Proposal

BIO SAFETY

Please complete the form to submit your project proposal.

Project Title: Funding Source:

PI Name: Dept: Phone#:

Position: Protocol#:

Research Protocol Summary-Define all Acronyms (A summary, in lay terms, of the proposed project, which highlights the safety, measures to be taken when conducting experimentation. Please provide a copy of your “methods” and any relevant copies of citations or articles. Please define all acronyms.)

Biological Agents Involved

Viruses: Specific Name, Strain, Quantity, Bioengineered Controls, Source info.

Bacteria: Specific Name, Strain, Quantity, Bioengineered Controls, Source info.

Fungi: Specific Name, Strain, Quantity, Bioengineered Controls, Source info.

Parasites: Specific Name, Strain, Quantity, Bioengineered Controls, Source info.

Cell lines/strains: Specific Name, Strain, Quantity, Bioengineered Controls, Source info.

Human Subjects: Purpose for use; systems to be used, IRB approval #

Animals/Transgenic/KO: Specific Name, Strain, housing, Bioengineered Controls, Source info., IACUC #

This research protocol is described in the most recent NIH Guidelines For Research Involving Recombinant

DNA Molecules, (April 2002) as amended in Section: III-D-3-b (Experiments Involving the Use of Infectious DNA or RNA Viruses in the Presence of Helper Virus (Risk Group 3) in Tissue Culture Systems).

III-A

III-B

III-C

III-D

III-E

III-F

*If rDNA is to be used please list each of the original sources of DNA, which go into the composite along with a percentage break down of DNA provided, by the original sources.

Risk Group 1 (RG1)	Agents that are not associated with disease in healthy adult humans
Risk Group 2 (RG2)	Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available
Risk Group 3 (RG3)	Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk)
Risk Group 4 (RG4)	Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk)

Applicable Regulations/Guidelines/References: NIH Guidelines for Research Involving Recombinant DNA Molecules (April 2002) as amended, CDC-NIH Biosafety in Microbiological and Biomedical Laboratories (4th edition-1999).

The containment and facilities for the biological agent(s) to be used in the protocol must meet Biosafety Level 2 requirements. Information on Biosafety Levels can be found in the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories Guidelines (4th Edition-1999).

Proposed Biosafety Level (BSL):

Animal Care and Use Committee Approval:

IRB-HSR Approval:

Safety Requirements

Personnel: (Please list each person who will be participating on the project along with a summary of education, experience and training as it relates to the use of the proposed biological agents.
Protective equipment: (Please provide a summary of your intended personal protective equipment including locations and certification dates for biological safety cabinets.)
Location of work: (Room #’s for all work areas, storage, animal housing, autoclave locations, and BSC locations)
Biological waste disposal: (Describe waste disposal / disinfection practices and methods for transport of waste through the facility for disposal.)
Shipping Infectious Substances (if any): (Please indicate whether you intend to ship or receive infectious. Please note crossing any public road is considered shipping,
Conditions (if any): (To be determined by IBC and Office of Risk Management. Required training such as Bloodborne Pathogens training is most often cited here.)
Projected start date:

Date received (for review): (Date application is received by IBC and Office of Risk Management

Principal Investigator Acknowledgment

I agree to comply with all applicable safety guidelines and standards established for this work and understand that I am primarily responsible for the health and safety of all related activities under my direction. I also understand that this Memorandum of Understanding and Agreement is not effective until the appropriate signature(s) is/are obtained from the official(s) designated below.

P.I. Name:
Date:

Office of Risk Management

The Office of Risk Management has reviewed this proposal, verified the classification and/or containment level indicated above, and confirmed that the identified facilities and practices meet the Biosafety Level specifications. The protocol review requirements are:

1.	III-E	………………protocol requires IBC notification simultaneous with initiation of work
2.	III-F	………………protocol is exempted from IBC review.
3.	BSL-1	………………protocol is exempted from IBC review.
4.	BSL-2	………………protocol must be submitted for full review and approval by IBC.
5.	BSL-3	………………protocol must be submitted for full review and approval by IBC.
6.	Other

Risk Mgt. Representative/BSO
Date:

Institutional Biosafety Committee Review (For BSL-2 And Greater)

The Institutional Biosafety Committee has reviewed the proposal and has found it to be in compliance with the appropriate Guidelines. The Committee will review this research annually.

IBC Chair Signature:
Date: