October 2011
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University of Texas at El Paso
Synopsis for Research Involving the Use of
Infectious Agents, Toxins or recombinant DNA (rDNA)
The following guidance is required for preparing research proposals and other plans involving
recombinant DNA, infectious agents or toxins for review by the Institutional rDNA/Biosafety
Committee (IBC) All protocol information must be typed. The NIH Guidelines can be found
at: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html. The Synopsis is submitted to the Office of
Research and Sponsored Projects (ORSP), IBC Coordinator.
Protocol Submission Process: The IBC Coordinator will administratively screen all protocols.
The IBC Chair will assign an IBC committee member and the Biosafety Officer (BSO) to provide
the committee with a summary at the next IBC committee meeting. All protocols must be
reviewed at full IBC meeting. After review and discussion of each protocol, the IBC members will
vote to table, approve or approve with modifications. All approved protocols will be active for a
three year term and subject to the NIH Guidelines for Research Involving Recombinant DNA
Molecules (see http://oba.od.nih.gov/rdna/nih_guidelines_oba.html). Compliance with the NIH
Guidelines is a requirement for all research performed at the University.
Progress reports will be required annually from PIs who wish to keep their IBC protocols
active. Progress report should provide sufficient information to enable the IBC to make an
informed risk assessment of the project. Any spills or injuries that occur while conducting
research covered by IBC protocols must be reported to the Biosafety Officer (747-7179)
and the IBC Chair (747-8715) or IBC Coordinator (747-7007) immediately.
October 2011
I.
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General Information:
Principal Investigator:
Dept:
Funding Agency:
Funding Period:
Protocol Title:
Attach a summary in non-technical lay terms of the overall aim and scope of the research
protocol. The summary should not be more than a page in length.
II. Biological Agents Used:
List and describe organism(s) used such as bacteria, parasites, toxins, fungi, viruses, cell
lines, and animals to be used. Include specific name, strain, source information, host(s) and
included bioengineered controls, if any. Also, describe the biological agent or microorganism
characteristics (e.g. virulence, pathogenicity, environmental stability and infectious dose)
What is the biological safety level (BSL) for this project:
BSL1
BSL2
BSL3
See Biosafety in Microbiological and Biomedical Laboratories (BMBL)
http://www.cdc.gov/biosafety/publications/bmbl5/index.htm
5th Edition at:
III. Protocol Classification
Does your protocol involve the generation of transgenic organisms, animals or recombinant
DNA?
Yes, If YES, complete the entire form and all sections.
No, If NO, you can skip Section IV and Section V of the form.
IV. Recombinant DNA Classification:
(Check 'yes' or 'no' to the following questions. The relevant section of the NIH Guidelines
(see http://oba.od.nih.gov/rdna/nih_guidelines_oba.html) is referenced for each question.
1. Does your project include deliberate transfer of a drug resistance
Yes
No
Yes
No
trait to pathogenic microorganisms that are not known to acquire
the trait naturally (Section III-A-1-a, experiments falling under this
section of the NIH Guidelines require IBC approval, Recombinant
DNA Advisory (RAC) Committee review and NIH Director
Approval before initiation. For example, the introduction of the
gene encoding chloramphenicol resistance into Rickettsia
conorii)?
2. Does your project include cloning toxin molecules with a lethal dose
(LD50) of less than 100 nanograms per kilogram body weight
(Section III-B-1, experiments falling under this section of the NIH
Guidelines require IBC approval, and submission to the NIH Office
of Biotechnology Activities [OBA] before initiation. For example the
cloning of the gene coding for the botulinum toxin.)?
October 2011
3. Does your project include experiments involving the deliberate
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Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
transfer of recombinant DNA, or DNA or RNA derived from
recombinant DNA, into one or more human research participants
(Section III-C-1, experiments falling under this section of the NIH
Guidelines require IBC approval, Recombinant DNA Advisory
(RAC) Committee review and IRB approval before initiation)?
4. Does your project include experiments using Risk Group 2, Risk
Group 3, Risk Group 4, or Restricted Agents as host-vector
systems (Section III-D-1) that would require BSL-2 or BSL-3
containment (experiments falling under this section of the NIH
Guidelines require IBC approval before initiation )?
5. Does your project include experiments in which DNA from Risk
Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is
cloned into nonpathogenic prokaryotic or lower eukaryotic hostvector systems (Section III-D-2, experiments falling under this
section of the NIH Guidelines require IBC approval)?
If Yes, is the cloning into an E. coli K-12 strain or K-12 derivative (If
Yes, this work falls under Section III-F-6 and Appendix C-II)?
6. Does your project include 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 (Section III-D-3,
experiments falling under this section of the NIH Guidelines require
IBC approval)?
7. Does your project include experiments involving whole animals in
which the animal’s genome has been altered by the introduction of
DNA into the germ line or experiments involving rDNA modified
microorganisms tested on whole animals (Section III-D-4, III-E-3 – If
only Section III-E-3 is applicable then these experiments may be
initiated at the same time as IBC registration is in process)?
8. Does your project include experiments involving whole plants
(Section III-D-5, III-E-2, If only Section III-E-2 is applicable then
these experiments may be initiated at the same time as IBC
registration is in process)?
9. Does your project include experiments involving more than 6 liters of
culture (Section III-D-6)?
10. Does your project include experiments involving the formation of
recombinant DNA molecules containing two-thirds or more of the
genome of any eukaryotic virus (Section III-E-1, If only Section III-E1 is applicable then these experiments may be initiated at the same
time as IBC registration is in process)?
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V. Description of rDNA Experiments
Describe the specific methods and experiments that will be performed under the rDNA
protocol and include:
1. List IRB, IACUC or IBC protocol number as references, where applicable;
2. Provide literature references, if appropriate. (For example, Naldini, L., Blomer, U., Gage,
F. H., Trono, D., and Verma, I. M. (1996) Efficient Transfer, Integration, and Sustained
Long-Term Expression of the Transgene in Adult Rat Brains Injected with a Lentiviral
Vector. Proc. Natl. Acad. Sci. USA 93, 11382-11388);
3. Include methods or processes which will generate hazardous aerosols such as sonicating
or cell sorting (For example – In addition to the experiments and methods detailed above,
we will be extracting proteins via sonication. Sonication methods include … Additionally,
hearing protecting muffs or ear plugs will be provided to lab personnel doing sonication).
4. Describe the manipulations that will be performed under the protocol. For example, (a)
describe the cloning of gene Y into bacterial plasmid for protein expression; (b). describe
the cloning of protein X into a lentiviral vector; (c) describe the experiments leading to the
cloning of transgene Z for generation of transgenic animals:
5. What is the source of rDNA, DNA, RNA to be inserted or cloned – include species of
organism from which it is derived.
6. What is the nature of rDNA, DNA, RNA to be inserted or cloned. For example is it a
structural gene or oncogene.
7. What is the host system to be used? For example, Rat cardiomyocytes and HEK-293
cells.
8. What is the vector(s) to be used? Include information such as product literature, or vector
map describing construction of vector. (For example, Lentiviral vector, Invitrogen
ViraPower TM):
9. Are any helper virus or packaging cells used? (For example 293FT cell line);
VI. Location of Research:
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Please list all locations where work will be conducted. Include building and room numbers for
storage areas, work areas, biosafety cabinet locations and autoclave locations. (For
example, stocks and materials will be stored in room VRB 6.218, we will dedicate the BSC in
room VRB 7.456 for lentiviral work and the BSC in room 7.268 for all other work, animal
studies will be conducted in Research Hall 9.236 and finally the biowaste will be
decontaminated using the autoclave in room 7.345):
VII. Indicate the Personal Protective Equipment that will be used to perform the work:
Single-use disposable latex gloves
Safety glasses
Open-front Laboratory coat
Dust mask
Sleeve guards
Ear plugs
Shoe covers
2 pairs of single-use disposable gloves
VIII.
Single-use disposable nitrile gloves
Safety goggles
Closed-front lab gown
N-95 Filtering Face piece
Face shield
Ear muffs
Hair bonnet
Biological Safety Practices:
1. Provide a description of the appropriate containment conditions and biosafety practices
that will be implemented for the proposed project based on risk assessment and biosafety
level. Certain experiments have special considerations that must be taken into account
such as the use of cell sorters for infectious agents or the use of viral vectors. See,
CDC/NIH Publication, Biosafety in Microbiological and Biomedical Laboratories (BMBL)
5th Edition:; http://www.cdc.gov/biosafety/publications/bmbl5/index.htm.
2. List the disinfectant(s) to be used under this protocol?
3. Describe biological waste disposal methods:
4. Will Biosafety cabinets be used? If yes, include last certification date:
5. Do you intend to ship infectious substances or hazardous chemicals?
Yes
If YES, please, contact Environmental Health and Safety (EH&S x7124) to make
arrangements.
No.
6. List the 24 hour emergency contact phone number for the PI, lab director or responsible
person to contact.
IX. Protocols Involving Lentiviral Vectors must describe the criteria for risk assessment of
the lentivirus vector(s) used: YES
NO
See also, the NIH guidance document, Biosafety Considerations for Research with Lentiviral
Vectors, http://oba.od.nih.gov/rdna_rac/rac_guidance_lentivirus.html
1. Describe the nature of the vector system and the potential for regeneration of replication
competent virus from the vector components.
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2. Describe the nature of the transgene insert (e.g., known oncogenes or genes with high
oncogenic potential may merit special care).
3. Describe the anticipated vector titer and anticipated total amount of vector to be produced.
4. Describe the inherent biological containment of the animal host, if relevant.
X. Personnel: Please list the names of the individuals who are covered under this protocol.
Include their full name, title (faculty, post doctoral, graduate and undergraduate students,
visiting scientist, and staff), UTEP 800 ID #, and laboratory experience directly related to the
experiments covered under the protocol, UTEP Safety Classes and date taken. All
individuals must have current safety training in order to work under the protocol. Please
contact EHS for training dates, if necessary. Please be informed that if all individuals are
not current with all training requirements, this protocol will not be reviewed.
Name
Principal
Investigator:
Title
PI/
UTEP
ID
Experience
Required Safety Classes
Basic Laboratory Safety
Bloodborne Pathogens
Occupational Health Program
Basic Laboratory Safety
Bloodborne Pathogens
Occupational Health Program
Basic Laboratory Safety
Bloodborne Pathogens
Occupational Health Program
Basic Laboratory Safety
Bloodborne Pathogens
Occupational Health Program
Basic Laboratory Safety
Bloodborne Pathogens
Occupational Health Program
Basic Laboratory Safety
Bloodborne Pathogens
Occupational Health Program
Basic Laboratory Safety
Bloodborne Pathogens
Occupational Health Program
Basic Laboratory Safety
Bloodborne Pathogens
Occupational Health Program
Date
Taken
October 2011
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XI. Investigator Agreement:
I attest that the information provided or attached is accurate and complete. I am familiar with
and agree to abide by provisions of the current NIH Guidelines for Research Involving
Recombinant DNA Molecules and accept the responsibilities listed in Section IV-B-7.
As the Principal Investigator, I accept responsibility for making sure all laboratory personnel
involved in the project have been appropriately trained. All research personnel are familiar
with and understand the potential biohazards and relevant biosafety practices, techniques,
and emergency procedures associated with this research protocol as dictated by the CDC
and NIH document Biosafety in Microbiological and Biomedical Laboratories, 5thd Edition
(http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm). I certify that I will immediately
report any injuries or spills that occur while conducting research covered by this IBC
protocol to the UTEP Biosafety Officer (747-7179) and the IBC Chair (747-8715) or IBC
Coordinator (747-7007).
Signature:
Date:
Department Chair: __________________________________________
Date:
IBC REVIEW RESULTS
Date of Full Committee Meeting:
IBC Committee Determined Containment Level:
Applicable NIH Guidelines Section:
Protocol Status:
Tabled Needs Modification (not approved)
Approved
Conditionally Approved with Listed Modifications
Modifications and Remarks:
IBC Chairman:
Date:
October 2011
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STANDARD OPERATING PROCEDURES FOR HANDLING INJURIES, BIOLOGICAL SPILLS AND
BIOHAZARDOUS WASTE IN THE LABORATORY
Purpose:
This Standard Operating Procedure outlines the necessary steps to take when someone is injured,
when cleaning up biological spills or handling biohazardous waste in Dr.
laboratory.
Scope:
Everyone working in Dr.
laboratory who handles human cell lines, human blood,
microbiological cultures, parasites, viruses and other biological material such as recombinant DNA
or proteins.
NOTE: This SOP must be posted in the lab and be distributed to all current and incoming
research students and staff.
Procedures:
1. Injury to an Individual in the Lab (i.e. needle stick, cut, biological/chemical exposure
incident – splash, etc.):
a. Immediately stop work and flush affected area with soap and water for 15
minutes.
b. If the injury is a Medical Emergency call 911 or campus police x5611.
c. Secure all infectious materials.
d. Notify Dr.
at ( )
and EH&S Biosafety Officer at (915) 726-7887 or
Campus police x5611 after working hours. This is very important as the University
maintains an ongoing log/list of spills and injuries and as applicable reports these
as required under the NIH Guidelines for Research Involving Recombinant DNA
Molecules.
e. Use First Aid Kit located in the Glass Wash Room or Tissue Culture Room
whichever is the closest.
f. If during working hours seek medical attention at the Student Health Center
under the UTEP Occupational Health Program.
g. Dr.
will complete the Workers Compensation Injury/Incident Report form
documenting the route of exposure and the circumstances under which the
incident occurred.
2. Small Spill Decontamination and Clean Up (less than 1 liter):
a. Stop work and secure all items you are working with.
b. Replace any contaminated personal protective equipment (PPE).
c. Make sure you are wearing the appropriate PPE such as disposable gloves, lab
coat and eye protection (safety glasses or goggles).
d. Using the Lab Spill Kit provided by Environmental Health & Safety, take the
absorbent pads and place over the spill area.
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e. Make a fresh solution of 10% bleach and pour over the absorbent pads. The
absorbent pads absorb the spill, help contain the 10% bleach solution and help
prevent splattering.
f. Let the bleach solution inactivate and decontaminate the biological material for a
minimum of 15 minutes.
g. Report the spill to Dr.
at ( )
and EH&S Biosafety Officer (915) 7267887 or after hours at x5611. This is very important as the University maintains
an ongoing log/list of spills and injuries and as applicable reports these as
required under the NIH Guidelines for Research Involving Recombinant DNA
Molecules.
h. Soak up and clean up the excess bleach solution and decontaminated material
with extra absorbent pads or paper towels.
i. Dispose in the red biowaste can.
3. Large Spill (greater than a liter):
a. Stop work immediately, secure all items and avoid inhaling airborne aerosols.
b. Notify others to leave room immediately.
c. Label the area off-limits for at least 30 minutes. This allows the ventilation
system to purge the air.
d. Remove contaminated PPE and or clothing, turn exposed clothing inward, and put
in autoclave bag or red biohazard bag. Wash all exposed skin with soap and
water.
e. Report the spill to Dr.
at ( )
and EH&S Biosafety Officer (915) 7267887 or after hours at x5611 Campus Police. This is very important as the
University maintains an ongoing log/list of spills and injuries and as applicable
reports these as required under the NIH Guidelines for Research Involving
Recombinant DNA Molecules.
f. After at least 30 minutes, EH&S personnel will enter the area to clean up the spill.
4. Liquid Biohazardous Waste Disposal:
All liquid biological waste from the lab must be treated prior to disposal. Examples of
biological waste include cell lines, recombinant DNA, recombinant proteins, and bacterial
cells. The procedures below outline the steps to take to treat liquid biohazardous waste
generated in Dr.
lab:
a. Always wear appropriate PPE such as disposable gloves, lab coat and eye
protection (safety glasses or goggles) when working with biohazardous waste.
b. When liquid biohazardous waste is anticipated to be generated, add 100 ml of
undiluted Clorox Bleach into a 1 L beaker.
c. Label beaker appropriately as to its contents
d. If more than 1L of liquid biohazardous waste is anticipated prepare a second 1 L
beaker by adding 100 ml of undiluted Clorox bleach to the second 1L beaker.
e. As experiments are performed and completed pour the biological waste into the
beaker with the Clorox Bleach.
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f.
Once experiments are complete and if the beaker is less than 1L add water to
bring the volume to 1L.
g. Once the beaker is full the Clorox bleach has been diluted to a 10% solution.
h. Let 10% bleach and biological waste solution stand for at least 1 hour.
i. Dispose of the solution with care to avoid splatter down the lab sink and rinse
beaker.
4. Solid Biohazardous Waste Disposal:
The procedures below outline the steps to take to treat solid biohazardous waste
generated in Dr.
lab:
a. All solid lab waste that has come in contact with biological waste from the lab
must be treated prior to disposal. Examples of biological waste include used
personal protective equipment such as disposable gloves, paper towels, pipette
tips, disposable Petri dishes, pipettes and culture flasks.
b. Always wear appropriate PPE such as disposable gloves, lab coat and eye
protection (safety glasses or goggles) when working with biohazardous waste.
c. Place all potentially contaminated or contaminated items in a red biohazardous
waste bag.
d. Once the bag is ¾ full close bag and place autoclave tape on the bag.
e. Take the biowaste bag to the Glass Wash Room and place in the autoclave.
f. Complete autoclave log book entry and autoclave biohazardous waste at least 30
minutes following manufacturers’ recommendations for autoclave operation.
g. Once the autoclave cycle is complete the load within has been sterilized if the
autoclave tape has turned color and the autoclave display shows no errors.
h. Place the red autoclaved biohazardous bag into a large 55 gallon red bin for
removal from the facility by EH&S.
i. If the autoclave tape did not turn color and or autoclave display indicates errors
occurred during operation or an incomplete cycle the load has not been sterilized.
j. Immediately call the Bioscience Building Manager at x6881 and EH&S Biosafety
Officer (915) 726-7887 or x7179 as the load is still considered biohazardous.
Other special concerns, if applicable: