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. 

New Protocol Approval

Protocols must be submitted in eProtocol IBC for review and approval by the IBC. Most rDNA and Biosafety protocols are approved for one year. Some low-risk rDNA protocols have up to a three-year approval.

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 (and the AALAS Learning Library training modules) 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 rDNA and/or 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, IACUC or IBC protocol numbers. To make a change, create a protocol AMENDMENT in eProtocol IBC. 

Extend a Protocol

When a protocol is approved for one year, it may be renewed two times before a de novo review is required. To extend the approval period of your protocol by one year, create a protocol CONTINUING REVIEW in eProtocol IBC. 

Complete a Protocol

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.

Requirements for Protocol Approval

Safety Training

The PI and research personnel must complete or maintain required training before IBC 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 IBC 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 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 rDNA and/or 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.

 

IBC Protocol Review Process

Protocols undergo a pre-review that includes an assessment for completeness and confirmation of content before being sent to the committee for review. Once a protocol is complete and pre-review questions have been answered, it is scheduled on a committee agenda.

Complex protocols such as those describing multiple aims, RG-2 vectors, pathogenic agents or novel procedures and technology should be submitted at least four weeks prior to the next committee meeting. Researchers are encouraged to split complex projects, especially those with multiple aims, into additional protocol(s) to facilitate a faster review process.

If funding is pending IBC approval, email ibc@austin.utexas.edu. IBC personnel will help facilitate the protocol submission, review and approval process.

Meeting Dates

At the discretion of the IBC, scheduled meeting dates may change or additional meeting dates may be added to the schedule.

2024 Scheduled IBC Meeting Dates Submission Date
January 30 January 9
No February Meeting
March 5 February 13
April 9 March 19
May 14 April 23
June 11 May 21
July 30 July 9
No August Meeting
September 10 August 20
October 15 September 24
November 12 October 22
December 10 November 19

IBC Fees 

IBC issues fees for protocol review, amendment and closure. These fees should be considered when writing proposals. Fees are assessed in the following situations:

  • Industry sponsored clinical trials submitted for review and approval by the IBC
  • Research requiring IBC approval conducted in UT facilities on behalf of non-UT institutions when there is no award to UT

IBC Action Fee
Initial Convened IBC Review $2,500
Tri-Annual Renewal Review $2,500
Amendment Review $700
Closure $100