What needs to be registered with the IBC?
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?
What is the role of the Academic Compliance Manager?
Whom can I contact if I have other questions?
What needs to be registered with the IBC?
ALL microorganisms regardless of their risk group (RG) (E. coli and other RG 1 organisms included), biotoxins, and recombinant DNA (rDNA) MUST be registered with the IBC.
How should I handle registration of siRNA?
The use of siRNA or silencing RNA 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. As this is a relatively new technique that was not anticipated by the rDNA guidelines of 2002, the following is meant to help you determine whether or not you need to register prior to conducting experiments employing this material.
- First you should conduct a complete and thorough risk assessment of the consequences associated with introducing a silencing RNA into your experimental system. You should be certain to address in your assessment whether or not any deleterious consequences will manifest themselves should the material be accidentally introduced into an animal or laboratory worker.
- If you are going to produce this material in your laboratory using an expression system, you will need to register this as recombinant DNA (rDNA) since you are involving genes beyond the expression system, unless you are making siRNA for bacteria in bacteria.
- If you are purchasing siRNA from a vendor and will be "transfecting" this into a cell culture system or animal, you will not need to complete infectious agent and rDNA registrations unless you will be using a virus to deliver the siRNA. If you are using a virus to deliver the gene that will make the siRNA, you will need to register the virus and describe the inserted gene and the consequence(s) of silencing its expression. Recall that all work involving viruses, bacteria, fungi and parasites must be registered with the IBC. Consequently, if you are taking the RNA and using a commercially available facilitator of transferring the RNA into the host cell, you need not register.
Please keep in mind that the current understanding of siRNA registration issues is subject to change as new regulations and rulings are made. It is important that every PI routinely check to see if the NIH has changed or adjusted the requirements for siRNA work. When must approval be obtained?
Registration must be obtained 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.
Where are IBC forms located?
The forms page, which also has a listing of IBC meeting dates and deadlines for submissions as well as links to informational resources to assist with completion of the forms, is located at: http://research.musc.edu/ori/ibc/forms.htm. Links to both the Infectious Agents and Recombinant DNA registration forms as well as the Termination Form are on this page.
A links to the IBC Forms page may also be found at: http://research.musc.edu/orsp/forms.htm
How long are registrations good?
Registrations are approved for a period of one year. Principal investigators and the MUSC Office of Risk Management (ORM) receive copies of the approved registrations. Renewal notices are e-mailed to investigators and contacts listed on forms two months prior to expiration.
Who does laboratory inspections and when?
Laboratory inspections must be conducted by the Institutional Biosafety Officer, Dr. Lisa Steed, prior to work being initiated. Satisfactory inspections are necessary before conditionally approved registrations are released. A satisfactory safety protocol signed by all those working with the registered agents is required to achieve a satisfactory inspection. Reinspections are required every two years and reminders are e-mailed two months ahead of expiration. Inspections are required if one or more of the following is changed: laboratory, investigator, or agent. Inspection and reinspection checklists are sent to the ORM.
What is the role of the Academic Compliance Manager?
A departmental compliance manager may be contacted if an investigator’s registration expires, if a required inspection is not conducted in a timely manner, if assistance is needed with initial registration, or if termination forms have not been submitted or are incomplete.
Whom can I contact if I have other questions?
If you have any questions, please contact Cynthia Karr (karrc@musc.edu or 2-3370), Cyndi Egbert (egbert@musc.edu or 2-0021), or Sue Franklin (franklsk@musc.edu or 2-6553).
07/30/07 |
