Standards for research and clinical laboratories are outlined by the Centers for Disease Control in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) document, available here. Additionally, refer to the ABSA guidelines available here.
You should amend your current umbrella protocol to include the new research proposal by updating the summary statement and modifying the microorganism and rDNA sections as needed.
Yes, you must register with the IBC. Depending on the genetic material being manipulated, this may require a simple registration or a full review and approval by the IBC. Please submit an IBC application.
There is no required order for submitting IACUC and IBC applications. However, IACUC final approval will not be granted until IBC approval is received. To avoid delays, it is advisable to submit your IBC proposal before or simultaneously with your IACUC proposal.
Yes, annual laboratory inspections are conducted by the Biosafety Officer. Additionally, OUHSC laboratories are subject to inspections by federal, state, and local regulatory agencies, as well as funding and accrediting agencies.
No, all viral vectors are not the same. The class of gene insert can change the biosafety level of the construct.
Request a copy by emailing IBC@ouhsc.edu or ask your Principal Investigator (PI) for a copy. Approval letters are sent to the PI once the protocol has been approved.