LOUISIANA STATE UNIVERSITY
HEALTH SCIENCES CENTER-Shreveport
Biosafety Committee
INSTITUTIONAL REVIEW FORM
Submit original to the Office of Sponsored Programs & Technology Transfer, Rm F1-53.
IMPORTANT!!! Incomplete forms will be returned! FORMS MUST BE TYPED.
NOTE: The Safety Office will inspect to ensure compliance with the Chemical Hygiene Plan prior to approval of the Biosafety Protocol. Call the Safety Office one (1) month in advance prior to your Biosafety Submission.
- To be completed by the Principal Investigator -
Principal Investigator Name: Last: / First: / Degree: / MDMD, PhDDOPhDDScMSAcademic Title: / Assistant ProfessorAssociate ProfessorProfessorInstructorClinical Assistant ProfessorClinical Associate ProfessorClinical ProfessorClinical Instructor
Department: / AnesthesiologyCardiopulmonary ScienceCellular Biology - AnatomyCommunications DisordersEmergency MedicineFamily MedicineMedicineMolecular - Cellular PhysiologyNeurologyNeurosurgeryOrthopedic SurgeryObstetrics & GynecologyOphthamologyOtolaryngologyPathologyPediatricsPharmacology - TherapeuticsPhysical TherapyPsychiatryRadiologySocial ServicesSurgeryUrology / Section: / Burn SurgeryCardiologyCardiothoracic SurgeryClinical PharmacologyClinical ToxicologyCritical CareDermatologyEndocrinologyGastroenterologyHematology/OncologyInfectious DiseasesMaternal FetalNeonatologyNephrologyOncologyPediatric SurgeryPlastic-ReconstructivePulmonary/AllergyPulmonary/Critical CareOral-MaxillofacialRheumatologyTransplant SurgeryTraumaVascular Surgery / Phone:
Research Topic:
Biosafety Level: IIIIIIIV See question II-1D for information to help determine the appropriate
Biosafety Level.
Laboratory Room Numbers: ___, , :
If you are not the investigator to whom this space is assigned, please submit a letter of collaboration or cooperation from the assigned investigator.
Your signatures will assure that the individuals indicated will conduct the project as described herein and comply with appropriate institutional guidelines. The most recently revised protocol, and MSDS sheets, must be available in the PI's laboratory.
Principal investigator / Signature / Date*Department Head / Signature / Date
* If the Principal Investigator is the Department Head, please have the Dean of the School of Medicine sign in place of the Department Head.
No changes in the project will be made without prior notification and approval of the appropriate committees.
I. ABSTRACT OF RESEARCH
Include a general description of the experimental methods and overall research goals (750 words or less). This section provides an overview of the detailed information documented in this application. Please include: i) general description of experiments, ii) description of activities which might pose biohazards (chemical or biological) and iii) possible effects of biohazards on exposed humans. Chemical agents should be described only if they pose an unusual hazard (not normally found in academic laboratories) or if they are used in unusually large quantities, (for questions, please call Michael Stroud in Safety), or in methods that pose exceptional hazards, (e.g., aerosol formation outside the hood or used for injection).
II. TYPES OF AGENTS AND HAZARDS POSED BY THEIR USE
II-1. Does this research involve Recombinant DNA?
Yes No (If answer is No, then proceed to Section II-2)
II-1A. If your research involves recombinant DNA, mark the statement below that applies to this work, according to the latest Guidelines for Research involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), Section III, November 2013. http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html.
The proposed experiments require specific RAC (Recombinant Advisory Committee) review and NIH or IBC (Institutional Biosafety Committee) approval before initiation of the experiments.
The proposed experiments require IBC approval before initiation of the experiment.
The proposed experiments require IBC notification at the initiation of the experiment.
The proposed experiments are exempt from the procedures detailed in the Federal Register.
Please cite the page number for this reference.
II-1B. To avoid consequences of unintended expression in humans, provide a table listing all vector and host systems that will be employed in the proposed studies, listed in categories according to intent. This should include any recombinant nucleic acid elements such as bacterial plasmids, eukaryotic expression vectors or virus vectors and prokaryotic or eukaryotic cells used for propagation or expression. List all types of recombinant protein coding or regulatory DNA sequences to be expressed. Indicate whether or not vectors are self-replicating or self-transmissible. Describe any helper systems used to produce infectious forms of the vectors.
II-1C. Describe the potential consequences of human exposure to recombinant DNA elements, including expressed sequences (unintended expression in humans). Cite references to support these statements if possible.
II-1D. What is the level of containment recommended/required for the recombinant DNA materials? Please cite a reference including page number (e.g., Guidelines for Research involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), Section III, November 2013 or Biosafety in Microbiologiocal and Biomedical Laboratories (BMBL) - 5th Edition 2009 - U.S. Department of Health and Human Services). To purchase a copy of the BMBL, please visit www.cdc.gov/biosafety/publications/index.htm. A copy of the publication is also available in Adobe PDF form on the Institutional Biosafety Committee webpage at http://www.lsuhscshreveport.edu/Research/assurancecommittees/institutionalbiosafetycommittee/index under Policies and Guidelines.
II-2. Does this research involve Biological Agents (e.g. human cell lines that may harbor infectious agents, biological stocks of infectious agents or infectious entities derived from recombinant DNA)?
Yes No (If the answer is No, proceed to Section II-3)
II-2A. Provide a table listing potentially hazardous biological agents (e.g., human cell lines, human or veterinary pathogens, packaged expression vectors capable of infecting humans)
II-2B. Describe the potential consequences of human exposure to these biological agents (include vectors expressing heterologous genetic elements). Cite references to support these statements if possible.
II-2C. What is the level of containment recommended/required for the biological materials? Please cite a reference including page number (e.g., Biosafety in Microbiologiocal and Biomedical Laboratories - 5th Edition 2009 - U.S. Department of Health and Human Services).
II-3. Does this research involve Chemical Agents that pose extraordinary risk to humans? Only fill out this section if chemicals used are unusually hazardous, used in unusually large quantities, or used with techniques that pose exceptional hazards.
Yes No
If you are not sure whether this applies, call the Safety Office at extension 5-4753.
II-3A. Provide a table listing unusually hazardous chemical agents and describe consequences of human exposure to these chemicals via techniques used in the laboratory. Cite references to support these statements if possible.
II-4. Does the research involve Human Clinical Samples?
Yes No
Check appropriate sample type(s): Blood Tissue Serum
II-4A. If the sample will be processed in a manner that is expected to inactivate any or all infectious agents, describe this process and proceed to Section III.
II-4B. By initialing below, you certify that you have received the appropriate Bloodborne Pathogen Exposure Control Plan and University Hospital Safety Manual available in the Safety Office. (If you have not yet received the Manual, pick up a copy in the Safety Office).
initial here
Reminder: All samples are to be treated with Standard Universal Procedures
II-4C. If IRB approval is necessary for the research, supply the IRB number:
III. AGENT USE AND STORAGE
Briefly describe the following aspects as they relate to individual biological or chemical agents. Please include LSUHSC room numbers for storage and experimental procedures.
III-1. Methods of physical containment and security, for example, how will access to BL2 agents or select agents be limited?
III-2. Physical handling of the agent
III-2A. Safety procedures for individuals working with the agent(s). Descriptions should be specific to agents and procedures used in your laboratory. Please cite references for these procedures if possible.
III-2B. Procedures associated with use of agents in animals, if applicable.
III-2C. Disposal and decontamination procedures for contaminated material and laboratory equipment.
a. How will contaminated equipment or surfaces be treated? State the disinfectants to be used.
b. How will disposable items be treated and stored prior to disposal?
c. How will non-disposable items be treated and stored before re-use?
d. If research involves animals, how will animals or tissue be disposed following each experiment?
IV. TRAINING/EXPERIENCE IN AGENT USE
Describe any prior training you have had in handling agent(s) listed in Section II or any similar materials. Include references to any manuscripts you have published employing these agents.
V. LSUHSC POLICY COMPLIANCE
V-1. All laboratory personnel who might have direct contact with human clinical samples MUST Bloodborne Pathogen Training (Contact Safety Office 5-4753). Place certificates from the training session in departmental file for Safety Office inspection. This protocol cannot be approved unless training has occurred and appropriate documentation has been confirmed by the Safety Office.
V-1A. By initialing below, you certify that you have received the appropriate training in Bloodborne Pathogen, Lab Safety, Chemical Safety, Biological Safety and Shipping of Dangerous Goods.
initial here
V-2. Each laboratory must conform to the Chemical Hygiene Plan. Contact the Safety Office for compliance guidelines. This protocol cannot be approved unless the “Safety Evaluation of Laboratory Areas” is attached with no restrictions. What is the status of your Chemical Hygiene Plan?
Approved
Submitted
Not Submitted
V-3. If the research project requires the use of a Biosafety cabinet, provide the most recent inspection date for cabinet:
V-4. Will animals be used for this research?
Yes No
What is the Status of the Animal Care Protocol?
Submitted
Approved Protocol Number(s):
Not Submitted
V-5. Will radioisotopes be used in this research?
Yes No
What is the status of the radiation Safety Protocol?
Submitted
Approved Protocol Number(s):
Not Submitted
VI. LABORATORY PERSONNEL
For all persons who are currently or will be working with potentially hazardous agents, provide name, position, and SIGNATURE. Persons should sign this form only after reading it and becoming familiar with its contents. Signatures will document that these individuals have been informed of the identity and nature of biological hazards present in the laboratory and have been trained in proper safety procedures for their use.
Name (Please print) / Signature1
Revised 10/21/15