Will you be…

• Cloning and expressing recombinant or synthetic nucleic acid sequences or proteins including recombinant or synthetic nucleic acid molecules activities exempt from the NIH Guidelines?
• Using, synthesizing, or amplifying recombinant or synthetic nucleic acid molecules that can replicate in a living cell or can base pair with naturally occurring nucleic acid molecules?
• Genetically modify infectious, pathogenic, or opportunistically pathogenic organisms or use, culture, or genetically modify Select Agents?
• Cloning and/or expressing toxins or toxin subunits with LD50 less than 100 mg/kg BW including Select Toxins?
• Using recombinant or synthetic nucleic acid molecules, genetically modified cells, or genetically modified organisms in animals?
• Using, creating, propagating, or releasing into the environment genetically modified microorganisms, cells, plants, or animals including insects?
• Using or creating recombinant or synthetic nucleic acid molecules modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular membranes?
• The culture of any recombinant microorganisms greater than 10 liters?
• Using or modifying agents or toxins that can pose a significant threat to public health and safety, agricultural crops, the environment, or national security as Dual Use Research of Concern (DURC)?

Below are additional documents that will provide you with some guidance:

OSP – Animal Experiments Covered Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
OSP – FAQs for Research on Genetically Modified (Transgenic) Animals