed all safety, biological, animal and/or human research training requirements.
First & Last Name, Degree
Role in Project If not an LSUHSC-NO employee/student, list employer or institution
Date of Biosafety training1
Date of Bloodborne Pathogen training1
If working with blood or body fluids, has individual received the Hep B vaccine series2
Role in Project If not an LSUHSC-NO employee/student, list employer or institution
Date of Biosafety training1
Date of Bloodborne Pathogen training1
If working with blood or body fluids, has individual received the Hep B vaccine series2
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1 Bloodborne Pathogens Training (Initial or Refresher) is mandatory for ALL participates. Biological Safety Training is required every three years for personnel who will have physical contact with humans or animals and/or who will physically handle biological materials, biohazardous agents or recombinant DNA molecules.For non-LSUHSC participates, equivalent Biological Safety and Bloodborne Pathogen Training from other institutions or hospitals will be accepted by LSUHSC-NO IBC by providing documentation of completion.Web pages for information on safety and training requirements:
Training Required to Participate in Research: http://www.lsuhsc.edu/administration/academic/ors/training.aspxEH&S Safety Training: http://www.is.lsuhsc.edu/safety/training.aspx.
2Although highly recommended, Hepatitis B vaccine may be declined, but individuals must sign the declination form. If declined, the vaccine may be obtained at future date. Contact your Department Business Manager about receiving the Hepatitis B vaccine at no charge. For more information, refer to the Bloodborne Pathogens Exposure Control Policy #EHS-300.04, Section 9.0 and Appendix A: http://www.is.lsuhsc.edu/safety/bio_policies.aspx.
Containment Equipment (e.g., chemical fume hood, biosafety cabinet, containment centrifuge)
3. Will any samples be prescreened for pathogens? NO YESIf “Yes”, list the sample and what pathogens are screened. Indicate if positive test samples are accepted or declined.
4. Have any samples been intentionally or is it suspected of being infected with any pathogens? NO YESIf “Yes”, list the sample and identify the pathogens.
5. Will any samples be infected with any pathogens as part of this protocol? NO YESIf “Yes”, list the sample and identify the pathogens to be used and complete Part D.
PART B: Research Involving Human or Non-Human Primate Blood, Blood Components, Cell Lines and/or Other Potentially Infectious Materials (OPIM)
1. If not using live animals, list what animal carcasses and/or animal parts will be used and the source.
Species (common name)
Parts Source
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2. If using live animals, list the animal species that will be used and the source.
Species (common name)
Strain (if applicable) Source Indicate if transgenic (knock in or knock out). If transgenic, complete Part E
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3. Indicate where the animals/animal parts will be housed/stored and where animal work will be performed.
Species (common name)
Strain/PartsBSL
(1,2,3,4)
Housing/Storage -enter DAC or Bldg/Room
Bldg/Room where animal work is performed
Place “X” if performance site is shared(if not on LSUHSC-NO campus, provide
physical address)
4. Complete the following table if live animals will be exposed to live organisms or viruses. Complete Parts D and/or E where applicable.
Species (common name) Strain (if applicable) Agent/Toxic Route of Administration (e.g., Subcutaneous, Intravenous, Intracranial, IP, IM)
5. Will any rDNA be introduced into the animal model? NO YES. If “Yes”, complete Part E. [NIH/OBA covered animal experiments: http://oba.od.nih.gov/oba/ibc/FAQs/TableAnimalResearchCoveredUnderNIHGuidelines-Aug2011.pdf ; additional information on OBA FAQs: http://oba.od.nih.gov/oba/ibc/FAQs/TransgenicAnimalFAQs-Aug2011.pdf ]
6. Identify the material(s) and describe procedure(s) used to minimize occupational exposure to personnel where there is any possibility that research materials (carcinogens, recombinant molecule, vectors, toxins, or pathogens) introduced to live animals could remain a viable hazard (e.g., in animal secreta, excreta and/or soiled bedding).
7. Explain any special procedures or alterations required to safely conduct this research beyond LSUHSC-NO Animal Care’s Standard Operating Procedures. [Depending upon IBC risk assessment, you could be notified that new SOPs will be required whereby you must consult with the Animal Care Facility Veterinarians to modify or develop new SOPs specific to the procedures and/or the biosafety hazards of this project before the IBC application can be approved.]
8. Describe the procedures for disposal of animal materials and carcasses.
PART C: Research Involving Research Involving the Use of Animals
To be completed by laboratories handling toxins and/or biological agents (actual or potential human pathogens, oncogenic viruses). Regulatory websites are listed below for reference. Contact the IBC or EH&S office if you need further assistance. 1NIH Guidelines Appendix B: http://oba.od.nih.gov/oba/rac/guidelines_02/Appendix_B.htm#_Toc30231812CAS Registry Number: http://www.cas.org/expertise/cascontent/registry/regsys.html3CDC/APHIS List of Select Agents: http://www.selectagents.gov/SelectAgentsandToxinsList.html 4EAR - CCL Database: Part 774 (In particular, see Category 1, pages 58 -73) http://www.access.gpo.gov/bis/ear/pdf/ccl1.pdf5National Select Agent Registry (NSAR): http://www.selectagents.gov/
For a list of Select Agents/Toxins, Exclusions, Restricted Experiments or Permissible Toxin Amounts go to: http://www.selectagents.gov/SelectAgentsandToxins.html
1. Complete the following table for every biological agent and/or toxin that will be used in this protocol.Agent or Toxin Specific Strain Genotype Risk Group
(1,2,3,4)Chemical Abstract Service (CAS) Registry Number
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2. List any research material in this protocol that is listed by the government in any of the following categories. You must also contact the LSUHSC-NO Director of Office of Research Services for additional registrations.
“Select Agent” [http://www.selectagents.gov/] “Dual Use” [http://www.access.gpo.gov/bis/ear/pdf/ccl1.pdf] “Dual Use Research of Concern” [http://oba.od.nih.gov/biosecurity/bio_usg_activities.html]
3. Identify and explain what toxin(s) will be produced as a result of this project.
4. Complete the following table for every toxin associated with this protocol. [If more than two toxins will be used, copy and paste this table below before completing.]
Toxin 1 Toxin 2Name of ToxinAmount of ToxinMethod of aliquotteDoes Toxin have LD50 more than 100 nanograms per kilogram body weight? Usual volume to be used in litersLargest volume to be used in litersWill dilutions be prepared?
5. Complete the following table for every pathogen associated with this protocol. [If more than two pathogens will be used, copy and paste this table below before completing.]
Pathogen 1 Pathogen 2Name of PathogenList other markers expressed and provide details.Is there a possibility of new strains being created? If “yes”, provide details.Is the organism inactivated prior to other manipulation? Method of inactivation: Method to verify inactivation:Do you culture the organism? If “yes”, specify the amount.Do you concentrate the organism? If “yes”, specify method.
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6. If dilutions will be prepared, identify the method and how they will be aliquotted. 7. Identify the containment equipment that will be used. (e.g., biosafety cabinet, chemical fume hood, containment
centrifuge, secured cabinets) 8. Describe the procedures for disposal and inactivation of agents or contaminated/infectious materials.
NOTE: Complete Part A.11 if human exposure to research materials requires special treatments beyond the medical “standard of care” complete Part G: Medical Information for Bioagents.
NIH/Office of Biotechnology Activities (OBA): http://oba.od.nih.gov/oba/index.html NIH Guidelines for Research Involving rDNA Molecules: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html NIH Section III Guidelines: http://oba.od.nih.gov/rdna/nih_guidelines_new.htmNIH - Animal Experiments: http://oba.od.nih.gov/oba/ibc/FAQs/TableAnimalResearchCoveredUnderNIHGuidelines-Aug2011.pdf OBA FAQs: http://oba.od.nih.gov/oba/ibc/FAQs/TransgenicAnimalFAQs-Aug2011.pdf
A. Research exempt from NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid MoleculesEnter “X” by the appropriate exempt category for this project and answer #1. If not requesting NIH Guideline exemption, skip this section and go to Section B.
Section III-F-1. Those synthetic nucleic acids that: (1) can neither replicate nor generate nucleic acids that can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or contain elements known to interact with either DNA or RNA polymerase), and (2) are not designed to integrate into DNA, and (3) do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight. If a synthetic nucleic acid is deliberately transferred into one or more human research participants and meets the criteria of Section III-C, it is not exempt under this Section.
Section III-F-2. Those that are not in organisms, cells, or viruses and that have not been modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular membranes.
Section III-F-3. Those that consist solely of the exact recombinant or synthetic nucleic acid sequence from a single source that exists contemporaneously in nature.
Section III-F-4. Those that consist entirely of nucleic acids from a prokaryotic host, including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well established physiological means.
Section III-F-5. Those that consist entirely of nucleic acids from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species).
Section III-F-6. Those that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent. A list of such exchangers will be prepared and periodically revised by the NIH Director with advice of the RAC after appropriate notice and opportunity for public comment (see Section IV-C-1-b-(1)-(c), Major Actions). See Appendices A-I through A-VI, Exemptions under Section III-F-6--Sublists of Natural Exchangers, for a list of natural exchangers that are exempt from the NIH Guidelines. Section III-F-7. Those genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any recombinant and/or synthetic DNA. Section III-F-8. Those that do not present a significant risk to health or the environment (see Section IV-C-1-b-(1)-(c), Major Actions), as determined by the NIH Director and listed under Appendix C, Exemptions under Section III-F-8 for other classes of experiments which are exempt from the NIH Guidelines. Appendix C categories listed below contain exceptions; you must refer to the NIH Guidelines Appendix C to determine if this project meets the exemption criteria.
Indicate which applicable subpart(s) C- I-VII: C-I. Recombinant or Synthetic Nucleic Acid Molecules in Tissue Culture C-II. Escherichia coli K-12 Host-Vector Systems C-III. Saccharomyces Host-Vector Systems C-IV. Kluyveromyces Host-Vector Systems C-V. Bacillus subtilis or Bacillus licheniformis Host-Vector Systems C-VI. Extrachromosomal Elements of Gram Positive Organisms C-VII. The Purchase or Transfer of Transgenic Rodents for experiments that requires BL1 containment C-VIII. Generation of BL1 Transgenic Rodents via Breeding
1. Explain why you believe this project is within the parameters of the above checked exempt category. STOP here if requesting Section A “Exemption from NIH Guidelines”; do not complete Section B.
PART E: Research Using Transgenic Animals or Recombinant DNA Research subject to the NIH Guidelines MUST have LSUHSC-NO IBC Full Committee review and approval before the project can begin. Submit application by the last Monday of the month for the next IBC Meeting
B. Research subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid MoleculesEnter “X” by the appropriate category and indicate the subpart classification(s) for this project. Complete all the remaining items of Part E.
Section III-A.1 or A-1-a. Major Actions under the NIH Guidelines (e.g., deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally)
Section III-B-1 or B-2. Experiments Involving the Cloning of Toxin Molecules with LD50 of Less than 100 Nanograms per Kilogram Body Weight
Section III-C-1. Experiments Involving the Deliberate Transfer of Recombinant DNA, or DNA or RNA Derived from Recombinant DNA, into One or More Human Research Participants
Section III-D-1. Experiments Using Risk Group (RG) 2, RG 3, RG 4, or Restricted Agents as Host-Vector Systems Indicate applicable subpart(s) a, b, c, d
Section III-D-2. Experiments in Which DNA From RG 2, RG 3, RG 4, or Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems
Indicate applicable subpart(s) a, b Section III-D-3. Experiments Involving the Use of Infectious DNA or RNA Viruses or Defective DNA or RNA Viruses in the Presence of Helper Virus in Tissue Culture Systems
Indicate applicable subpart(s) a, b, c, d, e Section III-D-4. Experiments Involving Whole Animals; NIH Classification Table for Animal experiments: http://oba.od.nih.gov/oba/ibc/FAQs/TableAnimalResearchCoveredUnderNIHGuidelines-Aug2011.pdf ; additional information on OBA FAQs: http://oba.od.nih.gov/oba/ibc/FAQs/TransgenicAnimalFAQs-Aug2011.pdf
Indicate applicable subpart(s) a, b Section III-D-5. Experiments Involving Whole Plants. Experiments Involving Whole Plants. Experiments to
genetically engineer plants by recombinant or synthetic nucleic acid molecule methods, to use such plants for other experimental purposes, to propagate such plants, or to use plants together with microorganisms or insects containing recombinant or synthetic nucleic acid.
Indicate applicable subpart(s) a, b, c, d, e Section III-D-6. Experiments Involving More than 10 Liters of Culture Section III-D-7. Experiments Involving influenza viruses
Indicate applicable subpart(s) a, b, c, d Section III-E-1. Experiments Involving the Formation of Recombinant DNA Molecules Containing No More than
Two-Thirds of the Genome of any Eukaryotic Virus Section III-E-2. Experiments Involving Whole Plants. Experiments Involving Whole Plants. Experiments involving
nucleic acid molecule-modified whole plants, and/or modified organisms associated with whole plants, that do not fall under Section III-A, III-B, III-D, or III-F.
Indicate applicable subpart(s) a, b-1, b-2, b-3, b-4, b-5 Section III-E-3. Experiments Involving Transgenic Rodents under BSL1, not under Section III-D-4 and not exempted
under Section III-F.
Provide an answer to each of the following items. Where applicable, enter “none” or “not applicable”.
1. Briefly describe, in NON-TECHNICAL LANGUAGE, the specific recombinant work falling under the category selected above.
2. Identify and describe the gene sequences used to make the recombinant. Provide the nature of the inserted DNA sequence (e.g., structural gene, oncogene), source of the inserted DNA sequences (e.g., species), and the hosts and vectors to be used. If obtained commercially, give a detailed description and submit the catalog description with this application.
3. Explain the function of the foreign genetic material in this experiment
4. In consideration of the agent characteristics (e.g., virulence, pathogenicity, environmental stability), list the hazards where there is a deliberate attempt made to obtain expression of foreign gene(s) (including antibiotic resistance markers) in the cloning vehicle.
Gene/proteinPotential hazards associated with expression of each foreign protein or
vector
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5. List any viruses or viral-based promoters to be used in this protocol. [If using more than one virus/viral promoter, copy and paste this table below before completing.]
Amount of viral genomic material: (whole; <2/3; <1/2)
Is virus used as a donor of genetic information or a vector?
For use as a vector: List specific phage, virus or plasmid and the function of eachFor use as a vector: If using mammalian expression system, provide a comprehensive description of the system
For use as a vector: If using human or amphotropic viral vectors, provide a detail description.
If virus replication is competent or mobilizable, what is the host range?
Is virus capable of infecting human cells?
Is strain attenuated?
Is a less virulent strain available?
Any potential for producing aerosols? (Indicate how this will be handled in Part A)
Organism Risk Group (1,2,3,4)
NIH Guidelines Appendix B – Risk Group: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
NOTE: Complete Part A.11 if human exposure to research materials requires special treatments beyond the medical “standard of care” complete Part G: Medical Information for Bioagents.
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6. List any animals, animal cells or plant cells that will be exposed to the recombinant. Identify and describe any infectious virus, oncogenic agents or toxins that will be produced during this work and describe the potential hazards and the planned mitigation measures.
Plant/Animal CellInfectious virus, oncogenic agents or toxins produced Potential Hazards Mitigation Measures
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7. If rDNA will be introduced into animal or cell models, and/or if the genome has been modified by rDNA, provide an answer to the following.
a. Identify any posed threat to other animals or humans.
b. Indicate what cells are permissive to further infection.
c. Is any rDNA used from a virus?
d. Is there any reasonable expectation that this viral segment could help mobilize part or all of the transgene, either by itself or by interaction with other viruses (including endogenous viruses)?
e. If part or all of the transgene was mobilized, would it carry any particular risk (is part or all of the transgene a known oncogene/anti-oncogene, toxin, immunosuppressant, or could it reasonably be expected to confer pathogenic properties on a virus that carried it?
f. If there is a possibility of viral vector sequences recombining with endogenous or exogenous helper viruses to produce new and unpredictable forms of infectious viruses, please explain:
g. Is rDNA used to make a transgenic animal model?
Contact Information Name Office or Lab Telephone
Cell Phone or After Hours Telephone
Principal InvestigatorLab ManagerOther
Provide the information that can assist the health care provider in the medical evaluation and treatment by completing the following tables. Alternatively, submit a copy of the Safety Data Sheet if the source/vendor provided one. Retain a copy of this factsheet with other safety documents in the laboratory. In the event of an exposure, it should be brought with the individual seeking medical attention.There are many resources available regarding genetic background and vectors online. Basic medical information for a variety of common pathogens can be found at http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/index-eng.php
Medical Precautions/TreatmentProphylaxisVaccineTreatmentMedical SurveillanceAdditional information
List the Safety Data Sheets or any other information that is being submitted with this application.
PART G: Medical Information for Bioagents In the event of a human exposure to research materials, special treatments beyond the medical “standard of care” is required.
