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Protocol for the Use of

Recombinant DNA Molecules and Infectious Agents

  1. Project Title:
  1. Principal Investigator:

Mail Address:

Office Phone: () -

Lab Phone: () -

Home Phone: () -

  1. Alternative Responsible Individual:

Mail Address:

Office Phone: () -

Lab Phone: () -

Home Phone: () -

  1. This application is: New Renewal Modification

3.Anticipated study dates: From To

  1. Please provide an abstract and specific aims of proposal.
  1. At what site will the research be conducted?
  1. Will this research involve human gene transfer experiments (i.e., the deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA into human subjects)?

Yes No

Updated 03-16

Protocol for the Use ofRecombinant DNA

Molecules and Infectious Agents

Will this research involve:

  1. the cloning of toxin molecules with LD50 of less than 100 nanograms per kilogram of body weight in vertebrates?

Yes No

  1. the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally?

Yes No

  1. If you answered yes to question 8, is the drug also used in the treatment of disease caused by this microorganism in humans or animals?

Yes No

  1. the use of human blood products, body fluids or tissues?

Yes No

  1. either infectious DNA/RNA viruses OR defective viruses (<2/3 of the viral genome) in the presence of helper virus in tissue culture systems?

Yes No

  1. the creation of transgenic animals or plants?

Yes No

  1. List all microbial organisms that will be used either directly or as a source of DNA for this research. Include the indicated information (see Appendix of NIH Guidelines, Safety Materials section of CHORI library, for Risk Group Classification).

Organism

/

Risk Group

/

Live

Yes/No /

Source of DNA

Yes/No /

Human Pathogen

Yes/No
  1. Describe any use of infectious agents and/or recombinant DNA activities that will be performed in pursuing this project. Address the following questions in your response, or check box below.

Neither infections agents or recombinant DNA molecules are used in this project.

  1. Will greater than 10 liters of culture be used at one time?
  2. If the organism is a human pathogen, is a vaccine available?
  3. If the answer to 14b is yes, has this vaccine been offered to all laboratory employees, and does the P.I. have written documentation of either vaccination or refusal to receive vaccination on all employees?
  4. Will this proposal involve animal inoculation?
  5. Will there be a high likelihood of aerosolization in the handling of this organism?
  6. Indicate:
  1. the source(s) of DNA (from which animal/organism is sequence derived?)
  2. the nature of inserted DNA sequences
  3. the host(s) and vector(s) to be used
  4. if any attempt will be made to obtain expression of a foreign gene, and if so, indicate the protein that will be produced
  5. the containment conditions that will be implemented, as specified in the NIH Guidelines.
  1. Provide a brief plan to be used in the event of emergency spills or contamination or personnel and/or environment.
  1. Describe any real or potential risk to humans or the environment posed by this research, or check box below. What steps are you taking to prevent such risks?

No risks to humans or the environment are posed by this research.

Signature of Principal InvestigatorDate

Updated 03-16