IBC Protocol Approval and Maintenance
All research, teaching and testing activities that involve recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins must have IBC approval before work can begin and throughout the life of the activity. Depending on the agents and materials involved and the nature of the research, additional approval from the IRE or SCRO may also be required. All three committees utilize the same base IBC protocol form.
New Protocol Approval
Protocols must be submitted in eProtocol IBC for review and approval by the IBC. Most Biosafety protocols are approved for three years with a requirement for an annual review.
To create a new protocol, log in and click the blue "Create Protocol" button. Enter a protocol title, select the "IBC" check box and "IBC Protocol Form" radio button, and then click the blue "Create" button before the protocol application will be generated, a protocol number assigned, and saved.
Access to eProtocol IBC is restricted to current faculty, staff and students. Email IBC@austin.utexas.edu if unable to access eProtocol. Provide full name, UT EID, principal investigator’s name and a brief description of the problem.
Change a Protocol
Any changes to the work described in a Biosafety protocol need to be submitted for approval prior to implementing the change. Protocol amendments are required with any change in host, vector or modified gene expression, any change in biohazardous materials, agents, or toxins used, and any change in procedures, location of the work, or to update IRB or IACUC protocol numbers. To make a change, create a protocol AMENDMENT in eProtocol IBC.
Continuing Review of a Protocol
At the first and second anniversary of the approved protocol, a CONTINUING REVIEW must be submitted in eProtocol IBC.
Protocol Closure
If all work on a protocol is complete, you must request to retire the protocol by creating and submitting a Protocol Closure Report in eProtocol IBC. See the FAQs for additional information on protocol submission, edits and review.
Additional IRE Forms
All researchers working with pathogens or toxins of a biological origin should complete the Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) Self-Assessment and indicate if they believe that their research falls under Category 1 or Category 2 in the grant application. The Dual Use Research of Concern (DURC) & Pathogens with Enhanced Pandemic Potential (PEPP) Proposal Declaration Form should be attached to your funding proposal in UTRMS-Grants.
Requirements for Protocol Approval
Safety Training
The PI and research personnel must complete or maintain required training before Biosafety protocols will be approved. All courses are available on UT Learn except for OH 102. Direct links to all the courses, including the template for OH 102, are available on the EHS training website.
Required by the PI and all laboratory personnel applying for Biosafety approval:
- OH 101 Hazard Communication (General)
- OH 102 Hazard Communication (Site-Specific) – Taught by the laboratory’s Principal Investigator or Supervisor. The training must be documented using the standardized HazCom Training Record – Labs Site-Specific with a checklist covering training topics that is available from EHS.
- OH 201 Laboratory Safety
- OH 202 Hazardous Waste Management
- OH 207 Biological Safety
- OH 238 Laboratory Safety Refresher – Required three years after OH 201 and every three years thereafter
Required by the PI applying for Biosafety approval:
- DURC/PEPP Principal Investigator Training (coming soon)
- NIH Guidelines Training (coming soon)
Required by some labs applying for IBC approval:
- OH 218 Bloodborne Pathogens – Required annually for all personnel working in labs with human blood or tissues
- OH 601 Dry Ice Shipping – Required every two years for all personnel involved in dry ice shipments
Lab Biosafety Manual and Inspection
A currently approved lab biosafety manual and inspection is required for approval of IBC protocols. The lab biosafety manual must be maintained with current information in Appendices A, B and C.
All research and teaching activities involving rDNA, and biohazardous materials, agents and toxins must have the lab and any related animal housing space inspected by EHS for the biocontainment level (BSL or ABSL) appropriate for the work described in the Biosafety protocols. Annual biosafety inspections are required but may be more often depending on risk or funding agency.
Contact EHS at 512-471-3511 for additional information on the lab biosafety manual or to schedule a biosafety inspection. For more information, refer to the EHS Biosafety website.