Please select only those activities for which approval is needed as this will limit the sections of the application that are required for completion. The activities include:
Recombinant or Synthetic Nucleic Acid Molecules (r/sNA):
- Activities involving any of the following:
- Molecules that are constructed by the joining of nucleic acid molecules and can replicate in a living cell (i.e. recombinant nucleic acids)
- Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e. synthetic nucleic acids)
- Molecules that result from the replication of the examples described above.
- The acquisition and use of pre-made, genetically engineered organisms, cells or agents containing r/sNA molecules (i.e., animals, plants, fungi, cell lines or cells – of any domain of life, and viruses). (see: r/sNA section for further details on the use of agents that typically present a minimal biosafety risk).
- Research involving r/sNA must be conducted in accordance with the NIH Guidelines and the requirements of the IBC.
- Both NIH non-exempt and exempt (Section III-F of the NIH Guidelines) research are subject to UMN IBC review.
- Examples of NIH non-exempt r/sNA research include: transfection of cells with plasmid DNA, use of siRNAs, use of lentivirus, adenovirus, or AAV for the transfer of genetic material.
- Please note that information on recombinant biological agents/vectors does not need to be repeated in the infectious agent section unless these agents/vectors are replication competent.
- Non-exempt r/sNA work will require full review by the committee at the monthly IBC meetings.
- Examples of NIH exempt r/sNA research: Cloning in K-12 E.coli strains and the breeding of transgenic rodents.
- If only NIH exempt work will be involved in the application, the application will be reviewed through an expedited process.
- The use of unfractionated mixtures and purified preparations of biologically-derived toxins having (1) high acute toxicity (i.e. a mammalian LD50 of less than or equivalent to 100 micrograms/kg body weight) or (2) significant potential for serious subacute or chronic toxicity (e.g. carcinogenicity).
- Examples: diphtheria toxin and pertussis toxin.
- Storage of potentially hazardous biological toxins that are not actively used in research or teaching activities does not require IBC oversight but may be subject to UHS requirements.
- Work which involves the use of agents which are infectious (bacteria, fungi, parasites, viruses, viroids, prions).
- Includes agents that are known to cause disease in healthy humans and/or classified by the NIH Guidelines into Risk Groups 2, 3, or 4.
- Includes agents that may negatively impact animals, plants or the environment.
- If a recombinant replication-competent infectious agent will be used, include the agent in the infectious agent section and r/sNA section of the application.
- Research or teaching activities with animal or plant pathogens (and other potentially hazardous biological agents generally not infectious to humans) are described in IBC policy 411. Factors to consider if evaluating these:
- Contain recombinant or synthetic nucleic acid molecules
- USDA regulated agents
- Prevalence in Minnesota
- Risk to the environment
- Activities that involve biological material of unknown makeup that are reasonably expected to contain potentially hazardous infectious agents may require IBC review and approval. Please contact the Office of Biotechnology Activities Oversight (email@example.com or 612-626-2161).
- Do not include non-infectious E. coli used for cloning in this section or replication incompetent vectors for gene transfer (i.e. lentivirus or adenovirus). These will be accounted for in the r/sNA section instead.
- Storage of potentially hazardous biological agents that are not actively used in research or teaching activities do not require IBC oversight.
Human Gene Transfer:
- Human gene transfer (HGT) is the deliberate transfer of the following into human research participants in a clinical trial:
- Recombinant nucleic acid molecules, or DNA/RNA derived from recombinant nucleic acid molecules.
- Synthetic nucleic acid molecules, or DNA/RNA derived from synthetic molecules that meet any of the following criteria:
- Contain more than 100 nucleotides.
- Possess biological properties that enable integration into the genome.
- Have the potential to replicate in a cell.
- Can be translated or transcribed.
- All HGT experiments require approval from the U of MN’s IBC and Institutional Review Board.
Genetic Modification of Animals:
- Please note that the generation of any recombinant animals should be described here - even though the section looks rodent-specific.
- Please answer all questions in light of your recombinant animal of interest (ignoring the application tailoring to “rodents”).
- Select only for the creation of transgenic animals.
- Breeding of transgenics or the creation of new strains by genetic modification will be entered under the “Gen Mod of Rodents” section of the application.
- Select for genetic modifications which can be performed with BSL-1/ABSL-1 containment.
Whole Vertebrate Animals:
- Select if r/sNA, transduced/transfected cells, infectious agents, or toxins will be administered to whole vertebrate animals.
- Do not select this box if only seeking approval for genetic modification of animals.
- Work that involves r/sNA, biological toxins, or infectious agents with insects, arachnids, or other invertebrates.
- Include the species and an approximate number. The number should seem reasonable for the activities proposed.
- Work with r/sNA, biological toxins, or infectious agents in whole plants.
- Include the species of plants used and the approximate number. The number should seem reasonable for the activities proposed.
In Vitro Work (cell culture) and Minimal Risk Assessment Applications:
- Select to indicate any insect, animal, plant, human, or non-human primate cell lines used in your study.
- Only include cell lines that are directly involved with work under IBC purview (r/sNA, biological toxins, infectious agents, or human gene transfer).
- If submitting an application only for the use of recombinant K-12 E. coli or a different minimal risk recombinant organism, please select “Other” and note the recombinant organism/cells.