What Must Be Registered

Experiments involving the following must be registered with the IBC:

• Pathogens affecting humans, animals or plants
• Materials potentially containing human pathogens (for example, unfixed human specimens, human blood)
• Recombinant DNA molecules including virus vectors
  • Use this reference chart to determine which recombinant DNA experiments must be registered with NIH and IBC, and when
• Work that does not qualify under NIH Guidelines Appendix CI-IX
• Human cell lines that are not well-characterized or require Risk Group 2 containment
• Generation of de novo transgenic animals, defined as the addition of foreign DNA or subtraction of a portion of the animal genome using recombinant DNA technology. The breeding of transgenic animals to generate additional transgenic offspring does not require IBC approval. Those transgenic animals that already exist or which have been purchased also do not require IBC approval. 
• All research involving the use of recombinant or synthetic nucleic acid molecules containing no more than two-thirds of the genome of any eukaryotic virus, or biohazards
• Animal Subjects: All research involving the use of recombinant molecules or biohazards in whole animals requires both IBC and IACUC approval
• Human Subjects: Any research involving the introduction of recombinant molecules or biohazards into human subjects must be approved by the IBC and by the IRB.

Human Cells and Tissues

Human and non-human primate cells should be handled using Risk Group 2 (RG-2) practices and containment. All work should be performed in a biosafety cabinet and all material should be decontaminated by autoclaving or disinfection before discarding. Appropriate training in the handling of blood-borne pathogens and up-to-date hepatitis B vaccinations may be required.

Select Agents and Toxins

Select agents are specific pathogens and toxins that have the potential to pose a severe threat to public health and safety as defined by the USA PATRIOT Act and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The institution must be registered with the CDC and/or USDA before these materials are obtained, used or stored.

Risk Group One (RG-1)

Risk Group One (RG-1) agents are usually not placed on a list but include all microorganisms that do not pose a health risk to healthy adult humans. It must not be assumed that an organism not listed as a RG 2, 3, or 4 agent is an RG-1 agent; emerging or unknown organisms should be treated as biohazardous until research proves otherwise. Examples of agents in RG-1 include Bacillus subtilus, infectious canine hepatitis viruses, influenza reference strains A/PR/8/34, A/WS/33, Escherichia coli K12, Saccharomyces cerevisiae and other agents listen in Appendix C-II of the NIH Guidelines for Research Involving Recombinant DNA Molecules and other vectors such as Baculovirus.

In addition to the examples listed above, the following low-risk oncogenic viruses have been identified as RG-1 agents: