Institutional Biosafety Committee

Animal welfare:

  • Reviews research for compliance with NIH Guidelines for Research with recombinant and synthetic DNA molecules
  • Advises the IACUC on the appropriate procedures for safe conduct of animal use involving recombinant DNA
  • Conducts joint training programs for research personnel using recombinant DNA

Biosafety/Recombinant and Synthetic DNA Molecules:

  • Reviews research involving gene transfer
  • Reviews research involving viruses, bacteria, parasites
  • Reviews research for compliance with the NIH Guidelines for Research with recombinant and synthetic DNA molecules which includes:
    • Assessment of facilities, procedures and practices
    • Assessment of training/expertise of personnel
  • Ensures that investigator has addressed issues in the NIH Guidelines for Research with recombinant and synthetic DNA molecules
  • Facilitates development of and approves a study-specific Human Gene Transfer Research Plan
  • Notifies investigator of results of review/approval
  • Reviews submitted adverse events
  • Refers to IRB, OBA, etc. any concerns regarding conduct of the HGT study and/or adverse events
  • Notifies investigator of results of review
  • Requires that investigators seek review and approval from the IRB for new, continuing and modified applications involving Human Gene Transfer
  • Provide any information requested by the IRB to facilitate review and approval
  • Consults with OBA/RAC for experiments not explicitly covered in the Guidelines
  • Files annual report with OBA with roster and CVs of members
  • Reports problems, violations, accidents/illnesses to the University of Utah and NIH/OBA within 30 days

Conflict of interest: N/A

Data and safety monitoring: N/A

Education and training:

  • Conducts joint training with IACUC for research personnel using recombinant DNA in animal studies

Environmental health and safety:

  • Reviews research for compliance with NIH Guidelines for Research with recombinant and synthetic DNA molecules which includes:
    • Assessment of containment level required
    • Assessment of facilities, procedures and practices
    • Assessment of training/expertise of personnel
  • Notifies investigator of results of review
  • Provides any information requested by IACUC, IRB to facilitate review and approval
  • Refers issues involving animal or human subjects to IACUC or IRB
  • Consults with OBA/RAC for experiments not explicitly covered in the Guidelines
  • Chair reports any problems, violations, accidents/illnesses to the University of Utah and NIH/OBA within 30 days

Financial management of research: N/A

Human gene transfer:

  • Reviews research for compliance with NIH Guidelines for Research with recombinant and synthetic DNA molecules which includes:
    • Assessment of containment level required
    • Assessment of facilities, procedures and practices
    • Assessment of training/expertise of personnel
  • Notifies investigator of results of review
  • Provides any information requested by IRB to facilitate review and approval
  • Refers issues involving human subjects to IRB
  • Consults with OBA/RAC for experiments not explicitly covered in the Guidelines
  • Chair reports problems, violations, accidents/illnesses to University of Utah and NIH/OBA within 30 days

Human subjects:

  • Reviews research for compliance with NIH Guidelines for Research with recombinant and synthetic DNA molecules which includes:
    • Assessment of containment level required
    • Assessment of facilities, procedures and practices
    • Assessment of training/expertise of personnel
  • Notifies investigator of results of review
  • Provides any information requested by IRB to facilitate review and approval
  • Refers issues involving human subjects to IRB
  • Consults with OBA/RAC for experiments not explicitly covered in the Guidelines
  • Provides any information requested by IRB to facilitate review and approval

Human tissue samples: N/A

Patents and inventions: N/A

Radiation safety: N/A

Sponsored projects administration:

  • Provides assurance of review and approval of any protocol using recombinant DNA

Last updated: 09/09/2004