Biosafety Committee Approvals Frequently Asked Questions

List of Terms & Abbreviations

IBC         Institutional Biosafety Committee (Senate-Level Committee responsible for Biosafety and GMO Approvals)

FBC        Faculty Biosafety Committee (FHS, Science, and EBE each maintain an FBC)

HREC     Human Research Ethics Committee

AEC        Animal Ethics Committee

PI            Principal Investigator

pHBAs   Potentially Hazardous Biological Agents

GMOs   Genetically Modified Organisms

Important Info

  •  

    Why do I need Biosafety (F/IBC) approval? 

    ü  It is UCT’s institutional policy that all research involving genetically modified organisms (GMOs), recombinant or synthetic nucleic acid molecules and potentially hazardous biological agents (pHBAs) must be approved by the F/IBC.

    ü  The full IBC policy document is available here.

    ü  The IBC Terms of Reference are available here

      

      

  •  

    Can I commence research involving recombinant DNA and potentially hazardous biological agents before getting F/IBC approval?

     

     

    ü  No. All research involving recombinant or synthetic nucleic acid molecules or pHBAs must be approved by the F/IBC before work can be initiated.

     

    ü  Note that F/IBC approval cannot be given retrospectively.

      

     

  •  

    When can I start my research?

     

    ü  Only after your research protocol has received F/IBC approval, in addition to any other required approvals such as HREC, where needed.

Before Submission

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    What forms and supporting documents do I need to complete?

     

    ü  Please refer to the FHS FBC website for all forms and supporting documents http://www.health.uct.ac.za/fhs/research/faculty-biosafety-committee 

  •  

    Can I submit directly to the IBC?

      

    ü  No. All IBC applications must be submitted to the FBC; where required, applications will be escalated to the IBC for final review and approval (see Table 2 in IBC Policy Document for guidance)

  •  

    Do I still need to submit to the FBC if I already have HREC and/or AEC approval?

    • Yes. If your research involves GMOs, or recombinant or synthetic nucleic acid molecules and pHBAs, it will require F/IBC pproval.

     

     

 

The Application Form

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    What signatures are required?

     

    The HOD’s signature must be included on the application form.

Submission Process

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    How do I submit an application to the FBC?  

    PIs are asked to submit applications in electronic format to fhs.fbc@uct.ac.za

  •  

    Can I submit to the FBC for retrospective review?

    No – only prospective review is considered. Therefore, please use a project start date that will accommodate the F/IBC review timeline.

  •  

    Can I submit directly to IBC?

     

    No, please only submit to the FBC via email fhs.fbc@uct.ac.za 

  • When is the deadline for FBC submission?

     

    Please submit at least two weeks prior to an FBC meeting for review at that monthly meeting. The FBC has meeting dates and submission deadlines posted on its webpage http://www.health.uct.ac.za/fhs/research/faculty-biosafety-committee

 

Post Submission

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    How long does it take for FBC to review a protocol?

     

    The FBC aims to review all proposals within 3 weeks of receipt; review comments are returned to the applicant and, following revision/correction, the revised application will be re-circulated among the FBC. Generally, the re-review is faster, and a decision letter will be issued within two weeks of submission of the revised proposal. Depending on the type of project, escalation to the IBC for final review and approval may be required.

      

  •  

    How often do I have to renew my protocol?

     

    The PI is required to submit an Annual Progress Report on active projects to the FBC

      

  • Do I still need approvals from other committees such as HREC, AEC? 

     

    Yes, having FBC approval does not exempt you from other required institutional and national approvals. It is recommended that you submit your FBC application prior to, or concurrent with, your HREC or AEC and/or DAFF Section 20 permit applications if your research protocol involves humans or animals, respectively. Please refer to their respective webpages for the required paperwork.

      

 

Amendments

 

 

 

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