What needs to be registered with the IBC?
What biotoxins require IBC registration?
How should I handle registration of siRNA?
When must approval be obtained?
Where are IBC forms located?
How long are registrations good?
Who does laboratory inspections and when?
Whom can I contact if I have other questions?
All microorganisms, regardless of their risk group (RG) (E. coli and other RG 1 organisms included), all biotoxins, and all recombinant DNA (rDNA) MUST be registered with the IBC.
All biotoxins must be registered with the MUSC IBC. This is done in section 6 of the on-line application. In addition, their use in animals must also be indicated in the MUSC Vertebrate Animal Review Application as part of the IACUC approval process.
The use of siRNA or silencing RNA (and other RNA interference methods) has become an increasingly popular method for the evaluation of consequences of the expression and/or lack of expression of a particular gene and its resulting gene product. The NIH Guidelines makes an exemption for research with certain low-biosafety-risk synthetic nucleic acid molecules. Specifically, synthetic nucleic acids molecules that meet the following criteria will be exempt:
Those synthetic nucleic acids that:
- Can neither replicate nor generate nucleic acids that can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or contain elements known to interact with either DNA or RNA polymerase), and
- Are not designed to integrate into DNA, and
- Do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight.
An example of an exempt molecule would be research with a synthetic short-interfering RNA (siRNA) that targets an HIV viral protein required for transcription activation, even if this siRNA is injected into animals or used in cell culture. Please call the IBC Office if you have any questions.
For Clinical research, however, Section III-C-1 of the amended NIH Guidelines covers human gene transfer experiments. Registration with the IBC is required if research involves the deliberate transfer into human research participants of either:
- Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria:
- Contains more than 100 nucleotides; or
- Possesses biological properties that enable integration into the genome (e.g., cis elements involved in integration); or
- Have the potential to replicate in a cell; or
- Can be translated or transcribed.
The above criteria are designed to capture synthetic nucleic acid agents that share common characteristics with current gene transfer agents that are delivered by vectors.
Please call the IBC Office if you have any questions.
For additional information, see NIH OBA FAQ.
Registration must be completed before ANY work is begun using the agents named above. Sufficient time should be allowed for review of the submission and other additional requested information and any associated laboratory inspections. Registration of Select Agents must be completed before shipping to MUSC.
The IBC application can be accessed from the link "IBC Application", bottom left on the ERMA home page. The IBC investigator home page that you will be taken to has a sample application and Instructions (Registration) to assist you in completing your own application. Select “Add New Form”to begin. Note: Only MUSC faculty members can submit IBC applications. Principal investigators, however, can grant access to one or all of their IBC forms to others.
A link to the Continuing Review form is provided on the home page for each approved IBC application/registration.
Likewise, the amendment process can be initiated from a link on the home page for each approved IBC application/registration.
The IBC home page has a link to the Termination Form.
The initial IBC application is in effect for one year after approval. Towards the end of that year and the year following, the principal investigator will receive an e-mail notification that a Continuing Review form must be submitted to keep the registration in effect. Towards the end of the third year following initial approval, the investigator will be requested to submit a new application.
Laboratory inspections must be conducted by the Biosafety Officer (BSO), Dr. Chris Voelkel-Johnson, prior to initiation of work with IBC registered agents. A satisfactory inspection is necessary before conditionally approved registrations are released. A satisfactory safety protocol covering the use of all registered agents in the inspected space must be signed by all those working with these agents as one requirement of a satisfactory inspection. Re-inspections by the BSO are required every two years. In addition, inspections are required if one or more of the following is changed: laboratory location, investigator, or agent.