Recombinant DNA Categories
Please Classify Your Protocol According to These Guidelines Most rDNA Work Will Fall Under Category III-E
As described in Section III of the NIH Guidelines for Research Involving Recombinant DNA Molecules (please select link for Guidelines),
the Institutional Biosafety Committee functions on behalf of the Institution to oversee and approve rDNA work. Recombinant DNA experiments have been grouped into the following six categories by NIH. The first five (non-exempt) categories are subject to IBC oversight.
NIH Guidelines Section III-A: Experiments that Require Institutional Biosafety Committee Approval, RAC Review, and NIH Director Approval Before Initiation (Loyola rDNA Application Must be Filed and Approved)
The deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture, will be reviewed by RAC.
NIH Guidelines Section III-B: Experiments That Require NIH/OBA and Institutional Biosafety Committee Approval Before Initiation (Loyola rDNA Application Must be Filed and Approved)
Experiments Involving the Cloning of Toxin Molecules with LD50 of Less than 100 Nanograms per Kilogram Body Weight
NIH Guidelines Section III-C: Experiments that Require Institutional Biosafety Committee and Institutional Review Board Approvals and RAC Review Before Research Participant Enrollment (Loyola rDNA Application Must be Filed and Approved)
Experiments Involving the Deliberate Transfer of Recombinant DNA or DNA or RNA Derived from Recombinant DNA into One or More Human Research Participants. Note that RAC approval must be granted before the IBC can approve any such protocol
NIH Guidelines Section III-D: Experiments that Require Institutional Biosafety Committee Approval Before Initiation (Loyola rDNA Application Must be Filed and Approved)
Experiments Using Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents as Host-Vector Systems
Experiments in Which DNA From Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems
Experiments Involving the Use of Infectious DNA or RNA Viruses or Defective DNA or RNA Viruses in the Presence of Helper Virus in Tissue Culture Systems
Experiments Involving Whole Animals
Experiments Involving Whole Plants (involving use of pathogenic plant microorganisms/insects, or recombinant plants with potentially hazardous properties)
Experiments Involving More than 10 Liters of Culture
NIH Guidelines Section III-E: Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation (Loyola rDNA Application Must be Filed and Approved)
Experiments not included in categories A-D or F, are considered in category E. All such experiments may be conducted at BL1 containment. For example, experiments in which all components derived from non-pathogenic prokaryotes and non-pathogenic lower eukaryotes may be conducted at BL1 containment.
Experiments Involving the Formation of Recombinant DNA Molecules Containing No More than Two-Thirds of the Genome of any Eukaryotic Virus
Experiments Involving Whole Plants (involving use of non-pathogenic plant microorganisms, or recombinant plants with non-hazardous properties)
Experiments Involving Transgenic Rodents
NIH Guidelines Section III-F: Exempt Experiments (Loyola rDNA Exempt Status Application Must be Filed and Approved)
Definitions from the NIH Guidelines for use of Exempt rDNA Molecules
In the context of the NIH guidelines, recombinant DNA molecules are defined as either:
- 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
- Molecules that result from the replication of those described in 1.
Exempt Categories of rDNA Experiments (if any apply, Complete this registration):
--NIH Guidelines (Section III-F; Appendix A, Appendix C)
- rDNA containing less than 2/3 of an eukaryotic viral genome propagated in cell culture (with the exception of DNA from Risk Group 3, 4, or restricted agents)
- rDNA work involving E. coli K12, S. cerevisiae, and B. subtilis hot-vector systems (with the exception of DNA from Risk Group 3, 4, or restricted agents). Exempt registrations are reviewed by an expedited process.
- Those that are not in organisms or viruses.
- Those that consist entirely of DNA segments from a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent.
- Those that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well established physiological means.
- Those that consist entirely of DNA from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species).
- Those that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent. A list of such exchangers can be found in Section IV-C-1-b-(1)-(c), Major Actions). For a list of natural exchangers that are exempt from the NIH Guidelines, see Appendices A-I through A-VI, Exemptions Under Section III-F-5--Sub lists of Natural Exchangers.
- Those that do not present a significant risk to health or the environment (see Section IV-C-1-b-(1)-(c), Major Actions), as determined by the NIH Director, with the advice of the RAC, and following appropriate notice and opportunity for public comment. See Appendix C, Exemptions under Section III-F-6 for other classes of experiments which are exempt from the NIH Guidelines.