Human Gene Transfer Experimentation Involving
Recombinant or Synthetic Nucleic Acid Molecules
Institutional Biosafety Committee
Proposed clinical trials involving human gene transfer also require registration and approval from UC IRB and
federal agencies (NIH-OBA and/or FDA) before initiation.
Receipt Date
Review Date(s)
Approval Date
IBC #
IBC administration only
I.
BASIC INFORMATION
Title of Project:
IRB #
NIH RAC #
FDA #
Approval Date
Approval Date
Approval Date
Section I. A: Principal Investigator
Please provide at least one after hours emergency contact number. This is required by facilities maintenance.
Name:
Department:
Office Phone:
Lab Phone:
Pager :
Title:
Mail Code:
Fax:
Cell phone:
E-Mail Address:
Section I. B: Clinical Personnel
Table 1. List of personnel involved in supervising activities/treatments covered under this research registration
First Name/ Last Name
Job Title
Department / Institution
Phone Number
1.
2.
3.
4.
5.
6.
7.
8.
9.
University of Cincinnati - HGT/ IBC form (Last update on Jan 2014)
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Table 2. Personnel training information (Consult Table 1 to designate personnel’s number)
Clinical
Personnel
Annual BBP Training
Dates
Specific Procedure(s) Training
Provided by (i.e. Institution)
Dates
Specify / Provided by
PI
1.
2.
3.
4.
5.
6.
7.
8.
9.
II. RESEARCH ELEMENTS
Section II. A: Research Description
Please, provide a brief description of your research objectives and experimental design anticipating the risks and benefits for
the research proposal. Also, include any pre-clinical study data such as animal and/or cell culture models which insure safety,
efficacy and feasibility of the proposed procedures.
Section II. B: Recombinant or Synthetic Nucleic Acid
Gene Source(s)
Gene Name
Function of Insert/Protein
Expressed
(Genus, species, strain)
Regulatory Elements in
the Construct
(e.g. promoters, enhancers, polyA,
replication origins, terminators)
Section II. C: Vector Description
Vector type:
Plasmid
Vector Administration Route:
Viral
IV
Naked DNA or RNA
IM
IP
University of Cincinnati - HGT/ IBC form (Last update on Jan 2014)
Other (specify):
Other (specify):
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Vector Source
Technical Name of
Vector
(Genus, species; if
plasmid or viral)
Provide reference or source
(if commercially available)
Vector characteristics
Type of Gene
Transfer
( e.g. Replicating? Replication
defective? Integrating? Oncolytic?
Latency potential?)
Host Target Cells
In vivo
Ex vivo
III. BIOLOGICAL RISK ASSESSMENT and SAFETY PRECAUTIONS
Section III. A: Biological Safety Level
Indicate the highest BSL applied in the experiment
BSL 1
BSL 2
BSL 2+
Section III. B: Experiment Location(s) / PPE
Building Name / Room
Number
Description of work
(Surgery, treatment, prep, patient care,
other)
Patient
Isolation
(select
from drop
down)**
PPE (check all that apply)
SG
DG
LC
DLC
SM
R
G
FS
N/A
N/A
N/A
N/A
N/A
N/A
*Patient Isolation : Standard (S), Contact (C), Droplet (D), Aerosol (A)
** PPE: Single Glove (SG); Double Glove (DG); Lab Coat (LC); Disposable Lab Coat/Gown (DLC); Surgical Mask (SM); Respirators*** (e.g. N95)
(R); Goggles or safety glasses(G); Face Shield (FS)
***The use of respirators requires medical evaluation and fit test prior use.
Specific Location Features
Will be there any additional specification for work locations (e.g. room ventilation, room signage )?
YES:
NO:
If YES, list :
University of Cincinnati - HGT/ IBC form (Last update on Jan 2014)
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Section III. C: Containment Equipment
i)
YES:
Biosafety Cabinet used :
NO:
Make [Model] Serial Number:
Last Certification Date:
Used during which activities?
ii) Additional containment equipment used (e.g., centrifuge safety cups, glove box, draft table):
YES:
NO:
If YES, list and describe activities involved :
Section III. D: Additional Safety Precautions
Describe any additional safety precautions to specialized equipment, procedures or situations. Also, include how materials are
going to be transported from different location sites.
Section III. E: Surface Disinfection
Soap & water
Other (specify):
Bleach
%
70% ethanol
Section III. F: Disposal
Disposal Material
Solid biohazardous waste
Liquid biohazardous waste
Metal Sharps
Non-Metal Sharps
University of Cincinnati - HGT/ IBC form (Last update on Jan 2014)
Disposal method
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Section III. G: Spill Cleanup Procedures
Describe how biohazardous spills will be cleaned up. If a spill protocol already exists, please, append SOP to the form.
Section III. H: Exposure Prophylaxis
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.
IV. PUBLIC HEALTH CONSIDERATIONS
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.
V. PRINCIPAL INVESTIGATOR ASSURANCE
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 and the NIH’s Office of
Recombinant DNA Activities 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 understand that research participants enrollment cannot begin until RAC review process has been completed. I
certify 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.
Principal Investigator - Print
Principal Investigator - Signature
Chair,Institutional Biosafety Committee
University of Cincinnati - HGT/ IBC form (Last update on Jan 2014)
Date
Date
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