Application-Research Involving Biosafety Level 3 or 4 Pathogens

MCRF requires that all work involving pathogens at CDC-defined Biosafety Level 3 or 4 conducted at this institution be registered with and approved by the Institutional Biosafety Committee (IBC) prior to initiation. Whenever possible, use lay language. Do not abbreviate medical or scientific terminology.

SP Code:	Protocol Date:

Title:

Principal Investigator:

Routing Location:	Phone:

Co-Investigator(s):

Research Coordinator:	Routing Location:

Person Completing Form:	Routing Location:

Bio-hazardous Agent(s) Used:

Controlled Substances: No

Yes If yes, indicate name of substance:

Section 1

For Projects involving Biohazardous Agents

Pertains only to Class 2 or 3 agents, exclusive of recombinant DNA constructs. Please describe in detail.

1. Name of the agent(s).

Describe the source of the agent (where the agent was acquired).

Provide a hazard assessment (nature of the hazards to personnel - sections of the CDC-NIH Guidelines must be cited when relevant), including use of radiological hazards in conjunction with biohazardous agents.

Describe the concentration and amount of agents to be generated.

5. CONTROLLED SUBSTANCES

This project DOES DOES NOT involve a controlled substance.

If you check “Does,” list the name(s) and total amount of the substance(s) needed.

Section 2

Description of the Project

Please attach a copy of your research protocol. If the answer to any question is included in your attached protocol, please reference the section of the protocol.

Briefly describe your research objectives, specific aims, and experimental procedures.

Discuss the location (building and room) where the experiment will be conducted.

Describe the procedures for handling, transport (both within and outside Marshfield Clinic Research Foundation), and disposal of wastes. (i.e., disinfectant used for cleanup; procedures for spill control and waste disposal.)

Describe the containment capabilities and give a brief assessment of the risk involved.

Name each person (including the principal investigator) who will engage directly in the conduct of the experiment and others for whom a potential risk exists by virtue of their presence within the research environment. Include a description of the experience and training that personnel have had or will have.

Describe the medical surveillance plan for personnel at risk. (i.e., Do you plan to draw a baseline sample? Is a vaccine available? What are your plans for routine monitoring of personnel handling the organisms?)

Section 3

Physical Containment Requirements

Indicate the level of physical containment that the research activity addressed in this document will be conducted under

Biosafety Level 1: suitable for work involving agents of unknown or minimal potential hazard to laboratory personnel and the environment. The laboratory is not separated from the general traffic patterns in the building. Work is generally conducted on open bench tops. Special containment equipment is not required or generally used. Laboratory personnel have specific training in the procedures conducted in the laboratory and are supervised by a scientist with general training in microbiology or a related science.

Biosafety Level 2: similar to Level 1 and is suitable for work involving agents of moderate potential hazard to personnel and the environment. It differs in that: (1) laboratory personnel have specific training in handling pathogenic agents and are directed by competent scientists; (2) access to the laboratory is limited when work is being conducted; and (3) certain procedures in which infectious aerosols are created are conducted in biological safety cabinets or other physical containment equipment.

Biosafety Level 3: applicable to clinical, diagnostic, teaching, research, or production facilities in which work is conducted with indigenous or exotic agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation route. Laboratory personnel have specific training in handling pathogenic and potentially lethal agents and are supervised by competent scientists who are experienced in working with these agents. All procedures involving the manipulation of infectious material are conducted within biological safety cabinets or other physical containment devices or by personnel wearing appropriate personal protective clothing and devices. The laboratory has special engineering and design features.

Physical Containment Equipment [Biological Safety Cabinets]

Cabinet#	Building	Room
Serial#	Date of Certification	Class
Type
Cabinet#	Building	Room
Serial#	Date of Certification	Class
Type
Cabinet#	Building	Room
Serial#	Date of Certification	Class
Type

Contact the MCRF Safety Liason for recommended practices if you plan to use volatile radioactive isotopes in work involving viable bio-hazardous materials at Biosafety Level 3 or above.

TransportING and shipping of biological materials

I agree to comply with the requirements at 49 CFR 173 pertaining to shipment and transfer of hazardous materials. (These regulations can be found at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title49/49cfr173_main_02.tpl. The shipment and transfer requirements can also be obtained from the Marshfield Clinic Specimen Processing Lab.)

Signature of Principal Investigator	Date

Investigator Assurance

By signing this document, the Principal Investigator attests that information is true and accurate to the best of his/her knowledge.

Signature of Principal Investigator	Date

Printed Name of Principal Investigator

Submit completed paperwork to Research Integrity & Protections – 1R4.

IBC Application – Research Involving Biosafety Level 3 or 4 Pathogens

Page 3 of 3

Version – October 1, 2011

Institutional Biosafety Committee

fleisnem

2015-07-31

Knecht, Justin E

Marshfield Clinic