Research Compliance

Exempt Experiments Requiring Case IBC Review before Letter of Exemption

• Expression of proteins in prokaryotic hosts as long as culture volume is less than 10 liters, the protein is nontoxic and the source DNA is not from a classified pathogen.
• Expression of genes from either prokaryotic or eukaryotic sources when introduced in vertebrate cells in culture as long as the vector contains less than 2/3 of a viral genome, cannot be packaged into a viral particle, and cannot replicate autonomously.
• Expression of genes in yeasts unless the source of DNA is from a classified pathogen.
• Cloning of all other DNA in E. coli K12,S. cervisiae, and B. subtilis host-vector systems (with the exception of DNA from Class 2, 3, or 4 pathogens).
• Introduction into cultured cells of any recombinant DNA (not-virus vector) containing less than half of a eukaryotic viral genome (with the exception of Class 2, 3, or 4 pathogens).
• Purchase or transfer of transgenic rodents except those requiring BL-2 or higher containment.

As found in the NIH Guidelines for Research Involving Recombinant DNA Molecules

*Refer to the Guidelines, Section III-F for a detailed explanation of exempt experiments below:

• III-F-1: Experiments that are not in organisms or viruses.
• III-F-2: Experiments that consist entirely of DNA segments from a single nonchromosomal or viral DNA source.
• III-F-3: Experiments that consist entirely of DNA from prokaryotic host when propagated only in that host or transferred to another host by a well established physiological means.
• III-F-4: Experiments that consist entirely of DNA from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host.
• III-F-5: Experiments that involve DNA segments from different species that exchange DNA by known physiological processes.
• III-F-6: Experiments that do not pose a risk to health or the environment, as determined by the NIH Director, with the advice of RAC and following appropriate notice and opportunity for public comment.

*Refer to the Guidelines, Appendix C for a detailed explanation of exempt experiments below:

• Appendix C-1: Recombinant DNA (not virus-vector) conducted in tissue culture; containing less than half of a eukaryotic viral genome (with the exception of Class 2, 3, or 4 pathogens); under BL-1 conditions.
• Appendix C-II: Escherichia coli K-12 host-vector system conducted at BL-1.
• Appendix C-III: Saccharomyces host-vector system conducted at BL-1.
• Appendix C-IIII:Bacillius subtilis or Bacillus licheniformis host-vector systems conducted at BL-1.
• Appendix C-IV: Purchase or transfer of transgenic rodents, except those requiring BL-2 or higher containment.
• Appendix C-V: DNA experiments involving recombinant DNA molecules derived entirely from extrachromosomal elements of a gram positive organism distributed and maintained in organisms (from this list) which are conducted at BL-1.