FACULTY OF VETERINARY SCIENCE INSTITUTIONAL BIOSAFETY COMMITTEE (CU-VET-IBC) Protocol Review No. IBC Protocol review numbers are composed of the last two digits of Christian Era, followed by two digits of faculty code number, and the last three digits run by faculty IBC on queue. **ให้ กรอกหมายเลข 2 ตัวแรกเป็ นปี ค.ศ.ตามด้ วยรหัสของคณะ 2 ตัว และ 3 ตัวท้ ายเป็ นลาดับการขออนุญาต** ***Hand Written Forms Will Not Be Accepted*** APPROVAL DATE: DATE EXPIRED: OFFICE DATE RECEIVED: USE …..……………………………………………………………………… ………………………………………………………………………… 1. Project or Proposal (if applicable): …………………………………………………………………….. 2. Protocol Title:(Eng)………………………………………………… …................................................ (Thai)................................................................................................................................................... 3. Submission of this protocol as: New submission Approved protocol number ….………………………..… Amendment for: Principal and/or Co-investigator (s) Experimental design/procedure Extension of the approval period Other, please specify ………………………………………………………………… 4. Name of Principal Investigator (PI): Name: ……………………………………………………………….............................................. Degree: …………………………………………...Position: ……………………………………… Department: ………………………………………………………………………………………… Faculty/Institute: ………………………………………………………………………….………… Tel: …………………………………….…………. Fax: …………………………………………… E-mail: ……………………………………………………………………………………………….. 5. Co-Investigator(s) and personnel: Name: ……………………………………………………………….............................................. Degree: …………………………………………...Position: ……………………………………… Department: ………………………………………………………………………………………… Faculty/Institute: ………………………………………………………………………….………… Tel: …………………………………….…………. Fax: …………………………………………… E-mail: ……………………………………………………………………………………………….. Name: ……………………………………………………………….............................................. Degree: …………………………………………...Position: ……………………………………… Department: ………………………………………………………………………………………… Faculty/Institute: ………………………………………………………………………….………… Tel: …………………………………….…………. Fax: …………………………………………… E-mail: ……………………………………………………………………………………………….. 6. Name of Secondary or Emergency Contact Information: Name: ……………………………………………………………….............................................. Degree: …………………………………………...Position: ……………………………………… Department: ………………………………………………………………………………………… Faculty/Institute: ………………………………………………………………………….………… Tel: …………………………………….…………. Fax: …………………………………………… E-mail: ……………………………………………………………………………………………….. 7. Nature of protocol: Research in the field of …………………………………………………..…………………… Teaching: Course ……………………………………………………………...……………… Other, please specify …………………………………………………………………………. 8. Funding source/Budget Grant has been: Submitted Sponsor:…………………………………………………… ………….……….. Approved Sponsor:……………………………………… ………….……………..……… Duration of approval …………………………………..………………………. Amount: ………………………….………….…….….…………….……………. Other, please specify ………………………………………………. DEPARTMENT/CENTER OF EXCELLENCE (CE) ENDORSEMENT (Required) I endorse this project for review. Head of Department or CE Comments: Signature Date BODY OF PROTOCOL 1. Descriptive Summary: [Using non-technical language, provide the following information in context so that the committee can make an appropriate risk assessment of your research project a) provide a hypothesis for the proposed research b) provide an abstract of the proposed research; including descriptions of any rDNA constructs, definitions of all acronyms and a list of relevant methodologies and c) discuss any biosafety concerns for the committee’s consideration.] ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ 2. Procedures and Place of Study: Detection Propagation/Culture Other, please specify ………………………..…………………………………………………. Please explain the place of study: …........................................................................................................................................................ …........................................................................................................................................................ Please explain how the waste is decontaminated and disposed: …........................................................................................................................................................ …........................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ Please explain how the carcasses are disposed after termination (if applicable): …........................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ 3. Exposure Assessment and Personal Protective Equipment (PPE): [If a loss of containment or spill of the agent were to occur and humans, animals, or plants in the immediate or surrounding area were exposed, please describe possible occupational and environmental consequences (i.e. symptoms in affected persons/animals, impact on plants, corps, and livestock in surrounding areas, etc.)] …........................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ …........................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ Please indicate the Personal Protective Equipment (PPE) that will be used: Gown Glove Mask Safety glass Shoe cover Hair bonnet Tyvek Other, please specify ………………….. Please indicate specific treatment provision/incidence response for accidental exposure: ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ 4. Occupational Exposure Assessment and Risk Groups: [Check all practices and procedures that may result in occupational exposures] Injection/needlestick Inhalation Splash Ingestion Cut/Abrasion others, please specify ………………………… Highest Risk Group (Please consult IBC for appropriate risk group): RG1 Agents that are not associated with disease in healthy adult humans/animals RG2 Agents that are associated with human disease/ Animals that is rarely serious and for which preventative of therapeutic interventions are often available. All human/ animals source material (including blood, cell lines, and other potentially infectious materials) are considered RG2 RG3 Agents associated with serious or lethal human/ animals disease for which preventative or therapeutic interventions may be available (high individual risk but low community risk) Appropriate Biocontainment Level (http://www.cdc.gov/biosafety/publications/bmbl5/): BSL1 Suitable for work involving well-characterized agents not known to consistently cause disease in healthy adult humans, and of minimal potential hazard to laboratory personnel and the environment. BSL2 Suitable for work involving agents of moderate potential hazard to personnel and the environment. Includes the use of Universal Precautions in all clinical settings. BSL3 Suitable for work involving indigenous or exotic agents that may cause serious or potentially lethal disease through inhalation route exposure. Please list relevant occupational medical health provision (if applicable): …........................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ ............................................................................................................................................................ 5. Biohazard Identification: Identify all biohazards to be used in this protocol. List each biohazard in the appropriate box (include genus, species, strain, subtype, as applicable) Virus: …………………………………………………………………………………………… Bacteria: ………………………………………………………………………………………… Rickettsiae: ……………………………………………………………………………………… Fungi: …………………………………………………………………………………………… Toxin: …………………………………………………………………………………………… Parasite: ………………………………………………………………………………………… Human source material: ………………………………………………….…………………… Select Agent (http://www.selectagents.gov/SelectAgentsandToxinsList.html): ………… .......................................................................................................................................... Hazardous chemical(s)/carcinogen(s)/radioactive material(s): …………………………... Recombinant agent(s): ………………………………………………………………………… 6. Study Involving Animals: Animals: Identify Species (check all that apply) Mouse Dog Rat Cat Rabbit Poultry Pig Fish Gerbil Ferret Other, please specify: ………………………………………………………………… Are the Animals used in the experiment immunocompromised? No Yes Which of the following present exposure risks to the investigator or animal? (check at least one) Aerosols Animal Bite/Scratch Bedding Blood Feces Saliva Urine Contact with lesions on the animal Mucous membrane contact with secretions or excretions Other, splease specify ………………………………………………………………... PRINCIPAL INVESTIGATOR ASSURANCES Protocol Number: Approval Date: 1. I agree to abide by all relevant institutional policy at Faculty of Veterinary Science, Chulalongkorn University. 2. Should I use the work described in this protocol for a proposal for funding, I assure the description of the animal use in such funding proposal to be identical to that contained within this protocol. 3. I assure that I will complete and submit protocol for renewal prior to the annual anniversary of protocol approval to avoid expiration of such approval and cessation of all research activities. 4. I assure that the work described within this protocol will not be initiated until notification of IBC approval has been received. 5. I assure that I will notify IBC of any proposed changes regarding the work described within this protocol and agree that no such changes will be implemented until approved by the IBC (except where absolutely necessary to eliminate apparent immediate hazards to individual(s) and/or animal(s)). 6. I am aware that I will be responsible for loss of containment or spill of the agent that may cause serious effects to environment, animals, and personnel. I verify that the information provided in this Animal Use Protocol is accurate and complete. I understand that as Principal Investigator I have ultimate responsibility for the ethical performance of the research and strict adherence to any condition imposed by the IBC. Principal Investigator’s Name: Signature: Date: