The NIH Guidelines require all rDNA research at NIH sponsored institutions to be reviewed and approved by the IBC. (Note: NIH has classified certain rDNA work as Exempt from the requirements of the Guidelines. However, local regulations do not accept this exemption and do require all rDNA, including that considered Exempt by the NIH, to be registered with and approved by the IBC.) rDNA work (not considered exempt) cannot be administratively approved.
Determination of Administrative Approval or Full Committee Approval
There are two types of IBC approvals that can be obtained. See “Administrative Approval Policy.” Much of the determination is based on the type of biohazardous agent used. Some registrations and amendments do not need to be reviewed by the full Committee. For this research, the Biosafety Officer has the authority to approve. The BSO may contact you directly for required revisions prior to providing the Approval. For other research, full Committee review is required. ALL NON-EXEMPT rDNA MUST BE REVIEWED BY FULL COMMITTEE. For this research, the following submission and review processed is explained further in the following section.
A Biosafety Officer (BSO) will be responsible for pre-reviewing the draft prior to approval or full Committee submission. The Biosafety Officer will work directly with the PI if changes or additional information is needed. It is in the PI’s best interest to work closely with the BSO to obtain a well-drafted version of the form.
If full Committee review is required, the BSO will forward the final version to the IBC Office for inclusion in the Agenda for the next IBC meeting. Please note that adhering to pre-review and submission deadlines is critical to being included on the next meeting agenda. These dates, along with the meeting dates, can be found here.
The registration will be reviewed at the IBC meeting. The Committee’s decision will be communicated in writing to the PI shortly after the meeting.
Requirements to be Met after Approval
If your Approval letter contains stipulations, it is the Principal Investigator’s responsibility to ensure that these requirements are addressed as stated in the letter.
Laboratories must be inspected annually to ensure compliance with all regulatory and institutional policies and procedures. This inspection will be completed by a Biosafety Officer.
All staff listed on an active registration must participate in specified training. Please review the training requirements on the training/personnel page.
Amendments to an approved registration should be submitted via email to the email@example.com and will be sent on to the Biosafety Officer for review. Amendments include changes to a currently approved registration, with the exception of personnel (please see Personnel Additions/Deletions). The Biosafety Officer will determine if the change can be approved as an amendment or if a new Biological Materials Registration Form is necessary instead. The Biosafety Officer will communicate this decision back to the investigator during the preliminary pre-review stage.
GEM Rodent Form Usage
If the PI is not breeding imported genetically engineered animals or if the particular breeding has already been approved by the IBC, it is not necessary to complete the GEM form. The IBC is notified of genetically modified animals in approved IACUC protocols/amendments (information provided is found in Section V. Species Information of IACUC forms).
The PI is importing genetically engineered animals from a noncommercial source AND will be breeding the animals and/or creating a new genetically modified strain of animals by way of breeding. The imported genetically modified strain has not been included on an approved IACUC protocol/amendment form nor has the IBC reviewed this particular breeding.
If you have questions on whether or not this form is required, please contact theIBC Office.