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Institutional Biosafety Committee

 

Application Process

 

Experiments using BL-2 or BL-3 containment must be reviewed and approved prior to the initiation of experiments.

 

Experiments using BL-1 containment must also undergo IBC review however, this review process is expedited and research may commence simultaneously with submission of the IRB application. Experiments using BL-4 are not authorized for conduct at this Institution.

 

The application process is as follows:

  • For the review of a new protocol not using human gene transfer protocols.
    1. Obtain an "IBC Protocol for Research Involving Biohazardous Materials" form (electronically available under the forms section of this web site).
    2. Electronically send the completed pre-application (which includes Section 1 without the signature page and the narrative for Section II) to Dr. Oksana Lockridge, Chair of the IBC at olockrid@unmc.edu.
    3. Applications using BL-1 containment will be reviewed by the IBC Chair and those using BL-2 and BL-3 containment will be reviewed by the full IBC membership.
    4. Following the review process, the principal investigator may be asked to amend the pre-application. (During this review process, all laboratories using BL-2 or BL-3 containment will be requested to have a laboratory inspection by the Biosafety Officer. A "Laboratory Inspection Checklist" is available on the "Form" section of this website.)
    5. The PI will submit the amended application with the signature page to Dr. Lockridge for a final review.
    6. If it has been determined that the protocol successfully complies to the requirements of the NIH Guidelines, a letter approving the protocol authorizing initiation of the experiments will be sent to the PI (experiments using BL-1 containment may commence simultaneously with submission of the protocol to the IBC and do not require receipt of this final authorization to begin).

  • For the review of a new protocol using human gene transfer protocols.
          -The IRB and IBC review may occur simultaneously.
    1. Obtain an "IBC Protocol for Research Involving Biohazardous Materials" form (electronically available under the forms section of this web site).
    2. Electronically send the completed pre-application (which includes Section 1 without the signature page and the narrative for Section II and Section III) to Dr. Oksana Lockridge, Chair of the IBC at olockrid@unmc.edu. (This must include a copy of the documents submitted to the NIH/OBA in fulfillment of the submission requirement for human gene transfer experiments as outlined in Appendix M of the NIH Guidelines, and a copy of the letter from the NIH/OBA to the PI about the results of the Recombinant DNA Advisory Committee's initial review.)
    3. The full IBC membership will convene a meeting to review the application
    4. Following the review process, the principal investigator may be asked to amend the pre-application.
    5. The PI will submit the amended application with the signature page to Dr. Lockridge for a final review. A copy of the letter from the NIH/OBA to the PI stating that the review process has been satisfactorily completed must also be sent with this application if it was not included with the original submission documents.
    6. If it has been determined that the protocol successfully complies to the requirements of the NIH Guidelines, a letter approving the protocol and authorizing initiation of the experiments will be sent to the PI.
    7. It is requested that the PI submit a copy of the IRB approval letter to the IBC chair to complete the application.

  • For re-review of previously approved IBC protocols using BL-1 containment

    IBC protocols are approved for one year intervals after which time a re-review is required. Prior to the expiration date, the principal investigator will be notified that the IBC protocol is up for re-review and instructed to do the following:

    1. Indicate on the notification letter that the project is
      1. inactive and should be terminated
      2. active with no change in protocol, or
      3. active with a change in protocol
    2. This letter is submitted to the Dr. Lockridge.
    3. Individuals listed as investigators and laboratory support on active projects with no change in protocol will be evaluated for their biosafety training status (training is required on an annual basis).
    4. If training is determined to be current, the project will be approved for another year.
    5. Active projects with a change in protocol (which may include the addition or subtraction of personnel) require the submission of those changes along with the notification letter to Dr. Lockridge.
    6. Dr. Lockridge will review the protocol and if in compliance (includes the training of participants is current) will grant approve of the proposal for another year.

  • For re-review of previously approved IBC protocols using BL-2 or BL-3 containment

    IBC protocols are approved for one year intervals after which time a re-review is required. Prior to the expiration date, the principal investigator will be notified that the IBC protocol is up for re-review and instructed to do the following:

    1. Indicate on the notification letter that the project is
      1. inactive and should be terminated
      2. active with no change in protocol, or
      3. active with a change in protocol.
    2. This letter is submitted to the Dr. Lockridge.
    3. Individuals listed as investigators or laboratory support on projects that are active with no change in protocol will be evaluated for their biosafety training status (training required on an annual basis).
    4. A laboratory inspection will be scheduled by the biosafety officer during this review process.
    5. If personnel training are current and the laboratory passes inspection, the project will be approved for another year.
    6. Projects that are active with a change in protocol will require the submission of the changes to Dr. Lockridge.
    7. Dr. Lockridge may request a full review of the IBC membership to evaluate the proposal.
    8. If it is determined that the proposal meets approval (includes that the training is current) and the laboratory passes inspection, the proposal will be approved for another year.