ORCS Main Section 2011
IBC Application Form
Main Section
INSTRUCTIONS FOR COMPLETING THE IBC APPLICATION FORM
Instructions:
1. You are encouraged to contact the Biological Safety Officer (BSO) to determine the level of oversight required for your research.
2. All 13 sections of the Main form must be completed. In the event that there is a box for which there is no entry or the item does not apply, please respond using N/A. If you need assistance or have questions concerning the form, contact the Institutional Biosafety Committee (IBC) Chair or the BSO.
3. Fill out the Individual Biohazard Section(s) that applies to your research. The categories include:
a. Known Human/Zoonotic Pathogen or Biohazard
b. Unknown Human/Zoonotic Pathogen or Biohazard
c. Recombinant DNA
d. Animal Pathogens/Biohazard
e. Plant Pathogens/Plant Pests
f. Animals Used in the proposed research
4. Send both the Main Section and each Individual Biohazard Section to the BSO.
5. The Biosafety Office will accept either a signed hard copy or an electronically signed copy of the application.
6. Principal Investigators (PIs) will receive electronic notification of the IBC approval date, expiration date and IBC approval number.
7. The PI must notify the BSO in writing when changes occur in the project. Changes that require proposal amendments include but are not limited to the following:
· Change in personnel
· Change in laboratory location
· Change in experimental methods
· Change in infectious agents
· Change in human/nonhuman primate cell lines
· Change in facility containment level.
8. This application form must be typed or printed legibly.
9. Please append any documentation you feel is needed to explain the work being proposed.
10. Please read and initial the Responsibilities listed on the next page.
Principal Investigator Responsibilities
Please initial beside each item indicating that you have read and understood it.
____Develop specific protocols to ensure the safe use of biohazardous materials by following instructions set forth in the University Biosafety Manual and ensure that all laboratory personnel comply with the specific safety protocols.
____ Make the initial determination of the required levels of physical and biological containment as well as the appropriate microbiological practices and laboratory techniques.
____ Ensure that the containment equipment and facility requirements for activities performed under his/her direction meet the criteria for the appropriate BSL level.
____ Ensure that all maintenance work in, on or around contaminated equipment is conducted only after that piece of equipment is thoroughly decontaminated by the laboratory staff. Ensure that all equipment is decontaminated before removal from laboratory.
____ Develop specific protocols that outline proper emergency procedures for response to an accidental exposure of personnel or the environment to the biological agents and ensure that all laboratory staff are familiar with and comply with the emergency procedures.
____ Submit an IBC application and obtain approval from the IBC prior to commencement of the work. In, addition, the PI is responsible for submitting any changes to the IBC-approved project using the IBC Update/Amendment Form.
____ Obtain approval from the other regulatory committees if required: IACUC – animal care and use; IRB - human subjects research; RSC – radiation safety.
____ Comply with all applicable University policies and federal, state, and local laws.
____ Ensure that all laboratory staff under his/her supervision are appropriately trained in the safe use of biohazardous materials. Training includes animal care personnel who provide husbandry and care for infected research animals.
____ Comply with medical waste laws in the handling and disposal of biohazardous waste.
____ Ensure that all laboratory staff, maintenance personnel and visitors are informed of the potential risk and the practices/procedures used to minimize that risk.
____ Report any significant problems or violations or any significant research related accident or laboratory acquired infection to the Biological Safety Officer or IBC Chair.
____ Comply with import/export/shipping requirements of biohazardous materials.
Mississippi State University
Institutional Biosafety Committee Application Review Form
Principal Investigator (PI): / Phone:Mailstop:
Department: / Email Address:
Co-Investigator: / Email Address:
Address: / Phone:
Project Title: / IBC #
Anticipated Dates of Performance:[mm/dd/yy]
§ I certify that the information provided in this application is complete, accurate and consistent with any proposal(s) submitted to a funding agency.
§ I agree that I will not begin this project until receipt of official approval from the appropriate committee(s).
§ I agree that modification to the originally approved project will not take place without prior review and approval by the appropriate committee(s), and that all activities will be performed in accordance with all applicable federal, state, local and University policies.
§ I will follow applicable biosafety level requirements, comply with all shipping requirements and required waste management practices.
§ I will ensure that all personnel have appropriate training including but not limited to: biosafety principles and techniques, hazard identification, accidental spills, shipping regulations, proper handling of biohazardous materials and waste management.
§ I am aware that the IBC reserves the right to conduct inspections of the research facilities at any time.
______
Signature of Principal Investigator Date
I have reviewed the proposed research and approve its submission:
______
Signature of Department Chair Date
INSTITUTIONAL BIOSAFETY COMMITTEE ONLY
IBC APPLICATION NUMBER:
PROPOSAL APPROVAL: / APPROVED
APPROVAL PENDING CONDITION(S)
NOT APPROVED
DEFERRED
REGISTERED
EXEMPTED
DATE OF FINAL APPROVAL:
EXPIRATION DATE:
______
Signature of IBC Chair Date
______
Signature of Biosafety Officer Date
1. KEY PERSONNEL: List all project personnel and describe experience and training with biohazardous agents in GENERAL and with this SPECIFIC project. Additional personnel can be grouped into the last box.
NAME / DEGREE(S) / Years of Training/Experience with Biohazardous Material / Duties Related to This Project / Describe the Training & Experience Level with the Specific Duties
2. LOCATION OF WORK:
Building/Room Where Work Will Be Conducted / Building/Room Where Materials Will Be Stored3. CLASSIFICATION: Check the biological material(s) to be used.
Virus / Bacterium / Fungus / Parasite / Cell CultureSpecies:
Human Tissue / Human Body Fluid / Prion / Toxin / rDNA
Other
4. PROJECT SUMMARY: In lay terms, understandable by a nonscientist, give a general description of the project including the objectives.
5. EXPERIMENTAL DESIGN INCLUDING WORK PRACTICES: In the space below, provide a description of the experimental design. Include information on procedures, methods, and/or manipulations with the biohazardous material. Describe the work practices that will be in place to mitigate risk of exposure. The intent is to provide information such that the IBC can understand and assess biological risk.
6. SECURITY MEASURES: The access requirements and training specified by the BMBL for BSL-2 laboratories may provide sufficient security for the agent(s) being handled. However, additional measures may be required for precursors of select agents, select agents, agents of high commercial value such as a new vaccine candidate or agents with high public health/agricultural impact. Please describe any security measures you will take to protect the study agent(s) if applicable.
7. PERSONAL PROTECTIVE EQUIPMENT: Check the types of appropriate PPE that will be used.
Lab coatGloves
Safety Glasses
Face Shield / Goggles
N-95 mask*
*must be fit tested
Foot Covers
Tyvek cover-alls / Wrap-around gown
Head covering
Other
Explain:
8. PRIMARY BARRIERS: Check the types of primary barriers that will be used to contain the agent(s).
Biological Safety CabinetChemical Fume Hood
Sharps Container / Plexiglass Shielding
Glove Box
Vacuum Protector/Trap
/ Animal Caging
Type:
Other
Explain:
9. EQUIPMENT: Will you work with the biohazardous material in any of the following aerosol-producing devices/procedures?
CentrifugeDoes the rotor have a cover or do the buckets have lids?
/ Tissue grinders
Sonicators
Vortexers / Blenders
Shakers
Pressurized vessels (besides autoclaves)
/ Other
Explain:
10.DECONTAMINATION: Check the specific decontamination method(s) to be used for all biohazardous waste (except animal carcasses) and contaminated equipment. Decontamination may include autoclaving, chemical disinfection etc. If a chemical disinfectant is used, state type and concentration.
BleachConcentration / Autoclave
Autoclave Verification Program
Yes No / 70% ethanol
Other
Explain:
11. SPECIAL PRECAUTIONS: Please list any special precautions, in addition to the PPE and use of primary barriers, which may be employed in the laboratory for safety.
12. MEDICAL SURVEILLANCE: Medical surveillance requirements are usually determined on a case-by-case basis. Identify any medical surveillance requirements or practices for this project. If none, state “None”.
13. OTHER INSTITUTIONAL APPROVALS: If an approval has been received from the responsible review committee, indicate the registration number in the corresponding box below. If the application is in progress, check “Pending”.
YES / NO / PENDING / REGISTRATION NO.IACUC
IRB
RSC
IACUC – Institutional Animal Care and Use Committee
IRB – Institutional Review Board
RSC – Radiological Safety Committee
Page 4 of 7