TTUHSC Institutional Biohazards Committee (IBC) Instructions for Protocol Registration TO APPLY FOR A NEW IBC PROTOCOL: WHEN: Prior to commencement of any experimentation using highly hazardous materials (see definition below) Prior to HSC reporting to granting agencies regarding approval of protocols utilizing hazardous materials Your application must be submitted no later than two weeks prior to the IBC committee meeting, which will occur on the first Tuesday of each month. If the application is received late, it may not be considered until the following monthly meeting. WHAT: IBC protocol approval is required before purchasing, storing, or using: Highly toxic chemicals or toxins (LD50 (oral/rat) < 50 mg/kg). Any Biosafety Level-2 or above agents. (i.e. microorganisms or viruses associated with human disease) “Select agents” in any amount (infectious agents and toxins listed in 42 CFR Part 73). Any tissues (fixed or unfixed), fluids or cell lines derived from humans or non-human primates (i.e. cell lines, including established, immortalized cell lines like HeLa and Hep-2). Proprietary compounds of unknown toxicity **If you do not have any of the above, then your chemical inventory will serve. Contact Safety Services for more information on chemical inventories. HOW: Fill out a registration application: http://www.ttuhsc.edu/Admin/safety/lab/IBC_Application2008.doc ALSO fill out one copy of Addendum A for each registered biological agent, http://www.ttuhsc.edu/Admin/safety/lab/IBC_AddendumA_2008.doc AND one copy of Addendum B for each registered chemical agent. http://www.ttuhsc.edu/Admin/safety/lab/IBC_ Addendum B_2008.doc Then submit all forms (via email) to Lee Paradise (Lee.Paradise@ttuhsc.edu), Office of Sponsored Programs. After any changes have been made and the protocol has been approved you will be asked to sign a final copy of the application and it will be filed in the Office of Sponsored Programs. Please place a copy of your approved IBC application, with addendums, in the TTUHSC Laboratory Compliance Manual and keep the manual in the laboratory so that it is available to your employees. TO MAKE A CHANGE TO YOUR CURRENT IBC PROTOCOL: WHEN: Any time there is a change to what is currently approved by the IBC WHAT: Add or Delete personnel, chemicals, biologicals, or room numbers. HOW: Fill out the amendment form: http://www.ttuhsc.edu/Admin/safety/lab/IBC_AmendmentForm.doc Return the completed form via email to Lee.Paradise@ttuhsc.edu, ALSO send a signed hard copy to Lee Paradise in Sponsored Programs at Mail STOP 6721. ANNUAL STATUS REPORTS (ASRs): WHEN: On the anniversary of your IBC protocol approval. WHAT: Lee Paradise will send you an Annual Status Report form. It will be printed on purple paper. HOW: Fill out the form Lee sent you, making any changes to personnel, lab rooms, or registered agents*, sign, and send the form back to Lee Paradise in Sponsored Programs at STOP 6271. *If you add any chemicals or biologicals to your protocol via the ASR, then you must also send an Addendum for each agent. Fill out one copy of Addendum A for each registered biological agent, http://www.ttuhsc.edu/Admin/safety/lab/IBC_AddendumA_2008.doc AND/OR one copy of Addendum B for each registered chemical agent. http://www.ttuhsc.edu/Admin/safety/lab/IBC_ Addendum B_2008.doc RENEWAL (every 3rd year): WHEN: On the 3rd anniversary of your IBC protocol approval. . Lee will send you a renewal notice on green colored paper. WHAT: You will be required to renew the entire protocol. HOW: Fill out a registration application: http://www.ttuhsc.edu/Admin/safety/lab/IBC_Application2008.doc ALSO fill out one copy of Addendum A for each registered biological agent, http://www.ttuhsc.edu/Admin/safety/lab/IBC_AddendumA_2008.doc AND one copy of Addendum B for each registered chemical agent. http://www.ttuhsc.edu/Admin/safety/lab/IBC_AddendumB_2008.doc Then submit all forms (via email) to Lee Paradise (Lee.Paradise@ttuhsc.edu), Office of Sponsored Programs. After any changes have been made and the protocol has been approved you will be asked to sign a final copy of the application and it will be filed in the Office of Sponsored Programs. Please place a copy of your approved IBC application, with addendums, in the TTUHSC Laboratory Compliance Manual and keep the manual in the laboratory so that it is available to your employees. REFERENCE MATERIAL: Non-comprehensive listings of biohazards or highly hazardous chemicals/toxins which MUST be registered are available at: Chemicals Requiring IBC Registration Biologicals Requiring IBC Registration A list of CDC select biological agents and toxins: http://www.cdc.gov/od/sap/docs/salist.pdf To determine the Biosafety level of your laboratory, and the containment level needed, the following document provides a general guideline: Summary of Recommended Biosafety Levels Biosafety questions: Lab Safety (806) 743-2597 Safety.Services@ttuhsc.edu. Administrative questions: Lee Paradise Office of Sponsored Programs (806) 743-2960 Lee.Paradise@ttuhsc.edu