Navigating the IBC at IUPUI
The Institutional Biosafety Committee (IBC) has recently updated its form in an effort to streamline the approval process for research on campus. In the past there was an IBC submission form, an exempt IBC submission form, a Biohazard Committee submission form, and a Human/Primate Cell Culture Registration form. There is now one form that incorporates all of the agents from the four forms into the single form. This form will allow the IBC to collect and review the necessary information but will reduce the confusion of what forms to fill out for researchers.
The IBC review process can be a long and sometimes difficult process to navigate. What research needs approval? How does the approval process work? When can research begin? All research involving rDNA, transgenic or knockout animals, and/or biohazardous agents at BL2 or higher (including human cell lines, tissues, and fluids), needs to be submitted for IBC review and approval. If the agents are exempt according to the NIH Guidelines then the study will not have to receive full committee review. Once it is determined that a study is needed, the PI should fill out an IBC protocol submission and submit the form to the Office of Research Administration (ORA) at IBCBHC@iupui.edu.
Be sure that when filling out the submission all necessary information is included to assist the reviewer in understanding the research project, what agents are being utilized, what the potential hazards are, and what will be done to reduce the potential for exposure. Providing all necessary information will help to eliminate delays in the approval process. Also be sure to submit the study to the ORA by the submission deadline. The submission deadline for full committee review is typically two weeks prior to the monthly scheduled IBC meeting. Submitting the study after the monthly deadline will mean that the study cannot be reviewed at that month’s meeting and will have to wait until the next month for review. To access the meeting dates and deadlines, the IBC submission form, and other helpful information visit the ORA IUPUI website.
Once a study has been reviewed, it is typical for a couple of clarifications or revisions to be requested. After a study has been revised it will be signed by the primary reviewer and sent to the Biological Safety Office. If the study is Biosafety Level 2 or higher, then it will need a pre-approval inspection and training checks prior to approval. Studies using biohazardous agents that can contain a bloodborne pathogen or agents that can be transmitted through a bloodborne pathogen route of infection will require current Bloodborne Pathogens Training prior to approval. Training can be taken either in class or through our online training site and updated at any point through the approval process. Being current with training before the lab inspection will help prevent any delays in the approval process. When the lab inspection is complete and training is up to date the study will be signed by the Biological Safety Office and sent back to the ORA for processing. The ORA will send an approval email containing the official approval letter and all of the approval documents. Once this email has been received the research may begin.
Studies considered to be exempt according to the NIH Guidelines will require approval though the Biological Safety Office including inspection and training when necessary. If anyone has questions regarding the necessity for registering their research or filling out the form they are encouraged to contact the ORA at IBCBHC@iupui.edu or the IUPUI Biological Safety Office: Biological Safety Manager, Jim Klenner, at 274-2830 or the Assistant Biological Safety Officer, Amanda Snyder, at 274-2103.