Important Notice for Investigators who use Recombinant Materials in Animal Studies

As part of the review process associated with IACUC Protocols, the Department of Environmental Health and Safety (EH&S) must assure that all studies involving animals are conducted at the appropriate biosafety level.

However, the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules assign the responsibility for designating a biosafety level for studies involving recombinant materials to the University's Institutional Biosafety Committee (formerly called the RDNA Committee). Consequently, in the future investigators must submit a protocol to the Institutional Biosafety Committee describing the use of recombinant materials in their animal study before the associated IACUC protocol can be approved.

The Institutional Biosafety Committee reviews low-risk studies (Biosafety levels 1 and 2) electronically, such that the Committee can confirm a biosafety level within 2-3 weeks of receiving a protocol. However, the  NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules require that higher-risk studies (Biosafety levels 2+ or 3) be discussed and approved at a convened meeting of the Institutional Biosafety Committee.

Consequently, approval of such protocols can take a number of weeks, depending on when the protocol is submitted relative to the date of the monthly meeting of the Institutional Biosafety Committee. Note that one protocol submitted to the Institutional Biosafety Committee can cover several of an investigator's IACUC protocols, provided the use of recombinant materials in each protocol is similar. An investigator also has the option of amending an existing protocol approved by the Institutional Biosafety Committee to describe new uses of recombinant materials in a study.

Investigators who use recombinant materials in animal studies are thus urged to submit a protocol describing this use to the Institutional Biosafety Committee well before the associated IACUC protocol is submitted via the ARO system.   The IACUC cannot grant approval for an animal use protocol until the protocol submitted to the Institutional Biosafety Committee is approved.