NIH Self-Audit Review

Representatives from the National Institutes of Health (NIH) recently completed a Site Visit to The University of Alabama. They have requested an updated audit of recombinant/synthetic DNA research activities currently being performed on the UA campus. Please complete and submit this survey to begin this audit process.

*Please note - All recombinant and synthetic DNA work performed at UA is subject to the NIH Guidelines, regardless of the project's funding source. A response is REQUIRED, even if all the answers are 'NO'.

If you have any questions about these items, please contact the Institutional Biosafety Officer, Marcy Huey, at 205-348-5912 or or Tanta Myles at Research Compliance 205-348-8461 or
1. Responsible Party
2. Person completing survey (if not PI)
3. Do you have any of the following items in use or storage:
Human cells
Human tissue
Human fluids (including blood, plasma or saliva)
Animal tissue
Animal fluids
Plant materials
Any other type of biological materials
4. If you answered 'YES' to any items in Question 3, please list all such materials and their biosafety levels. If you answered 'NO' to all items in Question 3, please enter N/A
5. Are you currently working with DNA, recombinant DNA or synthetic DNA materials?
6. Do any of your DNA experiments involve:
A. The deliberate transfer of a drug resistance trait to microorganisms not know to acquire the trait naturally?
B. The cloning of toxin molecules with an LD50 of less than 100ng/kg body weight?
C. The deliberate transfer of recombinant or synthetic DNA into one or more human research participants?
D. Use risk group 2,3,4 or otherwise restricted agents as host-vector systems?
E. Exposing any animal to recombinant or synthetic modified microbes?
F. Cloning DNA material from Risk Group 2,3,4 or other restricted agents into a nonpathogenic prokaryotic or lower eukaryotic host vector system?
G. The use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems?
H. The purchase, creation, use or breeding of transgenic or knock-out rodents?
I. The purchase, creation, use or breeding of transgenic animals other than rodents?
J. The purchase creation, use or breeding of recombinant or synthetic DNA modified arthropods?
K. Experiments with whole plants?
L. More than 10L of culture?
M. The use of any strain of influenza viruses?
7. The NIH Guidelines provide specific experiments that are exempt from the full requirements of the Guidelines and from NIH oversight. However, UA policy requires that even exempt experiments be reviewed by the Institutional Biosafety Officer and the IBC.

If you suspect that your work is exempt, please answer the following questions (some of these may require additional information or verification after review):
Do the DNA experiments involve:
A. Synthetic nucleic acids that can 1) neither replicate nor generate nucleic acids that can replicate in any living cell AND 2) are not designed to integrate into DNA AND 3) do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100ng/kg body weight?
B. DNA molecules that are not in organisms, cells, or viruses and that have not been modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular membranes?
C. DNA molecules that consist entirely of DNA segments from a single non-chromosomal or viral DNA source, though one of more of the segments may be a synthetic equivalent?
D. DNA molecules that consist entirely of DNA from a prokaryotic host including indigenous plasmids or viruses when propagated only in that host or when transferred to another host by well-established physiological means?
E. DNA molecules that consist entirely of DNA from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (excluding viruses) when propagated only in that host or a related strain of the same species?
F. DNA molecules that consist entirely of DNA segments from different species that exchange DNA by a known physiological process, though one or more segments may be a synthetic equivalent?
G. Genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any recombinant or synthetic DNA?
H. DNA molecules that contain less than 1/2 of any eukaryotic viral genome that are propagated and maintained in cells in tissue culture?
I. Escherichia coli K-12 host-vector systems where 1) the e.coli does not contain conjugation proficient plasmids or generalized transducing phages OR 2) Lambda or lamboid or Ff bacteriophages or non-conjugative plasmids shall be used as vectors?
J. Experiments involving Saccharomyces cerevisiae and Saccharomyces uvarun host-vector system?
K. Experiments involving Kluyveromyces lactis host-vector system?
L. Any asporogenic Bacillus subtilis or asporogenic Bacillus licheniformis strain which does not revert to a spore-former?
M. DNA molecules that are derived from extrachromosomal elements of organisms?
8. Do you have any DNA experiments involving recombinant or synthetic DNA that have not been addressed by any of the previous categories?

If 'YES' please enter information in the 'Other' field. In 'NO' please enter NA in the 'Other' field.
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