WESTERN CAROLINA UNIVERSITY

MEMORANDUM OF UNDERSTANDING AND AGREEMENT (MUA)

FOR RECOMBINANT DNA EXPERIMENTS

DATE: _______________________

RESEARCHER’S NAME _______________________________________________________________

RESEARCHER'S TITLE _________________________________ PHONE NO:___________________

DEPARTMENT _____________________________BUILDING & ROOM NO(s)__________________

GRANTING AGENCY _____________________GRANT NO. (IF APPLICABLE)_________________

TITLE OF GRANT OR PROJECT:________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

For purposes of this MUA, bio-hazardous materials are defined as any organism known to or suspected of causing infection in humans, and a toxin is a proteinaceous poison which is highly toxic to humans. Experiments using bio-hazardous materials and toxins should follow the most current CDC/NIH Biosafety in Microbiological and Biomedical Laboratories Guidelines.

The Principal Investigator is responsible for completing the appropriate parts of this document. The Principal Investigator shall be responsible for notifying the Western Carolina University (“WCU” or “University”) Institutional Biosafety Committee when work with any potentially infectious material is terminated or when other significant changes occur, such as changes in protocol, personnel or relocation of the laboratory.

This registration is to be forwarded to the WCU Institutional Biosafety Committee prior to the initiation of work. Each individual and/or laboratory personnel should be informed of the potential hazards associated with the work, the appropriate safety practices to be used, the availability of medical programs, and applicable training requirements.

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Describe the experiment involving recombinant DNA techniques. Your description is to be sufficiently complete so as to provide committee members an understanding of what you intend to do and how you will do it. A summary or abstract of your methods and materials section will also be helpful. Please reference this discussion to appropriate NIH Guidelines and/or USDA/APHIS, and EPA regulations.

Please include the following (if applicable):

Source or type of Infectious Agent (List complete Latin names for organisms, no abbreviations) and host (i.e. cell line, animal species);

Recombinant DNA/Plasmids/Vectors to be used and hosts (List specific source of plasmids and vectors, i.e. commercial vendor or collaborator); and

Brief Description of Procedure.

Health and Safety: (Please include additional documentation, if necessary.)

If you are working with human body fluids/tissues, do you have a written Bloodborne Pathogen Plan that has been approved by Environmental Health and Safety (if applicable)?

If you are using carcinogens, mutagens or teratogens do you have written Standard Operating Procedures per the University’s Lab Safety manual that have been reviewed by Environmental Health and Safety (if applicable)?

Are vaccinations required?

Is serum banking required?

Assessment levels of physical and biological containment.

Describe how you intend to meet physical and biological containment requirements (reference NIH/USDA/EPA guidelines).

NIH Guidelines: (http://www.cdc.gov/od/ohs/biosfty/bsc/bsc.htm)

APHIS: (http://www.aphis.usda.gov/forms/index.html)

Will this project involve environmental release?

If animals will be used in the project, how will be the animals be disposed of?

Describe procedures and precautions to be followed in transporting bio-hazardous agents between laboratories.

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Principal Investigator agrees to the following:

Inform all laboratory personnel of the risks of exposure while working with these organisms and/or toxins and accept responsibility for training of all laboratory personnel involved in the project;

Comply with all appropriate requirements pertaining to shipment and transfer of recombinant DNA materials;

Be familiar with and abide by the provisions of the current NIH/USDA/EPA Guidelines and other specific instructions pertaining to the proposed project;

Follow NIH requirements pertaining to shipment and transfer of recombinant DNA materials.

Acknowledgment (Department)

I hereby warrant and represent that the above information is accurate and complete.

_______________________________________	____________________

Principal Investigator	Date

_______________________________________	____________________

Department Head	Date

Western Carolina University (“WCU”) agrees to the following:

WCU shall certify that the WCU Institutional Biosafety Committee has reviewed the proposed project for recombinant DNA experiments for compliance with the NIH/USDA/EPA and SMSU Guidelines;

The WCU Institutional Biosafety Committee will monitor throughout the duration of the project the facilities, procedures, and the training and expertise of the personnel involved in the recombinant DNA activity; and

The WCU Institutional Biosafety Committee shall determine, based on information provided by the Principal Investigator, when special medical surveillance (other than usual University health programs) are required for the project described in this MUA.

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G.	Special Instructions:

H.	Acknowledgement (WCU Institutional Biosafety Committee):
__________________________________________	______________________

Burton Ogle, Ph.D., Chairperson	Date

WCU Institutional Biosafety Committee

RETURN THIS FORM TO:

OFFICE OF RESEARCH ADMINISTRATION

110 CORDELIA CAMP BUILDING

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Memorandum of Understanding and Agreement (MUA) for Recombinant DNA

smsu

2011-09-23

ashe

SMSU