Viral Vectors Registration Form – Institutional Biosafety Committee

General Information

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Principal Investigator:

Department:

Phone number:

Email

Project title:

Locations where experiments will be performed (building and room number)

Locations where rDNA or viral vectors will be stored (building and room number)

Recombinant DNA

This experiment will involve the following recombinant DNA methods (choose all that apply):

Cloning of DNA encoding toxin molecules lethal to vertebrates at an LD50 of less than 100ng/kg
Human gene therapy or human subjects
Transfer of drug resistance to an organism not know to naturally acquire that trait, if such an acquisition could compromise ability to control the disease in humans, veterinary medicine, or agriculture
RG 2 agents as host-vector systems
Cloning of DNA from RG 2 microorganisms into nonpathogenic prokaryotic or lower eukaryotic host-vector systems
Use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus tissue culture systems
Use of transgenic animals at RG 2 or above
Use of viable rDNA modified microorganisms involving whole animals or whole plants
Administration of rDNA to animals or plants
Less than 1L of culture
1-10L of culture
More than 10L of culture
Propagation and maintenance of tissue culture of rDNA containing less than 2/3 of the genome of any eukaryotic virus in the demonstrable absence of helper virus or a virus that has been show to be non-replicating
Propagation and maintenance in tissue culture of rDNA containing a virus that has been shown to be non-replicating
Formation of rDNA containing no more than 2/3 of the genome of any eukaryotic virus
Use of transgenic animals at RG 1
rDNA not in an organism or virus
DNA segments from a single non-chromosomal or virual DNA source
DNA entirely from a prokaryotic host when propagated only in that host
DNA entirely from a prokaryotic host when transferred to another host by well-established physiological means
DNA from a eukaryotic host when propataged only in that host or closely related strain of the same species
DNA segments from different species that exchange DNA by known physiological processes

Does the donor rDNA, RNA, or cDNA source or its vector have any recognized or anticipated pathogenic, toxigenic, or viral potential for animals, plants, or humans?

Yes
No

If yes, please explain:

Description of viral vector (virus name, strain, other identifying information). If more than one, list all that will be used.

Specify the cloned source DNA genus, species, gene name, and gene product (if expressed). If more than one, list all that will be used:

Will the inserted gene(s) be expressed?

Yes
No

If so, what are the gene product effects? Specifically identify any toxicity, physiological activity, allerginicity, oncogenic potential, or ability to alter the cell cycle.

Host cell(s) or packaging cell line in which recombinant vector will be amplified. Include strain name:

Is the vector replication competent?

Is a helper virus used?

Yes
No

If yes, specify type:

What cells, tissues, animals, humans, insects, or plants will be exposed to the recombinant?

Will you work with transgenic animals?

Yes
No

What is the source of this material (ATCC, colleague, vendor, other)?

Please provide a BRIEF description of proposed research

Are biohazard warning labels in use?

Yes
No

If a stock culture wlll be prepared (or purchased), indicate total volume of stock culture, volume of aliquots, and titer:

Indicate maximum volume used in an experiment:

Do you concentrate the organism in your protocol?

Yes
No

If other, please indicate the concentration method:

Animal Uses

Will the biohazardous materials listed above be administered to animals?

Yes
No

If yes, what species will be exposed?

Provide the Institutional Animal Care and Use Committee active or pending protocol number:

State the maximum volume and concentration to be administered per animal:

State the maximum volume and concentration to be administered per experiment:

Animal Risk Group (ARG) required:

Indicate proposed route of administration:

Aerosol
Catheter or cannula
Intranasal
IV, IM, IP
Other

If other, please specify

Will the animals be anesthetized or tranquilized during administration?

Yes
No

Is the agent(s) an:

animal pathogen
human pathogen
insect pathogen
plant pathogen
transmissible from animal to human
transmissible from animal to animal

Will the agent(s) be inactivated prior to use in animals?

Yes
No

Will the animals be housed in micro-isolator cages?

Yes
No

Will there be any special procedures or containment needed?

Yes
No

If yes, describe any special requirements:

Will the animal work be performed in a biosafety cabinet?

Yes
No

Safety Measures

Indicate any engineering controls used to prevent potential contamination:

Containment suite (BSL-2)
Biocontainment animal housing (if applicable)
Class II biological safety cabinet
Centrifuge safety cups
Other

If other, please specify:

Will syringes, scalpels, glass, or other sharps be used?

Sharps used at RG 2 and above should be minimized.

Yes
No

Has the research protocol been reviewed to eliminate or minimize the use of sharps where possible?

Yes
No

Are sharps with integrated safety devices or mechanisms available and used?

Yes
No

Indicate any Personal Protective Equipment (PPE) that will be required for your work:

Lab coat
Safety glasses
Apron or rear-fastening gown
Bonnet or other hair cover
Gloves

-- For each type of clean up, please indicate disinfectant methods. --

Routine spill cleanup

Autoclave
1/10 bleach solution
Poviodone or iodine product
70 percent ethanol
Phenolic product
Cholorine dioxide product
Quaternary ammonium product
Other

If other, please specify

Solid waste cleanup

Autoclave
1/10 bleach solution
Poviodone or iodine product
70 percent ethanol
Phenolic product
Cholorine dioxide product
Quaternary ammonium product
Other

If other, please specify

Liquid waste cleanup

Autoclave
1/10 bleach solution
Poviodone or iodine product
70 percent ethanol
Phenolic product
Cholorine dioxide product
Quaternary ammonium product
Other

If other, please specify

Animal carcasses will be stored in a -20C freezer in biohazard bags and disposed of via incineration

Yes
No

If other, please specify

If you would use other methods of disinfecting, or can identify other types of waste that you would need to address, please provide detailed information here:

-- Principal Investigator's Assessment of Risk --

What is the most serious adverse effect you can foresee as a result of this experiment?

Is there any potential for this material to be contaminated with an organism of a higher risk group?

Yes
No

Additional vaccination is required for work on this project

Yes
No

If yes, please specify