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Protocol Risk Assessment and Hazard Management GW University
Protocol Risk Assessment and Hazard Management
for Basic Science and Animal Research Protocols
Instructions for Completing the Forms
The basic premise of the GW biosafety policy is that the Principal Investigator (PI) is
responsible for the risk assessment and hazard management of biological (to include rDNA
variants), chemical and radioactive agents used in research. Risk assessment is the evaluation
of potential adverse health events and environmental contamination from a hazardous agent.
Hazard management is the specification of policies and procedures that control health and
environmental hazards. This form does not address the use of radioactive materials.
The submitted research protocol must explicitly demonstrate that the PI has completed a
health, safety, and environmental risk assessment of the research agent(s). This form must be
completed in its entirety and submitted to the appropriate committee for review and approval.
Additional documentation may be required with your submission, and are specified below.
Please note that approval by one committee does not necessarily mean the submission has
been approved for work to begin.
To submit a protocol for review and approval the following guidelines have been established:
IRAC Submissions: All submissions are made to the Office of Health Research,
Compliance, and Technology Transfer, Ross Hall 712, (202) 994-2995. The submission
packet must include, at a minimum, ten (10) copies of the following items:
1- Committee Application
2- Protocol Risk Assessment and Hazard Management Form
IACUC Submissions: All submissions are made to the Animal Research Facility, Ross Hall
B13, (202) 994-2871. The submission packet must include, at a minimum, the following items:
1- IACUC “A” Form
2- Protocol Risk Assessment and Hazard Management Form
3- Complete Grant (salary information is not required)
Material Transfer Agreements: All submissions are made to the Office of Health Research,
Compliance, and Technology Transfer, Ross Hall 712, (202) 994-2995. The submission
packet must include the following items at a minimum:
1- Material Transfer Agreement
2- Protocol Risk Assessment and Hazard Management Form
Special Core (BSL-3, etc.) and University Submissions involving Select Agents and
Toxins: All submissions must be made to the Office of Laboratory Safety & Compliance,
Ross Hall 617, (202) 994-3282. The submission packet must include the following items at a
minimum:
1- Protocol Risk Assessment and Hazard Management Form
2- Protocol
3- Complete Grant (salary information is not required)
Incomplete Submissions Will Result in a Delay in the Approval of Your Submission.
Monday, December 13, 2010 version 3.12.16
Protocol Risk Assessment and Hazard Management GW University
Protocol Risk Assessment and Hazard Management
Official Use Only: Date (yyyy-mm-dd)
Principal Investigator:
Phone #:
Protocol Title:
IACUC ID #:
Work Location:
Storage Location:
Proposed Research Staff:
Name and Title:
Name and Title:
Name and Title:
Name and Title:
Name and Title:
Students: Yes No
Biological MSDS(s) Attached: Yes No
Chemical MSDS(s) Attached: Yes No
Complete Protocol Attached: Yes No
Safety Equipment Available: Yes No
Bio-Safety Cabinet Yes No
Chemical Fume Hood: Yes No
Perchloric Acid Hood: Yes No
Laminar Flow Cabinet: Yes No
Fire Extinguisher: Yes No
Negative Pressure Animal Cages: Yes No
Anticipated Occupational Exposure Form Submitted: Yes No (animal research requirement)
The active manipulation of the research agent(s) will be conducted in/on:
Biosafety cabinet Chemical Fume Hood Bench top
Centrifuge Other (describe)
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Protocol Risk Assessment and Hazard Management GW University
Hazard Management (all questions must be answered)
1. Research staff, to include any newly hired staff, are experienced and trained for the
procedures in this protocol
Yes No
2. Research staff will be actively supervised in the conduct of this research
Yes No
3. Research staff have reviewed the risk assessment for the agent(s) used in this study
and have been given the opportunity to ask questions and discuss procedures
Yes No
4. Research staff was informed that certain medical conditions might increase their risk for
health problems. These conditions include, but are not limited to: pregnancy,
immunosuppression, animal related allergies, and chronic skin conditions.
Yes No
5. Research staff are current in their compliance training:
Chemical Hygiene Plan Yes No. OSHA 1910.1450
Bloodborne Pathogens Yes No. OSHA 1910.1030
Hazard Communication Yes No. OSHA 1910.1200
Fire Safety Yes No. OSHA 1910.157
6. The protocol contains instructions for what to do in the event of a splash, spill or release
of the agent(s)
Yes No.
7. The protocol contains instructions for what to do in the event of a suspected or known
exposure (dermal, aerosol, ingestion, and needlesticks)
Yes No.
8. Medical surveillance---the active medical examination, testing, and monitoring of
researchers----is recommended for this study
Yes No.
9. The protocol requires the use of personal protective equipment
Yes No.
10. The protocol specifies routine decontamination of work areas and equipment
Yes No.
11. The protocol specifies procedures for the disposal of research agent(s)
Yes No.
12. Does this research require the shipping of hazardous materials (to include DOT, IATA,
CDC, APHIS regulations) Yes No.
NOTE: If “Yes” then staff are required to complete DOT / IATA training.
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Protocol Risk Assessment and Hazard Management GW University
Risk Assessment
I have reviewed the Material Safety Data Sheet(s), other references, and the
literature on research with this agent(s). Yes No
Biological: Biological:
rDNA: rDNA:
Chemical: Chemical:
Biosafety Level: 1 2 3 Biosafety Level: 1 2 3
-OR- -OR-
Risk Group 1 2 3. Risk Group 1 2 3.
Biological: Biological:
rDNA: rDNA:
Chemical: Chemical:
Biosafety Level: 1 2 3 Biosafety Level: 1 2 3
-OR- -OR-
Risk Group 1 2 3. Risk Group 1 2 3.
Biological: Biological:
rDNA: rDNA:
Chemical: Chemical:
Biosafety Level: 1 2 3 Biosafety Level: 1 2 3
-OR- -OR-
Risk Group 1 2 3. Risk Group 1 2 3.
Biological: Biological:
rDNA: rDNA:
Chemical: Chemical:
Biosafety Level: 1 2 3 Biosafety Level: 1 2 3
-OR- -OR-
Risk Group 1 2 3. Risk Group 1 2 3.
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Protocol Risk Assessment and Hazard Management GW University
1.0 Biological agents are characterized by the following risk assessment factors:
1.1 Pathogenic to Humans Animals Plants Environment
1.2 Route of transmission Inhalation Mucocutaneous Ingestion.
1.3 Stability (resistance to inactivation) High Low.
1.4 Concentration (number of organisms per unit volume) High Low.
1.5 Available animal data Yes No.
1.6 Available prophylaxis or therapeutic intervention Yes No.
1.7 Medical surveillance recommended Yes No.
1.8 Staff trained and experienced with agent Yes No.
1.9 P.P.E. Required Yes No
1.9.1 Gloves Yes No
1.9.2 Goggles Yes No
1.9.3 Lab Coat Yes No
1.9.4 Shoe Cover Yes No
1.9.5 Respirator Yes No
1.9.6 Tyvek Coverall Yes No
1.9.7 Other
1.10 Does the research involve the use of a Select Agent Yes No.
(refer to http://www.cdc.gov/od/sap/docs/salist.pdf for the latest list of Select Agents and Toxins)
(If “YES” – Contact OLSC at 202-994-3282)
1.11 Hazard Management Plan:
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Protocol Risk Assessment and Hazard Management GW University
2.0 Chemical agents are characterized by the aggregate hazard posed by the chemicals
proposed to be used, stored, or transferred during the course of the protocol:
2.1 The following classes of chemicals will be used under this protocol (please mark each
applicable hazard box for all chemicals anticipated to be used under this protocol) :
Flammable Reactive Carcinogenic Toxic Corrosive Oxidizer
Mutagen Teratogen Organic Peroxide Radioactive Poison Explosive
2.2 Overall Health Hazard Potential (based on NFPA 704) Choose One
2.3 Overall Flammability Hazard Potential (based on NFPA 704) Choose One
2.4 Overall Reactivity Hazard Potential (based on NFPA 704 Choose One
2.5 Special Hazards (based on NFPA 704)
OX COR No Water ACID Radioactive
2.6 Quantities to be used Milliliters Liters Milligrams Micrograms Grams
2.7 P.P.E. Required Yes No
2.7.1 Gloves Yes No
2.7.2 Goggles Yes No
2.7.3 Lab Coat Yes No
2.7.4 Shoe Cover Yes No
2.7.5 Respirator Yes No (if “YES” – fit testing is required)
2.7.6 Tyvek Coverall Yes No
2.7.7 Other
2.8 MSDS available Yes No
2.9 MSDS attached for review Yes No (required for each chemical classified as either
Reactive, Carcinogenic, Mutagen, Teratogen, Organic Peroxide, Explosive)
2.10 Hazard Management Plan:
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Protocol Risk Assessment and Hazard Management GW University
3.0 rDNA agents are characterized by the following risk assessment factors:
Agent Risk Group 1 2 3.
Agent Risk Group 1 2 3.
Agent Risk Group 1 2 3.
Agent Risk Group 1 2 3.
3.1 Does the inserted gene encode a known toxin Yes No
3.2 Is the pathogenicity attenuated Yes No
3.3 Modes of transmission .
3.4 Will it generate replication competent viruses Yes No.
3.5 Does the gene encode an oncogene, alter the cell cycle? Yes No
3.6 Does the viral DNA integrate into the host genome Yes No?
3.7 Proposed for In Vivo Use: Yes No
3.8 Proposed for In Vitro Use: Yes No
The protocol must describe the rDNA constructs and method of transfer or transfection. The
construct description must include:
Gene Sources Gene Name Nature of Insert/ Use of Construct
(genus, strain, Protein (cloning for
species) (toxin, marker, viral sequencing,
sequence, expression in
oncogene, etc) microbe, tissue,
organ or culture)
Vector Type Vector Source Technical Name of Risk Attenuation
(plasmid, viral, (genus, species; if Vector (replication
cosmid, phage) plasmid or viral) defective, helper
virus, disarmed, K-
12 derivative)
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Protocol Risk Assessment and Hazard Management GW University
3.9 rDNA Hazard Management Plan:
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4.0 Safe Use and Storage of Animals (required if any animal work is anticipated):
Note: This form should be completed for each agent (chemical, biological, or rDNA) planned for use in
animals that potentially poses a hazard to the researchers, staff, animal handlers, or the environment.
Your response should clearly demonstrate the risks to laboratory staff, to include Animal Research
Facility Staff, and your plan to mitigate those risks.
Agent:
Source(s) of Exposure (confine responses to in vivo use – e.g. stock or dispensed materials,
animal breath, bite, scratch, blood, serum, cells, dander, fur, excrement or secretions, caging
or research equipment, hood surface, aerosolized materials from centrifugation, sonication
stirring, mixing or other manipulation in the vivarium, etc.)
Proposed ABSL: 1 2 3.
Assessment of the Risk (confine responses to in vivo use – e.g. does the inoculation of
material pose a risk, transport of agent to or from vivarium, handling or contact with bedding)
Hazard Management Plan:
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Protocol Risk Assessment and Hazard Management GW University
Agent:
Source(s) of Exposure (confine responses to in vivo use – e.g. stock or dispensed materials,
animal breath, bite, scratch, blood, serum, cells, dander, fur, excrement or secretions, caging
or research equipment, hood surface, aerosolized materials from centrifugation, sonication
stirring, mixing or other manipulation in the vivarium, etc.)
Proposed ABSL: 1 2 3.
Assessment of the Risk (confine responses to in vivo use – e.g. does the inoculation of
material pose a risk, transport of agent to or from vivarium, handling or contact with bedding)
Hazard Management Plan:
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Protocol Risk Assessment and Hazard Management GW University
Agent:
Source(s) of Exposure (confine responses to in vivo use – e.g. stock or dispensed materials,
animal breath, bite, scratch, blood, serum, cells, dander, fur, excrement or secretions, caging
or research equipment, hood surface, aerosolized materials from centrifugation, sonication
stirring, mixing or other manipulation in the vivarium, etc.)
Proposed ABSL: 1 2 3.
Assessment of the Risk (confine responses to in vivo use – e.g. does the inoculation of
material pose a risk, transport of agent to or from vivarium, handling or contact with bedding)
Hazard Management Plan:
Monday, December 13, 2010 version 3.12.16
Protocol Risk Assessment and Hazard Management GW University
Agent:
Source(s) of Exposure (confine responses to in vivo use – e.g. stock or dispensed materials,
animal breath, bite, scratch, blood, serum, cells, dander, fur, excrement or secretions, caging
or research equipment, hood surface, aerosolized materials from centrifugation, sonication
stirring, mixing or other manipulation in the vivarium, etc.)
Proposed ABSL: 1 2 3.
Assessment of the Risk (confine responses to in vivo use – e.g. does the inoculation of
material pose a risk, transport of agent to or from vivarium, handling or contact with bedding)
Hazard Management Plan:
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Protocol Risk Assessment and Hazard Management GW University
5.0 Work Process Statement:
Procedure(s) for Chemical or Biological Spill or Release:
Procedure(s) for Accidental Exposure (regardless of route):
Procedure(s) for Medical Surveillance (including vaccinations):
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Protocol Risk Assessment and Hazard Management GW University
Procedure(s) for Loss or Theft of Materials:
Procedure(s) for Personal Protective Equipment:
Procedure(s) for Waste Disposal:
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Protocol Risk Assessment and Hazard Management GW University
Procedure(s) for Decontamination of Work Surfaces (to include any location the agent is
stored, used, or otherwise manipulated):
Security and/or Access Control Procedure(s):
Proposed Method(s) of Manipulation:
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Protocol Risk Assessment and Hazard Management GW University
Procedure(s) for Movement (e.g. storage to bench top, etc.):
Procedure(s) for Disposal/Deactivation of Agent or Toxin :
Procedure(s) for Disposal of Contaminated Supplies or Materials:
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Protocol Risk Assessment and Hazard Management GW University
I certify that I am qualified to perform the procedures listed, understand the risks associated
with working with biological agents, chemicals, rDNA, and Select Agents and Toxins, and will
abide by all applicable Federal laws and Institutional Policies. I understand that violations of
these policies may result in disciplinary action and referral to appropriate Federal Authorities
for further action.
Signature _________________________________ Date:________________
Principal Investigator
I certify that the above individual is competent with the Institutional and Federal procedures,
policies, laws, and regulations regarding Select Agent research and understands the risks
associated with working with biological agents, chemicals, rDNA, and Select Agents and
Toxins. I understand that violations of these policies by a member of my staff may result in
disciplinary action and referral to appropriate Federal Authorities for further action.
Signature_________________________________ Date:________________
Chair of Department
APPROVED FULL COMMITTEE REVIEW
Signature_________________________________ Date:________________
Reviewer, Lab Safety & Compliance
Signature_________________________________ Date:________________
Director, Lab Safety & Compliance
Monday, December 13, 2010 version 3.12.16
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