University of Cincinnati / Institutional Biosafety Commitee IBC Protocol - Human Clinical Studies
______ ______ Biosafety Office Use ONLY IBC Number: ______ Last Submission: ______ Initial APPROVAL DATE : ______
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Additional Information?
Section I. A: Principal Investigator
First Name: Last Name: Job Title: E-Mail Address: Department: Mail Code: Office Phone: Cell Phone:
Study Primary Contact (individual to be included in the IBC notifications) :
First & Last Name: E-Mail Address:
First & Last Name Job Title E-Mail Address Depatment/Institution
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Table 2. Provide the date of the most current OSHA Blood Borne Pathogens ( BBP) training for the following individuals:
OSHA BBP Training Records
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Section II. A: Study Documents
Clinical Protocol Investigator's Brochure
Additional Documentation?
Additional Documentation?
Additional Documentation?
Additional Documentation?
Section II. B: Research Description - Lay Abstract Provide a brief and lay abstract of your clinical study, including a description of the investigational product, why they are being used, study population and other relevant information.
Section II. C: Recombinant or Synthetic Nucleic Acids (DNA and/or RNA)
Section II. C.1: Gene Table
* Gene Source ( e.g. human, mouse, bacterium)
** Regulatory Elements in the Construct (e.g. promoters, enhancers, polyA, replication origins, terminators)
Gene Name Gene Source *
Natural Function of Insert/Protein Expressed Regulatory Elements in the Construct **
Gene Name Gene Source
Natural Function of Insert/Protein Expressed Regulatory Elements in the Construct
Additional Gene?
Gene Name Gene Source
Natural Function of Insert/Protein Expressed Regulatory Elements in the Construct
Gene Name Gene Source(s)
Natural Function of Insert/Protein Expressed Regulatory Elements in the Construct
Section II. C. 2: Gene Delivery Method
Additional Information?
Section II. C. 3: Vector Description
* Vector Type ( e.g. lentivirus, adenovirus, plasmid DNA, oligonucleotide)
** Vector Chracteristics (e.g. Replicating, Replication Defective, Integrating, Oncolytic, Latency Potential)
Vector Type * Technical Name of the Vector
Vector Characteristics ** Host Target Cells
Type of Gene Transer
1. 2.
Vector Type * Technical Name of the Vector
Vector Characteristics ** Host Target Cells
Type of Gene Transer
3.
Vector Type * Technical Name of the Vector
Vector Characteristics ** Host Target Cells
Type of Gene Transer
4.
Additional Information?
Section II. C. 4: Vector Admnistration Route
Additional Information?
Additional Vector?
Additional Vector?
Vector Transfer 1 in vivo
in vivo
Vector Transfer 2 in vivo
in vivo
Vector Transfer 3 in vivo
in vivo
Vector Transfer 4 in vivo
in vivo
Vector Transfer 1 ex vivo
ex vivo
Vector Transfer 2 ex vivo
ex vivo
Vector Transfer 3 ex vivo
ex vivo
Vector Transfer 4 ex vivo
ex vivo
Additional Gene?
Additional Gene?
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Section III. A: Study Location(s)/ PPE
1. Building Name/Room Number Description of Work Patient Isolation
PPE Used in the Location (check all that apply)
The use of respirators requires medical evaluation and fit test prior use.
Specific Location Features - Will be there any additional specification for this work location (e.g. room ventilation, room signage)?
Add Another Location?
2. Building Name/Room Number Description of Work Patient Isolation
PPE Used in the Location (check all that apply):
The use of respirators requires medical evaluation and fit test prior use.
Specific Location Features - Will be there any additional specification for this work location (e.g. room ventilation, room signage)?
Add Another Location?
3. Building Name/Room Number Description of Work Patient Isolation
PPE Used in the Location (check all that apply):
The use of respirators requires medical evaluation and fit test prior use.
Specific Location Features - Will be there any additional specification for this work location (e.g. room ventilation, room signage)?
Add Another Location?
4. Building Name/Room Number Description of Work Patient Isolation
PPE Used in the Location (check all that apply):
The use of respirators requires medical evaluation and fit test prior use.
Specific Location Features - Will be there any additional specification for this work location (e.g. room ventilation, room signage)?
Add Another Location?
5. Building Name/Room Number Description of Work Patient Isolation
PPE Used in the Location (check all that apply):
The use of respirators requires medical evaluation and fit test prior use.
Specific Location Features - Will be there any additional specification for this work location (e.g. room ventilation, room signage)?
Add Another Location?
6. Building Name/Room Number Description of Work Patient Isolation
PPE Used in the Location (check all that apply):
The use of respirators requires medical evaluation and fit test prior use.
Specific Location Features - Will be there any additional specification for this work location (e.g. room ventilation, room signage)?
Add Another Location?
7. Building Name/Room Number Description of Work Patient Isolation
PPE Used in the Location (check all that apply):
The use of respirators requires medical evaluation and fit test prior use.
Specific Location Features - Will be there any additional specification for this work location (e.g. room ventilation, room signage)?
Standard Contact Droplet Aerosol N/A
Standard Contact Droplet Aerosol N/A
Standard Contact Droplet Aerosol N/A
Standard Contact Droplet Aerosol N/A
Standard Contact Droplet Aerosol N/A
Standard Contact Droplet Aerosol N/A
Standard Contact Droplet Aerosol N/A
e.g. Main Lab, open lab bench, tissue culture room, freezer room, cold room, microscopy room
e.g. Main Lab, open lab bench, tissue culture room, freezer room, cold room, microscopy room
e.g. Main Lab, open lab bench, tissue culture room, freezer room, cold room, microscopy room
e.g. Main Lab, open lab bench, tissue culture room, freezer room, cold room, microscopy room
e.g. Main Lab, open lab bench, tissue culture room, freezer room, cold room, microscopy room
e.g. Main Lab, open lab bench, tissue culture room, freezer room, cold room, microscopy room
e.g. Main Lab, open lab bench, tissue culture room, freezer room, cold room, microscopy room
e.g. Main Lab, open lab bench, tissue culture room, freezer room, cold room, microscopy room
e.g. Main Lab, open lab bench, tissue culture room, freezer room, cold room, microscopy room
e.g. Main Lab, open lab bench, tissue culture room, freezer room, cold room, microscopy room
e.g. Main Lab, open lab bench, tissue culture room, freezer room, cold room, microscopy room
e.g. Main Lab, open lab bench, tissue culture room, freezer room, cold room, microscopy room
e.g. Main Lab, open lab bench, tissue culture room, freezer room, cold room, microscopy room
e.g. Main Lab, open lab bench, tissue culture room, freezer room, cold room, microscopy room
Yes No
Make [Model] Serial Number:
Used during which activities?
Other Engineering Controls
Centrifuge Safety Cup
Centrifuge Sealed Rotors
Glove Box
Draft Table
Needle Safety Device
Scalp Safety Device
Sharps Container
OTHER
Additional Information ?
PPE (gloves, lab coat, body suit, f mask)
PPE (gloves, lab coat, body suit, f mask)
PPE (gloves, lab coat, body suit, f mask)
PPE (gloves, lab coat, body suit, f mask)
PPE (gloves, lab coat, body suit, f mask)
PPE (gloves, lab coat, body suit, f mask)
PPE (gloves, lab coat, body suit, f mask)
PPE (dgloves, fr lab coat, saf goggles, face shield)
PPE (dgloves, fr lab coat, saf goggles, face shield )
PPE (dgloves, fr lab coat, saf goggles, face shield )
PPE (dgloves, fr lab coat, saf goggles, face shield)
PPE (dgloves, fr lab coat, saf goggles, face shield)
PPE (dgloves, fr lab coat, saf goggles, face shield)
PPE (dgloves, fr lab coat, saf goggles, face shield)
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Section III. C: Surface Disinfection
For proper disinfection, disinfectants must remain in contact with the material or surface to ensure proper disinfection. Contact time will vary depending on the product and organism targeted; read the label of the brand you choose.
Check ALL that apply
Additional Information? IMPORTANT INFORMATION:
* Alcohol based solutions evaporate too quickly (especially if used inside a BSC). Surface might need to be saturated to achieve proper contact time (around 1 to 2 min ).
** The contact time for Sodium Hypochlorite is normally 5 min. Sodium Hypochlorite is corrosive and to prevent damage to metal surfaces, after sufficient contact time, rinse surfaces with sterile water or 70% ethanol. SEE how to prepare a 10% bleach solution
Section III. D: Spill Cleanup Procedures
Describe how biohazardous spills will be cleaned up. If a spill protocol already exists, please, attach SOP to the form .
Primary container(s) with infectious or potentially infectious materials is transferred between locations inside a specially designated leak-proof secondary container labeled with the universal biohazard symbol. Secondary container also should have enough absorbent material to totally contain a spill should the primary container fail. If materials are transported in public streets, a tertiary container (e.g. cardboard box) is used. When materials are shipped out-of-UC Campus, the Biosafety Office is contacted for information about shipping requirements.
I will follow the above method. I have a different method (describe below).
Yes No
Yes No
Disinfectant (ethanol, clorox, Super sanicloth)
disinfectants (bleach, dispatch, sporklens)
Consider the possibility of an accidental exposure (e.g. skin, mucosal, percutaneous and aerosol) while handling human or microbial materials and provide response procedures for each possible situation, including recommendation for available prophylactic therapy.
Describe aspects of the protocol which have potential environmental impact or a potential impact on public health, providing any safety instructions given to staff and family during hospitalization and household contacts after patients are discharged.
By checking the boxes and signing my name below, I , ______ ______ , attest that:
I agree to fully comply with the policies and procedures outlined in University of Cincinnati Biosafety Policy as well as all applicable rules and regulations. I certify that all personnel involved in this project have been trained in all applicable safety procedures and is made aware of all risks involved in this project. The information provided is accurate and complete.
I agree to conduct the research presented in the protocol or changes/modifications to it as approved by University of Cincinnati Institutional Biosafety Committee (IBC). I will also submit any proposed changes/modifications for review and approval. I will submit written reports to the Institutional Biosafety Committee concerning any research related accident, exposure incident or release of recombinant or synthetic nucleic acid materials to the environment, or problems pertaining to the implementation of containment procedures.
I certify that I have read the above listed protocol and am qualified to perform the procedures described herein. I further agree to abide by the protocol and notify the IBC of any proposed deviation from it.
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