MOUA - University of Nevada, Reno

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REV. APRIL 11, 2013
University of Nevada, Reno
Memorandum of Understanding and Agreement on
Use of Biological Agents and Recombinant DNA
PRINCIPAL INVESTIGATOR:
PI's TITLE:
DEPARTMENT:
TELEPHONE NUMBERS (office):
; (labs):
E-MAIL ADDRESS:
By signing below, I certify that I agree to conduct the research covered by this protocol in
compliance with current guidelines regarding use and disposal of recombinant DNA, biological
agents and toxins, specified in the NIH Guidelines for Research Involving Recombinant DNA
Molecules, the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, the UNR
Biosafety Manual, and the UNR Bloodborne Pathogens Exposure Control Plan.
The PI accepts responsibility for the health and safety of all personnel involved in this
project as it relates to the scope of this work. Additionally, I certify that I have read the
following statements and agree that all persons working under this protocol will comply with
these statements:
* Personnel have received or will receive appropriate safety training (including lab-specific
training) prior to working in the laboratory.
* Notify EH&S (327-5040), 24 hr/dy) as soon as possible of laboratory associated injuries or
illnesses and spills or environmental releases of hazardous materials.
* Notify Worker's Compensation for work-related injuries and illnesses.
* Request approval from the IBC of any modifications to biological agents or toxins, facilities,
or procedures by submitting an amended MOUA.
Signature of Principal Investigator
Date
Signature of Department Chair
Date
Page 1 of 8
REV. APRIL 11, 2013
PERSONNEL INVOLVED IN THE PROJECT:
Include name and job title (e.g., Associate Professor, Postdoctoral Fellow, Ph.D. student, etc.)
1.
BIOLOGICAL AGENT(S) AND RECOMBINANT DNA TO BE USED:
Check all that apply:
Microbial agents (bacteria (including eubacteria), archaea, viruses, fungi, parasites)
Lentiviral Vectors (if lentiviral vectors will be used, MOUA Supplement 1 must be
submitted with this MOUA).
Recombinant DNA (check all that apply)
Specify the section(s) of the NIH Guidelines that correspond to the proposed recombinant DNA
research:
IBC and NIH Approval Required Before Initiation
Section III-A: Transfer of drug resistance to microorganisms
Section III-B: Cloning of genes coding for toxins with a LD50 less than 100 ng/kg
IBC, IRB, and NIH Approval Required Before Initiation
Section III-C: Transfer of recombinant DNA to humans (gene therapy)
IBC Approval Required Before Initiation
Section III-D-1: Use of Risk Group 2 or above agent as host-vector system
Section III-D-2: DNA from Risk Group 2 or above agent is cloned into a host-vector system
Section III-D-3: Use of infectious viruses (> 2/3 of viral genome) in tissue culture
Section III-D-4: Experiments involving whole animals (BL2-N or greater)
Section III-D-5: Experiments involving whole plants (BL2-P or greater)
Section III-D-6: Greater than 10 liters of culture
IBC Notification (MOUA submittal) Simultaneous With Initiation
Section III-E-1: Formation of recombinant DNA containing less than 2/3 of an eukaryotic
viral genome
Section III-E-2: Experiments involving whole plants (BL1 only)
Section III-E-3: Experiments involving transgenic rodents (BL1 only)
Exempt From NIH Guidelines
Section III-F: Specify applicable section of NIH Guidelines
Toxins or toxic products (produced by biological agents)
CDC or USDA Select Agent (Click here for list)
Humans, human blood, human body fluids, human tissues, or human cells/cell lines#
Animals (non-human except insects), animal blood, body fluids, tissues, or cells
Plants, plant tissues, plant cell culture, or eukaryotic algae
Arthropods (e.g., insects, arachnids; insect or arachnid tissues; or insect or arachnid cell
cultures)
#
The use of unfixed human tissue, or human cell or tissue culture normally requires inclusion in the UNR Bloodborne
Pathogens Program. Contact Ben Owens (x5196) or Mike Kivistik (x4981) of EH&S for additional information.
Page 2 of 8
REV. APRIL 11, 2013
List all agents and the biosafety containment level (BSL) assigned to each agent (including
toxins). Identify all CDC and USDA Select Agents. Include preserved stocks (even if not
currently in use), and organisms and toxins “inherited” from other researchers. Indicate current
use status (currently in use or only preserved stock).
--------------------------------------------------------------------------------------------------------------------If introducing foreign DNA or RNA into a gene expression system, indicate the source DNA or
RNA, and any expected toxic gene products. If not, indicate “NA.”
Source DNA or RNA:
Expected toxic gene products:
Location of use (indicate lab and site within lab, if restricted):
Location of storage:
If biological agents are stored in a freezer that is located in either the Howard Medical Sciences (HMS) freezer room
(140) or the Fleischmann Agriculture (FA) freezer room (229), please indicate here the building and freezer number
(as indicated on the freezer room maps for HMS 140 and FA 229). Additionally, please print a copy of the relevant
freezer room map, label the appropriate freezer, and attach the map to the completed MOUA form.
Period/Frequency of use:
Quantity (give typical and maximal culture volumes, number of organisms, etc.):
List any permits required (e.g., CDC or USDA Import or Export, CDC or USDA Select Agent
Registration). For each permit indicate the agency or group issuing the permit; the agents,
materials, and work covered by the permit, and expiration date (if no permits are required
indicate “none”).
--------------------------------------------------------------------------------------------------------------------2.
PROJECT SUMMARY
Provide a short summary (no more than 2 – 3 sentences) of the work to be conducted that
describes the overall purpose and goals.
---------------------------------------------------------------------------------------------------------------------
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REV. APRIL 11, 2013
3.
EXPERIMENTAL PROCEDURES:
Provide an overview of the experimental work involving each biological agent and the biosafety
practices to be used. Provide sufficient detail to allow the IBC to evaluate the risks and
proposed biosafety containment levels and procedures.
--------------------------------------------------------------------------------------------------------------------4.
BIOLOGICAL HAZARDS
For the biological agents and recombinant DNA to be used describe the following. a) the
hazards of the materials to be used with respect to humans, animals, and plants and the
potential for an environmental hazard. If agents are considered low risk (BSL1), briefly describe
why this is the case (do not simply indicate not applicable); b) The infectivity (or toxicity for
toxins), and routes of transmission to humans, the risk to humans from exposure, and
symptoms that an infected person may display.
--------------------------------------------------------------------------------------------------------------------5.
a.
Personal Protective Equipment:
EXPOSURE CONTROL PROCEDURES:
b.
Engineered Containment Devices:
c.
Facility Controls:
d.
Administrative Controls:
Safety glasses
Disposable gloves
Face shield
Other (specify)
Biosafety cabinet (show location
on lab map; see Section 10)
Other (specify)
Hand washing available*
Room
air
HEPA
filtered
exhausted to outside
Lab hood (toxins)
Negative room pressure
Controlled laboratory access and door
sign*
Lab-specific safety training for lab
workers*
Written safety procedures (SOPs)*
* Required for all biological agents
Lab coat
Centrifuge safety
cups/rotors
One-pass ventilation
UNR laboratory safety training for lab
workers *
Procedures for sharps collection and
disposal
IACUC protocol using any agents listed in
sect. 1; provide protocol #:
Describe any additional controls used to protect personnel, animals, and plants from inadvertent
exposure to the agent(s), with consideration of unknown infectious agents (e.g., potential
unidentified agents in primary tissue or cells).
--------------------------------------------------------------------------------------------------------------------Page 4 of 8
REV. APRIL 11, 2013
6.
SECURITY
a. Describe security procedures used to prevent unauthorized access to the agent(s) or
release of viable material to the environment (e.g., laboratory locked when not occupied,
storage freezers locked, security swipe cards, security cameras, etc.).
--------------------------------------------------------------------------------------------------------------------b. Describe procedures used to account for the agent(s) and to detect missing material (e.g.,
monthly inventory of biological materials).
--------------------------------------------------------------------------------------------------------------------7.
a.
DECONTAMINATION AND DISPOSAL:
Chemical Disinfectants for Decontamination of Surfaces and Equipment:
Ethanol (70%)
Phenolic*
Bleach (10%
household bleach)
Quaternary
ammonium*
Iodophore*
Other* (specify)
* mix and use according to manufacturer’s instructions
If any BSL-2 or BSL-3 pathogens (human, animal, or plant) are used or present, specify
chemical disinfectants and concentrations used for decontamination of surfaces and equipment.
--------------------------------------------------------------------------------------------------------------------b.
Biohazardous Waste Decontamination:
Autoclave# (indicate location)
Bleach*
Sanitary Sewer (small quantities of blood/body fluids)
# A minimum autoclave time of 60 minutes is required by regulation for decontamination of biohazardous waste.
* The only chemical disinfectant allowed by regulation for treatment of biohazardous waste (liquid microbial
cultures and stocks) is sodium hypochlorite at a minimum final concentration of 5,000 ppm and a minimum 30
minutes residence time. A concentration of 5,000 ppm can be achieved by a 1/10 final dilution of consumer
bleach (5-6% sodium hypochlorite). Sodium hypochlorite solutions used to treat spore-forming pathogenic
organisms must be pH adjusted to 7 prior to treatment (must be freshly prepared).
If toxins are used, describe deactivation and disposal procedures (for chemical treatment
include residence time). If no toxins are used, indicate “none.”
---------------------------------------------------------------------------------------------------------------------
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REV. APRIL 11, 2013
8.
EMERGENCY PROCEDURES:
Standard response and reporting procedures for incidents involving personnel exposure to
biological agents, or spills or releases of biological agents, are described in chapters 10 and 11
of the UNR Biosafety Manual.
a. Location of nearest eyewash:
b. Indicate response procedures for personnel exposure incidents involving biological agents
covered by this MOUA.
--------------------------------------------------------------------------------------------------------------------The standard response procedures described in the UNR Biosafety Manual have been
reviewed, are judged to be adequate, and will be implemented as needed.
Additional or alternative response procedures are needed and are described below.
c. Indicate response procedures for spills or releases of biological agents covered by this MOUA.
--------------------------------------------------------------------------------------------------------------------The standard response procedures described in the UNR Biosafety Manual have been
reviewed, are judged to be adequate, and will be implemented as needed.
Additional or alternative response procedures are needed and are described below.
9.
MONITORING PROCEDURES:
a. List vaccinations* and medical surveillance required for the work covered by this MOUA,
including animal handlers#.
--------------------------------------------------------------------------------------------------------------------Vaccinations:
hepatitis B
tetanus
other (specify)
Describe applicable medical surveillance and personnel sampling procedures or indicate “not
applicable” as appropriate.
* personnel exposed to human fluids, cells, or unfixed tissue (or other sources of HIV or HBV) must take UNR's
#
bloodborne pathogens training annually and be offered the Hepatitis B vaccination, which they may decline.
personnel included in the animal handlers program must be offered the tetanus vaccination, which they may
decline.
b. Describe applicable laboratory and environmental monitoring or indicate “not applicable” as
appropriate.
--------------------------------------------------------------------------------------------------------------------Page 6 of 8
REV. APRIL 11, 2013
10.
FACILITY OPERATIONAL PROCEDURES:
Describe any special facility access control measures, controlled areas, and other special
facility/laboratory procedures not normally associated with standard laboratories.
--------------------------------------------------------------------------------------------------------------------11.
LAB MAP:
Attach a floor plan of each laboratory that shows the following: 1) where the agent(s) will be
cultured, incubated, and stored; 2) location of biological safety cabinets and other safety
equipment; and 3) any special room ventilation features not included in standard laboratories
(including items marked in Section 4, Facility Controls).
---------------------------------------------------------------------------------------------------------------------
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REV. APRIL 11, 2013
12.
INSTITUTIONAL BIOSAFETY COMMITTEE APPROVAL
The procedures and facilities described in this document have been reviewed by the University
of Nevada, Reno (UNR) Institutional Biosafety Committee (IBC). The IBC considers the
procedures and facilities listed to be appropriate for the described project, and consistent with
NIH and UNR guidelines. The IBC, in conjunction with the Environmental Health and Safety
Department, will monitor the procedures, facilities, and training of personnel.
Signature of IBC Chair
Protocol Activation Date
Protocol Termination Date
Page 8 of 8
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