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.
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.
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.
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).
Therefore, the Genetically Modified Rodent (GEM) Form is to be filled out only if the following criteria are met:
If you have questions on whether or not this form is required, please contact the IBC Office.
For further information on IBC review of genetically modified animals, please see IBC’s Policy on Genetically Engineered Animals. For a list of DLAM approved commercial vendors, please contact DLAM (note: restricted website, contact (617) 636-2899.