What Must be Registered

Experiments involving the following must be registered with the IBC:

• Recombinant DNA molecules
• Pathogens affecting humans, animals or plants;
• Materials potentially containing human pathogens (for example, unfixed human specimens, human blood)
• Virus vectors
• 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.
• 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.
• 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.

recombinant dna

The NIH requires all labs working with recombinant DNA to register with their local Institutional Biosafety Committee (IBC). The guidelines distinguish among the five kinds of registrations. The type depends on the potential hazard of the work. More hazardous means more approvals are needed.

1.Exempt from approval but requires registration  

(Section III-F and Appendix C): “Exempt” from NIH guidelines means that work with these constructs need not be approved by the IBC. However, Vassar College and the NIH requires that all recombinant work, exempt or non-exempt, be registered. Thus investigators using any rDNA must register with the IBC. The exempt work can be performed at BL1.

2.Notify IBC Before Work Starts

Notification is necessary because all recombinant DNA studies must be registered with Vassar College IBC. These studies involve “Low Hazard” recombinant DNA (Section III-E). You don’t need to wait for IBC approval to begin work.

• Non-pathogenic prokaryotes or non-pathogenic lower eukaryotes (use BL1)
• Recombinant DNA with less than 2/3 of a eukaryotic viral genome (and no helper) used exclusively in tissue culture (BL1 recommended)
• Some host plants carrying rDNA. BL1-P level containment is recommended when the host is: o a non-noxious weed, o a plant or microorganism thought not to damage the ecosystem
• Some other host plants carrying recombinant DNA.
• BL3-P or BL1-P+ level containment is recommended when:
  • the host is a noxious weed,
  • the introduced DNA is the complete genome of an infectious agent known to normally exist in the United States
  • the host is a plant or microorganism that may damage ecosystems,
  • the host is a plant with recombinant DNA from foreign microorganisms that is thought to be safe for the ecosystem.

3.IBC Approval Needed Before Starting

These studies are examined by the IBC to recommend safe procedures and containment. It is often useful to classify the risk associated with a proposed study according to the risk associated with the organism(s) to be used. The NIH classifies biological agents into four Risk Groups according to their human pathogenecity (see NIH Guidelines, Section II-A-1). Those agents not listed in Risk Group (RGs) 2, 3 and 4 are not automatically or implicitly in RG1: a risk assessment must be conducted based on the known and potential properties of the agents and their relationship to agents that are listed.

Risk Group One (RG-1) agents are 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 are: Bacillus subtilus, Escherichia coli K12, Saccharomyces cerevisiae, and others listed here.

RG-2 agents are of moderate potential hazard to healthy adult humans and the environment. Such agents may produce disease of varying degrees of severity from accidental inoculation, injection, or other means of cutaneous penetration but can usually be adequately and safely contained by ordinary laboratory techniques. Some agents may cause disease by contact or respiratory routes, but they are self-limiting and do not cause a serious illness, such as the cause of the common cold, the rhinoviruses. The NIH provides a list of RG-2 agents here.

Risk Group 3 and 4 are associated with serious or lethal disease for which therapeutic or preventive options may be available (3) or lethal disease for which therapeutic or preventive options not usually available (4). Work with RG3 and RG4 agents can not be performed at Vassar.

Appendix B in the NIH Guidelines lists a number of biologic agents according to their Risk Group.

4. requires nih and ibc approval before initiation

NIH approval and IBC Approval Required (from NIH Guidelines Sections III-A and III-B) • Making drug-resistant constructs of microorganisms if they compromise the drug’s therapeutic potential • Making constructs that synthesize vertebrate toxins with an LD50 of 100ng/Kg or less. • Making constructs in E. coli that synthesize vertebrate toxins that are “lethal” between 100ng/Kg and 100µg/Kg

NIH Review and IBC Approval Required (from Section IIIC) Studies in which genes are transferred into humans must be submitted to the NIH OBA for review. If the OBA finds the study to be “novel,” it will place the study on the next RAC meeting agenda. IBC approval must wait for the RAC’s review. If, on the other hand, OBA does not deem the study to be “novel,” IBC can act immediately.

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.