Biohazards and rDNA

Forms and Instructions


Application Process

Principal investigators (PIs) are required to submit an application to use rDNA, biohazardous agents or unfixed human fluids and tissues prior to the initiation of the research. An application (IBC Form 1A) has been developed for this purpose. If at any time, the research expands or changes beyond the current protocol description an amendment describing the changes must be submitted to the IBC before work is initiated (IBC Form 2a). For example, changes in the type of organism being studied or a change in biosafety level containment will require that an amendment be submitted. Initial protocol application forms and protocol amendment forms are available below.

Send forms by campus mail to:

Institutional Biosafety Committee Secretary
Bob Golden
REM/CIVL

To drop off forms: Visit the IBC Office at PUSH, B21

The IBC recommends that PIs develop an umbrella rDNA application describing their research projects. This umbrella application would ideally encompass most, if not all, of the PI’s current and anticipated research designs in sufficient detail to enable review. However, if the research involves the use of a select agent, a separate protocol must be submitted for review and approval for each select agent proposed for study.

Investigators using or obtaining unfixed human blood, blood products, body fluids, tissue or cell lines in the course of their research are now required to complete the biohazards/rDNA application in addition to a human subjects application to use these materials. This is being done in order to facilitate training and monitor the use of these materials in research. This monitoring process is being phased in by the IBC in cooperation with the Office of Research Administration (ORA) as protocols come in for review or renewal, or at the time when grant accounts are established for new awards or non-competing renewals.

Customarily all IBC applications or amendments will be reviewed within two weeks of receipt. Protocols requesting use of any Class III, IV, and V biohazardous agents, as well as all Select Agents, must be presented for full committee review and approval. If applications are incomplete or further information is needed (e.g. documentation if field-testing is involved), the PI will be contacted by the Chair or the IBC Secretary. PIs are advised to have their protocols reviewed and approved in advance of submitting any proposals. Failure to have a current IBC approval reference number on file will delay the receipt of any grant funding until such approval is obtained.

Integrity

Regulatory

Contact

IBC General Office
PUSH B21