Applying for a Registration Document from the Institutional Biosafety Committee IBC to use Recombina

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Applying for a Registration Document from the
Institutional Biosafety Committee (IBC) to use
Recombinant DNA and / or Infectious Agents

• Key information that the PI must provide the IBC
  is the level of containment required for the
  proposed activity.
• If your work uses recombinant DNA (rDNA) or
  biological agents, you need to be aware of the
  appropriate section of the NIH Guidelines.
• This module will help you determine the correct
  Biosafety level (BSL) for your research.
• This exercise must be performed prior to
  commencing EACH research project.

Do I need to fill out an MUA? Am I using
Recombinant DNA
Biological or Pathogenic Agents
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Flow Chart to determine Risk Level and Section of
NIH Guidelines

• The NIH Guidelines can be accessed online at
• http//www4.od.nih.gov/oba/rac/guidelines_02/NIH_G
  uidelines_Apr_02.htm
• To determine which section of the Guidelines
  apply, you should ask the following 4 questions
• Is rDNA to be put in an organism?
• What is the nature of the gene(s) to be cloned?
• What is the nature of the host and vector to be
  used?
• Does the experiment involve cultures of more than
  10 liters?

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Do you intend to put rDNA into another
organism-bacteria or other cells (i.e., clone
it)?
YES Continue on to the next question
NO I am only using PCR or an
oligonucleotide synthesizer to make DNA the
experiment is exempt Section (III-F-1)
NOTE Even exempt experiments are performed
under BSL-1 conditions
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What is the nature of the DNA to be cloned?

• .

It produces a TOXIN molecule that is lethal for
vertebrates at an LD50 of less than 100ng/kg
body weight. This is a Section III-B
experiment which requires direct NIH approval.
If it is a from a biosafety level 2, 3 or
restricted agent, it will fall under Section
III-D-2, or Section III-F (continue to
host/vector slides).
None of the above? continue for additional
information
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Biosafety Levels

• Biosafety Level 1 Agents not known to cause
  disease in healthy humans
• Examples
• Bacillus subtilis
• Escherichia coli, (non-pathogenic strains such as
  K-12)

• Biosafety Level 2 Agents associated with human
  disease, moderate
• potential hazard
• Examples
• Measles Virus
• Hepatitis B Virus
• Salmonellae, such as S. typhi

• Biosafety Level 3 Agents that may cause serious
  or potentially lethal
• disease in humans
• Examples
• Mycobacterium tuberculosis
• Coccidioides immitis
• HIV-1

For complete list of bacterial, viral and
fungal agents and their corresponding biosafety
levels and risk groups, please visit
http//www.absa.org/resriskgroup.html
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What host(s)/vector(s) will be used?
IF A HOST OR VECTOR IS A Biosafety Level 2 or
3 agent
The experiment may be EXEMPT if
SECTION III-D-1 Applies
IF ALL HOSTS TO BE USED ARE Non-pathogenic
laboratory strains of E.coli K-12 OR laboratory
strains of Saccharomyces cerevisiae
If an INFECTIOUS VIRUS is being used as a
vector, OR a DEFECTIVE VIRUS is being used in
the Presence of a helper virus or helper cells
(e.g., 293 cells)
It does NOT involve cloning genes from
Biosafety Level 2 or 3 organisms
SECTION III-D-1 Applies
All components of the rDNA molecule Comes from
the same species (III-F-3, or -4), or from
species that naturally exchange DNA (III-F-5)
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Does the experiment involve cultures of more than
10 Liters?

• YES Section III-D-6 Should be consulted
• Remember Complete NIH Guidelines can be
  accessed at
• http//www4.od.nih.gov/oba/rac/guidelines_02/NIH_G
  uidelines_Apr_02.htm
• Summary
• If you have worked through this flow sheet and
  have truly found your project to be exempt, then
• If your project is NOT EXEMPT under the NIH
  Guidelines, then you must fill out a Memorandum
  of Understanding and Agreement form, which can be
  accessed at www.ibc.arizona.edu/mua
• If you have any questions, please do not hesitate
  to contact the University of Arizona
  Institutional Biosafety Committee. Visit
  www.ibc.arizona.edu for contact information.
• Special thanks to Kansas State University for use
  of flow chart

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Agreement FormPlease Fax to 621-6159
I ________________ certify that I have used this
module in order to determine that the scope of
my research project is exempt according to the
NIH guidelines for recombinant DNA and
pathogens. Title of Project ___________________
___________
________________________
PI Signature and Date