Protocol Risk Assessment and Hazard Management

Protocol Risk Assessment and Hazard ManagementGW 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.

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:

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)

Hazard Management(all questions must be answered)

Research staff, to include any newly hired staff, are experienced and trained for the procedures in this protocol

Yes No

Research staff will be actively supervised in the conduct of this research

Yes No

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

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

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

The protocol contains instructions for what to do in the event of a splash, spill or release of the agent(s)

Yes No.

The protocol contains instructions for what to do in the event of a suspected or known exposure (dermal, aerosol, ingestion, and needlesticks)

Yes No.

Medical surveillance---the active medical examination, testing, and monitoring of researchers----is recommended for this study

Yes No.

The protocol requires the use of personal protective equipment

Yes No.

The protocol specifies routine decontamination of work areas and equipment

Yes No.

The protocol specifies procedures for the disposal of research agent(s)

Yes No.

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.

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:
rDNA:
Chemical: / Biological:
rDNA:
Chemical:
Biosafety Level: 1 2 3
-OR-
Risk Group 1 2 3. / Biosafety Level: 1 2 3
-OR-
Risk Group 1 2 3.
Biological:
rDNA:
Chemical: / Biological:
rDNA:
Chemical:
Biosafety Level: 1 2 3
-OR-
Risk Group 1 2 3. / Biosafety Level: 1 2 3
-OR-
Risk Group 1 2 3.
Biological:
rDNA:
Chemical: / Biological:
rDNA:
Chemical:
Biosafety Level: 1 2 3
-OR-
Risk Group 1 2 3. / Biosafety Level: 1 2 3
-OR-
Risk Group 1 2 3.
Biological:
rDNA:
Chemical: / Biological:
rDNA:
Chemical:
Biosafety Level: 1 2 3
-OR-
Risk Group 1 2 3. / Biosafety Level: 1 2 3
-OR-
Risk Group 1 2 3.

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.

1.3Stability (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

1.9.1Gloves Yes No

1.9.2Goggles Yes No

1.9.3Lab Coat Yes No

1.9.4Shoe Cover Yes No

1.9.5Respirator Yes No

1.9.6Tyvek Coverall Yes No

1.9.7Other

1.10 Does the research involve the use of a Select Agent Yes No.

(refer to for the latest list of Select Agents and Toxins)

(If “YES” – Contact OLSC at 202-994-3282)

1.11Hazard Management Plan:

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

MutagenTeratogen Organic PeroxideRadioactivePoisonExplosive

2.2 Overall Health Hazard Potential (based on NFPA 704)

2.3 Overall Flammability Hazard Potential (based on NFPA 704)

2.4 Overall Reactivity Hazard Potential (based on NFPA 704

2.5 Special Hazards (based on NFPA 704)

OX CORNo WaterACID Radioactive

2.6 Quantities to be used Milliliters Liters Milligrams MicrogramsGrams

2.7 P.P.E. Required Yes No

2.7.1Gloves Yes No

2.7.2Goggles Yes No

2.7.3Lab Coat Yes No

2.7.4Shoe Cover Yes No

2.7.5Respirator Yes No(if “YES” – fit testing is required)

2.7.6Tyvek Coverall Yes No

2.7.7Other

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:

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

(genus, strain, species) /

Gene Name

/ Nature of Insert/Protein
(toxin, marker, viral sequence, oncogene, etc) /

Use of Construct

(cloning for sequencing, expression in microbe, tissue, organ or culture)

Vector Type

(plasmid, viral, cosmid, phage) /

Vector Source

(genus, species; if plasmid or viral) / Technical Name of Vector /

Risk Attenuation

(replication defective, helper virus, disarmed, K-12 derivative)

3.9 rDNA Hazard Management Plan:

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:

Agent:

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):
Procedure(s) for Loss or Theft of Materials:
Procedure(s) for Personal Protective Equipment:
Procedure(s) for Waste Disposal:
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:
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:

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

APPROVEDFULL COMMITTEE REVIEW

Signature______Date:______

Reviewer, Lab Safety & Compliance

Signature______Date:______

Director, Lab Safety & Compliance

Wednesday, October 03, 2018 version 3.12.16