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COMMITTEE USE ONLY
TEMPLE UNIVERSITY
REGISTRATION NUMBER
Research Administration
Institutional Biosafety Committee
(215) 707-4482 Fax: (215) 707-8387
SPAF NUMBER
TRA - Institutional Biosafety Committee (IBC) - Home
APPROVAL DATE
BIOSAFETY REGISTRATION FORM (BRF)
Please follow all instructions. Use additional paper when necessary. This form can be downloaded at the website reference above.
1. PERSONNEL
a. PRINCIPAL INVESTIGATOR
(1) Name, Degree(s)
(3) Office Phone
(2) Job Title
(4) Cell/pager
(6) Fax:
(5) School/College/Center/Department and section (if applicable)
(8) e-mail address
(7) Interoffice Address:
b. LIST ALL OTHER PERSONNEL DIRECTLY INVOLVED IN THIS PROJECT
NAME
PHONE
PROJECT POSITION(S)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
2. GENERAL
a. FUNDING SOURCE (check only one)
Funded internally with departmental funds.
Funded externally by:
Center No:
b. PROJECT TITLE
c. RESEARCH INVOLVES (check all that apply)
In vitro work
Whole animals (attached one Biosafety Registration Addendum A for each species)
IACUC No:
Human subjects
IRB No:
Human gene transfer (attach a narrative response to Appendix M of the NIH Guidelines for Research Involving Recombinant DNA
Molecules.
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d. BRIEF ABSTRACT
3. RECOMBINANT DNA
a. RECOMBINAT INSERT (TRANSGENE)
(1)
Specify the source of the DNA/RNA sequences (including genus, species, gene name(s) and abbreviations(s)):
(2)
If the recombinant contains viral DNA, does the insert represent more than 2/3 of the viral genome?
(3)
Will a deliberate attempt be made to obtain expression of the foreign gene encoded in the recombinant DNA?
(4)
What is the biological activity of the gene product or sequence inserted?
N/A
No
Yes
No
Yes
b. VECTOR
(1)
Specify the host strain for propagation of the recombinant (include genus, species and parent strain):
(2)
Is the host strain prokaryotic? If yes, complete the following.
(a)
Is it a plasmid, phage, or other? If other, specify:
No
Yes
(b)
No
Yes
No
Yes
(3)
Is a packaging cell line or transfected plasmid with helper functions required? If yes, specify:
Is the host strain eukaryotic? If yes, complete the following.
(a)
Is the strain a virus, clone viral genome, pro-virus, or other? If other, specify:
(b)
Can it infect human cells?
No
Yes
(c)
Is a helper virus required?
No
Yes, specify:
(d)
If a viral vector, what % of the viral genome remains?
N/A
or
c. TARGET RECIPIENT
(1)
Specify the target recipient of the vector-recombinant DNA combination (indicate species or cell lines used):
%
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d. NIH GUIDELINES
(1)
Identify the section of the NIH guidelines that apply to this project (check that all apply, see NIH Guidelines for Research Involving
Recombinant DNA Molecules):
III-A Experiments that Require Institutional Biosafety Committee Approval (IBC), RAC Review, and NIH Director Approval
Before Initiation
III-A-1 Major Actions under the NIH Guidelines
III-B Experiments That Require NIH/OBA and IBC Approval Before Initiation
III-B-1 Experiments Involving the Cloning of Toxin Molecules with LD50 of Less than 100 ng per kg Body Weight
III-C Experiments that Require IBC and Institutional Review Board Approvals (IRB) and RAC Review Before Research
Participant Enrollment
III-C-1 Experiments Involving the Deliberate Transfer of Recombinant DNA, or DNA or RNA Derived from
Recombinant DNA, into One or More Human Research Participants
III-D Experiments that Require IBC Approval Before Initiation (see Appendix B of NIH guidelines to identify your risk group).
III-D-1 Experiments Using Risk Group (RG) 2, RG 3, RG 4, or Restricted Agents as Host-Vector Systems
III-D-2 Experiments in Which DNA From RG 2, RG 3, RG 4, or Restricted Agents is Cloned into Nonpathogenic
Prokaryotic or Lower Eukaryotic Host-Vector Systems
III-D-3 Experiments Involving the Use of Infectious DNA or RNA Viruses or Defective DNA or RNA Viruses in the
Presence of Helper Virus in Tissue Culture Systems
III-D-4 Experiments involving the generation or maintenance of transgenic rodents requiring BL2, BL3 and
BL4 containment
III-D-5 Experiments Involving Whole Plants
III-D-6 Experiments Involving More than 10 Liters of Culture
III-D-7 Experiments Involving Influenza Viruses
III-E Experiments that Require IBC Notice Simultaneous with Initiation
III E-1 Experiments Involving the Formation of Recombinant DNA Molecules Containing No More than Two-Thirds of the
Genome of any Eukaryotic Virus
III-E-2 Experiments Involving Whole Plants
III-E-3 Experiments involving creation of transgenic rodents that can be housed under Biosafety Level 1
III-F Exempt Experiments, please use biosafety level 1 registration form
4. SAFETY AND PROTECTION
a. SUMMARY CHART OF BIOHAZARDS/HAZARDOUS DRUGS, LABORATORIES AND HOODS (use one line for each biohazard/
location combination, see Section IV and Appendix A of the Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, for
the biosafety level (BSL) criteria and biosafety cabinet (BSC) descriptions, respectively).
BIOHAZARDS/
HAZARDOUS DRUGS
(1)
(2)
(3)
(4)
(5)
(6)
(7)
BUILDING
ROOM
BSL*
QTY/VOL
USES (“x” all that apply)
BSC *
Type
Date Certified
Stored
Prep’d
Used
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b. PERSONL PROTECTIVE EQUIPMENT
Indicate which of the following will be used as personal protective equipment, see Section IV of the Biosafety in Microbiological and Biomedical
Laboratories, 5th Edition (check all that apply):
Goggles
Lab coat
Gloves (type):
Shoe covers
Disposable gown
Other (specify):
Mask
Hair cover
Other (specify):
Face shield
Respirator
Other (specify):
c. EHRS TRAINING AND RESPIRATORY FIT TEST (dates should be provided for the PI and personnel listed above in 1. b)
RADIATION
HAZ-COM
CHEMICAL
CHEMICAL
HYGIENE
WASTE
BLOODBORNE
BIOSAFETY
PATHOGEN
NIH
GUIDLINES
DANGEROUS
GOODS SHIP.
AIRBORNE
PATHOGENS
RESPIRATOR
Y MASK FIT
TEST
(PI)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
d. NARRATIVE
(1)
Are there any special groups of workers at risk of infection or disease from the use of the biohazard(s)/
hazardous drugs (e.g. pregnant, immuno-compromised, allergic, etc.)? If yes, describe below.
No
Yes
(2)
Are any special immunizations necessary for personnel involved in the research (e.g. Hepatitis B, etc.)?
If yes, describe below.
No
Yes
(3)
Is there a need to monitor the health of personnel involved (e.g. testing)?
If yes, describe. Contact Employee/Occupational Health if you are uncertain.
No
Yes
(4)
Provide a brief description of the PIs training and experience in the safe handling of the above listed biohazards. It is the PI’s
responsibility to ensure all other individuals involved in the project are appropriately trained.
(5)
Describe the decontamination procedures that will be utilized with the biohazardous agents/tissues. If none, provide a justification.
e. CHECKLIST
(1)
Are doors closed during the experiments and locked when the room is unoccupied?
Yes
No
(2)
Are work surfaces cleaned on a daily basis and immediately following spills with 70% ethanol or diluted
bleach (e.g. 10% Clorox)?
Yes
No
(3)
Are biohazardous wastes disposed of as Biohazard waste? If not, describe the nature of waste
and method of decontamination.
N/A
Yes
No
(4)
Are hazardous drug wastes disposed according to EHRS hazardous drug management policy?
N/A
Yes
No
(5)
Are chemotherapeutical wastes disposed of as chemotherapeutic waste (in special yellow
bags)? If not, describe the nature of waste and method of decontamination.
N/A
Yes
No
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(6)
Is the laboratory kept neat and clean?
(7)
Are materials that are to be decontaminated at a site away from the laboratory placed in
durable, leak-proof, sealed containers and appropriately labeled before removal?
(8)
Yes
No
Yes
No
Are contaminated materials (e.g. glassware, animal cages, lab equipment) decontaminated before washing,
reuse or disposal? If yes, describe how (e.g. incineration, autoclave), If no, provide a justification.
Yes
No
(9)
Is all pipetting done by mechanical devices? If no, provide a justification.
Yes
No
(10)
Is there clear and obvious signage indicating “No Eating, Drinking or Smoking” in the laboratory?
Yes
No
(11)
Is the storage of food in the laboratory prohibited?
Yes
No
(12)
Is the wearing of laboratory clothing to lunchrooms and outside the building prohibited?
Yes
No
(13)
Is a sink available for hand washing within the laboratory? If no, provide a justification.
Yes
No
(14)
Are procedures that can produce aerosols (e.g. vortexing, sonication or centrifugation) used with
biohazards? If yes, describe aerosol containment methods (e.g. laminar flow hoods, aerosol safe leak-proof
centrifuge buckets, or sealed containers).
Yes
No
(15)
Is access to the laboratory limited to persons advised of the nature of the biohazardous materials used in
this research?
Yes
No
(16)
If sharps (e.g. hypodermic needles, syringes, scalpels, pipettes and culture dishes) are used,
are they handled appropriately and disposed of in an approved sharps container?
N/A
Yes
No
(17)
Are experiments of lesser biohazard potential that are being carried out concurrently in the
laboratory carefully kept separated?
N/A
Yes
No
(18)
Are all personnel in the laboratory aware of the emergency plan concerning accidental spills and personnel
contamination?
Yes
No
(19)
Are all personnel in the laboratory aware of seeking medical attention in case of exposure and incident
reporting procedures?
Yes
No
(20)
When samples are moved between areas outside of the laboratory, are they transported in appropriate,
leak-proof containers?
Yes
No
(21)
Is this Biosafety Registration form made available to all personnel involved in the research?
Yes
No
(22)
Is the facility kept in negative pressure?
Yes
No
(23)
Does the facility have a fire extinguisher?
Yes
No
(24)
Does the facility have emergency eyewashes and a shower?
Yes
No
(25)
Are animals allowed into the laboratory? If yes, what is their relationship to the research involving
biohazards?
Yes
No
(26)
Will hazardous materials be shipped, transferred or transported?
EHRS notification and approval is required prior to any shipment, transfer and transportation.
Yes
No
(27)
Has the ECP been submitted to IBC if using human blood, cells, cell lines or tissues, etc?
N/A
Yes
No
(28)
Has the SOP been submitted to IBC if using biohazards or hazardous drugs?
N/A
Yes
No
(29)
Have the lab workers and PI received EHRS hazardous drug safety training if using
hazardous drugs?
N/A
Yes
No
(30)
Has the Animal Addendum A been submitted to IBC if working with animals?
N/A
Yes
No
N/A
N/A
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5. ASSUREANCE
a. PRINCIPAL INVESTIGATOR
I certify the information provided in the Biosafety Registration form is complete and accurate and understand my responsibilities as
noted in it. No changes will be made without advance approval form the Institutional Biosafety committee.
I acknowledge my responsibility for the safe conduct of this research in accordance with section IV-B-7 of the NIH Guidelines for
Research Involving Recombinant DNA Molecules. I will inform all associated personnel of the nature and risks of this work, as well as
necessary precautions and safe practices. I also agree to comply with the requirements for the shipment and transfer of recombinant
DNA materials in appendix H.
I further acknowledge my responsibility to ensure compliance with the following:
(1) Work surfaces will be appropriately decontaminated at least daily and immediately after working with biohzardous materials.
(2) All personnel involved will wash thoroughly with soap and water. Clothing will be changed as needed.
(3) All contaminated materials will be discarded appropriately according to Environmental Health & Radiation Safety (EHRS)
guidelines (e.g. as Biohazard waste, as Hazardous drug waste, as Chemotherapeutic waste).
(4) EHRS, the Institutional Biosafety Committee and the NIH OBA will be immediately notified of all spill or
incidents occurred at biosafety level 2 and up laboratories.
(5) In the event of an incident where there is a risk of infection or other consequences to incident, affected personnel will be counseled to
seek appropriated medical attention.
SIGNATURE
DATE
b. CO-INVESTIGATOR(S)
I certify that I have reviewed this Biosafety Registration form and that the information provided in it is complete and accurate.
SIGNATURE OF CO-INVESTOR
DATE
SIGNATURE OF CO-INVESTOR
DATE
SIGNATURE OF CO-INVESTOR
DATE
SIGNATURE OF CO-INVESTOR
DATE
C PI’S DEPARTMENT CHAIRPERSON, DEAN, OR DEAN’S DESIGNEE
In addition to endorsing the PI’s certification, if the experiments are supported primarily by department or university funds, I certify that
I have reviewed the protocol and it is judged to be of scientific merit.
PRINT NAME
SIGNATURE OF PI’S DEPARTMENT CHAIRPERSON, DEAN, OR DEAN’S
DESIGNEE
DATE