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Biological Materials Registration Form for R-DNA

What Research Must Be Registered

This outline is intended to serve as an overview of the "Guidelines for Research Involving recombinant DNA molecules (NIH Guidelines)". In the context of the NIH Guidelines, recombinant DNA molecules are defined as either: (i)molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii)molecules that result from the replication of those described in (i). It is the responsibility of each investigator to make sure that his/her laboratory is in compliance. If your experiments require registration with the Institutional Biosafety Committee, check the Guidelines for the appropriate biosafety level and relevant section. For additional information, copies of the Guidelines or registration forms, or if you are unsure into which category your experiments fall, please call the Office of Environmental Health and Safety at 581-6590.

Environmental Health and Safety
(801)581-6590
Fax:(801)585-7240
http://www.ehs.utah.edu

Experiments which must be registered and approved prior to initiation.

  1. Deliberate transfer of a drug trait to a microorganism not known to acquire it naturally (if it could compromise the use of the drug to control disease agents in humans, animal or agriculture).
  2. Human gene transfer experiments.
  3. Cloning of DNA encoding molecules lethal to vertebrates at an LD 50 of <100ug/kg body weight.
  4. Cloning using human or animal pathogens as host-vector systems.
  5. Cloning of DNA from all Risk Group 3, 4 or restricted human or animal pathogens (including HIV and related viruse, and human tumor viruses).
  6. Experiments using more than 2/3 of the genome of infectious animal or plant viruses or defective viruses grown in the presence of helper virus.
  7. Recombinant DNA experiments involving whole animlals or plants.
  8. Large scale DNA project (>= 10 liters of culture combined).

Experiments that require registration simultanous with initiation:

  1. Experiments using as vectors <= 2/3 of the genome of a eukaryotic virus, free of helper virus.
  2. Low risk plant rDNA experiments
  3. BL1 transgenic or knockout rodent experiments. (Note: the purchase of transgenic rodents for BL1 experiments is exempt from registration).
  4. All experiments not specified on this sheet.
Exempt experiments that do not require registration:
  1. rDNA containing less than 1/2 of an eukaryotic viral genome propagate in cell culture (with the exception of DNA from Risk Group 3, 4 or restricted agents.
  2. rDNA work involving E.coli K12, S. cerevisiae, and B. subtilis host-vector systems (with the exception of DNA from Risk Group 3, 4 or restricted agents).
All laboratories that work with human pathogenic material (human tissue and blood products) must register with the Biological Safety Committee.